CE2004103EN.01002501.xml

Ioannis Patakis spoke on protests by Greek farmers against the common agricultural policy.

The Committee on Budgets had examined the request of the Committee of the Regions of 8 March 2004 concerning a transfer of appropriations (inf 1/2004), in accordance with Article 22 of the Financial Regulation.

It decided to raise the following objection: pursuant to Article 43 of the Financial Regulation, the transfer request should have been submitted under Article 24 of the Financial Regulation.

The Committee of the Regions was requested to refrain from transferring the appropriations in question for the time being.

The Committee on Budgets called on the Committee of the Regions to submit to it a new request for a transfer of appropriations under Article 24 of the Financial Regulation.

4. Political Dialogue and Cooperation Agreement with Central America * — Political Dialogue and Cooperation Agreement with the Andean Community * (debate)

Report on the proposal for a Council decision on the signature of a Political Dialogue and Cooperation Agreement between the European Community and its Member States, of the one part, and the Republics of Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua and Panama [COM(2003) 677 — C5-0658/2003 — 2003/0266(CNS)] — Committee on Foreign Affairs, Human Rights, Common Security and Defence Policy.

Report on the proposal for a Council decision on the conclusion of a Political Dialogue and Cooperation Agreement between the European Community and its Member States, of the one part, and the Andean Community and its member countries, the Republics of Bolivia, Colombia, Ecuador, Peru and the Bolivarian Republic of Venezuela, of the other part [COM(2003) 695 — C5-0657/2003 — 2003/0268(CNS)] — Committee on Foreign Affairs, Human Rights, Common Security and Defence Policy.

The following spoke: Ana Miranda de Lage (draftsman of the opinion of the ITRE Committee), Margrietus J. van den Berg (draftsman of the opinion of the DEVE Committee), Fernando Fernández Martín, on behalf of the PPE-DE Group, Manuel Medina Ortega, on behalf of the PSE Group, Sérgio Ribeiro, on behalf of the GUE/NGL Group, and Richard Howitt

5. Hygiene of foodstuffs ***II — Hygiene rules for food of animal origin ***II — Production and marketing of food of animal origin ***II — Official controls on food of animal origin ***II (debate)

Recommendation for second reading on the common position of the Council with a view to adopting a regulation of the European Parliament and of the Council on the hygiene of foodstuffs [10543/2/2002 — C5-0008/2004 — 2000/0178(COD)] — Committee on the Environment, Public Health and Consumer Policy.

Recommendation for second reading on the common position adopted by the Council with a view to adopting a regulation of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin [5420/2/2003 — C5-0009/2004 — 2000/0179(COD)] — Committee on the Environment, Public Health and Consumer Policy.

Recommendation for second reading on the common position adopted by the Council with a view to adopting a directive of the European Parliament and of the Council repealing certain directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption and amending Council Directives 89/662/EEC and 92/118/EEC and Council Decision 95/408/EC [11584/1/2003 — C5-0010/2004 — 2000/0182(COD)] — Committee on the Environment, Public Health and Consumer Policy.

Recommendation for second reading on the common position adopted by the Council with a view to adopting a regulation of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption [11583/1/2003 — C5-0011/2004 — 2002/0141(COD)] — Committee on the Environment, Public Health and Consumer Policy.

The following spoke: Peter Liese, on behalf of the PPE-DE Group, Dorette Corbey, on behalf of the PSE Group, Marit Paulsen, on behalf of the ELDR Group, Patricia McKenna, on behalf of the Verts/ALE Group, Francesco Fiori, David Robert Bowe, Ria G.H.C. Oomen-Ruijten, Catherine Stihler and Phillip Whitehead

Report on the proposal for a Council regulation on the protection of animals during transport and related operations and amending Directives 64/432/EEC and 93/119/EEC [COM(2003) 425 — C5-0438/2003 — 2003/0171(CNS)] — Committee on Agriculture and Rural Development.

The following spoke: Patricia McKenna (draftsman of the opinion of the ENVI Committee), Neil Parish, on behalf of the PPE-DE Group, Niels Busk, on behalf of the ELDR Group, Salvador Jové Peres, on behalf of the GUE/NGL Group, and Caroline Lucas, on behalf of the Verts/ALE Group

The following spoke: Bent Hindrup Andersen, on behalf of the EDD Group, Dominique F.C. Souchet, Nonattached Member, Francesco Fiori, María Rodríguez Ramos, Elspeth Attwooll, Christel Fiebiger, Alexander de Roo, Gerard Collins, Gordon J. Adam, Daniela Raschhofer, Samuli Pohjamo, Jonas Sjöstedt, Eurig Wyn, Sebastiano (Nello) Musumeci, Agnes Schierhuber, Torben Lund, Chris Davies, Liam Hyland, Jan Marinus Wiersma, Encarnación Redondo Jiménez, Christa Prets, James Nicholson, Cristina Gutiérrez-Cortines, María Esther Herranz García, Giacomo Santini, Marialiese Flemming and David Byrne

Details of voting (amendments, separate and split votes, etc.) appear in Annex I to the Minutes.

Recommendation on a proposal for a Council decision on the position of the European Community on the draft Regulation of the United Nations Economic Commission for Europe concerning the adoption of uniform technical prescriptions applicable to the approval of cornering lamps for power-driven vehicles [COM(2003) 498 — 5925/2004 — C5-0113/2004 — 2003/0188(AVC)] (Simplified procedure — Rule 158(1) of the Rules of Procedure) — Committee on Industry, External Trade, Research and Energy.

Report on the proposal for a Council directive repealing Directive 72/462/EEC [COM(2004) 71 — C5-0110/2004 — 2004/0022(CNS)] — Committee on the Environment, Public Health and Consumer Policy.

Report on the proposal for a regulation of the European Parliament and of the Council on Community statistics concerning balance of payments, international trade in services and foreign direct investment [COM(2003) 507 — C5-0402/2003 — 2003/0200(COD)] — Committee on Industry, External Trade, Research and Energy.

7.4. Rules for Community financial aid in the field of trans-European networks ***II (Rule 110a) (vote)

Recommendation for second reading on the common position of the Council with a view to adopting a regulation of the European Parliament and of the Council amending Council Regulation (EC) No 2236/95 laying down general rules for the granting of Community financial aid in the field of trans-European networks [5633/1/2004 — C5-0095/2004 — 2001/0226(COD) — Committee on Budgets.

Recommendation for second reading on the common position of the Council with a view to adopting a Council regulation creating a European enforcement order for uncontested claims [16041/1/2003 — C5-0067/2004 — 2002/0090(COD)] — Committee on Legal Affairs and the Internal Market.

Recommendation for second reading on the common position of the Council with a view to adopting a European Parliament and Council directive on the limitation of emissions of volatile organic compounds due to the use of organic solvents in decorative paints and varnishes and vehicle refinishing products and amending Directive 1999/13/EC [14780/2/2003 — C5-0019/2004 — 2002/0301(COD)] — Committee on the Environment, Public Health and Consumer Policy.

Recommendation for second reading on the common position of the Council with a view to adopting a European Parliament and Council regulation on the negotiation and implementation of air service agreements between Member States and third countries [13732/1/2003 — C5-0013/2004 — 2003/0044(COD)] — Committee on Regional Policy, Transport and Tourism.

Report on the proposal for a Parliament and Council decision on the mobilisation of the EU Solidarity Fund in accordance with point 3 of the interinstitutional agreement of 7 November 2002 between Parliament, the Council and the Commission on the financing of the European Union Solidarity Fund, supplementing the interinstitutional agreement of 6 May 1999 on budgetary discipline and improvement of the budgetary procedure [COM(2004) 168 — C5-0134/2004 — 2004/2025(ACI)] — Committee on Budgets.

Report on draft amending budget 5/2004 of the European Union for the financial year 2004 — Section III — Commission [7684/2004 — C5-0166/2004 — 2004/2023(BUD)] — Committee on Budgets.

Report on requests to European Agencies [2004/2008(REG)] — Committee on Constitutional Affairs.

7.11. Quarterly non-financial accounts by institutional sector ***I (Rule 110a) (vote)

Report on the proposal for a European Parliament and Council regulation on the compilation of quarterly non-financial accounts by institutional sector [COM(2003) 789 — C5-0645/2003 — 2003/0296(COD)] — Committee on Economic and Monetary Affairs.

Before the vote, the rapporteur made a statement pursuant to Rule 110a(4). She also made a statement on her report A5-0170/2004 (Item 7.20).

Report on the proposal for a Council directive amending Directive 2003/96/EC as regards the possibility for certain Member States to apply, in respect of energy products and electricity, temporary exemptions or reductions in the levels of taxation [COM(2004) 42 — C5-0090/2004 — 2004/0016(CNS)] — Committee on Economic and Monetary Affairs.

Report on the proposal for a Council decision on the conclusion of the Agreement between the European Community and the Swiss Confederation providing for measures equivalent to those laid down in Council Directive 2003/48/EC of 3 June 2003 on taxation of savings income in the form of interest payments and the accompanying Memorandum of Understanding [COM(2004) 75 — C5-0103/2004 — 2004/0027(CNS)] — Committee on Economic and Monetary Affairs.

7.14. Taxation of interest and royalty payments in different Member States * (Rule 110a) (vote)

Report on the proposal for a Council directive amending Directive 2003/49/EC on a common system of taxation applicable to interest and royalty payments made between associated companies of different Member States [COM(2003) 841 — C5-0054/2004 — 2003/0331(CNS)] — Committee on Economic and Monetary Affairs.

Report on the proposal for a Council decision establishing the European Civil Service Tribunal [COM(2003) 705 — C5-0581/2003 — 2003/0280(CNS)] — Committee on Legal Affairs and the Internal Market.

Report on a draft Council decision amending Articles 16 and 17 of the Protocol on the Statute of the Court of Justice [14617/2003 — C5-0579/2003 — 2003/0823(CNS)] — Committee on Legal Affairs and the Internal Market.

7.17. Rules of Procedure of the Court of Justice governing languages * (Rule 110a) (vote)

Report on the draft Council decision amending the Rules of Procedure of the Court of Justice with regard to the rules governing languages (Article 29) [15167/2003 — C5-0585/2003 — 2003/0824(CNS)] — Committee on Legal Affairs and the Internal Market.

7.18. Rules of Procedure of the Court of First Instance governing the language of proceedings * (Rule 110a) (vote)

Report on the draft Council decision amending Article 35 of the Rules of Procedure of the Court of First Instance with regard to the language of proceedings, with a view to the new division of jurisdiction in direct actions and the enlargement of the Union [15738/2003 — C5-0625/2003 — 2003/0825(CNS)] — Committee on Legal Affairs and the Internal Market.

Report on the proposal for a Council directive laying down animal health rules for the importation into the Community of certain live ungulate animals, and amending Directives 90/426/EEC and 92/65/EEC [COM(2003) 570 — C5-0483/2003 — 2003/0224(CNS)] — Committee on the Environment, Public Health and Consumer Policy.

Report on the proposal for a Council regulation concerning the compilation and transmission of data on the quarterly government debt [COM(2003) 761 — C5-0649/2003 — 2003/0295(CNS)] — Committee on Economic and Monetary Affairs.

Report on the request for defence of the parliamentary immunity of Mr Marco Pannella [2003/2116(IMM)] — Committee on Legal Affairs and the Internal Market.

Report on the request for defence of parliamentary immunity and privileges submitted by Martin Schulz [2004/2016(IMM)] — Committee on Legal Affairs and the Internal Market.

The rapporteur moved an oral amendment to paragraph 4. The change applied also to report A5-0185/2004 (Item 7.23).

Report on the request for defence of parliamentary immunity and privileges submitted by Klaus-Heiner Lehne [2004/2015(IMM)] — Committee on Legal Affairs and the Internal Market.

Recommendation for second reading on the common position adopted by the Council with a view to adopting a European Parliament and Council directive on markets in financial instruments, amending Council Directives 85/611/EEC and 93/6/EEC and Directive 2000/12/EC of the European Parliament and of the Council and repealing Council Directive 93/22/EEC [13421/3/2003 — C5-0015/2004 — 2002/0269(COD)] — Committee on Economic and Monetary Affairs.

7.25. Exposure of workers to the risks arising from electromagnetic fields ***II (vote)

Recommendation for second reading on the common position of the Council with a view to adopting a directive of the European Parliament and of the Council on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (18th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) [13599/1/2003 — C5-0016/2004 — 1992/0449C(COD)] — Committee on Employment and Social Affairs.

Recommendation for second reading on the common position of the Council with a view to adopting a decision of the European Parliament and of the Council establishing a Community action programme to promote organisations active at European level in the field of equality between men and women [16185/1/2003 — C5-0068/2004 — 2003/0109(COD)] — Committee on Women's Rights and Equal Opportunities.

Recommendation for second reading on the common position of the Council with a view to adopting a regulation of the European Parliament and of the Council on promoting gender equality in development co-operation [5402/1/2004 — C5-0093/2004 — 2003/0176(COD)] — Committee on Women's Rights and Equal Opportunities.

Recommendation for second reading on the common position adopted by the Council with a view to adopting a regulation of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption [11583/1/2003 — C5-0011/2004 — 2002/0141(COD)] — Committee on the Environment, Public Health and Consumer Policy.

Report on the proposal for a European Parliament and Council directive on the harmonisation of transparency requirements with regard to information about issuers whose securities are admitted to trading on a regulated market and amending Directive 2001/34/EC (Enhanced cooperation between committees — Rule 162a) [COM(2003) 138 — C5-0151/2003 — 2003/0045(COD)] — Committee on Economic and Monetary Affairs.

Report on the proposal for a Council directive implementing the principle of equal treatment between women and men in the access to and supply of goods and services [COM(2003) 657 — C5-0654/2003 — 2003/0265(CNS)] — Committee on Women's Rights and Equal Opportunities.

Robert J.E. Evans asked for the vote to be held over until the following day. More than 32 Members supported the request. Albert Jan Maat, rapporteur, spoke on the request.

Patricia McKenna pointed out that the Verts/ALE Group had asked for a separate vote on amendment 81.

7.35. Fight against fraud and protection of the financial interests of the Communities (2002) (vote)

Report on the protection of the financial interests of the Communities and fight against fraud — Annual Report 2002 [COM(2003) 445 — C5-0593/2003 — 2003/2248(INI)] — Committee on Budgetary Control.

Explanations of vote submitted in writing under Rule 137(3) appear in the verbatim report of proceedings for this sitting.

Arlette Laguiller, Chantal Cauquil and Armonia Bordes were present but did not take part in the vote on report A5-0079/2004.

The vote on the Reimer Böge report (A5-0194/2004), which was scheduled to be taken the following day, was postponed until the April 2004 part-session in order to seek agreement at first reading with the Council.

12. Joint initiative for peace, stability and democracy throughout the Middle East (statements followed by debate)

Council and Commission statements: Joint initiative for peace, stability and democracy throughout the Middle East

Dick Roche (President-in-Office of the Council) and Christopher Patten (Member of the Commission) made the statements.

The President recalled that the Euro-Mediterranean Parliamentary Assembly had been inaugurated a week ago in Athens.

The following spoke: Philippe Morillon, on behalf of the PPE-DE Group, Enrique Barón Crespo, on behalf of the PSE Group, Cecilia Malmström, on behalf of the ELDR Group, Luisa Morgantini, on behalf of the GUE/NGL Group, Per Gahrton, on behalf of the Verts/ALE Group, Franz Turchi, on behalf of the UEN Group, Paul Coûteaux, on behalf of the EDD Group, Gianfranco Dell'Alba, Non-attached Member, Armin Laschet and Pasqualina Napoletano

The following spoke: Luciana Sbarbati, Yasmine Boudjenah, Nelly Maes, Ulla Margrethe Sandbæk, Charles Tannock, Emilio Menéndez del Valle, Jean-Thomas Nordmann, Alima Boumediene-Thiery, Rijk van Dam, Edward H.C. McMillan-Scott, Margrietus J. van den Berg, Willy C.E.H. De Clercq, Mary Elizabeth Banotti, Johannes (Hannes) Swoboda, Ioannis Souladakis, Maj Britt Theorin, Proinsias De Rossa, Jan Dhaene and Dick Roche

Dick Roche (President-in-Office of the Council) and Christopher Patten (Member of the Commission) made the statements.

The following spoke: Johannes (Hannes) Swoboda, on behalf of the PSE Group, Hans Modrow, on behalf of the GUE/NGL Group, Joost Lagendijk, on behalf of the Verts/ALE Group, Cristiana Muscardini, on behalf of the UEN Group, Bruno Gollnisch, Non-attached Member, Jan Marinus Wiersma and Bart Staes.

Report on the proposal for a European Parliament and Council regulation laying down requirements for feed hygiene [COM(2003) 180 — C5-0175/2003 — 2003/0071(COD)] — Committee on the Environment, Public Health and Consumer Policy.

The following spoke: Neil Parish (draftsman of the opinion of the AGRI Committee), Phillip Whitehead, on behalf of the PSE Group, and David Byrne.

15. Materials and articles intended to come into contact with food ***I (debate)

Report on the proposal from the Commission to the European Parliament and the Council on materials and articles intended to come into contact with food [COM(2003) 689 — C5-0549/2003 — 2003/0272(COD)] — Committee on the Environment, Public Health and Consumer Policy.

The following spoke: Dorette Corbey (draftsman of the opinion of the ITRE Committee), Phillip Whitehead, on behalf of the PSE Group, Jonas Sjöstedt, on behalf of the GUE/NGL Group, Didier Rod, on behalf of the Verts/ALE Group, and David Byrne.

Report on the proposal for a European Parliament and Council regulation on certain fluorinated greenhouse gases [COM(2003) 492 — C5-0397/2003 — 2003/0189(COD)] — Committee on the Environment, Public Health and Consumer Policy.

The following spoke: David Robert Bowe (draftsman of the opinion of the ITRE Committee), Eija-Riitta Anneli Korhola, on behalf of the PPE-DE Group, Dorette Corbey, on behalf of the PSE Group, Chris Davies, on behalf of the ELDR Group, Caroline Lucas, on behalf of the Verts/ALE Group, Bernd Lange and Margot Wallström.

Report on a European environment and health strategy [COM(2003) 338 — C5-0551/2003 — 2003/2222(INI)] — Committee on the Environment, Public Health and Consumer Policy.

The following spoke: Antonios Trakatellis, on behalf of the PPE-DE Group, Minerva Melpomeni Malliori, on behalf of the PSE Group, Didier Rod, on behalf of the Verts/ALE Group, Riitta Myller and Catherine Stihler.

18. Conclusion of the Arhus Convention * — Application of the Århus Convention to EC institutions and bodies ***I — Access to justice in environmental matters ***I (debate)

Report on the proposal for a Council decision on the conclusion, on behalf of the European Community, of the Convention on access to information, public participation in decision making and access to justice regarding environmental matters [COM(2003) 625 — C5-0526/2003 — 2003/0249(CNS)] — Committee on the Environment, Public Health and Consumer Policy.

Report on the proposal for a European Parliament and Council regulation on the application of the provisions of the Århus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to EC institutions and bodies [COM(2003) 622 — C5-0505/2003 — 2003/0242(COD)] — Committee on the Environment, Public Health and Consumer Policy.

Report on the proposal for a European Parliament and Council directive on access to justice in environmental matters [COM(2003) 624 — C5-0513/2003 — 2003/0246(COD)] — Committee on the Environment, Public Health and Consumer Policy.

Eija-Riitta Anneli Korhola introduced her reports (A5-0173/2004 and A5-0190/2004).

The following spoke: Hartmut Nassauer (draftsman of the opinion of the LIBE Committee), Claude Moraes (deputising for the draftsman of the opinion of the LIBE Committee), Anne-Marie Schaffner (draftsman of the opinion of the JURI Committee), Françoise Grossetête, on behalf of the PPE-DE Group, María Sornosa Martínez, on behalf of the PSE Group, Astrid Thors, on behalf of the ELDR Group, Jonas Sjöstedt, on behalf of the GUE/NGL Group, Jean-Louis Bernié, on behalf of the EDD Group, Giorgio Lisi, Johannes (Hans) Blokland, Margot Wallström and Astrid Thors (the President cut her off).

Report on the joint text approved by the Conciliation Committee of a directive of the European Parliament and of the Council on environmental liability with regard to the prevention and remedying of environmental damage [PE-CONS 3622/2004 — C5-0079/2004 — 2002/0021(COD) — Parliament's delegation to the Conciliation Committee.

The following spoke: Angelika Niebler, on behalf of the PPE-DE Group, Evelyne Gebhardt, on behalf of the PSE Group, Inger Schörling, on behalf of the Verts/ALE Group, Inglewood, Manuel Medina Ortega, Othmar Karas, Malcolm Harbour, Toine Manders and Margot Wallström.

Report on the proposal for a European Parliament and Council directive on the management of waste from the extractive industries [COM(2003) 319 — C5-0256/2003 — 2003/0107(COD)] — Committee on the Environment, Public Health and Consumer Policy.

The following spoke: Marjo Matikainen-Kallström (draftsman of the opinion of the ITRE Committee), Christa Klaß, on behalf of the PPE-DE Group, Jutta D. Haug, on behalf of the PSE Group, Patricia McKenna, on behalf of the Verts/ALE Group, David Robert Bowe and Margot Wallström.

TEXTS ADOPTED

P5_TA(2004)0189

Cornering lamps for power-driven vehicles ***I

European Parliament legislative resolution on the proposal for a Council decision on the position of the European Community on the draft Regulation of the United Nations Economic Commission for Europe concerning the adoption of uniform technical prescriptions applicable to the approval of cornering lamps for power-driven vehicles (COM(2003) 498 — 5925/2004 — C5-0113/2004 — 2003/0188(AVC))

(Assent procedure)

The European Parliament,

—	having regard to the proposal for a Council decision (COM(2003) 498 — 5925/2004) (1),

—	having regard to the Council Decision 97/836/EC of 27 November 1997 (2),

—	having regard to the request for assent submitted by the Council pursuant to Article 300(3), second subparagraph of the EC Treaty (C5-0113/2004),

—	having regard to Rules 86(1), 97(7) and 158(1) of its Rules of Procedure,

—	having regard to the recommendation of the Committee on Industry, External Trade, Research and Energy (A5-0146/2004),

1.	Gives its assent to proposal for a Council decision;

2.	Instructs its President to forward its position to the Council and Commission.

(1) Not yet published in the OJ.

(2) OJ L 346, 17.12.1997, p. 78.

P5_TA(2004)0190

Repeal of Directive 72/462/EEC *

European Parliament legislative resolution on the proposal for a Council directive repealing Directive 72/462/EEC (COM(2004) 71 — C5-0110/2004 — 2004/0022(CNS))

(Consultation procedure)

The European Parliament,

—	having regard to the Commission proposal to the Council (COM(2004) 71) (1),

—	having regard to Articles 37 and 94 of the EC Treaty, pursuant to which the Council consulted Parliament (C5-0110/2004),

—	having regard to Rule 67 and 158(1) of its Rules of Procedure,

—	having regard to the report of the Committee on the Environment, Public Health and Consumer Policy (A5-0178/2004),

1.	Approves the Commission proposal;

2.	Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament;

3.	Calls for initiation of the conciliation procedure under the Joint Declaration of 4 March 1975 if the Council intends to depart from the text approved by Parliament;

4.	Asks the Council to consult Parliament again if it intends to amend the Commission proposal substantially;

5.	Instructs its President to forward its position to the Council and Commission.

(1) Not yet published in the OJ.

P5_TA(2004)0191

Statistics on international trade ***I

European Parliament legislative resolution on the proposal for a European Parliament and Council regulation on Community statistics concerning balance of payments, international trade in services and foreign direct investment (COM(2003) 507 — C5-0402/2003 — 2003/0200 (COD))

(Codecision procedure: first reading)

The European Parliament,

—	having regard to the Commission proposal to the European Parliament and the Council (COM(2003) 507) (1),

—	having regard to Articles 251(2) and 285(1) of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C5-0402/2003),

—	having regard to Rule 67 of its Rules of Procedure,

—	having regard to the report of the Committee on Industry, External Trade, Research and Energy (A5-0210/2004),

1.	Approves the Commission proposal as amended;

2.	Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal substantially or replace it with another text;

3.	Instructs its President to forward its position to the Council and Commission.

(1) Not yet published in the OJ.

P5_TC1-COD(2003)0200

Position of the European Parliament adopted at first reading on 30 March 2004 with a view to the adoption of Regulation (EC) No .../2004 of the European Parliament and of the Council on Community statistics concerning balance of payments, international trade in services and foreign direct investment

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 285(1) thereof,

Having regard to the proposal from the Commission (1),

Having consulted the European Central Bank in accordance with Article 105(4) of the Treaty (2),

Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),

Whereas:

(1)	Article 99(3) of the Treaty requires the Commission to submit reports to the Council in order to enable the Council to monitor economic developments in each of the Member States and in the Community as well as the consistency of economic policies with certain broad guidelines.

(2)	Under Article 133(2) and (3) of the Treaty, the Commission must submit proposals to the Council for implementing the common commercial policy and the Council must authorise the Commission to open the necessary negotiations.

(3)

The implementation and the review of trade agreements including the General Agreement on Trade in Services (GATS) (4) and of the Trade-Related Intellectual Property Rights' Agreement (TRIPs) (5) as well as the current and future negotiations on further agreements call for the relevant statistical information to be made available.

(4)

Council Regulation (EC) No 2223/96 of 25 June 1996 on the European System of national and regional accounts in the Community (6) (ESA 95) contains the reference framework of common standards, definitions, classifications, and accounting rules for drawing up the accounts of the Member States for the statistical requirements of the European Community, in order to obtain comparable results between Member States.

(5)

The Action Plan on EMU Statistical Requirements presented to the Council in September 2000 and the 3rd, 4th and 5th Progress Reports, also supported by the Council , provide for quarterly European accounts by the institutional sector within 90 days. The timely provision of quarterly balance-of-payments figures is a prerequisite for the compilation of these quarterly European accounts.

(6)

Council Regulation (EC, Euratom) No 58/97 of 20 December 1996 on Structural Business Statistics (7)has established a common framework for the collection, compilation, transmission and evaluation of Community statistics on the structure, activity, competitiveness and performance of businesses in the Community and sets out the variables which should be collected in this area.

(7)

Regulation (EC) No 2560/2001 of the European Parliament and of the Council of 19 December 2001 on cross-border payments in euro (8) had a direct impact on the collection of statistics and an increase in the threshold provided in that Regulation would have a significant impact on the reporting burden of undertakings and on the quality of balance of payments of Member States, especially in the countries that have collection systems based on settlements.

(8)

Collectively, the Balance of Payments Manual of the International Monetary Fund, the Guideline of the European Central Bank of 2 May 2003 on the statistical reporting requirements of the European Central Bank in the field of balance of payments statistics and international investment position statistics, and the international reserves template (9), the Manual on statistics of international trade in services of the United Nations, and the OECD Benchmark Definition of Foreign Direct Investment, define the general rules for compiling statistics on balance of payments, international trade in services, and foreign direct investment.

(9)

In the field of balance of payments statistics, the European Central Bank and the Commission coordinate work on compilation issues as appropriate. This Regulation defines in particular the statistical information that the Commission needs from the Member States in order to produce Community statistics on balance of payments, international trade in services and foreign direct investment; for the purposes of producing and disseminating these Community statistics, the Commission and the Member States consult with each other on matters concerning the quality of the data supplied and its dissemination.

(10)

According to Article 3(2) of Council Regulation (Euratom, EEC) No 1588/90 of 11 June 1990 on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities (10), national rules on statistical confidentiality may not be invoked to prevent the transmission of confidential statistical data to the Community authority (Eurostat) where an act of Community law provides for the transmission of such data.

(11)	Article 8 of Council Regulation (EC) No 2533/98 of 23 November 1998 concerning the collection of statistical information by the European Central Bank (11) has laid down a confidentiality regime that applies to confidential statistical information transmitted to the European Central Bank.

(12)	The production of specific Community statistics is governed by the rules set out in Council Regulation (EC) No 322/97 of 17 February 1997 (12) .

(13)

Since the objective of the action to be taken, namely the creation of common statistical quality standards for the production of comparable statistics on balance of payments, international trade in services and foreign direct investment, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale or effects of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(14)	There is a clear need to produce Community level statistics on balance of payments, international trade in services and foreign direct investment which adhere to common statistical quality standards.

(15)

In order to guarantee the fulfilment of the obligations laid down in this Regulation, the national institutions responsible for the collection of the data within the Member States may need access to administrative data sources such as enterprise registers held by other public institutions and other data bases containing information on cross-border transactions and positions, wherever such data are necessary for the production of Community statistics.

(16)	The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (13),

HAVE ADOPTED THIS REGULATION:

Article 1

Subject matter

This Regulation establishes a common framework for the systematic production of Community statistics on balance of payments, international trade in services and foreign direct investment.

Article 2

Submission of data

1. Member States shall submit to the Commission (Eurostat) data on balance of payments, international trade in services and foreign direct investment as referred to in Annex I. The data shall be as defined in Annex II.

2. Member States shall submit the data to the Commission in accordance with the deadlines shown in Annex I.

Article 3

Data sources

1. Member States shall collect the information required under this Regulation using all the sources they consider relevant and appropriate. These may include administrative data sources such as business registers .

2. Natural and legal persons required to supply information shall, when responding, comply with the time limits and definitions set by the national institutions responsible for the collection of data within the Member States in accordance with this Regulation.

3. Where the required data cannot be collected at a reasonable cost, best estimates may be transmitted (zero values included) .

Article 4

Quality criteria and reports

1. Member States shall take all reasonable measures they consider necessary to ensure the quality of the data transmitted according to common quality standards.

2. Member States shall supply the Commission with a report on the quality of the data transmitted (hereinafter referred to as ‘quality reports’).

3. The common quality standards, as well as the content and periodicity of the quality reports, shall be specified in accordance with the procedure referred to in Article 11(2) taking into account the implications as regards the cost of collecting and compiling the data and important changes concerning data collection .

The quality of the data transmitted shall be assessed, on the basis of the quality reports, by the Commission with the assistance of the Balance of Payments Committee. This assessment by the Commission shall be sent to the European Parliament for information.

4. Member States shall inform the Commission of major methodological or other changes that would influence the data transmitted, not later than three months after any such change enters into force. The Commission shall notify the European Parliament and the other Member States of any such communication.

Article 5

Data Flows

The statistics to be produced shall be grouped for transmission to the Commission according to the following data flows:

(a)	balance of payments euro indicators;

(b)	balance of payments quarterly statistics;

(c)	international trade in services;

(d)	foreign direct investments (‘FDI’) flows;

(e)	FDI positions.

The data flows shall be as further specified in Annex I.

Article 6

Time reference and periodicity

Member States shall compile the data flows according to the relevant first reference period and periodicity as specified in Annex I.

Article 7

Transmission of data

Member States shall transmit to the Commission the data required by this Regulation following a format and a procedure defined by the Commission, in accordance with the procedure referred to in Article 11(2).

Article 8

Transmission and exchange of confidential data

1. Notwithstanding the rules laid down in Article 5(4) of Regulation (Euratom, EEC) No 1588/90, the transmission of confidential data between Eurostat and the European Central Bank may take place to the extent this transmission is necessary to ensure coherence between the balance of payments figures of the European Union and those of the economic territory of the Member States which have adopted the single currency in accordance with the Treaty.

The first subparagraph shall apply on condition that the European Central Bank takes due account of the principles defined in Article 10 of Regulation (EC) No 322/97 and under the provisions laid down in Article 14 of that Regulation .

2. The exchange of confidential data, as defined by Article 13 of Regulation (EC) No 322/97, shall be allowed between Member States where the exchange is necessary to ensure the quality of the balance of payments figures of the European Union.

Member States receiving confidential data from other Member States shall treat that information confidentially.

Article 9

Dissemination

The Commission shall disseminate the Community statistics produced pursuant to this Regulation, with a periodicity similar to that specified in Annex I.

Article 10

Adaptation to economic and technical progress

The measures necessary to take account of economic and technical changes shall be laid down in accordance with the procedure referred to in Article 11(2).

Such measures shall concern:

(a)	the updating of the definitions (Annex II);

(b)	the updating of data requirements, including submission deadlines as well as revisions, extensions and eliminations of the data flows (Annex I).

Article 11

Committee

1. The Commission shall be assisted by a Committee, to be referred to as ‘the Balance of Payments Committee.’

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period referred to in Article 5(6) of Decision 1999/468/EC shall be three months.

3. The Committee shall adopt its rules of procedure.

4. The European Central Bank may attend the meetings of the Committee as an observer.

Article 12

Report on implementation

Within five years of the entry into force of this Regulation, the Commission shall submit a report to the European Parliament and the Council on its implementation.

In particular, the report shall:

(a)	record the quality of the statistics produced;

(b)	assess the benefits accruing to the Community, the Member States and the providers and users of statistical information of the statistics produced in relation to the their costs;

(c)	identify areas for potential improvement and amendments considered necessary in the light of the results obtained ;

(d)	review the operation of the Balance of Payments Committee and recommend whether the scope of implementing measures should be redefined.

Article 13

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Done at ..., on ...

For the European Parliament

The President

For the Council

The President

(1) OJ C [...], [...], p. [...].

(2) OJ C [...], [...], p. [...].

(3) Position of the European Parliament of 30 March 2004.

(4) OJ L 336, 23.12.1994, p. 191.

(5) OJ L 336, 23.12.1994, p. 214.

(6) OJ L 310, 30.11.1996, p.1. Regulation as last amended by Regulation (EC) No 1267/2003 of the European Parliament and of the Council (OJ L 180, 18.7.2003, p. 1).

(7) OJ L 14, 17.1.1997, p. 1. Regulation as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

(8) OJ L 344, 28.12.2001, p. 13.

(9) OJ L 131, 28.5.2003, p. 20.

(10) OJ L 151, 15.6.1990, p. 1. Regulation as last amended by Regulation (EC) No 1882/2003.

(11) OJ L 318, 27.11.1998, p. 8.

(12) OJ L 52, 22.2.1997, p. 1. Regulation as amended by Regulation (EC) No 1882/2003.

(13) OJ L 184, 17.7.1999, p. 23.

ANNEX I

DATA FLOWS

1. Balance of Payments Euro Indicators

BOP_EUR Euro Indicators	Deadline: T + 2 months Periodicity: Quarter
	Credit	Debit	Net
Current Account	Extra-EU	Extra-EU	Extra-EU
Services	Extra-EU	Extra-EU	Extra-EU

2. Balance of Payments Quarterly Statistics

BOP_Q Quarterly Data		Deadline: T + 3 months Periodicity: Quarter
		Credit	Debit	Net
I.	Current Account	Level 1	Level 1	Level 1
	Goods	Level 1	Level 1	Level 1
	Services	Level 1	Level 1	Level 1
	Transport	Level 1	Level 1	Level 1
	Travel	Level 1	Level 1	Level 1
	Communications services	Level 1	Level 1	Level 1
	Construction services	Level 1	Level 1	Level 1
	Insurance services	Level 1	Level 1	Level 1
	Financial services	Level 1	Level 1	Level 1
	Computer and information services	Level 1	Level 1	Level 1
	Royalties and licence fees	Level 1	Level 1	Level 1
	Other business services	Level 1	Level 1	Level 1
	Personal, cultural and recreational services	Level 1	Level 1	Level 1
	Government services, n.i.e.	Level 1	Level 1	Level 1
	Income	Level 1	Level 1	Level 1
	Compensation of employees	Level 1	Level 1	Level 1
	Investment Income
	— Direct Investment	Level 1	Level 1	Level 1
	— Portfolio Investment	Extra-EU		World
	— Other investment	Extra-EU	Extra-EU	Extra-EU
	Current transfers	Level 1	Level 1	Level 1
	General Government	Extra-EU	Extra-EU	Extra-EU
	Other sectors	Extra-EU	Extra-EU	Extra-EU
II.	Capital account	Extra-EU	Extra-EU	Extra-EU
		Net assets	Net liabilities	Net
III.	Financial Account
	Direct Investment			Level 1
	Abroad			Level 1
	— Equity			Level 1
	— Reinvested earnings			Level 1
	— Other capital			Level 1
	In the reporting economy			Level 1
	— Equity			Level 1
	— Reinvested earnings			Level 1
	— Other capital			Level 1
	Portfolio Investment	Extra-EU	World
	Financial derivatives			World
	Other Investment	Extra-EU	Extra-EU	Extra-EU

3. International Trade in Services

BOP_ITS

International Trade in Services

Deadline: T + 9 months

Periodicity: Annual

Credit

Debit

Net

Total Services

Level 3

Transportation

Level 2

Sea transport

Level 2

— Passenger

Level 2

— Freight

Level 2

— Other

Level 2

Air transport

Level 2

— Passenger

Level 2

— Freight

Level 2

— Other

Level 2

Other transport

Level 2

— Passenger

Level 2

— Freight

Level 2

— Other

Level 2

Extended classification of other transport

Level 2

Space transport

Level 2

Rail transport

Level 2

— Passenger

Level 2

— Freight

Level 2

— Other

Level 2

Road transport

Level 2

— Passenger

Level 2

— Freight

Level 2

— Other

Level 2

Inland waterway transport

Level 2

— Passenger

Level 2

— Freight

Level 2

— Other

Level 2

Pipeline transport and electricity transmission

Level 2

Other supporting and auxiliary transport services

Level 2

Travel

Level 2

Business travel

Level 2

— Expenditure by seasonal and border workers

Level 2

— Other

Level 2

Personal travel

Level 2

— Health-related expenditure

Level 2

— Education-related expenditure

Level 2

— Other

Level 2

Communications services

Level 2

Postal and courier services

Level 2

Telecommunications services

Level 2

Construction services

Level 2

Construction abroad

Level 2

Construction in the compiling economy

Level 2

Insurance services

Level 2

Life insurance and pension funding

Level 2

Freight insurance

Level 2

Other direct insurance

Level 2

Reinsurance

Level 2

Auxiliary services

Level 2

Financial services

Level 2

Computer and information services

Level 2

Computer services

Level 2

Information services

Level 2

— News agency services

Level 2

— Other information provision services

Level 2

Royalties and license fees

Level 2

Franchises and similar rights

Level 2

Other royalties and license fees

Level 2

Other business services

Level 2

Merchanting and other trade-related services

Level 2

— Merchanting

Level 2

— Other trade-related services

Level 2

— Operational leasing services

Level 2

Miscellaneous business, professional, and technical services

Level 2

—	Legal, accounting, management consulting, and public relations

Level 2

— Legal services

Level 2

—	Accounting, auditing, bookkeeping, and tax consulting services

Level 2

—	Business and manag. consulting and public relations services

Level 2

— Advertising, market research, and public opinion polling

Level 2

— Research and development

Level 2

— Architectural, engineering, and other technical services

Level 2

— Agricultural, mining, and on-site processing services

Level 2

— Waste treatment and depollution

Level 2

— Agricultural, mining, and other on-site processing services

Level 2

— Other business services

Level 2

— Services between related enterprises, n.i.e.

Level 2

Personal, cultural, and recreational services

Level 2

Audiovisual and related services

Level 2

Other personal, cultural, and recreational services

Level 2

— Education services

Level 2

— Health services

Level 2

— Other

Level 2

Government services, n.i.e.

Level 2

Embassies and consulates

Level 2

Military units and agencies

Level 2

Other government services

Level 2

Memorandum items

Audiovisual transactions

Level 1

Postal services

Level 1

Courier services

Level 1

4. Questionnaires for foreign Direct Investments (FDI) Flows

BOP_FDI Direct Investment Flows (1)		Deadline: T + 9 months Periodicity: Year
A	Geographical breakdown Item	Data type	Geographical breakdown	Activity breakdown
	Direct investment abroad
510	Equity capital	Net	Level 2	Not required
525	Reinvested earnings	Net	Level 2	Not required
530	Other capital	Net	Level 2	Not required
505	Direct investment abroad: Total	Net	Level 3	Not required
	Direct investment in reporting economy
560	Equity capital	Net	Level 2	Not required
575	Reinvested earnings	Net	Level 2	Not required
580	Other capital	Net	Level 2	Not required
555	Direct investment in reporting economy: Total	Net	Level 3	Not required
	Direct investment income
332	Dividends	Credit, debit, net	Level 2	Not required
333	Reinvested earn. and undistrib. branch profits	Credit, debit, net	Level 2	Not required
334	Income on debt	Credit, debit, net	Level 2	Not required
330	Direct investment income: Total	Credit, debit, net	Level 3	Not required

BOP_FDI Direct Investment Flows		Deadline: T + 21 months Periodicity: Year
A	Geographical breakdown Item	Data type	Geographical breakdown	Activity breakdown
	Direct investment abroad
510	Equity capital	Net	Level 2	Not required
525	Reinvested earnings	Net	Level 2	Not required
530	Other capital	Net	Level 2	Not required
505	Direct investment abroad: Total	Net	Level 3	Not required
	Direct investment in reporting economy
560	Equity capital	Net	Level 2	Not required
575	Reinvested earnings	Net	Level 2	Not required
580	Other capital	Net	Level 2	Not required
555	Direct investment in reporting economy: Total	Net	Level 3	Not required
	Direct investment income
332	Dividends	Credit, debit, net	Level 2	Not required
333	Reinvested earn. And undistrib. Branch profits	Credit, debit, net	Level 2	Not required
334	Income on debt	Credit, debit, net	Level 2	Not required
330	Direct investment income: Total	Credit, debit, net	Level 3	Not required
B	Activity breakdown Item	Data type	Geographical breakdown	Activity breakdown
505	Direct investment abroad: Total	Net	Net	Level 1
		Level 2	Level 2	Level 1
555	Direct investment in reporting economy: Total	Net	Net	Level 1
		Level 2	Level 2	Level 1
330	Direct investment income: Total	Credit, debit, net	Credit, debit, net	Level 1
		Level 2	Level 2	Level 1

5. Questionnaires for foreign Direct Investments (FDI) Positions

BOP_POS Direct Investment Positions (2)		Deadline: T + 9 months Periodicity: Year
A	Geographical breakdown Item	Data type	Geographical breakdown	Activity breakdown
	Direct investment assets
506	Equity capital and reinvested earnings	Net Positions	Level 1	Not required
530	Other capital	Net Positions	Level 1	Not required
505	Direct investment abroad: Total assets, net	Net Positions	Level 2	Not required
	Direct investment liabilities
556	Equity capital and reinvested earnings	Net Positions	Level 1	Not required
580	Other capital	Net Positions	Level 1	Not required
555	Direct invest. in report. Econ.: Total liabilities, net	Net Positions	Level 2	Not required

BOP_POS Direct Investment Positions		Deadline: T + 21 months Periodicity: Year
A	Geographical breakdown Item	Data type	Geographical breakdown	Activity breakdown
	Direct investment assets
506	Equity capital and reinvested earnings	Net Positions	Level 2	Not required
530	Other capital	Net Positions	Level 2	Not required
505	Direct investment abroad: Total assets, net	Net Positions	Level 3	Not required
	Direct investment liabilities
556	Equity capital and reinvested earnings	Net Positions	Level 2	Not required
580	Other capital	Net Positions	Level 2	Not required
555	Direct invest. in report. Econ.: Total liabilities, net	Net Positions	Level 3	Not required
B	Activity breakdown Item	Data type	Geographical breakdown	Activity breakdown
505	Direct investment abroad: Total assets, net	Net positions	Level 1	Level 2
			Level 2	Level 1
555	Direct invest. in report. Econ.: Total liabilities, net	Net positions	Level 1	Level 2
			Level 2	Level 1

6. Geographical breakdown Levels

	Level 1		Level 2
A1	World (all entities)	A1	World (all entities)
D2	EU-15 (Intra-EU-15)	D2	EU-15 (Intra-EU-15)
U4	Extra-euro-zone	U4	Extra-euro-zone
4A	European Union Institutions	4A	European Union Institutions
D4	Extra-EU-15	D4	Extra-EU15
		IS	Iceland
		LI	Liechtenstein
		NO	Norway
CH	Switzerland	CH	Switzerland
		BG	Bulgaria
		HR	Croatia
		RO	Romania
		RU	Russian Federation
		TR	Turkey
		EG	Egypt
		MA	Morocco
		NG	Nigeria
		ZA	South Africa
CA	Canada	CA	Canada
US	United States of America	US	United States
		MX	Mexico
		AR	Argentina
		BR	Brazil
		CL	Chile
		UY	Uruguay
		VE	Venezuela
		IL	Israel
		CN	China
		HK	Hong Kong
		IN	India
		ID	Indonesia
JP	Japan	JP	Japan
		KR	South Korea
		MY	Malaysia
		PH	Philippines
		SG	Singapore
		TW	Taiwan
		TH	Thailand
		AU	Australia
		NZ	New Zealand
Z8	Extra EU-15 non allocated	Z8	Extra EU-15 non allocated
C4	Offshore Financial Centres (3)	C4	Offshore Financial Centres (3)

Level 3
7Z	International Organisations excluding European Union Institutions	EG	Egypt	LK	Sri Lanka	SG	Singapore
AD	Andorra	ER	Eritrea	LR	Liberia	SH	St Helena
AE	United Arab Emirates	ES	Spain	LS	Lesotho	SI	Slovenia
AF	Afghanistan	ET	Ethiopia	LT	Lithuania	SK	Slovakia
AG	Antigua and Barbuda	FI	Finland	LU	Luxembourg	SL	Sierra Leone
AI	Anguilla	FJ	Fiji	LV	Latvia	SM	San Marino
AL	Albania	FK	Falkland Islands (Malvinas)	LY	Lybian Arab Jamahiriya	SN	Senegal
AM	Armenia	FM	Micronesia, Federated States of	MA	Morocco	SO	Somalia
AN	Netherlands Antilles	FO	Faroe Islands	MD	Moldova, Republic of	SR	Suriname
AO	Angola	FR	France	MG	Madagascar	ST	Sao Tome and Principe
AQ	Antarctica	GA	Gabon	MH	Marshall Islands	SV	El Salvador
AR	Argentina	GB	United Kingdom	MK (4)	Macedonia, the Former Yugoslav Republic of	SY	Syrian Arab Republic
AS	American Samoa	GD	Grenada	ML	Mali	SZ	Swaziland
AT	Austria	GE	Georgia	MM	Myanmar	TC	Turks and Caicos Islands
AU	Australia	GG	Guernsey (No official ISO 3166-1 country code, exceptionnally reserved code elements)	MN	Mongolia	TD	Chad
AW	Aruba	GH	Ghana	MO	Macau	TG	Togo
AZ	Azerbaijan	GI	Gilbraltar	MP	Northern Mariana Islands	TH	Thailand
BA	Bosnia and Herzegovina	GL	Greenland	MQ	Martinique	TJ	Tajikistan
BB	Barbados	GM	Gambia	MR	Mauritania	TK	Tokelau
BD	Bangladesh	GN	Guinea	MS	Montserrat	TM	Turkmenistan
BE	Belgium	GQ	Equatorial Guinea	MT	Malta	TN	Tunisia
BF	Burkina Faso	GR	Greece	MU	Mauritius	TO	Tonga
BG	Bulgaria	GS	South Georgia and the South Sandwich Islands	MV	Maldives	TP	East Timor
BH	Bahrain	GT	Guatemala	MW	Malawi	TR	Turkey
BI	Burundi	GU	Guam	MX	Mexico	TT	Trinidad and Tobago
BJ	Benin	GW	Guinea-Bissau	MY	Malaysia	TV	Tuvalu
BM	Bermuda	GY	Guyana	MZ	Mozambique	TW	Taiwan, Province of China
BN	Brunei Darussalam	HK	Hong Kong	NA	Namibia	TZ	Tanzania, United Republic of
BO	Bolivia	HM	Heard Island and McDonald Islands	NC	New Caledonia	UA	Ukraine
BR	Brazil	HN	Honduras	NE	Niger	UG	Uganda
BS	Bahamas	HR	Croatia	NF	Norfolk Island	UM	United States Minor Outlying Islands
BT	Bhutan	HT	Haiti	NG	Nigeria	US	United States
BV	Bouvet Island	HU	Hungary	NI	Nicaragua	UY	Uruguay
BW	Botswana	ID	Indonesia	NL	Netherlands	UZ	Uzbekistan
BY	Belarus	IE	Ireland	NO	Norway	VA	Holy See (Vatican City State)
BZ	Belize	IL	Israel	NP	Nepal	VC	St Vincent and the Grenadines
CA	Canada	IM	Isle of Man (No official ISO 3166-1 country code, exceptionally reserved code elements)	NR	Nauru	VE	Venezuela
CC	Cocos (Keeling) Islands	IN	India	NU	Niue	VG	Virgin Islands, British
CD	Congo, the Democratic Republic of the	IO	British Indian Ocean Territory	NZ	New Zealand	VI	Virgin Islands, US
CF	Central African Republic	IQ	Iraq	OM	Oman	VN	Viet Nam
CG	Congo	IR	Iran, Islamic Republic of	PA	Panama	VU	Vanuatu
CH	Switzerland	IS	Iceland	PE	Peru	WF	Wallis and Futuna
CI	Côte d'Ivoire	IT	Italy	PF	French Polynesia	WS	Samoa
CK	Cook Islands	JE	Jersey (No official ISO 3166-1 country code, exceptionnally reserved code elements)	PG	Papua New Guinea	YE	Yemen
CL	Chile	JM	Jamaica	PH	Philippines	YT	Mayotte
CM	Cameroon	JO	Jordan	PK	Pakistan	YU	Yugoslavia
CN	China	JP	Japan	PL	Poland	ZA	South Africa
CO	Colombia	KE	Kenya	PN	Pitcairn	ZM	Zambia
CR	Costa Rica	KG	Kyrgyzstan	PR	Puerto Rico	ZW	Zimbabwe
CU	Cuba	KH	Cambodia (Kampuchea)	PS	Palestinian Territory, Occupied
CV	Cape Verde	KI	Kiribati	PT	Portugal
CX	Christmas Island	KM	Comoros	PW	Palau
CY	Cyprus	KN	St Kitts and Nevis	PY	Paraguay
CZ	Czech Republic	KP	Korea, Democratic People's Republic of (North Korea)	QA	Qatar
DE	Germany	KR	Korea, Republic of (South Korea)	RO	Romania
DJ	Djibouti	KW	Kuwait	RU	Russian Federation
DK	Denmark	KY	Cayman Islands	RW	Rwanda
DM	Dominica	KZ	Kazakstan	SA	Saudi Arabia
DO	Dominican Republic	LA	Lao People's Democratic Republic	SB	Solomon Islands
DZ	Algeria	LB	Lebanon	SC	Seychelles
EC	Ecuador	LC	Saint Lucia	SD	Sudan
EE	Estonia	LI	Liechtenstein	SE	Sweden

7. Activity breakdown Levels

Level 1	Level 2
	ICFA	NACE rev. 1
	AGRICULTURE AND FISHING	Section A, B
MINING AND QUARRYING	MINING AND QUARRYING	Section C
	Of which:
	Extraction of petroleum and gas	Division 11
MANUFACTURING	MANUFACTURING	Section D
	Food products	Subsection DA
	Textiles and wearing apparel	Subsection DB
	Wood, publishing and printing	Subsections DD & DE
	TOTAL textiles + wood activities
	Refined petroleum prod. and other treatments	Division 23
	Manufacture of chemicals & chemical products	Division 24
	Rubber and plastic products	Division 25
Petroleum, chemical, rubber, plastic products	TOTAL petroleum, chemic., rubber, plastic products
	Metal products	Subsection DJ
	Mechanical products	Division 29
	TOTAL metal and mechanical products
	Office machinery and computers	Division 30
	Radio, TV, communication equipments	Division 32
Office machinery, computers, RTV, communications equipment	TOTAL machinery, computers, RTV, communications equipment
	Motor vehicles	Division 34
	Other transport equipment	Division 35
Vehicles, other transport equipment	TOTAL vehicles + other transport equipment
	Manufacturing n.i.e.
ELECTRICITY, GAS AND WATER	ELECTRICITY, GAS AND WATER	Section E
CONSTRUCTION	CONSTRUCTION	Section F
TOTAL SERVICES	TOTAL SERVICES
TRADE AND REPAIRS	TRADE AND REPAIRS	Section G
	Sale, maintenance and repair of motor vehicles and motor cycles; retail sale of automotive fuel	Division 50
	Wholesale trade and commission trade, except of motor vehicles and motor cycles	Division 51
	Retail trade, except of motor vehicles and motor cycles; repair of personal and household goods	Division 52
HOTELS AND RESTAURANTS	HOTELS AND RESTAURANTS	Section H
TRANSPORTS, STORAGE AND COMMUNICATION	TRANSPORTS, STORAGE AND COMMUNICATION	Section I
	Transport and storage	Divisions 60, 61, 62, 63
	Land transport; transport via pipelines	Division 60
	Water transport	Division 61
	Air transport	Division 62
	Supporting and auxiliary transport activities; activities of travel agencies	Division 63
	Post and telecommunications	Division 225
	Post and courier activities	Group 2251
	Telecommunications	Group 2252
FINANCIAL INTERMEDIATION	FINANCIAL INTERMEDIATION	Section J
	Financial intermediation, except insurance and pension funding	Division 65
	Insurance and pension funding, except compulsory social security	Division 66
	Activities auxiliary to financial intermediation	Division 67
	REAL ESTATE ACTIVITIES	Section K, Division 70
	RENTING OF MACHINERY AND EQUIPMENT WITHOUT OPERATOR AND OF PERSONAL AND HOUSEHOLD GOODS	Section K, Division 71
COMPUTER AND RELATED ACTIVITIES	COMPUTER AND RELATED ACTIVITIES	Section K, Division 72
RESEARCH AND DEVELOPMENT	RESEARCH AND DEVELOPMENT	Section K, Division 73
OTHER BUSINESS ACTIVITIES	OTHER BUSINESS ACTIVITIES	Section K, Division 74
	Legal, account., market research, consultancy	Group 741
	Legal activities	Class 7411
	Account., bookkeeping and audit.; tax consult.	Class 7412
	Market research and public opinion polling	Class 7413
	Business and manag. consultancy activities	Class 7414, 7415
	Architectural, engineering and other tech. act.	Group 742
	Advertising	Group 744
	Business activities n.e.c.	Group 743, 745, 746, 747, 748
	EDUCATION	Section M
	HEALTH AND SOCIAL WORK	Section N
	SEWAGE AND REFUSE DISPOSAL	Section O, Division 90
	ACTIVITIES OF MEMBERSHIP ORGANIS. N.E.C.	Section O, Division 91
RECREATIONAL, CULTURAL, SPORTING ACTIVITIES.	RECREATIONAL, CULTURAL, SPORTING ACTIVITIES	Section O, Division 92
	Motion picture, radio, television, other entertainment activities	Group 921, 922, 923
	News agency activities	Group 924
	Library, archives, museums, other cultural activities	Group 925
	Sporting and other recreational activities	Group 926, 927
	OTHER SERVICE ACTIVITIES	Section O, Division 93
	Not allocated

8. Transmission of data

(First reference periods)

Balance of Payments Euro Indicators

BOP_EUR

Euro Indicators

Deadline: T + 2 months

Periodicity: Quarter

First reference period: Q1 2006

Balance of Payments Quarterly Statistics

BOP_Q

Quarterly Data

Deadline: T + 3 months

Periodicity: Quarter

First reference period: Q1 2006

International Trade in Services

BOP_ITS

International Trade in Services

Deadline: T + 9 months

Periodicity: Year

First reference period: 2006

Questionnaires for foreign Direct Investments (FDI) Flows

BOP_FDI A

Direct Investment Flows

Deadline: T + 9 months

Periodicity: Year

First reference period: 2006

BOP_FDI A + B

Direct Investment Flows

Deadline: T + 21 months

Periodicity: Year

First reference period: 2006

Questionnaires for foreign Direct Investments (FDI) Positions

BOP_POS A (5)

Direct Investment Positions

Deadline: T+ 9 months

Periodicity: Year

First reference period: 2006

BOP_POS A + B (6)

Direct Investment Positions

Deadline: T+ 21 months

Periodicity: Year

First reference period: 2006

(1) Only the geographical breakdown.

(2) Only the geographical breakdown.

(3) Only for FDI.

(4) Provisional code that does not affect the definitive denomination of the country to be attributed after the conclusion of the negotiations currently taking place in the United Nations.

(5) FDI positions as at 31.12.2005 will be transmitted in September 2007 according to existing gentlemen's agreements.

(6) The revised data on FDI positions as at 31.12.2005 will be transmitted in September 2008 according to the provisions of this Regulation.

ANNEX II

DEFINITIONS

GOODS (code 100)

The goods component of the Balance of Payments Current Account covers moveable goods for which change of ownership (between residents and non-residents) occur. These goods should be measured at market value on an f.o.b. basis. Exceptions to the change of ownership rule (transactions in these items are recorded in goods) include: goods on financial lease, goods transferred between a parent enterprise and a branch, and some goods for processing. Intra-EU Trade in Goods: the partner country should be defined according to the consignment principle.

It includes: general merchandise, goods for processing, repairs on goods, goods procured in ports by carriers, and non monetary gold.

SERVICES (code 200)

—	Transportation (code 205) Covers all transportation services that are performed by residents of one economy for those of another and that involve the carriage of passengers, the movement of goods (freight), rentals (charters) of carriers with crew, and related supporting and auxiliary services.

—	Sea Transport (code 206) Covers all transportation services by sea. The following breakdown is required: Passenger Sea Transport (code 207), Freight Sea Transport (code 208) and Other Sea Transport (code 209).

—	Air Transport (code 210) Covers all transportation services provided by air. The following breakdown is required: Passenger Air Transport (code 211), Freight Air Transport (code 212) and Other Air Transport (code 213).

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Other transport (code 214)

Covers all transportation services not provided by sea or air. The following breakdown is required: Passenger on Other Transport (code 215), Freight on Other Transport (code 216) and Other on Other Transport (code 217)

An extended classification for Other Transport (code 214) is required as follows:

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Space Transport (code 218)

Includes satellite launches undertaken by commercial enterprises for the owners of the satellites (such as telecommunication enterprises) and other operations performed by operators of space equipment, such as transport of goods and people for scientific experiments. Also included is space passenger transport and the payments made by an economy in order to have its residents included on the space vehicles of another economy.

—	Rail Transport (code 219) Covers transport by trains. A further sub-division between Passenger Rail Transport (code 220), Freight Rail Transport (code 221) and Other Rail Transport (code 222) is required.

—	Road Transport (code 223) Covers transport by lorries, trucks, buses and coaches. A further sub-division between Passenger Road Transport (code 224), Freight Road Transport (code 225) and Other Road Transport (code 226) is required.

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Inland Waterway Transport (code 227)

Relates to international transportation on rivers, canals and lakes. Included are waterways that are internal to one country and those that are shared among two or more countries. A further subdivision between Passenger Inland Waterway Transport (code 228), Freight Inland Waterway Transport (code 229) and Other Inland Waterway Transport (code 230) is required.

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Pipeline Transport and Electricity Transmission (code 231)

Covers international transport of goods in pipelines. Also included are charges for the transmission of electricity when this is separate from the production and distribution process. The provision of electricity itself is excluded, as is the provision of petroleum and related products, water and other goods supplied through pipelines. Also excluded are distribution services of electricity, water, gas and other petroleum products (included in Other business services, Other business services (code 284)).

—	Other Supporting and Auxiliary Transport Services (code 232) Other supporting and auxiliary transport services covers all other transportation services that cannot be allocated to any of the components of transportation services described above.

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Travel (code 236)

Travel covers primarily the goods and services acquired from an economy by travellers during visits of less than one year to that economy. The goods and services are purchased by, or on behalf of, the traveller or provided, without a quid pro quo (that is, are provided as a gift), for the traveller to use or give away. Excluded are transportation of travellers within the economies that they are visiting, where such transportation is provided by carriers not resident in the particular economy being visited, as well as the international carriage of travellers, both of which are covered in passenger services under transportation. Also excluded are goods purchased by a traveller for resale in the traveller's own economy or in any other economy. Travel is divided in two sub-components: Business Travel (code 237) and Personal Travel (code 240).

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Business Travel (237)

Business travel covers the acquisition of goods and services by business travellers. Also includes the acquisition of goods and services for personal use by seasonal, border and other workers who are not resident in the economy in which they are employed and whose employer is resident in that economy. Business travel is further dissagregated into Expenditure by seasonal and border workers (code 238) and Other Business Travel (code 239).

—	Expenditure by seasonal and border workers (code 238) Includes the acquisition of goods and services for personal use by seasonal, border and other workers, who are not resident in the economy in which they are employed and whose employer is resident in that economy.

—	Other Business Travel (code 239) Covers all Other Bussines Travel (code 237) not included in Expenditure by seasonal and border workers (code 238).

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Personal Travel (code 240)

Personal travel covers goods and services acquired by travellers going abroad for purposes other than business, such as holidays, participation in recreational and cultural activities, visits with friends and relations, pilgrimage, and education- and health-related purposes. Personal Travel (code 240) is divided in three sub-components: Health-related Expenditure (code 241), Education-related expenditure (code 242) and Other Personal Travel (code 243).

—	Health-related Expenditure (code 241) It is defined as the total expenditure by those travelling for medical reasons.

—	Education-related expenditure (code 242) It is defined as the total expenditure by students.

—	Other Personal Travel (code 243) Covers all Personal Travel (code 240) not included in Health-related Expenditure (code 241) or Education-related expenditure (code 242).

—	Other services (981) All Services (code 200) not included in Transportation (code 205) or Travel (code 236).

—	Communication services (code 245) They comprise Postal and Courier Services (code 246) and Telecommunication Services (code 247).

—	Postal and Courier Services (code 246) Comprises Postal Services (958) and Courier Services (959).

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Postal Services (code 958)

Includes poste restante services, telegram services and post office counter services, such as sales of stamps, money orders etc. Postal services are often, but not exclusively, supplied by national postal administrations. Postal services are subject to international agreements, and the flows between operators of different economies should be recorded on a gross basis.

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Courier Services (code 959)

Courier services focuses on express and door-to-door delivery. Couriers may use self-owned, privately shared or public transportation to carry out these services. Included are express delivery services, which might include, for example, on-demand pick-up or time-definite delivery.

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Telecommunications Services (code 247)

Encompasses the transmission of sound, images or other information by telephone, telex, telegram, radio and television cable and broadcasting, satellite, electronic mail, facsimile services etc., including business network services, teleconferencing and support services. It does not include the value of the information transported. Also included are cellular telephone services, Internet backbone services and on-line access services, including provision of access to the Internet.

—	Construction services (code 249) Comprises Construction Abroad (code 250) and Construction in the Compiling Economy (code 251).

—	Construction Abroad (code 250) Construction abroad comprises the construction services provided to non-residents by enterprises resident in the compiling economy (credit) and the goods and services purchased in the host economy by these enterprises (debit).

—	Construction in the Compiling Economy (code 251) Comprises construction services provided to residents of the compiling economy by nonresident construction enterprises (debit) and the goods and services purchased in the compiling economy by these non-resident enterprises (credit).

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Insurance Services (code 253)

Covers the provision of various types of insurance to non-residents by resident insurance enterprises, and vice versa. These services are estimated or valued by the service charges included in total premiums rather than by the total value of the premiums. It comprises life insurance and pension funding (code 254), freight insurance (code 255), other direct insurance (code 256), reinsurance (code 257) and auxiliary services (code 258) to insurance.

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Life Insurance and Pension Funding (code 254)

Life insurance policies, both with profit and without profit, make regular payments to an insurer (there may be just a single payment), in return for which the insurer guarantees to pay the policy holder an agreed minimum sum or an annuity, at a given date or at the death of the policy holder, if this occurs earlier. Term life insurance, where benefits are provided in the case of death but in no other circumstances, is a form of direct insurance, and is excluded here and included in other insurance.

Pension funds are separate funds established for the purpose of providing income on retirement for specific groups of employees. They are organized and directed by private or public employers or jointly by employers and their employees. They are funded by contributions from the employer and/or the employees and by the investment income earned on fund assets, and they also engage in financial transactions on their own account. They do not include social security schemes organized for large sections of the community that are imposed, controlled or financed by general government. Pension fund management services are included. In the case of pension funds, ‘premiums’ are generally described as ‘contributions’, while ‘claims’ are generally described as ‘benefits’.

—	Freight Insurance (code 255) Freight insurance services relate to insurance provided on goods that are in the process of being exported or imported, on a basis that is consistent with the measurement of goods f.o.b. and freight transportation.

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Other direct insurance (code 256)

Other direct insurance covers all other forms of casualty insurance. Included are term life insurance; accident and health insurance (unless these are provided as part of government social security schemes); marine, aviation and other transport insurance; fire and other property damage; pecuniary loss insurance; general liability insurance; and other insurance, such as travel insurance and insurance related to loans and credit cards.

—	Reinsurance (code 257) Reinsurance is the process of subcontracting parts of the insurance risk, often to specialized operators, in return for a proportionate share of the premium income. Reinsurance transactions may relate to packages that mix several types of risks.

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Auxiliary services (code 258)

Comprises transactions that are closely related to insurance and pension fund operations. Included are agents' commissions, insurance brokering and agency services, insurance and pension consultancy services, evaluation and adjustment services, actuarial services, salvage administration services, and regulatory and monitoring services on indemnities and recovery services.

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Financial Services (code 260)

Financial services covers financial intermediation and auxiliary services, except those of life insurance enterprises and pension funds (which are included in life insurance and pension funding) and other insurance services that are conducted between residents and non-residents. Such services may be provided by banks, stock exchanges, factoring enterprises, credit card enterprises and other enterprises. Included are services provided in connection with transactions in financial instruments, as well as other services related to financial activity, such as advisory, custody and asset management services.

—	Computer and information services (code 262) Comprises Computer services (code 263) and Information services (code 2225).

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Computer services (code 263)

Consists of hardware and software-related services and data-processing services. Included are hardware and software consultancy and implementation services; maintenance and repair of computers and peripheral equipment; disaster recovery services, provision of advice and assistance on matters related to the management of computer resources; analysis, design and programming of systems ready to use (including web page development and design), and technical consultancy related to software; development, production, supply and documentation of customized software, including operating systems made on order for specific users; systems maintenance and other support services, such as training provided as part of consultancy; data-processing services, such as data entry, tabulation and processing on a time-sharing basis; web page hosting services (i.e., the provision of server space on the Internet to host clients' web pages); and computer facilities management.

—	Information services (code 2225) Comprises News Agency Services (code 889) and Other information provision services (code 890).

—	News Agency Services (code 889) News agency services include the provision of news, photographs, and feature articles to the media.

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Other information provision services (code 890)

Includes database services — database conception, data storage and the dissemination of data and databases (including directories and mailing lists), both on-line and through magnetic, optical or printed media; and web search portals (search engine services that find internet addresses for clients who input keyword queries). Also included are direct, non-bulk subscriptions to newspapers and periodicals, whether by mail, electronic transmission or other means.

—	Royalties and license fees (code 266) Comprises Franchises and similar rights (code 891) and Other royalties and license fees (code 892).

—	Franchises and similar rights (code 891) Comprises international payments and receipts of franchising fees and the royalties paid for the use of registered trademarks

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Other royalties and license fees (code 892)

Includes international payments and receipts for the authorised use of intangible, non-produced, nonfinancial assets and proprietary rights (such as patents, copyrights and industrial processes and designs) and with the use, through licensing agreements, of produced originals or prototypes (such as manuscripts, computer programs, and cinematographic works and sound recordings).

—	Other business services (code 268) Comprises Merchanting and other trade-related services (code 269), Operational leasing services (code 272) and Miscellaneous business, professional, and technical services (code 273).

—	Merchanting and other trade-related services (code 269) Comprise Merchanting (code 270) and Other trade-related services (code 271)

—	Merchanting (code 270) Merchanting is defined as the purchase of a good by a resident of the compiling economy from a nonresident and the subsequent resale of the good to another non-resident; during the process, the good does not enter or leave the compiling economy.

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Other trade-related services (code 271)

Covers commissions on goods and service transactions between

(a)	resident merchants, commodity brokers, dealers, and commission agents and

(b)	non-residents.

—	Operational leasing services (code 272) Covers resident/non-resident leasing (rental) and charters, without operators, of ships, aircraft and transportation equipment, such as railway cars, containers and rigs, without crew.

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Miscellaneous business, professional, and technical services (code 273)

Comprises Legal, accounting, management consulting, and public relations (code 274), Advertising, market research and public opinion polling (code 278), Research and development (code 279), Architectural, engineering and other technical services (code 280), Agriculture, mining, and other on-site processing (code 283), Other business services (code 284) and Services between related enterprises, n.i.e. (code 285).

—	Legal, accounting, management consulting, and public relations (code 274) Comprises Legal services (code 275), Accounting, auditing, bookkeeping and tax consultancy services (code 276) and Business and management consulting and public relations services (code 277).

—	Legal services (code 275) Covers legal advisory and representation services in any legal, judicial and statutory procedures; drafting services of legal documentation and instruments; certification consultancy; and escrow and settlement services.

—	Accounting, auditing, bookkeeping and tax consultancy services (code 276) Covers the recording of commercial transactions for businesses and others; examination services of accounting records and financial statements; business tax planning and consulting; and preparation of tax documents.

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Business and management consulting and public relations services (code 277)

Covers advisory, guidance and operational assistance services provided to businesses for business policy and strategy and the overall planning, structuring and control of an organization. Included are management auditing; market management, human resources, production management and project management consulting; and advisory, guidance and operational services related to improving the image of the clients and their relations with the general public and other institutions.

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Advertising, market research and public opinion polling (code 278)

Services transacted between residents and non-residents covers the design, creation and marketing of advertisements by advertising agencies; media placement, including the purchase and sale of advertising space; exhibition services provided by trade fairs; the promotion of products abroad; market research; telemarketing; and public opinion polling on various issues.

—	Research and development (code 279) Covers those services that are transacted between residents and non-residents and associated with basic research, applied research and experimental development of new products and processes.

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Architectural, engineering and other technical services (code 280)

Covers transactions between residents and non-residents related to architectural design of urban and other development projects; planning and project design and supervision of dams, bridges, airports, turnkey projects etc.; surveying; cartography; product testing and certification; and technical inspection services.

—	Agriculture, mining and on-site processing services (code 281) Comprises Waste treatment and depollution (code 282) and Agriculture, mining, and other on-site processing (code 283).

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Waste treatment and depollution (code 282)

Includes the treatment of radioactive and other waste; stripping of contaminated soil; cleaning up of pollution including oil spills; restoration of mining sites; and decontamination and sanitation services. Also included are all other services that relate to the cleaning or restoring of the environment.

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Agriculture, mining, and other on-site processing (code 283)

Comprises:

(a)

Agricultural services that are incidental to agriculture, such as the provision of agricultural machinery with crew, harvesting, treatment of crops, pest control, animal boarding, animal care, and breeding services. Services in hunting, trapping, forestry and logging, and fishing are also included here.

(b)	Mining services provided at oil and gas fields, including drilling, derrick building, repair and dismantling services, and oil and gas well casing cementing. Services incidental to mineral prospecting and exploration, as well as mining engineering and geological surveying, are also included here.

(c)

Other on-site processing services, which covers on-site processing of or work on goods that have been imported without change of ownership, processed but not re-exported to the country from which the goods were consigned (but are instead either sold in the processing economy or sold to a third economy) or vice versa.

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Other business services (code 284)

Covers services transactions between residents and non-residents, such as the placement of personnel, security and investigative services, translation and interpretation, photographic services, building cleaning, real estate services to businesses and any other business services that cannot be classified to any of the business services listed above.

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Services between related enterprises, n.i.e. (code 285)

It is a residual category. It covers payments between related enterprises for services that cannot be specifically classified to any other component. It includes payments from branches, subsidiaries and associates to their parent enterprise or other related enterprises that represent contributions to the general management costs of the branches, subsidiaries and associates (for planning, organizing and controlling) and also reimbursements of expenses settled directly by parent enterprises. Also included are transactions between parent enterprises and their branches, subsidiaries and associates to cover overhead expenses.

—	Personal, cultural and recreational services (code 287) Comprises Audiovisual and related services (code 288) and Other personal, cultural and recreational services (code 289).

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Audiovisual and related services (code 288)

Comprises services and associated fees related to the production of motion pictures (on film or videotape), radio and television programmes (live or on tape) and musical recordings. Included are receipts or payments for rentals; fees received by resident actors, producers etc. for productions abroad (or by non-residents for work carried out in the compiling economy); fees for distribution rights sold to the media for a limited number of showings in specified areas; and access to encrypted television channels (such as cable services). Fees to actors, directors and producers involved with theatrical and musical productions, sporting events, circuses and other similar events and fees for distribution rights (for television, radio, and film) for these activities are included.

—	Other personal, cultural and recreational services (code 289) Comprises Education services (code 895), Health services (code 896) and Other on Other personal, cultural and recreational services (code 897).

—	Education services (code 895) Comprises services supplied between residents and non-residents relating to education, such as correspondence courses and education via television or the Internet, as well as by teachers etc. who supply services directly in host economies.

—	Health services (code 896) Comprises services provided by doctors, nurses and paramedical and similar personnel, as well as laboratory and similar services, whether rendered remotely or on-site. Excluded is all expenditure by travellers on education and health (included in travel).

—	Other on Other personal, cultural and recreational services (code 897) Is a residual category covering Other personal, cultural and recreational services (code 289) not included in Education services (895) and Health services (code 896).

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Government services, n.i.e. (code 291)

It is a residual category covering government transactions (including those of international organizations) not contained in the other components of EBOPS as defined above. Included are all transactions (in both goods and services) by embassies, consulates, military units and defence agencies with residents of economies in which the embassies, consulates, military units and defence agencies are located and all transactions with other economies. Excluded are transactions with residents of the home economies represented by the embassies, consulates, military units and defence agencies, and transactions in the commissaries, post exchanges and these embassies and consulates.

A breakdown of this item into services transacted by Embassies and consulates (code 292), services transacted by Military units and agencies (code 293) and Other government services n.i.e. (code 294) is required.

INCOME (code 300)

Income covers two types of transactions between residents and non-residents:

(i)	those involving compensation of employees, which is paid to non-resident workers (e.g. border, seasonal and other short-term workers), and

(ii)	those involving investment income receipts and payments on external financial assets and liabilities.

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Compensation of employees (code 310)

Compensation of employees comprises wages, salaries, and other benefits, in cash or in kind, earned by individuals — in economies other than those in which they are resident — for work performed for (and paid for by) residents of those economies. Included are contributions paid by employers, on behalf of employees, to social security schemes or to private insurance or pension funds (whether funded or unfunded) to secure benefits for employees.

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Investment Income (code 320)

Investment income is income derived from ownership of external financial assets and payable by residents of one economy to residents of another economy. Investment income includes interest, dividends, remittances of branch profits, and direct investors' shares of the retained earnings of direct investment enterprises. Investment income should be classified by direct, portfolio and other investment components.

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Direct investment income (code 330)

Direct investment income namely income on equity and income on debt covers income accruing to a direct investor resident in one economy from ownership of direct investment capital in an enterprise in another economy. Income on direct investment is presented on a net basis for both direct investment abroad and in the reporting economy (i.e. receipts of income on equity and income on debt less payments on income on equity and income on debt for each). Income on equity is subdivided into

(i)	distributed income (dividends and distributed branch profits), and

(ii)

reinvested earnings and undistributed branch profits. Income on debt consists of interest payable — on intercompany debt — to/from direct investors from/ to associated enterprises abroad. Income on nonparticipating preference shares is treated as interest income, rather than dividend income, and is included in income on debt.

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Dividends and distributed branch profits (code 332)

Dividends, including stock dividends, are the distribution of earnings allocated to shares and other forms of participation in the equity of incorporated private enterprises, co-operatives, and public corporations. Distributed income may be in the form of dividends on common or preferred shares owned by direct investors in associated enterprises abroad, or vice versa.

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Reinvested earnings and undistributed branch profits (code 333)

Reinvested earnings comprise direct investors' shares — in proportion to equity held — of

(i)	earnings that foreign subsidiaries and associated enterprises do not distribute as dividends and

(ii)	earnings that branches and other unincorporated enterprises do not remit to direct investors. (If that part of earnings is not identified, all branch earnings are considered, by convention, to be distributed).

—	Income on debt (code 334) Income on debt consists of interest payable — on intercompany debt — to/from direct investors from/to associated enterprises abroad. Income on nonparticipating preference shares is treated as interest income, rather than dividend income, and is included in income on debt.

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Equity capital and reinvested earnings abroad (code 506)

Equity capital comprises equity in branches, all shares (whether voting or nonvoting) in subsidiaries and associates (except nonparticipating, preferred shares that are treated as debt securities and included under other direct investment capital), and other capital contributions. Reinvested earnings consist of the direct investor's share (in proportion to direct equity participation) of earnings not distributed as dividends by subsidiaries or associates and earnings of branches not remitted to the direct investor.

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Equity capital and reinvested earnings in the reporting economy (code 556)

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Portfolio investment income (code 339)

Portfolio investment income comprises income transactions between residents and non-residents and is derived from holdings of shares, bonds, notes, and money market instruments This category is subdivided into income on equity (dividends) and income on debt (interest).

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Other investment income (370)

Other investment income covers interest receipts and payments on all other resident claims (assets) on and liabilities to non-residents, respectively. This category also includes, in principle, imputed income to households from net equity in life insurance reserves and in pension funds. Interest on assets comprises interest on long- and short-term loans, on deposits, on other commercial and financial claims, and on an economy's creditor position in the IMF. Interest on liabilities covers interest on loans, on deposits, and on other claims and interest related to the use of IMF credit and loans form the IMF. Also included is interest paid to the IMF on the Fund's SDR holdings in the General Resources Account.

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Current transfers (code 379)

Current transfers are offset items to unilateral transactions in which one economic entity provides a real resource or a financial item to another entity without receiving any real resource or financial item in exchange. These resources are immediately consumed or shortly consumed after the transfer is made. Current transfers are all transfers that are not capital. Current transfers are classified according to the sector of the compiling economy into general government and other sectors.

—	General government current transfers (code 380) General government transfers comprise current international cooperation, which covers current transfers — in cash or in kind — between governments of different economies or between governments and international organizations.

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Other sectors (code 390)

Current transfers between other sectors of an economy and non-residents comprise those occuring between individuals, between non-governmental institutions or organizations (or between the two groups), or between non-resident governmental institutions and individuals or non-governmental institutions.

—	Capital account (code 994) The capital account covers all transactions that involve the receipt or payment of capital transfers and acquisition/disposal of non-produced, non-financial assets.

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Financial account (code 995)

The financial account covers all transactions associated with changes of ownership in the foreign financial assets and liabilities of an economy. Such changes include the creation and liquidation of claims on, or by the rest of the world. All components are classified according to type of investment or by functional subdivision (direct investment, portfolio investment, financial derivatives, other investment, reserve assets).

DIRECT INVESTMENT (code 500)

Foreign direct investment is the category of international investment that reflects the objective of a resident entity in one economy (direct investor) obtaining a lasting interest in an enterprise resident in an economy other than that of the investor (direct investment enterprise). ‘Lasting interest’ implies the existence of a long-term relationship between the direct investor and the enterprise and a significant degree of influence by the investor on the management of the direct investment enterprise. Direct investment comprises the initial transaction between the two entities — that is, the transaction that establishes the direct investment relationship — and all subsequent transactions between them and among affiliated enterprises, both incorporated and unincorporated.

—	Direct Investment abroad (code 505) Direct investment is classified primarily on a directional basis — resident direct investment abroad and non-resident investment in the reporting economy.

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Equity capital (code 510)

Equity capital comprises equity in branches, all shares (whether voting or nonvoting) in subsidiaries and associates (except nonparticipating, preferred shares that are treated as debt securities and included under other direct investment capital), and other capital contributions. Equity capital also covers the acquisition by a direct investment enterprise of shares in its direct investor.

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Reinvested earnings (code 525)

Reinvested earnings consist of the direct investor's share (in proportion to direct equity participation) of earnings not distributed as dividends by subsidiaries or associates and earnings of branches not remitted to the direct investor. These reinvested earnings are recorded as income with an offsetting capital transaction.

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Other direct investment capital (code 530)

Other direct investment capital (or intercompany debt transactions) covers the borrowing and lending of funds — including debt securities, suppliers' credits and nonparticipating preferred shares (which are treated as debt securities) — between direct investors and subsidiaries, branches, and associates. Debt claims on the direct investor by the direct investment enterprise are also recorded as direct investment capital.

—	Direct investment in the reporting economy (code 555) Direct investment is classified primarily on a directional basis — resident direct investment abroad and non-resident investment in the reporting economy.

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Equity capital (code 560)

Equity capital comprises equity in branches, all shares (whether voting or nonvoting) in subsidiaries and associates (except nonparticipating, preferred shares that are treated as debt securities and included under other direct investment capital), and other capital contributions. Equity capital also covers the acquisition by a direct investment enterprise of shares in its direct investor.

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Reinvested earnings (code 575)

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Other direct investment capital (code 580)

PORTFOLIO INVESTMENT (600)

Portfolio investment covers transactions in equity and debt securities. Debt securities are subdivided into bonds and notes, money market instruments, and financial derivatives when the derivatives generate financial claims and liabilities. Unless they are categorized either as direct investment or as reserve assets.

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Financial derivatives (code 910)

A Financial derivatives contract is a financial instrument that is linked to another specific financial instrument or indicator or commodity and through which specific financial risks (such as interest rate risk, foreign exchange risk, equity and commodity price risks, credit risks, etc.) can, in their own right, be traded in financial markets.

OTHER INVESTMENT (code 700)

The other investment item is defined as a residual category that includes all financial transactions not covered in direct investment, portfolio investment, financial derivatives or reserve assets accounts.

P5_TA(2004)0192

Rules for Community financial aid in the field of trans-European networks ***II

European Parliament legislative resolution on the Council common position with a view to adopting a Regulation of the European Parliament and of the Council amending Council Regulation (EC) No 2236/95 laying down general rules for the granting of Community financial aid in the field of trans-European networks (5633/1/2004 — C5-0095/2004 — 2001/0226(COD))

(Codecision procedure: second reading)

The European Parliament,

—	having regard to the Council common position (5633/1/2004 — C5-0095/2004),

—	having regard to its position at first reading (1) on the amended Commission proposal to Parliament and the Council (COM(2002) 134) (2),

—	having regard to the amended Commission proposals (COM(2003) 38) (3) and (COM(2003) 561) (3),

—	having regard to Article 251(2) of the EC Treaty,

—	having regard to Rule 78 of its Rules of Procedure,

—	having regard to the recommendation for second reading of the Committee on Budgets (A5-0134/2004),

1.	Approves the common position;

2.	Notes that the act is adopted in accordance with the common position;

3.	Instructs its President to sign the act with the President of the Council pursuant to Article 254(1) of the EC Treaty;

4.	Instructs its Secretary-General duly to sign the act and, in agreement with the Secretary-General of the Council, to have it published in the Official Journal of the European Union;

5.	Instructs its President to forward its position to the Council and Commission.

(1) OJ C 271 E, 12.11.2003, p. 163.

(2) OJ C 151 E, 25.6.2002, p. 291.

(3) Not yet published in the OJ.

P5_TA(2004)0193

European enforcement order for uncontested claims ***II

European Parliament legislative resolution on the Council common position for adopting a European Parliament and Council regulation on creating a European enforcement order for uncontested claims (16041/1/2003 — C5-0067/2004 — 2002/0090(COD))

(Codecision procedure: second reading)

The European Parliament,

—	having regard to the Council common position (16041/1/2003 — C5-0067/2004) (1),

—	having regard to its position at first reading (2) on the Commission proposal to Parliament and the Council (COM(2002) 159) (3), and the amended proposal (COM(2003) 61) (1),

—	having regard to the Commission's amended proposal (COM(2003) 341) (1)

—	having regard to Article 251(2) of the EC Treaty,

—	having regard to Rule 78 of its Rules of Procedure,

—	having regard to the recommendation for second reading of the Committee on Legal Affairs and the Internal Market (A5-0187/2004),

1.	Approves the common position as follows;

2.	Notes that the act is adopted in accordance with the common position;

3.	Instructs its President to sign the act with the President of the Council pursuant to Article 254(1) of the EC Treaty;

4.	Instructs its Secretary-General duly to sign the act and, in agreement with the Secretary-General of the Council, to have it published in the Official Journal of the European Union;

5.	Instructs its President to forward its position to the Council and the Commission.

(1) Not yet published in the OJ.

(2) OJ C 64 E, 12.3.2004, p. 79.

(3) OJ C 203 E, 27.8.2002, p. 86.

P5_TA(2004)0194

Emissions of volatile organic compounds ***II

European Parliament legislative resolution on the Council common position for adopting a European Parliament and Council directive on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain paints and varnishes and vehicle refinishing products and amending Directive 1999/13/EC (14780/2/2003 — C5-0019/2004 — 2002/0301(COD))

(Codecision procedure: second reading)

The European Parliament,

—	having regard to the Council common position (14780/2/2003 — C5-0019/2004) (1),

—	having regard to its position at first reading (2) on the Commission proposal to Parliament and the Council (COM(2002) 750) (1),

—	having regard to Article 251(2) of the EC Treaty,

—	having regard to Rule 78 of its Rules of Procedure,

—	having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Consumer Policy (A5-0136/2004),

1.	Approves the common position;

2.	Notes that the act is adopted in accordance with the common position;

3.	Instructs its President to sign the act with the President of the Council pursuant to Article 254(1) of the EC Treaty;

4.	Instructs its Secretary-General duly to sign the act and, in agreement with the Secretary-General of the Council, to have it published in the Official Journal of the European Union;

5.	Instructs its President to forward its position to the Council and Commission.

(1) Not yet published in the OJ.

(2) Texts Adopted,25.9.2003, P5_TA(2003)0411.

P5_TA(2004)0195

Air service agreements ***II

European Parliament legislative resolution on the Council common position with a view to the adoption of a European Parliament and Council regulation on the negotiation and implementation of air service agreements between Member States and third countries (13732/1/2003 — C5-0013/ 2004 — 2003/0044(COD))

(Codecision procedure: second reading)

The European Parliament,

—	having regard to the Council common position (13732/1/2003 — C5-0013/2004) (1),

—	having regard to its position at first reading (2) on the Commission proposal to Parliament and the Council (COM(2003) 94) (3),

—	having regard to Article 251(2) of the EC Treaty,

—	having regard to Rule 80 of its Rules of Procedure,

—	having regard to the recommendation for second reading of the Committee on Regional Policy, Transport and Tourism (A5-0179/2004),

Takes the view that, when negotiating agreements on an open aviation area, it should be ensured that direct and indirect subsidies to air carriers are made inadmissible, as the market would otherwise be distorted to the detriment of Member State or Community carriers, and that bilateral air service agreements should not be replaced by Community agreements unless the third country concerned has a liberalised market or a Community agreement with a third country would result in added value for the Member States;

2.	Amends the common position as follows;

3.	Instructs its President to forward its position to the Council and Commission.

(1) OJ C 54 E, 2.3.2004, p. 33.

(2) Texts Adopted, 2.9.2003, P5_TA(2003)0356.

(3) Not yet published in the OJ.

P5_TC2-COD(2003)0044

Position of the European Parliament adopted at second reading on 30 March 2004 with a view to the adoption of Regulation (EC) No .../2004 of the European Parliament and of the Council on the negotiation and implementation of air service agreements between Member States and third countries

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 80(2) thereof,

Having regard to the proposal from the Commission,

Having regard to the Opinion of the European Economic and Social Committee (1),

Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),

Whereas:

(1)	International aviation relations between Member States and third countries have been traditionally governed by bilateral air service agreements between Member States and third countries, their Annexes and other related bilateral or multilateral arrangements.

(2)	Following the judgments of the Court of Justice of the European Communities in cases C-466/98, C-467/98, C-468/98, C-469/98, C-471/98, C-472/98, C-475/98 and C-476/98, the Community has exclusive competence with respect to various aspects of such agreements.

(3)	The Court has also clarified the right of Community air carriers to benefit from the right of establishment within the Community, including the right to non-discriminatory market access.

(4)

Where it is apparent that the subject-matter of an agreement falls partly within the competence of the Community and partly within that of its Member States, it is essential to ensure close cooperation between the Member States and the Community institutions, both in the process of negotiation and conclusion and in the fulfilment of the commitments entered into. That obligation to cooperate flows from the requirement of unity in the international representation of the Community. The Community institutions and the Member States should take all necessary steps to ensure the best possible cooperation in that regard.

(5)	The cooperation procedure between Member States and the Commission established by this Regulation should be without prejudice to the division of competencies between the Community and Member States, in accordance with Community law as interpreted by the Court of Justice.

(6)	All existing bilateral agreements between Member States and third countries that contain provisions contrary to Community law should be amended or replaced by new agreements that are wholly compatible with Community law.

(7)	Without prejudice to the Treaty, and in particular Article 300 thereof, Member States may wish to make amendments to existing agreements and make provision to manage their implementation until such time as an agreement concluded by the Community enters into force.

(8)	It is essential to ensure that a Member State conducting negotiations takes account of Community law, broader Community interests and ongoing Community negotiations.

(9)	If a Member State wishes to involve air carriers in the process of negotiation, all air carriers with an establishment in the territory of the Member State concerned should be treated equally.

(10)

Establishment on the territory of a Member State implies the effective and real exercise of air transport activity through stable arrangements; the legal form of such an establishment, whether a branch or a subsidiary with a legal personality, should not be the determining factor in this respect. When an undertaking is established on the territory of several Member States, as defined by the Treaty, it should ensure, in order to avoid any circumvention of national law, that each of the establishments fulfils the obligations which may, in accordance with Community law, be imposed by the national law applicable to its activities.

(11)	In order to ensure that the rights of Community air carriers are not unduly restricted, no new arrangements that reduce the number of Community air carriers which may be designated to provide air services in a given market should be introduced in bilateral air service agreements.

(12)	Member States should establish non-discriminatory and transparent procedures for the distribution of traffic rights between Community air carriers. In applying those procedures Member States should have due regard to the need to preserve continuity of air services.

(13)	The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (3).

(14)	Any Member State may invoke the confidentiality of the provisions of bilateral agreements it has negotiated and request the Commission not to share the information with other Member States.

(15)	Arrangements for greater cooperation over the use of Gibraltar airport were agreed in London on 2 December 1987 by the Kingdom of Spain and the United Kingdom in a joint declaration by the Ministers of Foreign Affairs of the two countries. Such arrangements have yet to enter into operation.

(16)

Since the objectives of this Regulation, namely the coordination of negotiations with third countries with a view to concluding air service agreements, the necessity to guarantee a harmonised approach in the implementation and application of those agreements and the verification of their compliance with Community law, cannot be sufficiently achieved by the Member States and can therefore, by reason of the Community-wide scope of this Regulation, be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity, as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives,

HAVE ADOPTED THIS REGULATION:

Article 1

Notification to the Commission

1. A Member State may, without prejudice to the respective competencies of the Community and its Member States, enter into negotiations with a third country concerning a new air service agreement or the modification of an existing air service agreement, its Annexes or any other related bilateral or multilateral arrangement, the subject matter of which falls partly within the competence of the Community, provided that:

—	any relevant standard clauses, developed and laid down jointly between Member States and the Commission, are included in such negotiations; and

—	the notification procedure set out in paragraphs 2, 3 and 4 is complied with.

Where appropriate, the Commission shall be invited to participate as an observer in any such negotiations.

2. Where a Member State intends to enter into such negotiations it shall notify the Commission of its intentions in writing. This notification shall include a copy of the existing agreement, if available, other relevant documentation and an indication of the provisions to be addressed in the negotiations, the objectives of the negotiations and any other relevant information. The Commission shall make the notification and, on request, the accompanying documentation, available to other Member States, subject to the requirements of confidentiality.

The information shall be transmitted at least one calendar month before formal negotiations are scheduled to commence with the third country concerned. If, due to exceptional circumstances, formal negotiations are scheduled at less than one month's notice, the Member State shall transmit the information as soon as possible.

3. Member States may make comments to the Member State which has notified its intention to enter into negotiations in accordance with paragraph 2. That Member State shall take such comments into account as far as possible in the course of the negotiations.

4. If, within 15 working days of receipt of the notification referred to in paragraph 2, the Commission concludes that the negotiations are likely to:

—	undermine the objectives of Community negotiations underway with the third country concerned, and/or

—	lead to an agreement which is incompatible with Community law

it shall inform the Member State accordingly.

Article 2

Consultation of stakeholders and participation in negotiations

Insofar as air carriers and other interested parties are to be involved in the negotiations referred to in Article 1, Member States shall treat equally all Community air carriers with an establishment on their respective territories to which the Treaty applies.

Article 3

Prohibition on introducing more restrictive arrangements

A Member State shall not enter into any new arrangement with a third country, which reduces the number of Community air carriers which may, in accordance with existing arrangements, be designated to provide services between its territory and that country, neither in respect of the entire air transport market between the two parties nor on the basis of specific city pairs.

Article 4

Conclusion of agreements

1. Upon signature of an agreement, the Member State concerned shall notify the Commission of the outcome of the negotiations together with any relevant documentation.

2. Where the negotiations have resulted in an agreement which incorporates the relevant standard clauses referred to in Article 1(1), the Member State shall be authorised to conclude the agreement.

3. Where the negotiations have resulted in an agreement which does not incorporate the relevant standard clauses referred to in Article 1(1), the Member State shall be authorised, in accordance with the procedure referred to in Article 7(2), to conclude the agreement, provided that this does not harm the object and purpose of the Community common transport policy. The Member State may provisionally apply the agreement pending the outcome of this procedure.

4. Notwithstanding paragraphs 2 and 3, if the Commission is actively negotiating with the same third country on the basis of a country-specific mandate or on the basis of Council Decision 2004/.../EC of ... authorising the Commission to open negotiations with third countries on the replacement of certain provisions in existing bilateral agreements with a Community agreement (4), the Member State concerned may be authorised, in accordance with the procedure referred to in Article 7(2), to apply provisionally and/ or conclude the agreement.

Article 5

Distribution of traffic rights

Where a Member State concludes an agreement, or amendments to an agreement or its Annexes, that provide for limitations on the use of traffic rights or the number of Community air carriers eligible to be designated to take advantage of traffic rights, that Member State shall ensure a distribution of traffic rights among eligible Community air carriers on the basis of a non-discriminatory and transparent procedure.

Article 6

Publication of procedures

Member States shall inform the Commission without delay of the procedures that they shall apply for the purposes of Article 5 and, where appropriate, Article 2. For information purposes, the Commission shall ensure that these procedures are published in the Official Journal of the European Union within eight weeks of their receipt. Any new procedures and subsequent changes to existing procedures shall be communicated to the Commission at least eight weeks before they enter into force, so that the Commission can ensure their publication in the Official Journal of the European Union within that eight-week period.

Article 7

Committee procedure

1. The Commission shall be assisted by the committee established under Article 11 of Council Regulation (EEC) No 2408/92 of 23 July 1992 on access for Community air carriers to intra-Community air routes (5).

2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

3. The Committee shall adopt its rules of procedure.

Article 8

Confidentiality

In notifying the Commission of negotiations and their outcome as envisaged in Articles 1 and 4, Member States shall clearly inform the Commission if any information therein is to be considered confidential and whether it can be shared with other Member States. The Commission and Member States shall ensure that any information identified as confidential is treated according to Article 4(1)(a) of Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (6).

Article 9

Gibraltar

1. The application of this Regulation to the airport of Gibraltar is understood to be without prejudice to the respective legal positions of the Kingdom of Spain and the United Kingdom with regard to the dispute over sovereignty over the territory in which the airport is situated.

2. Application of this Regulation to Gibraltar airport shall be suspended until the arrangements included in the Joint Declaration made by the Foreign Ministers of the Kingdom of Spain and the United Kingdom on 2 December 1987 enter into operation. The Governments of Spain and the United Kingdom will inform the Council of such date of entry into operation.

Article 10

Entry into force

This Regulation shall enter into force on the thirtieth day following its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at ..., on ...

For the European Parliament

The President

For the Council

The President

(1) OJ C 234, 30.9.2003, p. 21.

(2) Position of the European Parliament of 2 September 2003 (not yet published in the Official Journal), Council Common Position of 5 December 2003 (OJ C 54 E, 2.3.2004, p. 33) and Position of the European Parliament of 30 March 2004.

(3) OJ L 184, 17.7.1999, p. 23.

(4) OJ L...

(5) OJ L 240, 24.8.1992, p. 8. Regulation as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

(6) OJ L 145, 31.5.2001, p. 43.

P5_TA(2004)0196

Mobilisation of the EU Solidarity Fund

European Parliament resolution on the proposal for a decision of the European Parliament and the Council on the mobilisation of the EU Solidarity Fund according to point 3 of the Interinstitutional Agreement of 7 November 2002 between the European Parliament, the Council and the Commission on the financing of the European Union Solidarity Fund, supplementing the Interinstitutional Agreement of 6 May 1999 on budgetary discipline and improvement of the budgetary procedure (COM(2004) 168 — C5-0134/2004 — 2004/2025(ACI))

The European Parliament,

—	having regard to the Commission proposal (COM(2004) 168 — C5-0134/2004),

—

having regard to the Interinstitutional Agreement of 7 November 2002 between the European Parliament, the Council and the Commission on the financing of the European Union Solidarity Fund supplementing the Interinstitutional Agreement of 6 May 1999 on budgetary discipline and improvement of the budgetary procedure (1),

—	having regard to Council Regulation (EC) No 2012/2002 of 11 November 2002 establishing the European Union Solidarity Fund (2),

—	having regard to the results of the trialogue of 16 March 2004,

—	having regard to the report of the Committee on Budgets (A5-0195/2004),

having regard to the urgent need for the European Union to set up the appropriate institutional and budgetary instruments to allow it to cover the damage resulting from the forest fires in Spain (August 2003), the heavy storm and flooding which hit Malta (15 September 2003) and the flooding in southern France (December 2003),

1.	Approves the decision annexed to this resolution on the mobilisation of the EU Solidarity Fund;

2.	Instructs its President to forward this resolution, including the Annex, to the Council and the Commission.

(1) OJ C 283, 20.11.2002, p. 1.

(2) OJ L 311, 14.11.2002, p. 3.

ANNEX

DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 30 March 2004

on the mobilisation of the EU Solidarity Fund in accordance with point 3 of the Interinstitutional Agreement of 7 November 2002 between the European Parliament, the Council and the Commission on the financing of the European Union Solidarity Fund, supplementing the Interinstitutional Agreement of 6 May 1999 on budgetary discipline and improvement of the budgetary procedure

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Interinstitutional Agreement of 7 November 2002 between the European Parliament, the Council and the Commission on the financing of the European Union Solidarity Fund, supplementing the Interinstitutional Agreement of 6 May 1999 on budgetary discipline and improvement of the budgetary procedure (1), and in particular point 3 thereof,

Having regard to Council Regulation (EC) No 2012/2002 of 11 November 2002 establishing the European Union Solidarity Fund (2),

Having regard to the proposal from the Commission,

Whereas:

(1)	The European Union has created a European Union Solidarity Fund (the ‘Fund’) to show solidarity with the population of regions struck by disasters.

(2)	Malta submitted an application to mobilise the Fund on 10 November 2003, concerning a disaster caused by storm and flooding; Spain submitted one on 1 October 2003 concerning a fire-related disaster; and France did the same on 26 January 2004 concerning a disaster caused by flooding.

(3)	The Interinstitutional Agreement of 7 November 2002 allows the mobilisation of the Fund within the annual ceiling of EUR 1 billion.

(4)	The cases of the storm and flooding in Malta in September 2003, the forest fire in Spain in the summer of 2003 and the flooding in southern France in December 2003 fulfil the criteria for mobilisation of the European Union Solidarity Fund,

HAVE DECIDED AS FOLLOWS:

Article 1

For the general budget of the European Union for the financial year 2004, the European Union Solidarity Fund shall be mobilised to provide the sum of EUR 21 916 995 in commitment appropriations.

Article 2

This Decision shall be published in the Official Journal of the European Union.

Done at Strasbourg, 30 March 2004

The European Parliament

The President

For the Council

The President

(1) OJ C 283, 20.11.2002, p. 1.

(2) OJ L 311, 14.11.2002, p. 3.

P5_TA(2004)0197

Draft amending budget 5/2004

European Parliament resolution on the Draft amending budget No 5/2004 of the European Union for the financial year 2004 (7684/2004 — C5-0166/2004 — 2004/2023(BUD))

The European Parliament,

—	having regard to Article 272 of the EC Treaty and Article 177 of the Euratom Treaty,

—	having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (1) and in particular Articles 37 and 38 thereof,

—	having regard to the general budget of the European Union for the financial year 2004, as finally adopted on 18 December 2003 (2),

—	having regard to the Interinstitutional Agreement of 6 May 1999 between the European Parliament, the Council and the Commission on budgetary discipline and improvement of the budgetary procedure (3),

—

—	having regard to the conclusions of the Trialogue of 16 March 2004, including the decision of the European Parliament and the Council to mobilise the flexibility mechanism relating to the European Union Solidarity Fund for the amount of EUR 21 916 995,

—	having regard to the Preliminary Draft amending budget No 5/2004 of the European Union for the financial year 2004, which the Commission presented on 9 March 2004 (SEC(2004) 269),

—	having regard to Draft amending budget No 5/2004, which the Council established on 26 March 2004 (7684/2004 — C5-0166/2004),

—	having regard to Rule 92 of and Annex IV to its Rules of Procedure,

—	having regard to the report of the Committee on Budgets (A5-0203/2004),

A.	whereas the European Union should show its solidarity with the population of regions of Member States and accession countries concerned by natural disasters, which have serious repercussions on living conditions, the natural environment or the economy,

B.	whereas the appropriate budgetary resources for the European Union's financial assistance have been mobilised in accordance with the provisions of the European Union Solidarity Fund and the Interinstitutional Agreement relating to its financing,

C.	whereas, on 17 March 2004, representatives of the affected regions and Member States and accession countries presented the impact of the natural disasters to Parliament,

D.	whereas the purpose of amending budget No 5/2004 is to formally enter these budgetary resources in the 2004 budget,

1.	Welcomes amending budget No 5/2004, the purpose of which is to enter without delay the budgetary resources mobilised as part of the European Union Solidarity Fund in the 2004 budget so that those affected by these natural disasters can be assisted;

2.	Emphasises the fact that the adoption of amending budget No 5/2004 in one single reading has ensured the most rapid assistance possible from the EU budget, following the applications presented therefor, to the countries and regions concerned;

3.	Approves unamended Draft Amending Budget No 5/2004;

4.	Instructs its President to forward this resolution to the Council and the Commission.

(1) OJ L 248, 16.9.2002, p. 1.

(2) OJ L 53, 23.2.2004.

(3) OJ C 172, 18.6.1999, p. 1. Agreement as amended by Decision 2003/429/EC (OJ L 147, 14.6.2003, p. 25).

(4) OJ C 283, 20.11.2002, p. 1.

P5_TA(2004)0198

Requests to European agencies

European Parliament decision on insertion of a new Rule on requests to European Agencies in Parliament's Rules of Procedure (2004/2008(REG))

The European Parliament,

—	having regard to the letter from its President dated 21 November 2003,

—	having regard to Rules 180 and 181 of its Rules of Procedure,

—	having regard to the report of the Committee on Constitutional Affairs (A5-0152/2004),

1.	Decides to amend its Rules of Procedure as shown below;

2.	Points out that the amendments will enter into force on the first day of the next part-session;

3.	Instructs its President to forward this decision to the Council and Commission, for information.

PRESENT TEXT	AMENDMENTS
Amendment 1
Chapter VI, title
RELATIONS WITH OTHER INSTITUTIONS	RELATIONS WITH OTHER BODIES
Amendment 2
Rule 54a (new)
	Rule 54a Requests to European Agencies 1. Where Parliament has a right to submit a request to a European Agency, any Member may submit such a request in writing to the President of Parliament. Such requests shall be on matters falling within the mission of the Agency concerned and shall be accompanied by background information explaining the issue and the Community interest. 2. The President shall, after consulting the committee responsible, either forward the request to the Agency or take any other appropriate course of action. The Member submitting the request shall be immediately informed thereof. Any request sent by the President to an Agency shall include a time limit for response. 3. If the Agency considers that it is unable to respond to the request as formulated, or seeks to have it modified, it shall inform the President forthwith, who shall take any appropriate action, after consulting the committee responsible as necessary .

P5_TA(2004)0199

Quarterly non-financial accounts by institutional sector ***I

European Parliament legislative resolution on the proposal for a European Parliament and Council regulation on the compilation of quarterly non-financial accounts by institutional sector (COM(2003) 789 — C5-0645/2003 — 2003/0296(COD))

(Codecision procedure: first reading)

The European Parliament,

—	having regard to the Commission proposal to the European Parliament and the Council (COM(2003) 789) (1),

—	having regard to Articles 251(2) and 285 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C5-0645/2003),

—	having regard to Rule 67 of its Rules of Procedure,

—	having regard to the report of the Committee on Economic and Monetary Affairs (A5-0151/2004),

1.	Approves the Commission proposal as amended;

2.	Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal substantially or replace it with another text;

3.	Instructs its President to forward its position to the Council and Commission.

(1) Not yet published in the OJ.

P5_TC1-COD(2003)0296

Position of the European Parliament adopted at first reading on 30 March 2004 with a view to the adoption of Regulation (EC) No .../2004 of the European Parliament and of the Council on the compilation of quarterly non-financial accounts by institutional sector

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 285(1) thereof,

Having regard to the proposal from the Commission (1),

Having consulted the European Central Bank in accordance with Article 105(4) of the Treaty,

Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),

Whereas:

(1)	The Action Plan on Economic and Monetary Union (EMU) Statistical Requirements endorsed by the Ecofin Council in September 2000 specifies that a limited set of quarterly sector accounts is urgently needed, and that these should be available within 90 days of the end of the quarter concerned.

(2)

The Joint Report of the Ecofin Council and the Commission to the European Council on Eurozone statistics and indicators, as adopted by the Ecofin Council on 18 February 2003, emphasizes that high priority actions in several fields, including quarterly national accounts by institutional sector, should be fully implemented by 2005.

(3)

The analysis of cyclical movements in the European Union economy and the conduct of monetary policy within the Economic and Monetary Union require macroeconomic statistics on the economic behaviour and the interrelationship of individual institutional sectors which are impossible to identify in data compiled at the level of the economy as a whole. There is, therefore, a need to produce quarterly accounts by institutional sector, for the European Union as a whole and for the euro area.

(4)

Production of these accounts is part of the overall aim to compile a system of annual and quarterly accounts for the European Union and for the euro area. The system includes the main macro-economic aggregates and the financial and non-financial accounts by institutional sector. The aim is to achieve consistency across all these accounts and, with regard to the rest of the world accounts, between the balance of payments and the national accounts data.

(5)

The compilation of European accounts by institutional sector, in accordance with the principles of the European System of national and regional Accounts in the Community (3), requires the transmission of quarterly national accounts by institutional sector of the Member States. However, the European accounts must reflect the economy of the European area as a whole and may differ from the simple aggregation of Member States' accounts. In particular, the objective is to take account of the transactions of the Institutions and bodies of the European Union in the accounts of the area concerned (the European Union or the euro-zone, whichever is applicable) .

(6)	The production of specific Community statistics is governed by the rules set out in Council Regulation (EC) No 322/97 of 17 February 1997 (4).

(7)

Since the objective of the action to be taken, namely the compilation of quarterly non-financial accounts by institutional sector for the European Union and the euro area, cannot be achieved satisfactorily by the Member States and can therefore, by reason of the scale and effects of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary to achieve that objective. In particular, where Member States make a negligible contribution to the European totals, they should not be required to report the full detail of data.

(8)	The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (5).

(9)	The Statistical Programme Committee and the Committee on Monetary, Financial and Balance of Payments Statistics have been consulted,

HAVE ADOPTED THIS REGULATION:

Article 1

Purpose

This Regulation provides a common framework for the contributions of the Member States to the compilation of quarterly European non-financial accounts by institutional sector.

Article 2

Transmission of quarterly non-financial accounts by institutional sector

1. Member States shall transmit to the Commission quarterly non-financial accounts by institutional sector, as specified in the Annex, except, in the first instance, items P.1, P.2, D.42, D.43, D.44, D.45 and B.4G.

2. A timetable for the transmission of items P.1, P.2, D.42, D.43, D.44, D.45, and B.4G, respectively, and any decision to require a breakdown of the transactions listed in the Annex by counterpart sector shall be adopted in accordance with the procedure referred to in Article 8(2).

3. The quarterly data referred to in paragraph 1 shall be delivered to the Commission at the latest 90 calendar days after the end of the quarter to which the data relate. Any revision of the data for previous quarters shall be transmitted at the same time.

4. The time of transmission specified in paragraph 3 may be adjusted, by a maximum of five days, in accordance with the procedure referred to in Article 8(2).

5. The first transmission of quarterly data shall relate to data for the first quarter of 2005. Member States shall deliver these data no later than 30 June 2005. This first transmission shall include back data for the periods from the first quarter of 1999.

Article 3

Reporting obligations

1. All Member States shall transmit the data described in the Annex, with respect to the rest of the world sector (S.2) and the general government sector (S.13). A Member State for which gross domestic product at current prices normally represents more than 1 % of the corresponding Community total shall transmit the data described in the Annex for all institutional sectors.

2. The Commission shall determine the percentage of Community total gross domestic product at current prices that a Member State's gross domestic product normally represents, as specified in paragraph 1, on the basis of the arithmetic mean of the latest three years' annual data transmitted by Member States.

3. The proportion (1 %) of the Community total referred to in paragraph 1 may be adjusted in accordance with the procedures referred to in Article 8(2).

4. Derogations from this Regulation may be accepted by the Commission if national statistical systems require major adaptation. Such derogations shall not last more than three years from the date of entry into force of this Regulation, or that of the implementing measures adopted in accordance with the procedure referred to in Article 8(2).

Article 4

Definitions and standards

The standards, definitions, classifications, and accounting rules for data transmitted for the purposes of this Regulation shall be those laid down in Regulation (EC) No 2223/96 (6) (hereinafter referred to as the ‘ESA Regulation’).

Article 5

Data sources and consistency requirements

1. Member States shall compile the information requested in this Regulation using all sources they consider relevant, giving priority to direct information such as administrative sources or surveys of enterprises and households.

When such direct information cannot be collected, in particular for the back data required under Article 2(5), best estimates may be transmitted.

2. Data transmitted by Member States for the purposes of this Regulation shall be consistent with the quarterly non-financial accounts of the general government and the quarterly main aggregates of the total economy, transmitted to the Commission under the data transmission programme of the ESA Regulation.

3. The quarterly data transmitted by Member States for the purposes of this Regulation shall be aligned with the corresponding annual data transmitted under the data transmission programme of the ESA Regulation.

Article 6

Quality standards and reports

1. Member States shall take all measures necessary to ensure that the quality of the data transmitted improves over time to meet the common quality standards to be defined in accordance with the procedure referred to in Article 8(2).

2. Member States shall supply the Commission with an up-to-date description of the sources, methods and statistical treatments used within a year of their first transmission of data.

3. Member States shall inform the Commission of major methodological or other changes that would affect the data transmitted not later than three months after such change takes effect.

Article 7

Implementing measures

The implementing measures shall be laid down in accordance with the procedure referred to in Article 8(2). Such measures shall include:

(a)	determining the timetable for the transmission of the items P.1, P.2, D.42, D.43, D.44, D.45 and B.4G pursuant to Article 2(2);

(b)	requiring the transactions shown in the Annex to be broken down by counterpart sector in accordance with Article 2(2);

(c)	revising the timetable of quarterly transmissions pursuant to Article 2(4);

(d)	adjusting the proportion (1 %) of the Community total to determine the obligation to transmit data for all institutional sectors pursuant to Article 3(3);

(e)	defining data quality standards in accordance with Article 6(1).

Article 8

Committee

1. The Commission shall be assisted by the Statistical Programme Committee set up by Council Decision 89/382/EEC, Euratom of 19 June 1989 (7).

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period referred to in Article 5(6) of Decision 1999/468/EC shall be three months.

3. The Committee shall adopt its rules of procedure.

Article 9

Report on implementation

Within five years of the entry into force of this Regulation, the Commission shall submit a report to the European Parliament and the Council on its implementation.

In particular, this report shall:

(a)	provide information on the quality of the statistics produced;

(b)	assess the benefits accruing to the Community, the Member States and the providers and users of statistical information of the statistics produced in relation to their costs;

(c)	identify areas for potential improvement and amendments considered necessary in light of the results obtained.

Article 10

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at ..., on ...

For the European Parliament

The President

For the Council

The President

(1) OJ C [...], [...], p. [...].

(2) Position of the European Parliament of 30 March 2004.

(3) Council Regulation (EC) No 2223/96 of 25 June 1996 (OJ L 310, 30.11.1996, p. 1).

(4) OJ L 52, 22.2.1997, p. 1. Regulation as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

(5) OJ L 184, 17.7.1999, p. 23.

(6) OJ L 310, 30.11.1996, p. 1.

(7) OJ L 181, 28.6.1989, p. 47.

Annex

Data transmission

USES

RESOURCES

S1N

S11

S12

S13

S14_S15

S1N

S11

S12

S13

S14_S15

Total economy

Unspecified Total Economy

Nonfinancial corporations

Financial corporations

General government

Households and NPISH

Rest of the world

Total economy

Unspecified Total Economy

Nonfinancial corporations

Financial corporations

General government

Households and NPISH

Rest of the world

P.1

Output

P.2

Intermediate Consumption

P.3

Final consumption expenditure

P.31

Individual consumption expenditure

P.32

Collective consumption expenditure

P.5

Gross capital formation

P.51

Gross fixed capital formation

P.5N

Changes in inventories and acquisitions less disposals of valuables

P.6

Exports of goods and services

P.7

Imports of goods and services

D.1

Compensation of employees

D.2

Taxes on production and imports

D.21

Taxes on products

D.29

Other taxes on production

D.3

Subsidies

D.31

Subventions sur les produits

D.39

Other subsidies on production

D.21-D.31

Taxes less subsidies (on products)

D.4

Property income

D.41

Interest

D.4N

Property income other than interest

D.42

Distributed income of corporations

D.43

Reinvested earings on F.D.I

D.44

Property income att. to policy insurance holders

D.45

Rents

D.5

Social contributions and benefits

D.6

Current taxes on income, wealth, etc.

D.61

Social contributions

D.62

Social benefits other than social transfers in kind

D.63

Social transfers in kind

D.7

Other current transfers

D.71

Net non-life insurance premiums

D.72

Non-life insurance claims

D.7N

Other current transfers, n.e.c

D.8

Adjustment for the change in net equity of households in pension funds reserves

D.9

Capital transfers

D.91

Capital taxes

D.9N

Investment grants and other capital transfers capital

K.1

Consumption of fixed capitals

K.2

Acqu. less disp. of non-fin. non-prod. assets

		BALANCING ITEMS
		S1	S1N	S11	S12	S13	S14_S15	S2
		Total Economy	Unspecified Total Economy	Nonfinancial corporations	Financial corporations	General government	Households and NPISH	Rest of the world
B.1G	Gross value added	X	X	X	X	X	X
B.1N	Net value added	X	X	X	X	X	X
B.2G	Operating surplus (Gross)	X		X	X	X	X
B.3G	Mixed income (Gross)	X					X
B.4G	Entrepreneurial income (Gross)	X		X	X		X
B.5G	Balance of primary incomes (Gross)	X		X	X	X	X
B.6G	Disposable income (Gross)	X		X	X	X	X
B.7G	Adjusted disposable income (Gross)	X				X	X
B.8G	Saving (Gross)	X		X	X	X	X
B.9	Net lending/net borrowing	X		X	X	X	X	X
B.11	External balance of goods and services							X
B.12	Current external balance							X

P5_TA(2004)0200

Temporary tax reductions for energy *

European Parliament legislative resolution on the proposal for a Council directive amending Directive 2003/96/EC as regards the possibility for certain Member States to apply, in respect of energy products and electricity, temporary exemptions or reductions in the levels of taxation (COM(2004) 42 — C5-0090/2004 — 2004/0016(CNS))

(Consultation procedure)

The European Parliament,

—	having regard to the Commission proposal to the Council (COM(2004) 42) (1),

—	having regard to Article 93 of the EC Treaty, pursuant to which the Council consulted Parliament (C5-0090/2004),

—	having regard to Rule 67 of its Rules of Procedure,

—	having regard to its opinion of 24 September 2003 on the draft Council directive on restructuring the Community framework for the taxation of energy products and electricity (2),

—	having regard to the report of the Committee on Economic and Monetary Affairs (A5-0158/2004),

1.	Approves the Commission proposal;

2.	Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament;

3.	Asks the Council to consult Parliament again if it intends to amend the Commission proposal substantially;

4.	Instructs its President to forward its position to the Council and Commission.

(1) Not yet published in the OJ.

(2) P5_TA(2003)0404.

P5_TA(2004)0201

EC-Swiss agreement on taxation of savings *

European Parliament legislative resolution on the proposal for a Council decision on the conclusion of the Agreement between the European Community and the Swiss Confederation providing for measures equivalent to those laid down in Council Directive 2003/48/EC of 3 June 2003 on taxation of savings income in the form of interest payments and the accompanying Memorandum of Understanding (COM(2004) 75 — C5-0103/2004 — 2004/0027(CNS))

(Consultation procedure)

The European Parliament,

—	having regard to the proposal for a Council decision (COM(2004) 75) (1),

—

having regard to the draft agreement between the European Community and the Swiss Confederation providing for measures equivalent to those laid down in Council Directive 2003/48/EC of 3 June 2003 on taxation of savings income in the form of interest payments and the accompanying Memorandum of Understanding,

—	having regard to Articles 94 and 300(2), first subparagraph, of the EC Treaty,

—	having regard to Article 300(3), first subparagraph, of the EC Treaty, pursuant to which the Council consulted Parliament (C5-0103/2004),

—	having regard to Rules 67 and 97(7) of its Rules of Procedure,

—	having regard to the report of the Committee on Economic and Monetary Affairs (A5-0169/2004),

1.	Approves the proposal for a Council decision as amended and approves the conclusion of the agreement;

2.	Instructs its President to forward its position to the Council and Commission, and the governments and parliaments of the Member States and the Swiss Confederation.

TEXT PROPOSED BY THE COMMISSION	AMENDMENTS BY PARLIAMENT
Amendment 1
Recital 4a (new)
	(4a) The ultimate aim is to enable savings income in the form of interest payments made in one Member State to beneficial owners, individuals, resident in another Member State to be made subject to effective taxation which is needed to fight against harmful tax competition and to contribute towards improving the functioning of the single market by removing artificial incentives to the flow of capital in the EU and beyond.
Amendment 2
Recital 4b (new)
	(4b) The equitable and effective tax treatment of savings in Europe necessarily implies that Member States should have the right to tax the EU-wide income of their residents according to their own domestic tax rules and tax scales.
Amendment 3
Recital 4c (new)
	(4c) The best method of taxing savings effectively is for information to be exchanged automatically between tax authorities.
Amendment 4
Recital 4d (new)
	(4d) Switzerland, like some Member States, has opted for a withholding tax at source, in connection with Directive 2003/48/EC, and will introduce such a tax on funds from European Union residents, 75% of the revenue generated by the tax being transferred to the Member State of residence of the beneficial owner.
Amendment 5
Recital 4e (new)
	(4e) Nevertheless, consideration needs to be given to the needs of the banking sectors of some Member States and their structural differences by allowing them to have a transitional period during which they will levy a withholding tax, at a rate increasing progressively to 35 %; until full information exchange is achieved this will ensure a minimum level of effective taxation; the greater part of this revenue should be transferred to the Member State of residence of the beneficial owner of the interest.
Amendment 6
Recital 4f (new)
	(4f) In order to prevent the flight of capital from the European Union, the application of this agreement is conditional upon the adoption and implementation by the dependent or associated territories of the Member States mentioned in the Feira European Council Decision of 19 and 20 June 2000, as well as the United States of America, Andorra, Liechtenstein, Monaco and San Marino, respectively, of measures which conform with or are equivalent to those contained in Directive 2003/48/EC or in the present agreement on the taxation of savings income in the form of interest payments.
Amendment 7
Recital 4g (new)
	(4g) The conclusion of an agreement with Switzerland should not be linked to ongoing negotiations with other parties.
Amendment 8
Recital 4h (new)
	(4h) It is imperative that negotiations with the above-mentioned third countries be concluded in a timely manner; no further counter-requests from these countries should be accepted; agreements with these countries should include the same fundamental elements as those in the agreement with Switzerland.
Amendment 9
Recital 4i (new)
	(4i) The same measures will be applied in all relevant dependent or associated territories (the Channel Islands, Isle of Man and the dependent or associated territories in the Caribbean).

(1) Not yet published in the OJ.

P5_TA(2004)0202

Taxation of interest and royalty payments in different Member States *

European Parliament legislative resolution on the proposal for a Council directive amending Directive 2003/49/EC on a common system of taxation applicable to interest and royalty payments made between associated companies of different Member States (COM(2003) 841 — C5-0054/2004 — 2003/0331(CNS))

(Consultation procedure)

The European Parliament,

—	having regard to the Commission proposal to the Council (COM(2003) 841) (1),

—	having regard to Article 94 of the EC Treaty, pursuant to which the Council consulted Parliament (C5-0054/2004),

—	having regard to Rule 67 of its Rules of Procedure,

—	having regard to the report of the Committee on Economic and Monetary Affairs (A5-0150/2004),

1.	Approves the Commission proposal as amended;

2.	Calls on the Commission to alter its proposal accordingly, pursuant to Article 250(2) of the EC Treaty;

3.	Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament;

4.	Asks the Council to consult Parliament again if it intends to amend the Commission proposal substantially;

5.	Instructs its President to forward its position to the Council and Commission.

TEXT PROPOSED BY THE COMMISSION

AMENDMENTS BY PARLIAMENT

Amendment 3

ARTICLE 1, POINT 1a (new)

Article 3, point (a), subparagraph (i) (Directive 2003/49/EC)

1a)

Article 3, point (a), subparagraph (i) shall be modified as follows:

(i)	taking one of the forms listed in the Annex to Council Directive 90/435/EEC of 23 July 1990 on the common system of taxation applicable in the case of parent companies and subsidiaries of different Member States (2); and

Amendment 1

ARTICLE 1, POINT 1b (new)

Article 3, point (b), subparagraph 1 (Directive 2003/49/EC)

1b)

Article 3, point b, subparagraph 1 shall be modified as follows:

(b)

a company is an ‘associated company’ of a second company if, at least:

(i)	the first company has a direct minimum holding of 20% (from 1 January 2007 the minimum shall be 15 %; from 1 January 2009 the minimum shall be 10 %) in the capital of the second company, or

(ii)	the second company has a direct minimum holding of 20% (from 1 January 2007 the minimum shall be 15 %; from 1 January 2009 the minimum shall be 10 %) in the capital of the first company, or

(iii)

a third company has a direct minimum holding of 20% (from 1 January 2007 the minimum shall be 15 %; from 1 January 2009 the minimum shall be 10 %) both in the capital of the first company and in the capital of the second company.

Amendment 2

ARTICLE 1, paragraph 2

Annex (Directive 2003/49/EC)

2.	The Annex is replaced by the text in the Annex to this Directive.

2. The Annex is deleted.

(1) Not yet published in the OJ.

(2) OJ L 225, 20.8.1990, p. 6. Directive as last amended by Directive 2003/123/EC (OJ L 7, 13.1.2004, p. 41).

P5_TA(2004)0203

European Civil Service Tribunal *

European Parliament legislative resolution on the proposal for a Council decision establishing the European Civil Service Tribunal (COM(2003) 705 — C5-0581/2003 — 2003/0280(CNS))

(Consultation procedure)

The European Parliament,

—	having regard to the Commission proposal to the Council (COM(2003) 705) (1),

—	having regard to Articles 225a and 245 of the EC Treaty and Articles 140b and 160 of the EAEC Treaty, pursuant to which the Council consulted Parliament (C5-0581/2003),

—	having regard to Rule 67 of its Rules of Procedure,

—	having regard to the report of the Committee on Legal Affairs and the Internal Market (A5-0181/2004),

1.	Approves the Commission proposal as amended;

2.	Calls on the Commission to alter its proposal accordingly, pursuant to Article 250(2) of the EC Treaty and Article 119, second paragraph, of the EAEC Treaty;

3.	Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament;

4.	Calls for initiation of the conciliation procedure under the Joint Declaration of 4 March 1975 if the Council intends to depart from the text approved by Parliament;

5.	Asks the Council to consult Parliament again if it intends to amend the Commission proposal substantially;

6.	Instructs its President to forward its position to the Council and Commission.

TEXT PROPOSED BY THE COMMISSION

AMENDMENTS BY PARLIAMENT

Amendment 1

ARTICLE 2, POINT 1

Title VI (Protocol on the Statute of the Court of Justice)

The following Title VI shall be added:

Titre VI

JUDICIAL PANELS

Article 65

The provisions relating to the jurisdiction, composition, organisation and procedure of the judicial panels established under Articles 225a of the EC Treaty and 140b of the Euratom Treaty are set forth in an Annex to this Statute.

The following Title IVa shall be added:

Title IVa

JUDICIAL PANELS

Article 62a

Amendment 2

ANNEX

Annex I, Article 2, paragraph 1 (Protocol on the Statute of the Court of Justice)

The Civil Service Tribunal shall consist of six judges, appointed for a period of six years by the Council from among candidates presented by the Member States after consulting the committee provided for by Article 3.

The Civil Service Tribunal shall consist of six judges, appointed for a period of six years by the Council from among candidates appearing on the list presented by the committee provided for by Article 3 , following a procedure calling for applications. The committee shall adopt an opinion before the Council takes its decision .

Amendment 3

ANNEX

Annex I, Article 3 (Protocol on the Statute of the Court of Justice)

A committee shall be set up to give an opinion on candidates' suitability to perform the duties of judge at the Civil Service Tribunal before the appointment decision is taken. The committee may append to its Opinion a list of candidates having the most suitable high-level experience. Such list shall contain the names of twice as many candidates as there are judges to be appointed by the Council. The committee shall comprise seven persons chosen from among former members of the Court of Justice and the Court of First Instance and lawyers of recognised competence.

A committee shall be set up to give an opinion on candidates' suitability to perform the duties of judge at the Civil Service Tribunal before the appointment decision is taken. The committee shall append to its Opinion a list of candidates having the most suitable high-level experience. Such list shall contain the names of twice as many candidates as there are judges to be appointed by the Council. The committee shall comprise seven persons chosen from among former members of the Court of Justice and the Court of First Instance and lawyers of recognised competence , one of whom shall be proposed by the European Parliament .

The committee's membership and operating rules shall be determined by the Council, acting by a qualified majority on a recommendation by the President of the Court of Justice.

The committee's membership and operating rules shall be determined by the Council, acting by a qualified majority , after consulting the European Parliament and on a recommendation by the President of the Court of Justice.

Amendment 4

ANNEX

Annex I, Article 7, paragraph 2 (Protocol on the Statute of the Court of Justice)

2. Without prejudice to Article 40 of the Statute of the Court of Justice, the written stage of the procedure shall comprise the presentation of the application and of the statement of defence, unless the Civil Service Tribunal decides that a second exchange of written pleadings is necessary. Where there is such second exchange, the Civil Service Tribunal may, after hearing the parties, decide to proceed to judgment without an oral procedure.

2. Without prejudice to Article 40 of the Statute of the Court of Justice, the written stage of the procedure shall comprise the presentation of the application and of the statement of defence, unless the Civil Service Tribunal decides that a second exchange of written pleadings is necessary. The Civil Service Tribunal may, after hearing the parties, decide to proceed to judgment without an oral procedure.

Amendment 5

ANNEX

Annex I, Article 7, paragraph 3 (Protocol on the Statute of the Court of Justice)

3. At all stages of the procedure, including the time when the application is filed, the Civil Service Tribunal shall examine the possibilities of an amicable settlement of the dispute and shall be at pains to facilitate such settlement.

Deleted

(1) Not yet published in the OJ.

P5_TA(2004)0204

Protocol on the Statute of the Court of Justice *

European Parliament legislative resolution on a draft Council decision amending Articles 16 and 17 of the Protocol on the Statute of the Court of Justice (14617/2003 — C5-0579/2003 — 2003/0823(CNS))

(Consultation procedure)

The European Parliament,

—	having regard to the draft Council decision (14617/2003) (1),

—	having regard to Article 245(2) of the EC Treaty and Article 160(2) of the EAEC Treaty, pursuant to which the Council consulted Parliament (C5-0579/2003),

—	having regard to Rule 67 of its Rules of Procedure,

—	having regard to the report of the Committee on Legal Affairs and the Internal Market (A5-0128/2004),

1.	Approves the draft Council decision;

2.	Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament;

3.	Calls for initiation of the conciliation procedure under the Joint Declaration of 4 March 1975 if the Council intends to depart from the text approved by Parliament;

4.	Instructs its President to forward its position to the Council and Commission.

(1) Not yet published in the OJ.

P5_TA(2004)0205

Rules of Procedure of the Court of Justice governing languages *

European Parliament legislative resolution on the draft Council decision amending the Rules of Procedure of the Court of Justice of the European Communities with regard to the rules governing languages (Article 29) (15167/2003 — C5-0585/2003 — 2003/0824(CNS))

(Consultation procedure)

The European Parliament,

—	having regard to the Council draft decision (15167/2003) (1),

—

having regard to the Commission opinion under the second paragraph of Article 245 of the EC Treaty on the requests for amendment of Article 29 of the Rules of Procedure of the Court of Justice and Article 35 of the Rules of Procedure of the Court of First Instance, presented by the Court of Justice and the Court of First Instance in accordance with Article 64 of the Statute of the Court of Justice (SEC(2004) 223),

—	having regard to Article 245(2) of the EC Treaty and Article 160(2) of the EAEC Treaty, pursuant to which the Council consulted Parliament (C5-0585/2003),

—	having regard to Rule 67 of its Rules of Procedure,

—	having regard to the report of the Committee on Legal Affairs and the Internal Market (A5-0127/2004),

1.	Approves the Council draft decision;

2.	Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament;

3.	Calls for initiation of the conciliation procedure under the Joint Declaration of 4 March 1975 if the Council intends to depart from the text approved by Parliament;

4.	Instructs its President to forward its position to the Council and Commission.

(1) Not yet published in the OJ.

P5_TA(2004)0206

Rules of Procedure of the Court of First Instance governing the language of proceedings *

European Parliament legislative resolution on the proposal for a Council decision amending Article 35 of the Rules of Procedure of the Court of First Instance with regard to the language of proceedings, with a view to the new division of jurisdiction in direct actions and the enlargement of the Union (15738/2003 — C5-0625/2003 — 2003/0825(CNS))

(Consultation procedure)

The European Parliament,

—	having regard to the proposal for a Council decision (15738/2003) (1),

—

having regard to the Commission's opinion under the second paragraph of Article 245 of the EC Treaty on the requests for amendment of Article 29 of the Rules of Procedure of the Court of Justice and Article 35 of the Rules of Procedure of the Court of First Instance, presented by the Court of Justice and the Court of First Instance in accordance with Article 64 of the Statute of the Court of Justice (SEC(2004) 223),

—	having regard to Article 245(2) of the EC Treaty and Article 160(2) of the EAEC Treaty, pursuant to which the Council consulted Parliament (C5-0625/2003),

—	having regard to Rule 67 of its Rules of Procedure,

—	having regard to the report of the Committee on Legal Affairs and the Internal Market (A5-0126/2004),

1.	Approves the proposal for a Council decision;

2.	Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament;

3.	Calls for initiation of the conciliation procedure under the Joint Declaration of 4 March 1975 if the Council intends to depart from the text approved by Parliament;

4.	Instructs its President to forward its position to the Council and Commission.

(1) Not yet published in the OJ.

P5_TA(2004)0207

Imports of live ungulate animals *

European Parliament legislative resolution on the proposal for a Council directive on laying down animal health rules for the importation into the Community of certain live ungulate animals, and amending Directives 90/426/EEC and 92/65/EEC (COM(2003) 570 — C5-0483/2003 — 2003/0224(CNS))

(Consultation procedure)

The European Parliament,

—	having regard to the Commission proposal to the Council (COM(2003) 570) (1),

—	having regard to Article 37 of the EC Treaty, pursuant to which the Council consulted Parliament (C5-0483/2003),

—	having regard to Rule 67 of its Rules of Procedure,

—	having regard to the report of the Committee on the Environment, Public Health and Consumer Policy (A5-0186/2004),

1.	Approves the Commission proposal as amended;

2.	Calls on the Commission to alter its proposal accordingly, pursuant to Article 250(2) of the EC Treaty;

3.	Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament;

4.	Asks the Council to consult Parliament again if it intends to amend the Commission proposal substantially;

5.	Instructs its President to forward its position to the Council and Commission.

TEXT PROPOSED BY THE COMMISSION

AMENDMENTS BY PARLIAMENT

Amendment 1

ARTICLE 1

This Directive lays down the animal health requirements for the importation into the Community of live ungulate animals of the species listed in Annex I.

This Directive lays down the animal health requirements for the importation into or transit through the Community of live ungulate animals of the species listed in Annex I

(This amendment applies throughout the text.)

Amendment 2

ARTICLE 2, POINT (ca) (new)

(ca)	‘ungulates’: means those animals listed in Annex I.

Amendment 3

ARTICLE 8, POINT (e)

(e)	accompany their owners as pet animals or;

(e)

accompany their owners as pet animals notwithstanding their absence from the animal health requirements of Regulation (EC) No 998/2003 of the European Parliament and of the Council of 26 May 2003 on the animal health requirements applicable to the non-commercial movement of pet animals and amending Council Directive 92/65/EEC (2), if they are listed in this Directive as ungulates acceptable as pets or;

Amendment 4

ARTICLE 9

By way of derogation from Article 7(a), and in accordance with the procedure referred to in Article 14(2), conditions may be established for the importation of live ungulate animals into the Community from an authorised third country where certain diseases listed in Annex II are present and/or vaccinations against those diseases are carried out;

By way of derogation from Article 7 (a), and in accordance with the procedure referred to in Article 14 (2), conditions may be established for the importation of live ungulate animals into the Community from an authorised third country where certain diseases listed in Annex II are present and/or vaccinations against those diseases are carried out. Derogations shall be made on a case-by-case basis.

Amendment 5

ARTICLE 17, POINT 1a (NEW)

Article 19, point (iiia) (new) (Directive 90/426/EEC)

1a.

In Article 19 the following point is added:

(iiia)

may designate a Community Reference Laboratory for one or more of the equine diseases mentioned in Annex A and establish the functions, duties and the procedures for collaboration with laboratories in charge of diagnosing equine infectious diseases in Member States.

(1) Not yet published in the OJ.

(2) OJ L 146, 13.6.2003, p. 1.

P5_TA(2004)0208

Data on the quarterly government debt *

European Parliament legislative resolution on the proposal for a Council regulation on the compilation and transmission of data on the quarterly government debt (COM(2003) 761 — C5-0649/2003 — 2003/0295(CNS))

(Consultation procedure)

The European Parliament,

—	having regard to the Commission proposal to the Council (COM(2003) 761) (1),

—	having regard to Article 104 of the EC Treaty, pursuant to which the Council consulted Parliament (C5-0649/2003),

—	having regard to Rule 67 of its Rules of Procedure,

—	having regard to the report of the Committee on Economic and Monetary Affairs (A5-0170/2004),

1.	Approves the Commission proposal as amended;

2.	Calls on the Commission to alter its proposal accordingly, pursuant to Article 250(2) of the EC Treaty;

3.	Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament;

4.	Calls for initiation of the conciliation procedure under the Joint Declaration of 4 March 1975 if the Council intends to depart from the text approved by Parliament;

5.	Asks the Council to consult Parliament again if it intends to amend the Commission proposal substantially;

6.	Instructs its President to forward its position to the Council and Commission.

TEXT PROPOSED BY THE COMMISSION	AMENDMENTS BY PARLIAMENT
Amendment 1
Article 4, paragraph 1
1. If the Council decides to amend Regulation (EC) No 3605/93, in accordance with the rules on competence and procedure laid down in the Treaty, the Council shall simultaneously amend this Regulation, so that the definitions of quarterly government debt and of government debt outstanding at the end of the year are kept consistent.	1. If the Council decides to amend Regulation (EC) No 3605/93, in accordance with the rules on competence and procedure laid down in the Treaty, the Council shall simultaneously amend Article 1 of this Regulation, so that the definitions of quarterly government debt and of government debt outstanding at the end of the year are kept consistent.
Amendment 2
Article 4, paragraph 2
2. If the Commission introduces new references to ESA 95 into Article 1(5) of Regulation (EC) No 3605/93, in accordance with Article 7 thereof, the Commission shall simultaneously introduce the same new references into this Regulation, so that the definitions of quarterly government debt and of government debt outstanding at the end of the year are kept consistent.	2. If the Commission introduces new references to ESA 95 into Article 1(5) of Regulation (EC) No 3605/93, in accordance with Article 7 thereof, the Commission shall simultaneously introduce the same new references into Article 1 of this Regulation, so that the definitions of quarterly government debt and of government debt outstanding at the end of the year are kept consistent.

(1) Not yet published in OJ.

P5_TA(2004)0209

Parliamentary immunity of Mr Pannella

European Parliament decision on the request for defence of the immunity of Mr Marco Pannella (2003/2116(IMM))

The European Parliament,

—

having regard to a request for the defence of the immunity of Mr Marco Pannella, following his sentencing to a term of imprisonment, — subsequently commuted to an order restricting his freedom of movement — for acts which took place in Italy, as submitted by Mr Maurizio Turco on 29 April 2003 and communicated to Parliament, meeting in plenary, on 4 June 2003,

—	having regard to Articles 9 and 10 of the Protocol on the Privileges and Immunities of the European Communities of 8 April 1965, and to Article 4(2) of the Act of 20 September 1976 concerning the election of representatives to the European Parliament by direct universal suffrage,

—	having regard to the judgments of the Court of Justice of the European Communities of 12 May 1964 and 10 July 1986 (1),

—	having regard to Rules 6 and 6a of its Rules of Procedure,

—	having regard to the report of the Committee on Legal Affairs and the Internal Market (A5-0180/2004),

A.	whereas Article 10(a) of the aforementioned Protocol confers on Members of the European Parliament in their own State immunity from legal proceedings equivalent to that of a Member of the Parliament of that State,

B.	whereas Mr Pannella was elected as a Member of Parliament in Italy,

C.	whereas Mr Pannella, following a conviction having the force of res judicata pronounced by the Italian authorities, was in the past subject to an order restricting his freedom of movement for eight months, in connection with public actions concerning the use of prohibited drugs,

D.	whereas such actions were clearly a part of his political activity carried on in good faith and involving collective acts of symbolic law-breaking,

E.	whereas, however, it appears that Members of the Italian Parliament do not enjoy Parliamentary immunity in such circumstances,

F.	whereas, on the evidence provided, Mr Pannella is not protected by parliamentary immunity in respect of the legal proceedings which have been drawn to the attention of the President of the European Parliament,

1.	Decides that it would not be appropriate to take any action to raise questions concerning Mr Pannella's political activity with the Italian authorities.

(1) Case 101/63 Wagner v. Fohrmann and Krier [1964] ECR 195 and Case 149/85 Wybot v. Faure [1986] ECR 2391.

P5_TA(2004)0210

Parliamentary immunity of Mr Schulz

European Parliament decision on the request for defence of parliamentary immunity and privileges submitted by Martin Schulz (2004/2016(IMM))

The European Parliament,

—	having regard to a request for defence of his immunity and privileges submitted by Martin Schulz and announced in plenary session on 26 February 2004 in connection with civil legal proceedings (application for interim relief and main proceedings) pending before the Hamburg District Court,

—	having regard to Article 9 of the Protocol on the privileges and immunities of the European Communities of 8 April 1965, and to Article 4(2) of the Act concerning the election of representatives to the European Parliament by direct universal suffrage of 20 September 1976,

—	having regard to the judgments of the Court of Justice of the European Communities of 12 May 1964 and 10 July 1986 (1),

—	having regard to Rules 6 and 6a of its Rules of Procedure,

—	having regard to the report of the Committee on Legal Affairs and the Internal Market (A5-0184/2004),

A.	whereas Martin Schulz was elected to the European Parliament in the fifth elections held from 10 to 13 June 1999, and whereas his credentials were verified by Parliament on 15 December 1999 (2),

B.	whereas Members of the European Parliament may not be subject to any form of inquiry, detention or legal proceedings in respect of opinions expressed or votes cast by them in the performance of their duties (3),

C.	whereas the civil proceedings engaged against Martin Schulz before the Hamburg District Court refer to opinions expressed in a press statement directly linked to a matter at that time under discussion in Parliament,

D.	whereas the immunity from legal proceedings enjoyed by Members of the European Parliament also covers immunity from civil proceedings,

E.	whereas, in order to be effective, this protection must cover both the application for interim relief and the main proceedings,

F.	whereas Members of the European Parliament have a responsibility to participate in political affairs or make press statements, and accordingly when they publish such statements on controversial topics, they are properly deemed to be engaged in the performance of their duties as MEPs,

1.	Decides to defend the immunity and privileges of Martin Schulz;

2.	Proposes, on the grounds of Article 9 of the aforementioned protocol and with due respect for the procedures in the Member State concerned, to hold that in the case in question, proceedings may not be pursued and invites the Court to draw the necessary conclusions;

Requests the Commission to verify whether § 5, second sentence, of the Europaabgeordnetengesetz (Members of the European Parliament Act) of the Federal Republic of Germany is compatible with Community law, in particular Article 9 of the Protocol on the privileges and immunities of the European Communities;

4.	Instructs its President immediately to forward this decision and the report of its committee to the German authorities and the Hamburg District Court and to the Commission.

(1) See Case 101/63 Wagner v. Fohrmann and Krier [1964] ECR 399 and Case 149/85 Wybot v. Faure [1986] ECR 2403.

(2) European Parliament decision on the verification of credentials of Members following the fifth direct elections to the European Parliament on 10 to 13 June 1999 (OJ C 296, 18.10.2000, p. 93).

(3) Article 9 of the Protocol on the privileges and immunities of the European Communities.

P5_TA(2004)0211

Parliamentary immunity of Mr Lehne

European Parliament decision on the request for defence of parliamentary immunity and privileges submitted by Klaus-Heiner Lehne (2004/2015(IMM))

The European Parliament,

—	having regard to a request for defence of his immunity and privileges submitted by Klaus-Heiner Lehne and announced in plenary session on 26 February 2004 in connection with civil legal proceedings (application for interim relief and main proceedings) pending before the Hamburg District Court,

—	having regard to Article 9 of the Protocol on the privileges and immunities of the European Communities of 8 April 1965, and to Article 4(2) of the Act concerning the election of representatives to the European Parliament by direct universal suffrage of 20 September 1976,

—	having regard to the judgments of the Court of Justice of the European Communities of 12 May 1964 and 10 July 1986 (1),

—	having regard to Rules 6 and 6a of its Rules of Procedure,

—	having regard to the report of the Committee on Legal Affairs and the Internal Market (A5-0185/2004),

A.	whereas Klaus-Heiner Lehne was elected to the European Parliament in the fifth elections held from 10 to 13 June 1999, and whereas his credentials were verified by Parliament on 15 December 1999 (2),

B.	whereas Members of the European Parliament may not be subject to any form of inquiry, detention or legal proceedings in respect of opinions expressed or votes cast by them in the performance of their duties (3),

C.	whereas the civil proceedings engaged against Klaus-Heiner Lehne before the Hamburg District Court refer to opinions expressed in a press statement directly linked to a matter at that time under discussion in Parliament,

D.	whereas the immunity from legal proceedings enjoyed by Members of the European Parliament also covers immunity from civil proceedings,

E.	whereas, in order to be effective, this protection must cover both the application for interim relief and the main proceedings,

F.	whereas Members of the European Parliament have a responsibility to participate in political affairs or make press statements, and accordingly, when they publish such statements on controversial topics they are properly deemed to be engaged in the performance of their duties as MEPs,

1.	Decides to defend the immunity and privileges of Klaus-Heiner Lehne;

2.	Proposes, on the grounds of Article 9 of the aforementioned protocol and with due respect for the procedures in the Member State concerned, to hold that in the case in question, proceedings may not be pursued and invites the Court to draw the necessary conclusions;

Requests the Commission to verify whether § 5, second sentence, of the Europaabgeordnetengesetz [Members of the European Parliament Act] of the Federal Republic of Germany is compatible with Community law, in particular Article 9 of the Protocol on the privileges and immunities of the European Communities;

4.	Instructs its President immediately to forward this decision and the report of its committee to the German authorities and the Hamburg District Court and to the Commission.

(1) See Case 101/63 Wagner v. Fohrmann and Krier [1964] ECR 399 and Case 149/85 Wybot v. Faure [1986] ECR 2403.

(2) European Parliament decision on the verification of credentials of Members following the fifth direct elections to the European Parliament on 10 to 13 June 1999 (OJ C 296, 18.10.2000, p. 93).

(3) Article 9 of the Protocol on the privileges and immunities of the European Communities.

P5_TA(2004)0212

Markets in financial instruments ***II

European Parliament legislative resolution on the Council common position for adopting a European Parliament and Council directive on markets in financial instruments, amending Council Directives 85/611/EEC and 93/6/EEC and Directive 2000/12/EC of the European Parliament and of the Council and repealing Council Directive 93/22/EEC (13421/3/2003 — C5-0015/2004 — 83/0269(COD))

(Codecision procedure: second reading)

The European Parliament,

—	having regard to the Council common position (13421/3/2003 — C5-0015/2004) (1),

—	having regard to its position at first reading (2) on the Commission proposal to Parliament and the Council (COM(83) 625) (3),

—	having regard to Article 251(2) of the EC Treaty,

—	having regard to Rule 80 of its Rules of Procedure,

—	having regard to the recommendation for second reading of the Committee on Economic and Monetary Affairs (A5-0114/2004),

1.	Amends the common position as follows;

2.	Instructs its President to forward its position to the Council and Commission.

(1) Not yet published in OJ.

(2) Texts Adopted, 25.9.2003, P5_TA(2003)0410.

(3) OJ C 71 E, 25.3.2003, p. 62.

P5_TC2-COD(83)0269

Position of the European Parliament adopted at second reading on 30 March 2004 with a view to the adoption of European Parliament and Council Directive 2004/.../EC on markets in financial instruments, amending Council Directives 85/611/EEC and 93/6/EEC and Directive 2000/12/EC of the European Parliament and of the Council and repealing Council Directive 93/22/EEC

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 47(2) thereof,

Having regard to the proposal from the Commission (1),

Having regard to the Opinion of the European Economic and Social Committee (2),

Having regard to the opinion of the European Central Bank (3),

Acting in accordance with the procedure laid down in Article 251 of the Treaty (4),

Whereas:

(1)

Council Directive 93/22/EEC of 10 May 1993 on investment services in the securities field (5) sought to establish the conditions under which authorised investment firms and banks could provide specified services or establish branches in other Member States on the basis of home country authorisation and supervision. To this end, that Directive aimed to harmonise the initial authorisation and operating requirements for investment firms including conduct of business rules. It also provided for the harmonisation of some conditions governing the operation of regulated markets.

(2)

In recent years more investors have become active in the financial markets and are offered an even more complex wide-ranging set of services and instruments. In view of these developments the legal framework of the Community should encompass the full range of investor-oriented activities. To this end, it is necessary to provide for the degree of harmonisation needed to offer investors a high level of protection and to allow investment firms to provide services throughout the Community, being a Single Market, on the basis of home country supervision. In view of the preceding, Directive 93/22/EEC should be replaced by a new Directive.

(3)	Due to the increasing dependence of investors on personal recommendations, it is appropriate to include the provision of investment advice as an investment service requiring authorisation.

(4)	It is appropriate to include in the list of financial instruments certain commodity derivatives and others which are constituted and traded in such a manner as to give rise to regulatory issues comparable to traditional financial instruments.

(5)

It is necessary to establish a comprehensive regulatory regime governing the execution of transactions in financial instruments irrespective of the trading methods used to conclude those transactions so as to ensure a high quality of execution of investor transactions and to uphold the integrity and overall efficiency of the financial system. A coherent and risk-sensitive framework for regulating the main types of order-execution arrangement currently active in the European financial marketplace should be provided for. It is necessary to recognise the emergence of a new generation of organised trading systems alongside regulated markets which should be subjected to obligations designed to preserve the efficient and orderly functioning of financial markets. With a view to establishing a proportionate regulatory framework provision should be made for the inclusion of a new investment service which relates to the operation of an MTF.

(6)

Definitions of regulated market and MTF should be introduced and closely aligned with each other to reflect the fact that they represent the same organised trading functionality. The definitions should exclude bilateral systems where an investment firm enters into every trade on own account and not as a riskless counterparty interposed between the buyer and seller. The term ‘system’ encompasses all those markets that are composed of a set of rules and a trading platform as well as those that only function on the basis of a set of rules. Regulated markets and MTFs are not obliged to operate a ‘technical’ system for matching orders. A market which is only composed of a set of rules that governs aspects related to membership, admission of instruments to trading, trading between members, reporting and, where applicable, transparency obligations is a regulated market or an MTF within the meaning of this Directive and the transactions concluded under those rules are considered to be concluded under the systems of a regulated market or an MTF. The term ‘buying and selling interests’ is to be understood in a broad sense and includes orders, quotes and indications of interest. The requirement that the interests be brought together in the system by means of nondiscretionary rules set by the system operator means that they are brought together under the system's rules or by means of the system's protocols or internal operating procedures (including procedures embodied in computer software). The term ‘non-discretionary rules’ means that these rules leave the investment firm operating an MTF with no discretion as to how interests may interact. The definitions require that interests be brought together in such a way as to result in a contract, meaning that execution takes place under the system's rules or by means of the system's protocols or internal operating procedures.

(7)	The purpose of this Directive is to cover undertakings the regular occupation or business of which is to provide investment services and/or perform investment activities on a professional basis. Its scope should not therefore cover any person with a different professional activity.

(8)

Persons administering their own assets and undertakings, who do not provide investment services and/or perform investment activities other than dealing on own account unless they are market makers or they dealon own account outside a regulated market or an MTF on an organised, frequent and systematic basis, by providing a system accessible to third parties in order to engage in dealings with them should not be covered by the scope of this Directive.

(9)	References in the text to persons should be understood as including both natural and legal persons.

(10)

Insurance or assurance undertakings the activities of which are subject to appropriate monitoring by the competent prudential-supervision authorities and which are subject to Council Directive 64/225/EEC of 25 February 1964 on the abolition of restrictions on freedom of establishment and freedom to provide services in respect of reinsurance and retrocession (6), First Council Directive 73/239/EEC of 24 July 1973 on the coordination of laws, regulations and administrative provisions relating to the taking up and pursuit of direct insurance other than life assurance (7) and Council Directive 2002/83/EC of 5 November 2002 concerning life assurance (8) should be excluded.

(11)	Persons who do not provide services for third parties but whose business consists in providing investment services solely for their parent undertakings, for their subsidiaries, or for other subsidiaries of their parent undertakings should not be covered by this Directive.

(12)

Persons who provide investment services only on an incidental basis in the course of professional activity should also be excluded from the scope of this Directive, provided that activity is regulated and the relevant rules do not prohibit the provision, on an incidental basis, of investment services.

(13)	Persons who provide investment services consisting exclusively in the administration of employeeparticipation schemes and who therefore do not provide investment services for third parties should not be covered by this Directive.

(14)

It is necessary to exclude from the scope of this Directive central banks and other bodies performing similar functions as well as public bodies charged with or intervening in the management of the public debt, which concept covers the investment thereof, with the exception of bodies that are partly or wholly State-owned the role of which is commercial or linked to the acquisition of holdings.

(15)	It is necessary to exclude from the scope of this Directive collective investment undertakings and pension funds whether or not coordinated at Community level, and the depositaries or managers of such undertakings, since they are subject to specific rules directly adapted to their activities.

(16)

In order to benefit from the exemptions from this Directive the person concerned should comply on a continuous basis with the conditions laid down for such exemptions. In particular, if a person provides investment services or performs investment activities and is exempted from this Directive because such services or activities are ancillary to his main business, when considered on a group basis, he should no longer be covered by the exemption related to ancillary services where the provision of those services or activities ceases to be ancillary to his main business.

(17)	Persons who provide the investment services and/or perform investment activities covered by this Directive should be subject to authorisation by their home Member States in order to protect investors and the stability of the financial system.

(18)

Credit institutions that are authorised under Directive 2000/12/EC of the European Parliament and of the Council of 20 March 2000 relating to the taking up and pursuit of the business of credit institutions (9) should not need another authorisation under this Directive in order to provide investment services or perform investment activities. When a credit institution decides to provide investment services or perform investment activities the competent authorities, before granting an authorisation, should verify that it complies with the relevant provisions of this Directive.

(19)	In cases where an investment firm provides one or more investment services not covered by its authorisation, or performs one or more investment activities not covered by its authorisation, on a non-regular basis it should not need an additional authorisation under this Directive.

(20)	For the purposes of this Directive, the business of the reception and transmission of orders should also include bringing together two or more investors thereby bringing about a transaction between those investors.

(21)

In the context of the forthcoming revision of the Capital Adequacy framework in Basel II, Member States recognise the need to re-examine whether or not investment firms who execute client orders on a matched principal basis are to be regarded as acting as principals, and thereby be subject to additional regulatory capital requirements.

(22)

The principles of mutual recognition and of home Member State supervision require that the Member States' competent authorities should not grant or should withdraw authorisation where factors such as the content of programmes of operations, the geographical distribution or the activities actually carried on indicate clearly that an investment firm has opted for the legal system of one Member State for the purpose of evading the stricter standards in force in another Member State within the territory of which it intends to carry on or does carry on the greater part of its activities. An investment firm which is a legal person should be authorised in the Member State in which it has its registered office. An investment firm which is not a legal person should be authorised in the Member State in which it has its head office. In addition, Member States should require that an investment firm's head office must always be situated in its home Member State and that it actually operates there.

(23)

An investment firm authorised in its home Member State should be entitled to provide investment services or perform investment activities throughout the Community without the need to seek a separate authorisation from the competent authority in the Member State in which it wishes to provide such services or perform such activities.

(24)

Since certain investment firms are exempted from certain obligations imposed by Council Directive 93/6/EEC of 15 March 1993 on the capital adequacy of investment firms and credit institutions (10), they should be obliged to hold either a minimum amount of capital or professional indemnity insurance or a combination of both. The adjustments of the amounts of that insurance should take into account adjustments made in the framework of Directive 2002/92/EC of the European Parliament and of the Council of 9 December 2002 on insurance mediation (11). This particular treatment for the purposes of capital adequacy should be without prejudice to any decisions regarding the appropriate treatment of these firms under future changes to Community legislation on capital adequacy.

(25)

Since the scope of prudential regulation should be limited to those entities which, by virtue of running a trading book on a professional basis, represent a source of counterparty risk to other market participants, entities which deal on own account in financial instruments, including those commodity derivatives covered by this Directive, as well as those that provide investment services in commodity derivatives to the clients of their main business on an ancillary basis to their main business when considered on a group basis, provided that this main business is not the provision of investment services within the meaning of this Directive, should be excluded from the scope of this Directive.

(26)

In order to protect an investor's ownership and other similar rights in respect of securities and his rights in respect of funds entrusted to a firm those rights should in particular be kept distinct from those of the firm. This principle should not, however, prevent a firm from doing business in its name but on behalf of the investor, where that is required by the very nature of the transaction and the investor is in agreement, for example stock lending.

(27)

Where a client, in line with Community legislation and in particular Directive 2002/47/EC of the European Parliament and of the Council of 6 June 2002 on financial collateral arrangements (12), transfers full ownership of financial instruments or funds to an investment firm for the purpose of securing or otherwise covering present or future, actual or contingent or prospective obligations, such financial instruments or funds should likewise no longer be regarded as belonging to the client.

(28)

The procedures for the authorisation, within the Community, of branches of investment firms authorised in third countries should continue to apply to such firms. Those branches should not enjoy the freedom to provide services under the second paragraph of Article 49 of the Treaty or the right of establishment in Member States other than those in which they are established. In view of cases where the Community is not bound by any bilateral or multilateral obligations it is appropriate to provide for a procedure intended to ensure that Community investment firms receive reciprocal treatment in the third countries concerned.

(29)

The expanding range of activities that many investment firms undertake simultaneously has increased potential for conflicts of interest between those different activities and the interests of their clients. It is therefore necessary to provide for rules to ensure that such conflicts do not adversely affect the interests of their clients.

(30)

A service should be considered to be provided at the initiative of a client unless the client demands it in response to a personalised communication from or on behalf of the firm to that particular client, which contains an invitation or is intended to influence the client in respect of a specific financial instrument or specific transaction. A service can be considered to be provided at the initiative of the client notwithstanding that the client demands it on the basis of any communication containing a promotion or offer of financial instruments made by any means that by its very nature is general and addressed to the public or a larger group or category of clients or potential clients.

(31)	One of the objectives of this Directive is to protect investors. Measures to protect investors should be adapted to the particularities of each category of investors (retail, professional and counterparties).

(32)

By way of derogation from the principle of home country authorisation, supervision and enforcement of obligations in respect of the operation of branches, it is appropriate for the competent authority of the host Member State to assume responsibility for enforcing certain obligations specified in this Directive in relation to business conducted through a branch within the territory where the branch is located, since that authority is closest to the branch, and is better placed to detect and intervene in respect of infringements of rules governing the operations of the branch.

(33)	It is necessary to impose an effective ‘best execution’ obligation to ensure that investment firms execute client orders on terms that are most favourable to the client. This obligation should apply to the firm which owes contractual or agency obligations to the client.

(34)

Fair competition requires that market participants and investors be able to compare the prices that trading venues (i.e. regulated markets, MTFs and intermediaries) are required to publish. To this end, it is recommended that Member States remove any obstacles which may prevent the consolidation at European level of the relevant information and its publication.

(35)	When establishing the business relationship with the client the investment firm might ask the client or potential client to consent at the same time to the execution policy as well as to the possibility that his orders may be executed outside a regulated market or an MTF.

(36)	Persons who provide investment services on behalf of more than one investment firm should not be considered as tied agents but as investment firms when they fall under the definition provided in this Directive, with the exception of certain persons who may be exempted.

(37)	This Directive should be without prejudice to the right of tied agents to undertake activities covered by other Directives and related activities in respect of financial services or products not covered by this Directive, including on behalf of parts of the same financial group.

(38)	The conditions for conducting activities outside the premises of the investment firm (door-to-door selling) should not be covered by this Directive.

(39)

Member States' competent authorities should not register or should withdraw the registration where the activities actually carried on indicate clearly that a tied agent has opted for the legal system of one Member State for the purpose of evading the stricter standards in force in another Member State within the territory of which it intends to carry on or does carry on the greater part of its activities.

(40)	For the purposes of this Directive eligible counterparties should be considered as acting as clients.

(41)

For the purposes of ensuring that conduct of business rules (including rules on best execution and handling of client orders) are enforced in respect of those investors most in need of these protections, and to reflect well-established market practice throughout the Community, it is appropriate to clarify that conduct of business rules may be waived in the case of transactions entered into or brought about between eligible counterparties.

(42)	In respect of transactions executed between eligible counterparties, the obligation to disclose client limit orders should only apply where the counter party is explicitly sending a limit order to an investment firm for its execution.

(43)

Member States shall protect the right to privacy of natural persons with respect to the processing of personal data in accordance with Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and of the free movement of such data (13).

(44)

With the two-fold aim of protecting investors and ensuring the smooth operation of securities markets, it is necessary to ensure that transparency of transactions is achieved and that the rules laid down for that purpose apply to investment firms when they operate on the markets. In order to enable investors or market participants to assess at any time the terms of a transaction in shares that they are considering and to verify afterwards the conditions in which it was carried out, common rules should be established for the publication of details of completed transactions in shares and for the disclosure of details of current opportunities to trade in shares. These rules are needed to ensure the effective integration of Member State equity markets, to promote the efficiency of the overall price formation process for equity instruments, and to assist the effective operation of ‘best execution’ obligations. These considerations require a comprehensive transparency regime applicable to all transactions in shares irrespective of their execution by an investment firm on a bilateral basis or through regulated markets or MTFs. The obligations for investment firms under this Directive to quote a bid and offer price and to execute an order at the quoted price do not relieve investment firms of the obligation to route an order to another execution venue when such internalisation could prevent the firm from complying with ‘best execution’ obligations.

(45)	Member States should be able to apply transaction reporting obligations of the Directive to financial instruments that are not admitted to trading on a regulated market.

(46)

A Member State may decide to apply the pre- and post-trade transparency requirements laid down in this Directive to financial instruments other than shares. In that case those requirements should apply to all investment firms for which that Member State is the home Member State for their operations within the territory of that Member State and those carried out cross-border through the freedom to provide services. They should also apply to the operations carried out within the territory of that Member State by the branches established in its territory of investment firms authorised in another Member State.

(47)

Investment firms should all have the same opportunities of joining or having access to regulated markets throughout the Community. Regardless of the manner in which transactions are at present organised in the Member States, it is important to abolish the technical and legal restrictions on access to regulated markets.

(48)

In order to facilitate the finalisation of cross-border transactions, it is appropriate to provide for access to clearing and settlement systems throughout the Community by investment firms, irrespective of whether transactions have been concluded through regulated markets in the Member State concerned. Investment firms which wish to participate directly in other Member States' settlement systems should comply with the relevant operational and commercial requirements for membership and the prudential measures to uphold the smooth and orderly functioning of the financial markets.

(49)

The authorisation to operate a regulated market should extend to all activities which are directly related to the display, processing, execution, confirmation and reporting of orders from the point at which such orders are received by the regulated market to the point at which they are transmitted for subsequent finalisation, and to activities related to the admission of financial instruments to trading. This should also include transactions concluded through the medium of designated market makers appointed by the regulated market which are undertaken under its systems and in accordance with the rules that govern those systems. Not all transactions concluded by members or participants of the regulated market or MTF are to be considered as concluded within the systems of a regulated market or MTF. Transactions which members or participants conclude on a bilateral basis and which do not comply with all the obligations established for a regulated market or an MTF under this Directive should be considered as transactions concluded outside a regulated market or an MTF for the purposes of the definition of systematic internaliser. In such a case the obligation for investment firms to make public firm quotes should apply if the conditions established by this Directive are met.

(50)	Systematic internalisers might decide to give access to their quotes only to retail clients, only to professional clients, or to both. They should not be allowed to discriminate within those categories of clients.

(51)	Article 27 does not oblige systematic internalisers to publish firm quotes in relation to transactions above standard market size.

(52)	Where an investment firm is a systematic internaliser both in shares and in other financial instruments, the obligation to quote should only apply in respect of shares without prejudice to Recital 46.

(53)

It is not the intention of this Directive to require the application of pre-trade transparency rules to transactions carried out on an OTC basis, the characteristics of which include that they are ad-hoc and irregular and are carried out with wholesale counterparties and are part of a business relationship which is itself characterised by dealings above standard market size, and where the deals are carried out outside the systems usually used by the firm concerned for its business as a systematic internaliser.

(54)	The standard market size for any class of share should not be significantly disproportionate to any share included in that class.

(55)	Revision of Directive 93/6/EEC should fix the minimum capital requirements with which regulated markets should comply in order to be authorised, and in so doing should take into account the specific nature of the risks associated with such markets.

(56)	Operators of a regulated market should also be able to operate an MTF in accordance with the relevant provisions of this Directive.

(57)

The provisions of this Directive concerning the admission of instruments to trading under the rules enforced by the regulated market should be without prejudice to the application of Directive 2001/34/EC of the European Parliament and of the Council of 28 May 2001 on the admission of securities to official stock exchange listing and on information to be published on those securities (14). A regulated market should not be prevented from applying more demanding requirements in respect of the issuers of securities or instruments which it is considering for admission to trading than are imposed pursuant to this Directive.

(58)

Member States should be able to designate different competent authorities to enforce the wide-ranging obligations laid down in this Directive. Such authorities should be of a public nature guaranteeing their independence from economic actors and avoiding conflicts of interest. In accordance with national law, Member States should ensure appropriate financing of the competent authority. The designation of public authorities should not exclude delegation under the responsibility of the competent authority.

(59)	Any confidential information received by the contact point of one Member State through the contact point of another Member State should not be regarded as purely domestic.

(60)

It is necessary to enhance convergence of powers at the disposal of competent authorities so as to pave the way towards an equivalent intensity of enforcement across the integrated financial market. A common minimum set of powers coupled with adequate resources should guarantee supervisory effectiveness.

(61)

With a view to protecting clients and without prejudice to the right of customers to bring their action before the courts, it is appropriate that Member States encourage public or private bodies established with a view to settling disputes out-of-court, to cooperate in resolving cross-border disputes, taking into account Commission Recommendation 98/257/EC of 30 March 1998 on the principles applicable to the bodies responsible for out-of-court settlement of consumer disputes (15). When implementing provisions on complaints and redress procedures for out-of-court settlements, Member States should be encouraged to use existing cross-border cooperation mechanisms, notably the Financial Services Complaints Network (FIN-Net).

(62)	Any exchange or transmission of information between competent authorities, other authorities, bodies or persons should be in accordance with the rules on transfer of personal data to third countries as laid down in Directive 95/46/EC.

(63)

It is necessary to reinforce provisions on exchange of information between national competent authorities and to strengthen the duties of assistance and cooperation which they owe to each other. Due to increasing cross-border activity, competent authorities should provide each other with the relevant information for the exercise of their functions, so as to ensure the effective enforcement of this Directive, including in situations where infringements or suspected infringements may be of concern to authorities in two or more Member States. In the exchange of information, strict professional secrecy is needed to ensure the smooth transmission of that information and the protection of particular rights.

(64)

At its meeting on 17 July 2000, the Council set up the Committee of Wise Men on the Regulation of European Securities Markets. In its final report, the Committee of Wise Men proposed the introduction of new legislative techniques based on a four-level approach, namely framework principles, implementing measures, cooperation and enforcement. Level 1, the Directive, should confine itself to broad general ‘framework’ principles while Level 2 should contain technical implementing measures to be adopted by the Commission with the assistance of a committee.

(65)	The Resolution adopted by the Stockholm European Council of 23 March 2001 endorsed the final report of the Committee of Wise Men and the proposed four-level approach to make the regulatory process for Community securities legislation more efficient and transparent.

(66)	According to the Stockholm European Council, Level 2 implementing measures should be used more frequently, to ensure that technical provisions can be kept up to date with market and supervisory developments, and deadlines should be set for all stages of Level 2 work.

(67)

The Resolution of the European Parliament of 5 February 2002 on the implementation of financial services legislation also endorsed the Committee of Wise Men's report, on the basis of the solemn declaration made before Parliament the same day by the Commission and the letter of 2 October 2001 addressed by the Internal Market Commissioner to the chairman of Parliament's Committee on Economic and Monetary Affairs with regard to the safeguards for the European Parliament's role in this process.

(68)	The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (16).

(69)

The European Parliament should be given a period of three months from the first transmission of draft implementing measures to allow it to examine them and to give its opinion. However, in urgent and duly justified cases, this period could be shortened. If, within that period, a resolution is passed by the European Parliament, the Commission should re-examine the draft measures.

(70)

With a view to taking into account further developments in the financial markets the Commission should submit reports to the European Parliament and the Council on the application of the provisions concerning professional indemnity insurance, the scope of the transparency rules and the possible authorisation of specialised dealers in commodity derivatives as investment firms.

(71)

The objective of creating an integrated financial market, in which investors are effectively protected and the efficiency and integrity of the overall market are safeguarded, requires the establishment of common regulatory requirements relating to investment firms wherever they are authorised in the Community and governing the functioning of regulated markets and other trading systems so as to prevent opacity or disruption on one market from undermining the efficient operation of the European financial system as a whole. Since this objective may be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve this objective,

HAVE ADOPTED THIS DIRECTIVE:

TITLE I

DEFINITIONS AND SCOPE

Article 1

Scope

1. This Directive shall apply to investment firms and regulated markets.

2. The following provisions shall also apply to credit institutions authorised under Directive 2000/12/EC, when providing one or more investment services and/or performing investment activities:

—	Articles 2(2), 11, 13 and 14,

—	Chapter II of Title II excluding Article 23(2) second subparagraph,

—	Chapter III of Title II excluding Articles 31(2) to 31(4) and 32(2) to 32(6), 32(8) and 32(9),

—	Articles 48 to 53, 57, 61 and 62, and

—	Article 71(1).

Article 2

Exemptions

1. This Directive shall not apply to:

(a)	insurance undertakings as defined in Article 1 of Directive 73/239/EEC or assurance undertakings as defined in Article 1 of Directive 2002/83/EC or undertakings carrying on the reinsurance and retrocession activities referred to in Directive 64/225/EEC;

(b)	persons which provide investment services exclusively for their parent undertakings, for their subsidiaries or for other subsidiaries of their parent undertakings;

(c)	persons providing an investment service where that service is provided in an incidental manner in the course of a professional activity and that activity is regulated by legal or regulatory provisions or a code of ethics governing the profession which do not exclude the provision of that service;

(d)

persons who do not provide any investment services or activities other than dealing on own account unless they are market makers or deal on own account outside a regulated market or an MTF on an organised, frequent and systematic basis by providing a system accessible to third parties in order to engage in dealings with them;

(e)	persons which provide investment services consisting exclusively in the administration of employeeparticipation schemes;

(f)	persons which provide investment services which only involve both administration of employee-participation schemes and the provision of investment services exclusively for their parent undertakings, for their subsidiaries or for other subsidiaries of their parent undertakings;

(g)	the members of the European System of Central Banks and other national bodies performing similar functions and other public bodies charged with or intervening in the management of the public debt;

(h)	collective investment undertakings and pension funds whether coordinated at Community level or not and the depositaries and managers of such undertakings;

(i)

persons dealing on own account in financial instruments, or providing investment services in commodity derivatives or derivative contracts included in Annex I, Section C 10 to the clients of their main business, provided this is an ancillary activity to their main business, when considered on a group basis, and that main business is not the provision of investment services within the meaning of this Directive or banking services under Directive 2000/12/EC;

(j)	persons providing investment advice in the course of providing another professional activity not covered by this Directive provided that the provision of such advice is not specifically remunerated;

(k)

persons whose main business consists of dealing on own account in commodities and/or commodity derivatives.

This exception shall not apply where the persons that deal on own account in commodities and/or commodity derivatives are part of a group the main business of which is the provision of other investment services within the meaning of this Directive or banking services under Directive 2000/12/EC;

(l)

firms which provide investment services and/or perform investment activities consisting exclusively in dealing on own account on markets in financial futures or options or other derivatives and on cash markets for the sole purpose of hedging positions on derivatives markets or which deal for the accounts of other members of those markets or make prices for them and which are guaranteed by clearing members of the same markets, where responsibility for ensuring the performance of contracts entered into by such firms is assumed by clearing members of the same markets;

(m)	associations set up by Danish and Finnish pension funds with the sole aim of managing the assets of pension funds that are members of those associations;

(n)	‘agenti di cambio’ whose activities and functions are governed by Article 201 of Italian Legislative Decree No 58 of 24 February 1998.

2. The rights conferred by this Directive shall not extend to the provision of services as counterparty in transactions carried out by public bodies dealing with public debt or by members of the European System of Central Banks performing their tasks as provided for by the Treaty and the Statute of the European System of Central Banks and of the European Central Bank or performing equivalent functions under national provisions.

3. In order to take account of developments on financial markets, and to ensure the uniform application of this Directive, the Commission, acting in accordance with the procedure referred to in Article 64(2), may, in respect of exemptions (c) (i), and (k) define the criteria for determining when an activity is to be considered as ancillary to the main business on a group level as well as for determining when an activity is provided in an incidental manner.

Article 3

Optional exemptions

1. Member States may choose not to apply this Directive to any persons for which they are the home Member State that:

—	are not allowed to hold clients' funds or securities and which for that reason are not allowed at any time to place themselves in debit with their clients, and

—	are not allowed to provide any investment service except the reception and transmission of orders in transferable securities and units in collective investment undertakings and the provision of investment advice in relation to such financial instruments, and

—

in the course of providing that service, are allowed to transmit orders only to:

(i)	investment firms authorised in accordance with this Directive;

(ii)	credit institutions authorised in accordance with Directive 2000/12/EC;

(iii)

branches of investment firms or of credit institutions which are authorised in a third country and which are subject to and comply with prudential rules considered by the competent authorities to be at least as stringent as those laid down in this Directive, in Directive 2000/12/EC or in Directive 93/6/EEC;

(iv)	collective investment undertakings authorised under the law of a Member State to market units to the public and to the managers of such undertakings;

(v)

investment companies with fixed capital, as defined in Article 15(4) of Second Council Directive 77/91/EEC of 13 December 1976 on coordination of safeguards which, for the protection of the interests of members and others, are required by Member States of companies within the meaning of the second paragraph of Article 58 of the Treaty, in respect of the formation of public limited liability companies and the maintenance and alteration of their capital, with a view to making such safeguards equivalent (17), the securities of which are listed or dealt in on a regulated market in a Member State;

provided that the activities of those persons are regulated at national level.

2. Persons excluded from the scope of this Directive according to paragraph 1 cannot benefit from the freedom to provide services and/or activities or to establish branches as provided for in Articles 31 and 32 respectively.

Article 4

Definitions

1. For the purposes of this Directive, the following definitions shall apply:

‘Investment firm’ means any legal person whose regular occupation or business is the provision of one or more investment services to third parties and/or the performance of one or more investment activities on a professional basis;

Member States may include in the definition of investment firms undertakings which are not legal persons, provided that:

(a)	their legal status ensures a level of protection for third parties' interests equivalent to that afforded by legal persons, and

(b)	they are subject to equivalent prudential supervision appropriate to their legal form.

However, where a natural person provides services involving the holding of third parties' funds or transferable securities, he may be considered as an investment firm for the purposes of this Directive only if, without prejudice to the other requirements imposed in this Directive and in Directive 93/6/EEC, he complies with the following conditions:

(a)	the ownership rights of third parties in instruments and funds must be safeguarded, especially in the event of the insolvency of the firm or of its proprietors, seizure, set-off or any other action by creditors of the firm or of its proprietors;

(b)	the firm must be subject to rules designed to monitor the firm's solvency and that of its proprietors;

(c)	the firm's annual accounts must be audited by one or more persons empowered, under national law, to audit accounts;

(d)	where the firm has only one proprietor, he must make provision for the protection of investors in the event of the firm's cessation of business following his death, his incapacity or any other such event;

‘Investment services and activities’ means any of the services and activities listed in Section A of Annex I relating to any of the instruments listed in Section C of Annex I;

The Commission shall determine, acting in accordance with the procedure referred to in Article 64(2):

—	the derivative contracts mentioned in Section C 7 of Annex I that have the characteristics of other derivative financial instruments, having regard to whether, inter alia, they are cleared and settled through recognised clearing houses or are subject to regular margin calls

—

the derivative contracts mentioned in Section C 10 of Annex I that have the characteristics of other derivative financial instruments, having regard to whether, inter alia, they are traded on a regulated market or an MTF, are cleared and settled through recognised clearing houses or are subject to regular margin calls;

3)	‘Ancillary service’ means any of the services listed in Section B of Annex I;

4)	‘Investment advice’ means the provision of personal recommendations to a client, either upon its request or at the initiative of the investment firm, in respect of one or more transactions relating to financial instruments;

5)	‘Execution of orders on behalf of clients’ means acting to conclude agreements to buy or sell one or more financial instruments on behalf of clients;

6)	‘Dealing on own account’ means trading against proprietary capital resulting in the conclusion of transactions in one or more financial instruments;

7)	‘Systematic internaliser’ means an investment firm which, on an organised, frequent and systematic basis, deals on own account by executing client orders outside a regulated market or an MTF;

8)	‘Market maker’ means a person who holds himself out on the financial markets on a continuous basis as being willing to deal on own account by buying and selling financial instruments against his proprietary capital at prices defined by him;

9)	‘Portfolio management’ means managing portfolios in accordance with mandates given by clients on a discretionary client-by-client basis where such portfolios include one or more financial instruments;

10)	‘Client’ means any natural or legal person to whom an investment firm provides investment and/or ancillary services;

11)	‘Professional client’ means a client meeting the criteria laid down in Annex II;

12)	‘Retail client’ means a client who is not a professional client;

13)	‘Market operator’ means a person or persons who manages and/or operates the business of a regulated market. The market operator may be the regulated market itself;

14)

‘Regulated market’ means a multilateral system operated and/or managed by a market operator, which brings together or facilitates the bringing together of multiple third-party buying and selling interests in financial instruments — in the system and in accordance with its non-discretionary rules — in a way that results in a contract, in respect of the financial instruments admitted to trading under its rules and/or systems, and which is authorised and functions regularly and in accordance with the provisions of Title III;

15)

‘Multilateral trading facility (MTF)’ means a multilateral system, operated by an investment firm or a market operator, which brings together multiple third-party buying and selling interests in financial instruments — in the system and in accordance with non-discretionary rules — in a way that results in a contract in accordance with the provisions of Title II;

16)	‘Limit order’ means an order to buy or sell a financial instrument at its specified price limit or better and for a specified size;

17)	‘Financial instrument’ means those instruments specified in Section C of Annex I;

18)

‘Transferable securities’ means those classes of securities which are negotiable on the capital market, with the exception of instruments of payment, such as:

(a)	shares in companies and other securities equivalent to shares in companies, partnerships or other entities, and depositary receipts in respect of shares;

(b)	bonds or other forms of securitised debt, including depositary receipts in respect of such securities;

(c)	any other securities giving the right to acquire or sell any such transferable securities or giving rise to a cash settlement determined by reference to transferable securities, currencies, interest rates or yields, commodities or other indices or measures;

19)	‘Money-market instruments’ means those classes of instruments which are normally dealt in on the money market, such as treasury bills, certificates of deposit and commercial papers and excluding instruments of payment;

20)

‘Home Member State’ means:

(a)

in the case of investment firms:

(i)	if the investment firm is a natural person, the Member State in which its head office is situated;

(ii)	if the investment firm is a legal person, the Member State in which its registered office is situated;

(iii)

if the investment firm has, under its national law, no registered office, the Member State in which its head office is situated;

(b)	in the case of a regulated market, the Member State in which the regulated market is registered or, if under the law of that Member State it has no registered office, the Member State in which the head office of the regulated market is situated;

21)

‘Host Member State’ means the Member State, other than the home Member State, in which an investment firm has a branch or performs services and/or activities or the Member State in which a regulated market provides appropriate arrangements so as to facilitate access to trading on its system by remote members or participants established in that same Member State;

22)	‘Competent authority’ means the authority, designated by each Member State in accordance with Article 48, unless otherwise specified in this Directive;

23)	‘Credit institutions’ means credit institutions as defined under Directive 2000/12/EC;

24)	‘UCITS management company’ means a management company as defined in Council Directive 85/611/EEC of 20 December 1985, on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (18);

25)

‘Tied agent’ means a natural or legal person who, under the full and unconditional responsibility of only one investment firm on whose behalf it acts, promotes investment and/or ancillary services to clients or prospective clients, receives and transmits instructions or orders from the client in respect of investment services or financial instruments, places financial instruments and/or provides advice to clients or prospective clients in respect of those financial instruments or services;

26)

‘Branch’ means a place of business other than the head office which is a part of an investment firm, which has no legal personality and which provides investment services and/or activities and which may also perform ancillary services for which the investment firm has been authorised; all the places of business set up in the same Member State by an investment firm with headquarters in another Member State shall be regarded as a single branch;

27)

‘Qualifying holding’ means any direct or indirect holding in an investment firm which represents 10% or more of the capital or of the voting rights, as set out in Article 92 of Directive 2001/34/EC, or which makes it possible to exercise a significant influence over the management of the investment firm in which that holding subsists;

28)	‘Parent undertaking’ means a parent undertaking as defined in Articles 1 and 2 of Seventh Council Directive 83/349/EEC of 13 June 1983 on consolidated accounts (19);

29)	‘Subsidiary’ means a subsidiary undertaking as defined in Articles 1 and 2 of Directive 83/349/EEC, including any subsidiary of a subsidiary undertaking of an ultimate parent undertaking;

30)	‘Control’ means control as defined in Article 1 of Directive 83/349/EEC;

31)

‘Close links’ means a situation in which two or more natural or legal persons are linked by:

(a)	participation which means the ownership, direct or by way of control, of 20% or more of the voting rights or capital of an undertaking,

(b)

control which means the relationship between a parent undertaking and a subsidiary, in all the cases referred to in Article 1(1) and (2) of Directive 83/349/EEC, or a similar relationship between any natural or legal person and an undertaking, any subsidiary undertaking of a subsidiary undertaking also being considered a subsidiary of the parent undertaking which is at the head of those undertakings.

A situation in which two or more natural or legal persons are permanently linked to one and the same person by a control relationship shall also be regarded as constituting a close link between such persons.

2. In order to take account of developments on financial markets, and to ensure the uniform application of this Directive, the Commission, acting in accordance with the procedure referred to in Article 64(2), may clarify the definitions laid down in paragraph 1 of this Article.

TITLE II

AUTHORISATION AND OPERATING CONDITIONS FOR INVESTMENT FIRMS

CHAPTER I

CONDITIONS AND PROCEDURES FOR AUTHORISATION

Article 5

Requirement for authorisation

1. Each Member State shall require that the performance of investment services or activities as a regular occupation or business on a professional basis be subject to prior authorisation in accordance with the provisions of this Chapter. Such authorisation shall be granted by the home Member State competent authority designated in accordance with Article 48.

2. By way of derogation from paragraph 1, Member States shall allow any market operator to operate an MTF, subject to the prior verification of their compliance with the provisions of this Chapter, excluding Articles 11 and 15.

3. Member States shall establish a register of all investment firms. This register shall be publicly accessible and shall contain information on the services and/or activities for which the investment firm is authorised. It shall be updated on a regular basis.

4. Each Member State shall require that:

—	any investment firm which is a legal person have its head office in the same Member State as its registered office,

—	any investment firm which is not a legal person or any investment firm which is a legal person but under its national law has no registered office have its head office in the Member State in which it actually carries on its business.

5. In the case of investment firms which provide only investment advice or the service of reception and transmission of orders under the conditions established in Article 3, Member States may allow the competent authority to delegate administrative, preparatory or ancillary tasks related to the granting of an authorisation, in accordance with the conditions laid down in Article 48(2).

Article 6

Scope of authorisation

1. The home Member State shall ensure that the authorisation specifies the investment services or activities which the investment firm is authorised to provide. The authorisation may cover one or more of the ancillary services set out in Section B of Annex I. Authorisation shall in no case be granted solely for the provision of ancillary services.

2. An investment firm seeking authorisation to extend its business to additional investment services or activities or ancillary services not foreseen at the time of initial authorisation shall submit a request for extension of its authorisation.

3. The authorisation shall be valid for the entire Community and shall allow an investment firm to provide the services or perform the activities, for which it has been authorised, throughout the Community, either through the establishment of a branch or the free provision of services.

Article 7

Procedures for granting and refusing requests for authorisation

1. The competent authority shall not grant authorisation unless and until such time as it is fully satisfied that the applicant complies with all requirements under the provisions adopted pursuant to this Directive.

2. The investment firm shall provide all information, including a programme of operations setting out inter alia the types of business envisaged and the organisational structure, necessary to enable the competent authority to satisfy itself that the investment firm has established, at the time of initial authorisation, all the necessary arrangements to meet its obligations under the provisions of this Chapter.

3. An applicant shall be informed, within six months of the submission of a complete application, whether or not authorisation has been granted.

Article 8

Withdrawal of authorisations

The competent authority may withdraw the authorisation issued to an investment firm where such an investment firm:

(a)	does not make use of the authorisation within 12 months, expressly renounces the authorisation or has provided no investment services or performed no investment activity for the preceding six months, unless the Member State concerned has provided for authorisation to lapse in such cases;

(b)	has obtained the authorisation by making false statements or by any other irregular means;

(c)	no longer meets the conditions under which authorisation was granted, such as compliance with the conditions set out in Directive 93/6/EEC;

(d)	has seriously and systematically infringed the provisions adopted pursuant to this Directive governing the operating conditions for investment firms;

(e)	falls within any of the cases where national law, in respect of matters outside the scope of this Directive, provides for withdrawal.

Article 9

Persons who effectively direct the business

1. Member States shall require the persons who effectively direct the business of an investment firm to be of sufficiently good repute and sufficiently experienced as to ensure the sound and prudent management of the investment firm.

Where the market operator that seeks authorisation to operate an MTF and the persons that effectively direct the business of the MTF are the same as those that effectively direct the business of the regulated market, those persons are deemed to comply with the requirements laid down in the first subparagraph.

2. Member States shall require the investment firm to notify the competent authority of any changes to its management, along with all information needed to assess whether the new staff appointed to manage the firm are of sufficiently good repute and sufficiently experienced.

3. The competent authority shall refuse authorisation if it is not satisfied that the persons who will effectively direct the business of the investment firm are of sufficiently good repute or sufficiently experienced, or if there are objective and demonstrable grounds for believing that proposed changes to the management of the firm pose a threat to its sound and prudent management.

4. Member States shall require that the management of investment firms is undertaken by at least two persons meeting the requirements laid down in paragraph 1.

By way of derogation from the first subparagraph, Member States may grant authorisation to investment firms that are natural persons or to investment firms that are legal persons managed by a single natural person in accordance with their constitutive rules and national laws. Member States shall nevertheless require that alternative arrangements be in place which ensure the sound and prudent management of such investment firms.

Article 10

Shareholders and members with qualifying holdings

1. The competent authorities shall not authorise the performance of investment services or activities by an investment firm until they have been informed of the identities of the shareholders or members, whether direct or indirect, natural or legal persons, that have qualifying holdings and the amounts of those holdings.

The competent authorities shall refuse authorisation if, taking into account the need to ensure the sound and prudent management of an investment firm, they are not satisfied as to the suitability of the shareholders or members that have qualifying holdings.

Where close links exist between the investment firm and other natural or legal persons, the competent authority shall grant authorisation only if those links do not prevent the effective exercise of the supervisory functions of the competent authority.

2. The competent authority shall refuse authorisation if the laws, regulations or administrative provisions of a third country governing one or more natural or legal persons with which the undertaking has close links, or difficulties involved in their enforcement, prevent the effective exercise of its supervisory functions.

3. Member States shall require any natural or legal person that proposes to acquire or sell, directly or indirectly, a qualifying holding in an investment firm, first to notify, in accordance with the second subparagraph, the competent authority of the size of the resulting holding. Such persons shall likewise be required to notify the competent authority if they propose to increase or reduce their qualifying holding, if in consequence the proportion of the voting rights or of the capital that they hold would reach or fall below or exceed 20 %, 33% or 50% or the investment firm would become or cease to be their subsidiary.

Without prejudice to paragraph 4, the competent authority shall have up to three months from the date of the notification of a proposed acquisition provided for in the first subparagraph to oppose such a plan if, in view of the need to ensure sound and prudent management of the investment firm, it is not satisfied as to the suitability of the persons referred to in the first subparagraph. If the competent authority does not oppose the plan, it may fix a deadline for its implementation.

4. If the acquirer of any holding referred to in paragraph 3 is an investment firm, a credit institution, an insurance undertaking or a UCITS management company authorised in another Member State, or the parent undertaking of an investment firm, credit institution, insurance undertaking or a UCITS management company authorised in another Member State, or a person controlling an investment firm, credit institution, insurance undertaking or a UCITS management company authorised in another Member State, and if, as a result of that acquisition, the undertaking would become the acquirer's subsidiary or come under his control, the assessment of the acquisition shall be subject to the prior consultation provided for in Article 60.

5. Member States shall require that, if an investment firm becomes aware of any acquisitions or disposals of holdings in its capital that cause holdings to exceed or fall below any of the thresholds referred to in the first subparagraph of paragraph 3, that investment firm is to inform the competent authority without delay.

At least once a year, investment firms shall also inform the competent authority of the names of shareholders and members possessing qualifying holdings and the sizes of such holdings as shown, for example, by the information received at annual general meetings of shareholders and members or as a result of compliance with the regulations applicable to companies whose transferable securities are admitted to trading on a regulated market.

6. Member States shall require that, where the influence exercised by the persons referred to in the first subparagraph of paragraph 1 is likely to be prejudicial to the sound and prudent management of an investment firm, the competent authority take appropriate measures to put an end to that situation.

Such measures may consist in applications for judicial orders and/or the imposition of sanctions against directors and those responsible for management, or suspension of the exercise of the voting rights attaching to the shares held by the shareholders or members in question.

Similar measures shall be taken in respect of persons who fail to comply with the obligation to provide prior information in relation to the acquisition or increase of a qualifying holding. If a holding is acquired despite the opposition of the competent authorities, the Member States shall, regardless of any other sanctions to be adopted, provide either for exercise of the corresponding voting rights to be suspended, for the nullity of the votes cast or for the possibility of their annulment.

Article 11

Membership of an authorised Investor Compensation Scheme

The competent authority shall verify that any entity seeking authorisation as an investment firm meets its obligations under Directive 97/9/EC of the European Parliament and of the Council of 3 March 1997 on investor-compensation schemes (20) at the time of authorisation.

Article 12

Initial capital endowment

Member States shall ensure that the competent authorities do not grant authorisation unless the investment firm has sufficient initial capital in accordance with the requirements of Directive 93/6/EEC having regard to the nature of the investment service or activity in question.

Pending the revision of Directive 93/6/EEC, the investment firms provided for in Article 67 shall be subject to the capital requirements laid down in that Article.

Article 13

Organisational requirements

1. The home Member State shall require that investment firms comply with the organisational requirements set out in paragraphs 2 to 8.

2. An investment firm shall establish adequate policies and procedures sufficient to ensure compliance of the firm including its managers, employees and tied agents with its obligations under the provisions of this Directive as well as appropriate rules governing personal transactions by such persons.

3. An investment firm shall maintain and operate effective organisational and administrative arrangements with a view to taking all reasonable steps designed to prevent conflicts of interest as defined in Article 18 from adversely affecting the interests of its clients.

4. An investment firm shall take reasonable steps to ensure continuity and regularity in the performance of investment services and activities. To this end the investment firm shall employ appropriate and proportionate systems, resources and procedures.

5. An investment firm shall ensure, when relying on a third party for the performance of operational functions which are critical for the provision of continuous and satisfactory service to clients and the performance of investment activities on a continuous and satisfactory basis, that it takes reasonable steps to avoid undue additional operational risk. Outsourcing of important operational functions may not be undertaken in such a way as to impair materially the quality of its internal control and the ability of the supervisor to monitor the firm's compliance with all obligations.

An investment firm shall have sound administrative and accounting procedures, internal control mechanisms, effective procedures for risk assessment, and effective control and safeguard arrangements for information processing systems.

6. An investment firm shall arrange for records to be kept of all services and transactions undertaken by it which shall be sufficient to enable the competent authority to monitor compliance with the requirements under this Directive, and in particular to ascertain that the investment firm has complied with all obligations with respect to clients or potential clients.

7. An investment firm shall, when holding financial instruments belonging to clients, make adequate arrangements so as to safeguard clients' ownership rights, especially in the event of the investment firm's insolvency, and to prevent the use of a client's instruments on own account except with the client's express consent.

8. An investment firm shall, when holding funds belonging to clients, make adequate arrangements to safeguard the clients' rights and, except in the case of credit institutions, prevent the use of client funds for its own account.

9. In the case of branches of investment firms, the competent authority of the Member State in which the branch is located shall, without prejudice to the possibility of the competent authority of the home Member State of the investment firm to have direct access to those records, enforce the obligation laid down in paragraph 6 with regard to transactions undertaken by the branch.

10. In order to take account of technical developments on financial markets and to ensure the uniform application of paragraphs 2 to 9, the Commission shall adopt, in accordance with the procedure referred to in Article 64(2), implementing measures which specify the concrete organisational requirements to be imposed on investment firms performing different investment services and/or activities and ancillary services or combinations thereof.

Article 14

Trading process and finalisation of transactions in an MTF

1. Member States shall require that investment firms or market operators operating an MTF, in addition to meeting the requirements laid down in Article 13, establish transparent and non-discretionary rules and procedures for fair and orderly trading and establish objective criteria for the efficient execution of orders.

2. Member States shall require that investment firms or market operators operating an MTF establish transparent rules regarding the criteria for determining the financial instruments that can be traded under its systems.

Member States shall require that, where applicable, investment firms or market operators operating an MTF provide, or are satisfied that there is access to, sufficient publicly available information to enable its users to form an investment judgement, taking into account both the nature of the users and the types of instruments traded.

3. Member States shall ensure that Articles 19, 21 and 22 are not applicable to the transactions concluded under the rules governing an MTF between its members or participants or between the MTF and its members or participants in relation to the use of the MTF. However, the members of or participants in the MTF shall comply with the obligations provided for in Articles 19, 21 and 22 with respect to their clients when, acting on behalf of their clients, they execute their orders through the systems of an MTF.

4. Member States shall require that investment firms or market operators operating an MTF establish and maintain transparent rules, based on objective criteria, governing access to its facility. These rules shall comply with the conditions established in Article 42(3).

5. Member States shall require that investment firms or market operators operating an MTF clearly inform its users of their respective responsibilities for the settlement of the transactions executed in that facility. Member States shall require that investment firms or market operators operating an MTF have put in place the necessary arrangements to facilitate the efficient settlement of the transactions concluded under the systems of the MTF.

6. Where a transferable security, which has been admitted to trading on a regulated market, is also traded on an MTF without the consent of the issuer, the issuer shall not be subject to any obligation relating to initial, ongoing or ad hoc financial disclosure with regard to that MTF.

7. Member States shall require that any investment firm or market operator operating an MTF comply immediately with any instruction from its competent authority pursuant to Article 50(1) to suspend or remove a financial instrument from trading.

Article 15

Relations with third countries

1. Member States shall inform the Commission of any general difficulties which their investment firms encounter in establishing themselves or providing investment services and/or performing investment activities in any third country.

2. Whenever it appears to the Commission, on the basis of information submitted to it under paragraph 1, that a third country does not grant Community investment firms effective market access comparable to that granted by the Community to investment firms from that third country, the Commission may submit proposals to the Council for an appropriate mandate for negotiation with a view to obtaining comparable competitive opportunities for Community investment firms. The Council shall act by a qualified majority.

3. Whenever it appears to the Commission, on the basis of information submitted to it under paragraph 1, that Community investment firms in a third country are not granted national treatment affording the same competitive opportunities as are available to domestic investment firms and that the conditions of effective market access are not fulfilled, the Commission may initiate negotiations in order to remedy the situation.

In the circumstances referred to in the first subparagraph, the Commission may decide, in accordance with the procedure referred to in Article 64(2), at any time and in addition to the initiation of negotiations, that the competent authorities of the Member States must limit or suspend their decisions regarding requests pending or future requests for authorisation and the acquisition of holdings by direct or indirect parent undertakings governed by the law of the third country in question. Such limitations or suspensions may not be applied to the setting-up of subsidiaries by investment firms duly authorised in the Community or by their subsidiaries, or to the acquisition of holdings in Community investment firms by such firms or subsidiaries. The duration of such measures may not exceed three months.

Before the end of the three-month period referred to in the second subparagraph and in the light of the results of the negotiations, the Commission may decide, in accordance with the procedure referred to in Article 64(2), to extend these measures.

4. Whenever it appears to the Commission that one of the situations referred to in paragraphs 2 and 3 obtains, the Member States shall inform it at its request:

(a)	of any application for the authorisation of any firm which is the direct or indirect subsidiary of a parent undertaking governed by the law of the third country in question;

(b)	whenever they are informed in accordance with Article 10(3) that such a parent undertaking proposes to acquire a holding in a Community investment firm, in consequence of which the latter would become its subsidiary.

That obligation to provide information shall lapse whenever agreement is reached with the third country concerned or when the measures referred to in the second and third subparagraphs of paragraph 3 cease to apply.

5. Measures taken under this Article shall comply with the Community's obligations under any international agreements, bilateral or multilateral, governing the taking-up or pursuit of the business of investment firms.

CHAPTER II

OPERATING CONDITIONS FOR INVESTMENT FIRMS

SECTION 1

General provisions

Article 16

Regular review of conditions for initial authorisation

1. Member States shall require that an investment firm authorised in their territory comply at all times with the conditions for initial authorisation established in Chapter I of this Title.

2. Member States shall require competent authorities to establish the appropriate methods to monitor that investment firms comply with their obligation under paragraph 1. They shall require investment firms to notify the competent authorities of any material changes to the conditions for initial authorisation.

3. In the case of investment firms which provide only investment advice, Member States may allow the competent authority to delegate administrative, preparatory or ancillary tasks related to the review of the conditions for initial authorisation, in accordance with the conditions laid down in Article 48(2).

Article 17

General obligation in respect of on-going supervision

1. Member States shall ensure that the competent authorities monitor the activities of investment firms so as to assess compliance with the operating conditions provided for in this Directive. Member States shall ensure that the appropriate measures are in place to enable the competent authorities to obtain the information needed to assess the compliance of investment firms with those obligations.

2. In the case of investment firms which provide only investment advice, Member States may allow the competent authority to delegate administrative, preparatory or ancillary tasks related to the regular monitoring of operational requirements, in accordance with the conditions laid down in Article 48(2).

Article 18

Conflicts of interest

1. Member States shall require investment firms to take all reasonable steps to identify conflicts of interest between themselves, including their managers, employees and tied agents, or any person directly or indirectly linked to them by control and their clients or between one client and another that arise in the course of providing any investment and ancillary services, or combinations thereof.

2. Where organisational or administrative arrangements made by the investment firm in accordance with Article 13(3) to manage conflicts of interest are not sufficient to ensure, with reasonable confidence, that risks of damage to client interests will be prevented, the investment firm shall clearly disclose the general nature and/or sources of conflicts of interest to the client before undertaking business on its behalf.

3. In order to take account of technical developments on financial markets and to ensure uniform application of paragraphs 1 and 2, the Commission shall adopt, in accordance with the procedure referred to in Article 64(2), implementing measures to:

(a)	define the steps that investment firms might reasonably be expected to take to identify, prevent, manage and/or disclose conflicts of interest when providing various investment and ancillary services and combinations thereof;

(b)	establish appropriate criteria for determining the types of conflict of interest whose existence may damage the interests of the clients or potential clients of the investment firm.

SECTION 2

Provisions to ensure investor protection

Article 19

Conduct of business obligations when providing investment services to clients

1. Member States shall require that, when providing investment services and/or, where appropriate, ancillary services to clients, an investment firm act honestly, fairly and professionally in accordance with the best interests of its clients and comply, in particular, with the principles set out in paragraphs 2 to 8.

2. All information, including marketing communications, addressed by the investment firm to clients or potential clients shall be fair, clear and not misleading. Marketing communications shall be clearly identifiable as such.

3. Appropriate information shall be provided in a comprehensible form to clients or potential clients about:

—	the investment firm and its services,

—	financial instruments and proposed investment strategies; this should include appropriate guidance on and warnings of the risks associated with investments in those instruments or in respect of particular investment strategies,

—	execution venues, and

—	costs and associated charges

so that they are reasonably able to understand the nature and risks of the investment service and of the specific type of financial instrument that is being offered and, consequently, to take investment decisions on an informed basis. This information may be provided in a standardised format.

4. When providing investment advice or portfolio management the investment firm shall obtain the necessary information regarding the client's or potential client's knowledge and experience in the investment field relevant to the specific type of product or service, his financial situation and his investment objectives so as to enable the firm to recommend to the client or potential client the investment services and financial instruments that are suitable for him.

5. Member States shall ensure that investment firms, when providing investment services other than those referred to in paragraph 4, ask the client or potential client to provide information regarding his knowledge and experience in the investment field relevant to the specific type of product or service offered or demanded so as to enable the investment firm to assess whether the investment service or product envisaged is appropriate for the client.

In case the investment firm considers, on the basis of the information received under the previous subparagraph, that the product or service is not appropriate to the client or potential client, the investment firm shall warn the client or potential client. This warning may be provided in a standardised format.

In cases where the client or potential client elects not to provide the information referred to under the first subparagraph, or where he provides insufficient information regarding his knowledge and experience, the investment firm shall warn the client or potential client that such a decision will not allow the firm to determine whether the service or product envisaged is appropriate for him. This warning may be provided in a standardised format.

6. Member States shall allow investment firms when providing investment services that only consist of execution and/or the reception and transmission of client orders with or without ancillary services to provide those investment services to their clients without the need to obtain the information or make the determination provided for in paragraph 5 where all the following conditions are met:

—

the above services relate to shares admitted to trading on a regulated market or in an equivalent third country market, money market instruments, bonds or other forms of securitised debt (excluding those bonds or securitised debt that embed a derivative), UCITS and other non-complex financial instruments. A third country market shall be considered as equivalent to a regulated market if it complies with equivalent requirements to those established under Title III. The Commission shall publish a list of those markets that are to be considered as equivalent. This list shall be updated periodically,

—	the service is provided at the initiative of the client or potential client,

—

the client or potential client has been clearly informed that in the provision of this service the investment firm is not required to assess the suitability of the instrument or service provided or offered and that therefore he does not benefit from the corresponding protection of the relevant conduct of business rules; this warning may be provided in a standardised format,

—	the investment firm complies with its obligations under Article 18.

7. The investment firm shall establish a record that includes the document or documents agreed between the firm and the client that set out the rights and obligations of the parties, and the other terms on which the firm will provide services to the client. The rights and duties of the parties to the contract may be incorporated by reference to other documents or legal texts.

8. The client must receive from the investment firm adequate reports on the service provided to its clients. These reports shall include, where applicable, the costs associated with the transactions and services undertaken on behalf of the client.

9. In cases where an investment service is offered as part of a financial product which is already subject to other provisions of Community legislation or common European standards related to credit institutions and consumer credits with respect to risk assessment of clients and/or information requirements, this service shall not be additionally subject to the obligations set out in this Article.

10. In order to ensure the necessary protection of investors and the uniform application of paragraphs 1 to 8, the Commission shall adopt, in accordance with the procedure referred to in Article 64(2), implementing measures to ensure that investment firms comply with the principles set out therein when providing investment or ancillary services to their clients. Those implementing measures shall take into account:

(a)	the nature of the service(s) offered or provided to the client or potential client, taking into account the type, object, size and frequency of the transactions;

(b)	the nature of the financial instruments being offered or considered;

(c)	the retail or professional nature of the client or potential clients.

Article 20

Provision of services through the medium of another investment firm

Member States shall allow an investment firm receiving an instruction to perform investment or ancillary services on behalf of a client through the medium of another investment firm to rely on client information transmitted by the latter firm. The investment firm which mediates the instructions will remain responsible for the completeness and accuracy of the information transmitted.

The investment firm which receives an instruction to undertake services on behalf of a client in this way shall also be able to rely on any recommendations in respect of the service or transaction that have been provided to the client by another investment firm. The investment firm which mediates the instructions will remain responsible for the appropriateness for the client of the recommendations or advice provided.

The investment firm which receives client instructions or orders through the medium of another investment firm shall remain responsible for concluding the service or transaction, based on any such information or recommendations, in accordance with the relevant provisions of this Title.

Article 21

Obligation to execute orders on terms most favourable to the client

1. Member States shall require that investment firms take all reasonable steps to obtain, when executing orders, the best possible result for their clients taking into account price, costs, speed, likelihood of execution and settlement, size, nature or any other consideration relevant to the execution of the order. Nevertheless, whenever there is a specific instruction from the client the investment firm shall execute the order following the specific instruction.

2. Member States shall require investment firms to establish and implement effective arrangements for complying with paragraph 1. In particular Member States shall require investment firms to establish and implement an order execution policy to allow them to obtain, for their client orders, the best possible result in accordance with paragraph 1.

3. The order execution policy shall include, in respect of each class of instruments, information on the different venues where the investment firm executes its client orders and the factors affecting the choice of execution venue. It shall at least include those venues that enable the investment firm to obtain on a consistent basis the best possible result for the execution of client orders.

Member States shall require that investment firms provide appropriate information to their clients on their order execution policy. Member States shall require that investment firms obtain the prior consent of their clients to the execution policy.

Member States shall require that, where the order execution policy provides for the possibility that client orders may be executed outside a regulated market or an MTF, the investment firm shall, in particular, inform its clients about this possibility. Member States shall require that investment firms obtain the prior express consent of their clients before proceeding to execute their orders outside a regulated market or an MTF. Investment firms may obtain this consent either in the form of a general agreement or in respect of individual transactions.

4. Member States shall require investment firms to monitor the effectiveness of their order execution arrangements and execution policy in order to identify and, where appropriate, correct any deficiencies. In particular, they shall assess, on a regular basis, whether the execution venues included in the order execution policy provide for the best possible result for the client or whether they need to make changes to their execution arrangements. Member States shall require investment firms to notify clients of any material changes to their order execution arrangements or execution policy.

5. Member States shall require investment firms to be able to demonstrate to their clients, at their request, that they have executed their orders in accordance with the firm's execution policy.

6. In order to ensure the protection necessary for investors, the fair and orderly functioning of markets, and to ensure the uniform application of paragraphs 1, 3 and 4, the Commission shall, in accordance with the procedure referred to in Article 64(2), adopt implementing measures concerning:

(a)	the criteria for determining the relative importance of the different factors that, pursuant to paragraph 1, may be taken into account for determining the best possible result taking into account the size and type of order and the retail or professional nature of the client;

(b)

factors that may be taken into account by an investment firm when reviewing its execution arrangements and the circumstances under which changes to such arrangements may be appropriate. In particular, the factors for determining which venues enable investment firms to obtain on a consistent basis the best possible result for executing the client orders;

(c)	the nature and extent of the information to be provided to clients on their execution policies, pursuant to paragraph 3.

Article 22

Client order handling rules

1. Member States shall require that investment firms authorised to execute orders on behalf of clients implement procedures and arrangements which provide for the prompt, fair and expeditious execution of client orders, relative to other client orders or the trading interests of the investment firm.

These procedures or arrangements shall allow for the execution of otherwise comparable client orders in accordance with the time of their reception by the investment firm.

2. Member States shall require that, in the case of a client limit order in respect of shares admitted to trading on a regulated market which are not immediately executed under prevailing market conditions, investment firms are, unless the client expressly instructs otherwise, to take measures to facilitate the earliest possible execution of that order by making public immediately that client limit order in a manner which is easily accessible to other market participants. Member States may decide that investment firms comply with this obligation by transmitting the client limit order to a regulated market and/or MTF. Member States shall provide that the competent authorities may waive the obligation to make public a limit order that is large in scale compared with normal market size as determined under Article 44(2).

3. In order to ensure that measures for the protection of investors and fair and orderly functioning of markets take account of technical developments in financial markets, and to ensure the uniform application of paragraphs 1 and 2, the Commission shall adopt, in accordance with the procedure referred to in Article 64(2), implementing measures which define:

(a)

the conditions and nature of the procedures and arrangements which result in the prompt, fair and expeditious execution of client orders and the situations in which or types of transaction for which investment firms may reasonably deviate from prompt execution so as to obtain more favourable terms for clients;

(b)	the different methods through which an investment firm can be deemed to have met its obligation to disclose not immediately executable client limit orders to the market.

Article 23

Obligations of investment firms when appointing tied agents

1. Member States may decide to allow an investment firm to appoint tied agents for the purposes of promoting the services of the investment firm, soliciting business or receiving orders from clients or potential clients and transmitting them, placing financial instruments and providing advice in respect of such financial instruments and services offered by that investment firm.

2. Member States shall require that where an investment firm decides to appoint a tied agent it remains fully and unconditionally responsible for any action or omission on the part of the tied agent when acting on behalf of the firm. Member States shall require the investment firm to ensure that a tied agent discloses the capacity in which he is acting and the firm which he is representing when contacting or before dealing with any client or potential client.

Member States may allow, in accordance with Article 13(6), (7) and (8), tied agents registered in their territory to handle clients' money and/or financial instruments on behalf and under the full responsibility of the investment firm for which they are acting within their territory or, in the case of a cross-border operation, in the territory of a Member State which allows a tied agent to handle clients' money.

Member States shall require the investment firms to monitor the activities of their tied agents so as to ensure that they continue to comply with this Directive when acting through tied agents.

3. Member States that decide to allow investment firms to appoint tied agents shall establish a public register. Tied agents shall be registered in the public register in the Member State where they are established.

Where the Member State in which the tied agent is established has decided, in accordance with paragraph 1, not to allow the investment firms authorised by their competent authorities to appoint tied agents, those tied agents shall be registered with the competent authority of the home Member State of the investment firm on whose behalf it acts.

Member States shall ensure that tied agents are only admitted to the public register if it has been established that they are of sufficiently good repute and that they possess appropriate general, commercial and professional knowledge so as to be able to communicate accurately all relevant information regarding the proposed service to the client or potential client.

Member States may decide that investment firms can verify whether the tied agents which they have appointed are of sufficiently good repute and possess the knowledge as referred to in the third subparagraph.

The register shall be updated on a regular basis. It shall be publicly available for consultation.

4. Member States shall require that investment firms appointing tied agents take adequate measures in order to avoid any negative impact that the activities of the tied agent not covered by the scope of this Directive could have on the activities carried out by the tied agent on behalf of the investment firm.

Member States may allow competent authorities to collaborate with investment firms and credit institutions, their associations and other entities in registering tied agents and in monitoring compliance of tied agents with the requirements of paragraph 3. In particular, tied agents may be registered by an investment firm, credit institution or their associations and other entities under the supervision of the competent authority.

5. Member States shall require that investment firms appoint only tied agents entered in the public registers referred to in paragraph 3.

6. Member States may reinforce the requirements set out in this Article or add other requirements for tied agents registered within their jurisdiction.

Article 24

Transactions executed with eligible counterparties

1. Member States shall ensure that investment firms authorised to execute orders on behalf of clients and/or to deal on own account and/or to receive and transmit orders, may bring about or enter into transactions with eligible counterparties without being obliged to comply with the obligations under Articles 19, 21 and 22(1) in respect of those transactions or in respect of any ancillary service directly related to those transactions.

2. Member States shall recognise as eligible counterparties for the purposes of this Article investment firms, credit institutions, insurance companies, UCITS and their management companies, pension funds and their management companies, other financial institutions authorised or regulated under Community legislation or the national law of a Member State, undertakings exempted from the application of this Directive under Article 2(1)(k) and (l), national governments and their corresponding offices including public bodies that deal with public debt, central banks and supranational organisations.

Classification as an eligible counterparty under the first subparagraph shall be without prejudice to the right of such entities to request, either on a general form or on a trade-by-trade basis, treatment as clients whose business with the investment firm is subject to Articles 19, 21 and 22.

3. Member States may also recognise as eligible counterparties other undertakings meeting pre-determined proportionate requirements, including quantitative thresholds. In the event of a transaction where the prospective counterparties are located in different jurisdictions, the investment firm shall defer to the status of the other undertaking as determined by the law or measures of the Member State in which that undertaking is established.

Member States shall ensure that the investment firm, when it enters into transactions in accordance with paragraph 1 with such undertakings, obtains the express confirmation from the prospective counterparty that it agrees to be treated as an eligible counterparty. Member States shall allow the investment firm to obtain this confirmation either in the form of a general agreement or in respect of each individual transaction.

4. Member States may recognise as eligible counterparties third country entities equivalent to those categories of entities mentioned in paragraph 2.

Member States may also recognise as eligible counterparties third country undertakings such as those mentioned in paragraph 3 on the same conditions and subject to the same requirements as those laid down at paragraph 3.

5. In order to ensure the uniform application of paragraphs 2, 3 and 4 in the light of changing market practice and to facilitate the effective operation of the single market, the Commission may adopt, in accordance with the procedure referred to in Article 64(2), implementing measures which define:

(a)	the procedures for requesting treatment as clients under paragraph 2;

(b)	the procedures for obtaining the express confirmation from prospective counterparties under paragraph 3;

(c)	the predetermined proportionate requirements, including quantitative thresholds that would allow an undertaking to be considered as an eligible counterparty under paragraph 3.

SECTION 3

Market transparency and integrity

Article 25

Obligation to uphold integrity of markets, report transactions and maintain records

1. Without prejudice to the allocation of responsibilities for enforcing the provisions of Directive 2003/6/EC of the European Parliament and of the Council of 28 January 2003 on insider dealing and market manipulation (market abuse) (21), Member States shall ensure that appropriate measures are in place to enable the competent authority to monitor the activities of investment firms to ensure that they act honestly, fairly and professionally and in a manner which promotes the integrity of the market.

2. Member States shall require investment firms to keep at the disposal of the competent authority, for at least five years, the relevant data relating to all transactions in financial instruments which they have carried out, whether on own account or on behalf of a client. In the case of transactions carried out on behalf of clients, the records shall contain all the information and details of the identity of the client, and the information required under Council Directive 91/308/EEC of 10 June 1991 on prevention of the use of the financial system for the purpose of money laundering (22).

3. Member States shall require investment firms which execute transactions in any financial instruments admitted to trading on a regulated market to report details of such transactions to the competent authority as quickly as possible, and no later than the close of the following working day. This obligation shall apply whether or not such transactions were carried out on a regulated market.

The competent authorities shall, in accordance with Article 58, establish the necessary arrangements in order to ensure that the competent authority of the most relevant market in terms of liquidity for those financial instruments also receives this information.

4. The reports shall, in particular, include details of the names and numbers of the instruments bought or sold, the quantity, the dates and times of execution and the transaction prices and means of identifying the investment firms concerned.

5. Member States shall provide for the reports to be made to the competent authority either by the investment firm itself, a third party acting on its behalf or by a trade-matching or reporting system approved by the competent authority or by the regulated market or MTF through whose systems the transaction was completed. In cases where transactions are reported directly to the competent authority by a regulated market, an MTF, or a trade-matching or reporting system approved by the competent authority, the obligation on the investment firm laid down in paragraph 3 may be waived.

6. When, in accordance with Article 32(7), reports provided for under this Article are transmitted to the competent authority of the host Member State, it shall transmit this information to the competent authorities of the home Member State of the investment firm, unless they decide that they do not want to receive this information.

7. In order to ensure that measures for the protection of market integrity are modified to take account of technical developments in financial markets, and to ensure the uniform application of paragraphs 1 to 5, the Commission may adopt, in accordance with the procedure referred to in Article 64(2), implementing measures which define the methods and arrangements for reporting financial transactions, the form and content of these reports and the criteria for defining a relevant market in accordance with paragraph 3.

Article 26

Monitoring of compliance with the rules of the MTF and with other legal obligations

1. Member States shall require that investment firms and market operators operating an MTF establish and maintain effective arrangements and procedures, relevant to the MTF, for the regular monitoring of the compliance by its users with its rules. Investment firms and market operators operating an MTF shall monitor the transactions undertaken by their users under their systems in order to identify breaches of those rules, disorderly trading conditions or conduct that may involve market abuse.

2. Member States shall require investment firms and market operators operating an MTF to report significant breaches of its rules or disorderly trading conditions or conduct that may involve market abuse to the competent authority. Member States shall also require investment firms and market operators operating an MTF to supply the relevant information without delay to the authority competent for the investigation and prosecution of market abuse and to provide full assistance to the latter in investigating and prosecuting market abuse occurring on or through its systems.

Article 27

Obligation for investment firms to make public firm quotes

1. Member States shall require systematic internalisers in shares to publish a firm quote in those shares admitted to trading on a regulated market for which they are systematic internalisers and for which there is a liquid market. In the case of shares for which there is not a liquid market, systematic internalisers shall disclose quotes to their clients on request.

The provisions of this Article shall be applicable to systematic internalisers when dealing for sizes up to standard market size. Systematic internalisers that only deal in sizes above standard market size shall not be subject to the provisions of this Article.

Systematic internalisers may decide the size or sizes at which they will quote. For a particular share each quote shall include a firm bid and/or offer price or prices for a size or sizes which could be up to standard market size for the class of shares to which the share belongs. The price or prices shall also reflect the prevailing market conditions for that share.

Shares shall be grouped in classes on the basis of the arithmetic average value of the orders executed in the market for that share. The standard market size for each class of shares shall be a size representative of the arithmetic average value of the orders executed in the market for the shares included in each class of shares.

The market for each share shall be comprised of all orders executed in the European Union in respect of that share excluding those large in scale compared to normal market size for that share.

2. The competent authority of the most relevant market in terms of liquidity as defined in Article 25 for each share shall determine at least annually, on the basis of the arithmetic average value of the orders executed in the market in respect of that share, the class of shares to which it belongs. This information shall be made public to all market participants.

3. Systematic internalisers shall make public their quotes on a regular and continuous basis during normal trading hours. They shall be entitled to update their quotes at any time. They shall also be allowed, under exceptional market conditions, to withdraw their quotes.

The quote shall be made public in a manner which is easily accessible to other market participants on a reasonable commercial basis.

Systematic internalisers shall, while complying with the provisions set down in Article 21, execute the orders they receive from their retail clients in relation to the shares for which they are systematic internalisers at the quoted prices at the time of reception of the order.

Systematic internalisers shall execute the orders they receive from their professional clients in relation to the shares for which they are systematic internalisers at the quoted price at the time of reception of the order. However, they may execute those orders at a better price in justified cases provided that this price falls within a public range close to market conditions and provided that the orders are of a size bigger than the size customarily undertaken by a retail investor.

Furthermore, systematic internalisers may execute orders they receive from their professional clients at prices different than their quoted ones without having to comply with the conditions established in the fourth subparagraph, in respect of transactions where execution in several securities is part of one transaction or in respect of orders that are subject to conditions other than the current market price.

Where a systematic internaliser who quotes only one quote or whose highest quote is lower than the standard market size receives an order from a client of a size bigger than its quotation size, but lower than the standard market size, it may decide to execute that part of the order which exceeds its quotation size, provided that it is executed at the quoted price, except where otherwise permitted under the conditions of the previous two subparagraphs. Where the systematic internaliser is quoting in different sizes and receives an order between those sizes, which it chooses to execute, it shall execute the order at one of the quoted prices in compliance with the provisions of Article 22, except where otherwise permitted under the conditions of the previous two subparagraphs.

4. The competent authorities shall check:

(a)	that investment firms regularly update bid and/or offer prices published in accordance with paragraph 1 and maintain prices which reflect the prevailing market conditions;

(b)	that investment firms comply with the conditions for price improvement laid down in the fourth subparagraph of paragraph 3.

5. Systematic internalisers shall be allowed to decide, on the basis of their commercial policy and in an objective non-discriminatory way, the investors to whom they give access to their quotes. To that end there shall be clear standards for governing access to their quotes. Systematic internalisers may refuse to enter into or discontinue business relationships with investors on the basis of commercial considerations such as the investor credit status, the counterparty risk and the final settlement of the transaction.

6. In order to limit the risk of being exposed to multiple transactions from the same client systematic internalisers shall be allowed to limit in a non-discriminatory way the number of transactions from the same client which they undertake to enter at the published conditions. They shall also be allowed, in a non-discriminatory way and in accordance with the provisions of Article 22, to limit the total number of transactions from different clients at the same time provided that this is allowable only where the number and/or volume of orders sought by clients considerably exceeds the norm.

7. In order to ensure the uniform application of paragraphs 1 to 6, in a manner which supports the efficient valuation of shares and maximises the possibility of investment firms of obtaining the best deal for their clients, the Commission shall, in accordance with the procedure referred to in Article 64(2), adopt implementing measures which:

(a)	specify the criteria for application of paragraphs 1 and 2;

(b)

specify the criteria determining when a quote is published on a regular and continuous basis and is easily accessible as well as the means by which investment firms may comply with their obligation to make public their quotes, which shall include the following possibilities:

(i)	through the facilities of any regulated market which has admitted the instrument in question to trading;

(ii)	through the offices of a third party;

(iii)

through proprietary arrangements;

(c)	specify the general criteria for determining those transactions where execution in several securities is part of one transaction or orders that are subject to conditions other than current market price;

(d)	specify the general criteria for determining what can be considered as exceptional market circumstances that allow for the withdrawal of quotes as well as conditions for updating quotes;

(e)	specify the criteria for determining what is a size customarily undertaken by a retail investor;

(f)	specify the criteria for determining what constitutes considerably exceeding the norm as set down in paragraph 6;

(g)	specify the criteria for determining when prices fall within a public range close to market conditions.

Article 28

Post-trade disclosure by investment firms

1. Member States shall, at least, require investment firms which, either on own account or on behalf of clients, conclude transactions in shares admitted to trading on a regulated market outside a regulated market or MTF, to make public the volume and price of those transactions and the time at which they were concluded. This information shall be made public as close to real-time as possible, on a reasonable commercial basis, and in a manner which is easily accessible to other market participants.

2. Member States shall require that the information which is made public in accordance with paragraph 1 and the time-limits within which it is published comply with the requirements adopted pursuant to Article 45. Where the measures adopted pursuant to Article 45 provide for deferred reporting for certain categories of transaction in shares, this possibility shall apply mutatis mutandis to those transactions when undertaken outside regulated markets or MTFs.

3. In order to ensure the transparent and orderly functioning of markets and the uniform application of paragraph 1, the Commission shall adopt, in accordance with the procedure referred to in Article 64(2), implementing measures which:

(a)

specify the means by which investment firms may comply with their obligations under paragraph 1 including the following possibilities:

(i)	through the facilities of any regulated market which has admitted the instrument in question to trading or through the facilities of an MTF in which the share in question is traded;

(ii)	through the offices of a third party;

(iii)

through proprietary arrangements;

(b)	clarify the application of the obligation under paragraph 1 to transactions involving the use of shares for collateral, lending or other purposes where the exchange of shares is determined by factors other than the current market valuation of the share.

Article 29

Pre-trade transparency requirements for MTFs

1. Member States shall, at least, require that investment firms and market operators operating an MTF make public current bid and offer prices and the depth of trading interests at these prices which are advertised through their systems in respect of shares admitted to trading on a regulated market. Member States shall provide for this information to be made available to the public on reasonable commercial terms and on a continuous basis during normal trading hours.

2. Member States shall provide for the competent authorities to be able to waive the obligation for investment firms or market operators operating an MTF to make public the information referred to in paragraph 1 based on the market model or the type and size of orders in the cases defined in accordance with paragraph 3. In particular, the competent authorities shall be able to waive the obligation in respect of transactions that are large in scale compared with normal market size for the share or type of share in question.

3. In order to ensure the uniform application of paragraphs 1 and 2, the Commission shall, in accordance with the procedure referred to in Article 64(2) adopt implementing measures as regards:

(a)	the range of bid and offers or designated market-maker quotes, and the depth of trading interest at those prices, to be made public;

(b)	the size or type of orders for which pre-trade disclosure may be waived under paragraph 2;

(c)

the market model for which pre-trade disclosure may be waived under paragraph 2 and in particular, the applicability of the obligation to trading methods operated by an MTF which conclude transactions under their rules by reference to prices established outside the systems of the MTF or by periodic auction.

Except where justified by the specific nature of the MTF, the content of these implementing measures shall be equal to that of the implementing measures provided for in Article 44 for regulated markets.

Article 30

Post-trade transparency requirements for MTFs

1. Member States shall, at least, require that investment firms and market operators operating an MTF make public the price, volume and time of the transactions executed under its systems in respect of shares which are admitted to trading on a regulated market. Member States shall require that details of all such transactions be made public, on a reasonable commercial basis, as close to real-time as possible. This requirement shall not apply to details of trades executed on an MTF that are made public under the systems of a regulated market.

2. Member States shall provide that the competent authority may authorise investment firms or market operators operating an MTF to provide for deferred publication of the details of transactions based on their type or size. In particular, the competent authorities may authorise the deferred publication in respect of transactions that are large in scale compared with the normal market size for that share or that class of shares. Member States shall require MTFs to obtain the competent authority's prior approval to proposed arrangements for deferred trade-publication, and shall require that these arrangements be clearly disclosed to market participants and the investing public.

3. In order to provide for the efficient and orderly functioning of financial markets, and to ensure the uniform application of paragraphs 1 and 2, the Commission shall, in accordance with the procedure referred to in Article 64(2) adopt implementing measures in respect of:

(a)	the scope and content of the information to be made available to the public;

(b)	the conditions under which investment firms or market operators operating an MTF may provide for deferred publication of trades and the criteria to be applied when deciding the transactions for which, due to their size or the type of share involved, deferred publication is allowed.

Except where justified by the specific nature of the MTF, the content of these implementing measures shall be equal to that of the implementing measures provided for in Article 45 for regulated markets.

CHAPTER III

RIGHTS OF INVESTMENT FIRMS

Article 31

Freedom to provide investment services and activities

1. Member States shall ensure that any investment firm authorised and supervised by the competent authorities of another Member State in accordance with this Directive, and in respect of credit institutions in accordance with Directive 2000/12/EC, may freely perform investment services and/or activities as well as ancillary services within their territories, provided that such services and activities are covered by its authorisation. Ancillary services may only be provided together with an investment service and/or activity.

Member States shall not impose any additional requirements on such an investment firm or credit institution in respect of the matters covered by this Directive.

2. Any investment firm wishing to provide services or activities within the territory of another Member State for the first time, or which wishes to change the range of services or activities so provided, shall communicate the following information to the competent authorities of its home Member State:

(a)	the Member State in which it intends to operate;

(b)	a programme of operations stating in particular the investment services and/or activities as well as ancillary services which it intends to perform and whether it intends to use tied agents in the territory of the Member States in which it intends to provide services.

In cases where the investment firm intends to use tied agents, the competent authority of the home Member State of the investment firm shall, at the request of the competent authority of the host Member State and within a reasonable time, communicate the identity of the tied agents that the investment firm intends to use in that Member State. The host Member State may make public such information.

3. The competent authority of the home Member State shall, within one month of receiving the information, forward it to the competent authority of the host Member State designated as contact point in accordance with Article 56(1). The investment firm may then start to provide the investment service or services concerned in the host Member State.

4. In the event of a change in any of the particulars communicated in accordance with paragraph 2, an investment firm shall give written notice of that change to the competent authority of the home Member State at least one month before implementing the change. The competent authority of the home Member State shall inform the competent authority of the host Member State of those changes.

5. Member States shall, without further legal or administrative requirement, allow investment firms and market operators operating MTFs from other Member States to provide appropriate arrangements on their territory so as to facilitate access to and use of their systems by remote users or participants established in their territory.

6. The investment firm or the market operator that operates an MTF shall communicate to the competent authority of its home Member State the Member State in which it intends to provide such arrangements. The competent authority of the home Member State of the MTF shall communicate, within one month, this information to the Member State in which the MTF intends to provide such arrangements.

The competent authority of the home Member State of the MTF shall, on the request of the competent authority of the host Member State of the MTF and within a reasonable delay, communicate the identity of the members or participants of the MTF established in that Member State.

Article 32

Establishment of a branch

1. Member States shall ensure that investment services and/or activities as well as ancillary services may be provided within their territories in accordance with this Directive and Directive 2000/12/EC through the establishment of a branch provided that those services and activities are covered by the authorisation granted to the investment firm or the credit institution in the home Member State. Ancillary services may only be provided together with an investment service and/or activity.

Member States shall not impose any additional requirements save those allowed under paragraph 7, on the organisation and operation of the branch in respect of the matters covered by this Directive.

2. Member States shall require any investment firm wishing to establish a branch within the territory of another Member State first to notify the competent authority of its home Member State and to provide it with the following information:

(a)	the Member States within the territory of which it plans to establish a branch;

(b)	a programme of operations setting out inter alia the investment services and/or activities as well as the ancillary services to be offered and the organisational structure of the branch and indicating whether the branch intends to use tied agents;

(c)	the address in the host Member State from which documents may be obtained;

(d)	the names of those responsible for the management of the branch.

In cases where an investment firm uses a tied agent established in a Member State outside its home Member State, such tied agent shall be assimilated to the branch and shall be subject to the provisions of this Directive relating to branches.

3. Unless the competent authority of the home Member State has reason to doubt the adequacy of the administrative structure or the financial situation of an investment firm, taking into account the activities envisaged, it shall, within three months of receiving all the information, communicate that information to the competent authority of the host Member State designated as contact point in accordance with Article 56(1) and inform the investment firm concerned accordingly.

4. In addition to the information referred to in paragraph 2, the competent authority of the home Member State shall communicate details of the accredited compensation scheme of which the investment firm is a member in accordance with Directive 97/9/EC to the competent authority of the host Member State. In the event of a change in the particulars, the competent authority of the home Member State shall inform the competent authority of the host Member State accordingly.

5. Where the competent authority of the home Member State refuses to communicate the information to the competent authority of the host Member State, it shall give reasons for its refusal to the investment firm concerned within three months of receiving all the information.

6. On receipt of a communication from the competent authority of the host Member State, or failing such communication from the latter at the latest after two months from the date of transmission of the communication by the competent authority of the home Member State, the branch may be established and commence business.

7. The competent authority of the Member State in which the branch is located shall assume responsibility for ensuring that the services provided by the branch within its territory comply with the obligations laid down in Articles 19, 21, 22, 25, 27 and 28 and in measures adopted pursuant thereto.

The competent authority of the Member State in which the branch is located shall have the right to examine branch arrangements and to request such changes as are strictly needed to enable the competent authority to enforce the obligations under Articles 19, 21, 22, 25, 27 and 28 and measures adopted pursuant thereto with respect to the services and/or activities provided by the branch within its territory.

8. Each Member State shall provide that, where an investment firm authorised in another Member State has established a branch within its territory, the competent authority of the home Member State of the investment firm, in the exercise of its responsibilities and after informing the competent authority of the host Member State, may carry out on-site inspections in that branch.

9. In the event of a change in any of the information communicated in accordance with paragraph 2, an investment firm shall give written notice of that change to the competent authority of the home Member State at least one month before implementing the change. The competent authority of the host Member State shall also be informed of that change by the competent authority of the home Member State.

Article 33

Access to regulated markets

1. Member States shall require that investment firms from other Member States which are authorised to execute client orders or to deal on own account have the right of membership or have access to regulated markets established in their territory by means of any of the following arrangements:

(a)	directly, by setting up branches in the host Member States;

(b)

by becoming remote members of or having remote access to the regulated market without having to be established in the home Member State of the regulated market, where the trading procedures and systems of the market in question do not require a physical presence for conclusion of transactions on the market.

2. Member States shall not impose any additional regulatory or administrative requirements, in respect of matters covered by this Directive, on investment firms exercising the right conferred by paragraph 1.

Article 34

Access to central counterparty, clearing and settlement facilities and right to designate settlement system

1. Member States shall require that investment firms from other Member States have the right of access to central counterparty, clearing and settlement systems in their territory for the purposes of finalising or arranging the finalisation of transactions in financial instruments.

Member States shall require that access of those investment firms to such facilities be subject to the same non-discriminatory, transparent and objective criteria as apply to local participants. Member States shall not restrict the use of those facilities to the clearing and settlement of transactions in financial instruments undertaken on a regulated market or MTF in their territory.

2. Member States shall require that regulated markets in their territory offer all their members or participants the right to designate the system for the settlement of transactions in financial instruments undertaken on that regulated market, subject to:

(a)	such links and arrangements between the designated settlement system and any other system or facility as are necessary to ensure the efficient and economic settlement of the transaction in question; and

(b)

agreement by the competent authority responsible for the supervision of the regulated market that technical conditions for settlement of transactions concluded on the regulated market through a settlement system other than that designated by the regulated market are such as to allow the smooth and orderly functioning of financial markets.

This assessment of the competent authority of the regulated market shall be without prejudice to the competencies of the national central banks as overseers of settlement systems or other supervisory authorities on such systems. The competent authority shall take into account the oversight/supervision already exercised by those institutions in order to avoid undue duplication of control.

3. The rights of investment firms under paragraphs 1 and 2 shall be without prejudice to the right of operators of central counterparty, clearing or securities settlement systems to refuse on legitimate commercial grounds to make the requested services available.

Article 35

Provisions regarding central counterparty, clearing and settlement arrangements in respect of MTFs

1. Member States shall not prevent investment firms and market operators operating an MTF from entering into appropriate arrangements with a central counterparty or clearing house and a settlement system of another Member State with a view to providing for the clearing and/or settlement of some or all trades concluded by market participants under their systems.

2. The competent authority of investment firms and market operators operating an MTF may not oppose the use of central counterparty, clearing houses and/or settlement systems in another Member State except where this is demonstrably necessary in order to maintain the orderly functioning of that MTF and taking into account the conditions for settlement systems established in Article 34(2).

In order to avoid undue duplication of control, the competent authority shall take into account the oversight/supervision of the clearing and settlement system already exercised by the national central banks as overseers of clearing and settlement systems or by other supervisory authorities with a competence in such systems.

TITLE III

REGULATED MARKETS

Article 36

Authorisation and applicable law

1. Member States shall reserve authorisation as a regulated market to those systems which comply with the provisions of this Title.

Authorisation as a regulated market shall be granted only where the competent authority is satisfied that both the market operator and the systems of the regulated market comply at least with the requirements laid down in this Title.

In the case of a regulated market that is a legal person and that is managed or operated by a market operator other than the regulated market itself, Member States shall establish how the different obligations imposed on the market operator under this Directive are to be allocated between the regulated market and the market operator.

The operator of the regulated market shall provide all information, including a programme of operations setting out inter alia the types of business envisaged and the organisational structure, necessary to enable the competent authority to satisfy itself that the regulated market has established, at the time of initial authorisation, all the necessary arrangements to meet its obligations under the provisions of this Title.

2. Member States shall require the operator of the regulated market to perform tasks relating to the organisation and operation of the regulated market under the supervision of the competent authority. Member States shall ensure that competent authorities keep under regular review the compliance of regulated markets with the provisions of this Title. They shall also ensure that competent authorities monitor that regulated markets comply at all times with the conditions for initial authorisation established under this Title.

3. Member States shall ensure that the market operator is responsible for ensuring that the regulated market that he manages complies with all requirements under this Title.

Member States shall also ensure that the market operator is entitled to exercise the rights that correspond to the regulated market that he manages by virtue of this Directive.

4. Without prejudice to any relevant provisions of Directive 2003/6/EC, the public law governing the trading conducted under the systems of the regulated market shall be that of the home Member State of the regulated market.

5. The competent authority may withdraw the authorisation issued to a regulated market where it:

(a)	does not make use of the authorisation within 12 months, expressly renounces the authorisation or has not operated for the preceding six months, unless the Member State concerned has provided for authorisation to lapse in such cases;

(b)	has obtained the authorisation by making false statements or by any other irregular means;

(c)	no longer meets the conditions under which authorisation was granted;

(d)	has seriously and systematically infringed the provisions adopted pursuant to this Directive;

(e)	falls within any of the cases where national law provides for withdrawal.

Article 37

Requirements for the management of the regulated market

1. Member States shall require the persons who effectively direct the business and the operations of the regulated market to be of sufficiently good repute and sufficiently experienced as to ensure the sound and prudent management and operation of the regulated market. Member States shall also require the operator of the regulated market to inform the competent authority of the identity and any other subsequent changes of the persons who effectively direct the business and the operations of the regulated market.

The competent authority shall refuse to approve proposed changes where there are objective and demonstrable grounds for believing that they pose a material threat to the sound and prudent management and operation of the regulated market.

2. Member States shall ensure that, in the process of authorisation of a regulated market, the person or persons who effectively direct the business and the operations of an already authorised regulated market in accordance with the conditions of this Directive are deemed to comply with the requirements laid down in paragraph 1.

Article 38

Requirements relating to persons exercising significant influence over the management of the regulated market

1. Member States shall require the persons who are in a position to exercise, directly or indirectly, significant influence over the management of the regulated market to be suitable.

2. Member States shall require the operator of the regulated market:

(a)	to provide the competent authority with, and to make public, information regarding the ownership of the regulated market and/or the market operator, and in particular, the identity and scale of interests of any parties in a position to exercise significant influence over the management;

(b)	to inform the competent authority of and to make public any transfer of ownership which gives rise to a change in the identity of the persons exercising significant influence over the operation of the regulated market.

3. The competent authority shall refuse to approve proposed changes to the controlling interests of the regulated market and/or the market operator where there are objective and demonstrable grounds for believing that they would pose a threat to the sound and prudent management of the regulated market.

Article 39

Organisational requirements

Member States shall require the regulated market:

(a)

to have arrangements to identify clearly and manage the potential adverse consequences, for the operation of the regulated market or for its participants, of any conflict of interest between the interest of the regulated market, its owners or its operator and the sound functioning of the regulated market, and in particular where such conflicts of interest might prove prejudicial to the accomplishment of any functions delegated to the regulated market by the competent authority;

(b)	to be adequately equipped to manage the risks to which it is exposed, to implement appropriate arrangements and systems to identify all significant risks to its operation, and to put in place effective measures to mitigate those risks;

(c)	to have arrangements for the sound management of the technical operations of the system, including the establishment of effective contingency arrangements to cope with risks of systems disruptions;

(d)	to have transparent and non-discretionary rules and procedures that provide for fair and orderly trading and establish objective criteria for the efficient execution of orders;

(e)	to have effective arrangements to facilitate the efficient and timely finalisation of the transactions executed under its systems;

(f)	to have available, at the time of authorisation and on an ongoing basis, sufficient financial resources to facilitate its orderly functioning, having regard to the nature and extent of the transactions concluded on the market and the range and degree of the risks to which it is exposed.

Article 40

Admission of financial instruments to trading

1. Member States shall require that regulated markets have clear and transparent rules regarding the admission of financial instruments to trading.

Those rules shall ensure that any financial instruments admitted to trading in a regulated market are capable of being traded in a fair, orderly and efficient manner and, in the case of transferable securities, are freely negotiable.

2. In the case of derivatives, the rules shall ensure in particular that the design of the derivative contract allows for its orderly pricing as well as for the existence of effective settlement conditions.

3. In addition to the obligations set out in paragraphs 1 and 2, Member States shall require the regulated market to establish and maintain effective arrangements to verify that issuers of transferable securities that are admitted to trading on the regulated market comply with their obligations under Community law in respect of initial, ongoing or ad hoc disclosure obligations.

Member States shall ensure that the regulated market establishes arrangements which facilitate its members or participants in obtaining access to information which has been made public under Community law.

4. Member States shall ensure that regulated markets have established the necessary arrangements to review regularly the compliance with the admission requirements of the financial instruments which they admit to trading.

5. A transferable security that has been admitted to trading on a regulated market can subsequently be admitted to trading on other regulated markets, even without the consent of the issuer and in compliance with the relevant provisions of Directive 2003/71/EC of the European Parliament and of the Council of ... on the prospectus to be published when securities are offered to the public or admitted to trading and amending Directive 2001/34/EC (23). The issuer shall be informed by the regulated market of the fact that its securities are traded on that regulated market. The issuer shall not be subject to any obligation to provide information required under paragraph 3 directly to any regulated market which has admitted the issuer's securities to trading without its consent.

6. In order to ensure the uniform application of paragraphs 1 to 5, the Commission shall, in accordance with the procedure referred to in Article 64(2) adopt implementing measures which:

(a)

specify the characteristics of different classes of instruments to be taken into account by the regulated market when assessing whether an instrument is issued in a manner consistent with the conditions laid down in the second subparagraph of paragraph 1 for admission to trading on the different market segments which it operates;

(b)	clarify the arrangements that the regulated market is to implement so as to be considered to have fulfilled its obligation to verify that the issuer of a transferable security complies with its obligations under Community law in respect of initial, ongoing or ad hoc disclosure obligations;

(c)	clarify the arrangements that the regulated market has to establish pursuant to paragraph 3 in order to facilitate its members or participants in obtaining access to information which has been made public under the conditions established by Community law.

Article 41

Suspension and removal of instruments from trading

1. Without prejudice to the right of the competent authority under Article 50(2)(j) and (k) to demand suspension or removal of an instrument from trading, the operator of the regulated market may suspend or remove from trading a financial instrument which no longer complies with the rules of the regulated market unless such a step would be likely to cause significant damage to the investors' interests or the orderly functioning of the market.

Notwithstanding the possibility for the operators of regulated markets to inform directly the operators of other regulated markets, Member States shall require that an operator of a regulated market that suspends or removes from trading a financial instrument make public this decision and communicates relevant information to the competent authority. The competent authority shall inform the competent authorities of the other Member States.

2. A competent authority which demands the suspension or removal of a financial instrument from trading on one or more regulated markets shall immediately make public its decision and inform the competent authorities of the other Member States. Except where it could cause significant damage to the investors' interests or the orderly functioning of the market the competent authorities of the other Member States shall demand the suspension or removal of that financial instrument from trading on the regulated markets and MTFs that operate under their authority.

Article 42

Access to the regulated market

1. Member States shall require the regulated market to establish and maintain transparent and nondiscriminatory rules, based on objective criteria, governing access to or membership of the regulated market.

2. Those rules shall specify any obligations for the members or participants arising from:

(a)	the constitution and administration of the regulated market;

(b)	rules relating to transactions on the market;

(c)	professional standards imposed on the staff of the investment firms or credit institutions that are operating on the market;

(d)	the conditions established, for members or participants other than investment firms and credit institutions, under paragraph 3;

(e)	the rules and procedures for the clearing and settlement of transactions concluded on the regulated market.

3. Regulated markets may admit as members or participants investment firms, credit institutions authorised under Directive 2000/12/EC and other persons who:

(a)	are fit and proper;

(b)	have a sufficient level of trading ability and competence;

(c)	have, where applicable, adequate organisational arrangements;

(d)	have sufficient resources for the role they are to perform, taking into account the different financial arrangements that the regulated market may have established in order to guarantee the adequate settlement of transactions.

4. Member States shall ensure that, for the transactions concluded on a regulated market, members and participants are not obliged to apply to each other the obligations laid down in Articles 19, 21 and 22. However, the members or participants of the regulated market shall apply the obligations provided for in Articles 19, 21 and 22 with respect to their clients when they, acting on behalf of their clients, execute their orders on a regulated market.

5. Member States shall ensure that the rules on access to or membership of the regulated market provide for the direct or remote participation of investment firms and credit institutions.

6. Member States shall, without further legal or administrative requirements, allow regulated markets from other Member States to provide appropriate arrangements on their territory so as to facilitate access to and trading on those markets by remote members or participants established in their territory.

The regulated market shall communicate to the competent authority of its home Member State the Member State in which it intends to provide such arrangements. The competent authority of the home Member State shall communicate, within one month, this information to the Member State in which the regulated market intends to provide such arrangements.

The competent authority of the home Member State of the regulated market shall, on the request of the competent authority of the host Member State and within a reasonable time, communicate the identity of the members or participants of the regulated market established in that Member State.

7. Member States shall require the operator of the regulated market to communicate, on a regular basis, the list of the members and participants of the regulated market to the competent authority of the regulated market.

Article 43

Monitoring of compliance with the rules of the regulated market and with other legal obligations

1. Member States shall require that regulated markets establish and maintain effective arrangements and procedures for the regular monitoring of the compliance by their members or participants with their rules. Regulated markets shall monitor the transactions undertaken by their members or participants under their systems in order to identify breaches of those rules, disorderly trading conditions or conduct that may involve market abuse.

2. Member States shall require the operators of the regulated markets to report significant breaches of their rules or disorderly trading conditions or conduct that may involve market abuse to the competent authority of the regulated market. Member States shall also require the operator of the regulated market to supply the relevant information without delay to the authority competent for the investigation and prosecution of market abuse on the regulated market and to provide full assistance to the latter in investigating and prosecuting market abuse occurring on or through the systems of the regulated market.

Article 44

Pre-trade transparency requirements for regulated markets

1. Member States shall, at least, require regulated markets to make public current bid and offer prices and the depth of trading interests at those prices which are advertised through their systems for shares admitted to trading. Member States shall require this information to be made available to the public on reasonable commercial terms and on a continuous basis during normal trading hours.

Regulated markets may give access, on reasonable commercial terms and on a non-discriminatory basis, to the arrangements they employ for making public the information under the first subparagraph to investment firms which are obliged to publish their quotes in shares pursuant to Article 27.

2. Member States shall provide that the competent authorities are to be able to waive the obligation for regulated markets to make public the information referred to in paragraph 1 based on the market model or the type and size of orders in the cases defined in accordance with paragraph 3. In particular, the competent authorities shall be able to waive the obligation in respect of transactions that are large in scale compared with normal market size for the share or type of share in question.

3. In order to ensure the uniform application of paragraphs 1 and 2, the Commission shall, in accordance with the procedure referred to in Article 64(2) adopt implementing measures as regards:

(a)	the range of bid and offers or designated market-maker quotes, and the depth of trading interest at those prices, to be made public;

(b)	the size or type of orders for which pre-trade disclosure may be waived under paragraph 2;

(c)

the market model for which pre-trade disclosure may be waived under paragraph 2, and in particular, the applicability of the obligation to trading methods operated by regulated markets which conclude transactions under their rules by reference to prices established outside the regulated market or by periodic auction.

Article 45

Post-trade transparency requirements for regulated markets

1. Member States shall, at least, require regulated markets to make public the price, volume and time of the transactions executed in respect of shares admitted to trading. Member States shall require details of all such transactions to be made public, on a reasonable commercial basis and as close to real-time as possible.

2. Member States shall provide that the competent authority may authorise regulated markets to provide for deferred publication of the details of transactions based on their type or size. In particular, the competent authorities may authorise the deferred publication in respect of transactions that are large in scale compared with the normal market size for that share or that class of shares. Member States shall require regulated markets to obtain the competent authority's prior approval of proposed arrangements for deferred trade-publication, and shall require that these arrangements be clearly disclosed to market participants and the investing public.

(a)	the scope and content of the information to be made available to the public;

(b)	the conditions under which a regulated market may provide for deferred publication of trades and the criteria to be applied when deciding the transactions for which, due to their size or the type of share involved, deferred publication is allowed.

Article 46

Provisions regarding central counterparty and clearing and settlement arrangements

1. Member States shall not prevent regulated markets from entering into appropriate arrangements with a central counterparty or clearing house and a settlement system of another Member State with a view to providing for the clearing and/or settlement of some or all trades concluded by market participants under their systems.

2. The competent authority of a regulated market may not oppose the use of central counterparty, clearing houses and/or settlement systems in another Member State except where this is demonstrably necessary in order to maintain the orderly functioning of that regulated market and taking into account the conditions for settlement systems established in Article 34(2).

Article 47

List of regulated markets

Each Member State shall draw up a list of the regulated markets for which it is the home Member State and shall forward that list to the other Member States and the Commission. A similar communication shall be effected in respect of each change to that list. The Commission shall publish a list of all regulated markets in the Official Journal of the European Union and update it at least once a year. The Commission shall also publish and update the list at its website, each time the Member States communicate changes to their lists.

TITLE IV

COMPETENT AUTHORITIES

CHAPTER I

DESIGNATION, POWERS AND REDRESS PROCEDURES

Article 48

Designation of competent authorities

1. Each Member State shall designate the competent authorities which are to carry out each of the duties provided for under the different provisions of this Directive. Member States shall inform the Commission and the competent authorities of other Member States of the identity of the competent authorities responsible for enforcement of each of those duties, and of any division of those duties.

2. The competent authorities referred to in paragraph 1 shall be public authorities, without prejudice to the possibility of delegating tasks to other entities where that is expressly provided for in Articles 5(5), 16(3), 17(2) and 23(4).

Any delegation of tasks to entities other than the authorities referred to in paragraph 1 may not involve either the exercise of public authority or the use of discretionary powers of judgement. Member States shall require that, prior to delegation, competent authorities take all reasonable steps to ensure that the entity to which tasks are to be delegated has the capacity and resources to effectively execute all tasks and that the delegation takes place only if a clearly defined and documented framework for the exercise of any delegated tasks has been established stating the tasks to be undertaken and the conditions under which they are to be carried out. These conditions shall include a clause obliging the entity in question to act and be organised in such a manner as to avoid conflict of interest and so that information obtained from carrying out the delegated tasks is not used unfairly or to prevent competition. In any case, the final responsibility for supervising compliance with this Directive and with its implementing measures shall lie with the competent authority or authorities designated in accordance with paragraph 1.

Member States shall inform the Commission and the competent authorities of other Member States of any arrangements entered into with regard to delegation of tasks, including the precise conditions regulating such delegation.

3. The Commission shall publish a list of the competent authorities referred to in paragraphs 1 and 2 in the Official Journal of the European Union at least once a year and update it continuously on its website.

Article 49

Cooperation between authorities in the same Member State

If a Member State designates more than one competent authority to enforce a provision of this Directive, their respective roles shall be clearly defined and they shall cooperate closely.

Each Member State shall require that such cooperation also take place between the competent authorities for the purposes of this Directive and the competent authorities responsible in that Member State for the supervision of credit and other financial institutions, pension funds, UCITS, insurance and reinsurance intermediaries and insurance undertakings.

Member States shall require that competent authorities exchange any information which is essential or relevant to the exercise of their functions and duties.

Article 50

Powers to be made available to competent authorities

1. Competent authorities shall be given all supervisory and investigatory powers that are necessary for the exercise of their functions. Within the limits provided for in their national legal frameworks they shall exercise such powers:

(a)	directly; or

(b)	in collaboration with other authorities; or

(c)	under their responsibility by delegation to entities to which tasks have been delegated according to Article 48(2); or

(d)	by application to the competent judicial authorities.

2. The powers referred to in paragraph 1 shall be exercised in conformity with national law and shall include, at least, the rights to:

(a)	have access to any document in any form whatsoever and to receive a copy of it;

(b)	demand information from any person and if necessary to summon and question a person with a view to obtaining information;

(c)	carry out on-site inspections;

(d)	require existing telephone and existing data traffic records;

(e)	require the cessation of any practice that is contrary to the provisions adopted in the implementation of this Directive;

(f)	request the freezing and/or the sequestration of assets;

(g)	request temporary prohibition of professional activity;

(h)	require authorised investment firms and regulated markets' auditors to provide information;

(i)	adopt any type of measure to ensure that investment firms and regulated markets continue to comply with legal requirements;

(j)	require the suspension of trading in a financial instrument;

(k)	require the removal of a financial instrument from trading, whether on a regulated market or under other trading arrangements;

(l)	refer matters for criminal prosecution;

(m)	allow auditors or experts to carry out verifications or investigations.

Article 51

Administrative sanctions

1. Without prejudice to the procedures for the withdrawal of authorisation or to the right of Member States to impose criminal sanctions, Member States shall ensure, in conformity with their national law, that the appropriate administrative measures can be taken or administrative sanctions be imposed against the persons responsible where the provisions adopted in the implementation of this Directive have not been complied with. Member States shall ensure that these measures are effective, proportionate and dissuasive.

2. Member States shall determine the sanctions to be applied for failure to cooperate in an investigation covered by Article 50.

3. Member States shall provide that the competent authority may disclose to the public any measure or sanction that will be imposed for infringement of the provisions adopted in the implementation of this Directive, unless such disclosure would seriously jeopardise the financial markets or cause disproportionate damage to the parties involved.

Article 52

Right of appeal

1. Member States shall ensure that any decision taken under laws, regulations or administrative provisions adopted in accordance with this Directive is properly reasoned and is subject to the right to apply to the courts. The right to apply to the courts shall also apply where, in respect of an application for authorisation which provides all the information required, no decision is taken within six months of its submission.

2. Member States shall provide that one or more of the following bodies, as determined by national law, may, in the interests of consumers and in accordance with national law, take action before the courts or competent administrative bodies to ensure that the national provisions for the implementation of this Directive are applied:

(a)	public bodies or their representatives;

(b)	consumer organisations having a legitimate interest in protecting consumers;

(c)	professional organisations having a legitimate interest in acting to protect their members.

Article 53

Extra-judicial mechanism for investors' complaints

1. Member States shall encourage the setting-up of efficient and effective complaints and redress procedures for the out-of-court settlement of consumer disputes concerning the provision of investment and ancillary services provided by investment firms, using existing bodies where appropriate.

2. Member States shall ensure that those bodies are not prevented by legal or regulatory provisions from cooperating effectively in the resolution of cross-border disputes.

Article 54

Professional secrecy

1. Member States shall ensure that competent authorities, all persons who work or who have worked for the competent authorities or entities to whom tasks are delegated pursuant to Article 48(2), as well as auditors and experts instructed by the competent authorities, are bound by the obligation of professional secrecy. No confidential information which they may receive in the course of their duties may be divulged to any person or authority whatsoever, save in summary or aggregate form such that individual investment firms, market operators, regulated markets or any other person cannot be identified, without prejudice to cases covered by criminal law or the other provisions of this Directive.

2. Where an investment firm, market operator or regulated market has been declared bankrupt or is being compulsorily wound up, confidential information which does not concern third parties may be divulged in civil or commercial proceedings if necessary for carrying out the proceeding.

3. Without prejudice to cases covered by criminal law, the competent authorities, bodies or natural or legal persons other than competent authorities which receive confidential information pursuant to this Directive may use it only in the performance of their duties and for the exercise of their functions, in the case of the competent authorities, within the scope of this Directive or, in the case of other authorities, bodies or natural or legal persons, for the purpose for which such information was provided to them and/or in the context of administrative or judicial proceedings specifically related to the exercise of those functions. However, where the competent authority or other authority, body or person communicating information consents thereto, the authority receiving the information may use it for other purposes.

4. Any confidential information received, exchanged or transmitted pursuant to this Directive shall be subject to the conditions of professional secrecy laid down in this Article. Nevertheless, this Article shall not prevent the competent authorities from exchanging or transmitting confidential information in accordance with this Directive and with other Directives applicable to investment firms, credit institutions, pension funds, UCITS, insurance and reinsurance intermediaries, insurance undertakings regulated markets or market operators or otherwise with the consent of the competent authority or other authority or body or natural or legal person that communicated the information.

5. This Article shall not prevent the competent authorities from exchanging or transmitting in accordance with national law, confidential information that has not been received from a competent authority of another Member State.

Article 55

Relations with auditors

1. Member States shall provide, at least, that any person authorised within the meaning of Eighth Council Directive 84/253/EEC of 10 April 1984 on the approval of persons responsible for carrying out the statutory audits of accounting documents (24), performing in an investment firm the task described in Article 51 of Fourth Council Directive 78/660/EEC of 25 July 1978 on the annual accounts of certain types of companies (25), Article 37 of Directive 83/349/EEC or Article 31 of Directive 85/611/EEC or any other task prescribed by law, shall have a duty to report promptly to the competent authorities any fact or decision concerning that undertaking of which that person has become aware while carrying out that task and which is liable to:

(a)	constitute a material breach of the laws, regulations or administrative provisions which lay down the conditions governing authorisation or which specifically govern pursuit of the activities of investment firms;

(b)	affect the continuous functioning of the investment firm;

(c)	lead to refusal to certify the accounts or to the expression of reservations.

That person shall also have a duty to report any facts and decisions of which the person becomes aware in the course of carrying out one of the tasks referred to in the first subparagraph in an undertaking having close links with the investment firm within which he is carrying out that task.

2. The disclosure in good faith to the competent authorities, by persons authorised within the meaning of Directive 84/253/EEC, of any fact or decision referred to in paragraph 1 shall not constitute a breach of any contractual or legal restriction on disclosure of information and shall not involve such persons in liability of any kind.

CHAPTER II

COOPERATION BETWEEN COMPETENT AUTHORITIES OF DIFFERENT MEMBER STATES

Article 56

Obligation to cooperate

1. Competent authorities of different Member States shall cooperate with each other whenever necessary for the purpose of carrying out their duties under this Directive, making use of their powers whether set out in this Directive or in national law.

Competent authorities shall render assistance to competent authorities of the other Member States. In particular, they shall exchange information and cooperate in any investigation or supervisory activities.

In order to facilitate and accelerate cooperation, and more particularly exchange of information, Member States shall designate one single competent authority as a contact point for the purposes of this Directive. Member States shall communicate to the Commission and to the other Member States the names of the authorities which are designated to receive requests for exchange of information or cooperation pursuant to this paragraph.

2. When, taking into account the situation of the securities markets in the host Member State, the operations of a regulated market that has established arrangements in a host Member State have become of substantial importance for the functioning of the securities markets and the protection of the investors in that host Member State, the home and host competent authorities of the regulated market shall establish proportionate cooperation arrangements.

3. Member States shall take the necessary administrative and organisational measures to facilitate the assistance provided for in paragraph 1.

Competent authorities may use their powers for the purpose of cooperation, even in cases where the conduct under investigation does not constitute an infringement of any regulation in force in that Member State.

4. Where a competent authority has good reasons to suspect that acts contrary to the provisions of this Directive, carried out by entities not subject to its supervision, are being or have been carried out on the territory of another Member State, it shall notify this in as specific a manner as possible to the competent authority of the other Member State. The latter authority shall take appropriate action. It shall inform the notifying competent authority of the outcome of the action and, to the extent possible, of significant interim developments. This paragraph shall be without prejudice to the competences of the competent authority that has forwarded the information.

5. In order to ensure the uniform application of paragraph 2 the Commission may adopt, in accordance with the procedure referred to in Article 64(2), implementing measures to establish the criteria under which the operations of a regulated market in a host Member State could be considered as of substantial importance for the functioning of the securities markets and the protection of the investors in that host Member State.

Article 57

Cooperation in supervisory activities, on-the-spot verifications or in investigations

A competent authority of one Member State may request the cooperation of the competent authority of another Member State in a supervisory activity or for an on-the-spot verification or in an investigation. In the case of investment firms that are remote members of a regulated market the competent authority of the regulated market may choose to address them directly, in which case it shall inform the competent authority of the home Member State of the remote member accordingly.

Where a competent authority receives a request with respect to an on-the-spot verification or an investigation, it shall, within the framework of its powers:

(a)	carry out the verifications or investigations itself; or

(b)	allow the requesting authority to carry out the verification or investigation; or

(c)	allow auditors or experts to carry out the verification or investigation.

Article 58

Exchange of information

1. Competent authorities of Member States having been designated as contact points for the purposes of this Directive in accordance with Article 56(1) shall immediately supply one another with the information required for the purposes of carrying out the duties of the competent authorities, designated in accordance to Article 48(1), set out in the provisions adopted pursuant to this Directive.

Competent authorities exchanging information with other competent authorities under this Directive may indicate at the time of communication that such information must not be disclosed without their express agreement, in which case such information may be exchanged solely for the purposes for which those authorities gave their agreement.

2. The competent authority having been designated as the contact point may transmit the information received under paragraph 1 and Articles 55 and 63 to the authorities referred to in Article 49. They shall not transmit it to other bodies or natural or legal persons without the express agreement of the competent authorities which disclosed it and solely for the purposes for which those authorities gave their agreement, except in duly justified circumstances. In this last case, the contact point shall immediately inform the contact point that sent the information.

3. Authorities as referred to in Article 49 as well as other bodies or natural and legal persons receiving confidential information under paragraph 1 of this Article or under Articles 55 and 63 may use it only in the course of their duties, in particular:

(a)

to check that the conditions governing the taking-up of the business of investment firms are met and to facilitate the monitoring, on a non-consolidated or consolidated basis, of the conduct of that business, especially with regard to the capital adequacy requirements imposed by Directive 93/6/EEC, administrative and accounting procedures and internal-control mechanisms;

(b)	to monitor the proper functioning of trading venues;

(c)	to impose sanctions;

(d)	in administrative appeals against decisions by the competent authorities;

(e)	in court proceedings initiated under Article 52; or

(f)	in the extra-judicial mechanism for investors' complaints provided for in Article 53.

4. The Commission may adopt, in accordance with the procedure referred to in Article 64(2), implementing measures concerning procedures for the exchange of information between competent authorities.

5. Articles 54, 58 and 63 shall not prevent a competent authority from transmitting to central banks, the European System of Central Banks and the European Central Bank, in their capacity as monetary authorities, and, where appropriate, to other public authorities responsible for overseeing payment and settlement systems, confidential information intended for the performance of their tasks; likewise such authorities or bodies shall not be prevented from communicating to the competent authorities such information as they may need for the purpose of performing their functions provided for in this Directive.

Article 59

Refusal to cooperate

A competent authority may refuse to act on a request for cooperation in carrying out an investigation, on-the-spot verification or supervisory activity as provided for in Article 57 or to exchange information as provided for in Article 58 only where:

(a)	such an investigation, on-the-spot verification, supervisory activity or exchange of information might adversely affect the sovereignty, security or public policy of the State addressed;

(b)	judicial proceedings have already been initiated in respect of the same actions and the same persons before the authorities of the Member State addressed;

(c)	final judgment has already been delivered in the Member State addressed in respect of the same persons and the same actions.

In the case of such a refusal, the competent authority shall notify the requesting competent authority accordingly, providing as detailed information as possible.

Article 60

Inter-authority consultation prior to authorisation

1. The competent authorities of the other Member State involved shall be consulted prior to granting authorisation to an investment firm which is:

(a)	a subsidiary of an investment firm or credit institution authorised in another Member State; or

(b)	a subsidiary of the parent undertaking of an investment firm or credit institution authorised in another Member State; or

(c)	controlled by the same natural or legal persons as control an investment firm or credit institution authorised in another Member State.

2. The competent authority of the Member State responsible for the supervision of credit institutions or insurance undertakings shall be consulted prior to granting an authorisation to an investment firm which is:

(a)	a subsidiary of a credit institution or insurance undertaking authorised in the Community; or

(b)	a subsidiary of the parent undertaking of a credit institution or insurance undertaking authorised in the Community; or

(c)	controlled by the same person, whether natural or legal, who controls a credit institution or insurance undertaking authorised in the Community.

3. The relevant competent authorities referred to in paragraphs 1 and 2 shall in particular consult each other when assessing the suitability of the shareholders or members and the reputation and experience of persons who effectively direct the business involved in the management of another entity of the same group. They shall exchange all information regarding the suitability of shareholders or members and the reputation and experience of persons who effectively direct the business that is of relevance to the other competent authorities involved, for the granting of an authorisation as well as for the ongoing assessment of compliance with operating conditions.

Article 61

Powers for host Member States

1. Host Member States may, for statistical purposes, require all investment firms with branches within their territories to report to them periodically on the activities of those branches.

2. In discharging their responsibilities under this Directive, host Member States may require branches of investment firms to provide the information necessary for the monitoring of their compliance with the standards set by the host Member State that apply to them for the cases provided for in Article 32(7). Those requirements may not be more stringent than those which the same Member State imposes on established firms for the monitoring of their compliance with the same standards.

Article 62

Precautionary measures to be taken by host Member States

1. Where the competent authority of the host Member State has clear and demonstrable grounds for believing that an investment firm acting within its territory under the freedom to provide services is in breach of the obligations arising from the provisions adopted pursuant to this Directive or that an investment firm that has a branch within its territory is in breach of the obligations arising from the provisions adopted pursuant to this Directive which do not confer powers on the competent authority of the host Member State, it shall refer those findings to the competent authority of the home Member State.

If, despite the measures taken by the competent authority of the home Member State or because such measures prove inadequate, the investment firm persists in acting in a manner that is clearly prejudicial to the interests of host Member State investors or the orderly functioning of markets, the competent authority of the host Member State, after informing the competent authority of the home Member State shall take all the appropriate measures needed in order to protect investors and the proper functioning of the markets. This shall include the possibility of preventing offending investment firms from initiating any further transactions within their territories. The Commission shall be informed of such measures without delay.

2. Where the competent authorities of a host Member State ascertain that an investment firm that has a branch within its territory is in breach of the legal or regulatory provisions adopted in that State pursuant to those provisions of this Directive which confer powers on the host Member State's competent authorities, those authorities shall require the investment firm concerned to put an end to its irregular situation.

If the investment firm concerned fails to take the necessary steps, the competent authorities of the host Member State shall take all appropriate measures to ensure that the investment firm concerned puts an end to its irregular situation. The nature of those measures shall be communicated to the competent authorities of the home Member State.

If, despite the measures taken by the host Member State, the investment firm persists in breaching the legal or regulatory provisions referred to in the first subparagraph in force in the host Member State, the latter may, after informing the competent authorities of the home Member State, take appropriate measures to prevent or to penalise further irregularities and, in so far as necessary, to prevent that investment firm from initiating any further transactions within its territory. The Commission shall be informed of such measures without delay.

3. Where the competent authority of the host Member State of a regulated market or an MTF has clear and demonstrable grounds for believing that such regulated market or MTF is in breach of the obligations arising from the provisions adopted pursuant to this Directive, it shall refer those findings to the competent authority of the home Member State of the regulated market or the MTF.

If, despite the measures taken by the competent authority of the home Member State or because such measures prove inadequate, the said regulated market or the MTF persists in acting in a manner that is clearly prejudicial to the interests of host Member State investors or the orderly functioning of markets, the competent authority of the host Member State, after informing the competent authority of the home Member State, shall take all the appropriate measures needed in order to protect investors and the proper functioning of the markets. This shall include the possibility of preventing the said regulated market or the MTF from making their arrangements available to remote members or participants established in the host Member State. The Commission shall be informed of such measures without delay.

4. Any measure adopted pursuant to paragraphs 1, 2 or 3 involving sanctions or restrictions on the activities of an investment firm or of a regulated market shall be properly justified and communicated to the investment firm or to the regulated market concerned.

CHAPTER III

COOPERATION WITH THIRD COUNTRIES

Article 63

Exchange of information with third countries

1. Member States may conclude cooperation agreements providing for the exchange of information with the competent authorities of third countries only if the information disclosed is subject to guarantees of professional secrecy at least equivalent to those required under Article 54. Such exchange of information must be intended for the performance of the tasks of those competent authorities.

Member States may transfer personal data to a third country in accordance to Chapter IV of Directive 95/46/EC.

Member States may also conclude cooperation agreements providing for the exchange of information with third country authorities, bodies and natural or legal persons responsible for:

(i)	the supervision of credit institutions, other financial organisations, insurance undertakings and the supervision of financial markets;

(ii)	the liquidation and bankruptcy of investment firms and other similar procedures;

(iii)

carrying out statutory audits of the accounts of investment firms and other financial institutions, credit institutions and insurance undertakings, in the performance of their supervisory functions, or which administer compensation schemes, in the performance of their functions;

(iv)	overseeing the bodies involved in the liquidation and bankruptcy of investment firms and other similar procedures;

(v)	overseeing persons charged with carrying out statutory audits of the accounts of insurance undertakings, credit institutions, investment firms and other financial institutions,

only if the information disclosed is subject to guarantees of professional secrecy at least equivalent to those required under Article 54. Such exchange of information must be intended for the performance of the tasks of those authorities or bodies or natural or legal persons.

2. Where the information originates in another Member State, it may not be disclosed without the express agreement of the competent authorities which have transmitted it and, where appropriate, solely for the purposes for which those authorities gave their agreement. The same provision applies to information provided by third country competent authorities.

TITLE V

FINAL PROVISIONS

Article 64

Committee procedure

1. The Commission shall be assisted by the European Securities Committee established by Commission Decision 2001/528/EC (26) (hereinafter referred to as ‘the Committee’).

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof, provided that the implementing measures adopted in accordance with that procedure do not modify the essential provisions of this Directive.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. Without prejudice to the implementing measures already adopted, on the expiry of a four-year period following the entry into force of this Directive, the application of its provisions requiring the adoption of technical rules and decisions in accordance with paragraph 2 shall be suspended. On a proposal from the Commission, the European Parliament and the Council may renew the provisions concerned in accordance with the procedure laid down in Article 251 of the Treaty and, to that end, they shall review them prior to the expiry of that period.

Article 65

Reports and review

1. Before ... (27), the Commission shall, on the basis of public consultation and in the light of discussions with competent authorities, report to the European Parliament and Council on the possible extension of the scope of the provisions of the Directive concerning pre and post-trade transparency obligations to transactions in classes of financial instrument other than shares.

2. Before ... (28), the Commission shall present a report to the European Parliament and to the Council on the application of Article 27.

3. Before ... (29), the Commission shall, on the basis of public consultations and in the light of discussions with competent authorities, report to the European Parliament and Council on:

(a)	the continued appropriateness of the exemption under Article 2(1)(k) for undertakings whose main business is dealing on own account in commodity derivatives;

(b)	the content and form of proportionate requirements for the authorisation and supervision of such undertakings as investment firms within the meaning of this Directive;

(c)	the appropriateness of rules concerning the appointment of tied agents in performing investment services and/or activities, in particular with respect to the supervision on them;

(d)	the continued appropriateness of the exemption under of Article 2(1)(i).

4. Before ... (29), the Commission shall present a report to the European Parliament and the Council on the state of the removal of the obstacles which may prevent the consolidation at the European level of the information that trading venues are required to publish.

5. On the basis of the reports referred to in paragraphs 1 to 4, the Commission may submit proposals for related amendments to this Directive.

6. Before ... (30), the Commission shall, in the light of discussions with competent authorities, report to the European Parliament and Council on the continued appropriateness of the requirements for professional indemnity insurance imposed on intermediaries under Community law.

Article 66

Amendment of Directive 85/611/EEC

In Article 5 of Directive 85/611/EEC, paragraph 4 shall be replaced by the following:

‘4. Articles 2(2), 12, 13 and 19 of Directive 2004/ /EC of the European Parliament and of the Council of ... (31) on markets in financial instruments (32), shall apply to the provision of the services referred to in paragraph 3 of this Article by management companies.

Article 67

Amendment of Directive 93/6/EEC

Directive 93/6/EEC shall be amended as follows:

Article 2(2) shall be replaced by the following:

‘2. Investment firms shall mean all institutions that satisfy the definition in Article 4(1) of Directive 2004/.../EC (33) of the European Parliament and of the Council of ... on markets in financial instruments (34), which are subject to the requirements imposed by the same Directive, excluding:

(a)	credit institutions,

(b)	local firms as defined in 20, and

(c)	firms which are only authorised to provide the service of investment advice and/or receive and transmit orders from investors without in both cases holding money or securities belonging to their clients and which for that reason may not at any time place themselves in debit with their clients.

(34) OJ L ...’"

2)	Article 3(4) shall be replaced by the following: ‘4. The firms referred to in point (b) of Article 2(2) shall have initial capital of EUR 50 000 in so far as they benefit from the freedom of establishment or to provide services under Articles 31 or 32 of Directive 2004/39/EC.’

In Article 3 the following paragraphs shall be inserted:

‘(4a) Pending revision of Directive 93/6/EEC, the firms referred to in point (c) of Article 2(2) shall have:

(a)	initial capital of EUR 50 000; or

(b)	professional indemnity insurance covering the whole territory of the Community or some other comparable guarantee against liability arising from professional negligence, representing at least EUR 1 000 000 applying to each claim and in aggregate EUR 1 500 000 per year for all claims; or

(c)

a combination of initial capital and professional indemnity insurance in a form resulting in a level of coverage equivalent to points (a) or (b).

The amounts referred to in this paragraph shall be periodically reviewed by the Commission in order to take account of changes in the European Index of Consumer Prices as published by Eurostat, in line with and at the same time as the adjustments made under Article 4(7) of Directive 2002/92/EC of the European Parliament and the Council of 9 December 2002 on insurance mediation (35).

(4b) When an investment firm referred to in Article 2(2)(c), is also registered under Directive 2002/92/EC it has to comply with the requirement established by Article 4(3), of that Directive and in addition it has to have:

(a)	initial capital of EUR 25 000; or

(b)	professional indemnity insurance covering the whole territory of the Community or some other comparable guarantee against liability arising from professional negligence, representing at least EUR 500 000 applying to each claim and in aggregate EUR 750 000 per year for all claims; or

(c)	a combination of initial capital and professional indemnity insurance in a form resulting in a level of coverage equivalent to points (a) or (b).

(35) OJ L 9, 15.1.2003, p. 3.’"

Article 68

Amendment of Directive 2000/12/EC

Annex I of Directive 2000/12/EC shall be amended as follows:

At the end of the Annex I the following sentence is added:

‘The services and activities provided for in Section A and B of Annex I of Directive 2004/ /EC (36) of the European Parliament and of the Council of ... on markets in financial instruments (37) when referring to the financial instruments provided for in Section C of Annex I of that Directive are subject to mutual recognition according to this Directive.

Article 69

Repeal of Directive 93/22/EEC

Directive 93/22/EEC shall be repealed with effect from (38). References to Directive 93/22/EEC shall be construed as references to this Directive.

References to terms defined in, or Articles of, Directive 93/22/EEC shall be construed as references to the equivalent term defined in, or Article of, this Directive.

Article 70

Transposition

Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive by ... (38) at the latest. They shall forthwith inform the Commission thereof.

When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.

Article 71

Transitional provisions

1. Investment firms already authorised in their home Member State to provide investment services before the ... (38), shall be deemed to be so authorised for the purpose of this Directive, if the laws of those Member States provide that to take up such activities they must comply with conditions comparable to those imposed in Articles 9 to 14.

2. A regulated market or a market operator already authorised in its home Member State before the ... (38), shall be deemed to be so authorised for the purposes of this Directive, if the laws of such Member State provide that the regulated market or market operator (as the case may be) must comply with conditions comparable to those imposed in Title III.

3. Tied agents already entered in a public register before the ... (39), shall be deemed to be so registered for the purposes of this Directive, if the laws of those Member States provide that tied agents must comply with conditions comparable to those imposed in Article 23.

4. Information communicated before the ... (39), for the purposes of Articles 17, 18 or 30 of Directive 93/22/EEC shall be deemed to have been communicated for the purposes of Articles 31 and 32 of this Directive.

5. Any existing system falling under the definition of an MTF operated by a market operator of a regulated market, shall be authorised as an MTF at the request of the market operator of the regulated market provided it complies with rules equivalent to those required by this Directive for the authorisation and operation of MTFs, and provided that the request concerned is made within 18 months of the date referred to in Article 70.

6. Investment firms shall be authorised to continue considering existing professional clients as such provided that this categorisation has been granted by the investment firm on the basis of an adequate assessment of the expertise, experience and knowledge of the client which gives reasonable assurance, in light of the nature of the transactions or services envisaged, that the client is capable of making his own investment decisions and understands the risks involved. Those investment firms shall inform their clients about the conditions established in the Directive for the categorisation of clients.

Article 72

Entry into force

This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.

Article 73

Addressees

This Directive is addressed to the Member States.

Done at ..., on ...

For the European Parliament

The President

For the Council

The President

(1) OJ C 71 E, 25.3.2003, p. 62.

(2) OJ C 220, 16.9.2003, p. 1.

(3) OJ C 144, 20.6.2003, p. 6.

(4) Opinion of the European Parliament of 25 September 2003 (not yet published in the Official Journal), Council Common Position of 8 December 2003 (OJ C 60 E, 9.3.2004, p. 1), Position of the European Parliament of 30 March 2004.

(5) OJ L 141, 11.6.1993, p. 27. Directive as last amended by Directive 2002/87/EC of the European Parliament and of the Council (OJ L 35, 11.2.2003, p. 1).

(6) OJ 56, 4.4. 1964, p. 878/64. Directive as amended by the 1972 Act of Accession.

(7) OJ L 228, 16.8.1973, p. 3. Directive as last amended by Directive 2002/87/EC.

(8) OJ L 345, 19.12.2002, p. 1.

(9) OJ L 126, 26.5.2000, p. 1. Directive as last amended by Directive 2002/87/EC.

(10) OJ L 141, 11.6.1993, p. 1. Directive as last amended by Directive 2002/87/EC.

(11) OJ L 9, 15.1.2003, p. 3.

(12) OJ L 168, 27.6.2002, p. 43.

(13) OJ L 281, 23.11.1995, p. 31.

(14) OJ L 184, 6.7.2001, p. 1. Directive as last amended by European Parliament and Council Directive 2003/71/EC (OJ L 345, 31.12.2003, p. 64.).

(15) OJ L 115, 17.4.1998, p. 31.

(16) OJ L 184, 17.7.1999, p. 23.

(17) OJ L 26, 31.1.1977, p. 1. Directive as last amended by the 1994 Act of Accession.

(18) OJ L 375, 31.12.1985, p. 3. Directive as last amended by Directive 2001/108/EC of the European Parliament and of the Council (OJ L 41, 13.2.2002, p. 35).

(19) OJ L 193, 18.7.1983, p. 1. Directive as last amended by Directive 2003/51/EC of the European Parliament and of the Council (OJ L 178, 17.7.2003, p. 16).

(20) OJ L 84, 26.3.1997, p. 22.

(21) OJ L 96, 12.4.2003, p. 16.

(22) OJ L 166, 28.6.1991, p. 77. Directive as last amended by Directive 2001/97/EC of the European Parliament and of the Council (OJ L 344, 28.12.2001, p. 76).

(23) OJ L 345, 31.12.2003, p. 64.

(24) OJ L 126, 12.5.1984, p. 20.

(25) OJ L 222, 14.8.1978, p. 11. Directive as last amended by Directive 2003/51/EC of the European Parliament and of the Council (OJ L 178, 17.7.2003, p. 16).

(26) OJ L 191, 13.7.2001, p. 45.

(27) Two years after the entry into force of this Directive.

(28) Three years after the entry into force of this Directive.

(29) 30 months after the entry into force of this Directive.

(30) One year after the entry into force of this Directive.

(31) Not yet published in the OJ.

(33) Not yet published in the OJ.

(36) Not yet published in the OJ.

(38) 24 months after the entry into force of this Directive.

(39) 24 months after the entry into force of this directive.

ANNEX I

LIST OF SERVICES AND ACTIVITIES AND FINANCIAL INSTRUMENTS

Section A: Investment services and activities

(1)	Reception and transmission of orders in relation to one or more financial instruments.

(2)	Execution of orders on behalf of clients.

(3)	Dealing on own account.

(4)	Portfolio management.

(5)	Investment advice.

(6)	Underwriting of financial instruments and/or placing of financial instruments on a firm commitment basis.

(7)	Placing of financial instruments without a firm commitment basis

(8)	Operation of Multilateral Trading Facilities.

Section B: Ancillary services

(1)	Safekeeping and administration of financial instruments for the account of clients, including custodianship and related services such as cash/collateral management;

(2)	Granting credits or loans to an investor to allow him to carry out a transaction in one or more financial instruments, where the firm granting the credit or loan is involved in the transaction;

(3)	Advice to undertakings on capital structure, industrial strategy and related matters and advice and services relating to mergers and the purchase of undertakings;

(4)	Foreign exchange services where these are connected to the provision of investment services;

(5)	Investment research and financial analysis or other forms of general recommendation relating to transactions in financial instruments;

(6)	Services related to underwriting.

(7)	Investment services and activities as well as ancillary services of the type included under Section A or B of Annex 1 related to the underlying of the derivatives included under Section C 5, 6, 7 and 10, where these are connected to the provision of investment or ancillary services.

Section C: Financial Instruments

(1)	Transferable securities;

(2)	Money-market instruments;

(3)	Units in collective investment undertakings;

(4)	Options, futures, swaps, forward rate agreements and any other derivative contracts relating to securities, currencies, interest rates or yields, or other derivatives instruments, financial indices or financial measures which may be settled physically or in cash;

(5)	Options, futures, swaps, forward rate agreements and any other derivative contracts relating to commodities that must be settled in cash or may be settled in cash at the option of one of the parties (otherwise than by reason of a default or other termination event);

(6)	Options, futures, swaps, and any other derivative contract relating to commodities that can be physically settled provided that they are traded on a regulated market and/or an MTF;

(7)

Options, futures, swaps, forwards and any other derivative contracts relating to commodities, that can be physically settled not otherwise mentioned in C.6 and not being for commercial purposes, which have the characteristics of other derivative financial instruments, having regard to whether, inter alia, they are cleared and settled through recognised clearing houses or are subject to regular margin calls;

(8)	Derivative instruments for the transfer of credit risk;

(9)	Financial contracts for differences.

(10)

Options, futures, swaps, forward rate agreements and any other derivative contracts relating to climatic variables, freight rates, emission allowances or inflation rates or other official economic statistics that must be settled in cash or may be settled in cash at the option of one of the parties (otherwise than by reason of a default or other termination event), as well as any other derivative contracts relating to assets, rights, obligations, indices and measures not otherwise mentioned in this Section, which have the characteristics of other derivative financial instruments, having regard to whether, inter alia, they are traded on a regulated market or an MTF are cleared and settled through recognised clearing houses or are subject to regular margin calls.

ANNEX II

‘PROFESSIONAL CLIENTS’ FOR THE PURPOSE OF THIS DIRECTIVE

Professional client is a client who possesses the experience, knowledge and expertise to make its own investment decisions and properly assess the risks that it incurs. In order to be considered a professional client, the client must comply with the following criteria:

I. Categories of client who are considered to be professionals

The following should all be regarded as professionals in all investment services and activities and financial instruments for the purposes of the Directive.

(1)

Entities which are required to be authorised or regulated to operate in the financial markets. The list below should be understood as including all authorised entities carrying out the characteristic activities of the entities mentioned: entities authorised by a Member State under a Directive, entities authorised or regulated by a Member State without reference to a Directive, and entities authorised or regulated by a non-Member State:

(a)	Credit institutions,

(b)	Investment firms,

(c)	Other authorised or regulated financial institutions,

(d)	Insurance companies,

(e)	Collective investment schemes and management companies of such schemes,

(f)	Pension funds and management companies of such funds,

(g)	Commodity and commodity derivatives dealers,

(h)

Locals,

(i)	Other institutional investors.

(2)

Large undertakings meeting two of the following size requirements on a company basis:

—	balance sheet total: EUR 20 000 000,

—	net turnover: EUR 40 000 000,

—	own funds: EUR 2 000 000.

(3)	National and regional governments, public bodies that manage public debt, Central Banks, international and supranational institutions such as the World Bank, the IMF, the ECB, the EIB and other similar international organisations.

(4)	Other institutional investors whose main activity is to invest in financial instruments, including entities dedicated to the securitisation of assets or other financing transactions.

The entities mentioned above are considered to be professionals. They must however be allowed to request non-professional treatment and investment firms may agree to provide a higher level of protection. Where the client of an investment firm is an undertaking referred to above, the investment firm must inform it prior to any provision of services that, on the basis of the information available to the firm, the client is deemed to be a professional client, and will be treated as such unless the firm and the client agree otherwise. The firm must also inform the customer that he can request a variation of the terms of the agreement in order to secure a higher degree of protection.

It is the responsibility of the client, considered to be a professional client, to ask for a higher level of protection when it deems it is unable to properly assess or manage the risks involved.

This higher level of protection will be provided when a client who is considered to be a professional enters into a written agreement with the investment firm to the effect that it shall not be treated as a professional for the purposes of the applicable conduct of business regime. Such agreement should specify whether this applies to one or more particular services or transactions, or to one or more types of product or transaction.

II. Clients who may be treated as professionals on request

II.1. Identification criteria

Clients other than those mentioned in section I, including public sector bodies and private individual investors, may also be allowed to waive some of the protections afforded by the conduct of business rules.

Investment firms should therefore be allowed to treat any of the above clients as professionals provided the relevant criteria and procedure mentioned below are fulfilled. These clients should not, however, be presumed to possess market knowledge and experience comparable to that of the categories listed in section I.

Any such waiver of the protection afforded by the standard conduct of business regime shall be considered valid only if an adequate assessment of the expertise, experience and knowledge of the client, undertaken by the investment firm, gives reasonable assurance, in light of the nature of the transactions or services envisaged, that the client is capable of making his own investment decisions and understanding the risks involved.

The fitness test applied to managers and directors of entities licensed under Directives in the financial field could be regarded as an example of the assessment of expertise and knowledge.

In the case of small entities, the person subject to the above assessment should be the person authorised to carry out transactions on behalf of the entity.

In the course of the above assessment, as a minimum, two of the following criteria should be satisfied:

—	the client has carried out transactions, in significant size, on the relevant market at an average frequency of 10 per quarter over the previous four quarters,

—	the size of the client's financial instrument portfolio, defined as including cash deposits and financial instruments exceeds EUR 500 000,

—	the client works or has worked in the financial sector for at least one year in a professional position, which requires knowledge of the transactions or services envisaged.

II.2. Procedure

The clients defined above may waive the benefit of the detailed rules of conduct only where the following procedure is followed:

—	they must state in writing to the investment firm that they wish to be treated as a professional client, either generally or in respect of a particular investment service or transaction, or type of transaction or product,

—	the investment firm must give them a clear written warning of the protections and investor compensation rights they may lose,

—	they must state in writing, in a separate document from the contract, that they are aware of the consequences of losing such protections.

Before deciding to accept any request for waiver, investment firms must be required to take all reasonable steps to ensure that the client requesting to be treated as a professional client meets the relevant requirements stated in Section II.1 above.

However, if clients have already been categorised as professionals under parameters and procedures similar to those above, it is not intended that their relationships with investment firms should be affected by any new rules adopted pursuant to this Annex.

Firms must implement appropriate written internal policies and procedures to categorise clients. Professional clients are responsible for keeping the firm informed about any change, which could affect their current categorisation. Should the investment firm become aware however that the client no longer fulfils the initial conditions, which made him eligible for a professional treatment, the investment firm must take appropriate action.

P5_TA(2004)0213

Exposure of workers to the risks arising from electromagnetic fields ***II

European Parliament legislative resolution on the Council common position with a view to the adoption of a directive of the European Parliament and of the Council on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (18th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (13599/1/2003 — C5-0016/2004 — 1992/0449C(COD))

(Codecision procedure: second reading)

The European Parliament,

—	having regard to the Council common position (13599/1/2003 — C5-0016/2004) (1),

—	having regard to its position at first reading (2) on the Commission proposal to Parliament and the Council (COM(1992) 560) (3),

—	having regard to the amended proposal (COM(1994) 284) (4),

—	having regard to Article 251(2) of the EC Treaty,

—	having regard to Rule 80 of its Rules of Procedure,

—	having regard to the recommendation for second reading of the Committee on Employment and Social Affairs (A5-0196/2004),

1.	Amends the common position as follows;

2.	Instructs its President to forward its position to the Council and Commission.

(1) OJ C 66 E, 16.3.2004, p. 1.

(2) OJ C 128, 9.5.1994, p. 146.

(3) OJ C 77, 18.3.1993, p. 12.

(4) OJ C 230, 19.8.1994, p. 3.

P5_TC2-COD(1992)0449

Position of the European Parliament adopted at second reading on 30 March 2004 with a view to the adoption of European Parliament and Council Directive 2004/.../EC on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (18th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 137(2) thereof,

Having regard to the proposal from the Commission (1), presented after consultation with the Advisory Committee on Safety, Hygiene and Health Protection at Work,

Having regard to the Opinion of the European Economic and Social Committee (2),

Following consultation of the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),

Whereas:

(1)

Under the Treaty the Council may, by means of directives, adopt minimum requirements for encouraging improvements, especially in the working environment, to guarantee a better level of protection of the health and safety of workers. Such directives are to avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings.

(2)

The communication from the Commission concerning its action programme relating to the implementation of the Community Charter of the Fundamental Social Rights of Workers provides for the introduction of minimum health and safety requirements regarding the exposure of workers to the risks caused by physical agents. In September 1990 the European Parliament adopted a Resolution concerning this action programme (4), inviting the Commission in particular to draw up a specific directive on the risks caused by noise and vibration and by any other physical agents at the workplace.

(3)

As a first step, the European Parliament and the Council adopted Directive 2002/44/EC of 25 June 2002 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (vibration) (16th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (5). Next, on 6 February 2003, the European Parliament and the Council adopted Directive 2003/10/EC on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (noise) (17th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (6).

(4)

It is now considered necessary to introduce measures protecting workers from the risks associated with electromagnetic fields, owing to their effects on the health and safety of workers. However, the long-term effects, including possible carcinogenic effects due to exposure to time-varying electric, magnetic and electromagnetic fields for which there is no conclusive scientific evidence establishing a causal relationship, are not addressed in this Directive. These measures are intended not only to ensure the health and safety of each worker on an individual basis, but also to create a minimum basis of protection for all Community workers, in order to avoid possible distortions of competition.

(5)

This Directive lays down minimum requirements, thus giving Member States the option of maintaining or adopting more favourable provisions for the protection of workers, in particular the fixing of lower values for the action values or the exposure limit values for electromagnetic fields. The implementation of this Directive should not serve to justify any regression in relation to the situation which already prevails in each Member State.

(6)

A system of protection against electromagnetic fields should limit itself to a definition, free of excessive detail, of the objectives to be attained, the principles to be observed and the fundamental values to be applied, in order to enable Member States to apply the minimum requirements in an equivalent manner.

(7)

The level of exposure to electromagnetic fields can be more effectively reduced by incorporating preventive measures into the design of workstations and by selecting work equipment, procedures and methods so as to give priority to reducing the risks at source. Provisions relating to work equipment and methods thus contribute to the protection of the workers involved.

(8)	Employers should make adjustments in the light of technical progress and scientific knowledge regarding risks related to exposure to electromagnetic fields, with a view to improving the safety and health protection of workers.

(9)

Since this Directive is an individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (7), that Directive therefore applies to the exposure of workers to electromagnetic fields, without prejudice to more stringent and/or specific provisions contained in this Directive.

(10)	This Directive constitutes a practical step towards creating the social dimension of the internal market.

(11)	The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (8).

(12)

Adherence to the exposure limit and action values should provide a high level of protection as regards the established health effects that may result from exposure to electromagnetic fields but such adherence may not necessarily avoid interference problems with, or effects on the functioning of, medical devices such as metallic prostheses, cardiac pacemakers and defibrillators, cochlear implants and other implants; interference problems especially with pacemakers may occur at levels below the action values and should therefore be the object of appropriate precautions and protective measures,

HAVE ADOPTED THIS DIRECTIVE:

SECTION I

GENERAL PROVISIONS

Article 1

Aim and scope

1. This Directive, which is the 18th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC, lays down minimum requirements for the protection of workers from risks to their health and safety arising or likely to arise from exposure to electromagnetic fields (0 Hz to 300 GHz) during their work.

2. This Directive refers to the risk to the health and safety of workers due to known short-term adverse effects in the human body caused by the circulation of induced currents and by energy absorption as well as by contact currents.

3. This Directive does not address suggested long-term effects.

4. This Directive does not address the risks resulting from contact with live conductors.

5. Directive 89/391/EEC shall apply fully to the whole area referred to in paragraph 1, without prejudice to more stringent and/or more specific provisions contained in this Directive.

Article 2

Definitions

For the purposes of this Directive, the following definitions shall apply:

(a)	‘electromagnetic fields’: static magnetic and time-varying electric, magnetic and electromagnetic fields with frequencies up to 300 GHz;

(b)	‘exposure limit values’: limits on exposure to electromagnetic fields which are based directly on established health effects and biological considerations. Compliance with these limits will ensure that workers exposed to electromagnetic fields are protected against all known adverse health effects;

(c)

‘action values’: the magnitude of directly measurable parameters, provided in terms of electric field strength (E), magnetic field strength (H), magnetic flux density (B) and power density (S), at which one or more of the specified measures in this Directive must be undertaken. Compliance with these values will ensure compliance with the relevant exposure limit values.

Article 3

Exposure limit values and action values

1. The exposure limit values are as set out in the Annex, Table 1.

2. The action values are as set out in the Annex, Table 2.

3. For the assessment, measurement and/or calculation of workers' exposure to electromagnetic fields, until harmonised European standards from the European Committee for Electrotechnical Standardisation (Cenelec) cover all relevant assessment, measurement and calculation situations, Member States may employ other scientifically-based standards or guidelines.

SECTION II

OBLIGATIONS OF EMPLOYERS

Article 4

Determination of exposure and assessment of risks

1. In carrying out the obligations laid down in Articles 6(3) and 9(1) of Directive 89/391/EEC, the employer shall assess and, if necessary, measure and/or calculate the levels of electromagnetic fields to which workers are exposed. Assessment, measurement and calculation may, until harmonised European standards from Cenelec cover all relevant assessment, measurement and calculation situations, be carried out in accordance with the scientifically-based standards and guidelines referred to in Article 3 and, when relevant, by taking into account the emission levels provided by the manufacturers of the equipment when it is covered by the relevant Community Directives.

2. On the basis of the assessment of the levels of electromagnetic fields undertaken in accordance with paragraph 1, if the action values referred to in Article 3 are exceeded, the employer shall assess and, if necessary, calculate whether the exposure limit values are exceeded.

3. The assessment, measurement and/or calculations referred to in paragraphs 1 and 2 need not be carried out in workplaces open to the public provided that an evaluation has already been undertaken in accordance with the provisions of Council Recommendation 1999/519/EC of 12 July 1999 on the limitation of exposure of the general public to electromagnetic fields (0 Hz to 300 GHz) (9), and the restrictions as specified therein are respected for workers and safety risks are excluded.

4. The assessment, measurement and/or calculations referred to in paragraphs 1 and 2 shall be planned and carried out by competent services or persons at suitable intervals, taking particular account of the provisions of Article 7 and Article 11 of Directive 89/391/EEC concerning the necessary competent services or persons and the consultation and participation of workers. The data obtained from the assessment, measurement and/or calculation of the level of exposure shall be preserved in a suitable form so as to permit consultation at a later stage.

5. Pursuant to Article 6(3) of Directive 89/391/EEC, the employer shall give particular attention, when carrying out the risk assessment, to the following:

(a)	the level, frequency spectrum, duration and type of exposure;

(b)	the exposure limit values and action values referred to in Article 3 of this Directive;

(c)	any effects concerning the health and safety of workers at particular risk;

(d)

any indirect effects, such as:

(i)	interference with medical electronic equipment and devices (including cardiac pacemakers and other implanted devices);

(ii)	the projectile risk from ferromagnetic objects in static magnetic fields with a magnetic flux density greater than 3 mT;

(iii)

initiation of electro-explosive devices (detonators);

(iv)	fires and explosions resulting from ignition of flammable materials by sparks caused by induced fields, contact currents or spark discharges;

(e)	the existence of replacement equipment designed to reduce the levels of exposure to electromagnetic fields;

(f)	appropriate information obtained from health surveillance, including published information, as far as possible;

(g)	multiple sources of exposure;

(h)	simultaneous exposure to multiple frequency fields.

6. The employer shall be in possession of an assessment of the risk in accordance with Article 9(1)(a) of Directive 89/391/EEC and shall identify which measures must be taken in accordance with Articles 5 and 6 of this Directive. The risk assessment shall be recorded on a suitable medium, according to national law and practice; it may include a justification by the employer that the nature and extent of the risks related to electromagnetic fields make a further detailed risk assessment unnecessary. The risk assessment shall be updated on a regular basis, particularly if there have been significant changes which could render it out of date, or when the results of health surveillance show it to be necessary.

Article 5

Provisions aimed at avoiding or reducing risks

1. Taking account of technical progress and of the availability of measures to control the risk at source, the risks arising from exposure to electromagnetic fields shall be eliminated or reduced to a minimum.

The reduction of risks arising from exposure to electromagnetic fields shall be based on the general principles of prevention set out in Directive 89/391/EEC.

2. On the basis of the risk assessment referred to in Article 4, once the action values referred to in Article 3 are exceeded, the employer, unless the assessment carried out in accordance with Article 4(2) demonstrates that the exposure limit values are not exceeded and that safety risks can be excluded, shall devise and implement an action plan comprising technical and/or organisational measures intended to prevent exposure exceeding the exposure limit values, taking into account in particular:

(a)	other working methods that entail less exposure to electromagnetic fields;

(b)	the choice of equipment emitting less electromagnetic fields, taking account of the work to be done;

(c)	technical measures to reduce the emission of electromagnetic fields including, where necessary, the use of interlocks, shielding or similar health protection mechanisms;

(d)	appropriate maintenance programmes for work equipment, workplaces and workstation systems;

(e)	the design and layout of workplaces and workstations;

(f)	limitation of the duration and intensity of the exposure;

(g)	the availability of adequate personal protection equipment.

3. On the basis of the risk assessment referred to in Article 4, workplaces where workers could be exposed to electromagnetic fields exceeding the action values shall be indicated by appropriate signs in accordance with Council Directive 92/58/EEC of 24 June 1992 on the minimum requirements for the provision of safety and/or health signs at work (ninth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (10), unless the assessment carried out in accordance with Article 4(2) demonstrates that the exposure limit values are not exceeded and that safety risks can be excluded. The areas in question shall be identified, and access to them limited where this is technically possible and where there is a risk that the exposure limit values could be exceeded.

4. In any event, workers shall not be exposed above the exposure limit values.

If, despite the measures taken by the employer to comply with this Directive, the exposure limit values are exceeded, the employer shall take immediate action to reduce exposure below the exposure limit values. He shall identify the reasons why the exposure limit values have been exceeded, and shall amend the protection and prevention measures accordingly in order to prevent them being exceeded again.

5. Pursuant to Article 15 of Directive 89/391/EEC, the employer shall adapt the measures referred to in this Article to the requirements of workers at particular risk.

Article 6

Worker information and training

Without prejudice to Articles 10 and 12 of Directive 89/391/EEC, the employer shall ensure that workers who are exposed to risks from electromagnetic fields at work and/or their representatives receive any necessary information and training relating to the outcome of the risk assessment provided for in Article 4(1) of this Directive, concerning in particular:

(a)	measures taken to implement this Directive;

(b)	the values and concepts of the exposure limit values and action values and the associated potential risks;

(c)	the results of the assessment, measurement and/or calculations of the levels of exposure to electromagnetic fields carried out in accordance with Article 4 of this Directive;

(d)	how to detect adverse health effects of exposure and how to report them;

(e)	the circumstances in which workers are entitled to health surveillance;

(f)	safe working practices to minimise risks from exposure.

Article 7

Consultation and participation of workers

Consultation and participation of workers and/or of their representatives shall take place in accordance with Article 11 of Directive 89/391/EEC on the matters covered by this Directive.

SECTION III

MISCELLANEOUS PROVISIONS

Article 8

Health surveillance

1. With the objective of prevention and early diagnosis of any adverse health effects due to exposure to electromagnetic fields, appropriate health surveillance shall be carried out in accordance with Article 14 of Directive 89/391/EEC.

In any event, where exposure above the limit values is detected, a medical examination shall be made available to the worker(s) concerned in accordance with national law and practice. If health damage resulting from such exposure is detected, a reassessment of the risks shall be carried out by the employer in accordance with Article 4.

2. The employer shall take appropriate measures to ensure that the doctor and/or the medical authority responsible for the health surveillance has access to the results of the risk assessment referred to in Article 4.

3. The results of health surveillance shall be preserved in a suitable form so as to permit consultation at later date, taking account of confidentiality requirements. Individual workers shall, at their request, have access to their own personal health records.

Article 9

Sanctions

Member States shall provide for adequate sanctions to be applicable in the event of infringement of national legislation adopted pursuant to this Directive. These sanctions must be effective, proportionate and dissuasive.

Article 10

Technical amendments

1. Modifications of the exposure limit values and action values set out in the Annex shall be adopted by the European Parliament and the Council in accordance with the procedure laid down in Article 137(2) of the Treaty.

2. Amendments to the Annex of a strictly technical nature in line with:

(a)	the adoption of Directives in the field of technical harmonisation and standardisation with regard to the design, building, manufacture or construction of work equipment and/or workplaces;

(b)	technical progress, changes in the most relevant harmonised European standards or specifications, and new scientific findings concerning electromagnetic fields

shall be adopted in accordance with the regulatory procedure referred to in Article 11(2).

Article 11

Committee

1. The Commission shall be assisted by the Committee referred to in Article 17 of Directive 89/391/EEC.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period referred to in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. The Committee shall adopt its rules of procedure.

SECTION IV

FINAL PROVISIONS

Article 12

Reports

Every five years Member States shall provide a report to the Commission on the practical implementation of this Directive, indicating the points of view of the social partners.

Every five years the Commission shall inform the European Parliament, the Council, the European Economic and Social Committee and the Advisory Committee on Safety and Health Protection at Work of the content of these reports, of its assessment of developments in the field in question and of any initiative, in particular as regards exposure to static magnetic fields , that may be warranted in the light of new scientific knowledge.

Article 13

Transposition

1. The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than ... (11). They shall forthwith inform the Commission thereof.

2. Member States shall communicate to the Commission the provisions of national law which they adopt or have already adopted in the field covered by this Directive.

Article 14

Entry into force

This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.

Article 15

Addressees

This Directive is addressed to the Member States.

Done at ..., on ...

For the European Parliament

The President

For the Council

The President

(1) OJ C 77, 18.3.1993, p. 12 and OJ C 230, 19.8.1994, p. 3.

(2) OJ C 249, 13.9.1993, p. 28.

(3) Opinion of the European Parliament of 20 April 1994 (OJ C 128, 9.5.1994, p. 146) confirmed on 16 September 1999 (OJ C 54, 25.2.2000, p. 75), Council Common Position of 18 December 2003 (OJ C 66 E, 16.3.2004, p. 1), Position of the European Parliament of 30 March 2004.

(4) OJ C 260, 15.10.1990, p. 167.

(5) OJ L 177, 6.7.2002, p. 13.

(6) OJ L 42, 15.2.2003, p. 38.

(7) OJ L 183, 29.6.1989, p. 1. Directive as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

(8) OJ L 184, 17.7.1999, p. 23.

(9) OJ L 199, 30.7.1999, p. 59.

(10) OJ L 245, 26.8.1992, p. 23.

(11) Four years after the entry into force of this Directive.

ANNEX

EXPOSURE LIMIT AND ACTION VALUES FOR ELECTROMAGNETIC FIELDS

The following physical quantities shall be used to describe the exposure to electromagnetic fields:

Contact current (Ic) between a person and an object is expressed in amperes (A). A conductive object in an electric field can be charged by the field.

Current density (J) is defined as the current flowing through a unit cross section perpendicular to its direction in a volume conductor such as the human body or part of it, expressed in amperes per square metre (A/m2).

Electric field strength is a vector quantity (E) that corresponds to the force exerted on a charged particle regardless of its motion in space. It is expressed in volts per metre (V/m).

Magnetic field strength is a vector quantity (H), which, together with the magnetic flux density, specifies a magnetic field at any point in space. It is expressed in amperes per metre (A/m).

Magnetic flux density is a vector quantity (B), resulting in a force that acts on moving charges, expressed in teslas (T). In free space and in biological materials, magnetic flux density and magnetic field strength can be interchanged using the equivalence 1 A/m = 4π 10-7 T.

Power density (S) is the appropriate quantity used for very high frequencies, where the depth of penetration in the body is low. It is the radiant power incident perpendicular to a surface, divided by the area of the surface and is expressed in watts per square metre (W/m2).

Specific energy absorption (SA) is defined as the energy absorbed per unit mass of biological tissue, expressed in joules per kilogram (J/kg). In this directive it is used for limiting non-thermal effects from pulsed microwave radiation.

Specific energy absorption rate (SAR) averaged over the whole body or over parts of the body, is defined as the rate at which energy is absorbed per unit mass of body tissue and is expressed in watts per kilogram (W/kg). Whole body SAR is a widely accepted measure for relating adverse thermal effects to radio frequency (RF) exposure. Besides the whole body average SAR, local SAR values are necessary to evaluate and limit excessive energy deposition in small parts of the body resulting from special exposure conditions. Examples of such conditions are: a grounded individual exposed to RF in the low MHz range and individuals exposed in the near field of an antenna.

Of these quantities, magnetic flux density, contact current, electric and magnetic field strengths and power density can be measured directly.

A. EXPOSURE LIMIT VALUES

Depending on frequency, the following physical quantities are used to specify the exposure limit values of electromagnetic fields:

—	exposure limit values are provided for current density for time-varying fields up to 1 Hz, to prevent effects on the cardiovascular and central nervous system,

—	between 1 Hz and 10 MHz exposure limit values are provided on current density to prevent effects on central nervous system functions,

—	between 100 kHz and 10 GHz exposure limit values on SAR are provided to prevent whole-body heat stress and excessive localised heating of tissues. In the range 100 kHz to 10 MHz, exposure limit values on both current density and SAR are provided,

—	between 10 GHz and 300 GHz an exposure limit value on power density is provided to prevent excessive tissue heating at or near the body surface.

Table 1: Exposure limit values (Article 3(1)). All conditions to be satisfied

Frequency range	Current density for head and trunk J (mA/m2) (rms)	Whole body average SAR (W/kg)	Localised SAR (head and trunk) (W/kg)	Localised SAR (limbs) (W/kg)	Power density S (W/m2)
Up to 1 Hz	40	-	-	-	-
1-4 Hz	40/f	-	-	-	-
4-1 000 Hz	10	-	-	-	-
1 000 Hz-100 kHz	f/100	-	-	-	-
100 kHz-10 MHz	f/100	0,4	10	20	-
10 MHz-10 GHz	-	0,4	10	20	-
10-300 GHz	-	-	-	-	50

Notes:

1.	f is the frequency in Hertz.

The exposure limit values on the current density are intended to protect against acute exposure effects on central nervous system tissues in the head and trunk of the body. The exposure limit values in the frequency range 1 Hz to 10 MHz are based on established adverse effects on the central nervous system. Such acute effects are essentially instantaneous and there is no scientific justification to modify the exposure limit values for exposure of short duration. However, since the exposure limit values refer to adverse effects on the central nervous system, these exposure limit values may permit higher current densities in body tissues other than the central nervous system under the same exposure conditions.

3.	Because of the electrical inhomogeneity of the body, current densities should be calculated as averages over a cross-section of 1 cm2 perpendicular to the current direction.

4.	For frequencies up to 100 kHz, peak current density values can be obtained by multiplying the rms value by (2) .

For frequencies up to 100 kHz and for pulsed magnetic fields, the maximum current density associated with the pulses can be calculated from the rise/fall times and the maximum rate of change of magnetic flux density. The induced current density can then be compared with the appropriate exposure limit value. For pulses of duration tp, the equivalent frequency to apply for the exposure limit values should be calculated as f=1/(2tp).

6.	All SAR values are to be averaged over any six-minute period.

Localised SAR averaging mass is any 10 g of contiguous tissue; the maximum SAR so obtained should be the value used for estimating exposure. These 10 g of tissue are intended to be a mass of contiguous tissue with nearly homogeneous electrical properties. In specifying a contiguous mass of tissue, it is recognised that this concept can be used in computational dosimetry but may present difficulties for direct physical measurements. A simple geometry such as cubic tissue mass can be used provided that the calculated dosimetric quantities have conservative values relative to the exposure guidelines.

For pulsed exposures in the frequency range 0,3 to 10 GHz and for localised exposure of the head, in order to limit and avoid auditory effects caused by thermoelastic expansion, an additional exposure limit value is recommended. This is that the SA should not exceed 10 mJ/kg averaged over 10 g of tissue.

Power densities are to be averaged over any 20 cm2 of exposed area and any 68/f1,05 minute period (where f is in GHz) to compensate for progressively shorter penetration depth as the frequency increases. Spatial maximum power densities averaged over 1 cm2 should not exceed 20 times the value of 50 W/m2.

10.

With regard to pulsed or transient electromagnetic fields, or generally with regard to simultaneous exposure to multiple frequency fields, appropriate methods of assessment, measurement and/or calculation capable of analysing the characteristics of the waveforms and nature of biological interactions have to be applied, taking account of European harmonised standards developed by Cenelec.

B. ACTION VALUES

The action values referred to in Table 2 are obtained from the exposure limit values according to the rationale used by the International Commission on Non-ionising Radiation Protection (ICNIRP) in its guidelines on limiting exposure to non-ionising radiation (ICNIRP 7/99).

Table 2: Action values (Article 3(2)) (unperturbed rms values)

Frequency range	Electric field strength, E (V/m)	Magnetic field strength, H (A/m)	Magnetic flux density, B (μT)	Equivalent plane wave power density, Seq (W/m2)	Contact current, IC (mA)	Limb induced current, IL (mA)
0-1Hz		1,63 x 105	2 x 105	-	1,0	-
1-8 Hz	20 000	1,63 x 105/f2	2 x 105/f2	-	1,0	-
8-25 Hz	20 000	2 x 104/f	2,5 x 104/f	-	1,0	-
0,025-0,82kHz	500/f	20/f	25/f	-	1,0	-
0,82-2,5 kHz	610	24,4	30,7	-	1,0	-
2,5-65 kHz	610	24,4	30,7	-	0,4 f	-
65-100 kHz	610	1 600/f	2 000/f	-	0,4 f	-
0,1-1 MHz	610	1,6/f	2/f	-	40	-
1-10 MHz	610/f	1,6/f	2/f	-	40	-
10-110 MHz	61	0,16	0,2	10	40	100
110-400 MHz	61	0,16	0,2	10	-	-
400-2000 MHz	3f	0,008f	0,01f	f/40	-	-
2-300 GHz	137	0,36	0,45	50	-	-

Notes:

1.	f is the frequency in the units indicated in the frequency range column.

2.	For frequencies between 100 kHz and 10 GHz, Seq, E2, H2, B2 and IL 2 are to be averaged over any sixminute period.

3.	For frequencies exceeding 10 GHz, Seq, E2, H2 and B2 are to be averaged over any 68/f1,05 minute period (f in GHz).

For frequencies up to 100 kHz, peak action values for the field strengths can be obtained by multiplying the rms value by (2)1/2. For pulses of duration tp, the equivalent frequency to apply for the action values should be calculated as f=1/(2tp).

For frequencies between 100 kHz and 10 MHz, peak action values for the field strengths are calculated by multiplying the relevant rms values by 10a, where a = (0,665 log (f/105) + 0,176), f in Hz.

For frequencies between 10 MHz and 300 GHz, peak action values are calculated by multiplying the corresponding rms values by 32 for the field strengths and by 1 000 for the equivalent plane wave power density.

With regard to pulsed or transient electromagnetic fields, or generally with regard to simultaneous exposure to multiple frequency fields, appropriate methods of assessment, measurement and/or calculation capable of analysing the characteristics of the waveforms and nature of biological interactions have to be applied, taking account of harmonised European standards developed by Cenelec.

For peak values of pulsed modulated electromagnetic fields, it is also suggested that, for carrier frequencies exceeding 10 MHz, Seq as averaged over the pulse width should not exceed 1 000 times the Seq action values or that the field strength should not exceed 32 times the field strength action values for the carrier frequency.

P5_TA(2004)0214

Organisations working towards equality between men and women ***II

European Parliament legislative resolution on the common position adopted by the Council with a view to the adoption of a Decision of the European Parliament and of the Council establishing a Community action programme to promote organisations active at European level in the field of equality between men and women (16185/1/2003 — C5-0068/2004 — 2003/0109(COD))

(Codecision procedure: second reading)

The European Parliament,

—	having regard to the Council common position (16185/1/2003 — C5-0068/2004) (1),

—	having regard to its position at first reading (2) on the Commission proposal to Parliament and the Council (COM(2003) 279) (1),

—	having regard to the amended proposal (COM(2004) 17) (1),

—	having regard to Article 251(2) of the EC Treaty,

—	having regard to Rule 80 of its Rules of Procedure,

—	having regard to the recommendation for second reading of the Committee on Women's Rights and Equal Opportunities (A5-0161/2004),

1.	Amends the common position as follows;

2.	Instructs its President to forward its position to the Council and Commission.

(1) Not yet published in the OJ.

(2) Texts Adopted,20.11.2003, P5_TA(2003)0511.

P5_TC2-COD(2003)0109

Position of the European Parliament adopted at second reading on 30 March 2004 with a view to the adoption of European Parliament and Council Decision No .../2004/EC establishing a Community action programme to promote organisations active at European level in the field of equality between men and women

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular, Article 13(2) thereof,

Having regard to the proposal from the Commission,

Having regard to the Opinion of the European Economic and Social Committee (1),

Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),

Whereas:

(1)

The principle of equality between men and women is a fundamental principle of Community law, laid down in Article 2 and Article 3(2) of the Treaty and clarified by the case-law of the Court of Justice of the European Communities. Under the Treaty, equality between men and women is one of the Community's specific tasks and objectives and the Community is actively to promote such equality in all fields of Community action.

(2)

Article 13(1) of the Treaty confers on the Council the power to take appropriate action to combat all discrimination based, inter alia, on sex. Pursuant to Article 13(2), when the Council adopts Community incentive measures, excluding any harmonisation of the laws and regulations of the Member States, to support action taken by the Member States in order to contribute to the achievement of that objective, it is to act in accordance with the procedure referred to in Article 251 of the Treaty.

(3)	Article 21 of the Charter of Fundamental Rights of the European Union prohibits any discrimination on grounds of sex and Article 23 lays down the principle of equality between men and women in all areas.

(4)	Experience of action at Community level has shown that promoting gender equality calls in practice for a combination of measures and, in particular, of legislation and practical action designed to reinforce one another.

(5)	The Commission's White Paper on European Governance advocates the participation of citizens in shaping and implementing policy, the involvement of civil society and civil society organisations, and more effective and transparent consultation of interested parties.

(6)

The Fourth World Conference on Women held in Beijing adopted on 15 September 1995 a Declaration and a Platform for Action calling on governments, the international community and civil society to take strategic action to eliminate both discrimination against women and the barriers to gender equality.

(7)	By Decision 2001/51/EC (3), the Council established a Community Action Programme relating to the Community framework strategy on gender equality. These actions should be supplemented by support measures in the areas concerned.

(8)	Budget lines A-3037 (No ABB 040501) and A-3046 (No ABB 040503) of the general budget of the European Union for the year 2003 and preceding years were intended to support the European Women's Lobby and women's organisations working to promote equality between men and women.

(9)

Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (4), hereinafter referred to as ‘the Financial Regulation’, requires the adoption of a basic act for existing support measures which is in line with its provisions.

(10)	The activities of certain organisations help to promote gender equality, particularly in the case of Community measures targeted specifically at women.

(11)

The European Women's Lobby, in particular, which comprises most of the women's organisations in the 15 Member States and has over 3 000 members, plays a major role in promoting, monitoring and disseminating Community measures aimed at women with a view to achieving equality between men and women. Its activity serves the general European interest.

(12)

Consequently, a structured programme should be adopted to provide financial assistance to such organisations in the form of an operating grant for activities with aims of general European interest in the area of gender equality or with an objective which forms part of the European Union's policy in this area and in the form of certain grants for action.

(13)

This programme covers a wide geographic area owing to the fact that the new Treaty of Accession was signed on 16 April 2003 and that the Agreement on the European Economic Area (EEA) provides for increased cooperation in the field of gender equality between the European Community and its Member States, on the one hand, and the countries of the European Free Trade Association (EFTA), on the other. The EEA Agreement lays down the procedures for the participation of the EFTA States party to the EEA Agreement in Community programmes in this field. Furthermore, this programme should be opened up for participation by Romania and Bulgaria, in accordance with the conditions set out in their Europe Agreements, in their Additional Protocols and in the decisions of the respective Association Councils, and to Turkey in accordance with the conditions laid down in the Framework Agreement between the European Community and the Republic of Turkey on the general principles for the participation of the Republic of Turkey in Community programmes (5).

(14)	The specific nature of organisations active at European level in the field of the promotion of equality between men and women should be taken into account when laying down the procedures for granting such assistance.

(15)

This Decision lays down, for the entire duration of the programme, a financial framework constituting the prime reference, within the meaning of point 33 of the Interinstitutional Agreement of 6 May 1999 between the European Parliament, the Council and the Commission on budgetary discipline and improvement of the budgetary procedure (6), for the budgetary authority during the annual budgetary procedure.

(16)	The Joint Declaration of the European Parliament, the Council and the Commission of 24 November 2003 on the basic acts for grants provides, on an exceptional basis, for transitional clauses concerning the period of eligibility of expenditure to be introduced in this programme,

HAVE DECIDED AS FOLLOWS:

Article 1

Objective of the programme

1. This Decision hereby establishes a Community Action Programme (hereinafter referred to as ‘the programme’) to promote organisations active at European level in the field of equality between men and women.

2. The general objective of the programme is to support the activities of such organisations, of which an ongoing programme of work or a specific action serves the general European interest in the field of equality between men and women or pursues an objective which is part of the European Union's policy in this area.

3. The programme shall start on 1 January 2004 and shall end on 31 December 2005.

Article 2

Access to the programme

1. In order to be eligible for a grant, an organisation active at European level in the field of equality between women and men must comply with the provisions laid down in the Annex and its activities must:

(a)	contribute to the development and implementation of Community actions to promote equality between men and women;

(b)	be in accordance with the principles underlying, and the legal provisions governing, Community action in the policy area of equality between men and women;

(c)	have transnational potential.

2. The organisation in question must have been legally established for more than one year, acting alone or in the form of various coordinated associations.

Article 3

Participation of third countries

In addition to organisations established in the Member States, participation in the programme shall be open to organisations active at European level in the field of equality between men and women which are established in:

(a)	Accession States which signed the Treaty of Accession on 16 April 2003;

(b)	the EFTA/EEA countries, in accordance with the conditions laid down in the EEA Agreement;

(c)	Romania and Bulgaria, on the basis that the conditions for their participation are to be laid down in accordance with the European Agreements, their additional Protocols and the Decisions of the respective Association Councils;

(d)	Turkey, on the basis that the conditions for its participation are to be laid down in accordance with the Framework Agreement between the European Community and the Republic of Turkey on the general principles for the participation of the Republic of Turkey in Community programmes.

Article 4

Selection of beneficiaries

1. Operating grants shall be awarded directly to the beneficiaries referred to in point 2.1 of the Annex.

2. The award of an operating grant on the basis of an ongoing programme of work, or the award of a grant for a specific action, to an organisation which is pursuing an objective of general European interest forming part of the European Union's policy of promoting equality between men and women must meet the general criteria laid down in the Annex. Organisations entitled to receive grants under points 2.2 and 2.3 of the Annex shall be selected following a call for proposals.

Article 5

Awarding of the grant

1. Operating grants awarded under points 2.1 and 2.2 of the Annex to organisations active at European level in the field of equality between men and women may cover no more than 80 % of the organisation's total eligible expenditure for the calendar year for which the grant is awarded.

2. Pursuant to Article 113(2) of the Financial Regulation, and by reason of the nature of the organisations covered by this Decision, a derogation shall be made from the principle of degressivity for grants awarded under the programme.

Article 6

Financial provisions

1. The financial framework for the implementation of the programme for the period from 2004 to 2005 shall be EUR 2,2 million.

2. The annual appropriations shall be authorised by the budgetary authority within the limits of the financial perspective.

Article 7

Transitional clauses

For grants awarded in 2004, it will be possible for the period of eligibility of expenditure to start on 1 January 2004, provided that the expenditure does not precede the date on which the grant application was lodged or the date on which the beneficiary's budgetary year starts.

During 2004, in the case of beneficiaries whose budgetary year starts before 1 March, an exception may be granted to the obligation to sign the grant agreement within the first four months of the start of the beneficiary's budgetary year, as referred to in Article 112(2) of the Financial Regulation. In this case, the grant agreement should be signed by 30 June 2004 at the latest.

Article 8

Monitoring and evaluation

By 31 December 2006 at the latest, the Commission shall submit a report to the European Parliament and the Council on the achievement of the objectives of the programme. That report shall be based on the results obtained by the beneficiaries and shall assess, in particular, their effectiveness in achieving the objectives set out in Article 1 and the Annex.

Article 9

Entry into force

This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 January 2004.

Done at ..., on ...

For the European Parliament

The President

For the Council

The President

(1) OJ C 80, 30.3.2004, p. 115.

(2) Opinion of the European Parliament of 20 November 2003 (not yet published in the Official Journal), Council Common Position of 6 February 2004 (OJ C 95 E, 20.4.2004, p. 1) and Position of the European Parliament of 30 March 2004.

(3) OJ L 17, 19.1.2001, p. 22.

(4) OJ L 248, 16.9.2002, p. 1.

(5) OJ L 61, 2.3.2002, p. 29.

(6) OJ C 172, 18.6.1999, p. 1. Agreement as amended by Decision 2003/429/EC of the European Parliament and of the Council (OJ L 147, 14.6.2003, p. 25).

ANNEX

1. Activities to be supported

The general objective laid down in Article 1 is to reinforce Community action in the field of equality between men and women and the effectiveness of such action by offering financial support to organisations active at European level in the field of equality between women and men, including the European Women's Lobby.

1.1.

The activities of organisations working to promote equality between men and women which may help reinforce and increase the effectiveness of Community action will include the following:

—	the representation of interested parties at Community level,

—	awareness-raising activities aimed at promoting gender equality, in particular through studies, campaigns and seminars,

—	the dissemination of information on Community action to promote gender equality;

—	action promoting, inter alia, the reconciliation of working and family life, the involvement of women in decision-making, the fight against gender-related violence, gender stereotyping and discrimination at work,

—	measures fostering cooperation with women's organisations in third countries and raising awareness of the situation of women worldwide.

1.2.

Activities carried out by the European Women's Lobby in representing and coordinating non-governmental women's organisations, and in relaying information on women to the European institutions and non-governmental organisations, will include the following:

—	followingup the Beijing Platform for Action (United Nations),

—	working towards improving European legislation on gender equality and the inclusion of women in all policy areas,

—	participation at meetings and conferences on gender equality,

—	taking action to ensure that the views and interests of women are included in national and European policies, in particular by encouraging their participation in decision-making,

—	reinforcing equality between men and women in the EU enlargement process and developing cooperation with women's organisations in the acceding Member States.

2. Carrying-out of the activities to be supported

The activities carried out by organisations which are eligible to receive a Community grant under the programme will come under one of the following strands:

2.1.

Strand 1: ongoing activities of the European Women's Lobby, whose members are inter alia, women's organisations in the Member States of the European Union, subject to observance of the following principles:

—	it must be free to select its members,

—	it must be free to pursue its activities in accordance with point 1.2.

2.2.

Strand 2: ongoing activities of an organisation pursuing an objective of general European interest in the field of gender equality or an objective forming part of the European Union's policy in this area.

In accordance with Article 2, this applies to a non-profit-making body carrying out its activities exclusively in order to achieve equality between women and men or an organisation with a wider aim which carries out part of its activities exclusively to promote equality between women and men.

An annual operating grant may be awarded to support the implementation of such an organisation's ongoing programme of work.

2.3.	Strand 3: specific actions of an organisation pursuing an objective of general European interest in the field of equality between women and men or an objective forming part of the European Union's policy in this area.

3. Selection of beneficiaries

3.1.	An operating grant may be awarded directly to the European Women's Lobby under Strand 1 of the programme upon approval of an appropriate workplan and budget.

3.2.	Organisations entitled to receive an operating grant under Strand 2 of the programme will be selected on the basis of calls for proposals.

3.3.	Organisations entitled to receive a grant for specific action under Strand 3 of the programme will be selected on the basis of calls for proposals.

4. Checks and audits

4.1.

The beneficiary of an operating grant is to keep available for the Commission all the supporting documents, including the audited financial statement, regarding expenditure incurred during the grant year, for a period of five years following the last payment. The beneficiary of a grant is to ensure that, where applicable, supporting documents in the possession of partners or members of the organisations are made available to the Commission.

4.2.

The Commission may arrange for an audit of the use made of the grant to be carried out either by its own staff or by any other qualified outside body of its choice. Such audits may be carried out at any time during the lifetime of the grant agreement and during a period of five years from the date of payment of the balance. Where appropriate, the audit findings may lead to recovery decisions by the Commission.

4.3.	Commission staff and outside personnel authorised by the Commission are to have an appropriate right of access, in particular to the beneficiary's offices and to all such information, including information in electronic format, as may be needed in order to conduct such audits.

4.4.	The Court of Auditors and the European Anti-Fraud Office (OLAF) are to enjoy the same rights, especially of access, as the Commission.

4.5.

In order to protect the European Communities' financial interests against fraud and other irregularities, the Commission may carry out on-the-spot checks and inspections under the programme in accordance with Council Regulation (Euratom, EC) No 2185/96 (1). Where necessary, investigations shall be conducted by the European Anti-Fraud Office (OLAF) and these shall be governed by Regulation (EC) No 1073/1999 of the European Parliament and of the Council (2).

(1) OJ L 292, 15.11.1996, p. 2.

(2) OJ L 136, 31.5.1999, p. 1.

P5_TA(2004)0215

Gender equality in development cooperation ***II

European Parliament legislative resolution on the Council common position for adopting a European Parliament and Council regulation on promoting gender equality in development cooperation (5402/1/2004 — C5-0093/2004 — 2003/0176(COD))

(Codecision procedure: second reading)

The European Parliament,

—	having regard to the Council common position (5402/1/2004 — C5-0093/2004) (1),

—	having regard to its position at first reading (2) on the Commission proposal to Parliament and the Council (COM(2003) 465) (1),

—	having regard to Article 251(2) of the EC Treaty,

—	having regard to Rule 78 of its Rules of Procedure,

—	having regard to the recommendation for second reading of the Committee on Women's Rights and Equal Opportunities (A5-0160/2004),

1.	Approves the common position;

2.	Notes that the act is adopted in accordance with the common position;

3.	Instructs its President to sign the act with the President of the Council pursuant to Article 254(1) of the EC Treaty;

4.	Instructs its Secretary-General duly to sign the act and, in agreement with the Secretary-General of the Council, to have it published in the Official Journal of the European Union;

5.	Instructs its President to forward its position to the Council and Commission.

(1) Not yet published in the OJ.

(2) Texts Adopted, 18.12.2003, P5_TA(2003)0596.

P5_TA(2004)0216

Hygiene on foodstuffs ***II

European Parliament legislative resolution on the Council common position with a view to the adoption of a European Parliament and Council regulation on the hygiene of foodstuffs (10543/2/2002 — C5-0008/2004 — 2000/0178(COD))

(Codecision procedure: second reading)

The European Parliament,

—	having regard to the Council common position (10543/2/2002 — C5-0008/2004) (1),

—	having regard to its position at first reading (2) on the Commission proposal to Parliament and the Council (COM(2000) 438) (3),

—	having regard to the amended proposal (COM(2003) 33) (4),

—	having regard to Article 251(2) of the EC Treaty,

—	having regard to Rule 80 of its Rules of Procedure,

—	having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Consumer Policy (A5-0131/2004),

1.	Amends the common position as follows;

2.	Instructs its President to forward its position to the Council and Commission.

(1) OJ C 48 E, 24.2.2004, p. 1.

(2) OJ C 180 E, 31.7.2003, p. 267.

(3) OJ C 365, 19.12.2000, p. 43.

(4) Not yet published in the OJ.

P5_TC2-COD(2000)0178

Position of the European Parliament adopted at second reading on 30 March 2004 with a view to the adoption of European Parliament and Council Regulation (EC) No .../2004 on the hygiene of foodstuffs

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Articles 95 and 152(4)(b) thereof,

Having regard to the proposal from the Commission (1),

Having regard to the Opinion of the Economic and Social Committee (2),

Having consulted the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),

Whereas:

(1)

The pursuit of a high level of protection of human life and health is one of the fundamental objectives of food law, as laid down in Regulation (EC) No 178/2002 (4). That Regulation also lays down other common principles and definitions for national and Community food law, including the aim of achieving free movement of food within the Community.

(2)	Council Directive 93/43/EEC of 14 June 1993 on the hygiene of foodstuffs (5) laid down the general rules of hygiene for foodstuffs and the procedures for verification of compliance with these rules.

(3)

Experience has shown that these rules and procedures constitute a sound basis for ensuring food safety. In the context of the common agricultural policy, many Directives have been adopted to establish specific health rules for the production and placing on the market of the products listed in Annex I to the Treaty. These health rules have reduced trade barriers for the products concerned, contributing to the creation of the internal market while ensuring a high level of protection of public health.

(4)

With regard to public health, these rules and procedures contain common principles, in particular in relation to the manufacturers' and competent authorities' responsibilities, structural, operational and hygiene requirements for establishments, procedures for the approval of establishments, requirements for storage and transport and health marks.

(5)	These principles constitute a common basis for the hygienic production of all food, including products of animal origin listed in Annex I to the Treaty.

(6)	In addition to this common basis, specific hygiene rules are necessary for certain foodstuffs. Regulation (EC) No .../2004 of the European Parliament and of the Council of ... laying down specific hygiene rules for food of animal origin (6) lays down these rules.

(7)	The principal objective of the new general and specific hygiene rules is to ensure a high level of consumer protection with regard to food safety.

(8)	An integrated approach is necessary to ensure food safety from the place of primary production up to and including placing on the market or export. Every food business operator along the food chain should ensure that food safety is not compromised.

(9)

Community rules should not apply either to primary production for private domestic use, or to the domestic preparation, handling or storage of food for private domestic consumption. Moreover, they should apply only to undertakings, the concept of which implies a certain continuity of activities and a certain degree of organisation.

(10)

Food hazards present at the level of primary production should be identified and adequately controlled to ensure the achievement of the objectives of this Regulation. However, in the case of the direct supply of small quantities of primary products, by the food business operator producing them, to the final consumer or to a local retail establishment, it is appropriate to protect public health through national law, in particular because of the close relationship between the producer and the consumer.

(11)

The application of hazard analysis and critical control point (HACCP) principles to primary production is not yet generally feasible. However, guides to good practice should encourage the use of appropriate hygiene practices at farm level. Where necessary, specific hygiene rules for primary production should supplement these guides. It is appropriate for the hygiene requirements applicable to primary production and associated operations to differ from those for other operations.

(12)

Food safety is a result of several factors: legislation should lay down minimum hygiene requirements; official controls should be in place to check food business operators' compliance and food business operators should establish and operate food safety programmes and procedures based on the HACCP principles.

(13)

Successful implementation of the procedures based on the HACCP principles will require the full cooperation and commitment of food business employees. To this end, employees should undergo training. The HACCP system is an instrument to help food business operators attain a higher standard of food safety. The HACCP system should not be regarded as a method of self-regulation and should not replace official controls.

(14)

While the requirement of establishing procedures based on the HACCP principles should not initially apply to primary production, the feasibility of its extension will be one element of the review that the Commission will carry out following implementation of this Regulation. It is, however, appropriate for Member States to encourage operators at the level of primary production to apply such principles as far as possible.

(15)

The HACCP requirements should take account of the principles contained in the Codex Alimentarius. They should provide sufficient flexibility to be applicable in all situations, including in small businesses. In particular, it is necessary to recognise that, in certain food businesses, it is not possible to identify critical control points and that, in some cases, good hygienic practices can replace the monitoring of critical control points. Similarly, the requirement of establishing ‘critical limits’ does not imply that it is necessary to fix a numerical limit in every case. In addition, the requirement of retaining documents needs to be flexible in order to avoid undue burdens for very small businesses.

(16)

Flexibility is also appropriate to enable the continued use of traditional methods at any of the stages of production, processing or distribution of food and in relation to structural requirements for establishments. Flexibility is particularly important for regions that are subject to special geographical constraints, including the outermost regions referred to in Article 299(2) of the Treaty. However, flexibility should not compromise food hygiene objectives. Moreover, since all food produced in accordance with the hygiene rules will be in free circulation throughout the Community, the procedure allowing Member States to exercise flexibility should be fully transparent. It should provide, where necessary to resolve disagreements, for discussion within the Standing Committee on the Food Chain and Animal Health established by Regulation (EC) No 178/2002.

(17)

The setting of objectives such as pathogen reduction targets or performance standards may guide the implementation of hygiene rules. It is therefore necessary to provide procedures for that purpose. Such objectives would supplement existing food law, such as Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (7), which provides for the establishment of maximum tolerances for specific contaminants, and Regulation (EC) No 178/2002, which prohibits the placing on the market of unsafe food and provides a uniform basis for the use of the precautionary principle.

(18)

To take account of technical and scientific progress, close and effective cooperation should be ensured between the Commission and the Member States within the Standing Committee on the Food Chain and Animal Health. This Regulation takes account of international obligations laid down in the WTO Sanitary and Phytosanitary Agreement and the international food safety standards contained in the Codex Alimentarius.

(19)	The registration of establishments and the cooperation of food business operators are necessary to allow the competent authorities to perform official controls efficiently.

(20)

The traceability of food and food ingredients along the food chain is an essential element in ensuring food safety. Regulation (EC) No 178/2002 contains rules to ensure the traceability of food and food ingredients and provides a procedure for the adoption of implementing rules to apply these principles in respect of specific sectors.

(21)	Food imported into the Community is to comply with the general requirements laid down in Regulation (EC) No 178/2002 or satisfy rules that are equivalent to Community rules. The present Regulation defines certain specific hygiene requirements for food imported into the Community.

(22)	Food exported to third countries from the Community is to comply with the general requirements laid down in Regulation (EC) No 178/2002. The present Regulation defines certain specific hygiene requirements for food exported from the Community.

(23)	Scientific advice should underpin Community legislation on food hygiene. To this end, the European Food Safety Authority should be consulted whenever necessary.

(24)	Since this Regulation replaces Directive 93/43/EEC, the latter should be repealed.

(25)

The requirements of this Regulation should not apply until all parts of the new legislation on food hygiene have entered into force. It is also appropriate to provide for at least 18 months to elapse between entry into force and the application of the new rules, to allow the affected industries time to adapt.

(26)	The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (8),

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

1. This Regulation lays down general rules for food business operators on the hygiene of foodstuffs, taking particular account of the following principles:

(a)	primary responsibility for food safety rests with the food business operator;

(b)	it is necessary to ensure food safety throughout the food chain, starting with primary production;

(c)	it is important, for food that cannot be stored safely at ambient temperatures, particularly frozen food, to maintain the cold chain;

(d)	general implementation of procedures based on the HACCP principles, together with the application of good hygiene practice, should reinforce food business operators' responsibility;

(e)	guides to good practice are a valuable instrument to aid food business operators at all levels of the food chain with compliance with food hygiene rules and with the application of the HACCP principles;

(f)	it is necessary to establish microbiological criteria and temperature control requirements based on a scientific risk assessment;

(g)	it is necessary to ensure that imported foods are of at least the same hygiene standard as food produced in the Community, or are of an equivalent standard.

This Regulation shall apply to all stages of production, processing and distribution of food and to exports, and without prejudice to more specific requirements relating to food hygiene.

2. This Regulation shall not apply to:

(a)	primary production for private domestic use;

(b)	the domestic preparation, handling or storage of food for private domestic consumption;

(c)	the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the final consumer.

(d)	collection centres and tanneries which fall within the definition of food business only because they handle raw material for the production of gelatine or collagen.

3. Member States shall establish, under national law, rules governing the activities referred to in paragraph 2(c). Such national rules shall ensure the achievement of the objectives of this Regulation.

Article 2

Definitions

1. For the purposes of this Regulation:

(a)	‘food hygiene’, hereinafter called ‘hygiene’, means the measures and conditions necessary to control hazards and to ensure fitness for human consumption of a foodstuff taking into account its intended use;

(b)	‘primary products’ means products of primary production including products of the soil, of stock farming, of hunting and fishing;

(c)	‘establishment’ means any unit of a food business;

(d)

‘competent authority’ means the central authority of a Member State competent to ensure compliance with the requirements of this Regulation or any other authority to which that central authority has delegated that competence; it shall also include, where appropriate, the corresponding authority of a third country;

(e)	‘equivalent’ means, in respect of different systems, capable of meeting the same objectives;

(f)	‘contamination’ means the presence or introduction of a hazard;

(g)	‘potable water’ means water meeting the minimum requirements laid down in Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (9);

(h)	‘clean seawater’ means natural, artificial or purified seawater or brackish water that does not contain micro-organisms, harmful substances or toxic marine plankton in quantities capable of directly or indirectly affecting the health quality of food;

(i)	‘clean water’ means clean seawater and fresh water of a similar quality;

(j)	‘wrapping’ means the placing of a foodstuff in a wrapper or container in direct contact with the foodstuff concerned, and the wrapper or container itself;

(k)	‘packaging’ means the placing of one or more wrapped foodstuffs in a second container, and the latter container itself;

(l)	‘hermetically sealed container’ means a container that is designed and intended to be secure against the entry of hazards.

(m)	‘processing’ means any action that substantially alters the initial product, including heating, smoking, curing, maturing, drying, marinating, extraction, extrusion or a combination of those processes;

(n)	‘unprocessed products’ means foodstuffs that have not undergone processing, and includes products that have been divided, parted, severed, sliced, boned, minced, skinned, ground, cut, cleaned, trimmed, husked, milled, chilled, frozen, deep-frozen or thawed;

(o)	‘processed products’ means foodstuffs resulting from the processing of unprocessed products. These products may contain ingredients that are necessary for their manufacture or to give them specific characteristics.

2. The definitions laid down in Regulation (EC) No 178/2002 shall also apply.

3. In the Annexes to this Regulation the terms ‘where necessary’, ‘where appropriate’, ‘adequate’ and ‘sufficient’ shall mean respectively where necessary, where appropriate, adequate or sufficient to achieve the objectives of this Regulation.

CHAPTER II

FOOD BUSINESS OPERATORS' OBLIGATIONS

Article 3

General obligation

Food business operators shall ensure that all stages of production, processing and distribution of food under their control satisfy the relevant hygiene requirements laid down in this Regulation.

Article 4

General and specific hygiene requirements

1. Food business operators carrying out primary production and those associated operations listed in Annex I shall comply with the general hygiene provisions laid down in Part A of Annex I and any specific requirements provided for in Regulation (EC) No .../2004 (10).

2. Food business operators carrying out any stage of production, processing and distribution of food after those stages to which paragraph 1 applies shall comply with the general hygiene requirements laid down in Annex II and any specific requirements provided for in Regulation (EC) No .../2004 (10).

3. Food business operators shall, as appropriate, adopt the following specific hygiene measures:

(a)	compliance with microbiological criteria for foodstuffs;

(b)	procedures necessary to meet targets set to achieve the objectives of this Regulation;

(c)	compliance with temperature control requirements for foodstuffs;

(d)	maintenance of the cold chain;

(e)	sampling and analysis.

4. The criteria, requirements and targets referred to in paragraph 3 shall be adopted in accordance with the procedure referred to in Article 14(2).

Associated sampling and analysis methods shall be laid down in accordance with the same procedure.

5. When this Regulation, Regulation (EC) No .../2004 (10) and their implementing measures do not specify sampling or analysis methods, food business operators may use appropriate methods laid down in other Community or national legislation or, in the absence of such methods, methods that offer equivalent results to those obtained using the reference method, if they are scientifically validated in accordance with internationally recognised rules or protocols.

6. Food business operators may use the guides provided for in Articles 7, 8 and 9 as an aid to compliance with their obligations under this Regulation.

Article 5

Hazard analysis and critical control points

1. Food business operators shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles.

2. The HACCP principles referred to in paragraph 1 consist of the following:

(a)	identifying any hazards that must be prevented, eliminated or reduced to acceptable levels;

(b)	identifying the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels;

(c)	establishing critical limits at critical control points which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards;

(d)	establishing and implementing effective monitoring procedures at critical control points;

(e)	establishing corrective actions when monitoring indicates that a critical control point is not under control;

(f)	establishing procedures, which shall be carried out regularly, to verify that the measures outlined in subparagraphs (a) to (e) are working effectively; and

(g)	establishing documents and records commensurate with the nature and size of the food business to demonstrate the effective application of the measures outlined in subparagraphs (a) to (f).

When any modification is made in the product, process, or any step, food business operators shall review the procedure and make the necessary changes to it.

3. Paragraph 1 shall apply only to food business operators carrying out any stage of production, processing and distribution of food after primary production and those associated operations listed in Annex I.

4. Food business operators shall:

(a)	provide the competent authority with evidence of their compliance with paragraph 1 in the manner that the competent authority requires, taking account of the nature and size of the food business;

(b)	ensure that any documents describing the procedures developed in accordance with this Article are up-to-date at all times;

(c)	retain any other documents and records for an appropriate period.

5. Detailed arrangements for the implementation of this Article may be laid down in accordance with the procedure referred to in Article 14(2). Such arrangements may facilitate the implementation of this Article by certain food business operators, in particular by providing for the use of procedures set out in guides for the application of HACCP principles, in order to comply with paragraph 1. Such arrangements may also specify the period during which food business operators shall retain documents and records in accordance with paragraph 4(c).

Article 6

Official controls, registration and approval

1. Food business operators shall cooperate with the competent authorities in accordance with other applicable Community legislation or, if it does not exist, with national law.

2. In particular, every food business operator shall notify the appropriate competent authority, in the manner that the latter requires, of each establishment under its control that carries out any of the stages of production, processing and distribution of food, with a view to the registration of each such establishment.

Food business operators shall also ensure that the competent authority always has up-to-date information on establishments, including by notifying any significant change in activities and any closure of an existing establishment.

3. However, food business operators shall ensure that establishments are approved by the competent authority, following at least one on-site visit, when approval is required:

(a)	under the national law of the Member State in which the establishment is located;

(b)	under Regulation (EC) No .../2004 (11); or

(c)	by a decision adopted in accordance with the procedure referred to in Article 14(2).

Any Member State requiring the approval of certain establishments located on its territory under national law, as provided for in subparagraph (a), shall inform the Commission and other Member States of the relevant national rules.

CHAPTER III

GUIDES TO GOOD PRACTICE

Article 7

Development, dissemination and use of guides

Member States shall encourage the development of national guides to good practice for hygiene and for the application of HACCP principles in accordance with Article 8. Community guides shall be developed in accordance with Article 9.

The dissemination and use of both national and Community guides shall be encouraged. Nevertheless, food business operators may use these guides on a voluntary basis.

Article 8

National guides

1. When national guides to good practice are developed, they shall be developed and disseminated by food business sectors:

(a)	in consultation with representatives of parties whose interests may be substantially affected, such as competent authorities and consumer groups;

(b)	having regard to relevant codes of practice of the Codex Alimentarius; and

(c)	when they concern primary production and those associated operations listed in Annex I, having regard to the recommendations set out in Part B of Annex I.

2. National guides may be developed under the aegis of a national standards institute referred to in Annex II to Directive 98/34/EC (12).

3. Member States shall assess national guides in order to ensure that:

(a)	they have been developed in accordance with paragraph 1;

(b)	their contents are practicable for the sectors to which they refer; and

(c)	they are suitable as guides to compliance with Articles 3, 4 and 5 in the sectors and for the foodstuffs covered.

4. Member States shall forward to the Commission national guides complying with the requirements of paragraph 3. The Commission shall set up and run a registration system for such guides and make it available to Member States.

5. Guides to good practice drawn up under Directive 93/43/EEC shall continue to apply after the entry into force of this Regulation, provided that they are compatible with its objectives.

Article 9

Community guides

1. Before Community guides to good practice for hygiene or for the application of the HACCP principles are developed, the Commission shall consult the Committee referred to in Article 14. The objective of this consultation shall be to consider the case for such guides, their scope and subject matter.

2. When Community guides are prepared, the Commission shall ensure that they are developed and disseminated:

(a)	by or in consultation with appropriate representatives of European food business sectors, including SMEs, and other interested parties, such as consumer groups;

(b)	in collaboration with parties whose interests may be substantially affected, including competent authorities;

(c)	having regard to relevant codes of practice of the Codex Alimentarius; and

(d)	when they concern primary production and those associated operations listed in Annex I, having regard to the recommendations set out in Part B of Annex I.

3. The Committee referred to in Article 14 shall assess draft Community guides in order to ensure that:

(a)	they have been developed in accordance with paragraph 2;

(b)	their contents are practicable for the sectors to which they refer throughout the Community; and

(c)	they are suitable as guides to compliance with Articles 3, 4 and 5 in the sectors and for the foodstuffs covered.

4. The Commission shall invite the Committee referred to in Article 14 periodically to review any Community guides prepared in accordance with this Article, in cooperation with the bodies mentioned in paragraph 2.

The aim of this review shall be to ensure that the guides remain practicable and to take account of technological and scientific developments.

5. The titles and references of Community guides prepared in accordance with this Article shall be published in the C series of the Official Journal of the European Union.

CHAPTER IV

IMPORTS AND EXPORTS

Article 10

Imports

As regards the hygiene of imported food, the relevant requirements of food law referred to in Article 11 of Regulation (EC) No 178/2002 shall include the requirements laid down in Articles 3 to 6 of this Regulation.

Article 11

Exports

As regards the hygiene of exported or re-exported food, the relevant requirements of food law referred to in Article 12 of Regulation (EC) No 178/2002 shall include the requirements laid down in Articles 3 to 6 of this Regulation.

CHAPTER V

FINAL PROVISIONS

Article 12

Implementing measures and transitional arrangements

Implementing measures and transitional arrangements may be laid down in accordance with the procedure referred to in Article 14(2).

Article 13

Amendment and adaptation of Annexes I and II

1. Annexes I and II may be adapted or updated in accordance with the procedure referred to in Article 14(2), taking into account:

(a)	the need to revise the recommendations set out in Annex I, Part B, paragraph 2;

(b)	the experience gained from the implementation of HACCP-based systems pursuant to Article 5;

(c)	technological developments and their practical consequences and consumer expectations with regard to food composition;

(d)	scientific advice, particularly new risk assessments;

(e)	microbiological and temperature criteria for foodstuffs.

2. Derogations to Annexes I and II may be granted, in particular in order to facilitate the implementation of Article 5 for small businesses, in accordance with the procedure referred to in Article 14(2), taking into account the relevant risk factors, provided that such derogations do not affect the achievement of the objectives of this Regulation.

3. Member States may, without compromising achievement of the objectives of this Regulation, adopt, in accordance with paragraphs 4 to 7 of this Article, national measures adapting the requirements laid down in Annex II.

The national measures referred to in paragraph 3 shall have the aim of:

(i)	enabling the continued use of traditional methods, at any of the stages of production, processing or distribution of food; or

(ii)	accommodating the needs of food businesses situated in regions that are subject to special geographical constraints.

(b)

In other cases, they shall apply only to the construction, layout and equipment of establishments.

5. Any Member State wishing to adopt national measures as referred to in paragraph 3 shall notify the Commission and other Member States. The notification shall:

(a)	provide a detailed description of the requirements that that Member State considers need to be adapted and the nature of the adaptation sought;

(b)	describe the foodstuffs and establishments concerned;

(c)	explain the reasons for the adaptation, including, where relevant, by providing a summary of the hazard analysis carried out and any measures to be taken to ensure that the adaptation will not compromise the objectives of this Regulation; and

(d)	give any other relevant information.

6. The other Member States shall have three months from the receipt of a notification referred to in paragraph 5 to send written comments to the Commission. In the case of the adaptations arising from paragraph 4(b), this period shall, at the request of any Member State, be extended to four months. The Commission may, and when it receives written comments from one or more Member States shall, consult Member States within the committee referred to in Article 14(1). The Commission may decide, in accordance with the procedure referred to in Article 14(2), whether the envisaged measures may be implemented, subject, if necessary, to appropriate amendments. Where appropriate, the Commission may propose general measures in accordance with paragraph 1 or 2.

7. A Member State may adopt national measures adapting the requirements of Annex II only:

(a)	in compliance with a decision adopted in accordance with paragraph 6; or

(b)	if, one month after the expiry of the period referred to in paragraph 6, the Commission has not informed Member States that it has received written comments or that it intends to propose the adoption of a decision in accordance with paragraph 6.

Article 14

Committee procedure

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. The Committee shall adopt its rules of procedure.

Article 15

Consultation of the European Food Safety Authority

The Commission shall consult the European Food Safety Authority on any matter falling within the scope of this Regulation that could have a significant impact on public health and, in particular, before proposing criteria, requirements or targets in accordance with Article 4(4).

Article 16

Report to the European Parliament and the Council

1. The Commission shall, not later than ... (13), submit a report to the European Parliament and the Council.

2. The report shall, in particular, review the experience gained from the application of this Regulation and consider whether it would be desirable and practicable to provide for the extension of the requirements of Article 5 to food business operators carrying out primary production and those associated operations listed in Annex I.

3. The Commission shall, if appropriate, accompany the report with relevant proposals.

Article 17

Repeal

1. Directive 93/43/EEC shall be repealed with effect from the date of application of this Regulation.

2. References to the repealed Directive shall be construed as being made to this Regulation.

3. However, decisions adopted pursuant to Articles 3(3) and 10 of Directive 93/43/EEC shall remain in force pending their replacement by decisions adopted in accordance with this Regulation or Regulation (EC) No 178/2002. Pending the setting of the criteria or requirements referred to in Article 4(3), points (a) to (e) of this Regulation, Member States may maintain any national rules establishing such criteria or requirements that they had adopted in accordance with Directive 93/43/EEC.

4. Pending the application of new Community legislation laying down rules for official controls on food, Member States shall take all appropriate measures to ensure the fulfilment of the obligations laid down in or under this Regulation.

Article 18

Entry into force

This Regulation shall enter into force twenty days after the date of its publication in the Official Journal of the European Union.

It shall apply 18 months after the date on which all of the following acts have entered into force:

(a)	Regulation (EC) No .../2004 (14);

(b)	Regulation (EC) No .../2004 of the European Parliament and of the Council of ... laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (14); and

(c)	Directive 2004/41/EC of the European Parliament and of the Council of ... repealing certain Directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption (14).

However, it shall apply no earlier than 1 January 2006.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at ..., on ...

For the European Parliament

The President

For the Council

The President

(1) OJ C 365 E, 19.12.2000, p. 43.

(2) OJ C 155, 29.5.2001, p. 39.

(3) Position of the European Parliament of 15 May 2002 (OJ C 180 E, 31.7.2003, p. 267), Council Common Position of 27 October 2003 (OJ C 48 E, 24.2.2004, p. 1), Position of the European Parliament of 30 March 2004.

(4) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). Regulation as amended by Regulation (EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

(5) OJ L 175, 19.7.1993, p. 1. Directive as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

(6) Not yet published in the OJ.

(7) OJ L 37, 13.2.1993, p. 1. Regulation as amended by Regulation (EC) No 1882/2003.

(8) OJ L 184, 17.7.1999, p. 23.

(9) OJ L 330, 5.12.1998, p. 32. Directive as modified by Regulation (EC) No 1882/2003.

(10) Not yet published in the OJ.

(11) Not yet published in the OJ.

(12) Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations (OJ L 204, 21.7.1998, p. 37). Directive as amended by Directive 98/48/EC (OJ L 217, 5.8.1998, p. 18).

(13) Five years after the entry into force of this Regulation.

(14) Not yet published in the OJ.

ANNEX I

PRIMARY PRODUCTION

PART A: GENERAL HYGIENE PROVISIONS FOR PRIMARY PRODUCTION AND ASSOCIATED OPERATIONS

I. SCOPE

1. This Annex applies to primary production and the following associated operations:

(a)	the transport, storage and handling of primary products at the place of production, provided that this does not substantially alter their nature;

(b)	the transport of live animals, where this is necessary to achieve the objectives of this Regulation; and

(c)	in the case of products of plant origin, fishery products and wild game, transport operations to deliver primary products, the nature of which has not been substantially altered, from the place of production to an establishment.

II. HYGIENE PROVISIONS

2. As far as possible, food business operators are to ensure that primary products are protected against contamination, having regard to any processing that primary products will subsequently undergo.

3. Notwithstanding the general duty laid down in paragraph 2, food business operators are to comply with appropriate Community and national legislative provisions relating to the control of hazards in primary production and associated operations, including:

(a)	measures to control contamination arising from the air, soil, water, feed, fertilisers, veterinary medicinal products, plant protection products and biocides and the storage, handling and disposal of waste; and

(b)	measures relating to animal health and welfare and plant health that have implications for human health, including programmes for the monitoring and control of zoonoses and zoonotic agents.

4. Food business operators rearing, harvesting or hunting animals or producing primary products of animal origin are to take adequate measures, as appropriate:

(a)	to keep any facilities used in connection with primary production and associated operations, including facilities used to store and handle feed, clean and, where necessary after cleaning, to disinfect them in an appropriate manner;

(b)	to keep clean and, where necessary after cleaning, to disinfect, in an appropriate manner, equipment, containers, crates, vehicles and vessels;

(c)	as far as possible to ensure the cleanliness of animals going to slaughter and, where necessary, production animals;

(d)	to use potable water, or clean water, whenever necessary to prevent contamination;

(e)	to ensure that staff handling foodstuffs are in good health and undergo training on health risks;

(f)	as far as possible to prevent animals and pests from causing contamination;

(g)	to store and handle waste and hazardous substances so as to prevent contamination;

(h)	to prevent the introduction and spread of contagious diseases transmissible to humans through food, including by taking precautionary measures when introducing new animals and reporting suspected outbreaks of such diseases to the competent authority;

(i)	to take account of the results of any relevant analyses carried out on samples taken from animals or other samples that have importance to human health; and

(j)	to use feed additives and veterinary medicinal products correctly, as required by the relevant legislation.

5. Food business operators producing or harvesting plant products are to take adequate measures, as appropriate:

(a)	to keep clean and, where necessary after cleaning, to disinfect, in an appropriate manner, facilities, equipment, containers, crates, vehicles and vessels;

(b)	to ensure, where necessary, hygienic production, transport and storage conditions for, and the cleanliness of, plant products;

(c)	to use potable water, or clean water, whenever necessary to prevent contamination;

(d)	to ensure that staff handling foodstuffs are in good health and undergo training on health risks;

(e)	as far as possible to prevent animals and pests from causing contamination;

(f)	to store and handle wastes and hazardous substances so as to prevent contamination;

(g)	to take account of the results of any relevant analyses carried out on samples taken from plants or other samples that have importance to human health; and

(h)	to use plant protection products and biocides correctly, as required by the relevant legislation.

6. Food business operators are to take appropriate remedial action when informed of problems identified during official controls.

III. RECORD-KEEPING

7. Food business operators are to keep and retain records relating to measures put in place to control hazards in an appropriate manner and for an appropriate period, commensurate with the nature and size of the food business. Food business operators are to make relevant information contained in these records available to the competent authority and receiving food business operators on request.

8. Food business operators rearing animals or producing primary products of animal origin are, in particular, to keep records on:

(a)	the nature and origin of feed fed to the animals;

(b)	veterinary medicinal products or other treatments administered to the animals, dates of administration and withdrawal periods;

(c)	the occurrence of diseases that may affect the safety of products of animal origin;

(d)	the results of any analyses carried out on samples taken from animals or other samples taken for diagnostic purposes, that have importance for human health; and

(e)	any relevant reports on checks carried out on animals or products of animal origin.

9. Food business operators producing or harvesting plant products are, in particular, to keep records on:

(a)	any use of plant protection products and biocides;

(b)	any occurrence of pests or diseases that may affect the safety of products of plant origin; and

(c)	the results of any relevant analyses carried out on samples taken from plants or other samples that have importance to human health.

10. The food business operators may be assisted by other persons, such as veterinarians, agronomists and farm technicians, with the keeping of records.

PART B: RECOMMENDATIONS FOR GUIDES TO GOOD HYGIENE PRACTICE

1. National and Community guides referred to in Articles 7 to 9 of this Regulation should contain guidance on good hygiene practice for the control of hazards in primary production and associated operations.

2. Guides to good hygiene practice should include appropriate information on hazards that may arise in primary production and associated operations and actions to control hazards, including relevant measures set out in Community and national legislation or national and Community programmes. Examples of such hazards and measures may include:

(a)	the control of contamination such as mycotoxins, heavy metals and radioactive material;

(b)	the use of water, organic waste and fertilisers;

(c)	the correct and appropriate use of plant protection products and biocides and their traceability;

(d)	the correct and appropriate use of veterinary medicinal products and feed additives and their traceability;

(e)	the preparation, storage, use and traceability of feed;

(f)	the proper disposal of dead animals, waste and litter;

(g)	protective measures to prevent the introduction of contagious diseases transmissible to humans through food, and any obligation to notify the competent authority;

(h)	procedures, practices and methods to ensure that food is produced, handled, packed, stored and transported under appropriate hygienic conditions, including effective cleaning and pest-control;

(i)	measures relating to the cleanliness of slaughter and production animals;

(j)	measures relating to record-keeping.

ANNEX II

GENERAL HYGIENE REQUIREMENTS FOR ALL FOOD BUSINESS OPERATORS (EXCEPT WHEN ANNEX I APPLIES)

INTRODUCTION

Chapters V to XII apply to all stages of production, processing and distribution of food and the remaining Chapters apply as follows:

—	Chapter I applies to all food premises, except premises to which Chapter III applies;

—	Chapter II applies to all rooms where food is prepared, treated or processed, except dining areas and premises to which Chapter III applies;

—	Chapter III applies to those premises listed in the heading to the Chapter;

—	Chapter IV applies to all transportation.

CHAPTER I

GENERAL REQUIREMENTS FOR FOOD PREMISES

(OTHER THAN THOSE SPECIFIED IN CHAPTER III)

1. Food premises are to be kept clean and maintained in good repair and condition.

2. The layout, design, construction, siting and size of food premises are to:

(a)	permit adequate maintenance, cleaning and/or disinfection, avoid or minimise air-borne contamination, and provide adequate working space to allow for the hygienic performance of all operations;

(b)	be such as to protect against the accumulation of dirt, contact with toxic materials, the shedding of particles into food and the formation of condensation or undesirable mould on surfaces;

(c)	permit good food hygiene practices, including protection against contamination and, in particular, pest control; and

(d)	where necessary, provide suitable temperature-controlled handling and storage conditions of sufficient capacity for maintaining foodstuffs at appropriate temperatures and designed to allow those temperatures to be monitored and, where necessary, recorded.

3. An adequate number of flush lavatories are to be available and connected to an effective drainage system. Lavatories are not to open directly into rooms in which food is handled.

4. An adequate number of washbasins is to be available, suitably located and designated for cleaning hands. Washbasins for cleaning hands are to be provided with hot and cold running water, materials for cleaning hands and for hygienic drying. Where necessary, the facilities for washing food are to be separate from the hand-washing facility.

5. There is to be suitable and sufficient means of natural or mechanical ventilation. Mechanical airflow from a contaminated area to a clean area is to be avoided. Ventilation systems are to be so constructed as to enable filters and other parts requiring cleaning or replacement to be readily accessible.

6. Sanitary conveniences are to have adequate natural or mechanical ventilation.

7. Food premises are to have adequate natural and/or artificial lighting.

8. Drainage facilities are to be adequate for the purpose intended. They are to be designed and constructed to avoid the risk of contamination. Where drainage channels are fully or partially open, they are to be so designed as to ensure that waste does not flow from a contaminated area towards or into a clean area, in particular an area where foods likely to present a high risk to the final consumer are handled.

9. Where necessary, adequate changing facilities for personnel are to be provided.

10. Cleaning agents and disinfectants are not to be stored in areas where food is handled.

CHAPTER II

SPECIFIC REQUIREMENTS IN ROOMS WHERE FOODSTUFFS ARE PREPARED, TREATED OR PROCESSED

(EXCLUDING DINING AREAS AND THOSE PREMISES SPECIFIED IN CHAPTER III)

1. In rooms where food is prepared, treated or processed (excluding dining areas and those premises specified in Chapter III, but including rooms contained in means of transport) the design and layout are to permit good food hygiene practices, including protection against contamination between and during operations. In particular:

(a)

floor surfaces are to be maintained in a sound condition and be easy to clean and, where necessary, to disinfect. This will require the use of impervious, non-absorbent, washable and non-toxic materials unless food business operators can satisfy the competent authority that other materials used are appropriate. Where appropriate, floors are to allow adequate surface drainage;

(b)

wall surfaces are to be maintained in a sound condition and be easy to clean and, where necessary, to disinfect. This will require the use of impervious, non-absorbent, washable and non-toxic materials and require a smooth surface up to a height appropriate for the operations unless food business operators can satisfy the competent authority that other materials used are appropriate;

(c)	ceilings (or, where there are no ceilings, the interior surface of the roof) and overhead fixtures are to be constructed and finished so as to prevent the accumulation of dirt and to reduce condensation, the growth of undesirable mould and the shedding of particles;

(d)

windows and other openings are to be constructed to prevent the accumulation of dirt. Those which can be opened to the outside environment are, where necessary, to be fitted with insect-proof screens which can be easily removed for cleaning. Where open windows would result in contamination, windows are to remain closed and fixed during production;

(e)	doors are to be easy to clean and, where necessary, to disinfect. This will require the use of smooth and non-absorbent surfaces unless food business operators can satisfy the competent authority that other materials used are appropriate; and

(f)

surfaces (including surfaces of equipment) in areas where foods are handled and in particular those in contact with food are to be maintained in a sound condition and be easy to clean and, where necessary, to disinfect. This will require the use of smooth, washable corrosion-resistant and non-toxic materials, unless food business operators can satisfy the competent authority that other materials used are appropriate.

2. Adequate facilities are to be provided, where necessary, for the cleaning, disinfecting and storage of working utensils and equipment. These facilities are to be constructed of corrosion-resistant materials, be easy to clean and have an adequate supply of hot and cold water.

3. Adequate provision is to be made, where necessary, for washing food. Every sink or other such facility provided for the washing of food is to have an adequate supply of hot and/or cold potable water consistent with the requirements of Chapter VII and be kept clean and, where necessary, disinfected.

CHAPTER III

REQUIREMENTS FOR MOVABLE AND/OR TEMPORARY PREMISES (SUCH AS MARQUEES, MARKET STALLS, MOBILE SALES VEHICLES), PREMISES USED PRIMARILY AS A PRIVATE DWELLING HOUSE BUT WHERE FOODS ARE REGULARLY PREPARED FOR PLACING ON THE MARKET, AND VENDING MACHINES

1. Premises and vending machines are, so far as is reasonably practicable, to be so sited, designed, constructed and kept clean and maintained in good repair and condition as to avoid the risk of contamination, in particular by animals and pests.

2. In particular, where necessary:

(a)	appropriate facilities are to be available to maintain adequate personal hygiene (including facilities for the hygienic washing and drying of hands, hygienic sanitary arrangements and changing facilities);

(b)

surfaces in contact with food are to be in a sound condition and be easy to clean and, where necessary, to disinfect. This will require the use of smooth, washable, corrosion-resistant and non-toxic materials, unless food business operators can satisfy the competent authority that other materials used are appropriate;

(c)	adequate provision is to be made for the cleaning and, where necessary, disinfecting of working utensils and equipment;

(d)	where foodstuffs are cleaned as part of the food business' operations, adequate provision is to be made for this to be undertaken hygienically;

(e)	an adequate supply of hot and/or cold potable water is to be available;

(f)	adequate arrangements and/or facilities for the hygienic storage and disposal of hazardous and/or inedible substances and waste (whether liquid or solid) are to be available;

(g)	adequate facilities and/or arrangements for maintaining and monitoring suitable food temperature conditions are to be available;

(h)	foodstuffs are to be so placed as to avoid the risk of contamination so far as is reasonably practicable.

CHAPTER IV

TRANSPORT

1. Conveyances and/or containers used for transporting foodstuffs are to be kept clean and maintained in good repair and condition to protect foodstuffs from contamination and are, where necessary, to be designed and constructed to permit adequate cleaning and/or disinfection.

2. Receptacles in vehicles and/or containers are not to be used for transporting anything other than foodstuffs where this may result in contamination.

3. Where conveyances and/or containers are used for transporting anything in addition to foodstuffs or for transporting different foodstuffs at the same time, there is, where necessary, to be effective separation of products.

4. Bulk foodstuffs in liquid, granulate or powder form are to be transported in receptacles and/or containers/tankers reserved for the transport of foodstuffs. Such containers are to be marked in a clearly visible and indelible fashion, in one or more Community languages, to show that they are used for the transport of foodstuffs, or are to be marked ‘for foodstuffs only’.

5. Where conveyances and/or containers have been used for transporting anything other than foodstuffs or for transporting different foodstuffs, there is to be effective cleaning between loads to avoid the risk of contamination.

6. Foodstuffs in conveyances and/or containers are to be so placed and protected as to minimise the risk of contamination.

7. Where necessary, conveyances and/or containers used for transporting foodstuffs are to be capable of maintaining foodstuffs at appropriate temperatures and allow those temperatures to be monitored.

CHAPTER V

EQUIPMENT REQUIREMENTS

1. All articles, fittings and equipment with which food comes into contact are to:

(a)	be effectively cleaned and, where necessary, disinfected. Cleaning and disinfection are to take place at a frequency sufficient to avoid any risk of contamination;

(b)	be so constructed, be of such materials and be kept in such good order, repair and condition as to minimise any risk of contamination;

(c)	with the exception of non-returnable containers and packaging, be so constructed, be of such materials and be kept in such good order, repair and condition as to enable them to be kept clean and, where necessary, to be disinfected; and

(d)	be installed in such a manner as to allow adequate cleaning of the equipment and the surrounding area.

2. Where necessary, equipment is to be fitted with any appropriate control device to guarantee fulfilment of this Regulation's objectives.

3. Where chemical additives have to be used to prevent corrosion of equipment and containers, they are to be used in accordance with good practice.

CHAPTER VI

FOOD WASTE

1. Food waste, non-edible by-products and other refuse are to be removed from rooms where food is present as quickly as possible, so as to avoid their accumulation.

2. Food waste, non-edible by-products and other refuse are to be deposited in closable containers, unless food business operators can demonstrate to the competent authority that other types of containers or evacuation systems used are appropriate. These containers are to be of an appropriate construction, kept in sound condition, be easy to clean and, where necessary, to disinfect.

3. Adequate provision is to be made for the storage and disposal of food waste, non-edible by-products and other refuse. Refuse stores are to be designed and managed in such a way as to enable them to be kept clean and, where necessary, free of animals and pests.

4. All waste is to be eliminated in a hygienic and environmentally friendly way in accordance with Community legislation applicable to that effect, and is not to constitute a direct or indirect source of contamination.

CHAPTER VII

WATER SUPPLY

(a)	There is to be an adequate supply of potable water, which is to be used whenever necessary to ensure that foodstuffs are not contaminated;

(b)	Clean water may be used with whole fishery products. Clean seawater may be used with live bivalve molluscs, echinoderms, tunicates and marine gastropods; clean water may also be used for external washing. When such water is used, adequate facilities are to be available for its supply.

2. Where non-potable water is used, for example for fire control, steam production, refrigeration and other similar purposes, it is to circulate in a separate duly identified system. Non-potable water is not to connect with, or allow reflux into, potable water systems.

3. Recycled water used in processing or as an ingredient is not to present a risk of contamination. It is to be of the same standard as potable water, unless the competent authority is satisfied that the quality of the water cannot affect the wholesomeness of the foodstuff in its finished form.

4. Ice which comes into contact with food or which may contaminate food is to be made from potable water or, when used to chill whole fishery products, clean water. It is to be made, handled and stored under conditions that protect it from contamination.

5. Steam used directly in contact with food is not to contain any substance that presents a hazard to health or is likely to contaminate the food.

6. Where heat treatment is applied to foodstuffs in hermetically sealed containers it is to be ensured that water used to cool the containers after heat treatment is not a source of contamination for the foodstuff.

CHAPTER VIII

PERSONAL HYGIENE

1. Every person working in a food-handling area is to maintain a high degree of personal cleanliness and is to wear suitable, clean and, where necessary, protective clothing.

2. No person suffering from, or being a carrier of a disease likely to be transmitted through food or afflicted, for example, with infected wounds, skin infections, sores or diarrhoea is to be permitted to handle food or enter any food-handling area in any capacity if there is any likelihood of direct or indirect contamination. Any person so affected and employed in a food business and who is likely to come into contact with food is to report immediately the illness or symptoms, and if possible their causes, to the food business operator.

CHAPTER IX

PROVISIONS APPLICABLE TO FOODSTUFFS

1. A food business operator is not to accept raw materials or ingredients, other than live animals, or any other material used in processing products, if they are known to be, or might reasonably be expected to be, contaminated with parasites, pathogenic microorganisms or toxic, decomposed or foreign substances to such an extent that, even after the food business operator had hygienically applied normal sorting and/or preparatory or processing procedures, the final product would be unfit for human consumption.

2. Raw materials and all ingredients stored in a food business are to be kept in appropriate conditions designed to prevent harmful deterioration and protect them from contamination.

3. At all stages of production, processing and distribution, food is to be protected against any contamination likely to render the food unfit for human consumption, injurious to health or contaminated in such a way that it would be unreasonable to expect it to be consumed in that state.

4. Adequate procedures are to be in place to control pests. Adequate procedures are also to be in place to prevent domestic animals from having access to places where food is prepared, handled or stored (or, where the competent authority so permits in special cases, to prevent such access from resulting in contamination).

5. Raw materials, ingredients, intermediate products and finished products likely to support the reproduction of pathogenic micro-organisms or the formation of toxins are not to be kept at temperatures that might result in a risk to health. The cold chain is not to be interrupted. However, limited periods outside temperature control are permitted, to accommodate the practicalities of handling during preparation, transport, storage, display and service of food, provided that it does not result in a risk to health. Food businesses manufacturing, handling and wrapping processed foodstuffs are to have suitable rooms, large enough for the separate storage of raw materials from processed material and sufficient separate refrigerated storage.

6. Where foodstuffs are to be held or served at chilled temperatures they are to be cooled as quickly as possible following the heat-processing stage, or final preparation stage if no heat process is applied, to a temperature which does not result in a risk to health.

7. The thawing of foodstuffs is to be undertaken in such a way as to minimise the risk of growth of pathogenic microorganisms or the formation of toxins in the foods. During thawing, foods are to be subjected to temperatures that would not result in a risk to health. Where run-off liquid from the thawing process may present a risk to health it is to be adequately drained. Following thawing, food is to be handled in such a manner as to minimise the risk of growth of pathogenic microorganisms or the formation of toxins.

8. Hazardous and/or inedible substances, including animal feed, are to be adequately labelled and stored in separate and secure containers.

CHAPTER X

PROVISIONS APPLICABLE TO THE WRAPPING AND PACKAGING OF FOODSTUFFS

1. Material used for wrapping and packaging are not to be a source of contamination.

2. Wrapping materials are to be stored in such a manner that they are not exposed to a risk of contamination.

3. Wrapping and packaging operations are to be carried out so as to avoid contamination of the products. Where appropriate and in particular in the case of cans and glass jars, the integrity of the container's construction and its cleanliness is to be assured.

4. Wrapping and packaging material re-used for foodstuffs is to be easy to clean and, where necessary, to disinfect.

CHAPTER XI

HEAT TREATMENT

The following requirements apply only to food placed on the market in hermetically sealed containers:

1. Any heat treatment process used to process an unprocessed product or to process further a processed product is:

(a)	to raise every party of the product treated to a given temperature for a given period of time; and

(b)	to prevent the product from becoming contaminated during the process;

2. to ensure that the process employed achieves the desired objectives, food business operators are to check regularly the main relevant parameters (particularly temperature, pressure, sealing and microbiology), including by the use of automatic devices;

3. the process used should conform to an internationally recognised standard (for example, pasteurisation, ultra high temperature or sterilisation).

CHAPTER XII

TRAINING

Food business operators are to ensure:

1.	that food handlers are supervised and instructed and/or trained in food hygiene matters commensurate with their work activity;

2.	that those responsible for the development and maintenance of the procedure referred to in Article 5(1) of this Regulation or for the operation of relevant guides have received adequate training in the application of the HACCP principles; and

3.	compliance with any requirements of national law concerning training programmes for persons working in certain food sectors.

P5_TA(2004)0217

Hygiene rules for food of animal origin ***II

European Parliament legislative resolution on the common position adopted by the Council with a view to the adoption of a European Parliament and Council regulation laying down specific hygiene rules for food of animal origin (5420/2/2003 — C5-0009/2004 — 2000/0179(COD))

(Codecision procedure: second reading)

The European Parliament,

—	having regard to the Council common position (5420/2/2003 — C5-0009/2004) (1),

—	having regard to its position at first reading (2) on the Commission proposal to Parliament and the Council (COM(2000) 438) (3),

—	having regard to the amended proposal (COM(2003) 33) (4),

—	having regard to Article 251(2) of the EC Treaty,

—	having regard to Rule 80 of its Rules of Procedure,

—	having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Consumer Policy (A5-0129/2004),

1.	Amends the common position as follows;

2.	Instructs its President to forward its position to the Council and Commission.

(1) OJ C 48 E, 24.2.2004, p. 23.

(2) OJ C 180 E, 31.7.2003, p. 288.

(3) OJ C 365, 19.12.2000, p. 58.

(4) Not yet published in the OJ.

P5_TC2-COD(2000)0179

Position of the European Parliament adopted at second reading on 30 March 2004 with a view to the adoption of European Parliament and Council Regulation (EC) No .../2004/EC laying down specific hygiene rules for food of animal origin

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b) thereof,

Having regard to the proposal from the Commission, (1)

Having regard to the Opinion of the European Economic and Social Committee, (2)

Having consulted the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),

Whereas:

(1)	By Regulation (EC) No /2004 (4), the European Parliament and the Council laid down general rules for food business operators on the hygiene of foodstuffs.

(2)	Certain foodstuffs may present specific hazards to human health, requiring the setting of specific hygiene rules. This is particularly the case for food of animal origin, in which microbiological and chemical hazards have frequently been reported.

(3)

In the context of the common agricultural policy, many Directives have been adopted to establish specific health rules for the production and placing on the market of the products listed in Annex I to the Treaty. These health rules have reduced trade barriers for the products concerned, contributing to the creation of the internal market while ensuring a high level of protection of public health.

(4)

With regard to public health, these rules contain common principles, in particular in relation to the manufacturers' and competent authorities' responsibilities, structural, operational and hygiene requirements for establishments, procedures for the approval of establishments, requirements for storage and transport and health marks.

(5)	These principles constitute a common basis for the hygienic production of food of animal origin, permitting the simplification of the existing Directives.

(6)	It is desirable to achieve further simplification by applying the same rules wherever appropriate to all products of animal origin.

(7)

The requirement in Regulation (EC) No .../2004 (4) whereby food business operators carrying out any stage of production, processing and distribution of food after primary production and associated operations must put in place, implement and maintain procedures based on hazard analysis and critical control point (HACCP) principles also permits simplification.

(8)	Taken together, these elements justify a recasting of the specific hygiene rules contained in existing Directives.

(9)

The principal objectives of the recasting are to secure a high level of consumer protection with regard to food safety, in particular by making food business operators throughout the Community subject to the same rules, and to ensure the proper functioning of the internal market in products of animal origin, thus contributing to the achievement of the objectives of the common agricultural policy.

(10)	It is necessary to maintain and, where required to ensure consumer protection, to tighten detailed hygiene rules for products of animal origin.

(11)

Community rules should not apply either to primary production for private domestic use or to the domestic preparation, handling or storage of food for private domestic consumption. Moreover, where small quantities of primary products or of certain types of meat are supplied directly by the food business operator producing them to the final consumer or to a local retail establishment, it is appropriate to protect public health through national law, in particular because of the close relationship between the producer and the consumer.

(12)

The requirements of Regulation (EC) No /2004 (5) are generally sufficient to ensure food safety in establishments carrying out retail activities involving the direct sale or supply of food of animal origin to the final consumer. This Regulation should generally apply to wholesale activities (that is, when a retail establishment carries out operations with a view to supplying food of animal origin to another establishment). Nevertheless, with the exception of the specific temperature requirements laid down in this Regulation, the requirements of Regulation (EC) No .../2004 (5) should suffice for wholesale activities consisting only of storage or transport.

(13)

Member States should have some discretion to extend or to limit the application of the requirements of this Regulation to retail under national law. However, they may limit their application only if they consider that the requirements of Regulation (EC) No .../2004 (5) are sufficient to achieve food hygiene objectives and when the supply of food of animal origin from a retail establishment to another establishment is a marginal, localised and restricted activity. Such supply should therefore be only a small part of the establishment's business; the establishments supplied should be situated in its immediate vicinity; and the supply should concern only certain types of products or establishments.

(14)	In accordance with Article 10 of the Treaty, Member States are to take all appropriate measures to ensure that food business operators comply with the obligations laid down in this Regulation.

(15)

The traceability of food is an essential element in ensuring food safety. In addition to complying with the general rules of Regulation (EC) No 178/2002 (6), food business operators responsible for establishments that are subject to approval in accordance with this Regulation should ensure that all products of animal origin that they place on the market bear either a health mark or an identification mark.

(16)	Food imported into the Community is to comply with the general requirements laid down in Regulation (EC) No 178/2002 or to satisfy rules that are equivalent to Community rules. This Regulation defines specific hygiene requirements for food of animal origin imported into the Community.

(17)

The adoption of this Regulation should not reduce the level of protection provided by the additional guarantees agreed for Finland and Sweden on their accession to the Community and confirmed by Decisions 94/968/EC (7), 95/50/EC (8), 95/160/EC (9), 95/161/EC (10), 95/168/EC (11), 95/409/EC (12), 95/410/EC (13) and 95/411/EC (14). It should establish a procedure for the granting, for a transitional period, of guarantees to any Member State that has an approved national control programme which, for the food of animal origin concerned, is equivalent to those approved for Finland and Sweden. Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents (15) provides for a similar procedure in respect of live animals and hatching eggs.

(18)	It is appropriate for the structural and hygiene requirements laid down in this Regulation to apply to all types of establishments, including small businesses and mobile slaughterhouses.

(19)

Flexibility is appropriate to enable the continued use of traditional methods at any of the stages of production, processing or distribution of food and in relation to structural requirements for establishments. Flexibility is particularly important for regions that are subject to special geographical constraints, including the outermost regions referred to in Article 299(2) of the Treaty. However, flexibility should not compromise food hygiene objectives. Moreover, since all food produced in accordance with the hygiene rules will normally be in free circulation throughout the Community, the procedure allowing Member States to exercise flexibility should be fully transparent. It should provide, where necessary to resolve disagreements, for discussion within the Standing Committee on the Food Chain and Animal Health established by Regulation (EC) No 178/2002 and for the Commission to coordinate the process and take appropriate measures.

(20)

The definition of mechanically separated meat (MSM) should be a generic one covering all methods of mechanical separation. Rapid technological developments in this area mean that a flexible definition is appropriate. The technical requirements for MSM should differ, however, depending on a risk assessment of the product resulting from different methods.

(21)

There are interactions between food business operators, including the animal feed sector, and connections between animal health, animal welfare and public health considerations at all stages of production, processing and distribution. This requires adequate communication between the different stakeholders along the food chain from primary production to retail.

(22)

In order to ensure proper inspection of hunted wild game placed on the Community market, bodies of hunted animals and their viscera should be presented for official post-mortem inspection at a game-handling establishment. However, to preserve certain hunting traditions without prejudicing food safety, it is appropriate to provide for training for hunters who place wild game on the market for human consumption. This should enable hunters to undertake an initial examination of wild game on the spot. In these circumstances, it is not necessary to require trained hunters to deliver all viscera to the game-handling establishment for post-mortem examination, if they carry out this initial examination and identify no anomalies or hazards. However, Member States should be allowed to establish stricter rules within their territories to take account of specific risks.

(23)

This Regulation should establish criteria for raw milk pending the adoption of new requirements for its placing on the market. These criteria should be trigger values, implying that, in the event of any overshooting, food business operators are to take corrective action and to notify the competent authority. The criteria should not be maximum figures beyond which raw milk cannot be placed on the market. This implies that, in certain circumstances, raw milk not fully meeting the criteria can safely be used for human consumption, if appropriate measures are taken. As regards raw milk and raw cream intended for direct human consumption, it is appropriate to enable each Member State to maintain or establish appropriate health measures to ensure the achievement of the objectives of this Regulation on its territory.

(24)

It is appropriate for the criterion for raw milk used to manufacture dairy products to be three times as high as the criterion for raw milk collected from the farm. The criterion for milk used to manufacture processed dairy products is an absolute value, whereas for raw milk collected from the farm it is an average. Compliance with the temperature requirements laid down in this Regulation will not halt all bacterial growth during transport and storage.

(25)

The present recasting means that the existing hygiene rules can be repealed. Directive 2004/.../EC of the European Parliament and of the Council of ... repealing certain Directives on food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption (16) achieves this.

(26)	In addition, the rules of this Regulation on eggs replace those of Council Decision 94/371/EC of 20 June 1994 laying down specific public health conditions for the putting on the market of certain types of eggs (17), which the repeal of Annex II to Council Directive 92/118/EEC (18) renders void.

27)	Scientific advice should underpin Community legislation on food hygiene. To this end, the European Food Safety Authority should be consulted whenever necessary.

(28)	To take account of technical and scientific progress, close and effective cooperation should be ensured between the Commission and the Member States within the Standing Committee on the Food Chain and Animal Health.

(29)

(30)	The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (19),

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

1. This Regulation lays down specific rules on the hygiene of food of animal origin for food business operators. These rules supplement those laid down by Regulation (EC) No .../2004 (20). They shall apply to unprocessed and processed products of animal origin.

2. Unless expressly indicated to the contrary, this Regulation shall not apply to food containing both products of plant origin and processed products of animal origin. However, processed products of animal origin used to prepare such food shall be obtained and handled in accordance with the requirements of this Regulation.

3. This Regulation shall not apply in relation to:

(a)	primary production for private domestic use;

(b)	the domestic preparation, handling or storage of food for private domestic consumption;

(c)	the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the final consumer;

(d)	the direct supply, by the producer, of small quantities of meat from poultry and lagomorphs slaughtered on the farm to the final consumer or to local retail establishments directly supplying such meat to the final consumer as fresh meat;

(e)	hunters who supply small quantities of wild game or wild game meat directly to the final consumer or to local retail establishments directly supplying the final consumer.

4. Member States shall establish, under national law, rules governing the activities and persons referred to in paragraph 3(c), (d) and (e). Such national rules shall ensure the achievement of the objectives of this Regulation.

(a)

Unless expressly indicated to the contrary, this Regulation shall not apply to retail.

(b)

However, this Regulation shall apply to retail when operations are carried out with a view to the supply of food of animal origin to another establishment, unless:

(i)	the operations consist only of storage or transport, in which case the specific temperature requirements laid down in Annex III shall nevertheless apply; or

(ii)	the supply of food of animal origin from the retail establishment is to other retail establishments only and, in accordance with national law, is a marginal, localised and restricted activity.

(c)

Member States may adopt national measures to apply the requirements of this Regulation to retail establishments situated on their territory to which it would not apply pursuant to subparagraphs (a) or (b).

6. This Regulation shall apply without prejudice to:

(a)	relevant animal and public health rules, including more stringent rules laid down for the prevention, control and eradication of certain transmissible spongiform encephalopathies;

(b)	animal welfare requirements; and

(c)	requirements concerning the identification of animals and the traceability of products of animal origin.

Article 2

Definitions

The following definitions shall apply for the purposes of this Regulation:

1)	the definitions laid down in Regulation (EC) No 178/2002;

2)	the definitions laid down in Regulation (EC) No .../2004 (21);

3)	the definitions laid down in Annex I; and

4)	any technical definitions contained in Annexes II and III.

CHAPTER II

FOOD BUSINESS OPERATORS' OBLIGATIONs

Article 3

General obligations

1. Food business operators shall comply with the relevant provisions of Annexes II and III.

2. Food business operators shall not use any substance other than potable water — or, when Regulation (EC) No .../2004 (22) or this Regulation permits its use, clean water — to remove surface contamination from products of animal origin, unless use of the substance has been approved in accordance with the procedure referred to in Article 12(2). Food business operators shall also comply with any conditions for use that may be adopted under the same procedure. The use of an approved substance shall not affect the food business operator's duty to comply with the requirements of this Regulation.

Article 4

Registration and approval of establishments

1. Food business operators shall place products of animal origin manufactured in the Community on the market only if they have been prepared and handled exclusively in establishments:

(a)	that meet the relevant requirements of Regulation (EC) No .../2004 (22), those of Annexes II and III of this Regulation and other relevant requirements of food law; and

(b)	that the competent authority has registered or, where required in accordance with paragraph 2, approved.

2. Without prejudice to Article 6(3) of Regulation (EC) No .../2004 (22), establishments handling those products of animal origin for which Annex III to this Regulation lays down requirements shall not operate unless the competent authority has approved them in accordance with paragraph 3 of this Article, with the exception of establishments carrying out only:

(a)	primary production;

(b)	transport operations;

(c)	the storage of products not requiring temperature-controlled storage conditions; or

(d)	retail operations other than those to which this Regulation applies pursuant to Article 1(5)(b).

3. An establishment subject to approval in accordance with paragraph 2 shall not operate unless the competent authority has, in accordance with Regulation (EC) No .../2004 of the European Parliament and of the Council of ... laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (22):

(a)	granted the establishment approval to operate following an on-site visit; or

(b)	provided the establishment with conditional approval.

4. Food business operators shall cooperate with the competent authorities in accordance with Regulation (EC) No .../2004 (22). In particular, food business operators shall ensure that an establishment ceases to operate if the competent authority withdraws its approval or, in the case of conditional approval, fails to prolong it or to grant full approval.

5. This Article shall not prevent an establishment from placing food on the market between the date of application of this Regulation and the first subsequent inspection by the competent authority, if the establishment:

(a)	is subject to approval in accordance with paragraph 2 and placed products of animal origin on the market in accordance with Community legislation immediately prior to the application of this Regulation; or

(b)	is of a type in respect of which there was no requirement for approval before the application of this Regulation.

Article 5

Health and identification marking

1. Food business operators shall not place on the market a product of animal origin handled in an establishment subject to approval in accordance with Article 4(2) unless it has either:

(a)	a health mark applied in accordance with Regulation (EC) No .../2004 (23) or

(b)	when that Regulation does not provide for the application of a health mark, an identification mark applied in accordance with Annex II, Section I, of this Regulation.

2. Food business operators may apply an identification mark to a product of animal origin only if the product has been manufactured in accordance with this Regulation in establishments meeting the requirements of Article 4.

3. Food business operators may not remove a health mark applied in accordance with Regulation (EC) No .../2004 from meat unless they cut or process it or work upon it in another manner.

Article 6

Products of animal origin from outside the Community

1. Food business operators importing products of animal origin from third countries shall ensure that importation takes place only if:

(a)	the third country of dispatch appears on a list, drawn up in accordance with Article 11 of Regulation (EC) No [... (23)]/2004, of third countries from which imports of that product are permitted;

(b)

(i)	the establishment from which that product was dispatched, and in which it was obtained or prepared, appears on a list, drawn up in accordance with Article 12 of Regulation (EC) No [... (23)]/2004, of establishments from which imports of that product are permitted, when applicable,

(ii)

in the case of fresh meat, minced meat, meat preparations, meat products and MSM, the product was manufactured from meat obtained in slaughterhouses and cutting plants appearing on lists drawn up and updated in accordance with Article 12 of Regulation (EC) No [... (23)]/2004 or in approved Community establishments, and

(iii)

in the case of live bivalve molluscs, echinoderms, tunicates and marine gastropods, the production area appears on a list drawn up in accordance with Article 13 of that Regulation, when applicable;

(c)

the product satisfies:

(i)	the requirements of this Regulation, including the requirements of Article 5 on health and identification marking;

(ii)	the requirements of Regulation (EC) No [... (23)]/2004; and

(iii)

any import conditions laid down in accordance with Community legislation governing import controls for products of animal origin, and

(d)	the requirements of Article 14 of Regulation (EC) No [... (23)]/2004 concerning certificates and documents are satisfied, when applicable.

2. By way of derogation from paragraph 1, the importation of fishery products may also take place in accordance with the special provisions laid down in Article 15 of Regulation (EC) No [... (23)]/2004.

3. Food business operators importing products of animal origin shall ensure that:

(a)	products are made available for control upon importation in accordance with Directive 97/78/EC (24);

(b)	importation complies with the requirements of Directive 2002/99/EC (25); and

(c)	operations under their control that take place after importation are carried out in accordance with the requirements of Annex III.

4. Food business operators importing food containing both products of plant origin and processed products of animal origin shall ensure that the processed products of animal origin contained in such food satisfy the requirements of paragraphs 1 to 3. They must be able to demonstrate that they have done so (for example, through appropriate documentation or certification, which need not be in the format specified in paragraph 1(d)).

CHAPTER III

TRADE

Article 7

Documents

1. When required in accordance with Annex II or III, food business operators shall ensure that certificates or other documents accompany consignments of products of animal origin.

2. In accordance with the procedure referred to in Article 12(2):

(a)	model documents may be established; and

(b)	provision may be made for the use of electronic documents.

Article 8

Special guarantees

1. Food business operators intending to place the following food of animal origin on the market in Sweden or Finland shall comply with the rules set out in paragraph 2 in respect of salmonella:

(a)	meat from bovine and porcine animals, including minced meat but excluding meat preparations and MSM;

(b)	meat from poultry of the following species: domestic fowl, turkeys, guinea-fowl, ducks and geese, including minced meat but excluding meat preparations and MSM; and

(c)

eggs.

(a)

In the case of meat from bovine and porcine animals and meat from poultry, samples of consignments shall have been taken in the dispatching establishment and been subjected to a microbiological test with negative results in accordance with Community legislation.

(b)

In the case of eggs, packing centres shall provide a guarantee that consignments originate from flocks that have been subjected to a microbiological test with negative results in accordance with Community legislation.

(c)

In the case of meat from bovine and porcine animals, the test provided for in subparagraph (a) need not be carried out for consignments intended for an establishment for the purposes of pasteurisation, sterilisation or treatment having a similar effect. In the case of eggs, the test provided for in subparagraph (b) need not be carried out for consignments intended for the manufacture of processed products by a process that guarantees the elimination of salmonella.

(d)

The tests provided for in subparagraphs (a) and (b) need not be carried out for foodstuffs originating in an establishment that is subject to a control programme recognised, in respect of the food of animal origin concerned and in accordance with the procedure referred to in Article 12(2), as equivalent to that approved for Sweden and Finland.

(e)

In the case of meat from bovine and porcine animals and meat from poultry, a trade document or certificate conforming to a model laid down by Community legislation shall accompany the food and state that:

(i)	the checks referred to in subparagraph (a) have been carried out with negative results; or

(ii)	the meat is intended for one of the purposes referred to in subparagraph (c); or

(iii)

the meat comes from an establishment covered by subparagraph (d).

(f)

In the case of eggs, a certificate stating that the tests referred to in subparagraph (b) have been carried out with negative results, or that the eggs are destined to be used in the manner referred to in subparagraph (c), must accompany consignments.

3. In accordance with the procedure referred to in Article 12(2):

(a)	the requirements of paragraphs 1 and 2 may be updated to take account in particular of changes to Member States' control programmes or the adoption of microbiological criteria in accordance with Regulation (EC) No .../2004 (26); and

(b)

the rules laid down in paragraph 2 in respect of any of the foodstuffs referred to in paragraph 1 may be extended, in whole or in part, to any Member State, or any region of a Member State, that has a control programme recognised as equivalent to that approved for Sweden and Finland in respect of the food of animal origin concerned.

4. For the purposes of this Article, ‘control programme’ means a control programme approved in accordance with Regulation (EC) No 2160/2004.

CHAPTER IV

FINAL PROVISIONS

Article 9

Implementing measures and transitional measures

Implementing measures and transitional arrangements may be laid down in accordance with the procedure referred to in Article 12(2).

Article 10

Amendment and adaptation of Annexes II and III

1. Annexes II and III may be adapted or updated in accordance with the procedure referred to in Article 12(2), taking into account:

(a)	the development of guides to good practice;

(b)	the experience gained from the implementation of HACCP-based systems pursuant to Article 5 of Regulation (EC) No .../2004 (26);

(c)	the technological developments and their practical consequences and consumer expectations with regard to food composition;

(d)	scientific advice, particularly new risk assessments;

(e)	microbiological and temperature criteria for foodstuffs;

(f)	changes in patterns of consumption.

2. Exemptions from Annex II and III may be granted in accordance with the procedure referred to in Article 12(2), provided that they do not affect the achievement of the objectives of this Regulation.

3. Member States may, without compromising achievement of the objectives of this Regulation, adopt, in accordance with paragraphs 4 to 8, national measures adapting the requirements laid down in Annex III.

(a)

The national measures referred to in paragraph 3 shall have the aim of:

(i)	enabling the continued use of traditional methods at any of the stages of production, processing or distribution of food; or

(ii)	accommodating the needs of food businesses situated in regions that are subject to special geographic constraints.

(b)

In other cases, they shall apply only to the construction, layout and equipment of establishments.

5. Any Member State wishing to adopt national measures as referred to in paragraph 3 shall notify the Commission and other Member States. Each notification shall:

(a)	provide a detailed description of the requirements that that Member State considers need to be adapted and the nature of the adaptation sought;

(b)	describe the foodstuffs and establishments concerned;

(c)	explain the reasons for the adaptation, including, where relevant, by providing a summary of the hazard analysis carried out and any measures to be taken to ensure that the adaptation will not compromise the objectives of this Regulation; and

(d)	give any other relevant information.

6. The other Member States shall have three months from the receipt of a notification referred to in paragraph 5 to send written comments to the Commission. In the case of adaptations arising from paragraph 4(b), this period shall, at the request of any Member State, be extended to four months. The Commission may, and when it receives written comments from one or more Member States shall, consult Member States within the committee referred to in Article 12(1). The Commission may decide, in accordance with the procedure referred to in Article 12(2), whether the envisaged measures may be implemented, subject, if necessary, to appropriate amendments. Where appropriate, the Commission may propose general measures in accordance with paragraph 1 or 2 of this Article.

7. A Member State may adopt national measures adapting the requirements of Annex III only:

(a)	in compliance with a decision adopted in accordance with paragraph 6;

(b)	if, one month after the expiry of the period referred to in paragraph 6, the Commission has not informed Member States that it has received written comments or that it intends to propose the adoption of a decision in accordance with paragraph 6; or

(c)	in accordance with paragraph 8.

8. A Member State may, of its own initiative and subject to the general provisions of the Treaty, maintain or establish national rules:

(a)	prohibiting or restricting the placing on the market within its territory of raw milk or raw cream intended for direct human consumption; or

(b)

permitting the use, with the authorisation of the competent authority, of raw milk not meeting the criteria laid down in Annex III, Section IX, as regards plate count and somatic cell count of the manufacture of cheeses with an ageing or ripening period of at least 60 days, and dairy products obtained in connection with the manufacture of such cheeses, provided that this does not prejudice the achievement of the objectives of this Regulation.

Article 11

Specific decisions

Without prejudice to the generality of Article 9 and Article 10(1), implementing measures may be laid down, or amendments to Annex II or III adopted, in accordance with the procedure referred to in Article 12(2):

1)	to lay down rules for the transport of meat while it is warm;

2)	to specify, in respect of MSM, which calcium content is not significantly higher than that of minced meat;

3)	to lay down other treatments that may be applied in a processing establishment to live bivalve molluscs from class B or C production areas that have not been submitted to purification or relaying;

4)	to specify recognised testing methods for marine biotoxins;

to lay down additional health standards for live bivalve molluscs in cooperation with the relevant Community Reference Laboratory, including:

(a)	limit values and analysis methods for other marine biotoxins;

(b)	virus testing procedures and virological standards; and

(c)	sampling plans and the methods and analytical tolerances to be applied to check compliance with the health standards;

6)	to lay down health standards or checks, where there is scientific evidence indicating that they are necessary to protect public health;

7)	to extend Annex III, Section VII, Chapter IX, to live bivalve molluscs other than pectinidae;

to specify criteria for determining when epidemiological data indicate that a fishing ground does not present a health hazard with regard to the presence of parasites and, consequently, for determining when the competent authority may authorise food business operators not to freeze fishery products in accordance with Annex III, Section VIII, Chapter III, Part D;

9)	to lay down freshness criteria and limits with regard to histamine and total volatile nitrogen for fisheries products;

10)	to permit the use for the manufacture of certain dairy products of raw milk not meeting the criteria laid down in Annex III, Section IX, as regards its plate count and somatic cell count;

11)	without prejudice to Directive 96/23/EC (27), to fix a maximum permitted value for the combined total of residues of antibiotic substances in raw milk; and

12)	to approve equivalent processes for the production of gelatine or collagen.

Article 12

Committee procedure

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period provided for in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. The Committee shall adopt its rules of procedure.

Article 13

Consultation of the European Food Safety Authority

The Commission shall consult the European Food Safety Authority on any matter falling within the scope of this Regulation that could have a significant impact on public health and, in particular, before proposing to extend Annex III, Section III, to other animal species.

Article 14

Report to the European Parliament and to the Council

1. The Commission shall, not later than ... (28), submit a report to the European Parliament and the Council reviewing the experience gained from the implementation of this Regulation.

2. The Commission shall, if appropriate, accompany the report with relevant proposals.

Article 15

This Regulation shall enter into force twenty days after the date of its publication in the Official Journal of the European Union.

It shall apply 18 months after the date on which all of the following acts have entered into force:

(a)	Regulation (EC) No .../2004 (29);

(b)	Regulation (EC) No .../2004 (29); and

(c)	Directive 2004/.../EC (29).

However, it shall apply no earlier than 1 January 2006.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at ..., on ...

For the European Parliament

The President

For the Council

The President

(1) OJ C 365 E, 19.12.2000, p. 58.

(2) OJ C 155, 29.5.2001, p. 39.

(3) Position of the European Parliament of 15 May 2002 (OJ C 180 E, 31.7.2003, p. 288), Council Common Position of 27 October 2003 (OJ C 48 E, 24.2.2004, p. 23) and Position of the European Parliament of 30 March 2004.

(4) Not yet published in the OJ.

(5) Not yet published in the OJ.

(6) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). Regulation as amended by Regulation (EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

(7) OJ L 371, 31.12.1994, p. 36.

(8) OJ L 53, 9.3.1995, p. 31.

(9) OJ L 105 9.5.1995, p. 40.

(10) OJ L 105, 9.5.1995, p. 44.

(11) OJ L 109, 16.5.1995, p. 44.

(12) OJ L 243, 11.10.1995, p. 21.

(13) OJ L 243, 11.10.1995, p. 25.

(14) OJ L 243, 11.10.1995, p. 29.

(15) OJ L 325, 12.12.2003, p. 1.

(16) Not yet published in the OJ.

(17) OJ L 168, 2.7.1994, p. 34.

(18) Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A(I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC (OJ L 62, 15.3.1993, p. 49). Directive as last amended by Commission Regulation (EC) No 445/2004 (OJ L 72, 11.3.2004, p. 60).

(19) OJ L 184, 17.7.1999, p. 23.

(20) Not yet published in the OJ.

(21) Not yet published in the OJ.

(22) Not yet published in the OJ.

(23) Not yet published in the OJ.

(24) Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (OJ L 24, 30.1.1998, p. 9). Directive amended by the Act of Accession 2003.

(25) Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (OJ L 18, 23.1.2003, p. 11).

(26) Not yet published in the OJ.

(27) Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products (OJ L 125, 23.5.1996, p. 10). Directive as amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

(28) Five years after the entry into force of this Regulation.

(29) Not yet published in the OJ.

ANNEX I

DEFINITIONS

For the purpose of this Regulation:

1. MEAT

1.1. ‘Meat’ means edible parts of the animals referred to in points 1.2 to 1.8, including blood.

1.2. ‘Domestic ungulates’ means domestic bovine (including Bubalus and Bison species), porcine, ovine and caprine animals, and domestic solipeds.

1.3. ‘Poultry’ means farmed birds, including birds that are not considered as domestic but which are farmed as domestic animals, with the exception of ratites.

1.4. ‘Lagomorphs’ means rabbits, hares and rodents.

1.5. ‘Wild game’ means:

—	wild ungulates and lagomorphs, as well as other land mammals that are hunted for human consumption and are considered to be wild game under the applicable law in the Member State concerned, including mammals living in enclosed territory under conditions of freedom similar to those of wild game; and

—	wild birds that are hunted for human consumption.

1.6. ‘Farmed game’ means farmed ratites and farmed land mammals other than those referred to in point 1.2.

1.7. ‘Small wild game’ means wild game birds and lagomorphs living freely in the wild.

1.8. ‘Large wild game’ means wild land mammals living freely in the wild that do not fall within the definition of small wild game.

1.9. ‘Carcase’ means the body of an animal after slaughter and dressing.

1.10. ‘Fresh meat’ means meat that has not undergone any preserving process other than chilling, freezing or quick-freezing, including meat that is vacuum-wrapped or wrapped in a controlled atmosphere.

1.11. ‘Offal’ means fresh meat other than that of the carcase, including viscera and blood.

1.12. ‘Viscera’ means the organs of the thoracic, abdominal and pelvic cavities, as well as the trachea and oesophagus and, in birds, the crop.

1.13. ‘Minced meat’ means boned meat that has been minced into fragments and contains less than 1% salt.

1.14. ‘Mechanically separated meat’ or ‘MSM’ means the product obtained by removing meat from fleshbearing bones after boning or from poultry carcases, using mechanical means resulting in the loss or modification of the muscle fibre structure.

1.15. ‘Meat preparations’ means fresh meat, including meat that has been reduced to fragments, which has had foodstuffs, seasonings or additives added to it or which has undergone processes insufficient to modify the internal muscle fibre structure of the meat and thus to eliminate the characteristics of fresh meat.

1.16. ‘Slaughterhouse’ means an establishment used for slaughtering and dressing animals, the meat of which is intended for human consumption.

1.17. ‘Cutting plant’ means an establishment used for boning and/or cutting up meat.

1.18. ‘Game-handling establishment’ means any establishment in which game and game meat obtained after hunting are prepared for placing on the market.

2. LIVE BIVALVE MOLLUSCS

2.1. ‘Bivalve molluscs’ means filter-feeding lamellibranch molluscs.

2.2. ‘Marine biotoxins’ means poisonous substances accumulated by bivalve molluscs, in particular as an result of feeding on plankton containing toxins.

2.3. ‘Conditioning’ means the storage of live bivalve molluscs coming from class A production areas, purification centres or dispatch centres in tanks or any other installation containing clean seawater, or in natural sites, to remove sand, mud or slime, to preserve or to improve organoleptic qualities and to ensure that they are in a good state of vitality before wrapping or packaging.

2.4. ‘Gatherer’ means any natural or legal person who collects live bivalve molluscs by any means from a harvesting area for the purpose of handling and placing on the market.

2.5. ‘Production area’ means any sea, estuarine or lagoon area, containing either natural beds of bivalve molluscs or sites used for the cultivation of bivalve molluscs, and from which live bivalve molluscs are taken.

2.6. ‘Relaying area’ means any sea, estuarine or lagoon area with boundaries clearly marked and indicated by buoys, posts or any other fixed means, and used exclusively for the natural purification of live bivalve molluscs.

2.7. ‘Dispatch centre’ means any on-shore or off-shore establishment for the reception, conditioning, washing, cleaning, grading, wrapping and packaging of live bivalve molluscs fit for human consumption.

2.8. ‘Purification centre’ means an establishment with tanks fed by clean seawater in which live bivalve molluscs are placed for the time necessary to reduce contamination to make them fit for human consumption.

2.9. ‘Relaying’ means the transfer of live bivalve molluscs to sea, lagoon or estuarine areas for the time necessary to reduce contamination to make them fit for human consumption. This does not include the specific operation of transferring bivalve molluscs to areas more suitable for further growth or fattening.

3. FISHERY PRODUCTS

3.1. ‘Fishery products’ means all seawater or freshwater animals (except for live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods, and all mammals, reptiles and frogs) whether wild or farmed and including all edible forms, parts and products of such animals.

3.2. ‘Factory vessel’ means any vessel on board which fishery products undergo one or more of the following operations followed by wrapping or packaging and, if necessary, chilling or freezing: filleting, slicing, skinning, shelling, shucking, mincing or processing.

3.3. ‘Freezer vessel’ means any vessel on board which freezing of fishery products is carried out, where appropriate after preparatory work such as bleeding, heading, gutting and removal of fins and, where necessary, followed by wrapping or packaging.

3.4. ‘Mechanically separated fishery product’ means any product obtained by removing flesh from fishery products using mechanical means resulting in the loss or modification of the flesh structure.

3.5. ‘Fresh fishery products’ means unprocessed fishery products, whether whole or prepared, including products packaged under vacuum or in a modified atmosphere, that have not undergone any treatment to ensure preservation other than chilling.

3.6. ‘Prepared fishery products’ means unprocessed fishery products that have undergone an operation affecting their anatomical wholeness, such as gutting, heading, slicing, filleting, and chopping.

4. MILK

4.1. ‘Raw milk’ means milk produced by the secretion of the mammary gland of farmed animals that has not been heated to more than 40 °C or undergone any treatment that has an equivalent effect.

4.2. ‘Milk production holding’ means an establishment where one or more farmed animals are kept to produce milk with a view to placing it on the market as food.

5. EGGS

5.1. ‘Eggs’ means eggs in shell — other than broken, incubated or cooked eggs — that are produced by farmed birds and are fit for direct human consumption or for the preparation of egg products.

5.2. ‘Liquid egg’ means unprocessed egg contents after removal of the shell.

5.3. ‘Cracked eggs’ means eggs with damaged shell and intact membranes.

5.4. ‘Packing centre’ means an establishment where eggs are graded by quality and weight.

6. FROGS LEGS AND SNAILS

6.1. ‘Frogs' legs’ means the posterior part of the body divided by a transverse cut behind the front limbs, eviscerated and skinned, of the species RNA (family Ranidae).

6.2. ‘Snails’ means terrestrial gastropods of the species Helix pomatia Linné, Helix aspersa Muller, Helix lucorum and species of the family Achatinidae.

7. PROCESSED PRODUCTS

7.1. ‘Meat products’ means processed products resulting from the processing of meat or from the further processing of such processed products, so that the cut surface shows that the product no longer has the characteristics of fresh meat.

7.2. ‘Dairy products’ means processed products resulting from the processing of raw milk or from the further processing of such processed products.

7.3. ‘Egg products’ means processed products resulting from the processing of eggs, or of various components or mixtures of eggs, or from the further processing of such processed products.

7.4. ‘Processed fishery products’ means processed products resulting from the processing of fishery products or from the further processing of such processed products.

7.5. ‘Rendered animal fat’ means fat derived from rendering meat, including bones, and intended for human consumption.

7.6. ‘Greaves’ means the protein-containing residue of rendering, after partial separation of fat and water.

7.7. ‘Gelatine’ means natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals.

7.8. ‘Collagen’ means the protein-based product derived from animal bones, hides, skins and tendons manufactured in accordance with the relevant requirements of this Regulation.

7.9. ‘Treated stomachs, bladders and intestines’ means stomachs, bladders and intestines that have been submitted to a treatment such as salting, heating or drying after they have been obtained and after cleaning.

8. OTHER DEFINITIONS

8.1. ‘Products of animal origin’ means:

—	food of animal origin, including honey and blood;

—	live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods intended for human consumption; and

—	other animals destined to be prepared with a view to being supplied live to the final consumer.

8.2. ‘Wholesale market’ means a food business that includes several separate units which share common installations and sections where foodstuffs are sold to food business operators.

ANNEX II

REQUIREMENTS CONCERNING SEVERAL PRODUCTS OF ANIMAL ORIGIN

SECTION I

IDENTIFICATION MARKING

When required in accordance with Article 5 or 6, and subject to the provisions of Annex III, food business operators must ensure that products of animal origin have an identification mark applied in compliance with the following provisions.

A. APPLICATION OF THE IDENTIFICATION MARK

1.	The identification mark must be applied before the product leaves the establishment.

2.	However, a new mark need not be applied to a product unless its packaging and/or wrapping is removed or it is further processed in another establishment, in which case the new mark must indicate the approval number of the establishment where these operations take place.

3.	An identification mark is not necessary for eggs in respect of which Regulation (EEC) No 1907/90 (1) lays down requirements concerning labelling or marking.

4.	Food business operators must, in accordance with Article 18 of Regulation (EC) No 178/2002, have in place systems and procedures to identify food business operators from whom they have received, and to whom they have delivered, products of animal origin.

B. FORM OF THE IDENTIFICATION MARK

5.	The mark must be legible and indelible, and the characters easily decipherable. It must be clearly displayed for the competent authorities.

The mark must indicate the name of the country in which the establishment is located, which may be written out in full or shown as a two-letter code in accordance with the relevant ISO standard.

In the case of Member States, however, these codes are AT, BE, DE, DK, ES, FI, FR, GR, IE, IT, LU, NL, PT, SE and UK.

Food business operators may continue to use stocks and equipment that they ordered before the entry into force of this Regulation until they are exhausted or require replacement.

7.	The mark must indicate the approval number of the establishment. If an establishment manufactures both food to which this Regulation applies and food to which it does not, the food business operator may apply the same identification mark to both types of food.

8.	When applied in an establishment located within the Community, the mark must be oval in shape and include the abbreviation CE, EC, EF, EG, EK or EY.

C. METHOD OF MARKING

The mark may, depending on the presentation of different products of animal origin, be applied directly to the product, the wrapping or the packaging, or be printed on a label affixed to the product, the wrapping or the packaging. The mark may also be an irremovable tag made of a resistant material.

10.

In the case of packaging containing cut meat or offal, the mark must be applied to a label fixed to the packaging, or printed on the packaging, in such a way that it is destroyed when the packaging is opened. This is not necessary, however, if the process of opening destroys the packaging. When wrapping provides the same protection as packaging, the label may be affixed to the wrapping.

11.	For products of animal origin that are placed in transport containers or large packages and are intended for further handling, processing, wrapping or packaging in another establishment, the mark may be applied to the external surface of the container or packaging.

12.	In the case of liquid, granulate and powdered products of animal origin carried in bulk, and fishery products carried in bulk, an identification mark is not necessary if accompanying documentation contains the information specified in paragraphs 6, 7 and, where appropriate, 8.

13.	When products of animal origin are placed in a package destined for direct supply to the final consumer, it is sufficient to apply the mark to the exterior of that package only.

14.	When the mark is applied directly to products of animal origin, the colours used must be authorised in accordance with Community rules on the use of colouring substances in foodstuffs.

SECTION II

OBJECTIVES OF HACCP-BASED PROCEDURES

Food business operators operating slaughterhouses must ensure that the procedures that they have put in place in accordance with the general requirements of Article 5 of Regulation (EC) No .../2004 (2) meet the requirements that the hazard analysis shows to be necessary and the specific requirements listed in paragraph 2.

The procedures must guarantee that each animal or, where appropriate, each lot of animals accepted onto the slaughterhouse premises:

(a)	is properly identified;

(b)	is accompanied by the relevant information from the holding of provenance referred to in Section III;

(c)	does not come from a holding or an area subject to a movement prohibition or other restriction for reasons of animal or public health, except when the competent authority so permits;

(d)

is clean;

(e)	is healthy, as far as the food business operator can judge; and

(f)	is in a satisfactory state as regards welfare on arrival at the slaughterhouse.

3.	In the event of failure to comply with any of the requirements listed under paragraph 2, the food business operator must notify the official veterinarian and take appropriate measures.

SECTION III

FOOD CHAIN INFORMATION

Food business operators operating slaughterhouses must, as appropriate, request, receive, check and act upon food chain information as set out in this Section in respect of all animals, other than wild game, sent or intended to be sent to the slaughterhouse.

1.	Slaughterhouse operators must not accept animals onto the slaughterhouse premises unless they have requested and been provided with relevant food safety information contained in the records kept at the holding of provenance in accordance with Regulation (EC) No .../2004 (3).

2.	Slaughterhouse operators must be provided with the information no less than 24 hours before the arrival of animals at the slaughterhouse, except in the circumstances mentioned in point 7.

The relevant food safety information referred to in point 1 is to cover, in particular:

(a)	the status of the holding of provenance or the regional animal health status;

(b)	the animals' health status;

(c)	veterinary medicinal products or other treatments administered to the animals within a relevant period and with a withdrawal period greater than zero, together with their dates of administration and withdrawal periods;

(d)	the occurrence of diseases that may affect the safety of meat;

(e)

the results, if they are relevant to the protection of public health, of any analysis carried out on samples taken from the animals or other samples taken to diagnose diseases that may affect the safety of meat, including samples taken in the framework of the monitoring and control of zoonoses and residues;

(f)	relevant reports about previous ante- and post-mortem inspections of animals from the same holding of provenance including, in particular, reports from the official veterinarian;

(g)	production data, when this might indicate the presence of disease; and

(h)	the name and address of the private veterinarian normally attending the holding of provenance.

(a)

However, it is not necessary for the slaughterhouse operator to be provided with:

(i)	the information referred to in point 3(a), (b), (f) and (h), if the operator is already aware of this information (for example, through a standing arrangement or a quality assurance scheme); or

(ii)	the information referred to in point 3(a), (b), (f) and (g), if the producer declares that there is no relevant information to report.

(b)	The information need not be provided as a verbatim extract from the records of the holding of provenance. It may be provided through electronic data exchange or in the form of a standardised declaration signed by the producer.

Food business operators deciding to accept animals onto the slaughterhouse premises after evaluating the relevant food chain information must make it available to the official veterinarian without delay and, except in the circumstances mentioned in point 7, no less than 24 hours before the arrival of the animal or lot. The food business operator must notify the official veterinarian of any information that gives rise to health concerns before ante-mortem inspection of the animal concerned.

6.	If any animal arrives at the slaughterhouse without food chain information, the operator must immediately notify the official veterinarian. Slaughter of the animal may not take place until the official veterinarian so permits.

If the competent authority so permits, food chain information may accompany the animals to which it relates to the slaughterhouse, rather than arriving at least 24 hours in advance, in the case of:

(a)	porcine animals, poultry or farmed game that have undergone ante-mortem inspection at the holding of provenance, if a certificate that the veterinarian has signed stating that he or she examined the animals at the holding and found them to be healthy accompanies them;

(b)	domestic solipeds;

(c)	animals that have undergone emergency slaughter, if a declaration, that the veterinarian has signed recording the favourable outcome of the ante-mortem inspection accompanies them; and

(d)	animals that are not delivered directly from the holding of provenance to the slaughterhouse.

Slaughterhouse operators must evaluate the relevant information. If they accept the animals for slaughter, they must give the documents mentioned in subparagraphs (a) and (c) to the official veterinarian. Slaughter or dressing of the animals may not take place until the official veterinarian so permits.

8.	Food business operators must check passports accompanying domestic solipeds to ensure that the animal is intended for slaughter for human consumption. If they accept the animal for slaughter, they must give the passport to the official veterinarian.

(1) Council Regulation (EEC) No 1907/90 of 26 June 1990 on certain marketing standards for eggs (OJ L 173, 6.7.1990, p. 5). Regulation as last amended by Regulation (EC) No 2052/2003 (OJ L 305, 22.11.2003, p.1).

(2) Not yet published in the OJ.

(3) Not yet published in the OJ.

ANNEX III

SPECIFIC REQUIREMENTS

SECTION I

MEAT OF DOMESTIC UNGULATES

CHAPTER I: TRANSPORT OF LIVE ANIMALS TO THE SLAUGHTERHOUSE

Food business operators transporting live animals to slaughterhouses must ensure compliance with the following requirements.

1.	During collection and transport, animals must be handled carefully without causing unnecessary distress.

2.	Animals showing symptoms of disease or originating in herds known to be contaminated with agents of public health importance may only be transported to the slaughterhouse when the competent authority so permits.

CHAPTER II: REQUIREMENTS FOR SLAUGHTERHOUSES

Food business operators must ensure that the construction, layout and equipment of slaughterhouses in which domestic ungulates are slaughtered meet the following requirements.

(a)	Slaughterhouses must have adequate and hygienic lairage facilities or, climate permitting, waiting pens that are easy to clean and disinfect. These facilities must be equipped for watering the animals and, if necessary, feeding them. The drainage of the wastewater must not compromise food safety.

(b)	They must also have separate lockable facilities or, climate permitting, pens for sick or suspect animals with separate draining and sited in such a way as to avoid contamination of other animals, unless the competent authority considers that such facilities are unnecessary.

(c)	The size of the lairage facilities must ensure that the welfare of the animals is respected. Their layout must facilitate ante-mortem inspections, including the identification of the animals or groups of animals.

To avoid contaminating meat, they must:

(a)	have a sufficient number of rooms, appropriate to the operations being carried out;

(b)	have a separate room for the emptying and cleaning of stomachs and intestines, unless the competent authority authorises the separation in time of these operations within a specific slaughterhouse on a case-by-case basis;

(c)

ensure separation in space or time of the following operations:

(i)	stunning and bleeding;

(ii)	in the case of porcine animals, scalding, depilation, scraping and singeing;

(iii)

evisceration and further dressing;

(iv)	handling clean guts and tripe;

(v)	preparation and cleaning of other offal, particularly the handling of skinned heads if it does not take place at the slaughter line;

(vi)	packaging offal; and

(vii)

dispatching meat;

(d)	have installations that prevent contact between the meat and the floors, walls and fixtures; and

(e)

have slaughter lines (where operated) that are designed to allow constant progress of the slaughter process and to avoid cross-contamination between the different parts of the slaughter line. Where more than one slaughter line is operated in the same premises, there must be adequate separation of the lines to prevent cross-contamination.

3.	They must have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect.

4.	The equipment for washing hands used by the staff engaged in handling exposed meat must have taps designed to prevent the spread of contamination.

5.	There must be lockable facilities for the refrigerated storage of detained meat and separate lockable facilities for the storage of meat declared unfit for human consumption.

There must be a separate place with appropriate facilities for the cleaning, washing and disinfection of means of transport for livestock. However, slaughterhouses need not have these places and facilities if the competent authority so permits and official authorised places and facilities exist nearby.

7.	They must have lockable facilities reserved for the slaughter of sick and suspect animals. This is not essential if this slaughter takes place in other establishments authorised by the competent authority for this purpose, or at the end of the normal slaughter period.

8.	If manure or digestive tract content is stored in the slaughterhouse, there must be a special area or place for that purpose.

9.	They must have an adequately equipped lockable facility or, where needed, room for the exclusive use of the veterinary service.

CHAPTER III: REQUIREMENTS FOR CUTTING PLANTS

Food business operators must ensure that cutting plants handling meat of domestic ungulates:

are constructed so as to avoid contamination of meat, in particular by:

(a)	allowing constant progress of the operations; or

(b)	ensuring separation between the different production batches;

2.	have rooms for the separate storage of packaged and exposed meat, unless stored at different times or in such a way that the packaging material and the manner of storage cannot be a source of contamination for the meat;

3.	have cutting rooms equipped to ensure compliance with the requirements laid down in Chapter V;

4.	have equipment for washing hands with taps designed to prevent the spread of contamination, for use by staff engaged in handling exposed meat; and

5.	have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect.

CHAPTER IV: SLAUGHTER HYGIENE

Food business operators operating slaughterhouses in which domestic ungulates are slaughtered must ensure compliance with the following requirements.

1.	After arrival in the slaughterhouse, the slaughter of the animals must not be unduly delayed. However, where required for welfare reasons, animals must be given a resting period before slaughter.

(a)	Meat from animals other than those referred to in subparagraphs (b) and (c) must not be used for human consumption if they die otherwise than by being slaughtered in the slaughterhouse.

(b)

Only live animals intended for slaughter may be brought into the slaughter premises, with the exception of:

(i)	animals that have undergone emergency slaughter outside the slaughterhouse in accordance with Chapter VI;

(ii)	animals slaughtered at the place of production in accordance with Section III; and

(iii)

wild game, in compliance with Section IV, Chapter II.

(c)	Meat from animals that undergo slaughter following an accident in a slaughterhouse may be used for human consumption if, on inspection, no serious lesions other than those due to the accident are found.

3.	The animals or, where appropriate, each batch of animals sent for slaughter must be identified so that their origin can be traced.

4.	Animals must be clean.

5.	Slaughterhouse operators must follow the instructions of the veterinarian appointed by the competent authority in accordance with Regulation (EC) No .../2004 (1) to ensure that ante-mortem inspection of every animal to be slaughtered is carried out under suitable conditions.

6.	Animals brought into the slaughter hall must be slaughtered without undue delay.

Stunning, bleeding, skinning, evisceration and other dressing must be carried out without undue delay and in a manner that avoids contaminating the meat. In particular:

(a)	the trachea and oesophagus must remain intact during bleeding, except in the case of slaughter according to a religious custom;

(b)

during the removal of hides and fleece:

(i)	contact between the outside of the skin and the carcase must be prevented; and

(ii)	operators and equipment coming into contact with the outer surface of hides and fleece must not touch the meat;

(c)	measures must be taken to prevent the spillage of digestive tract content during and after evisceration and to ensure that evisceration is completed as soon as possible after stunning; and

(d)	removal of the udder must not result in contamination of the carcase with milk or colostrum.

8.	Complete skinning of the carcase and other parts of the body intended for human consumption must be carried out, except for porcine animals and the heads and feet of ovine and caprine animals and calves. Heads and feet must be handled so as to avoid contamination of other meat.

9.	When not skinned, porcine animals must have their bristles removed immediately. The risk of contamination of the meat with scalding water must be minimised. Only approved additives may be used for this operation. Porcine animals must be thoroughly rinsed afterwards with potable water.

10.	The carcases must not contain visible faecal contamination. Any visible contamination must be removed without delay by trimming or alternative means having an equivalent effect.

11.	Carcases and offal must not come into contact with floors, walls or work stands.

12.	Slaughterhouse operators must follow the instructions of the competent authority to ensure that postmortem inspection of all slaughtered animals is carried out under suitable conditions in accordance with Regulation (EC) No .../2004 (1).

13.

Until post-mortem inspection is completed, parts of a slaughtered animal subject to such inspection must:

(a)	remain identifiable as belonging to a given carcase; and

(b)	come into contact with no other carcase, offal or viscera, including those that have already undergone post-mortem inspection.

However, provided that it shows no pathological lesion, the penis may be discarded immediately.

14.	Both kidneys must be removed from their fatty covering. In the case of bovine and porcine animals, and solipeds, the peri-renal capsule must also be removed.

15.	If the blood or other offal of several animals is collected in the same container before completion of post-mortem inspection, the entire contents must be declared unfit for human consumption if the carcase of one or more of the animals concerned has been declared unfit for human consumption.

16.

After post-mortem inspection:

(a)	the tonsils of bovine animals and solipeds must be removed hygienically;

(b)	parts unfit for human consumption must be removed as soon as possible from the clean sector of the establishment;

(c)	meat detained or declared unfit for human consumption and inedible by-products must not come into contact with meat declared fit for human consumption; and

(d)	viscera or parts of viscera remaining in the carcase, except for the kidneys, must be removed entirely and as soon as possible, unless the competent authority authorises otherwise.

17.	After completion of slaughter and post-mortem inspection, the meat must be stored in accordance with the requirements laid down in Chapter VII.

18.

When destined for further handling:

(a)	stomachs must be scalded or cleaned;

(b)	intestines must be emptied and cleaned; and

(c)	heads and feet must be skinned or scalded and depilated.

19.

Where establishments are approved for the slaughter of different animal species or for the handling of carcases of farmed game and wild game, precautions must be taken to prevent cross-contamination by separation either in time or in space of operations carried out on the different species. Separate facilities for the reception and storage of unskinned carcases of farmed game slaughtered at the farm and for wild game must be available.

20.	If the slaughterhouse does not have lockable facilities reserved for the slaughter of sick or suspect animals, the facilities used to slaughter such animals must be cleaned, washed and disinfected under official supervision before the slaughter of other animals is resumed.

CHAPTER V: HYGIENE DURING CUTTING AND BONING

Food business operators must ensure that cutting and boning of meat of domestic ungulates takes place in accordance with the following requirements.

1.	Carcases of domestic ungulates may be cut into half-carcases or quarters, and half carcases into no more than three wholesale cuts, in slaughterhouses. Further cutting and boning must be carried out in a cutting plant.

The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food business operators must ensure in particular that:

(a)	meat intended for cutting is brought into the workrooms progressively as needed;

(b)	during cutting, boning, trimming, slicing, dicing, wrapping and packaging, the meat is maintained at not more than 3 °C for offal and 7 °C for other meat, by means of an ambient temperature of not more than 12 °C or an alternative system having an equivalent effect; and

(c)	where the premises are approved for the cutting of meat of different animal species, precautions are taken to avoid cross-contamination, where necessary by separation of the operations on the different species in either space or time.

3.	However, meat may be boned and cut before it reaches the temperature referred to in point 2(b) in accordance with Chapter VII, point 3.

Meat may also be boned and cut prior to reaching the temperature referred to in point 2(b) when the cutting room is on the same site as the slaughter premises. In this case, the meat must be transferred to the cutting room either directly from the slaughter premises or after a waiting period in a chilling or refrigerating room. As soon as it is cut and, where appropriate, packaged, the meat must be chilled to the temperature referred to in point 2(b).

CHAPTER VI: EMERGENCY SLAUGHTER OUTSIDE THE SLAUGHTERHOUSE

Food business operators must ensure that meat from domestic ungulates that have undergone emergency slaughter outside the slaughterhouse may be used for human consumption only if it complies with all the following requirements.

1.	An otherwise healthy animal must have suffered an accident that prevented its transport to the slaughterhouse for welfare reasons.

2.	A veterinarian must carry out an ante-mortem inspection of the animal.

The slaughtered and bled animal must be transported to the slaughterhouse hygienically and without undue delay. Removal of the stomach and intestines, but no other dressing, may take place on the spot, under the supervision of the veterinarian. Any viscera removed must accompany the slaughtered animal to the slaughterhouse and be identified as belonging to that animal.

4.	If more than two hours elapse between slaughter and arrival at the slaughterhouse, the animal must be refrigerated. Where climatic conditions so permit, active chilling is not necessary.

5.	A declaration by the food business operator who reared the animal, stating the identity of the animal and indicating any veterinary products or other treatments administered to the animal, dates of administration and withdrawal periods, must accompany the slaughtered animal to the slaughterhouse.

A declaration issued by the veterinarian recording the favourable outcome of the ante-mortem inspection, the date and time of, and reason for, emergency slaughter, and the nature of any treatment administered by the veterinarian to the animal, must accompany the slaughtered animal to the slaughterhouse.

7.	The slaughtered animal must be fit for human consumption following post-mortem inspection carried out in the slaughterhouse in accordance with Regulation (EC) No .../2004 (2), including any additional tests required in the case of emergency slaughter.

8.	Food business operators must follow any instructions that the official veterinarian may give after postmortem inspection concerning the use of the meat.

Food business operators may not place meat from animals having undergone emergency slaughter on the market unless it bears a special health mark which cannot be confused either with the health mark provided for in Regulation (EC) No .../2004 (2) or with the identification mark provided for in Annex II, Section I to this Regulation. Such meat may be placed on the market only in the Member State where slaughter takes place and in accordance with national law.

CHAPTER VII: STORAGE AND TRANSPORT

Food business operators must ensure that the storage and transport of meat of domestic ungulates takes place in accordance with the following requirements.

(a)

Unless other specific provisions provide otherwise, post-mortem inspection must be followed immediately by chilling in the slaughterhouse to ensure a temperature throughout the meat of not more than 3 °C for offal and 7 °C for other meat along a chilling curve that ensures a continuous decrease of the temperature. However, meat may be cut and boned during chilling in accordance with Chapter V, point 4.

(b)	During the chilling operations, there must be adequate ventilation to prevent condensation on the surface of the meat.

2.	Meat must attain the temperature specified in point 1 and remain at that temperature during storage.

Meat must attain the temperature specified in point 1 before transport, and remain at that temperature during transport. However, transport may also take place if the competent authority so authorises to enable the production of specific products, provided that:

(a)	such transport takes place in accordance with the requirements that the competent authority specifies in respect of transport from one given establishment to another; and

(b)	the meat leaves the slaughterhouse, or a cutting room on the same site as the slaughter premises, immediately and transport takes no more than two hours.

4.	Meat intended for freezing must be frozen without undue delay, taking into account where necessary a stabilisation period before freezing.

5.	Exposed meat must be stored and transported separately from packaged meat, unless stored or transported at different times or in such a way that the packaging material and the manner of storage or transport cannot be a source of contamination for the meat.

SECTION II

MEAT FROM POULTRY AND LAGOMORPHS

CHAPTER I: TRANSPORT OF LIVE ANIMALS TO THE SLAUGHTERHOUSE

Food business operators transporting live animals to slaughterhouses must ensure compliance with the following requirements.

1.	During collection and transport, animals must be handled carefully without causing unnecessary distress.

2.	Animals showing symptoms of disease or originating in flocks known to be contaminated with agents of public-health importance may only be transported to the slaughterhouse when permitted by the competent authority.

Crates for delivering animals to the slaughterhouse and modules, where used, must be made of noncorrodible material and be easy to clean and disinfect. Immediately after emptying and, if necessary, before re-use, all equipment used for collecting and delivering live animals must be cleaned, washed and disinfected.

CHAPTER II: REQUIREMENTS FOR SLAUGHTERHOUSES

Food business operators must ensure that the construction, layout and equipment of slaughterhouses in which poultry or lagomorphs are slaughtered meet the following requirements.

1.	They must have a room or covered space for the reception of the animals and for their inspection before slaughter.

To avoid contaminating meat, they must:

(a)	have a sufficient number of rooms, appropriate to the operations being carried out;

(b)	have a separate room for evisceration and further dressing, including the addition of seasonings to whole poultry carcases, unless the competent authority authorises separation in time of these operations within a specific slaughterhouse on a case-by-case basis;

(c)

ensure separation in space or time of the following operations:

(i)	stunning and bleeding;

(ii)	plucking or skinning, and any scalding; and

(iii)

dispatching meat;

(d)	have installations that prevent contact between the meat and the floors, walls and fixtures; and

(e)

have slaughter lines (where operated) that are designed to allow a constant progress of the slaughter process and to avoid cross-contamination between the different parts of the slaughter line. Where more than one slaughter line is operated in the same premises, there must be adequate separation of the lines to prevent cross-contamination.

3.	They must have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect.

4.	The equipment for washing hands used by the staff engaged in handling exposed meat must have taps designed to prevent the spread of contamination.

5.	There must be lockable facilities for the refrigerated storage of detained meat and separate lockable facilities for the storage of meat declared unfit for human consumption.

There must be a separate place with appropriate facilities for the cleaning, washing and disinfection of:

(a)	transport equipment such as crates; and

(b)	means of transport.

These places and facilities are not compulsory for (b) if officially authorised places and facilities exist nearby.

7.	They must have an adequately equipped lockable facility or, where needed, room for the exclusive use of the veterinary service.

CHAPTER III: REQUIREMENTS FOR CUTTING PLANTS

Food business operators must ensure that cutting plants handling meat from poultry or lagomorphs:

(a)

are constructed so as to avoid contamination of meat, in particular by:

(i)	allowing constant progress of the operations; or

(ii)	ensuring separation between the different production batches;

(b)	have rooms for the separate storage of packaged and exposed meat, unless stored at different times or in such a way that the packaging material and the manner of storage cannot be a source of contamination for the meat;

(c)	have cutting rooms equipped to ensure compliance with the requirements laid down in Chapter V;

(d)	have equipment for washing hands used by staff handling exposed meat with taps designed to prevent the spread of contamination; and

(e)	have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect.

If the following operations are undertaken in a cutting plant:

(a)	the evisceration of geese and ducks reared for the production of ‘foie gras’, which have been stunned, bled and plucked on the fattening farm; or

(b)	the evisceration of delayed eviscerated poultry,

food business operators must ensure that separate rooms are available for that purpose.

CHAPTER IV: SLAUGHTER HYGIENE

Food business operators operating slaughterhouses in which poultry or lagomorphs are slaughtered must ensure compliance with the following requirements.

(a)	Meat from animals other than those referred to in (b) must not be used for human consumption if they die otherwise than by being slaughtered in the slaughterhouse.

(b)

Only live animals intended for slaughter may be brought into the slaughter premises, with the exception of:

(i)	delayed eviscerated poultry, geese and ducks reared for the production of ‘foie gras’ and birds that are not considered as domestic but which are farmed as domestic animals, if slaughtered at the farm in accordance with Chapter VI;

(ii)	farmed game slaughtered at the place of production in accordance with Section III; and

(iii)

small wild game in accordance with Section IV, Chapter III.

2.	Slaughterhouse operators must follow the instructions of the competent authority to ensure that antemortem inspection is carried out under suitable conditions.

Where establishments are approved for the slaughter of different animal species or for the handling of farmed ratites and small wild game, precautions must be taken to prevent cross contamination by separation either in time or in space of the operations carried out on the different species. Separate facilities for the reception and storage of carcases of farmed ratites slaughtered at the farm and for small wild game must be available.

4.	Animals brought into the slaughter room must be slaughtered without undue delay.

5.	Stunning, bleeding, skinning or plucking, evisceration and other dressing must be carried out without undue delay in such a way that contamination of the meat is avoided. In particular, measures must be taken to prevent the spillage of digestive tract contents during evisceration.

6.	Slaughterhouse operators must follow the instructions of the competent authority to ensure that the post-mortem inspection is carried out under suitable conditions, and in particular that slaughtered animals can be inspected properly.

After post-mortem inspection:

(a)	parts unfit for human consumption must be removed as soon as possible from the clean sector of the establishment;

(b)	meat detained or declared unfit for human consumption and inedible by-products must not come into contact with meat declared fit for human consumption; and

(c)	viscera or parts of viscera remaining in the carcase, except for the kidneys, must be removed entirely, if possible, and as soon as possible, unless otherwise authorised by the competent authority.

8.	After inspection and evisceration, slaughtered animals must be cleaned and chilled to not more than 4 °C as soon as possible, unless the meat is cut while warm.

When carcases are subjected to an immersion chilling process, account must be taken of the following.

(a)	Every precaution must be taken to avoid contamination of carcases, taking into account parameters such as carcase weight, water temperature, volume and direction of water flow and chilling time.

(b)	Equipment must be entirely emptied, cleaned and disinfected whenever this is necessary and at least once a day.

10.

Sick or suspect animals, and animals slaughtered in application of disease eradication or control programmes, must not be slaughtered in the establishment except when permitted by the competent authority. In that event, slaughter must be performed under official supervision and steps taken to prevent contamination; the premises must be cleaned and disinfected before being used again.

CHAPTER V: HYGIENE DURING AND AFTER CUTTING AND BONING

Food business operators must ensure that cutting and boning of meat of poultry and lagomorphs takes place in accordance with the following requirements.

The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food business operators must ensure in particular that:

(a)	meat intended for cutting is brought into the workrooms progressively as needed;

(b)	during cutting, boning, trimming, slicing, dicing, wrapping and packaging, the temperature of the meat is maintained at not more than 4 °C by means of an ambient temperature of 12 °C or an alternative system having an equivalent effect; and

(c)	where the premises are approved for the cutting of meat of different animal species, precautions are taken to avoid cross-contamination, where necessary by separation of the operations on the different species in either space or time.

However, meat may be boned and cut prior to reaching the temperature referred to in point 1(b) when the cutting room is on the same site as the slaughter premises, provided that it is transferred to the cutting room either:

(a)	directly from the slaughter premises; or

(b)	after a waiting period in a chilling or refrigerating room.

3.	As soon as it is cut and, where appropriate, packaged, the meat must be chilled to the temperature referred to in point 1(b).

4.	Exposed meat must be stored and transported separately from packaged meat, unless stored or transported at different times or in such a way that the packaging material and the manner of storage or transport cannot be a source of contamination for the meat.

CHAPTER VI: SLAUGHTER ON THE FARM

Food business operators may slaughter poultry referred to in Chapter IV, point 1(b)(i), on the farm only with the authorisation of the competent authority and in compliance with the following requirements.

1.	The farm must undergo regular veterinary inspection.

2.	The food business operator must inform the competent authority in advance of the date and time of slaughter.

3.	The holding must have facilities for concentrating the birds to allow an ante-mortem inspection of the group to be made.

4.	The holding must have premises suitable for the hygienic slaughter and further handling of the birds.

5.	Animal welfare requirements must be complied with.

6.	The slaughtered birds must be accompanied to the slaughterhouse by a declaration by the food business operator who reared the animal indicating any veterinary products or other treatments administered to the animal, dates of administration and withdrawal periods, and the date and time of slaughter.

7.	The slaughtered animal must be accompanied to the slaughterhouse by a certificate issued by the official veterinarian or approved veterinarian in accordance with Regulation (EC) No .../2004 (3).

8.	In the case of poultry reared for the production of ‘foie gras’, the uneviscerated birds must be transported immediately and, if necessary, refrigerated to a slaughterhouse or cutting plant. They must be eviscerated within 24 hours of slaughter under the supervision of the competent authority.

9.	Delayed eviscerated poultry obtained at the farm of production may be kept for up to 15 days at a temperature of not more than 4 °C. It must then be eviscerated in a slaughterhouse or in a cutting plant located in the same Member State as the farm of production.

SECTION III

MEAT OF FARMED GAME

1.	The provisions of Section I apply to the production and placing on the market of meat from eventoed farmed game mammals (Crevice and Suede), unless the competent authority considers them inappropriate.

2.	The provisions of Section II apply to the production and placing on the market of meat from ratites. However, those of Section I apply where the competent authority considers them appropriate. Appropriate facilities must be provided, adapted to the size of the animals.

Notwithstanding points 1 and 2, food business operators may slaughter farmed ratites and farmed ungulates referred to in point 1 at the place of origin with the authorisation of the competent authority if:

(a)	the animals cannot be transported, to avoid any risk for the handler or to protect the welfare of the animals;

(b)	the herd undergoes regular veterinary inspection;

(c)	the owner of the animals submits a request;

(d)	the competent authority is informed in advance of the date and time of slaughter of the animals;

(e)	the holding has procedures for concentrating the animals to allow an ante-mortem inspection of the group to be made;

(f)	the holding has facilities suitable for the slaughter, bleeding and, where ratites are to be plucked, plucking of the animals;

(g)	animal welfare requirements are complied with;

(h)	slaughtered and bled animals are transported to the slaughterhouse hygienically and without undue delay. If transport takes more than two hours, the animals are, if necessary, refrigerated. Evisceration may take place on the spot, under the supervision of the veterinarian;

(i)	a declaration by the food business operator who reared the animals, stating their identity and indicating any veterinary products or other treatments administered, dates of administration and withdrawal periods, accompanies the slaughtered animals to the slaughterhouse; and

(j)

during transport to the approved establishment, a certificate issued and signed by the official veterinarian or approved veterinarian, attesting to a favourable result of the ante-mortem inspection, correct slaughter and bleeding and the date and time of slaughter, accompanies the slaughtered animals.

4.	Food business operators may also slaughter bison on the farm in accordance with paragraph 3 in exceptional circumstances.

SECTION IV

WILD GAME MEAT

CHAPTER I: TRAINING OF HUNTERS IN HEALTH AND HYGIENE

1.	Persons who hunt wild game with a view to placing it on the market for human consumption must have sufficient knowledge of the pathology of wild game, and of the production and handling of wild game and wild game meat after hunting, to undertake an initial examination of wild game on the spot.

2.	It is however enough if at least one person of a hunting team has the knowledge referred to in paragraph 1. References in this Section to a ‘trained person’ are references to that person.

The trained person could also be the gamekeeper or the game manager if he or she is part of the hunting team or located in the immediate vicinity of where hunting is taking place. In the latter case, the hunter must present the wild game to the gamekeeper or game manager and inform them of any abnormal behaviour observed before killing.

Training must be provided to the satisfaction of the competent authority to enable hunters to become trained persons. It should cover at least the following subjects:

(a)	the normal anatomy, physiology and behaviour of wild game;

(b)	abnormal behaviour and pathological changes in wild game due to diseases, environmental contamination or other factors which may affect human health after consumption;

(c)	the hygiene rules and proper techniques for the handling, transportation, evisceration etc. of wild game animals after killing; and

(d)	legislation and administrative provisions on the animal and public health and hygiene conditions governing the placing on the market of wild game.

5.	The competent authority should encourage hunters' organisations to provide such training.

CHAPTER II: HANDLING OF LARGE WILD GAME

1.	After killing, large wild game must have their stomachs and intestines removed as soon as possible and, if necessary, be bled.

2.	The trained person must carry out an examination of the body, and of any viscera removed, to identify any characteristics that may indicate that the meat presents a health risk. The examination must take place as soon as possible after killing.

Meat of large wild game may be placed on the market only if the body is transported to a gamehandling establishment as soon as possible after the examination referred to in point 2. The viscera must accompany the body as specified in point 4. The viscera must be identifiable as belonging to a given animal.

(a)

If no abnormal characteristics are found during the examination referred to in paragraph 2, no abnormal behaviour was observed before killing, and there is no suspicion of environmental contamination, the trained person must attach to the animal body a numbered declaration stating this. This declaration must also indicate the date, time and place of killing. In this case, the head and the viscera need not accompany the body, except in the case of species susceptible to Trichinosis (porcine animals, solipeds and others), whose head (except for tusks) and diaphragm must accompany the body. However, hunters must comply with any additional requirements imposed in the Member State where hunting takes place, in particular to permit the monitoring of certain residues and substances in accordance with Directive 96/23/EC;

(b)

In other circumstances, the head (except for tusks, antlers and horns) and all the viscera except for the stomach and intestines must accompany the body. The trained person who carried out the examination must inform the competent authority of the abnormal characteristics, abnormal behaviour or suspicion of environmental contamination that prevented him or her from making a declaration in accordance with (a);

(c)	If no trained person is available to carry out the examination referred to in paragraph 2 in a particular case, the head (except for tusks, antlers and horns) and all the viscera except for the stomach and the intestines must accompany the body.

5.	Chilling must begin within a reasonable period of time after killing and achieve a temperature throughout the meat of not more than 7 °C. Where climatic conditions so permit, active chilling is not necessary.

6.	During transport to the game-handling establishment, heaping must be avoided.

7.	Large wild game delivered to a game-handling establishment must be presented to the competent authority for inspection.

In addition, unskinned large wild game may be skinned and placed on the market only if:

(a)	before skinning, it is stored and handled separately from other food and not frozen; and

(b)	after skinning, it undergoes a final inspection in accordance with Regulation (EC) No .../2004 (4).

9.	The rules laid down in Section I, Chapter V, apply to the cutting and boning of large wild game.

CHAPTER III: HANDLING OF SMALL WILD GAME

1.	The trained person must carry out an examination to identify any characteristics that may indicate that the meat presents a health risk. The examination must take place as soon as possible after killing.

2.	If abnormal characteristics are found during the examination, abnormal behaviour was observed before killing, or environmental contamination is suspected, the trained person must inform the competent authority.

3.	Meat of small wild game may be placed on the market only if the body is transported to a gamehandling establishment as soon as possible after the examination referred to in point 1.

4.	Chilling must begin within a reasonable period of time of killing and achieve a temperature throughout the meat of not more than 4 °C. Where climatic conditions so permit, active chilling is not necessary.

5.	Evisceration must be carried out, or completed, without undue delay upon arrival at the game-handling establishment, unless the competent authority permits otherwise.

6.	Small wild game delivered to a game-handling establishment must be presented to the competent authority for inspection.

7.	The rules laid down in Section II, Chapter V, apply to the cutting and boning of small wild game.

SECTION V

MINCED MEAT, MEAT PREPARATIONS AND MECHANICALLY SEPARATED MEAT (MSM)

CHAPTER I: REQUIREMENTS FOR PRODUCTION ESTABLISHMENTS

Food business operators operating establishments producing minced meat, meat preparations or MSM must ensure that they:

are constructed so as to avoid contamination of meat and products, in particular by:

(a)	allowing constant progress of the operations; or

(b)	ensuring separation between the different production batches;

2.	have rooms for the separate storage of packaged and exposed meat and products, unless stored at different times or in such a way that the packaging material and the manner of storage cannot be a source of contamination for the meat or products;

3.	have rooms equipped to ensure compliance with the temperature requirements laid down in Chapter III;

4.	have equipment for washing hands used by staff handling exposed meat and products with taps designed to prevent the spread of contamination; and

5.	have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect.

CHAPTER II: REQUIREMENTS FOR RAW MATERIAL

Food business operators producing minced meat, meat preparations or MSM must ensure that the raw materials used satisfy the following requirements.

The raw material used to prepare minced meat must meet the following requirements.

(a)	It must comply with the requirements for fresh meat;

(b)	It must derive from skeletal muscle, including adherent fatty tissues;

(c)

It must not derive from:

(i)	scrap cuttings and scrap trimmings (other than whole muscle cuttings);

(ii)

MSM;

(iii)

meat containing bone fragments or skin; or

(iv)	meat of the head with the exception of the masseters, the non-muscular part of the linea alba, the region of the carpus and the tarsus, bone scrapings and the muscles of the diaphragm (unless the serosa has been removed).

The following raw material may be used to prepare meat preparations:

(a)	fresh meat;

(b)	meat meeting the requirements of point 1; and

(c)

if the meat preparation is clearly not intended to be consumed without first undergoing heat treatment:

(i)	meat derived from the mincing or fragmentation of meat meeting the requirements of point 1 other than point 1(c)(i); and

(ii)	MSM meeting the requirements of Chapter III, point 3(d).

The raw material used to produce MSM must meet the following requirements.

(a)	It must comply with the requirements for fresh meat;

(b)

The following material must not be used to produce MSM:

(i)	for poultry, the feet, neckskin and head; and

(ii)	for other animals, the bones of the head, feet, tails, femur, tibia, fibula, humerus, radius and ulna.

CHAPTER III: HYGIENE DURING AND AFTER PRODUCTION

Food business operators producing minced meat, meat preparations or MSM must ensure compliance with the following requirements.

The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food business operators must ensure in particular that the meat used is:

(a)	at a temperature of not more than 4 °C for poultry, 3 °C for offal and 7 °C for other meat; and

(b)	brought into the preparation room progressively as needed.

The following requirements apply to the production of minced meat and meat preparations.

(a)	Unless the competent authority authorises boning immediately before mincing, frozen or deepfrozen meat used for the preparation of minced meat or meat preparations must be boned before freezing. It may be stored only for a limited period.

(b)

When prepared from chilled meat, minced meat must be prepared:

(i)	in the case of poultry, within no more than 3 days of their slaughter;

(ii)	in the case of animal other than poultry, within no more than 6 days of their slaughter; or

(iii)

within no more than 15 days from the slaughter of the animals in the case of boned, vacuum-packed beef and veal.

(c)

Immediately after production, minced meat and meat preparations must be wrapped or packaged and be:

(i)	chilled to an internal temperature of not more than 2 °C for minced meat and 4 °C for meat preparations; or

(ii)	frozen to an internal temperature of not more than - 18 °C.

These temperature conditions must be maintained during storage and transport.

The following requirements apply to the production and use of MSM produced using techniques that do not alter the structure of the bones used in the production of MSM and the calcium content of which is not significantly higher than that of minced meat.

(a)	Raw material for deboning from an on-site slaughterhouse must be no more than 7 days old; otherwise, raw material for deboning must be no more than 5 days old. However, poultry carcases must be no more than 3 days old.

(b)	Mechanical separation must take place immediately after deboning.

(c)	If not used immediately after being obtained, MSM must be wrapped or packaged and then chilled to a temperature of not more than 2 °C or frozen to an internal temperature of not more than - 18 °C. These temperature requirements must be maintained during storage and transport.

(d)

If the food business operator has carried out analyses demonstrating that MSM complies with the microbiological criteria for minced meat adopted in accordance with Regulation (EC) No .../2004 (5) it may be used in meat preparations that are clearly not intended to be consumed without first undergoing heat treatment and in meat products.

(e)	MSM not shown to comply with the criteria referred to in (d) may be used only to manufacture heat-treated meat products in establishments approved in accordance with this Regulation.

The following requirements apply to the production and use of MSM produced using techniques other than those mentioned in point 3.

(a)	Raw material for deboning from an on-site slaughterhouse must be no more than 7 days old; otherwise, raw material for deboning must be no more than 5 days old. However, poultry carcases must be no more than 3 days old.

(b)	If mechanical separation does not take place immediately after deboning the flesh-bearing bones must be stored and transported at a temperature of not more than 2 °C or, if frozen, at a temperature of not more than - 18 °C.

(c)	Flesh-bearing bones obtained from frozen carcases must not be refrozen.

(d)	If not used within one hour of being obtained, MSM must be chilled immediately to a temperature of not more than 2 °C.

(e)	If, after chilling, MSM is not processed within 24 hours, it must be frozen within 12 hours of production and reach an internal temperature of not more than - 18 °C within six hours.

(f)	Frozen MSM must be wrapped or packaged before storage or transport, must not be stored for more than three months and must be maintained at a temperature of not more than - 18 °C during storage and transport.

(g)	MSM may be used only to manufacture heat-treated meat products in establishments approved in accordance with this Regulation.

5.	Minced meat, meat preparations and MSM must not be re-frozen after thawing.

CHAPTER IV: LABELLING

1.	In addition to the requirements of Directive 2000/13/EC (6), food business operators must ensure compliance with the requirement of point 2 if, and to the extent that, national rules in the Member State in the territory of which the product is placed on the market so require.

2.	Packages intended for supply to the final consumer containing minced meat from poultry or solipeds or meat preparations containing MSM must bear a notice indicating that such products should be cooked before consumption.

SECTION VI

MEAT PRODUCTS

Food business operators must ensure that the following items are not used in the preparation of meat products:

(a)	genital organs of either female or male animals, except testicles;

(b)	urinary organs, except the kidneys and the bladder;

(c)	the cartilage of the larynx, the trachea and the extra-lobular bronchi;

(d)	eyes and eyelids;

(e)	the external auditory meatus;

(f)	horn tissue; and

(g)	in poultry, the head — except the comb and the ears, the wattles and caruncles — the oesophagus, the crop, the intestines and the genital organs.

2.	All meat, including minced meat and meat preparations, used to produce meat product must meet the requirements for fresh meat. However, minced meat and meat preparations used to produce meat products need not satisfy other specific requirements of Section V.

SECTION VII

LIVE BIVALVE MOLLUSCS

1.	This Section applies to live bivalve molluscs. With the exception of the provisions on purification, it also applies to live echinoderms, tunicates and marine gastropods.

Chapters I to VIII apply to animals harvested from production areas that the competent authority has classified in accordance with Regulation (EC) No .../2004 (7). Chapter IX applies to pectinidae harvested outside those areas.

Chapters V, VI, VIII and IX, and paragraph 3 of Chapter VII, apply to retail.

The requirements of this Section supplement those laid down in Regulation (EC) No .../2004 (7).

(a)	In the case of operations that take place before live bivalve molluscs arrive at a dispatch or purification centre, they supplement the requirements of Annex I to that Regulation.

(b)	In the case of other operations, they supplement the requirements of Annex II to that Regulation.

CHAPTER I: GENERAL REQUIREMENTS FOR THE PLACING ON THE MARKET OF LIVE BIVALVE MOLLUSCS

1.	Live bivalve molluscs may not be placed on the market for retail sale otherwise than via a dispatch centre, where an identification mark must be applied in accordance with Chapter VII.

2.	Food business operators may accept batches of live bivalve molluscs only if the documentary requirements set out in paragraphs 3 to 7 have been complied with.

3.	Whenever a food business operator moves a batch of live bivalve molluscs between establishments, up to and including the arrival of the batch at a dispatch centre or processing establishment, a registration document must accompany the batch.

The registration document must be in at least one official language of the Member State in which the receiving establishment is located and contain at least the information specified below.

(a)

In the case of a batch of live bivalve molluscs sent from a production area, the registration document must contain at least the following information:

(i)	the gatherer's identity and address;

(ii)	the date of harvesting;

(iii)

the location of the production area described in as precise detail as is practicable or by a code number;

(iv)	the health status of the production area;

(v)	the shellfish species and quantity; and

(vi)	the destination of the batch.

(b)

In the case of a batch of live bivalve molluscs sent from a relaying area, the registration document must contain at least the information referred to in (a) and the following information:

(i)	the location of the relaying area; and

(ii)	the duration of relaying.

(c)

In the case of a batch of live bivalve molluscs sent from a purification centre, the registration document must contain at least the information referred to in (a) and the following information:

(i)	the address of the purification centre;

(ii)	the duration of purification; and

(iii)

the dates on which the batch entered and left the purification centre.

Food business operators sending batches of live bivalve molluscs must complete the relevant sections of the registration document so that they are easy to read and cannot be altered. Food business operators receiving batches must date-stamp the document on receipt of the batch or record the date of receipt in another manner.

6.	Food business operators must keep a copy of the registration document relating to each batch sent and received for at least twelve months after its dispatch or receipt (or such longer period as the competent authority may specify).

However, if:

(a)	the staff gathering live bivalve molluscs also operate the dispatch centre, purification centre, relaying area or processing establishment receiving the live bivalve molluscs; and

(b)	a single competent authority supervises all the establishments concerned,

registration documents are not necessary if that competent authority so permits.

CHAPTER II: HYGIENE REQUIREMENTS FOR THE PRODUCTION AND HARVESTING OF LIVE BIVALVE MOLLUSCS

A. REQUIREMENTS FOR PRODUCTION AREAS

1.	Gatherers may only harvest live bivalve molluscs from production areas with fixed locations and boundaries that the competent authority has classified — where appropriate, in cooperation with food business operators — as being of class A, B or C in accordance with Regulation (EC) No .../2004 (8).

2.	Food business operators may place live bivalve molluscs collected from class A production areas on the market for direct human consumption only if they meet the requirements of Chapter V.

3.	Food business operators may place live bivalve molluscs collected from class B production areas on the market for human consumption only after treatment in a purification centre or after relaying.

4.	Food business operators may place live bivalve molluscs collected from class C production areas on the market for human consumption only after relaying over a long period in accordance with Part C of this Chapter.

After purification or relaying, live bivalve molluscs from class B or C production areas must meet all of the requirements of Chapter V. However, live bivalve molluscs from such areas that have not been submitted for purification or relaying may be sent to a processing establishment, where they must undergo treatment to eliminate pathogenic microorganisms (where appropriate, after removal of sand, mud or slime in the same or another establishment). The permitted treatment methods are:

(a)	sterilisation in hermetically sealed containers; and

(b)

heat treatments involving:

(i)	immersion in boiling water for the period required to raise the internal temperature of the mollusc flesh to not less than 90 °C and maintenance of this minimum temperature for a period of not less than 90 seconds;

(ii)	cooking for three to five minutes in an enclosed space where the temperature is between 120 and 160 °C and the pressure is between 2 and 5 kg/cm2, followed by shelling and freezing of the flesh to a core temperature of - 20 °C; and

(iii)

steaming under pressure in an enclosed space satisfying the requirements relating to cooking time and the internal temperature of the mollusc flesh mentioned under (i). A validated methodology must be used. Procedures based on the HACCP principles must be in place to verify the uniform distribution of heat.

Food business operators must not produce live bivalve molluscs in, or harvest them from, areas that the competent authority has not classified, or which are unsuitable for health reasons. Food business operators must take account of any relevant information concerning areas' suitability for production and harvesting, including information obtained from own-checks and the competent authority. They must use this information, particularly information on environmental and weather conditions, to determine the appropriate treatment to apply to harvested batches.

B. REQUIREMENTS FOR HARVESTING AND HANDLING FOLLOWING HARVESTING

Food business operators harvesting live bivalve molluscs, or handling them immediately after harvesting, must ensure compliance with the following requirements.

Harvesting techniques and further handling must not cause additional contamination or excessive damage to the shells or tissues of the live bivalve molluscs or result in changes significantly affecting their suitability for treatment by purification, processing or relaying. Food business operators must in particular:

(a)	adequately protect live bivalve molluscs from crushing, abrasion or vibration;

(b)	not expose live bivalve molluscs to extreme temperatures;

(c)	not re-immerse live bivalve molluscs in water that could cause additional contamination; and

(d)	if carrying out conditioning in natural sites, use only areas that the competent authority has classified as being of class A.

2.	Means of transport must permit adequate drainage, be equipped to ensure the best survival conditions possible and provide efficient protection against contamination.

C. REQUIREMENTS FOR RELAYING LIVE BIVALVE MOLLUSCS

Food business operators relaying live bivalve molluscs must ensure compliance with the following requirements.

Food business operators may use only those areas that the competent authority has approved for relaying live bivalve molluscs. Buoys, poles or other fixed means must clearly identify the boundaries of the sites. There must be a minimum distance between relaying areas, and also between relaying areas and production areas, so as to minimise any risk of the spread of contamination.

Conditions for relaying must ensure optimal conditions for purification. In particular, food business operators must:

(a)	use techniques for handling live bivalve molluscs intended for relaying that permit the resumption of filter-feeding activity after immersion in natural waters;

(b)	not relay live bivalve molluscs at a density that prevents purification;

(c)

immerse live bivalve molluscs in seawater at the relaying area for an appropriate period, fixed depending on the water temperature, which period must be of at least two months' duration unless the competent authority agrees to a shorter period on the basis of the food business operator's risk analysis; and

(d)	ensure sufficient separation of sites within a relaying area to prevent mixing of batches; the ‘all in, all out’ system must be used, so that a new batch cannot be brought in before the whole of the previous batch has been removed.

3.	Food business operators managing relaying areas must keep permanent records of the source of live bivalve molluscs, relaying periods, relaying areas used and the subsequent destination of the batch after relaying, for inspection by the competent authority.

CHAPTER III: STRUCTURAL REQUIREMENTS FOR DISPATCH AND PURIFICATION CENTRES

1.	The location of premises on land must not be subject to flooding by ordinary high tides or run-off from surrounding areas.

Tanks and water storage containers must meet the following requirements:

(a)	Internal surfaces must be smooth, durable, impermeable and easy to clean.

(b)	They must be constructed so as to allow complete draining of water.

(c)	Any water intake must be situated in a position that avoids contamination of the water supply.

3.	In addition, in purification centres, purification tanks must be suitable for the volume and type of products to be purified.

CHAPTER IV: HYGIENE REQUIREMENTS FOR PURIFICATION AND DISPATCH CENTRES

A. REQUIREMENTS FOR PURIFICATION CENTRES

Food business operators purifying live bivalve molluscs must ensure compliance with the following requirements.

1.	Before purification commences, live bivalve molluscs must be washed free of mud and accumulated debris using clean water.

Operation of the purification system must allow live bivalve molluscs rapidly to resume and to maintain filter-feeding activity, to eliminate sewage contamination, not to become re-contaminated and to be able to remain alive in a suitable condition after purification for wrapping, storage and transport before being placed on the market.

The quantity of live bivalve molluscs to be purified must not exceed the capacity of the purification centre. The live bivalve molluscs must be continuously purified for a period sufficient to achieve compliance with allow the health standards of Chapter V and microbiological criteria adopted in accordance with Regulation (EC) No .../2004 (9).

4.	Should a purification tank contain several batches of live bivalve molluscs, they must be of the same species and the length of the treatment must be based on the time required by the batch needing the longest period of purification.

5.	Containers used to hold live bivalve molluscs in purification systems must have a construction that allows clean seawater to flow through. The depth of layers of live bivalve molluscs must not impede the opening of shells during purification.

6.	No crustaceans, fish or other marine species may be kept in a purification tank in which live bivalve molluscs are undergoing purification.

7.	Every package containing purified live bivalve molluscs sent to a dispatch centre must be provided with a label certifying that all molluscs have been purified.

B. REQUIREMENTS FOR DISPATCH CENTRES

Food business operators operating dispatch centres must ensure compliance with the following requirements.

1.	Handling of live bivalve molluscs, particularly conditioning, calibration, wrapping and packing, must not cause contamination of the product or affect the viability of the molluscs.

2.	Before dispatch, the shells of live bivalve molluscs must be washed thoroughly with clean water.

Live bivalve molluscs must come from:

(a)	a class A production area;

(b)	a relaying area;

(c)	a purification centre; or

(d)	another dispatch centre.

4.	The requirements laid down in points 1 and 2 also apply to dispatch centres situated on board vessels. Molluscs handled in such centres must come from a class A production area or a relaying area.

CHAPTER V: HEALTH STANDARDS FOR LIVE BIVALVE MOLLUSCS

In addition to ensuring compliance with microbiological criteria adopted in accordance with Regulation (EC) No .../2004 (10), food business operators must ensure that live bivalve molluscs placed on the market for human consumption meet the standards laid down in this Chapter.

1.	They must have organoleptic characteristics associated with freshness and viability, including shells free of dirt, an adequate response to percussion and normal amounts of intravalvular liquid.

They must not contain marine biotoxins in total quantities (measured in the whole body or any part edible separately) that exceed the following limits:

(a)	for Paralytic Shellfish Poison (PSP), 800 micrograms per kilogram;

(b)	for Amnesic Shellfish Poison (ASP), 20 milligrams of domoic acid per kilogram;

(c)	for okadaic acid, dinophysistoxins and pectenotoxins together, 160 micrograms of okadaic acid equivalents per kilogram;

(d)	for yessotoxins, 1 milligram of yessotoxin equivalent per kilogram; and

(e)	for azaspiracids, 160 micrograms of azaspiracid equivalents per kilogram.

CHAPTER VI: WRAPPING AND PACKAGING OF LIVE BIVALVE MOLLUSCS

1.	Oysters must be wrapped or packaged with the concave shell downwards.

2.	Individual consumer-size packages of live bivalve molluscs must be closed and remain closed after leaving the dispatch centre and until presented for sale to the final consumer.

CHAPTER VII: IDENTIFICATION MARKING AND LABELLING

1.	The label, including the identification mark, must be waterproof.

In addition to the general requirements for identification marks contained in Annex II, Section I, the following information must be present on the label:

(a)	the species of bivalve mollusc (common name and scientific name); and

(b)	the date of packaging, comprising at least the day and the month.

By way of derogation from Directive 2000/13/EC, the date of minimum durability may be replaced by the entry ‘these animals must be alive when sold’.

3.	The retailer must keep the label attached to the packaging of live bivalve molluscs that are not in individual consumer-size packages for at least 60 days after splitting up the contents.

CHAPTER VIII: OTHER REQUIREMENTS

1.	Food business operators storing and transporting live bivalve molluscs must ensure that they are kept at a temperature that does not adversely affect food safety or their viability.

2.	Live bivalve molluscs must not be re-immersed in, or sprayed with, water after they have been packaged for retail sale and left the dispatch centre.

CHAPTER IX: SPECIFIC REQUIREMENTS FOR PECTINIDAE HARVESTED OUTSIDE CLASSIFIED PRODUCTION AREAS

Food business operators harvesting pectinidae outside classified production areas or handling such pectinidae must comply with the following requirements.

1.	Pectinidae may not be placed on the market unless they are harvested and handled in accordance with Chapter II, Part B, and meet the standards laid down in Chapter V, as proved by a system of own-checks.

2.	In addition, where data from official monitoring programmes enable the competent authority to classify fishing grounds — where appropriate, in cooperation with food business operators —the provisions of Chapter II, Part A, apply by analogy to pectinidae.

Pectinidae may not be placed on the market for human consumption otherwise than via a fish auction, a dispatch centre or a processing establishment. When they handle pectinidae, food business operators operating such establishments must inform the competent authority and, as regards dispatch centres, comply with the relevant requirements of Chapters III and IV.

Food business operators handling pectinidae must comply:

(a)	with the documentary requirements of Chapter I, points 3 to 7, where applicable. In this case, the registration document must clearly indicate the location of the area where the pectinidae were harvested; or

(b)	as regards packaged pectinidae, and wrapped pectinidae if the wrapping provides protection equivalent to that of packaging, with the requirements of Chapter VII concerning identification marking and labelling.

SECTION VIII

FISHERY PRODUCTS

This Section does not apply to bivalve molluscs, echinoderms, tunicates and marine gastropods when placed on the market live. With the exception of Chapters I and II, it applies to such animals when not placed on the market live, in which case they must have been obtained in accordance with Section VII.

2.	Chapter III, Parts A, C and D, Chapter IV and Chapter V apply to retail.

The requirements of this Section supplement those laid down in Regulation (EC) No .../2004 (11).

(a)	In the case of establishments, including vessels, engaged in primary production and associated operations they supplement the requirements of Annex I to that Regulation.

(b)	In the case of other establishments, including vessels, they supplement the requirements of Annex II to that Regulation.

In relation to fishery products:

(a)	primary production covers the farming, fishing and collection of live fishery products with a view to their being placed on the market; and

(b)

associated operations cover any of the following operations, if carried out on board fishing vessels: slaughter, bleeding, heading, gutting, removing fins, refrigeration and wrapping; they also include:

(i)	the transport and storage of fishery products the nature of which has not been substantially altered, including live fishery products, within fish farms on land and,

(ii)	the transport of fishery products the nature of which has not been substantially altered, including live fishery products, from the place of production to the first establishment of destination.

CHAPTER I: REQUIREMENTS FOR VESSELS

Food business operators must ensure that:

1.	vessels used to harvest fishery products from their natural environment, or to handle or process them after harvesting, comply with the structural and equipment requirements laid down in Part I; and

2.	operations carried out on board vessels take place in accordance with the rules laid down in Part II.

I. STRUCTURAL AND EQUIPMENT REQUIREMENTS

A. Requirements for all vessels

1.	Vessels must be designed and constructed so as not to cause contamination of the products with bilge-water, sewage, smoke, fuel, oil, grease or other objectionable substances.

2.	Surfaces with which fishery products come into contact must be of suitable corrosion-resistant material that is smooth and easy to clean. Surface coatings must be durable and non-toxic.

3.	Equipment and material used for working on fishery products must be made of corrosion-resistant material that is easy to clean and disinfect.

4.	When vessels have a water intake for water used with fishery products, it must be situated in a position that avoids contamination of the water supply.

B. Requirements for vessels designed and equipped to preserve fresh fishery products for more than twenty-four hours

1.	Vessels designed and equipped to preserve fishery products for more than twenty-four hours must be equipped with holds, tanks or containers for the storage of fishery products at the temperatures laid down in Chapter VII.

Holds must be separated from the engine compartments and from the crew quarters by partitions which are sufficient to prevent any contamination of the stored fishery products. Holds and containers used for the storage of fishery products must ensure their preservation under satisfactory conditions of hygiene and, where necessary, ensure that melt water does not remain in contact with the products.

In vessels equipped for chilling fishery products in cooled clean seawater, tanks must incorporate devices for achieving a uniform temperature throughout the tanks. Such devices must achieve a chilling rate that ensures that the mix of fish and clean seawater reaches not more than 3 °C six hours after loading and not more than 0 °C after 16 hours and allow the monitoring and, where necessary, recording of temperatures.

C. Requirements for freezer vessels

Freezer vessels must:

1.	have freezing equipment with sufficient capacity to lower the temperature rapidly so as to achieve a core temperature of not more than - 18 °C;

have refrigeration equipment with sufficient capacity to maintain fishery products in the storage holds at not more than - 18 °C. Storage holds must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest; and

3.	meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part B, paragraph 2.

D. Requirements for factory vessels

Factory vessels must have at least:

(a)	a receiving area reserved for taking fishery products on board, designed to allow each successive catch to be separated. This area must be easy to clean and designed so as to protect the products from the sun or the elements and from any source of contamination;

(b)	a hygienic system for conveying fishery products from the receiving area to the work area;

(c)	work areas that are large enough for the hygienic preparation and processing of fishery products, easy to clean and disinfect and designed and arranged in such a way as to prevent any contamination of the products;

(d)	storage areas for the finished products that are large enough and designed so that they are easy to clean. If a waste-processing unit operates on board, a separate hold must be designated for the storage of such waste;

(e)	a place for storing packaging materials that is separate from the product preparation and processing areas;

(f)

special equipment for disposing waste or fishery products that are unfit for human consumption directly into the sea or, where circumstances so require, into a watertight tank reserved for that purpose. If waste is stored and processed on board with a view to its sanitation, separate areas must be allocated for that purpose;

(g)	a water intake situated in a position that avoids contamination of the water supply; and

(h)	hand-washing equipment for use by the staff engaged in handling exposed fishery products with taps designed to prevent the spread of contamination.

2.	However, factory vessels on board which crustaceans and molluscs are cooked, chilled and wrapped, need not meet the requirements of paragraph 1 if no other form of handling or processing takes place on board such vessels.

3.	Factory vessels that freeze fishery products must have equipment meeting the requirements for freezer vessels laid down in Part C, points 1 and 2.

II. HYGIENE REQUIREMENTS

1.	When in use, the parts of vessels or containers set aside for the storage of fishery products must be kept clean and maintained in good repair and condition. In particular, they must not be contaminated by fuel or bilge water.

2.	As soon as possible after they are taken on board, fishery products must be protected from contamination and from the effects of the sun or any other source of heat. When they are washed, the water used must be either potable water or, where appropriate, clean water.

3.	Fishery products must be handled and stored so as to prevent bruising. Handlers may use spiked instruments to move large fish or fish which might injure them, provided that the flesh of the products suffers no damage.

4.	Fishery products other than those kept alive must undergo chilling as soon as possible after loading. However, when chilling is not possible, fishery products must be landed as soon as possible.

5.	Ice used to chill fishery products must be made from potable water or clean water.

Where fish are headed and/or gutted on board, such operations must be carried out hygienically as soon as possible after capture, and the products must be washed immediately and thoroughly with potable water or clean water. In that event, the viscera and parts that may constitute a danger to public health must be removed as soon as possible and kept apart from products intended for human consumption. Livers and roes intended for human consumption must be preserved under ice, at a temperature approaching that of melting ice, or be frozen.

7.	Where freezing in brine of whole fish intended for canning is practised, a temperature of not more than - 9 °C must be achieved for the product. The brine must not be a source of contamination for the fish.

CHAPTER II: REQUIREMENTS DURING AND AFTER LANDING

Food business operators responsible for the unloading and landing of fishery products must:

(a)	ensure that unloading and landing equipment that comes into contact with fishery products is constructed of material that is easy to clean and disinfect and maintained in a good state of repair and cleanliness; and

(b)

avoid contamination of fishery products during unloading and landing, in particular by:

(i)	carrying out unloading and landing operations rapidly;

(ii)	placing fishery products without delay in a protected environment at the temperature specified in Chapter VII; and

(iii)

not using equipment and practices that cause unnecessary damage to the edible parts of the fishery products.

Food business operators responsible for auction and wholesale markets or parts thereof where fishery products are displayed for sale must ensure compliance with the following requirements.

(a)

(i)	There must be lockable facilities for the refrigerated storage of detained fishery products and separate lockable facilities for the storage of fishery products declared unfit for human consumption.

(ii)	If the competent authority so requires, there must be an adequately equipped lockable facility or, where needed, room for the exclusive use of the competent authority.

(b)

At the time of display or storage of fishery products:

(i)	the premises must not be used for other purposes;

(ii)	vehicles emitting exhaust fumes likely to impair the quality of fishery products must not have access to the premises;

(iii)

persons having access to the premises must not introduce other animals; and

(iv)	the premises must be well lit to facilitate official controls.

3.	When chilling was not possible on board the vessel, fresh fishery products, other than those kept alive, must undergo chilling as soon as possible after landing and be stored at a temperature approaching that of melting ice.

Food business operators must cooperate with relevant competent authorities so as to permit them to carry out official controls in accordance with Regulation (EC) No .../2004 (12), in particular as regards any notification procedures for the landing of fishery products that the competent authority of the Member State the flag of which the vessel is flying or the competent authority of the Member State where the fishery products are landed might consider necessary.

CHAPTER III: REQUIREMENTS FOR ESTABLISHMENTS, INCLUDING VESSELS, HANDLING FISHERY PRODUCTS

Food business operators must ensure compliance with the following requirements, where relevant, in establishments handling fishery products.

A. REQUIREMENTS FOR FRESH FISHERY PRODUCTS

Where chilled, unpackaged products are not distributed, dispatched, prepared or processed immediately after reaching an establishment on land, they must be stored under ice in appropriate facilities. Re-icing must be carried out as often as necessary. Packaged fresh fishery products must be chilled to a temperature approaching that of melting ice.

Operations such as heading and gutting must be carried out hygienically. Where gutting is possible from a technical and commercial viewpoint, it must be carried out as quickly as possible after the products have been caught or landed. The products must be washed thoroughly with potable water or, on board vessels, clean water immediately after these operations.

Operations such as filleting and cutting must be carried out so as to avoid contamination or spoilage of fillets and slices. Fillets and slices must not remain on the worktables beyond the time necessary for their preparation. Fillets and slices must be wrapped and, where necessary, packaged and must be chilled as quickly as possible after their preparation.

4.	Containers used for the dispatch or storage of unpackaged prepared fresh fishery products stored under ice must ensure that melt water does not remain in contact with the products.

Whole and gutted fresh fishery products may be transported and stored in cooled water on board vessels. They may also continue to be transported in cooled water after landing, and be transported from aquaculture establishments, until they arrive at the first establishment on land carrying out any activity other than transport or sorting.

B. REQUIREMENTS FOR FROZEN PRODUCTS

Establishments on land that freeze fishery products must have equipment that satisfies the requirements laid down for freezer vessels in Chapter I, Part I.C, points 1 and 2.

C. REQUIREMENTS FOR MECHANICALLY SEPARATED FISHERY PRODUCTS

Food business operators manufacturing mechanically separated fishery products must ensure compliance with the following requirements.

The raw materials used must satisfy the following requirements.

(a)	Only whole fish and bones after filleting may be used to produce mechanically separated fishery products;

(b)	All raw materials must be free from guts.

The manufacturing process must satisfy the following requirements:

(a)	Mechanical separation must take place without undue delay after filleting;

(b)	If whole fish are used, they must be gutted and washed beforehand;

(c)	After production, mechanically separated fishery products must be frozen as quickly as possible or incorporated in a product intended for freezing or a stabilising treatment.

D. REQUIREMENTS CONCERNING PARASITES

The following fishery products must be frozen at a temperature of not more than - 20 °C in all parts of the product for not less than 24 hours; this treatment must be applied to the raw product or the finished product:

(a)	fishery products to be consumed raw or almost raw;

(b)

fishery products from the following species, if they are to undergo a cold smoking process in which the internal temperature of the fishery product is not more than 60 °C:

(i)

herring;

(ii)

mackerel;

(iii)

sprat;

(iv)	(wild) Atlantic and Pacific salmon; and

(c)	marinated and/or salted fishery products, if the processing is insufficient to destroy nematode larvae.

Food business operators need not carry out the treatment required under paragraph 1 if:

(a)	epidemiological data are available indicating that the fishing grounds of origin do not present a health hazard with regard to the presence of parasites; and

(b)	the competent authority so authorises.

3.	A document from the manufacturer, stating the type of process they have undergone, must accompany fishery products referred to in paragraph 1 when placed on the market, except when supplied to the final consumer.

CHAPTER IV: REQUIREMENTS FOR PROCESSED FISHERY PRODUCTS

Food business operators cooking crustaceans and molluscs must ensure compliance with the following requirements.

1.	Rapid cooling must follow cooking. Water used for this purpose must be potable water or, on board vessels, clean water. If no other method of preservation is used, cooling must continue until a temperature approaching that of melting ice is reached.

2.	Shelling or shucking must be carried out hygienically, avoiding contamination of the product. Where such operations are done by hand, workers must pay particular attention to washing their hands.

3.	After shelling or shucking, cooked products must be frozen immediately, or be chilled as soon as possible to the temperature laid down in Chapter VII.

CHAPTER V: HEALTH STANDARDS FOR FISHERY PRODUCTS

In addition to ensuring compliance with microbiological criteria adopted in accordance with Regulation (EC) No .../2004 (13), food business operators must ensure, depending on the nature of the product or the species, that fishery products placed on the market for human consumption meet the standards laid down in this Chapter.

A. ORGANOLEPTIC PROPERTIES OF FISHERY PRODUCTS

Food business operators must carry out an organoleptic examination of fishery products. In particular, this examination must ensure that fishery products comply with any freshness criteria.

B. HISTAMINE

Food business operators must ensure that the limits with regard to histamine are not exceeded.

C. TOTAL VOLATILE NITROGEN

Unprocessed fishery products must not be placed on the market if chemical tests reveal that the limits with regard to TVB-N or TMA-N have been exceeded.

D. PARASITES

Food business operators must ensure that fishery products have been subjected to a visual examination for the purpose of detecting visible parasites before being placed on the market. They must not place fishery products that are obviously contaminated with parasites on the market for human consumption.

E. TOXINS HARMFUL TO HUMAN HEALTH

1.	Fishery products derived from poisonous fish of the following families must not be placed on the market: Tetraodontidae, Molidae, Diodontidae and Canthigasteridae.

Fishery products containing biotoxins such as ciguatoxin or muscle-paralysing toxins must not be placed on the market. However, fishery products derived from bivalve molluscs, echinoderms, tunicates and marine gastropods may be placed on the market if they have been produced in accordance with Section VII and comply with the standards laid down in Chapter V, point 2, of that Section.

CHAPTER VI: WRAPPING AND PACKAGING OF FISHERY PRODUCTS

1.	Receptacles in which fresh fishery products are kept under ice must be water-resistant and ensure that melt water does not remain in contact with the products.

2.	Frozen blocks prepared on board vessels must be adequately wrapped before landing.

When fishery products are wrapped on board fishing vessels, food business operators must ensure that wrapping material:

(a)	is not a source of contamination;

(b)	is stored in such a manner that it is not exposed to a risk of contamination;

(c)	intended for re-use is easy to clean and, where necessary, to disinfect.

CHAPTER VII: STORAGE OF FISHERY PRODUCTS

Food business operators storing fishery products must ensure compliance with the following requirements.

1.	Fresh fishery products, thawed unprocessed fishery products, and cooked and chilled products from crustaceans and molluscs, must be maintained at a temperature approaching that of melting ice.

2.	Frozen fishery products must be kept at a temperature of not more than - 18 °C in all parts of the product; however, whole frozen fish in brine intended for the manufacture of canned food may be kept at a temperature of not more than - 9°C.

3.	Fishery products kept alive must be kept at a temperature and in a manner that does not adversely affect food safety or their viability.

CHAPTER VIII: TRANSPORT OF FISHERY PRODUCTS

Food business operators transporting fishery products must ensure compliance with the following requirements.

During transport, fishery products must be maintained at the required temperature. In particular:

(a)	fresh fishery products, thawed unprocessed fishery products, and cooked and chilled products from crustaceans and molluscs, must be maintained at a temperature approaching that of melting ice;

(b)	frozen fishery products, with the exception of frozen fish in brine intended for the manufacture of canned food, must be maintained during transport at an even temperature of not more than - 18 °C in all parts of the product, possibly with short upward fluctuations of not more than 3 °C.

2.	Food business operators need not comply with point 1(b) when frozen fishery products are transported from a cold store to an approved establishment to be thawed on arrival for the purposes of preparation and/or processing, if the journey is short and the competent authority so permits.

3.	If fishery products are kept under ice, melt water must not remain in contact with the products.

4.	Fishery products to be placed on the market live must be transported in such a way as not adversely to affect food safety or their viability.

SECTION IX

RAW MILK AND DAIRY PRODUCTS

CHAPTER I: RAW MILK — PRIMARY PRODUCTION

Food business operators producing or, as appropriate, collecting raw milk must ensure compliance with the requirements laid down in this Chapter.

I. HEALTH REQUIREMENTS FOR RAW MILK PRODUCTION

Raw milk must come from animals:

(a)	that do not show any symptoms of infectious diseases communicable to humans through milk;

(b)	that are in a good general state of health, present no sign of disease that might result in the contamination of milk and, in particular, are not suffering from any infection of the genital tract with discharge, enteritis with diarrhoea and fever, or a recognisable inflammation of the udder;

(c)	that do not have any udder wound likely to affect the milk;

(d)	to which no unauthorised substances or products have been administered and that have not undergone illegal treatment within the meaning of Directive 96/23/EC; and

(e)	in respect of which, where authorised products or substances have been administered, the withdrawal periods prescribed for these products or substances have been observed.

(a)

In particular, as regards brucellosis, raw milk must come from:

(i)	cows or buffaloes belonging to a herd which, within the meaning of Directive 64/432/EEC (14), is free or officially free of brucellosis;

(ii)	sheep or goats belonging to a holding officially free or free of brucellosis within the meaning of Directive 91/68/EEC (15); or

(iii)

females of other species belonging, for species susceptible to brucellosis, to herds regularly checked for that disease under a control plan that the competent authority has approved.

(b)

As regards tuberculosis, raw milk must come from:

(i)	cows or buffaloes belonging to a herd which, within the meaning of Directive 64/432/EEC, is officially free of tuberculosis; or

(ii)	females of other species belonging, for species susceptible to tuberculosis, to herds regularly checked for this disease under a control plan that the competent authority has approved.

(c)	If goats are kept together with cows, such goats must be inspected and tested for tuberculosis.

However, raw milk from animals that do not meet the requirements of point 2 may be used with the authorisation of the competent authority:

(a)	in the case of cows or buffaloes that do not show a positive reaction to tests for tuberculosis or brucellosis, nor any symptoms of these diseases, after having undergone a heat treatment such as to show a negative reaction to the phosphatase test;

(b)

in the case of sheep or goats that do not show a positive reaction to tests for brucellosis, or which have been vaccinated against brucellosis as part of an approved eradication programme, and which do not show any symptom of that disease, either:

(i)	for the manufacture of cheese with a maturation period of at least two months; or

(ii)	after having undergone heat treatment such as to show a negative reaction to the phosphatase test; and

(c)

in the case of females of other species that do not show a positive reaction to tests for tuberculosis or brucellosis, nor any symptoms of these diseases, but belong to a herd where brucellosis or tuberculosis has been detected after the checks referred to in point 2(a)(iii) or 2(b)(ii), if treated to ensure its safety.

Raw milk from any animal not complying with the requirements of points 1 to 3 — in particular, any animal showing individually a positive reaction to the prophylactic tests vis-à-vis tuberculosis or brucellosis as laid down in Directive 64/432/EEC and Directive 91/68/EEC — must not be used for human consumption.

5.	The isolation of animals that are infected, or suspected of being infected, with any of the diseases referred to in point 1 or 2 must be effective to avoid any adverse effect on other animals' milk.

II. HYGIENE ON MILK PRODUCTION HOLDINGS

A. Requirements for premises and equipment

1.	Milking equipment, and premises where milk is stored, handled or cooled must be located and constructed so as to limit the risk of contamination of milk.

2.	Premises for the storage of milk must be protected against vermin, have adequate separation from premises where animals are housed and, where necessary to meet the requirements laid down in Part B, have suitable refrigeration equipment.

Surfaces of equipment that are intended to come into contact with milk (utensils, containers, tanks, etc. intended for milking, collection or transport) must be easy to clean and, where necessary, disinfect and be maintained in a sound condition. This requires the use of smooth, washable and non-toxic materials.

After use, such surfaces must be cleaned and, where necessary, disinfected. After each journey, or after each series of journeys when the period of time between unloading and the following loading is very short, but in all cases at least once a day, containers and tanks used for the transport of raw milk must be cleaned and disinfected in an appropriate manner before re-use.

B. Hygiene during milking, collection and transport

Milking must be carried out hygienically, ensuring in particular:

(a)	that, before milking starts, the teats, udder and adjacent parts are clean;

(b)	that milk from each animal is checked for organoleptic or physico-chemical abnormalities by the milker or a method achieving similar results and that milk presenting such abnormalities is not used for human consumption;

(c)	that milk from animals showing clinical signs of udder disease is not used for human consumption otherwise than in accordance with the instructions of a veterinarian;

(d)	the identification of animals undergoing medical treatment likely to transfer residues to the milk, and that milk obtained from such animals before the end of the prescribed withdrawal period is not used for human consumption; and

(e)	that teat dips or sprays are used only if the competent authority has approved them and in a manner that does not produce unacceptable residue levels in the milk.

2.	Immediately after milking, milk must be held in a clean place designed and equipped to avoid contamination. It must be cooled immediately to not more than 8 °C in the case of daily collection, or not more than 6 °C if collection is not daily.

3.	During transport the cold chain must be maintained and, on arrival at the establishment of destination, the temperature of the milk must not be more than 10 °C.

Food business operators need not comply with the temperature requirements laid down in points 2 and 3 if the milk meets the criteria provided for in Part III and either:

(a)	the milk is processed within 2 hours of milking; or

(b)	a higher temperature is necessary for technological reasons related to the manufacture of certain dairy products and the competent authority so authorises.

C. Staff hygiene

1.	Persons performing milking and/or handling raw milk must wear suitable clean clothes.

2.	Persons performing milking must maintain a high degree of personal cleanliness. Suitable facilities must be available near the place of milking to enable persons performing milking and handling raw milk to wash their hands and arms.

III. CRITERIA FOR RAW MILK

1.	The following criteria for raw milk apply pending the establishment of standards in the context of more specific legislation on the quality of milk and dairy products.

A representative number of samples of raw milk collected from milk production holdings taken by random sampling must be checked for compliance with points 3 and 4. The checks may be carried out by, or on behalf of:

(a)	the food business operator producing the milk;

(b)	the food business operator collecting or processing the milk;

(c)	a group of food business operators; or

(d)	in the context of a national or regional control scheme.

(a)

Food business operators must initiate procedures to ensure that raw milk meets the following criteria:

(i)

for raw cows' milk:

Plate count at 30 °C (per ml)	≤ 100 000 (16)
Somatic cell count (per ml)	≤ 400 000 (17)

(ii)

for raw milk from other species:

Plate count at 30 °C (per ml)

≤ 1 500 000 (16)

(b)

However, if raw milk from species other than cows is intended for the manufacture of products made with raw milk by a process that does not involve any heat treatment, food business operators must take steps to ensure that the raw milk used meets the following criterion.

Plate count at 30 °C (per ml)

≤ 500 000 (16)

Without prejudice to Directive 96/23/EC, food business operators must initiate procedures to ensure that raw milk is not placed on the market if either:

(a)	it contains antibiotic residues in a quantity that, in respect of any one of the substances referred to in Annexes I and III to Regulation (EEC) No 2377/90 (18), exceeds the levels authorised under that Regulation; or

(b)	the combined total of residues of antibiotic substances exceeds any maximum permitted value.

5.	When raw milk fails to comply with point 3 or 4, the food business operator must inform the competent authority and take measures to correct the situation.

CHAPTER II: REQUIREMENTS CONCERNING DAIRY PRODUCTS

I. TEMPERATURE REQUIREMENTS

1.	Food business operators must ensure that, upon acceptance at a processing establishment, milk is quickly cooled to not more than 6 °C and kept at that temperature until processed.

However, food business operators may keep milk at a higher temperature if:

(a)	processing begins immediately after milking, or within 4 hours of acceptance at the processing establishment; or

(b)	the competent authority authorises a higher temperature for technological reasons concerning the manufacture of certain dairy products.

II. REQUIREMENTS FOR HEAT TREATMENT

1.	When raw milk or dairy products undergo heat treatment, food business operators must ensure that this satisfies the requirements of Regulation (EC) No .../2004 (19), Annex II, Chapter XI.

When considering whether to subject raw milk to heat treatment, food business operators must:

(a)	have regard to the procedures developed in accordance with the HACCP principles pursuant to Regulation (EC) No .../2004 (19) and

(b)	comply with any requirements that the competent authority may impose in this regard when approving establishments or carrying out checks in accordance with Regulation (EC) No .../2004 (19).

III. CRITERIA FOR RAW COWS' MILK

Food business operators manufacturing dairy products must initiate procedures to ensure that, immediately before processing:

(a)	raw cows' milk used to prepare dairy products has a plate count at 30 °C of less than 300 000 per ml; and

(b)	processed cows' milk used to prepare dairy products has a plate count at 30 °C of less than 100 000 per ml.

2.	When milk fails to meet the criteria laid down in paragraph 1, the food business operator must inform the competent authority and take measures to correct the situation.

CHAPTER III: WRAPPING AND PACKAGING

Sealing of consumer packages must be carried out immediately after filling in the establishment where the last heat treatment of liquid dairy products takes place, by means of sealing devices that prevent contamination. The sealing system must be designed in such a way that, after opening, the evidence of its opening remains clear and easy to check.

CHAPTER IV: LABELLING

In addition to the requirements of Directive 2000/13/EC, except in the cases envisaged in Article 13(4) and (5) of that Directive, labelling must clearly show:

(a)	in the case of raw milk intended for direct human consumption, the words ‘raw milk’;

(b)	in the case of products made with raw milk, the manufacturing process for which does not include any heat treatment or any physical or chemical treatment, the words ‘made with raw milk’.

2.	The requirements of paragraph 1 apply to products destined for retail trade. The term ‘labelling’ includes any packaging, document, notice, label, ring or collar accompanying or referring to such products.

CHAPTER V: IDENTIFICATION MARKING

By way of derogation from the requirements of Annex II, Section I:

1.	rather than indicating the approval number of the establishment, the identification mark may include a reference to where on the wrapping or packaging the approval number of the establishment is indicated;

2.	in the case of the reusable bottles, the identification mark may indicate only the initials of the consigning country and the approval number of the establishment.

SECTION X

EGGS AND EGG PRODUCTS

CHAPTER I: EGGS

1.	At the producer's premises, and until sale to the consumer, eggs must be kept clean, dry, free of extraneous odour, effectively protected from shocks and out of direct sunshine.

2.	Eggs must be stored and transported at a temperature, preferably constant, that is best suited to assure optimal conservation of their hygiene properties.

3.	Eggs must be delivered to the consumer within a maximum time limit of 21 days of laying.

CHAPTER II: EGG PRODUCTS

I. REQUIREMENTS FOR ESTABLISHMENTS

Food business operators must ensure that establishments for the manufacture of egg products are constructed, laid out and equipped so as to ensure separation of the following operations:

1)	washing, drying and disinfecting dirty eggs, where carried out;

2)	breaking eggs, collecting their contents and removing parts of shells and membranes; and

3)	operations other than those referred to in points 1 and 2.

II. RAW MATERIALS FOR THE MANUFACTURE OF EGG PRODUCTS

Food business operators must ensure that raw materials used to manufacture egg products comply with the following requirements.

The shells of eggs used in the manufacture of egg products must be fully developed and contain no breaks. However, cracked eggs may be used for the manufacture of egg products if the establishment of production or a packing centre delivers them directly to a processing establishment, where they must be broken as soon as possible.

2.	Liquid egg obtained in an establishment approved for that purpose may be used as raw material. Liquid egg must be obtained in accordance with the requirements of points 1, 2, 3, 4 and 7 of Part III.

III. SPECIAL HYGIENE REQUIREMENTS FOR THE MANUFACTURE OF EGG PRODUCTS

Food business operators must ensure that all operations are carried out in such a way as to avoid any contamination during production, handling and storage of egg products, in particular by ensuring compliance with the following requirements.

1.	Eggs must not be broken unless they are clean and dry.

2.	Eggs must be broken in a manner that minimises contamination, in particular by ensuring adequate separation from other operations. Cracked eggs must be processed as soon as possible.

3.	Eggs other than those of hens, turkeys or guinea fowl must be handled and processed separately. All equipment must be cleaned and disinfected before processing of hens', turkeys' and guinea fowls' eggs is resumed.

4.	Egg contents may not be obtained by the centrifuging or crushing of eggs, nor may centrifuging be used to obtain the remains of egg whites from empty shells for human consumption.

After breaking, each particle of the egg product must undergo processing as quickly as possible to eliminate microbiological hazards or to reduce them to an acceptable level. A batch that has been insufficiently processed may immediately undergo processing again in the same establishment, if this processing renders it fit for human consumption. When a batch is found to be unfit for human consumption, it must be denatured so as to ensure that it is not used for human consumption.

6.	Processing is not required for egg white intended for the manufacture of dried or crystallised albumin destined subsequently to undergo heat treatment.

If processing is not carried out immediately after breaking, liquid egg must be stored either frozen or at a temperature of not more than 4 °C. The storage period before processing at 4 °C must not exceed 48 hours. However, these requirements do not apply to products to be de-sugared, if de-sugaring process is performed as soon as possible.

8.	Products that have not been stabilised so as to be kept at room temperature must be cooled to not more than 4 °C. Products for freezing must be frozen immediately after processing.

IV. ANALYTICAL SPECIFICATIONS

1.	The concentration of 3-OH-butyric acid must not exceed 10 mg/kg in the dry matter of the unmodified egg product.

2.	The lactic acid content of raw material used to manufacture egg products must not exceed 1 g/kg of dry matter. However, for fermented products, this value must be the one recorded before the fermentation process.

3.	The quantity of eggshell remains, egg membranes and any other particles in the processed egg product must not exceed 100 mg/kg of egg product.

V. LABELLING AND IDENTIFICATION MARKING

In addition to the general requirements for identification marking laid down in Annex II, Section I, consignments of egg products, destined not for retail but for use as an ingredient in the manufacture of another product, must have a label giving the temperature at which the egg products must be maintained and the period during which conservation may thus be assured.

2.	In the case of liquid eggs, the label referred to in paragraph 1 must also bear the words: ‘non-pasteurised egg products — to be treated at place of destination’ and indicate the date and hour of breaking.

SECTION XI

FROGS' LEGS AND SNAILS

Food business operators preparing frogs' legs or snails for human consumption must ensure compliance with the following requirements.

1.	Frogs and snails must be killed in an establishment constructed, laid out and equipped for that purpose.

2.	Establishment in which frogs' legs are prepared must have a room reserved for the storage and washing of live frogs, and for their slaughter and bleeding. This room must be physically separate from the preparation room.

3.	Frogs and snails that die otherwise than by being killed in the establishment must not be prepared for human consumption.

4.	Frogs and snails must be subjected to an organoleptic examination carried out by sampling. If that examination indicates that they might present a hazard, they must not be used for human consumption.

5.	Immediately following preparation, frogs' legs must be washed fully with running potable water and immediately chilled to a temperature approaching that of melting ice, frozen or processed.

6.	After killing, snails' hepato-pancreas must, if it might present a hazard, be removed and not be used for human consumption.

SECTION XII

RENDERED ANIMAL FATS AND GREAVES

CHAPTER I: REQUIREMENTS APPLICABLE TO ESTABLISHMENTS COLLECTING OR PROCESSING RAW MATERIALS

Food business operators must ensure that establishments collecting or processing raw materials for the production of rendered animal fats and greaves comply with the following requirements.

1.	Centres for the collection of raw materials and further transport to processing establishments must be equipped with facilities for the storage of raw materials at a temperature of not more than 7°C.

Each processing establishment must have:

(a)	refrigeration facilities;

(b)	a dispatch room, unless the establishment dispatches rendered animal fat only in tankers; and

(c)	if appropriate, suitable equipment for the preparation of products consisting of rendered animal fats mixed with other foodstuffs and/or seasonings.

3.	However, the refrigeration facilities required under points 1 and 2(a) are not necessary if the arrangements for the supply of raw materials ensure that they are never stored or transported without active refrigeration otherwise than as provided for in Chapter II, point 1(d).

CHAPTER II: HYGIENE REQUIREMENTS FOR THE PREPARATION OF RENDERED ANIMAL FAT AND GREAVES

Food business operators preparing rendered animal fats and greaves must ensure compliance with the following requirements.

Raw materials must:

(a)	derive from animals which have been slaughtered in a slaughterhouse, and which have been found fit for human consumption following ante-mortem and post-mortem inspection;

(b)	consist of adipose tissues or bones, which are reasonably free from blood and impurities;

(c)	come from establishments registered or approved under Regulation (EC) No .../2003 (20) or under this Regulation; and

(d)	be transported, and stored until rendering, in hygienic conditions and at an internal temperature of not more than 7 °C. However, raw materials may be stored and transported without active refrigeration if rendered within 12 hours after the day on which they were obtained.

2.	During rendering the use of solvents is prohibited.

3.	When the fat for refining meets the standards laid down in point 4, rendered animal fat prepared in accordance with points 1 and 2 may be refined in the same establishment or in another establishment with a view to improving its physico-chemical quality.

Rendered animal fat, depending on type, must meet the following standards:

	Ruminants			Porcine animals			Other animal fat
	Edible tallow		Tallow for refining	Edible fat		Lard and other fat for refining	Edible	For refining
	Premier jus (21)	Other		Lard (22)	Other
FFA (m/m% oleic acid) maximum	0,75	1,25	3,0	0,75	1,25	2,0	1,25	3,0
Peroxide maximum	4 meq/kg	4 meq/kg	6 meq/kg	4 meq/kg	4 meq/kg	6 meq/kg	4 meq/kg	10 meq/kg
Total insoluble impurities	Maximum 0,15%			Maximum 0,5%
Odour, taste, colour	Normal

Greaves intended for human consumption must be stored in accordance with the following temperature requirements.

(a)

When greaves are rendered at a temperature of not more than 70 °C, they must be stored:

(i)	at a temperature of not more than 7 °C for a period not exceeding 24 hours; or

(ii)	at a temperature of not more than - 18°C.

(b)

When greaves are rendered at a temperature of more than 70 °C and have a moisture content of 10% (m/m) or more, they must be stored:

(i)	at a temperature of not more than 7 °C for a period not exceeding 48 hours or a time/temperature ratio giving an equivalent guarantee; or

(ii)	at a temperature of not more than - 18 °C.

(c)	When greaves are rendered at a temperature of more than 70 °C and have a moisture content of less than 10% (m/m), there are no specific requirements.

SECTION XIII

TREATED STOMACHS, BLADDERS AND INTESTINES

Food business operators treating stomachs, bladders and intestines must ensure compliance with the following requirements.

Animal intestines, bladders and stomachs may be placed on the market only if:

(a)	they derive from animals which have been slaughtered in a slaughterhouse, and which have been found fit for human consumption following ante-mortem and post-mortem inspection;

(b)	they are salted, heated or dried; and

(c)	after the treatment referred to in (b), effective measures are taken to prevent re-contamination.

2.	Treated stomachs, bladders and intestines that cannot be kept at ambient temperature must be stored chilled using facilities intended for that purpose until their dispatch. In particular, products that are not salted or dried must be kept at a temperature of not more than 3 °C.

SECTION XIV

GELATINE

1.	Food business operators manufacturing gelatine must ensure compliance with the requirements of this Section.

2.	For the purpose of this Section, ‘tanning’ means the hardening of hides, using vegetable tanning agents, chromium salts or other substances such as aluminium salts, ferric salts, silicic salts, aldehydes and quinones, or other synthetic hardening agents.

CHAPTER I: REQUIREMENTS FOR RAW MATERIALS

For the production of gelatine intended for use in food, the following raw materials may be used:

(a)

bones;

(b)	hides and skins of farmed ruminant animals;

(c)	pig skins;

(d)	poultry skin;

(e)	tendons and sinews;

(f)	wild game hides and skins; and

(g)	fish skin and bones.

2.	The use of hides and skins is prohibited if they have undergone any tanning process, regardless of whether this process was completed.

Raw materials listed in point 1(a) to (e) must derive from animals which have been slaughtered in a slaughterhouse and whose carcases have been found fit for human consumption following ante-mortem and post-mortem inspection or, in the case of hides and skins from wild game, found fit for human consumption.

4.	Raw materials must come from establishments registered or approved under Regulation (EC) No .../2004 (23) or under this Regulation.

Collection centres and tanneries may also supply raw material for the production of gelatine intended for human consumption if the competent authority specifically authorises them for this purpose and they fulfil the following requirements.

(a)	They must have storage rooms with hard floors and smooth walls that are easy to clean and disinfect and, where appropriate, provided with refrigeration facilities.

(b)	The storage rooms must be kept in a satisfactory state of cleanliness and repair, so that they do not constitute a source of contamination for the raw materials.

(c)	If raw material not in conformity with this Chapter is stored and/or processed in these premises, it must be segregated from raw material in conformity with this Chapter throughout the period of receipt, storage, processing and dispatch.

CHAPTER II: TRANSPORT AND STORAGE OF RAW MATERIALS

In place of the identification mark provided for in Annex II, Section I, a document indicating the establishment of origin and containing the information set out in the Appendix to this Annex must accompany raw materials during transport, when delivered to a collection centre or tannery and when delivered to the gelatine-processing establishment.

Raw materials must be transported and stored chilled or frozen unless they are processed within 24 hours after their departure. However, degreased and dried bones or ossein, salted, dried and limed hides, and hides and skins treated with alkali or acid may be transported and stored at ambient temperature.

CHAPTER III: REQUIREMENTS FOR THE MANUFACTURE OF GELATINE

The production process for gelatine must ensure that:

(a)

all ruminant bone material derived from animals born, reared or slaughtered in countries or regions classified as having a low incidence of BSE in accordance with Community legislation is subjected to a process which ensures that all bone material is finely crushed and degreased with hot water and treated with dilute hydrochloric acid (at minimum concentration of 4% and pH < 1,5) over a period of at least two days, followed by an alkaline treatment of saturated lime solution (pH > 12,5) for a period of at least 20 days with a sterilisation step of 138-140 °C during four seconds or by any approved equivalent process; and

(b)	other raw material is subjected to a treatment with acid or alkali, followed by one or more rinses. The pH must be adjusted subsequently. Gelatine must be extracted by heating one or several times in succession, followed by purification by means of filtration and sterilisation.

2.	If a food business operator manufacturing gelatine complies with the requirements applying to gelatine intended for human consumption in respect of all the gelatine that it produces, it may produce and store gelatine not intended for human consumption in the same establishment.

CHAPTER IV: REQUIREMENTS FOR FINISHED PRODUCTS

Food business operators must ensure that gelatine complies with the residue limits set out in the following table.

Residue	Limit
As	1,00 ppm
Pb	5,00 ppm
Cd	0,50 ppm
Hg	0,15 ppm
Cr	10,00 ppm
Cu	30,00 ppm
Zn	50,00 ppm
SO2 (Reith Williams)	50,00 ppm
H2O2 (European Pharmacopoeia 1986 (V2O2))	10 ppm

SECTION XV

COLLAGEN

1.	Food business operators manufacturing collagen must ensure compliance with the requirements of this Section.

2.	For the purpose of this Section, ‘tanning’ means the hardening of hides, using vegetable tanning agents, chromium salts or other substances such as aluminium salts, ferric salts, silicic salts, aldehydes and quinones, or other synthetic hardening agents.

CHAPTER I: REQUIREMENTS FOR RAW MATERIALS

For the production of collagen intended for use in food, the following raw materials may be used:

(a)	hides and skins of farmed ruminant animals;

(b)	pig skins and bones;

(c)	poultry skin and bones;

(d)

tendons;

(e)	wild game hides and skins; and

(f)	fish skin and bones.

2.	The use of hides and skins is prohibited if they have undergone any tanning process, regardless of whether this process was completed.

Raw materials listed in point 1(a) to (d) must derive from animals which have been slaughtered in a slaughterhouse and whose carcases have been found fit for human consumption following ante-and post-mortem inspection or, in the case of hides and skins from wild game, found fit for human consumption.

4.	Raw materials must come from establishments registered or approved under Regulation (EC) No .../2004 (24) or under this Regulation.

Collection centres and tanneries may also supply raw material for the production of collagen intended for human consumption if the competent authority specifically authorises them for this purpose and they fulfil the following requirements.

(a)	They must have storage rooms with hard floors and smooth walls that are easy to clean and disinfect and, where appropriate, provided with refrigeration facilities.

(b)	The storage rooms must be kept in a satisfactory state of cleanliness and repair, so that they do not constitute a source of contamination for the raw materials.

(c)	If raw material not in conformity with this Chapter is stored and/or processed in these premises, it must be segregated from raw material in conformity with this Chapter throughout the period of receipt, storage, processing and dispatch.

CHAPTER II: TRANSPORT AND STORAGE OF RAW MATERIALS

CHAPTER III: REQUIREMENTS FOR THE MANUFACTURE OF COLLAGEN

1.	Collagen must be produced by a process that ensures that the raw material is subjected to a treatment involving washing, pH adjustment using acid or alkali followed by one or more rinses, filtration and extrusion or by an approved equivalent process.

2.	After having been subjected to the process referred to in paragraph 1 above, collagen may undergo a drying process.

3.	If a food business operator manufacturing collagen complies with the requirements applying to collagen intended for human consumption in respect of all the collagen that it produces, it may produce and store collagen not intended for human consumption in the same establishment.

CHAPTER IV: REQUIREMENTS FOR FINISHED PRODUCTS

Food business operators must ensure that collagen complies with the residue limits set out in the following table.

Residue	Limit
As	1,00 ppm
Pb	5,00 ppm
Cd	0,50 ppm
Hg	0,15 ppm
Cr	10,00 ppm
Cu	30,00 ppm
Zn	50,00 ppm
SO2 (Reith Williams)	50,00 ppm
H2O2 (European Pharmacopoeia 1986 (V2O2))	10,00 ppm

CHAPTER V: LABELLING

Wrapping and packaging containing collagen must bear the words ‘collagen fit for human consumption’ and indicate the date of preparation.

(1) Not yet published in the OJ.

(2) Not yet published in the OJ.

(3) Not yet published in the OJ.

(4) Not yet published in the OJ.

(5) Not yet published in the OJ.

(6) Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (OJ L 109, 6.5.2000, p. 29). Directive as last amended by Directive 2003/89/EC (OJ L 308, 25.11.2001, p. 15).

(7) Not yet published in the OJ.

(8) Not yet published in the OJ.

(9) Not yet published in the OJ.

(10) Not yet published in the OJ.

(11) Not yet published in the OJ.

(12) Not yet published in the OJ.

(13) Not yet published in the OJ.

(14) Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (OJ 121, 29.7.1964, p. 1977/64). Directive as last amended by the 2003 Act of Accession.

(15) Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals (OJ L 46, 19.2.1991, p. 19). Directive as last amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

(16) Rolling geometric average over a two-month period, with at least two samples per month.

(17) Rolling geometric average over a three-month period, with at least one sample per month, unless the competent authority specifies another methodology to take account of seasonal variations in production levels.

(18) Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (OJ L 224, 18.8.1990, p. 1). Regulation as last amended by Commission Regulation (EC) No 324/2004 (OJ L 58, 26.2.2004, p. 16).

(19) Not yet published in the OJ.

(20) Not yet published in the OJ.

(21) Rendered animal fat obtained by low-temperature rendering of fresh fat from the heart, caul, kidneys and mesentery of bovine animals, and fat from cutting rooms.

(22) Rendered animal fat obtained from the adipose tissues of porcine animals.

(23) Not yet published in the OJ.

(24) Not yet published in the OJ.

Appendix to ANNEX III

MODEL DOCUMENT TO ACCOMPANY RAW MATERIAL DESTINED FOR THE PRODUCTION OF GELATINE OR COLLAGEN

I. Identification of raw material: ...

Type of products: ...

Date of manufacture: ...

Type of packaging: ...

Number of packages: ...

Guaranteed storage period: ...

Net weight (kg): ...

II. Origin of raw material

Address(es) and registration number(s) of the approved production establishment(s): ...

III. Destination of raw material

The raw material will be sent: ...

from: ...

(place of loading)

to: ...

(country and place of destination)

by the following means of transport: ...

Name and address of consignor: ...

Name and address of consignee: ...

P5_TA(2004)0218

Production and marketing of food of animal origin ***II

European Parliament legislative resolution on the Council common position for adopting a European Parliament and Council directive repealing certain directives on the hygiene of foodstuffs and the health conditions for the production and placing on the market of certain products of animal origin intended for human consumption, and amending Council Directives 89/662/EEC and 92/118/EEC and Council Decision 95/408/EC (11584/1/2003 — C5-0010/2004 — 2000/0182(COD))

(Codecision procedure: second reading)

The European Parliament,

—	having regard to the Council common position (11584/1/2003 — C5-0010/2004) (1),

—	having regard to its position at first reading (2) on the Commission proposal to the European Parliament and the Council (COM(2000) 438) (3),

—	having regard to the amended Commission proposal (COM(2003) 455) (4),

—	having regard to Article 251(2) of the EC Treaty,

—	having regard to Rule 78 of its Rules of Procedure,

—	having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Consumer Policy (A5-0130/2004),

1.	Approves the common position;

2.	Notes that the act is adopted in accordance with the common position;

3.	Instructs its President to sign the act with the President of the Council pursuant to Article 254(1) of the EC Treaty;

4.	Instructs its Secretary-General duly to sign the act and, in agreement with the Secretary-General of the Council, to have it published in the Official Journal of the European Union;

5.	Instructs its President to forward its position to the Council and Commission.

(1) OJ C 48 E, 24.2.2004, p. 131.

(2) Texts adopted, 3.6.2003, P5_TA(2003)0228.

(3) OJ C 365 E, 19.12.2000, p. 132.

(4) Not yet published in OJ.

P5_TA(2004)0219

Official controls on food of animal origin ***II

European Parliament legislative resolution on the Council common position for adopting a European Parliament and Council regulation laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (11583/1/2003 — C5-0011/2004 — 2002/0141(COD))

(Codecision procedure: second reading)

The European Parliament,

—	having regard to the Council common position (11583/1/2003 — C5-0011/2004) (1),

—	having regard to its position at first reading (2) on the Commission proposal to Parliament and the Council (COM(2002) 377) (3),

—	having regard to the amended proposal (COM(2003) 577 (4),

—	having regard to Article 251(2) of the EC Treaty,

—	having regard to Rule 80 of its Rules of Procedure,

—	having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Consumer Policy (A5-0138/2004),

1.	Amends the common position as follows;

2.	Instructs its President to forward its position to the Council and Commission.

(1) OJ C 48 E, 24.2.2004, p. 82.

(2) Texts Adopted, 5.6.2003, P5_TA(2003)0254.

(3) OJ C 262, 29.10.2002, p. 449.

(4) Not yet published in the OJ.

P5_TC2-COD(2002)0141

Position of the European Parliament adopted at second reading on 30 March 2004 with a view to the adoption of European Parliament and Council Regulation (EC) No .../2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b) thereof,

Having regard to the proposal from the Commission (1) ,

Having regard to the Opinion of the European Economic and Social Committee (2),

Having consulted the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),

Whereas:

(1)	Regulation (EC) No .../2004 of the European Parliament and of the Council (4) lays down general hygiene rules applying to all foodstuffs and Regulation (EC) No .../2004 of the European Parliament and of the Council (4) lays down specific hygiene rules for products of animal origin.

(2)	Specific rules for official controls on products of animal origin are necessary to take account of specific aspects associated with such products.

(3)

The scope of the specific control rules should mirror the scope of the specific hygiene rules for food business operators laid down in Regulation (EC) No .../2004 (4). However, Member States should also carry out appropriate official controls to enforce national rules established in accordance with Article 1(4) of that Regulation. They may do so by extending the principles of this Regulation to such national rules.

(4)

Official controls on products of animal origin should cover all aspects that are important for protecting public health and, where appropriate, animal health and animal welfare. They should be based on the most recent relevant information available and it should therefore be possible to adapt them as relevant new information becomes available.

(5)	Community legislation on food safety should have a sound scientific basis. To that end, the European Food Safety Authority should be consulted whenever necessary.

(6)	The nature and intensity of the official controls should be based on an assessment of public health risks, animal health and welfare, where appropriate, the type and throughput of the processes carried out and the food business operator concerned.

(7)

It is appropriate to provide for the adaptation of certain specific control rules, through the transparent procedure provided for in Regulation (EC) No .../2004 (4) and Regulation (EC) No .../2004 (4), to provide flexibility in order to accommodate the specific needs of establishments which use traditional methods, have a low throughput or are located in regions that are subject to special geographical constraints. The procedure should also allow pilot projects to take place in order to try out new approaches to hygiene controls on meat. However, such flexibility should not compromise food hygiene objectives.

(8)

Official controls on the production of meat are necessary to verify that food business operators comply with hygiene rules and respect criteria and targets laid down in Community legislation. These official controls should comprise audits of food business operators' activities and inspections, including checks on food business operators' own controls.

(9)

In view of their specific expertise, it is appropriate for official veterinarians to carry out audits and inspections of slaughterhouses, game handling establishments and certain cutting plants. Member States should have discretion to decide which are the most appropriate staff for audits and inspections of other types of establishments.

(10)

Official controls on the production of live bivalve molluscs and on fishery products are necessary to check for compliance with the criteria and targets laid down in Community legislation. Official controls on the production of live bivalve molluscs should in particular target relaying and production areas for bivalve molluscs and the end product.

(11)	Official controls on the production of raw milk are necessary to check for compliance with criteria and targets laid down in Community legislation. Such official controls should in particular target milk production holdings and raw milk upon collection.

(12)

(13)	The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (5),

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

1. This Regulation lays down specific rules for the organisation of official controls on products of animal origin.

2. It shall apply only in respect of activities and persons to which Regulation (EC) No .../2004 (6) applies.

3. The performance of official controls pursuant to this Regulation shall be without prejudice to food business operators' primary legal responsibility for ensuring food safety, as laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council, of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety (7), and any civil or criminal liability arising from the breach of their obligations.

Article 2

Definitions

1. For the purposes of this Regulation, the following definitions shall apply:

(a)	‘official control’means any form of control that the competent authority performs for the verification of compliance with food law, including animal health and animal welfare rules;

(b)	‘verification’means checking, by examination and the provision of objective evidence, whether specified requirements have been fulfilled;

(c)	‘competent authority’means the central authority of a Member State competent to carry out veterinary checks or any authority to which it has delegated that competence;

(d)	‘audit’means a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives;

(e)

‘inspection’means the examination of establishments, of animals and food, and the processing thereof, of food businesses, and their management and production systems, including documents, finished product testing and feeding practices, and of the origin and destination of production inputs and outputs, in order to verify compliance with the legal requirements in all cases;

(f)	‘official veterinarian’means a veterinarian qualified, in accordance with this Regulation, to act in such a capacity and appointed by the competent authority;

(g)	‘approved veterinarian’means a veterinarian designated by the competent authority to carry out specific official controls on holdings on its behalf;

(h)	‘official auxiliary’means a person qualified, in accordance with this Regulation, to act in such a capacity, appointed by the competent authority and working under the authority and responsibility of an official veterinarian; and

(i)	‘health mark’means a mark indicating that, when it was applied, official controls had been carried out in accordance with this Regulation.

2. The definitions laid down in the following Regulations shall also apply as appropriate:

(a)	Regulation (EC) No 178/2002;

(b)

the definitions of ‘animal by-products’, ‘TSEs’ (transmissible spongiform encephalopathies) and ‘specified risk material’ laid down in Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption (8);

(c)	Regulation (EC) No .../2004 (9), except for the definition of ‘competent authority’; and

(d)	Regulation (EC) No .../2004 (9).

CHAPTER II

OFFICIAL CONTROLS IN RELATION TO COMMUNITY ESTABLISHMENTS

Article 3

Approval of establishments

(a)

When Community legislation requires the approval of establishments, the competent authority shall make an on-site visit. It shall approve an establishment for the activities concerned only if the food business operator has demonstrated that it meets the relevant requirements of Regulations (EC) No .../2004 (9) and No .../2004 (9) and other relevant requirements of food law.

(b)

The competent authority may grant conditional approval if it appears from the on-site visit that the establishment meets all the infrastructure and equipment requirements. It shall grant full approval only if it appears from a new on-site visit carried out within three months of the granting of conditional approval that the establishment meets the other requirements referred to in (a). If clear progress has been made but the establishment still does not meet all of these requirements, the competent authority may prolong conditional approval. However, conditional approval shall not exceed a total of six months.

2. In the case of factory and freezer vessels flying the flag of Member States, the maximum periods of three and six months applying to the conditional approval of other establishments may be extended, if necessary. However, conditional approval shall not exceed a total of 12 months. Inspections of such vessels shall take place as specified in Annex III.

3. The competent authority shall give each approved establishment, including those with conditional approval, an approval number, to which codes may be added to indicate the types of products of animal origin manufactured. For wholesale markets, secondary numbers indicating units or groups of units selling or manufacturing products of animal origin may be added to the approval number.

(a)	The competent authority shall keep the approval of establishments under review when carrying out official controls in accordance with Articles 4 to 8.
(b)	If the competent authority identifies serious deficiencies or has to stop production at an establishment repeatedly and the food business operator is not able to provide adequate guarantees regarding future production, the competent authority shall initiate procedures to withdraw the establishment's approval. However, the competent authority may suspend an establishment's approval if the food business operator can guarantee that it will resolve deficiencies within a reasonable time.
(c)	In the case of wholesale markets, the competent authority may withdraw or suspend approval in respect of certain units or groups of units.

5. Paragraphs 1, 2 and 3 shall apply both:

(a)	to establishments that begin placing products of animal origin on the market on or after the date of application of this Regulation; and

(b)	to establishments already placing products of animal origin on the market but in respect of which there was previously no requirement for approval. In the latter case, the competent authority's on-site visit required under paragraph 1 shall take place as soon as possible.

Paragraph 4 shall also apply to approved establishments that placed products of animal origin on the market in accordance with Community legislation immediately prior to the application of this Regulation.

6. Member States shall maintain up-to-date lists of approved establishments, with their respective approval numbers and other relevant information, and make them available to other Member States and to the public in a manner that may be specified in accordance with the procedure referred to in Article 19(2).

Article 4

General principles for official controls in respect of all products of animal origin falling within the scope of this Regulation

1. Member States shall ensure that food business operators offer all assistance needed to ensure that official controls carried out by the competent authority can be performed effectively

They shall in particular:

—	give access to all buildings, premises, installations or other infrastructures;

—	make available any documentation and record required under the present regulation or considered necessary by the competent authority for judging the situation.

2. The competent authority shall carry out official controls to verify food business operators' compliance with the requirements of:

(a)	Regulation (EC) No .../2004 (10);

(b)	Regulation (EC) No .../2004 (10); and

(c)	Regulation (EC) No 1774/2002.

3. The official controls referred to in paragraph 1 shall include:

(a)	audits of good hygiene practices and hazard analysis and critical control point (HACCP)-based procedures;

(b)	the official controls specified in Articles 5 to 8; and

(c)	any particular auditing tasks specified in the Annexes.

4. Audits of good hygiene practices shall verify that food business operators apply procedures continuously and properly concerning at least:

(a)	checks on food-chain information;

(b)	the design and maintenance of premises and equipment;

(c)	pre-operational, operational and post-operational hygiene;

(d)	personal hygiene;

(e)	training in hygiene and in work procedures;

(f)	pest control;

(g)	water quality;

(h)	temperature control; and

(i)	controls on food entering and leaving the establishment and any accompanying documentation.

5. Audits of HACCP-based procedures shall verify that food business operators apply such procedures continuously and properly, having particular regard to ensuring that the procedures provide the guarantees specified in Section II of Annex II to Regulation (EC) No .../2004 (10). They shall, in particular, determine whether the procedures guarantee, to the extent possible, that products of animal origin:

(a)	comply with microbiological criteria laid down under Community legislation;

(b)	comply with Community legislation on residues, contaminants and prohibited substances; and

(c)	do not contain physical hazards, such as foreign bodies.

When, in accordance with Article 5 of Regulation (EC) No .../2004 (10), a food business operator uses procedures set out in guides to the application of HACCP principles rather than establishing its own specific procedures, the audit shall cover the correct use of these guides.

6. Verification of compliance with the requirements of Regulation (EC) No .../2004 (11) concerning the application of identification marks shall take place in all establishments approved in accordance with that Regulation, in addition to verification of compliance with other traceability requirements.

7. In the case of slaughterhouses, game handling establishments and cutting plants placing fresh meat on the market, an official veterinarian shall carry out the auditing tasks referred to in paragraphs 3 and 4.

8. When carrying out auditing tasks, the competent authority shall take special care:

(a)

to determine whether staff and staff activities in the establishment at all stages of the production process comply with the relevant requirements of the Regulations referred to in paragraph 1(a) and (b). To support the audit, the competent authority may carry out performance tests, in order to ascertain that staff performance meets specified parameters;

(b)	to verify the food business operator's relevant records;

(c)	to take samples for laboratory analysis whenever necessary; and

(d)	to document elements taken into account and the findings of the audit.

9. The nature and intensity of auditing tasks in respect of individual establishments shall depend upon the assessed risk. To this end, the competent authority shall regularly assess:

(a)	public and, where appropriate, animal health risks;

(b)	in the case of slaughterhouses, animal welfare aspects;

(c)	the type and throughput of the processes carried out; and

(d)	the food business operator's past record as regards compliance with food law.

Article 5

Fresh meat

Member States shall ensure that official controls with respect to fresh meat take place in accordance with Annex I.

(1)

The official veterinarian shall carry out inspection tasks in slaughterhouses, game handling establishments and cutting plants placing fresh meat on the market in accordance with the general requirements of Section I, Chapter II, of Annex I, and with the specific requirements of Section IV, in particular as regards:

(a)	food chain information;

(b)	ante-mortem inspection;

(c)	animal welfare;

(d)	post-mortem inspection;

(e)	specified risk material and other animal by-products; and

(f)	laboratory testing.

(2)

The health marking of carcasses of domestic ungulates, farmed game mammals other than lagomorphs, and large wild game, as well as half-carcasses, quarters and cuts produced by cutting half-carcasses into three wholesale cuts, shall be carried out in slaughterhouses and game-handling establishments in accordance with Section I, Chapter III, of Annex I. Health marks shall be applied by, or under the responsibility of, the official veterinarian when official controls have not identified any deficiencies that would make the meat unfit for human consumption.

(3)

After carrying out the controls mentioned in points 1 and 2, the official veterinarian shall take appropriate measures as set out in Annex I, Section II, in particular as regards:

(a)	the communication of inspection results;

(b)	decisions concerning food chain information;

(c)	decisions concerning live animals;

(d)	decisions concerning animal welfare; and

(e)	decisions concerning meat.

(4)	Official auxiliaries may assist the official veterinarian with official controls carried out in accordance with Sections I and II of Annex I as specified in Section III, Chapter I. In that case, they shall work as part of an independent team.

(5)

(a)	Member States shall ensure that they have sufficient official staff to carry out the official controls required under Annex I with the frequency specified in Section III, Chapter II.

(b)

A risk-based approach shall be followed to assess the number of official staff that need to be present on the slaughter line in any given slaughterhouse. The number of official staff involved shall be decided by the competent authority and shall be such that all the requirements of this Regulation can be met.

(6)

(a)

Member States may allow slaughterhouse staff to assist with official controls by carrying out certain specific tasks, under the supervision of the official veterinarian, in relation to the production of meat from poultry and lagomorphs in accordance with Annex I, Section III, Chapter III, Part A. If they do so, they shall ensure that staff carrying out such tasks:

(i)	are qualified and undergo training in accordance with those provisions;

(ii)	act independently from production staff; and

(iii)

report any deficiency to the official veterinarian.

(b)	Member States may also allow slaughterhouse staff to carry out specific sampling and testing tasks in accordance with Annex I, Section III, Chapter III, Part B.

(7)	Member States shall ensure that official veterinarians and official auxiliaries are qualified and undergo training in accordance with Annex I, Section III, Chapter IV.

Article 6

Live bivalve molluscs

Member States shall ensure that the production and placing on the market of live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods undergo official controls as described in Annex II.

Article 7

Fishery products

Member States shall ensure that official controls with respect to fishery products take place in accordance with Annex III.

Article 8

Raw milk and dairy products

Member States shall ensure that official controls with respect to raw milk and dairy products take place in accordance with Annex IV.

Article 9

Action in the case of non-compliance

1. When the competent authority identifies non-compliance with the Regulations referred to in Article 4(2)(a) and (b), it shall take action to ensure that the food business operator remedies the situation. When deciding which action to take, the competent authority shall take account of the nature of the noncompliance and the food business operator's past record with regard to non-compliance.

2. Such action shall include, where appropriate, the following measures:

(a)	the imposition of sanitation procedures or any other corrective action deemed necessary to ensure the safety of products of animal origin or compliance with the relevant legal requirements;

(b)	the restriction or prohibition of the placing on the market, import or export of products of animal origin;

(c)	monitoring or, if necessary, ordering the recall, withdrawal and/or destruction of products of animal origin;

(d)	authorisation to use products of animal origin for purposes other than those for which they were originally intended;

(e)	the suspension of operations or closure of all or part of the food business concerned for an appropriate period of time;

(f)	the suspension or withdrawal of the establishment's approval;

(g)	in the case of consignments from third countries, seizure followed by destruction or re-dispatch;

(h)	any other measure that the competent authority deems appropriate.

3. The competent authority shall provide the food business operator concerned, or a representative, with:

(a)	written notification of its decision concerning the action to be taken in accordance with paragraph 1, together with the reasons for the decision; and

(b)	information on rights of appeal against such decisions and of the applicable procedure and time limits.

Where appropriate, the competent authority shall also notify the competent authority of the Member State of dispatch of its decision.

CHAPTER III

PROCEDURES CONCERNING IMPORTS

Article 10

General principles and conditions

To ensure the uniform application of the principles and conditions laid down in Article 11 of Regulation (EC) No 178/2002 the procedures laid down in this Chapter shall apply.

Article 11

Lists of third countries and parts of third countries from which imports of specified products of animal origin are permitted

1. Products of animal origin shall be imported only from a third country or a part of third country that appears on a list drawn up and updated in accordance with the procedure referred to in Article 19(2).

2. A third country shall appear on such lists only if a Community control in that country has taken place and demonstrates that the competent authority provides appropriate guarantees as specified in paragraph 4. However, a third country may appear on such lists without a Community control having taken place there if:

(a)	the risk determined in accordance with Article 18, point 18 does not warrant it; and

(b)	it is determined, when deciding to add a particular third country to a list in accordance with paragraph 1, that other information indicates that the competent authority provides the necessary guarantees.

3. Lists drawn up in accordance with this Article may be combined with other lists drawn up for public and animal health purposes.

4. When lists are drawn up or updated, particular account shall be taken of the following criteria:

(a)

the legislation of the third country on:

(i)	products of animal origin,

(ii)	the use of veterinary medicinal products, including rules on their prohibition or authorisation, their distribution, their placing on the market and the rules covering administration and inspection, and

(iii)

the preparation and use of feedingstuffs, including the procedures for using additives and the preparation and use of medicated feedingstuffs, as well as the hygiene quality of the raw materials used for preparing feedingstuffs and of the final product;

(b)	the organisation of the third countries' competent authorities, their powers and independence, the supervision to which they are subject and the authority that they have effectively to enforce the applicable legislation;

(c)	the training of staff in the performance of official controls;

(d)	the resources, including diagnostic facilities available to competent authorities;

(e)	the existence and operation of documented control procedures and control systems based on priorities;

(f)	where applicable, the situation regarding animal health and procedures for notifying the Commission and relevant international bodies of outbreaks of animal diseases;

(g)	the extent and operation of official controls on imports of animals and products of animal origin;

(h)	the assurances which the third country can give regarding compliance with, or equivalence to, Community requirements;

(i)	the hygiene conditions of production, manufacture, handling, storage and dispatch actually applied to products of animal origin destined for the Community;

(j)	any experience of marketing of the product from the third country and the results of any import controls carried out;

(k)	the results of Community controls carried out in the third country, in particular the results of the assessment of the competent authorities, and the action that competent authorities have taken in the light of any recommendations addressed to them following a Community control;

(l)	the existence, implementation and communication of an approved zoonoses control programme; and

(m)	the existence, implementation and communication of an approved residue control programme.

5. The Commission shall arrange for up-to-date versions of all lists drawn up or updated in accordance with this Article to be available to the public.

Article 12

List of establishments from which imports of specified products of animal origin are permitted

1. Products of animal origin may be imported into the Community only if they have been dispatched from, and obtained or prepared in, establishments that appear on lists drawn up and updated in accordance with this Article, except:

(a)

when, on a case-by-case basis, it is decided, in accordance with the procedure referred to in Article 19(2), that the guarantees that a specified third country provides in respect of imports of specified products of animal origin are such that the procedure provided for in this Article is unnecessary to ensure compliance with the requirements of paragraph 2; and

(b)	in the cases specified in Annex V.

In addition, fresh meat, minced meat, meat preparations, meat products and mechanically separated meat (MSM) may be imported into the Community only if they have been manufactured from meat obtained in slaughterhouses and cutting plants appearing on lists drawn up and updated in accordance with this Article or in approved Community establishments.

2. An establishment may be placed on such a list only if the competent authority of the third country of origin guarantees that:

(a)

that establishment, together with any establishments handling raw material of animal origin used in the manufacture of the products of animal origin concerned, complies with relevant Community requirements, in particular those of Regulation (EC) No .../2004 (12), or with requirements that were determined to be equivalent to such requirements when deciding to add that third country to the relevant list in accordance with Article 11;

(b)	an official inspection service in that third country supervises the establishments and makes available to the Commission, where necessary, all relevant information on establishments furnishing raw materials; and

(c)	it has real powers to stop the establishments from exporting to the Community in the event that the establishments fail to meet the requirements referred to under (a).

3. The competent authorities of third countries appearing on lists drawn up and updated in accordance with Article 11 shall guarantee that lists of the establishments referred to in paragraph 1 are drawn up, kept up-to-date and communicated to the Commission.

(a)	The Commission shall provide the contact points that Member States have designated for this purpose with regular notifications concerning new or updated lists that it has received from the competent authorities of third countries concerned in accordance with paragraph 3.
(b)	If no Member State objects to the new or updated list within 20 working days of the Commission's notification, imports shall be authorised from establishments appearing on the list 10 working days after the day on which the Commission makes it available to the public.
(c)	The Commission shall, whenever at least one Member State makes written comments, or whenever it considers that the modification of a list is necessary in the light of relevant information such as Community inspection reports or a notification under the rapid alert system, inform all Member States and include the point on agenda of the next meeting of the relevant section of the Standing Committee on the Food Chain and Animal Health for decision, where appropriate, in accordance with the procedure referred to in Article 19(2).

5. The Commission shall arrange for up-to-date versions of all lists to be available to the public.

Article 13

Live bivalve molluscs, echinoderms, tunicates and marine gastropods

1. Notwithstanding Article 12(1)(b), live bivalve molluscs, echinoderms, tunicates and marine gastropods shall come from production areas in third countries that appear on lists drawn up and updated in accordance with Article 12.

2. The requirement of paragraph 1 shall not apply to pectinidae harvested outside classified production areas. However, official controls with respect to pectinidae shall take place in accordance with Annex II, Chapter III.

(a)

Before the lists referred to in paragraph 1 are drawn up, particular account shall be taken of the guarantees that the competent authority of the third country can give concerning compliance with the requirements of this Regulation on the classification and control of production zones.

(b)

A Community inspection visit on-the-spot shall take place before such lists are drawn up unless:

(i)	the risk determined in accordance with Article 18, point 18 does not warrant it; and

(ii)	it is determined, when deciding to add a particular production area to a list in accordance with paragraph 1, that other information indicates that the competent authority provides the necessary guarantees.

4. The Commission shall arrange for up-to-date versions of all lists drawn up or updated in accordance with this Article to be available to the public.

Article 14

Documents

1. A document meeting the requirements set out in Annex VI shall accompany consignments of products of animal origin when they are imported into the Community.

2. The document shall certify that the products satisfy:

(a)	the requirements laid down for such products under Regulation (EC) No .../2004 (13) and Regulation (EC) No .../2004 (13) or provisions that are equivalent to those requirements; and

(b)	any special import conditions established in accordance with Article 18, point 19.

3. Documents may include details required in accordance with other Community legislation on public and animal health matters.

4. Exemptions from paragraph 1 may be granted in accordance with the procedure referred to in Article 19(2) when it is possible to obtain the guarantees referred to in paragraph 2 of this Article in another manner.

Article 15

Special provisions for fishery products

1. The procedures laid down in this Chapter do not apply to fresh fishery products landed in the Community directly from a fishing vessel flying the flag of a third country.

Official controls with respect to such fishery products shall take place in accordance with Annex III.

(a)

Fishery products imported from a factory or freezer vessel flying the flag of a third country shall come from vessels that appear on a list drawn up and updated in accordance with the procedure set out in Article 12(4).

(b)

However, by way of exemption from Article 12(2)(b), a vessel may also be included on such lists:

(i)

on the basis of a joint communication from the competent authority of the third country the flag of which the vessel is flying and from the competent authority of another third country to which the former competent authority has delegated responsibility for the inspection of the vessel concerned, on condition that:

—	that third country appears on the list of third countries, drawn up in accordance with Article 11, from which imports of fisheries products are permitted,

—	all fishery products from the vessel concerned that are destined for placing on the market in the Community are landed directly in that third country,

—	the competent authority of that third country has inspected the vessel and has declared that it complies with Community requirements, and

—	the competent authority of that third country has declared that it will regularly inspect the vessel to ensure that it continues to comply with Community requirements;

(ii)

on the basis of a joint communication from the competent authority of the third country the flag of which the vessel is flying and from the competent authority of a Member State, to which the former competent authority has delegated responsibility for the inspection of the vessel concerned, on condition that:

—	all fishery products from the vessel concerned that are destined for placing on the market in the Community are landed directly in that Member State,

—	the competent authority of that Member State has inspected the vessel and has declared that it complies with Community requirements, and

—	the competent authority of that Member State has declared that it will regularly inspect the vessel to ensure that it continues to comply with Community requirements.

(c)

The Commission shall arrange for up-to-date versions of all lists drawn up or updated in accordance with this Article to be available to the public.

3. When fishery products are imported directly from a fishing or freezer vessel, a document signed by the captain may replace the document required under Article 14.

4. Detailed rules for the implementation of this Article may be laid down in accordance with the procedure referred to in Article 19(2).

CHAPTER IV

FINAL PROVISIONS

Article 16

Implementing measures and transitional measures

Implementing measures and transitional arrangements may be laid down in accordance with the procedure referred to in Article 19(2).

Article 17

Amendment and adaptation of the Annexes

1. Annexes I, II, III, IV, V and VI may be amended or supplemented to take account of scientific and technical progress in accordance with the procedure referred to in Article 19(2).

2. Exemptions from Annexes I, II, III, IV, V and VI may be granted in accordance with the procedure referred to in Article 19(2), provided that they do not affect the achievement of the objectives of this Regulation.

3. Member States may, without compromising achievement of the objectives of this Regulation, adopt, in accordance with paragraphs 4 to 7, national measures adapting the requirements laid down in Annex I.

4. The national measures referred to in paragraph 3 shall:

(a)

have the aim of:

(i)	enabling the continued use of traditional methods at any of the stages of production, processing or distribution of food;

(ii)	accommodating the needs of food businesses with a low throughput or that are situated in regions that are subject to special geographic constraints; or

(iii)

permitting pilot projects to take place in order to try out new approaches to hygiene controls on meat;

(b)

concern in particular the following elements of Annex I:

(i)	food chain information;

(ii)	the presence of the competent authority in establishments.

5. Any Member State wishing to adopt national measures as referred to in paragraph 3 shall notify the Commission and other Member States. Each notification shall:

(a)	provide a detailed description of the requirements that that Member State considers need to be adapted and the nature of the adaptation sought;

(b)	describe the establishments concerned;

(c)	explain the reasons for the adaptation, including, where relevant, by providing a summary of the hazard analysis carried out and any measures to be taken to ensure that the adaptation will not compromise the objectives of this Regulation; and

(d)	give any other relevant information.

6. The other Member States shall have three months from the receipt of a notification referred to in paragraph 5 to send written comments to the Commission. The Commission may, and when it receives written comments from one or more Member States shall, consult Member States within the committee referred to in Article 19(1). The Commission may decide, in accordance with the procedure referred to in Article 19(2), whether the envisaged measures may be implemented subject, if necessary, to appropriate amendments. Where appropriate, the Commission may propose general measures in accordance with paragraphs 1 or 2 of this Article.

7. A Member State may adopt national measures adapting the requirements of Annex I only:

(a)	in compliance with a decision adopted in accordance with paragraph 6;

(b)	if, one month after the expiry of the period referred to in paragraph 6, the Commission has not informed Member States that it has received written comments or that it intends to propose the adoption of a decision in accordance with paragraph 6.

8. When a Member State adopts national measures implementing a pilot project to try out new approaches to hygiene controls on meat in accordance with paragraphs 3 to 7, the Member State shall communicate the results to the Commission as soon as they are available. The Commission shall then consider proposing general measures in accordance with paragraph 1.

Article 18

Specific decisions

Without prejudice to the generality of Article 16 and Article 17(1), implementing measures may be laid down, or amendments to Annexes I, II, III, IV, V or VI adopted, in accordance with the procedure referred to in Article 19(2), to specify:

1)	tests to assess the performance of food business operators and their staff;

2)	the method of communicating inspection results;

3)	criteria to determine when, on the basis of a risk analysis, the official veterinarian need not be present in slaughterhouses and game handling establishments throughout ante-mortem and post-mortem inspection;

4)	rules concerning the content of tests for official veterinarians and official auxiliaries;

5)	microbiological criteria for process control in relation to hygiene in establishments;

6)	alternative procedures, serological or other laboratory tests that provide guarantees at least equivalent to specific post-mortem inspection procedures described in Annex I, Section IV, and may therefore replace them, if the competent authority so decides;

7)	circumstances in which certain of the specific post-mortem inspection procedures described in Annex I, Section IV, are not necessary, having regard to the holding, region or country of origin and to the principles of risk analysis,

8)	rules for laboratory testing;

9)	the cold treatment to be applied to meat in relation to cysticercosis and trichinosis;

10)	conditions under which holdings and regions can be certified as officially free of cysticercus or trichinae;

11)	methods to be applied when examining for the conditions referred to in Annex I, Section IV, Chapter IX;

12)	for fattening pigs, criteria for controlled housing conditions and integrated production systems;

13)

criteria for the classification of production and relaying areas for live bivalve molluscs in cooperation with the relevant Community Reference Laboratory, including:

(a)	limit values and analysis methods for marine biotoxins,

(b)	virus testing procedures and virological standards, and

(c)	sampling plans and the methods and analytical tolerances to be applied to check compliance with the criteria;

14)	organoleptic criteria for the evaluation of the freshness of fishery products;

15)	analytical limits, methods of analysis and sampling plans for the official controls on fishery products required under Annex III, including with regard to parasites and environmental contaminants;

16)	the method by which the Commission will make lists of third countries and establishments in third countries available to the public pursuant to Articles 11, 12, 13 and 15;

17)	models for documents and criteria for the use of electronic documents;

18)	criteria for determining the risk that particular products of animal origin imported into the Community present;

19)

special import conditions for particular products of animal origin, taking account of the associated risks, information that relevant third countries have provided and, where necessary, the results of Community controls carried out in such third countries. These special import conditions may be established for a single product of animal origin or for group of products. They may apply to a single third country, to regions of a third country, or to a group of third countries; and

20)

the conditions governing imports of products of animal origin from a third country or a region of a third country pursuant to the implementation of an equivalence agreement, or to a satisfactory audit, recognising that measures applied in that third country or region offer guarantees equivalent to those applied in the Community, if the third country supplies objective proof in this respect.

Article 19

Committee procedure

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health instituted by Article 58 of Regulation (EC) No 178/2002.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. The Committee shall adopt its rules of procedure.

Article 20

Consultation of the European Food Safety Authority

The Commission shall consult the European Food Safety Authority on matters falling within the scope of this Regulation whenever necessary and, in particular:

1.	before proposing to modify the specific requirements concerning post-mortem inspection procedures laid down in Section IV of Annex I;

2.	before proposing to modify the rules of Annex I, Section IV, Chapter IX, on meat from animals in which post-mortem inspection has revealed lesions indicating infection with brucellosis or tuberculosis; and

3.	before proposing implementing measures on the matters referred to in Article 18, points (5) to (15).

Article 21

Report to the European Parliament and to the Council

1. The Commission shall, not later than ... (14) submit a report to the European Parliament and the Council reviewing the experience gained from the application of this Regulation.

2. The Commission shall, if appropriate, accompany the report with relevant proposals.

Article 22

Entry into force

This Regulation shall enter into force twenty days after the date of its publication in the Official Journal of the European Union.

It shall apply 18 months after the date on which all of the following acts have entered into force:

(a)	Regulation (EC) No .../2004 (15)

(b)	Regulation (EC) No .../2004 (15) and

(c)	Directive 2004/.../EC of the European Parliament and of the Council of ... repealing certain Directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption (15).

However, it shall apply no earlier than 1 January 2006.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at ..., on ...

For the European Parliament

The President

For the Council

The President

(1) OJ C 262 E, 29.10.2002, p. 449.

(2) OJ C 95, 23.4.2003, p. 22.

(3) Opinion of the European Parliament of 5 June 2003 (not yet published in the Official Journal), Council Common Position of 27 October 2003 (OJ C 48 E, 24.2.2004, p. 82), Position of the European Parliament of 30 March 2004.

(4) Not yet published in the OJ.

(5) OJ L 184, 17.7.1999, p. 23.

(6) Not yet published in the OJ.

(7) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Regulation (EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

(8) OJ L 273, 10.10.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 813/2003 (OJ L 117, 13.5.2003, p. 22).

(9) Not yet published in the OJ.

(10) Not yet published in the OJ.

(11) Not yet published in the OJ.

(12) Not yet published in the OJ.

(13) Not yet published in the OJ.

(14) Five years after the entry into force of this Regulation.

(15) Not yet published in the OJ.

ANNEX I

FRESH MEAT

SECTION I

TASKS OF THE OFFICIAL VETERINARIAN

CHAPTER I: AUDITING TASKS

In addition to the general requirements of Article 4(4) concerning audits of good hygiene practices, the official veterinarian is to verify continuous compliance with food business operators' own procedures concerning any collection, transport, storage, handling, processing and use or disposal of animal byproducts, including specified risk material, for which the food business operator is responsible.

In addition to the general requirements of Article 4(5) concerning audits of HACCP-based principles, the official veterinarian is to check that the operators' procedures guarantee, to the extent possible, that meat:

(a)	does not contain patho-physiological abnormalities or changes;

(b)	does not bear faecal or other contamination; and

(c)	does not contain specified risk material, except as provided for under Community legislation, and has been produced in accordance with Community legislation on TSEs.

CHAPTER II: INSPECTION TASKS

When carrying out inspection tasks in accordance with this Chapter, the official veterinarian is to take account of the results of the auditing tasks carried out in accordance with Article 4 and Chapter I of this Annex. Where appropriate he or she is to target inspection tasks accordingly.

A. Food chain information

1.	The official veterinarian is to check and analyse relevant information from the records of the holding of provenance of animals intended for slaughter and to take account of the documented results of this check and analysis when carrying out ante- and post-mortem inspection.

2.	When carrying out inspection tasks, the official veterinarian is to take account of official certificates accompanying animals, and any declarations made by veterinarians carrying out controls at the level of primary production, including official veterinarians and approved veterinarians.

When food business operators in the food chain take additional measures to guarantee food safety by implementing integrated systems, private control systems, independent third party certification or by other means, and when these measures are documented and animals covered by these schemes clearly identifiable, the official veterinarian may take this into account when carrying out inspection tasks and reviewing the HACCP-based procedures.

B. Ante-mortem inspection

Subject to paragraphs 4 and 5:

(a)	the official veterinarian is to carry out an ante-mortem inspection of all animals before slaughter;

(b)	that inspection must take place within 24 hours of arrival at the slaughterhouse and less than 24 hours before slaughter. In addition, the official veterinarian may require inspection at any other time.

Ante-mortem inspection must in particular determine whether, as regards the particular animal inspected, there is any sign:

(a)	that welfare has been compromised; or

(b)	of any condition which might adversely affect human or animal health, paying particular attention to the detection of zoonotic diseases and diseases on List A or, where appropriate, List B of the Office International des Epizooties (World organisation for animal health, OIE).

3.	In addition to routine ante-mortem inspection, the official veterinarian is to carry out a clinical inspection of all animals that the food business operator or an official auxiliary may have put aside.

In the case of emergency slaughter outside the slaughterhouse and of hunted wild game, the official veterinarian at the slaughterhouse or game handling establishment is to examine the declaration accompanying the body of the animal issued by the veterinarian or the trained person in accordance with Regulation (EC) No .../2004 (1)

5.	Where provided for in Section III, Chapter II, or in Section IV, ante-mortem inspection may be carried out at the holding of provenance. In such cases, the official veterinarian at the slaughterhouse need carry out ante-mortem inspection only when and to the extent specified.

C. Animal welfare

The official veterinarian is to verify compliance with relevant Community and national rules on animal welfare, such as rules concerning the protection of animals at the time of slaughter and during transport.

D. Post-mortem inspection

Carcases and accompanying offal are to be subjected without delay after slaughter to post-mortem inspection. All external surfaces are to be viewed. Minimal handling of the carcase and offal or special technical facilities may be required for that purpose. Particular attention is to be paid to the detection of zoonotic diseases and diseases on OIE List A and, where appropriate, OIE List B. The speed of the slaughter line and the number of inspection staff present are to be such as to allow for proper inspection.

Additional examinations are to take place, such as palpation and incision of parts of the carcase and offal and laboratory tests, whenever considered necessary:

(a)	to reach a definitive diagnosis; or

(b)

to detect the presence of:

(i)	an animal disease,

(ii)	residues or contaminants in excess of the levels laid down under Community legislation,

(iii)

non-compliance with microbiological criteria, or

(iv)	other factors that might require the meat to be declared unfit for human consumption or restrictions to be placed on its use,

particularly in the case of animals having undergone emergency slaughter.

The official veterinarian is to require carcases of domestic solipeds, bovine animals over six months old, and domestic swine over four weeks old to be submitted for post-mortem inspection split lengthways into half carcases down the spinal column. If the inspection so necessitates, the official veterinarian may also require any head or any carcase to be split lengthways. However, to take account of particular eating habits, technological developments or specific sanitary situations, the competent authority may authorise the submission for inspection of carcases of domestic solipeds, bovine animals over six months old, and domestic swine over four weeks old, not split in half.

4.	During the inspection, precautions must be taken to ensure that contamination of the meat by actions such as palpation, cutting or incision is kept to a minimum.

5.	In the event of an emergency slaughter, the carcass shall be subjected to post-mortem examination as soon as possible in accordance with paragraphs 1 to 4 before it is released for human consumption.

E. Specified risk material and other animal by-products

In accordance with specific Community rules on specified risk material and other animal by-products, the official veterinarian is to check the removal, separation and, where appropriate, marking of such products. The official veterinarian is to ensure that the food business operator takes all necessary measures to avoid contaminating meat with specified risk material during slaughter (including stunning) and removal of specified risk material.

F. Laboratory testing

The official veterinarian is to ensure that sampling takes place and that samples are appropriately identified and handled and sent to the appropriate laboratory within the framework of:

(a)	the monitoring and control of zoonoses and zoonotic agents;

(b)	specific laboratory testing for the diagnosis of TSEs in accordance with Regulation (EC) No 999/2001 of the European Parliament and of the Council (2);

(c)	the detection of unauthorised substances or products and the control of regulated substances, in particular within the framework of the National Residue Plans referred to in Council Directive 96/23/EC (3); and

(d)	the detection of OIE List A and, where appropriate, OIE List B diseases.

2.	The official veterinarian is also to ensure that any other necessary laboratory testing takes place.

CHAPTER III. HEALTH MARKING

1.	The official veterinarian is to supervise health marking and the marks used.

The official veterinarian is to ensure, in particular, that:

(a)

the health mark is applied only to animals (domestic ungulates, farmed game mammals other than lagomorphs, and large wild game) having undergone ante-mortem and post-mortem inspection in accordance with this Regulation and when there are no grounds for declaring the meat unfit for human consumption. However, the health mark may be applied before the results of any examination for trichinosis is available, if the official veterinarian is satisfied that meat from the animal concerned will be placed on the market only if the results are satisfactory; and

(b)	health-marking takes place on the external surface of the carcase, by stamping the mark in ink or hot branding, and in such a manner that, if carcases are cut into half carcases or quarters, or half carcases are cut into three pieces, each piece bears a health mark.

The health mark must be an oval mark at least 6,5 cm wide by 4,5 cm high bearing the following information in perfectly legible characters:

(a)

the mark must indicate name of the country in which the establishment is located, which may be written out in full in capitals or shown as a two-letter code in accordance with the relevant ISO standard.

In the case of Member States, however, these codes are AT, BE, DE, DK, ES, FI, FR, GR, IE, IT, LU, NL, PT, SE and UK;

(b)	the mark must indicate the approval number of the slaughterhouse; and

(c)	when applied in a slaughterhouse within the Community, the mark must include the abbreviation CE, EC, EF, EG, EK or EY.

4.	Letters must be at least 0,8 cm high and figures at least 1 cm high. The dimensions and characters of the mark may be reduced for health marking of lamb, kids and piglets.

5.	The colours used for health marking must be authorised in accordance with Community rules on the use of colouring substances in foodstuffs.

The health mark may also include an indication of the official veterinarian who carried out the health inspection of the meat. Competent authorities and food business operators may continue to use equipment that they ordered before entry into force of this Regulation until it is exhausted or requires replacement.

Meat from animals having undergone emergency slaughter outside the slaughterhouse must bear a special health mark, which cannot be confused either with the health mark provided for in this Chapter or with the identification mark provided for in Annex II, Section I, to Regulation (EC) No .../2004 (4)

8.	Meat from unskinned wild game cannot bear a health mark unless, after skinning in a game handling establishment, it has undergone post-mortem inspection and been declared fit for human consumption.

9.	This Chapter is to apply without prejudice to animal health rules on health marking.

SECTION II

ACTION FOLLOWING CONTROLS

CHAPTER I: COMMUNICTAION OF INSPECTION RESULTS

1.	The official veterinarian is to record and to evaluate the results of inspection activities.

(a)	If inspections reveal the presence of any disease or condition that might affect public or animal health, or compromise animal welfare, the official veterinarian is to inform the food business operator.

(b)

When the problem identified arose during primary production, the official veterinarian is to inform the veterinarian attending the holding of provenance, the food business operator responsible for the holding of provenance (provided that such information would not prejudice subsequent legal proceedings) and, where appropriate, the competent authority responsible for supervising the holding of provenance or the hunting area.

(c)

If the animals concerned were raised in another Member State or in a third country, the official veterinarian is to inform to the competent authority of the Member State where the establishment is located. That competent authority is to take appropriate measures in accordance with applicable Community legislation.

3.	The results of inspections and tests are to be included in relevant databases.

When the official veterinarian, while carrying out ante-mortem or post-mortem inspection or any other inspection activity, suspects the presence of an infectious agent mentioned on OIE List A or, where appropriate, OIE List B, the official veterinarian must immediately notify the competent authority and both must take all necessary measures and precautions to prevent the possible spread of the infectious agent in accordance with applicable Community legislation.

CHAPTER II: DECISIONS CONCERNING FOOD CHAIN INFORMATION

1.	The official veterinarian is to verify that animals are not slaughtered unless the slaughterhouse operator has been provided with and checked relevant food chain information.

However, the official veterinarian may allow animals to undergo slaughter in the slaughterhouse even if the relevant food chain information is not available. In this case, all relevant food chain information must be supplied before the carcase is approved for human consumption. Pending a final judgement, such carcases and related offal must be stored separately from other meat.

Notwithstanding paragraph 2, when relevant food chain information is not available within 24 hours of an animal's arrival at the slaughterhouse, all meat from the animal is to be declared unfit for human consumption. If the animal has not yet been slaughtered, it is to be killed separately from other animals.

When the accompanying records, documentation or other information shows that:

(a)	animals come from a holding or an area subject to a movement prohibition or other restriction for reasons of animal or public health;

(b)	rules on the use of veterinary medicinal products have not been complied with; or

(c)	any other condition which might adversely affect human or animal health is present,

animals may not be accepted for slaughter other than in accordance with procedures laid down under Community legislation to eliminate human or animal health risks.

If the animals are already present at the slaughterhouse, they must be killed separately and declared unfit for human consumption, taking precautions to safeguard animal and public health where appropriate. Whenever the official veterinarian considers it necessary, official controls are to be carried out on the holding of provenance.

The competent authority is to take appropriate action if it discovers that the accompanying records, documentation or other information do not correspond with the true situation on the holding of provenance or the true condition of the animals or aim deliberately to mislead the official veterinarian. The competent authority is to take action against the food business operator responsible for the holding of provenance of the animals, or any other person involved. This action may consist in particular of extra controls. The food business operator responsible for the holding of provenance or any other person involved are to bear the costs of such extra controls.

5. CHAPTER III: DECISIONS CONCERNING LIVE ANIMALS

The official veterinarian is to verify compliance with the food business operator's duty under Regulation (EC) No .../2004 (5) to ensure that animals accepted for slaughter for human consumption are properly identified. The official veterinarian is to ensure that animals whose identity is not reasonably ascertainable are killed separately and declared unfit for human consumption. Whenever the official veterinarian considers it necessary, official controls are to be carried out on the holding of provenance.

When there are overriding animal welfare considerations, horses may undergo slaughter at the slaughterhouse even if the legally required information concerning their identity has not been supplied. However, this information must be supplied before the carcase may be declared fit for human consumption. These requirements also apply in the case of emergency slaughter of horses outside the slaughterhouse.

The official veterinarian is to verify compliance with the food business operator's duty under Regulation (EC) No .../2004 (5) to ensure that animals that have such hide, skin or fleece conditions that there is an unacceptable risk of contamination of the meat during slaughter are not slaughtered for human consumption unless they are cleaned beforehand.

Animals with a disease or condition that may be transmitted to animals or humans through handling or eating meat and, in general, animals showing clinical signs of systemic disease or emaciation, are not to be slaughtered for human consumption. Such animals must be killed separately, under conditions such that other animals or carcases can not be contaminated, and declared unfit for human consumption.

The slaughter of animals suspected of having a disease or condition that may adversely affect human or animal health is to be deferred. Such animals are to undergo detailed ante-mortem examination in order to make a diagnosis. In addition, the official veterinarian may decide that sampling and laboratory examinations are to take place to supplement post-mortem inspection. If necessary, the animals are to be slaughtered separately or at the end of normal slaughtering, taking all necessary precautions to avoid contamination of other meat.

6.	Animals that might contain residues of veterinary medicinal products in excess of the levels laid down in accordance with Community legislation, or residues of forbidden substances, are to be dealt with in accordance with Directive 96/23/EC.

The official veterinarian is to impose the conditions under which animals are to be dealt with under a specific scheme for the eradication or control of a specific disease, such as brucellosis or tuberculosis, or zoonotic agents such as salmonella, under his/her direct supervision. The competent authority is to determine the conditions under which such animals may be slaughtered. These conditions must have the aim of minimising contamination of other animals and the meat of other animals.

8.	Animals that are presented to a slaughterhouse for slaughter must as a general rule be slaughtered there. However, in exceptional circumstances, such as a serious breakdown of the slaughter facilities, the official veterinarian may allow direct movements to another slaughterhouse.

CHAPTER IV: DECISIONS CONCERNING ANIMAL WELFARE

1.	When the rules concerning the protection of animals at the time of slaughter or killing are not respected, the official veterinarian is to verify that the food business operator immediately takes necessary corrective measures and prevents recurrence.

2.	The official veterinarian is to take a proportionate and progressive approach to enforcement action, ranging from issuing directions to slowing down and stopping production, depending on the nature and gravity of the problem.

3.	Where appropriate, the official veterinarian is to inform other competent authorities of welfare problems.

4.	When the official veterinarian discovers that rules concerning the protection of animals during transport are not being respected, he or she is to take necessary measures in accordance with the relevant Community legislation.

When:

(a)	an official auxiliary is carrying out checks on animal welfare pursuant to Sections III or IV; and

(b)	those checks identify non-compliance with the rules on the protection of animals,

the official auxiliary is immediately to inform the official veterinarian and, if necessary in cases of urgency, is to take the necessary measures referred to in paragraphs 1 to 4 pending the arrival of the official veterinarian.

CHAPTER V: DECISIONS CONCERNING MEAT

Meat is to be declared unfit for human consumption if it:

(a)	derives from animals that have not undergone ante-mortem inspection, except for hunted wild game;

(b)	derives from animals the offal of which has not undergone post-mortem inspection, unless otherwise provided for under this Regulation or Regulation (EC) No .../2004 (6);

(c)	derives from animals which are dead before slaughter, stillborn, unborn or slaughtered under the age of 7 days;

(d)	results from the trimming of sticking points;

(e)	derives from animals affected by an OIE List A or, where appropriate, OIE List B disease, unless otherwise provided for in Section IV;

(f)	derives from animals affected by a generalised disease, such as generalised septicaemia, pyaemia, toxaemia or viraemia;

(g)	is not in conformity with microbiological criteria laid down under Community legislation to determine whether food may be placed on the market;

(h)	exhibits parasitic infestation, unless otherwise provided for in Section IV;

(i)	contains residues or contaminants in excess of the levels laid down in Community legislation. Any overshooting of the relevant level should lead to additional analyses whenever appropriate;

(j)	without prejudice to more specific Community legislation, derives from animals or carcases containing residues of forbidden substances or from animals that have been treated with forbidden substances;

(k)	consists of the liver and kidneys of animals more than two years old from regions where implementation of plans approved in accordance with Article 5 of Directive 96/23/EC has revealed the generalised presence of heavy metals in the environment;

(l)	has been treated illegally with decontaminating substances;

(m)	has been treated illegally with ionising or UV-rays;

(n)	contains foreign bodies (except, in the case of wild game, material used to hunt the animal);

(o)	exceeds the maximum permitted radioactivity levels laid down under Community legislation;

(p)	indicates patho-physiological changes, anomalies in consistency, insufficient bleeding (except for wild game) or organoleptic anomalies, in particular a pronounced sexual odour;

(q)	derives from emaciated animals;

(r)	contains specified risk material, except as provided for under Community legislation;

(s)	shows soiling, faecal or other contamination;

(t)	consists of blood that may constitute a risk to public or animal health owing to the health status of any animal from which it derives or contamination arising during the slaughter process;

(u)	in the opinion of the official veterinarian, after examination of all the relevant information, it may constitute a risk to public or animal health or is for any other reason not suitable for human consumption.

2.	The official veterinarian may impose requirements concerning the use of meat derived from animals having undergone emergency slaughter outside the slaughterhouse.

SECTION III

RESPONSIBILITIES AND FREQUENCY OF CONTROLS

CHAPTER I: OFFICIAL AUXILIARIES

Official auxiliaries may assist the official veterinarian with all tasks, subject to the following restrictions and to any specific rules laid down in Section IV:

1.	in relation to auditing tasks, official auxiliaries may only collect information regarding good hygienic practices and HACCP-based procedures;

2.	in relation to ante-mortem inspection and checks concerning the welfare of animals, official auxiliaries may only make an initial check of animals and help with purely practical tasks; and

3.	in relation to post-mortem inspection, the official veterinarian must regularly check the work of official auxiliaries and, in the case of animals having undergone emergency slaughter outside the slaughterhouse, carry out the inspection personally.

CHAPTER II: FREQUENCY OF CONTROLS

The competent authority is to ensure that at least one official veterinarian is present:

(a)	in slaughterhouses, throughout both ante-mortem and post-mortem inspection; and

(b)	in game handling establishments, throughout post-mortem inspection.

However, the competent authority may adapt this approach in certain slaughterhouses and game handling establishments identified on the basis of a risk analysis and in accordance with criteria laid down in accordance with Article 18, point 3, if there are any. In such cases:

(a)

The official veterinarian need not be present at the time of ante-mortem inspection in the slaughterhouse if:

(i)	an official veterinarian or an approved veterinarian carried out ante-mortem inspection at the holding of provenance, checked the food chain information and communicated the results of the check to the official auxiliary at the slaughterhouse,

(ii)	the official auxiliary at the slaughterhouse is satisfied that the food chain information does not point to any possible problem for food safety and that the animal's general state of health and welfare is satisfactory, and

(iii)

the official veterinarian regularly satisfies himself/herself that the official auxiliary is carrying out such checks properly;

(b)

the official veterinarian need not be present at all times during post-mortem inspection if:

(i)	an official auxiliary carries out post-mortem inspection and puts aside meat with abnormalities and all other meat from the same animal,

(ii)	the official veterinarian subsequently inspects all such meat, and

(iii)

the official auxiliary documents his/her procedures and findings in a manner that allows the official veterinarian to be satisfied that standards are being met.

However, in the case of poultry and lagomorphs, the official auxiliary may discard meat with abnormalities and, subject to Section IV, the official veterinarian need not systematically inspect all such meat.

The flexibility provided for in paragraph 2 does not apply:

(a)	to animals that have undergone emergency slaughter;

(b)	to animals suspected of having a disease or condition that may adversely affect human health;

(c)	to bovine animals from herds that have not been declared officially free of tuberculosis;

(d)	to bovine, ovine and caprine animals from herds that have not been declared officially free of brucellosis;

(e)	in the case of an outbreak of a disease listed on OIE List A or, where appropriate, OIE List B. This concerns animals susceptible to the particular disease in question that come from the particular region as defined in Article 2 of Council Directive 64/432/EEC (7);

(f)	when stricter controls are necessary to take account of emerging diseases or particular OIE List B diseases.

4.	In cutting plants, the competent authority is to ensure that an official veterinarian or an official auxiliary is present when meat is being worked on with a frequency appropriate to achieving the objectives of this Regulation.

CHAPTER III: INVOLVEMENT OF SLAUGHTERHOUSE STAFF

A. SPECIFIC TASKS CONCERNING THE PRODUCTION OF MEAT FROM POULTRY AND LAGOMORPHS

The Member States may permit slaughterhouse staff to take over the activities of the official auxiliaries in controlling the production of poultry and rabbit meat under the following conditions:

(a)

Where the establishment has used good hygiene practice in accordance with Article 4, paragraph 4 of this Regulation and the HACCP procedure for at least twelve months, the competent authority may authorise staff of the establishment who have been trained in the same way as the official assistants and have passed the same examination to carry out tasks of the official auxiliaries and form part of the competent authority's independent inspection team, under the supervision, direction and responsibility of the official veterinarian. In these circumstances, the official veterinarian shall be present at anti-mortem and post-mortem examinations, shall supervise these activities and carry out regular performance tests to ensure that the performance of the slaughterhouse tasks meets the specific criteria laid down by the competent authority, and shall document the results of those performance tests. Detailed rules for the performance tests shall be laid down in accordance with the procedure set out in Article 18. Where the level of hygiene of the establishment is affected by the work of this staff, where this staff does not carry out the tasks properly or where in general this staff carries out its work in a manner that the competent authority considers unsatisfactory, this staff shall be replaced by official auxiliaries.

Responsibilities for production and inspection in the establishment must be kept separate and any establishment wishing to use the establishment's own inspectors must possess internationally recognised certification.

(b)

The competent authority of the Member State shall decide, in principle and on a case-by-case basis, whether to permit the implementation of the system described above. Where the Member State decides in principle in favour of this system, it shall inform the Commission of that decision and its associated conditions. For food business operators in a Member State implementing the system, the actual use of the system is optional. Food business operators shall not be forced by the competent authority to introduce the system described here. Where the competent authority is not convinced that the food business operator satisfies the requirements, the system shall not be implemented in that establishment. In order to assess this, the competent authority shall carry out an analysis of the production and inspection records, the type of activities undertaken in the establishment, the history of compliance with rules, the expertise, professional attitude and sense of responsibility of the slaughterhouse staff in regard to food safety, together with other relevant information.

B. SPECIFIC SAMPLING AND TESTING TASKS

Slaughterhouse staff who have received specific training, under the supervision of the official veterinarian, may, under the responsibility and the supervision of the official veterinarian, carry out specific sampling and testing tasks in respect of animals of all species.

CHAPTER IV: PROFESSIONAL QUALIFICATIONS

A. OFFICIAL VETERINARIANS

1.	The competent authority may appoint only veterinarians who have passed a test meeting the requirements of paragraph 2 as official veterinarians.

The competent authority must make arrangements for the test. The test is to confirm knowledge of the following subjects to the extent necessary depending on the veterinarian's background and qualifications:

(a)	national and Community legislation on veterinary public health, food safety, animal health, animal welfare and pharmaceutical substances;

(b)	principles of the Common Agricultural Policy, market measures, export refunds and fraud detection (including the global context: WTO, SPS, Codex Alimentarius, OIE);

(c)	essentials of food processing and food technology;

(d)	principles, concepts and methods of good manufacturing practice and quality management;

(e)	pre-harvest quality management (good farming practices);

(f)	promotion and use of food hygiene, food related safety (good hygiene practices);

(g)	principles, concepts and methods of risk-analysis;

(h)	principles, concepts and methods of HACCP, use of HACCP throughout the food production food chain;

(i)	prevention and control of food-borne hazards related to human health;

(j)	population dynamics of infection and intoxication;

(k)	diagnostic epidemiology;

(l)	monitoring and surveillance systems;

(m)	auditing and regulatory assessment of food safety management systems;

(n)	principles and diagnostic applications of modern testing methods;

(o)	information and communication technology as related to veterinary public health;

(p)	data-handling and applications of biostatistics;

(q)	investigations of outbreaks of food-borne diseases in humans;

(r)	relevant aspects concerning TSEs;

(s)	animal welfare at the level of production, transport and slaughter;

(t)	environmental issues related to food production (including waste management);

(u)	precautionary principle and consumer concerns; and

(v)	principles of training of personnel working in the production chain.

Candidates may acquire the required knowledge as part of their basic veterinary training, or through training undertaken, or professional experience acquired, after qualifying as veterinarians. The competent authority may arrange for different tests to take account of candidates' background. However, when the competent authority is satisfied that a candidate has acquired all the required knowledge as part of a university degree, or through continuing education resulting in a post-graduate qualification, it may waive the requirement for a test.

3.	The veterinarian is to have aptitude for multidisciplinary cooperation.

In addition, each official veterinarian is to undergo practical training for a probationary period of at least 200 hours before starting to work independently. During this period the probationer is to work under the supervision of existing official veterinarians in slaughterhouses, cutting plants, inspection posts for fresh meat and on holdings. The training is to concern the auditing of food safety management systems in particular.

5.	The official veterinarian is to maintain up-to-date knowledge and to keep abreast of new developments through regular continuing education activities and professional literature. The official veterinarian is, wherever possible, to undertake annual continuing education activities.

6.	Veterinarians already appointed as official veterinarians must have adequate knowledge of the subjects mentioned in paragraph 2. Where necessary, they are to acquire this knowledge through continuing education activities. The competent authority is to make adequate provision in this regard.

(7)	Notwithstanding paragraphs 1 to 6, Member States may lay down specific rules for official veterinarians working on a part-time basis who are responsible for inspecting small businesses.

B. OFFICIAL AUXILIARIES

1.	The competent authority may appoint as official auxiliaries only persons who have undergone training and passed a test in accordance with the following requirements.

The competent authority must make arrangements for such tests. To be eligible for these tests, candidates must prove that they have received:

(a)	at least 500 hours of theoretical training and at least 400 hours of practical training, covering the areas specified in paragraph 5; and

(b)	such additional training as is required to enable official auxiliaries to undertake their duties competently.

3.	The practical training referred to in paragraph 2(a) is to take place in slaughterhouses and cutting plants, under the supervision of an official veterinarian, and on holdings and in other relevant establishments.

Training and tests are to concern principally red meat or poultry meat. However, persons who undergo training for one of the two categories and passed the test, need only undergo abridged training to pass the test for the other category. Training and test should cover wild game, farmed game and lagomorphs, where appropriate.

Training for official auxiliaries is to cover, and tests are to confirm knowledge of, the following subjects:

(a)

in relation to holdings:

(i)

theoretical part:

—	familiarity with the farming industry organisation, production methods, international trade etc.,

—	good livestock husbandry practices,

—	basic knowledge of diseases, in particular zoonoses-viruses, bacteria, parasites etc.,

—	monitoring for disease, use of medicines and vaccines, residue testing,

—	hygiene and health inspection,

—	animal welfare on the farm and during transport,

—	environmental requirements — in buildings, on farms and in general,

—	relevant laws, regulations and administrative provisions,

—	consumer concerns and quality control;

(ii)

practical part:

—	visits to holdings of different types and using different rearing methods,

—	visits to production establishments,

—	observation of the loading and unloading of animals,

—	laboratory demonstrations,

—	veterinary checks,

—	documentation;

(b)

in relation to slaughterhouses and cutting plants:

(i)

theoretical part:

—	familiarity with the meat industry organisation, production methods, international trade and slaughter and cutting technology,

—	basic knowledge of hygiene and good hygienic practices, and in particular industrial hygiene, slaughter, cutting and storage hygiene, hygiene of work,

—	HACCP and the audit of HACCP-based procedures,

—	animal welfare on unloading after transport and at the slaughterhouse,

—	basic knowledge of the anatomy and physiology of slaughtered animals,

—	basic knowledge of the pathology of slaughtered animals,

—	basic knowledge of the pathological anatomy of slaughtered animals,

—	relevant knowledge concerning TSEs and other important zoonoses and zoonotic agents,

—	knowledge of methods and procedures for the slaughter, inspection, preparation, wrapping, packaging and transport of fresh meat,

—	basic knowledge of microbiology,

—	ante-mortem inspection,

—	examination for trichinosis,

—	post-mortem inspection,

—	administrative tasks,

—	knowledge of the relevant laws, regulations and administrative provisions,

—	sampling procedure,

—	fraud aspects;

(ii)

practical part:

—	animal identification,

—	age checks,

—	inspection and assessment of slaughtered animals,

—	post-mortem inspection in a slaughterhouse,

—	examination for trichinosis,

—	identification of animal species by examination of typical parts of the animal,

—	identifying and commenting on parts of slaughtered animals in which changes have occurred,

—	hygiene control, including the audit of the good hygiene practices and the HACCPbased procedures,

—	recording the results of ante-mortem inspection,

—

sampling,

—	traceability of meat,

—	documentation.

6.	Official auxiliaries are to maintain up-to-date knowledge and to keep abreast of new developments through regular continuing education activities and professional literature. The official auxiliary is, wherever possible, to undertake annual continuing education activities.

7.	Persons already appointed as official auxiliaries must have adequate knowledge of the subjects mentioned in paragraph 5. Where necessary, they are to acquire this knowledge through continuing education activities. The competent authority is to make adequate provision in this regard.

8.	However, when official auxiliaries carry out only sampling and analysis in connection with examinations for trichinosis, the competent authority need only ensure that they receive training appropriate to these tasks.

SECTION IV

SPECIFIC REQUIREMENTS

CHAPTER I: DOMESTIC BOVINE ANIMALS

A. BOVINE ANIMALS UNDER SIX WEEKS OLD

Carcases and offal of bovine animals under six weeks old are to undergo the following post-mortem inspection procedures:

1.	visual inspection of the head and throat; incision and examination of the retropharyngeal lymph nodes (Lnn retropharyngiales); inspection of the mouth and fauces; palpation of the tongue; removal of the tonsils;

visual inspection of the lungs, trachea and oesophagus; palpation of the lungs; incision and examination of the bronchial and mediastinal lymph nodes (Lnn. bifucationes, eparteriales and mediastinales). The trachea and the main branches of the bronchi must be opened lengthwise and the lungs must be incised in their posterior third, perpendicular to their main axes; these incisions are not necessary where the lungs are excluded from human consumption;

3.	visual inspection of the pericardium and heart, the latter being incised lengthwise so as to open the ventricles and cut through the interventricular septum;

4.	visual inspection of the diaphragm;

5.	visual inspection of the liver and the hepatic and pancreatic lymph nodes, (Lnn portales); palpation and, if necessary, incision of the liver and its lymph nodes;

6.	visual inspection of the gastro-intestinal tract, the mesentery, the gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales); palpation and, if necessary, incision of the gastric and mesenteric lymph nodes;

7.	visual inspection and, if necessary, palpation of the spleen;

8.	visual inspection of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes (Lnn. renales);

9.	visual inspection of the pleura and peritoneum;

10.	visual inspection and palpation of the umbilical region and the joints. In the event of doubt, the umbilical region must be incised and the joints opened; the synovial fluid must be examined.

B. BOVINE ANIMALS OVER SIX WEEKS OLD

Carcases and offal of bovine animals over six weeks old are to undergo the following post-mortem inspection procedures:

visual inspection of the head and throat; incision and examination of the sub-maxillary, retropharyngeal and parotid lymph nodes (Lnn retropharyngiales, mandibulares and parotidei); examination of the external masseters, in which two incisions must be made parallel to the mandible, and the internal masseters (internal pterygoid muscles), which must be incised along one plane. The tongue must be freed to permit a detailed visual inspection of the mouth and the fauces and must itself be visually inspected and palpated. The tonsils must be removed;

inspection of the trachea and oesophagus; visual examination and palpation of the lungs; incision and examination of the bronchial and mediastinal lymph nodes (Lnn. bifucationes, eparteriales and mediastinales). The trachea and the main branches of the bronchi must be opened lengthways and the lungs must be incised in their posterior third, perpendicular to their main axes; these incisions are not necessary where the lungs are excluded from human consumption;

3.	visual inspection of the pericardium and heart, the latter being incised lengthways so as to open the ventricles and cut through the interventricular septum;

4.	visual inspection of the diaphragm;

5.	visual inspection and palpation of the liver and the hepatic and pancreatic lymph nodes, (Lnn portales); incision of the gastric surface of the liver and at the base of the caudate lobe to examine the bile ducts;

6.	visual inspection of the gastro-intestinal tract, the mesentery, the gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales); palpation and, if necessary, incision of the gastric and mesenteric lymph nodes;

7.	visual inspection and, if necessary, palpation of the spleen;

8.	visual inspection of the kidneys and incision, if necessary, of the kidneys and the renal lymph nodes (Lnn. renales);

9.	visual inspection of the pleura and the peritoneum;

10.	visual inspection of the genital organs (except for the penis, if already discarded);

11.

visual inspection and, if necessary, palpation and incision of the udder and its lymph nodes (Lnn. supramammarii). In cows, each half of the udder must be opened by a long, deep incision as far as the lactiferous sinuses (sinus lactiferes) and the lymph nodes of the udder must be incised, except when the udder is excluded from human consumption.

CHAPTER II: DOMESTIC SHEEP AND GOATS

Carcases and offal of sheep and goats are to undergo the following post-mortem inspection procedures:

visual inspection of the head after flaying and, in the event of doubt, examination of the throat, mouth, tongue and retropharyngeal and parotid lymph nodes. Without prejudice to animal-health rules, these examinations are not necessary if the competent authority is able to guarantee that the head, including the tongue and the brains, will be excluded from human consumption;

2.	visual inspection of the lungs, trachea and oesophagus; palpation of the lungs and the bronchial and mediastinal lymph nodes (Lnn. bifucationes, eparteriales and mediastinales); in the event of doubt, these organs and lymph nodes must be incised and examined;

3.	visual inspection of the pericardium and heart; in the event of doubt, the heart must be incised and examined;

4.	visual inspection of the diaphragm;

5.	visual inspection of the liver and the hepatic and pancreatic lymph nodes, (Lnn portales); palpation of the liver and its lymph nodes; incision of the gastric surface of the liver to examine the bile ducts;

6.	visual inspection of the gastro-intestinal tract, the mesentery and the gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales);

7.	visual inspection and, if necessary, palpation of the spleen;

8.	visual inspection of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes (Lnn. renales);

9.	visual inspection of the pleura and peritoneum;

10.	visual inspection of the genital organs (except for the penis, if already discarded);

11.	visual inspection of the udder and its lymph nodes;

12.	visual inspection and palpation of the umbilical region and joints of young animals. In the event of doubt, the umbilical region must be incised and the joints opened; the synovial fluid must be examined.

CHAPTER III: DOMESTIC SOLIPEDS

Carcases and offal of solipeds are to undergo the following post-mortem inspection procedures:

visual inspection of the head and, after freeing the tongue, the throat; palpation and, if necessary, incision of the sub-maxillary, retropharyngeal and parotid lymph nodes (Lnn retropharyngiales, mandibulares and parotidei). The tongue must be freed to permit a detailed visual inspection of the mouth and the fauces and must itself be visually examined and palpated. The tonsils must be removed;

visual inspection of the lungs, trachea and oesophagus; palpation of the lungs; palpation and, if necessary, incision of the bronchial and mediastinal lymph nodes (Lnn. bifucationes, eparteriales and mediastinales). The trachea and the main branches of the bronchi must be opened lengthwise and the lungs must be incised in their posterior third, perpendicular to their main axes; however, these incisions are not necessary where the lungs are excluded from human consumption;

3.	visual inspection of the pericardium and the heart, the latter being incised lengthwise so as to open the ventricles and cut through the interventricular septum;

4.	visual inspection of the diaphragm;

5.	visual inspection, palpation and, if necessary, incision of the liver and the hepatic and pancreatic lymph nodes, (Lnn portales);

6.	visual inspection of the gastro-intestinal tract, the mesentery and the gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales); incision, if necessary, of the gastric and mesenteric lymph nodes;

7.	visual inspection and, if necessary, palpation of the spleen;

8.	visual inspection and palpation of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes (Lnn. renales);

9.	visual inspection of the pleura and peritoneum;

10.	visual inspection of the genital organs of stallions (except for the penis, if already discarded) and mares;

11.	visual inspection of the udder and its lymph nodes (Lnn. supramammarii) and, if necessary, incision of the supramammary lymph nodes;

12.	visual inspection and palpation of the umbilical region and joints of young animals. In the event of doubt, the umbilical region must be incised and the joints opened; the synovial fluid must be examined;

13.

all grey or white horses must be inspected for melanosis and melanomata by examination of the muscles and lymph nodes (Lnn. subrhomboidei) of the shoulders beneath the scapular cartilage after loosening the attachment of one shoulder. The kidneys must be exposed and examined by incision through the entire kidney.

CHAPTER IV: DOMESTIC SWINE

A. ANTE-MORTEM INSPECTION

The competent authority may decide that pigs intended for slaughter are to be submitted to antemortem inspection at the holding of provenance. In that case, slaughter of a lot of pigs from a holding may be authorised only if:

(a)	the health certificate provided for in Chapter X, Part A, accompanies them; and

(b)	the requirements of paragraphs 2 to 5 are complied with.

Ante-mortem inspection at the holding of provenance is to comprise:

(a)	checks on records or documentation at the holding, including food chain information;

(b)

the examination of the pigs to determine whether:

(i)	they have a disease or condition which may be transmitted to animals or humans through handling or eating the meat, or are behaving, individually or collectively, in a manner indicating that such a disease may occur,

(ii)	they show disturbance of general behaviour or signs of disease which may make the meat unfit for human consumption, or

(iii)

there is evidence or reasons to suspect that they may contain chemical residues in excess of the levels laid down in Community legislation, or residues of forbidden substances.

3.	An official veterinarian or an approved veterinarian is to carry out ante-mortem inspection at the holding. The pigs are to be sent directly to slaughter and not to be mixed with other pigs.

Ante-mortem inspection at the slaughterhouse need cover only:

(a)	a control of the animals' identification; and

(b)	a screening to ascertain whether animal welfare rules have been complied with and whether signs of any condition which might adversely affect human or animal health are present. An official auxiliary may carry out this screening.

When pigs are not slaughtered within three days of the issue of the health certificate provided for in paragraph 1(a):

(a)	if the pigs have not left the holding of provenance for the slaughterhouse, they are to be reexamined and a new health certificate issued;

(b)	if the pigs are already en route for or at the slaughterhouse, slaughter may be authorised once the reason for the delay has been assessed, provided that the pigs undergo a further veterinary ante-mortem inspection.

B. POST-MORTEM INSPECTION

Carcases and offal of pigs other than those referred to in paragraph 2 are to undergo the following post-mortem inspection procedures:

(a)	visual inspection of the head and throat; incision and examination of the submaxillary lymph nodes (Lnn. mandibulares); visual inspection of the mouth, fauces and tongue;

(b)

visual inspection of the lungs, trachea and oesophagus; palpation of the lungs and the bronchial and mediastinal lymph nodes (Lnn. bifucationes, eparteriales and mediastinales). The trachea and the main branches of the bronchi must be opened lengthwise and the lungs must be incised in their posterior third, perpendicular to their main axes; these incisions are not necessary where the lungs are excluded from human consumption;

(c)	visual inspection of the pericardium and heart, the latter being incised lengthwise so as to open the ventricles and cut through the interventricular septum;

(d)	visual inspection of the diaphragm;

(e)	visual inspection of the liver and the hepatic and pancreatic lymph nodes, (Lnn portales); palpation of the liver and its lymph nodes;

(f)	visual inspection of the gastro-intestinal tract, the mesentery, the gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales); palpation and, if necessary, incision of the gastric and mesenteric lymph nodes;

(g)	visual inspection and, if necessary, palpation of the spleen;

(h)	visual inspection of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes (Lnn. renales);

(i)	visual inspection of the pleura and peritoneum;

(j)	visual inspection of the genital organs (except for the penis, if already discarded);

(k)	visual inspection of the udder and its lymph nodes (Lnn. supramammarii); incision of the supramammary lymph nodes in sows;

(l)	visual inspection and palpation of the umbilical region and joints of young animals; in the event of doubt, the umbilical region must be incised and the joints opened.

The competent authority may decide, on the basis of epidemiological or other data from the holding, that fattening pigs housed under controlled housing conditions in integrated production systems since weaning need, in some or all of the cases referred to in paragraph 1, only undergo visual inspection.

CHAPTER V: POULTRY

A. ANTE-MORTEM INSPECTION

The competent authority may decide that poultry intended for slaughter are to be submitted to ante-mortem inspection at the holding of provenance. In that case, slaughter of a flock of birds from a holding may be authorised only if:

(a)	the health certificate provided for in Chapter X, Part A, accompanies them; and

(b)	the requirements of paragraphs 2 to 5 are complied with.

Ante-mortem inspection on the holding of provenance is to comprise:

(a)	checks on records or documentation at the holding, including food chain information;

(b)

a flock inspection, to determine whether the birds:

(i)	have a disease or condition which may be transmitted to animals or humans through handling or eating the meat, or are behaving in a manner indicating that such a disease may occur,

(ii)	show disturbance of general behaviour or signs of disease which may make the meat unfit for human consumption, or

(iii)

show evidence that they may contain chemical residues in excess of the levels laid down in Community legislation, or residues of forbidden substances.

3.	An official veterinarian or an approved veterinarian is to carry out ante-mortem inspection at the holding.

Ante-mortem inspection at the slaughterhouse need only cover:

(a)	a control of the animals' identification; and

(b)	a screening to ascertain whether animal welfare rules have been complied with and whether signs of any condition which might adversely affect human or animal health are present. An official auxiliary may carry out this screening.

When birds are not slaughtered within three days of the issue of the health certificate referred to in paragraph 1(a):

(a)	if the flock has not left the holding of provenance for the slaughterhouse, it is to be reexamined and a new health certificate issued;

(b)	if the flock is already en route for or at the slaughterhouse, slaughter may be authorised once the reason for the delay has been assessed, provided that the flock is re-examined.

6.	When ante-mortem inspection is not carried out at the holding, the official veterinarian is to carry out a flock inspection at the slaughterhouse.

If the birds show clinical symptoms of a disease, they may not be slaughtered for human consumption. However, killing of these birds on the slaughter line may take place at the end of the normal slaughter process, if precautions are taken to avoid the risk of spreading pathogenic organisms and to clean and disinfect the facilities immediately after killing.

In the case of poultry reared for the production of ‘foie gras’ and delayed eviscerated poultry slaughtered at the holding of provenance, ante-mortem inspection is to be carried out in accordance with paragraphs 2 and 3. A certificate conforming to the model set out in Part C is to accompany the uneviscerated carcasses to the slaughterhouse or cutting plant.

B. POST-MORTEM INSPECTION

All birds are to undergo post-mortem inspection in accordance with Sections I and III. In addition, the official veterinarian is personally to carry out the following checks:

(a)	daily inspection of the viscera and body cavities of a representative sample of birds;

(b)	a detailed inspection of a random sample, from each batch of birds having the same origin, of parts of birds or entire birds declared unfit for human consumption following post-mortem inspection; and

(c)	any further investigations necessary when there is reason to suspect that the meat from the birds concerned could be unfit for human consumption.

In the case of poultry reared for the production of ‘foie gras’ and delayed eviscerated poultry obtained at the holding of provenance, post-mortem inspection is to include a check on the certificate accompanying the carcases. When such carcases are transported directly from the holding to a cutting plant, post-mortem inspection is to take place at the cutting plant.

C. SPECIMEN HEALTH CERTIFICATE

HEALTH CERTIFICATE

for poultry intended for the production of foie gras and delayed eviscerated poultry slaughtered at the holding of provenance

Competent service: ...

No: ...

1. Identification of uneviscerated carcases

Species: ...

Number: ...

2. Provenance of uneviscerated carcases

Address of holding: ...

3. Destination of uneviscerated carcases

The uneviscerated carcases will be transported to the following cutting plant: ...

4. Declaration

I, the undersigned, declare that:

—	the uneviscerated carcases described above are of birds which were examined before slaughter on the abovementioned holding at ... (time) on ... (date) and found to be healthy;

—	the records and documentation concerning these animals satisfied the legal requirements and do not prohibit slaughter of the birds.

Done at: ...

(Place)

on: ...

(Date)

Stamp

...

(Signature of the official or approved veterinarian)

CHAPTER VI: FARMED LAGOMORPHS

The requirements for poultry are to apply to farmed lagomorphs.

CHAPTER VII: FARMED GAME

A. ANTE-MORTEM INSPECTION

1.	Ante-mortem inspection may be carried out at the holding of provenance when the requirements of Annex III, Section III, to Regulation (EC) No .../2004 (8) are satisfied. In this case, an official veterinarian or an approved veterinarian is to carry out ante-mortem inspection.

2.	Ante-mortem inspection at the holding is to include checks on the records or documentation at the holding, including food chain information.

When ante-mortem inspection takes place no more than three days before the arrival of the animals at the slaughterhouse, and animals are delivered to the slaughterhouse live, ante-mortem inspection at the slaughterhouse need only cover:

(a)	a control of the animals' identification; and

(b)	a screening to ascertain whether animal welfare rules have been complied with and whether signs of any condition which might adversely affect human or animal health are present.

4.	A certificate conforming to the specimen in Chapter X, Part A, is to accompany live animals inspected at the holding. A certificate conforming to the specimen in Chapter X, Part B, is to accompany animals inspected and slaughtered at the holding.

B. POST-MORTEM INSPECTION

1.	This inspection is to include palpation and, where judged necessary, incision of those parts of the animal which have undergone any change or are suspect for any other reason.

2.	Post-mortem inspection procedures described for bovine and ovine animals, domestic swine and poultry are to be applied to the corresponding species of farmed game.

3.	When the animals have been slaughtered at the holding, the official veterinarian at the slaughterhouse is to check the certificate accompanying them.

CHAPTER VIII: WILD GAME

A. POST-MORTEM INSPECTION

1.	Wild game is to be inspected as soon as possible after admission to the game handling establishment.

2.	The official veterinarian is to take account of the declaration or information that the trained person involved in hunting the animal has provided in accordance with Regulation (EC) No .../2004 (9).

During post-mortem inspection, the official veterinarian is to carry out:

(a)

a visual examination of the carcase, its cavities and, where appropriate, organs with a view to:

(i)	detecting any abnormalities not resulting from the hunting process. For this purpose, the diagnosis may be based on any information that the trained person has provided concerning the behaviour of the animal before killing,

(ii)	checking that death was not caused by reasons other than hunting.

If an assessment cannot be made on the basis of visual examination alone, a more extensive inspection must be carried out in a laboratory;

(b)	an investigation of organoleptic abnormalities;

(c)	palpation of organs, where appropriate;

(d)

where there are serious grounds for suspecting the presence of residues or contaminants, an analysis by sampling of residues not resulting from the hunting process, including environmental contaminants. When a more extensive inspection is made on the basis of such suspicions, the veterinarian must wait until that inspection has been concluded before assessing all the game killed during a specific hunt, or those parts suspected of showing the same abnormalities;

(e)

examination for characteristics indicating that the meat presents a health risk, including:

(i)	abnormal behaviour or disturbance of the general condition of the live animal, as reported by the hunter,

(ii)	the generalised presence of tumours or abscesses affecting different internal organs or muscles,

(iii)

arthritis, orchitis, pathological changes in the liver or the spleen, inflammation of the intestines or the umbilical region,

(iv)	the presence of foreign bodies not resulting from the hunting process in the body cavities, stomach or intestines or in the urine, where the pleura or peritoneum are discoloured (when relevant viscera are present),

(v)	the presence of parasites,

(vi)	formation of a significant amount of gas in the gastro-intestinal tract with discolouring of the internal organs (when these viscera are present),

(vii)

significant abnormalities of colour, consistency or odour of muscle tissue or organs,

(viii)

aged open fractures,

(ix)	emaciation and/or general or localised oedema,

(x)	recent pleural or peritoneal adhesions, and

(xi)	other obvious extensive changes, such as putrefaction.

4.	Where the official veterinarian so requires, the vertebral column and the head are to be split lengthwise.

In the case of small wild game not eviscerated immediately after killing, the official veterinarian is to carry out a post-mortem inspection on a representative sample of animals from the same source. Where inspection reveals a disease transmissible to man or any of the characteristics listed in paragraph 3(e), the official veterinarian is to carry out more checks on the entire batch to determine whether it must be declared unfit for human consumption or whether each carcase must be inspected individually.

6.	In the event of doubt, the official veterinarian may perform any further cuts and inspections of the relevant parts of the animals necessary to reach a final diagnosis.

B. DECISIONS FOLLOWING CONTROLS

In addition to the cases provided for in Section II, Chapter V, meat presenting during post-mortem inspection any of the characteristics listed in paragraph 3(e) of Part A are to be declared unfit for human consumption.

CHAPTER IX: SPECIFIC HAZARDS

A. TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

Official controls carried out in relation to TSEs are to take account of the requirements of Regulation (EC) No 999/2001 and other relevant Community legislation.

B. CYSTICERCOSIS

The post-mortem inspection procedures described in Chapters I and IV are the minimum requirements for the examination for cysticercosis in bovine animals over 6 weeks old and swine. In addition, specific serological tests may be used. In the case of bovines over 6 weeks old, incision of the masseters at post-mortem inspection is not compulsory when a specific serological test is used. The same applies when bovine animals over 6 weeks old have been raised on a holding officially certified to be free of cysticercosis.

2.	Meat infected with cysticercus is to be declared unfit for human consumption. However, when the animal is not generally infected with cysticercus, the parts not infected may be declared fit for human consumption after having undergone a cold treatment.

C. TRICHINOSIS

1.	Carcases of swine (domestic, farmed game and wild game), solipeds and other species susceptible to trichinosis are to be examined for trichinosis in accordance with applicable Community legislation, unless that legislation provides otherwise.

2.	Meat from animals infected with trichinae is to be declared unfit for human consumption.

D. GLANDERS

Where appropriate, solipeds are to be examined for glanders. Examination for glanders in solipeds is to include a careful examination of mucous membranes from the trachea, larynx, nasal cavities and sinuses and their ramifications, after splitting the head in the median plane and excising the nasal septum.

2.	Meat from horses in which glanders has been diagnosed are to be declared unfit for human consumption.

E. TUBERCULOSIS

When animals have reacted positively or inconclusively to tuberculin, or there are other grounds for suspecting infection, they are to be slaughtered separately from other animals, taking precautions to avoid the risk of contamination of other carcases, the slaughter line and staff present in the slaughterhouse.

All meat from animals in which post-mortem inspection has revealed localised tuberculous lesions in a number of organs or a number of areas of the carcase is to be declared unfit for human consumption. However, when a tuberculous lesion has been found in the lymph nodes of only one organ or part of the carcase, only the affected organ or part of the carcase and the associated lymph nodes need be declared unfit for human consumption.

F. BRUCELLOSIS

When animals have reacted positively or inconclusively to a brucellosis test, or there are other grounds for suspecting infection, they are to be slaughtered separately from other animals, taking precautions to avoid the risk of contamination of other carcases, the slaughter line and staff present in the slaughterhouse.

Meat from animals in which post mortem inspection has revealed lesions indicating acute infection with brucellosis is to be declared unfit for human consumption. In the case of animals reacting positively or inconclusively to a brucellosis test, the udder, genital tract and blood must be declared unfit for human consumption even if no such lesion is found.

CHAPTER X: SPECIMEN HEALTH CERTIFICATE

A. SPECIMEN HEALTH CERTIFICATE FOR LIVE ANIMALS

HEALTH CERTIFICATE

for live animals transported from the holding to the slaughterhouse

Competent service: ...

No: ...

1. Identification of the animals

Species: ...

Number of animals: ...

Identification marking: ...

2. Provenance of the animals

Address of holding of provenance: ...

Identification of house (10) ...

3. Destination of the animals

The animals will be transported to the following slaughterhouse: ...

by the following means of transport: ...

4. Other relevant information

...

5. Declaration

I, the undersigned, declare that:

—	the animals described above were examined before slaughter at the above-mentioned holding at ... (time) on ... (date) and were found to be healthy,

—	the records and documentation concerning these animals satisfied the legal requirements and do not prohibit slaughter of the animals.

Done at: ...

(Place)

on: ...

(Date)

Stamp

...

(Signature of official or approved veterinarian)

B. SPECIMEN HEALTH CERTIFICATE FOR ANIMALS SLAUGHTERED AT THE HOLDING

HEALTH CERTIFICATE

for animals slaughtered at the holding

Competent service: ...

No: ...

1. Identification of the animals

Species: ...

Number of animals: ...

Identification marking: ...

2. Provenance of the animals

Address of holding of provenance: ...

Identification of house (11): ...

3. Destination of the animals

The animals will be transported to the following slaughterhouse: ...

by the following means of transport: ...

4. Other relevant information

...

5. Declaration

I, the undersigned, declare that:

—	the animals described above were examined before slaughter at the above-mentioned holding at ... (time) on ... (date) and were found to be healthy,

—	they were slaughtered at the holding at ... (time) on ... (date) and slaughter and bleeding were carried out correctly,

—	the records and documentation concerning these animals satisfied the legal requirements and did not prohibit slaughter of the animals.

Done at: ...

(Place)

on: ...

(Date)

Stamp

...

(Signature of official or approved veterinarian)

(1) Not yet published in the OJ.

(2) OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 2245/2003 (OJ L 133, 20.12.2003, p. 28).

(3) OJ L 125, 23.5.1996, p. 10. Directive as amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

(4) Not yet published in the OJ.

(5) Not yet published in the OJ.

(6) Not yet published in the OJ.

(7) OJ L 121, 29.7.1964, p. 1977/64. Directive as last amended by Commission Regulation (EC) No 21/2004 (OJ L 5, 9.1.2004, p. 8).

(8) Not yet published in the OJ.

(9) Not yet published in the OJ.

(10) Optional.

(11) Optional.

ANNEX II

LIVE BIVALVE MOLLUSCS

CHAPTER I: SCOPE

This Annex applies to live bivalve molluscs and, by analogy, to live echinoderms, live tunicates and live marine gastropods.

CHAPTER II: OFFICIAL CONTROLS CONCERNING LIVE BIVALVE MOLLUSCS FROM CLASSIFIED PRODUCTION AREAS

A. CLASSIFICATION OF PRODUCTION AND RELAYING AREAS

1.	The competent authority must fix the location and boundaries of production and relaying areas that it classifies. It may, where appropriate, do so in cooperation with the food business operator.

2.	The competent authority must classify production areas from which it authorises the harvesting of live bivalve molluscs as being of one of three categories according to the level of faecal contamination. It may, where appropriate, do so in cooperation with the food business operator.

The competent authority may classify as being of Class A areas from which live bivalve molluscs may be collected for direct human consumption. Live bivalve molluscs taken from these areas must meet the health standards for live bivalve molluscs laid down in Annex III, Section VII, Chapter V, of Regulation (EC) No .../2004 (1).

The competent authority may classify as being of Class B areas from which live bivalve molluscs may be collected, but placed on the market for human consumption only after treatment in a purification centre or after relaying so as to meet the health standards referred to in paragraph 3. Live bivalve molluscs from these areas must not exceed the limits of a five-tube, three dilution Most Probable Number (MPN) test of 4 600E. coli per 100 g of flesh and intravalvular liquid.

The competent authority may classify as being of Class C areas from which live bivalve molluscs may be collected but placed on the market only after relaying over a long period so as to meet the health standards referred to in paragraph 3. Live bivalve molluscs from these areas must not exceed the limits of a five-tube, three dilution MPN test of 46 000E. coli per 100 g of flesh and intravalvular liquid.

If the competent authority decides in principle to classify a production or relaying area, it must:

(a)	make an inventory of the sources of pollution of human or animal origin likely to be a source of contamination for the production area;

(b)	examine the quantities of organic pollutants which are released during the different periods of the year, according to the seasonal variations of both human and animal populations in the catchment area, rainfall readings, waste water treatment, etc.;

(c)	determine the characteristics of the circulation of pollutants by virtue of current patterns, bathymetry and the tidal cycle in the production area; and

(d)

establish a sampling programme of bivalve molluscs in the production area which is based on the examination of established data, and with a number of samples, a geographical distribution of the sampling points and a sampling frequency which must ensure that the results of the analysis are as representative as possible for the area considered.

B. MONITORING OF CLASSIFIED RELAYING AND PRODUCTION AREAS

Classified relaying and production areas must be periodically monitored to check:

(a)	that there is no malpractice with regard to the origin, provenance and destination of live bivalve molluscs;

(b)	the microbiological quality of live bivalve molluscs in relation to the production and relaying areas;

(c)	for the presence of toxin-producing plankton in production and relaying waters and biotoxins in live bivalve molluscs; and

(d)	for the presence of chemical contaminants in live bivalve molluscs.

To implement paragraph 1(b), (c) and (d), sampling plans must be drawn up providing for such checks to take place at regular intervals, or on a case-by-case basis if harvesting periods are irregular. The geographical distribution of the sampling points and the sampling frequency must ensure that the results of the analysis are as representative as possible for the area considered.

Sampling plans to check the microbiological quality of live bivalve molluscs must take particular account of:

(a)	the likely variation in faecal contamination, and

(b)	the parameters referred to in paragraph 6 of Part A.

Sampling plans to check for the presence of toxin-producing plankton in production and relaying waters and for biotoxins in live bivalve molluscs must take particular account of possible variations in the presence of plankton containing marine biotoxins. Sampling must comprise:

(a)	periodic sampling to detect changes in the composition of plankton containing toxins and their geographical distribution. Results suggesting an accumulation of toxins in mollusc flesh must be followed by intensive sampling;

(b)	periodic toxicity tests using those molluscs from the affected area most susceptible to contamination.

The sampling frequency for toxin analysis in the molluscs is, as a general rule, to be weekly during the periods at which harvesting is allowed. This frequency may be reduced in specific areas, or for specific types of molluscs, if a risk assessment on toxins or phytoplankton occurrence suggests a very low risk of toxic episodes. It is to be increased where such an assessment suggests that weekly sampling would not be sufficient. The risk assessment is to be periodically reviewed in order to assess the risk of toxins occurring in the live bivalve molluscs from these areas.

When knowledge of toxin accumulation rates is available for a group of species growing in the same area, a species with the highest rate may be used as an indicator species. This will allow the exploitation of all species in the group if toxin levels in the indicator species are below the regulatory limits. When toxin levels in the indicator species are above the regulatory limits, harvesting of the other species is only to be allowed if further analysis on the other species shows toxin levels below the limits.

With regard to the monitoring of plankton, the samples are to be representative of the water column and to provide information on the presence of toxic species as well as on population trends. If any changes in toxic populations that may lead to toxin accumulation are detected, the sampling frequency of molluscs is to be increased or precautionary closures of the areas are to be established until results of toxin analysis are obtained.

8.	Sampling plans to check for the presence of chemical contaminants must enable the detection of any overshooting of the levels laid down in Commission Regulation (EC) No 466/2001 (2).

C. DECISIONS AFTER MONITORING

Where the results of sampling show that the health standards for molluscs are exceeded, or that there may be otherwise a risk to human health, the competent authority must close the production area concerned, preventing the harvesting of live bivalve molluscs. However, the competent authority may reclassify a production area as being of Class B or C if it meets the relevant criteria set out in Part A and presents no other risk to human health.

The competent authority may re-open a closed production area only if the health standards for molluscs once again comply with Community legislation. If the competent authority closes a production because of the presence of plankton or excessive levels of toxins in molluscs, at least two consecutive results below the regulatory limit separated at least 48 hours are necessary to reopen it. The competent authority may take account of information on phytoplankton trends when taking this decision. When there are robust data on the dynamic of the toxicity for a given area, and provided that recent data on decreasing trends of toxicity are available, the competent authority may decide to re-open the area with results below the regulatory limit obtained from one single sampling.

D. ADDITIONAL MONITORING REQUIREMENTS

1.	The competent authority is to monitor classified production areas from which it has forbidden the harvesting of bivalve molluscs or subjected harvesting to special conditions, to ensure that products harmful to human health are not placed on the market.

In addition to the monitoring of relaying and production zones referred to in paragraph 1 of Part B, a control system must be set up comprising laboratory tests to verify food business operators' compliance with the requirements for the end product at all stages of production, processing and distribution. This control system is, in particular, to verify that the levels of marine biotoxins and contaminants do not exceed safety limits and that the microbiological quality of the molluscs does not constitute a hazard to human health.

E. RECORDING AND EXCHANGE OF INFORMATION

The competent authority must:

(a)

establish and keep up to date a list of approved production and relaying areas, with details of their location and boundaries, as well as the class in which the area is classified, from which live bivalve molluscs may be taken in accordance with the requirements of this Annex. This list must be communicated to interested parties affected by this Annex, such as producers, gatherers and operators of purification centres and dispatch centres;

(b)	immediately inform the interested parties affected by this Annex, such as producers, gatherers and operators of purification centres and dispatch centres, about any change of the location, boundaries or class of a production area, or its closure, be it temporary or final; and

(c)	act promptly where the controls prescribed in this Annex indicate that a production area must be closed or reclassified or can be re-opened.

F. FOOD BUSINESS OPERATORS' OWN-CHECKS

To decide on the classification, opening or closure of production areas, the competent authority may take into account the results of controls that food business operators or organisations representing food business operators have carried out. In that event, the competent authority must have designated the laboratory carrying out the analysis and, if necessary, sampling and analysis must have taken place in accordance with a protocol that the competent authority and the food business operators or organisation concerned have agreed.

CHAPTER III: OFFICIAL CONTROLS CONCERNING PECTINIDAE HARVESTED OUTSIDE CLASSIFIED PRODUCTION AREAS

Official controls on pectinidae harvested outside classified production areas are to be carried out in fish auctions, dispatch centres and processing establishments. Such official controls are to verify compliance with the health standards for live bivalve molluscs laid down in Annex III, Section VII, Chapter V, to Regulation (EC) No .../2004 (3) as well as compliance with other requirements of Annex III, Section VII, Chapter IX, to that Regulation.

(1) Not yet published in the OJ.

(2) OJ L 77, 16.3.2001, p. 1. Regulation as last amended by Regulation (EC) No 655/2004 (OJ L 104, 8.4.2004, p. 48).

(3) Not yet published in the OJ.

ANNEX III

FISHERY PRODUCTS

CHAPTER I: OFFICIAL CONTROLS OF PRODUCTION AND PLACING ON THE MARKET

Official controls on the production and placing on the market of fishery products are to include, in particular:

(a)	a regular check on the hygiene conditions of landing and first sale;

(b)

inspections at regular intervals of vessels and establishments on land, including fish auctions and wholesale markets, to check, in particular:

(i)	where appropriate, whether the conditions for approval are still fulfilled,

(ii)	whether the fishery products are handled correctly,

(iii)

for compliance with hygiene and temperature requirements, and

(iv)	the cleanliness of establishments, including vessels, and their facilities and equipment, and staff hygiene; and

(c)	checks on storage and transport conditions.

However, subject to paragraph 3, official controls of vessels:

(a)	may be carried out when vessels call at a port in a Member State;

(b)	concern all vessels landing fishery products at ports in the Community, irrespective of flag; and

(c)	may, if necessary, when the competent authority of the Member State the flag of which the vessel is flying carries out the official control, be carried out while the vessel is at sea or when it is in a port in another Member State or in a third country.

(a)

In the case of an inspection of a factory or freezer vessel flying the flag of a Member State carried out with a view to the approval of the vessel, the competent authority of the Member State the flag of which the vessel is flying is to carry out inspections in such a manner as to comply with the requirements of Article 3, particularly the time limits of Article 3(2). If necessary, that competent authority may inspect the vessel while it is at sea or when it is in a port in another Member State or in a third country.

(b)

When the competent authority of the Member State the flag of which the vessel is flying has granted the vessel conditional approval in accordance with Article 3, that competent authority may authorise a competent authority of:

(i)	another Member State, or

(ii)	a third country that appears on a list of third countries from which imports of fishery products are permitted drawn up in accordance with Article 11,

to carry out a follow-up inspection with a view to granting full approval or prolonging conditional approval in accordance with Article 3(1)(b) or to keeping approval under review in accordance with Article 3(4). If necessary, that competent authority may inspect the vessel while it is at sea or when it is in a port in another Member State or in a third country.

When the competent authority of a Member State authorises the competent authority of another Member State or of a third country to carry out inspections on its behalf in accordance with paragraph 3, the two competent authorities are to agree on the conditions governing such inspections. These conditions are to ensure, in particular, that the competent authority of the Member State the flag of which the vessel is flying receives reports on the results of inspections and on any suspected non-compliance without delay, so as to enable it to take the necessary measures.

CHAPTER II: OFFICIAL CONTROLS OF FISHERY PRODUCTS

Official controls of fishery products are to include at least the following elements.

A. ORGANOLEPTIC EXAMINATIONS

Random organoleptic checks must be carried out at all stages of production, processing and distribution. One aim of these checks is to verify compliance with the freshness criteria established in accordance with Community legislation. In particular, this includes verifying, at all stages of production, processing and distribution, that fishery products at least exceed the baselines of freshness criteria established in accordance with Community legislation.

B. FRESHNESS INDICATORS

When the organoleptic examination reveals any doubt as to the freshness of the fishery products, samples may be taken and subjected to laboratory tests to determine the levels of total volatile basic nitrogen (TVB-N) and trimethylamine nitrogen (TMA-N).

The competent authority is to use the criteria laid down under Community legislation.

When the organoleptic examination gives cause to suspect the presence of other conditions which may affect human health, appropriate samples are to be taken for verification purposes.

C. HISTAMINE

Random testing for histamine is to be carried out to verify compliance with the permitted levels laid down under Community legislation.

D. RESIDUES AND CONTAMINANTS

Monitoring arrangements are to be set up to control the levels of residues and contaminants in accordance with Community legislation.

E. MICROBIOLOGICAL CHECKS

Where necessary, microbiological checks are to be performed in accordance with the relevant rules and criteria laid down under Community legislation.

F. PARASITES

Random testing is to take place to verify compliance with Community legislation on parasites.

G. POISONOUS FISHERY PRODUCTS

Checks are to take place to ensure that the following fishery products are not placed on the market:

1.	poisonous fish of the following families are not placed on the market: Tetraodontidae, Molidae, Diodontidae and Canthigasteridae; and

fishery products containing biotoxins such as Ciguatera or other toxins dangerous to human health. However, fishery products derived from bivalve molluscs, echinoderms, tunicates and marine gastropods may be placed on the market if they have been produced in accordance with Section VII of Annex III to Regulation (EC) No.../2004 (1) and comply with the standards laid down in Chapter V, point 2, of that Section.

CHAPTER III: DECISIONS AFTER CONTROLS

Fishery products are to be declared unfit for human consumption if:

1.	organoleptic, chemical, physical or microbiological checks or checks for parasites have shown that they are not in compliance with the relevant Community legislation;

2.	they contain in their edible parts contaminants or residues in excess of the limits laid down in Community legislation or at levels where the calculated dietary intake would exceed the acceptable daily or weekly intake for humans;

they derive from:

(i)	poisonous fish,

(ii)	fishery products not complying with the requirement of Part G, point 2, of Chapter II concerning biotoxins, or

(iii)

bivalve molluscs, echinoderms, tunicates or marine gastropods containing marine biotoxins in total quantities exceeding the limits referred to in Regulation (EC) No .../2004 (1); or

4.	the competent authority considers that they may constitute a risk to public or animal health or are for any other reason not suitable for human consumption.

(1) Not yet published in the OJ.

ANNEX IV

RAW MILK AND DAIRY PRODUCTS

CHAPTER I: CONTROL OF MILK PRODUCTION HOLDINGS

Animals on milk production holdings must be subject to official controls to verify that the health requirements for raw milk production, and in particular the health status of the animals and the use of veterinary medicinal products, are being complied with. These controls may take place at the occasion of veterinary checks carried out pursuant to Community provisions on animal or public health or animal welfare and may be carried out by an approved veterinarian.

2.	If there are grounds for suspecting that the animal health requirements are not being complied with, the general health status of the animals is to be checked.

Milk production holdings are to undergo official controls to verify that hygiene requirements are being complied with. These official controls may involve inspections and/or the monitoring of controls that professional organisations carry out. If it is shown that the hygiene is inadequate, the competent authority is to verify that appropriate steps are taken to correct the situation.

CHAPTER II: CONTROL OF RAW MILK UPON COLLECTION

1.	The competent authority is to monitor the checks carried out in accordance with Annex III, Section IX, Chapter I, Part III, to Regulation (EC) No .../2004 (1).

If the food business operator has not corrected the situation within three months of first notifying the competent authority of non-compliance with the criteria with regard to plate count and somatic cell count, delivery of raw milk from the production holding is to be suspended or — in accordance with a specific authorisation of, or general instructions from, the competent authority — subjected to requirements concerning its treatment and use necessary to protect public health. This suspension or these requirements are to remain in place until the food business operator has proved that the raw milk again complies with the criteria.

(1) Not yet published in the OJ.

ANNEX V

ESTABLISHMENTS NOT SUBJECT TO THE LISTING REQUIREMENT OF ARTICLE 12(1)

The following third country establishments need not appear on lists drawn up and updated in accordance with Article 12(4):

1.	establishments handling products of animal origin for which Annex III to Regulation (EC) No .../2004 (1) does not lay down requirements;

2.	establishments carrying out only primary production;

3.	establishments carrying out only transport operations;

4.	establishments carrying out only the storage of products of animal origin not requiring temperaturecontrolled storage conditions.

(1) Not yet published in the OJ.

ANNEX VI

REQUIREMENTS FOR CERTIFICATES ACCOMPANYING IMPORTS

The representative of the competent authority of the third country of dispatch issuing a certificate to accompany a consignment of products of animal origin destined for the Community must sign the certificate and ensure that it bears an official stamp. This requirement applies to each sheet of the certificate if it consists of more than one. In the case of factory vessels, the competent authority may authorise the captain or another ship's officer to sign the certificate.

Certificates must be drawn up in the official language or languages of the third country of dispatch and the Member State in which the border inspection takes place, or be accompanied by a certified translation into that language or languages. If the Member State of destination so requests, certificates must also be accompanied by a certified translation into the official language or languages of that Member State. However, a Member State may consent to the use of an official Community language other than its own.

3.	The original version of the certificate must accompany consignments on entry into the Community.

Certificates must consist of:

(a)	a single sheet of paper; or

(b)	two or more pages that are part of an integrated and indivisible sheet of paper; or

(c)	a sequence of pages numbered so as to indicate that it is a particular page in a finite sequence (for example, ‘page 2 of 4 pages’).

5.	Certificates must bear a unique identifying number. Where the certificate consists of a sequence of pages, each page must indicate this number.

6.	The certificate must be issued before the consignment to which it relates leaves the control of the competent authority of the third country of dispatch.

P5_TA(2004)0220

Transparency for securities traded on a regular market ***I

European Parliament legislative resolution on the proposal for a European Parliament and Council directive on the harmonisation of transparency requirements with regard to information about issuers whose securities are admitted to trading on a regulated market and amending Directive 2001/34/EC (COM(2003) 138 — C5-0151/2003 — 2003/0045(COD))

(Codecision procedure: first reading)

The European Parliament,

—	having regard to the Commission proposal to the European Parliament and the Council (COM(2003) 138) (1),

—	having regard to Articles 251(2) and Articles 44 and 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C5-0151/2003),

—	having regard to Rule 67 of its Rules of Procedure,

—	having regard to the report of the Committee on Economic and Monetary Affairs and the opinion of the Committee on Legal Affairs and the Internal Market (A5-0079/2004),

1.	Approves the Commission proposal as amended;

2.	Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal substantially or replace it with another text;

3.	Instructs its President to forward its position to the Council and Commission.

(1) Not yet published in the OJ.

P5_TC1-COD(2003)0045

Position of the European Parliament adopted at first reading on 30 March 2004 with a view to the adoption of European Parliament and Council Directive 2004/.../EC on the harmonisation of transparency requirements with regard to information about issuers whose securities are admitted to trading on a regulated market and amending Directive 2001/34/EC

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Articles 44 and 95 thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Economic and Social Committee (2),

Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),

Whereas:

(1)

Efficient, transparent and integrated securities markets contribute to a genuine single market in the Community and foster growth and job creation by better allocation of capital and by reducing costs. The disclosure of accurate, comprehensive and timely information about security issuers builds sustained investor confidence and allows an informed assessment of their business performance and assets. This enhances both investor protection and market efficiency.

(2)

To that end, security issuers should ensure appropriate transparency towards investors through a regular flow of information. To the same end, shareholders, or natural persons or legal entities holding voting rights or financial instruments that result in an entitlement to acquire existing shares with voting rights, should also inform issuers of the acquisition or other changes of major holdings in companies so that the latter are in a position to keep the public informed.

(3)

The Commission Communication of 11 May 1999, entitled ‘Implementing the framework for financial markets: Action Plan’ (4), identifies a series of actions that are needed in order to complete the single market for financial services. The Lisbon European Council of March 2000 called for the implementation of that Action Plan by 2005. The Action Plan stresses the need to draw up a Directive upgrading transparency requirements. That need was confirmed by the Barcelona European Council of March 2002.

(4)

This Directive should ensure its compatibility with the tasks and duties conferred upon the ESCB and the Member States' central banks by the Treaty and the Statute of the ESCB; particular attention in this regard needs to be given to the Member States' central banks whose shares are presently admitted to trading on a regulated market, in order to guarantee the pursuit of primary Community law objectives.

(5)

Greater harmonisation of provisions of national law on periodic and ongoing information requirements for security issuers should lead to a high level of investor protection throughout the Community. However, this Directive does not affect existing Community legislation on units issued by collective investment undertakings other than the closed-end type, or on units acquired or disposed of through such undertakings.

(6)

Supervision of an issuer of shares, or of debt securities the denomination per unit of which is less than EUR 1 000, for the purposes of this Directive would be best effected by the Member State in which the issuer has its registered office. In that respect, it is vital to ensure consistency with Directive 2003/71/EC of the European Parliament and the Council of 4 November 2003 on the prospectus to be published when securities are offered to the public or admitted to trading (5). Along the same lines, some flexibility should be introduced allowing third country issuers and EU companies issuing only other securities than those mentioned above a choice of home Member State.

(7)

A high level of investor protection throughout the Community would enable the removal of barriers to the admission of securities to regulated markets situated or operating in the territory of a Member State. Member States other than the home Member State should no longer be allowed to restrict admission of securities to their regulated markets by imposing more stringent requirements on periodic and ongoing information about issuers whose securities are admitted to trading on a regulated market.

(8)

The removal of barriers on the basis of the home Member State principle under this Directive should not affect areas not covered by this Directive, such as rights of shareholders to intervene in the management of an issuer. It should also not affect the home Member State's right to request the issuer to publish, in addition, parts or all regulated information through newspapers.

(9)

Regulation (EC) No 1606/2002 of the European Parliament and of the Council of 19 July 2002 on the application of international accounting standards (6) has already paved the way for a convergence of financial reporting standards throughout the Community for issuers whose securities are admitted to trading on a regulated market and who are required to prepare consolidated accounts. Thus, a specific regime for security issuers beyond the general system for all companies, as laid down in the Company Law Directives, is already established. This Directive continues to build on this approach with regard to annual and interim financial reporting , including the principle of providing a true and fair view of an issuer's assets, liabilities, financial position and profit or loss. A condensed set of financial statements, as part of a half-yearly financial report, also represents a sufficient basis for giving such a true and fair view of the first six months of an issuer's financial year .

(10)

An annual financial report should ensure information over the years once the issuer's securities have been admitted to a regulated market. Better comparability of annual financial reports only serve investors in securities markets if they can be sure that this information will be published within a certain time after the end of the financial year. As regards debt securities which have already been admitted to trading on a regulated market prior to 1 January 2005 and which have been issued by issuers incorporated in a third country, the home Member State may under certain conditions allow issuers not to prepare annual financial reports according to the standards required under this Directive.

(11)	The Directive will introduce more comprehensive half-yearly financial reports for issuers of shares admitted to trading on a regulated market. This should allow investors to make a more informed assessment of the issuer's situation.

(12)

A home Member State may provide for exemptions from half-yearly reporting by issuers of debt securities in the case of:

—	credit institutions acting as small-size issuers of debt securities, or

—	issuers already existing at the entry into force of this Directive, who exclusively issue debt securities unconditionally and irrevocably guaranteed by the home Member State or by one of its regional or local authorities, or

—

during a transitional period of ten years, only in respect of those debt securities which have already been admitted to trading on a regulated market prior to 1 January 2005 and which may be purchased by professional investors only. If such an exemption is given by the home Member State, it may not be extended in respect of any debt securities which will be admitted to a regulated market thereafter.

(13)

The European Parliament and the Council welcome the Commission's commitment to rapidly consider enhancing transparency on the remuneration policies, the total remuneration paid (including any contingent or deferred compensation) and benefits in kind granted to each member of the administrative, management or supervisory bodies under its Action Plan for ‘Modernising Company Law and Enhancing Corporate Governance in the European Union’ of 21 May 2003 and the Commission's intention to bring forward a recommendation on this topic in the near future.

(14)

The home Member State should encourage issuers whose shares are admitted to trading on a regulated market and whose principal activities lie in the extractive industry to disclose payments to governments in their annual financial report. The home Member State should also encourage an increase in the transparency of such payments within the framework established at various international financial fora.

(15)

The Directive will also make mandatory half-yearly reporting for issuers of only debt securities on regulated markets. Exemptions should only be provided for wholesale markets on the basis of an individual denomination per unit starting at EUR 50 000, as under Directive 2003/71/EC. Where debt securities are issued in another currency, exemptions are only possible where the denomination per unit in such a currency is, at the date of the issue, at least equivalent to the threshold above.

(16)

More timely and more reliable information about the share issuer's performance over the financial year also requires a higher frequency of interim information. A requirement should therefore be introduced to publish an interim management statement during the first six months and a second interim management statement during the second six months of a financial year. Share issuers who already publish quarterly financial reports should not be required to publish interim management statements.

(17)

Appropriate liability rules should be applicable to the issuer, its administrative, management, or supervisory bodies, or persons responsible within the issuer, as laid down by each Member State under its national law or regulations. Member States should remain free to determine the extent of the liability.

(18)

The public should be informed of changes to major holdings in issuers whose shares are traded on a regulated market situated or operating within the Community. This information should enable investors to acquire or dispose of shares in full knowledge of changes in the voting structure; it should also enhance effective control of share issuers and overall market transparency on important capital movement. Information about shares, or financial instruments as determined in Article 12, lodged as collateral should be provided in certain circumstances.

(19)

Articles 9 and 10(c) should not apply to shares provided to or by the members of the European System of Central Banks (ESCB) in carrying out their functions as monetary authorities provided that the voting rights attached to such shares are not exercised; the reference to a ‘short period’ should be understood with reference to credit operations carried out in accordance with the Treaty and ECB legal acts, in particular the ECB Guidelines on monetary policy instruments and procedures and TARGET, and to credit operations for the purpose of performing equivalent functions in accordance with national provisions.

(20)

In order to avoid unnecessary burdens for certain market participants and to clarify who actually exercises influence over an issuer, there is no need for notification requirements of major holdings of shares or other financial instruments as determined under Article 12 that result in an entitlement to acquire shares with regard to market makers or custodians, or of holdings of shares or such financial instruments acquired solely for clearing and settlement purposes, within limits and guarantees to be applied throughout the European Union. The home Member State should be allowed to provide limited exemptions as regards holdings of shares in trading books of credit institutions and investment firms.

(21)

In order to clarify who is actually a major holder of shares or other financial instruments in the same issuer throughout the European Union, parent undertakings should not be required to aggregate their own holdings with those managed by undertakings for collective investment in transferable securities (UCITS) or investment firms, provided that the latter exercise voting rights independently from parent undertaking and fulfil certain further conditions.

(22)

Ongoing information of holders of securities admitted to trading on a regulated market should continue to be based on the principle of equal treatment. Such equal treatment only relates to shareholders in the same position and does not therefore prejudice the issue of how many voting rights may be attached to a particular share. By the same token, holders of debt securities ranking pari passu should continue to benefit from equal treatment, even in the case of sovereign debt . Information of holders of shares and/or debt securities in general meetings should be facilitated. In particular, holders of shares and/or debt securities situated abroad should be more actively involved in that they should be able to mandate proxies to act on their behalf. For the same reasons, it should be decided in a general meeting of holders of shares and/or debt securities whether the use of modern information and communication technologies should become a reality. In that case, issuers should put in place arrangements in order to effectively inform holders of their shares and/or debt securities, in so far as it is possible for them to identify those holders.

(23)

Removal of barriers and effective enforcement of new Community information requirements also require adequate control by the competent authority of the home Member State. This Directive should at least provide for a minimum guarantee for the timely availability of such information. For this reason, at least one filing and storage system should exist in each Member State.

(24)

Any obligation for an issuer to translate all ongoing and periodic information into all the relevant languages in all the Member States where its securities are admitted to trading does not foster integration of securities markets, but has deterrent effects on cross-border admission of securities to trading on regulated markets. Therefore, the issuer should in certain cases be entitled to provide information drawn up in a language that is customary in the sphere of international finance. Since a particular effort is needed to attract investors from abroad, even outside the Community, Member States should no longer prevent shareholders, persons exercising voting rights, or holders of financial instruments, from making the required notifications to the issuer in a language customary in the sphere of international finance.

(25)

Access for investors to information about issuers should be more organised at European level in order to actively promote integration of European capital markets. Investors who are not situated in the issuer's home Member State should be put on an equal footing with investors situated in the issuer's home Member State when seeking access to such information. This would be achieved in that the home Member State should ensure compliance with minimum quality standards for disseminating information throughout the European Union in a fast manner on a non discriminatory basis and depending on the type of regulated information in question. In addition, information which has been disseminated should be available in the home Member State in a centralised way allowing to build up a European network, at affordable prices for retail investors, while not leading to unnecessary duplication of filing requirements for issuers. Issuers should benefit from free competition when choosing the media or operators for disseminating information under this Directive.

(26)

In order to further simplify investor access to corporate information across Member States, it should be left to the national supervisory authorities to formulate guidelines for setting up electronic networks, in close consultation with the other parties concerned, in particular security issuers, investors, market participants, operators of regulated markets and financial information providers.

(27)

So as to ensure the effective protection of investors and the proper operation of regulated markets within the Community, the rules relating to information to be published by issuers whose securities are admitted to trading on a regulated market within the Community should also apply to issuers which do not have a registered office in a Member State and which do not fall within the scope of Article 48 of the Treaty. It should equally be ensured that any additional relevant information about Community issuers or third country issuers, disclosure of which is required in a third country but not in a Member State, is made available to the public in the Community.

(28)

A single competent authority should be designated in each Member State to assume final responsibility for supervising compliance with the provisions adopted pursuant to this Directive, as well as for international cooperation. Such an authority should be of an administrative nature, and its independence of economic actors should be ensured in order to avoid conflicts of interest. Member States may however designate another competent authority for examining that information referred to in this Directive is drawn up in accordance with the relevant reporting framework and taking appropriate measures in case of discovered infringements; such an authority need not be of an administrative nature .

(29)

Increasing cross-border activities require improved co-operation between national competent authorities, including a comprehensive set of provisions for the exchange of information and for precautionary measures. The organisation of the regulatory and supervisory tasks in each Member State should not hinder efficient co-operation between the competent national authorities.

(30)

At its meeting on 17 July 2000, the Council set up the Committee of Wise Men on the Regulation of European securities markets. In its final report, that Committee proposed the introduction of new legislative techniques based on a four-level approach, namely essential principles, technical implementing measures, co-operation amongst national securities regulators, and enforcement of Community law. The Directive should confine itself to broad ‘framework’ principles, while implementing measures to be adopted by the Commission with the assistance of the European Securities Committee should lay down the technical details.

(31)	By its Resolution adopted in March 2001, the Stockholm European Council endorsed the final report of the Committee of Wise Men and the proposed four-level approach to make the regulatory process for Community securities legislation more efficient and transparent.

(32)	According to the Stockholm European Council Resolution, implementing measures should be used more frequently, to ensure that technical provisions can be kept up to date with market and supervisory developments, and deadlines should be set for all stages of implementing rules.

(33)

By its Resolution of 5 February 2002 on the implementation of financial services legislation, the European Parliament also endorsed the Committee of Wise Men's report, on the basis of the solemn declaration made before the European Parliament the same day by the President of the Commission and the letter of 2 October 2001 addressed by the Internal Market Commissioner to the Chairman of the Parliament's Committee on Economic and Monetary Affairs with regard to safeguards for the European Parliament's role in this process.

(34)	The measures necessary for implementing this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (7).

(35)

The European Parliament should be given a period of three months from the first transmission of draft implementing measures to allow it to examine them and to give its opinion. However, in urgent and duly justified cases, that period may be shortened. If, within that period, a resolution is passed by the European Parliament, the Commission should re-examine the draft measures.

(36)

Technical implementing measures for the rules laid down in this Directive may be necessary to take account of new developments on securities markets. The Commission should accordingly be empowered to adopt implementing measures, provided that they do not modify the essential elements of this Directive and provided that the Commission acts in accordance with the principles set out therein, after consulting the European Securities Committee established by Commission Decision 2001/528/EC of 6 June 2001 (8).

(37)

In exercising its implementing powers in accordance with this Directive, the Commission should respect the following principles:

—	the need to ensure confidence in financial markets among investors by promoting high standards of transparency in financial markets;

—	the need to provide investors with a wide range of competing investments and a level of disclosure and protection tailored to their circumstances;

—	the need to ensure that independent regulatory authorities enforce the rules consistently, especially as regards the fight against economic crime;

—	the need for high levels of transparency and consultation with all market participants and with the European Parliament and the Council;

—	the need to encourage innovation in financial markets if they are to be dynamic and efficient;

—	the need to ensure market integrity by close and reactive monitoring of financial innovation;

—	the importance of reducing the cost of, and increasing access to, capital;

—	the balance of costs and benefits to market participants on a long-term basis (including small and medium-sized businesses and small investors) in any implementing measures;

—	the need to foster the international competitiveness of EU financial markets without prejudice to a much-needed extension of international cooperation;

—	the need to achieve a level playing field for all market participants by establishing EU-wide regulations every time it is appropriate;

—	the need to respect differences in national markets where these do not unduly impinge on the coherence of the single market;

—	the need to ensure coherence with other EU legislation in this area, as imbalances in information and a lack of transparency may jeopardise the operation of the markets and above all harm consumers and small investors.

(38)

In order to ensure fulfilment of the requirements laid down pursuant to this Directive or measures implementing this Directive, an infringement of those requirements should be promptly detected and, if necessary, sanctioned . To that end, measures and sanctions should be sufficiently dissuasive, proportionate and consistently enforced. Member States should ensure that decisions taken by the competent national authorities are subject to the right of appeal to the courts .

(39)

This Directive aims to upgrade the current prevailing transparency requirements for security issuers and investors acquiring or disposing of major holdings in issuers whose shares are admitted to trading on a regulated market. This Directive replaces some of the requirements set out in Directive 2001/34/EC of the European Parliament and of the Council of 28 May 2001 on the admission of securities to official stock exchange listing and on information to be published on those securities (9). In order to gather transparency requirements in a single act it is necessary to amend it accordingly. Such an amendment however does not affect the ability of Member States to impose additional requirements under Articles 42 to 63 of Directive 2001/34/EC which remain valid.

(40)

Since the objectives of the action to be taken, namely to ensure investor confidence through equivalent transparency throughout the Community and thereby to complete the internal market, cannot be sufficiently achieved by the Member States on the basis of the existing Community legislation and can, by reason of the scale and effects of the measures, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve these objectives.

(41)	This Directive is in line with Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (10).

(42)	This Directive respects fundamental rights and observes the principles recognised in particular by the Charter of the Fundamental Rights of the European Union,

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject-matter and scope

This Directive establishes requirements in relation to the disclosure of periodic and ongoing information about issuers whose securities are already admitted to trading on a regulated market situated or operating within a Member State.

This Directive shall not apply to units issued by collective investment undertakings other than the closedend type or to units acquired or disposed of in such collective investment undertakings.

Member States may decide not to apply the provisions mentioned in Article 16(3) and in paragraphs 2 to 4 of Article 18 to securities which are admitted to trading on a regulated market issued by them or their regional or local authorities.

Member States may decide not to apply Article 17 to their national central banks in their capacity as issuers of shares admitted to trading on a regulated market if this admission took place before the entry into force of this Directive.

Article 2

Definitions

1. For the purposes of this Directive the following definitions shall apply:

(a)

‘securities’ means transferable securities as defined in Article 1(4), point 18, of Directive 2004/39/EC of the European Parliament and of the Council of 21 April 2004 on markets in financial instruments (11) with the exception of money-market instruments, as defined in Article 1(4), point 19, of that Directive, having a maturity of less than 12 months, for which national legislation may be applicable;

(b)

‘debt securities’ means bonds or other forms of transferable securitised debts, with the exception of securities which are equivalent to shares in companies or which, if converted or if the rights conferred by them are exercised, give rise to a right to acquire shares or securities equivalent to shares;

(c)	‘regulated market’ means a market as defined in Article 1(4), point 14 of Directive 2004/39/EC;

(d)	‘issuer’ means a legal entity governed by private or public law, including a State, whose securities are admitted to trading on a regulated market, the issuer being, in the case of depository receipts representing securities, the issuer of the securities represented;

(e)

‘ shareholder ’ means any natural person or legal entity governed by private or public law, who holds, directly or indirectly :

(i)	shares of the issuer in its own name and on its own account;

(ii)	shares of the issuer in its own name, but on behalf of another natural person or legal entity;

(iii)

depository receipts, in which case the holder of the depository receipt shall be considered as the shareholder of the underlying shares represented by the depository receipts ;

(f)

‘controlled undertaking’ means any undertaking

(i)	in which a natural person or legal entity has a majority of the voting rights; or

(ii)	of which a natural person or legal entity has the right to appoint or remove a majority of the members of the administrative, management or supervisory body and is at the same time a shareholder in, or member of, the undertaking in question; or

(iii)

of which a natural person or legal entity is a shareholder or member and alone controls a majority of the shareholders' or members' voting rights, respectively, pursuant to an agreement entered into with other shareholders or members of the undertaking in question; or

(iv)	over which a natural person or legal entity has the power to exercise, or actually exercises, dominant influence or control;(g) ‘collective investment undertaking other than the closed-end type’ means unit trusts and investment companies;

(g)

‘collective investment undertaking other than the closed-end type’ means unit trusts and investment companies:

(i)	the object of which is the collective investment of capital provided by the public, and which operate on the principle of risk spreading; and

(ii)	the units of which are, at the request of the holder of such units, repurchased or redeemed, directly or indirectly, out of the assets of those undertakings;

(h)	‘units of a collective investment undertaking’ means securities issued by a collective investment undertaking and representing rights of the participants in such an undertaking over its assets;

(i)

‘home Member State’ means

(i)

in the case of an issuer of debt securities the denomination of which does not exceed EUR 1 000 or an issuer of shares:

—	where the issuer is incorporated in the Community, the Member State in which it has its registered office;

—	where the issuer is incorporated in a third country, the Member State in which it is required to file the annual information with the competent authority in accordance with Article 10 of Directive 2003/71/EC ;

The same regime shall be applicable to debt securities in another currency than Euro, provided that the value of such denomination per unit is, at the date of the issue, less than EUR 1 000, unless it is nearly equivalent to EUR 1 000;

(ii)

for any issuer not covered by (i), the Member State chosen by the issuer from among the Member State in which the issuer has its registered office and those Member States which have admitted its securities to trading on a regulated market on their territory. The issuer may choose only one Member State as its home Member State. Such choice shall remain valid for at least three years unless its securities are no longer admitted to trading on any regulated market in the European Union ;

(j)	‘host Member State’ means a Member State in which securities are admitted to trading on a regulated market, if different from the home Member State;

(k)

‘regulated information’ means all information which the issuer, or any other person who has applied for the admission of securities to trading on a regulated market without the issuer's consent, is required to disclose under this Directive, under Article 6 of Directive 2003/6/EC of the European Parliament and of the Council of 28 January 2003 on inside dealing and market manipulation (market abuse) (12) , or under the laws, regulations or administrative provisions of a Member State, as adopted under Article 3(1) of this Directive ;

(l)	‘electronic means’ are means of electronic equipment for the processing (including the digital compression), storage and transmission of data, employing wires, radio, optical technologies, or any other electromagnetic means;

(m)	‘management company’ means a company as defined in Article 1a(2) of Council Directive 85/611/EEC of 20 December 1985 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (13);

(n)	‘market maker’ means a person who holds himself out on the financial markets on a continuous basis as being willing to deal on own account by buying and selling financial instruments against his proprietary capital at prices defined by him;

(o)	‘credit institution’ means an undertaking as defined in Article 1(1)(a) of Directive 2000/12/EC of 20 March 2000 of the European Parliament and of the Council relating to the taking up and pursuit of the business of credit institutions (14);

(p)	‘securities issued in a continuous or repeated manner’ means debt securities of the same issuer on tap or at least two separate issues of securities of a similar type and/or class.

2. For the purposes of the definition of ‘controlled undertaking’ in paragraph 1(f)(ii), the holder's rights in relation to voting, appointment and removal shall include the rights of any other undertaking controlled by the shareholder and those of any natural person or legal entity acting, albeit in its own name, on behalf of the shareholder or of any other undertaking controlled by the shareholder .

3. In order to take account of technical developments on financial markets and to ensure the uniform application of paragraph 1 of this Article, the Commission shall, in accordance with the procedure referred to in Article 27(2), adopt implementing measures concerning the definitions set out in paragraph 1 of this Article.

The Commission shall, in particular :

(a)	establish, for the purposes of paragraph 1(i)(ii), the procedural arrangements in accordance with which an issuer may make the choice referred to therein;

(b)	adjust, where appropriate for the purposes of the choice of the home Member State referred to in paragraph 1(i)(ii), the three-year period in relation to the issuer's track record in the light of any new requirement under Community law concerning admission to trading on a regulated market;

(c)

establish, for the purposes of paragraph 1(l), an indicative list of means which are not to be considered as electronic means, thereby taking into account Annex V to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations (15).

Article 3

Integration of securities markets

1. The home Member State may make an issuer subject to requirements more stringent than those laid down in this Directive.

The home Member State may also make a holder of shares, or a natural person or legal entity referred to in Articles 10 or 12 subject to requirements more stringent than those laid down in this Directive .

2. A host Member State may not:

(a)	as regards the admission of securities to a regulated market in its territory, impose disclosure requirements more stringent than those provided for in this Directive or in Article 6 of Directive 2003/6/EC;

(b)	as regards the notification of information, impose on holders of shares, or on natural persons or legal entities referred to in Articles 10 or 12, requirements more stringent than those laid down in this Directive.

CHAPTER II

PERIODIC INFORMATION

Article 4

Annual financial reports

1. The issuer shall make public its annual financial report at the latest four months after the end of each financial year and shall ensure that it remains publicly available for at least five years

2. The annual financial report shall comprise:

(a)	the audited financial statements;

(b)	the management report;

(c)

statements made by the persons responsible within the issuer, whose names and functions shall be clearly indicated, to the effect that, to the best of their knowledge, the financial statements prepared in accordance with the applicable set of accounting standards give a true and fair view of the assets, liabilities, financial position and profit or loss of the issuer and the undertakings included in the consolidation taken as a whole and that the management report includes a fair review of the development and performance of the business and the position of the issuer and the undertakings included in the consolidation taken as a whole, together with the description of the principal risks and uncertainties that they face.

3. Where the issuer is required to prepare consolidated accounts according to Council Directive 83/349/EEC of 13 June 1983 (16) , the audited financial statements shall comprise such consolidated accounts drawn up in accordance with Regulation (EC) No 1606/2002 and the annual accounts of the parent company drawn up in accordance with the national law of the Member State in which the parent company is incorporated.

Where the issuer is not required to prepare consolidated accounts, the audited financial statements shall comprise the accounts prepared in accordance with the national law of the Member State in which the company is incorporated.

4. The financial statements shall be audited in accordance with Articles 51 and 51a of Council Directive 78/660/EEC of 25 July 1978 on the annual accounts of certain types of companies (17) and, if the issuer is required to prepare consolidated accounts, in accordance with Article 37 of Directive 83/349/EEC.

The audit report, signed by the person or persons responsible for auditing the financial statements shall be disclosed in full to the public together with the annual financial report.

5. The management report shall be drawn up in accordance with Article 46 of Directive 78/660/EEC and, if the issuer is required to prepare consolidated accounts , in accordance with Article 36 of Council Directive 83/349/EEC.

6. The Commission shall, in accordance with the procedure referred to in Article 27(2), adopt implementing measures in order to take account of technical developments on financial markets and to ensure the uniform application of paragraph 1 of this Article.

The Commission shall in particular specify the technical conditions under which a published annual financial report, including the audit report, is to remain available to the public. Where appropriate, the Commission may also adapt the five-year period referred to in paragraph 1 .

Article 5

Half-yearly financial reports

1. The issuer of shares or debt securities shall make public a half-yearly financial report covering the first six months of the financial year as soon as possible after the end of the relevant period, but at the latest two months thereafter. The issuer shall ensure that the half-yearly financial report remains available to the public for at least five years .

2. The half-yearly financial report shall comprise:

(a)	the condensed set of financial statements;

(b)	an interim management report;

(c)

statements made by the persons responsible within the issuer, whose names and functions shall be clearly indicated, to the effect that, to the best of their knowledge, the condensed set of financial statements which has been prepared in accordance with the applicable set of accounting standards gives a true and fair view of the assets, liabilities, financial position and profit or loss of the issuer, or the undertakings included in the consolidation as a whole, as required under paragraph 3, and that the interim management report includes a fair review of the information required under paragraph 4.

3. Where the issuer is required to prepare consolidated accounts , the condensed set of financial statements shall be prepared in accordance with the international accounting standard applicable to the interim financial reporting as adopted pursuant to the procedure provided for under Article 6 of Regulation (EC) No 1606/2002.

Where the issuer is not required to prepare consolidated accounts, the condensed set of financial statements shall at least contain a condensed balance sheet, a condensed profit and loss account and explanatory notes on these accounts. In preparing the condensed balance sheet and the condensed profit and loss account, the issuer shall follow the same principles for recognising and measuring as when preparing annual financial reports.

4. The interim management report shall include at least an indication of important events that have occurred during the first six months of the financial year and its impact on the condensed set of financial statements together with a description of the principal risks and uncertainties for the remaining six months of the financial year. For issuers of shares, the interim management report shall also include major related parties transactions.

5. If the half-yearly financial report has been audited, the audit report shall be reproduced in full. The same shall apply in the case of an auditors' review. If the half-yearly financial report has not been audited or reviewed by auditors, the issuer shall make a statement to that effect in its report.

The Commission shall, in particular:

(a)	specify the technical conditions under which a published half-yearly financial report, including the auditors' review, is to remain available to the public ;

(b)	clarify the nature of the auditors' review ;

(c)

specify the minimum content of the condensed balance sheet and profit and loss accounts and explanatory notes on these accounts where they are not prepared in accordance with the international accounting standards, as adopted pursuant to the procedure provided for under Article 6 of Regulation (EC) No 1606/2002;

Where appropriate, the Commission may also adapt the five-year period referred to in paragraph 1.

Article 6

Interim management statements

1. Without prejudice to Article 6 of Directive 2003/6/EC, an issuer whose shares are admitted to trading on a regulated market shall make public a statement by its management during the first six-month period of the financial year and another statement by its management during the second six-month period of the financial year. Such statement shall be made in a period between ten weeks after the beginning and six weeks before the end of the relevant six-month period. It shall contain information covering the period between the beginning of the relevant six-month period and the date of publication. Such a statement shall provide:

—	an explanation of material events and transactions that have taken place during the relevant period and their impact on the financial position of the issuer and its controlled undertakings, and

—	a general description of the financial position and performance of the issuer and its controlled undertakings during the relevant period.

2. Issuers which under national legislation, the rules of the regulated market or of their own initiative, publish quarterly financial reports in accordance with the said legislation or rules shall not be required to make public statements by the management provided for in paragraph 1.

3. The Commission shall provide a report to the Council and the European Parliament at the latest five years after the entry into force of this Directive on the transparency of quarterly financial reporting and statements by management of issuers to examine whether the information provided meets the objective of allowing investors to make an informed assessment of the financial position of the issuer. Such a report shall include an impact assessment on areas where the Commission considers proposing amendments to this Article.

Article 7

Responsibility and liability

Member States shall ensure that responsibility for the information to be drawn up and to be made public in accordance with Articles 4, 5, 6 and 15 lies at least with the issuer or its administrative, management or supervisory bodies and Member States shall ensure that their laws laws, regulations and administrative provisions on liability apply to the issuers, the bodies referred to above or persons responsible within the issuers .

Article 8

Exemptions

1. Articles 4, 5 and 6 shall not apply to the following issuers:

(a)	a State, a regional or local authority of a State, a public international body of which at least one Member State is a member, the European Central Bank, and Member States' national central banks whether or not they issue shares or other securities; and

(b)

an issuer exclusively of debt securities admitted to trading on a regulated market in a Member State, the denomination per unit of which is at least EUR 50 000 or, in the case of debt securities denominated in another currency than Euro, the value of such denomination per unit is, at the date of the issue, equivalent to at least EUR 50 000 .

2. The home Member State may choose not to apply Article 5 to credit institutions whose shares are not admitted to trading on a regulated market and which have, in a continuous or repeated manner, only issued debt securities provided that the total nominal amount of all such debt securities remains below EUR 100 000 000 and that they have not published a prospectus under Directive 2003/71/EC.

3. The home Member State may choose not to apply Article 5 to issuers already existing at the date of the entry into force of Directive 2003/71/EC which exclusively issue debt securities unconditionally and irrevocably guaranteed by the home Member State or by one of its regional or local authorities, on a regulated market.

CHAPTER III

ONGOING INFORMATION

SECTION I

INFORMATION ABOUT MAJOR HOLDINGS

Article 9

Notification of the acquisition or disposal of major holdings

1. The home Member State shall ensure that, where a shareholder , acquires or disposes of shares of an issuer whose shares are admitted to trading on a regulated market and to which voting rights are attached, such shareholder notifies the issuer of the proportion of voting rights of the issuer held by the shareholder as a result of the acquisition or disposal where that proportion reaches, exceeds or falls below the thresholds of 5%, 10%, 15%, 20%, 25%, 30%, 50% and 75 %.

The voting rights shall be calculated on the basis of all shares to which voting rights are attached even if the exercise thereof is suspended. Moreover this information must be given also in respect of all shares which are in the same class and to which voting rights are attached.

2. The home Member States shall ensure that the shareholders notify the issuer of the proportion of voting rights, where that proportion reaches, exceeds or falls below the thresholds provided for in paragraph 1, as a result of events changing the breakdown of voting rights, and based on the information disclosed pursuant to Article 14. Where the issuer is incorporated in a third country, the notification shall be done for equivalent events.

3. The home Member State need not apply:

(a)	the 30% threshold where the home Member State applies a threshold of one third;

(b)	the 75% threshold where the home Member State applies a threshold of two thirds.

4. This Article shall not apply to shares acquired for the sole purpose of clearing and settling within the usual short settlement cycle, nor to custodians holding shares in their custodian capacity provided such custodians can only exercise the voting rights attached to such shares under instructions given in writing or by electronic means.

5. This Article shall also not apply to the acquisition or disposal of a major holding reaching or crossing the 5% threshold by a market maker acting in its capacity of a market maker, provided that:

(a)	it is authorised by its home Member State under Directive 2004/39/EC;

(b)	it does neither intervene in the management of the issuer concerned nor exert any influence on the issuer to buy such shares or back the share price.

6. Home Member States under Article 2(1)(i) may provide that voting rights held in the trading book, as defined in Article 2(6) of Directive 93/6/EEC, of a credit institution or investment firm shall not be counted for the purposes of this Article provided that:

(a)	the voting rights held in the trading book do not exceed 5%, and

(b)	the credit institution or investment firm ensures that the voting rights from shares held in the trading book are not exercised and not otherwise used to intervene in the management of the issuer.

7. The Commission shall, in accordance with the procedure referred to in Article 27(2), adopt implementing measures in order to take account of technical developments on financial markets and to ensure the uniform application of paragraphs 2, 4 and 5 of this Article.

The Commission shall in particular specify the maximum length of the ‘short settlement cycle’ referred to in paragraph 4, as well as appropriate control mechanisms by the competent authority of the home Member State. In addition, the Commission may list up the events referred to in paragraph 2.

Article 10

Acquisition or disposal of major proportions of voting rights

The notification requirements defined in paragraphs 1 and 2 of Article 9 shall also apply to a natural person or legal entity to the extent it is entitled to acquire, to dispose of, or to exercise voting rights in any of the following cases or a combination of them :

(a)	voting rights held by a third party with whom that person or entity has concluded an agreement , which obliges them to adopt, by concerted exercise of the voting rights they hold, a lasting common policy towards the management of the issuer in question;

(b)	voting rights held by a third party under an agreement concluded with that person or entity providing for the temporary transfer for consideration of the voting rights in question;

(c)	voting rights attaching to shares which are lodged as collateral with that person or entity, provided the latter controls the voting rights and declares its intention of exercising them;

(d)	voting rights attaching to shares in which that person or entity has the life interest;

(e)	voting rights which are held, or which may be exercised within the meaning of points (a) to (d), by an undertaking controlled by that person or entity;

(f)	voting rights attaching to shares deposited with that person or entity which the latter can exercise at its discretion in the absence of specific instructions from the shareholders ;

(g)	voting rights held by a third party in its own name on behalf of that person or entity;

(h)	voting rights which that person or entity may exercise as a proxy where it can exercise the voting rights at its discretion in the absence of specific instructions from the shareholders.

Article 11

Exemption relating to the European System of Central Banks

Articles 9 and 10(c) shall not apply to shares provided to or by the members of the European System of Central Banks (ESCB) in carrying out their functions as monetary authorities, including shares provided to or by members of the ESCB under a pledge or repurchase or similar agreement for liquidity granted for monetary policy purposes or within a payment system.

The exemption would apply to the above transactions lasting for a short period and provided that voting rights attached to such shares are not exercised.

Article 12

Procedures on the notification and disclosure of major holdings

1. The notification required under Articles 9 and 10 shall include the following information:

(a)	the resulting situation, in terms of voting rights ;

(b)	the chain of controlled undertakings through which voting rights are effectively held, if applicable;

(c)	the date on which the threshold was crossed or reached; and

(d)	the identity of the shareholder even if the latter is not entitled to exercise voting rights under the conditions laid down in Article 10 , and the natural person or legal entity entitled to exercise voting rights on behalf of the shareholder .

2. The notification to the issuer shall be effected as soon as possible, but not later than four trading days, the first of which shall be the day after the date on which the shareholder, or the natural person or legal entity referred to in Article 10:

(a)	learns of the acquisition or disposal or of the possibility to exercise voting rights, or on which, having regard to the circumstances, should have learned of it, regardless of the date on which the acquisition, disposal or possibility to exercise voting rights takes effect; or

(b)	is informed about the event mentioned in Article 9(2).

3. An undertaking shall be exempted from making the required notification in accordance with paragraph 1, if the notification is made by the parent undertaking or, where the parent undertaking is itself a controlled undertaking, by its own parent undertaking.

4. The parent undertaking of a management company shall not be required to aggregate its holdings under Articles 9 and 10 with the holdings managed by the management company under the conditions laid down in Directive 85/611/EEC, provided such management company exercises the voting rights independently from the parent undertaking.

However, Articles 9 and 10 shall apply where the parent undertaking, or another controlled undertaking of the parent undertaking, has invested in holdings managed by this management company and the management company has no discretion to exercise the voting rights attached to such holdings and may only exercise such voting rights under direct or indirect instructions from the parent or another controlled undertaking of the parent undertaking.

5. The parent undertaking of an investment firm authorised under Directive 2004/39/EC shall not be required to aggregate its holdings under Articles 9 and 10 with the holdings which such investment firm manages on a client-by-client basis within the meaning of Article 4(1)(9) of Directive 2004/39/EC, provided that:

—	the investment firm is authorised to provide such portfolio management under point 4 of Section A of Annex I to Directive 2004/39/EC;

—

it may only exercise the voting rights attached to such shares under instructions given in writing or by electronic means or it ensures that individual portfolio management services are conducted in an independent manner from any other services under conditions equivalent to those provided for under Directive 85/611/EEC by putting into place appropriate mechanisms;

—	investment firm exercises its voting rights independently from the parent undertaking.

However, Articles 9 and 10 shall apply where the parent undertaking, or another controlled undertaking of the parent undertaking, has invested in holdings managed by this investment firm and the investment firm has no discretion to exercise the voting rights attached to such holdings and may only exercise such voting rights under direct or indirect instructions from the parent or another controlled undertaking of the parent undertaking.

6. Upon receipt of the notification under paragraph 1, but no later than three trading days thereafter, the issuer shall make public all the information contained in the notification.

7. A home Member State may exempt issuers from the requirement in paragraph 4 if the information contained in the notification is made public by its competent authority, under the conditions laid down in Article 17, upon receipt of the notification, but no later than three trading days thereafter.

8. In order to take account of technical developments on financial markets and to ensure the uniform application of paragraphs 1, 2, 4, 5 and 6 of this Article, the Commission shall, in accordance with the procedure referred to in Article 27(2), adopt implementing measures:

(a)	to establish a standard form to be used throughout the Community when notifying the required information to the issuer under paragraph 1 or when filing information under Article 19(3) ;

(b)	to determine a calendar of ‘ trading days’ for all Member States;

(c)	to establish in which cases the shareholder or the natural person or legal entity referred to in Article 10 or both shall effect the necessary notification to the issuer;

(d)	to clarify the circumstances under which the shareholder, or the natural person or legal entity referred to in Article 10, should have learnt of the acquisition or disposal;

(e)	to clarify the conditions of independence to be complied with by management companies and their parent undertakings or by investment firms and their parent undertakings to benefit from the exemptions in paragraphs 4 and 5.

Article 13

Financial instruments entitling the holder to acquire shares

1. The notification requirements laid down in Article 9 shall also apply to a natural person or legal entity who holds, directly or indirectly, financial instruments that result in an entitlement to acquire, on such holder's own initiative alone, under a formal agreement, shares to which voting rights are attached already issued of an issuer whose shares are admitted to trading on a regulated market.

2. The Commission shall, in accordance with the procedure referred to in Article 27(2), adopt implementing measures in order to take account of technical developments on financial markets and to ensure the uniform application of paragraph 1 of this Article. It shall in particular determine:

(a)	the types of financial instruments referred to in paragraph 1 and their aggregation;

(b)	the nature of the formal agreement referred to in paragraph 1;

(c)	the contents of the notification to be made, establishing a standard form to be used throughout the Community for that purpose;

(d)	the notification period;

(e)	to whom the notification is to be made.

Article 14

Acquisition or disposal by the issuer of his own shares

1. Where an issuer of shares admitted to trading on a regulated market acquires or disposes of own shares, either itself or through a person acting in his own name but on the issuer's behalf, the home Member State shall ensure that the issuer shall make public the proportion of own shares as soon as possible, but not later than four trading days following such acquisition or disposal where that proportion reaches, exceeds or falls below the thresholds of 5 % or 10 % of the voting rights. The proportion shall be calculated on the basis of the total number of shares to which voting rights are attached.

Article 15

Total number of voting rights and capital

The home Member State shall at least require the disclosure to the public by the issuer of the total number of voting rights and capital (for the purpose of calculating the thresholds provided for in Article 9) at the end of each calendar month during which an increase or decrease of such total number has occurred.

Article 16

Additional information

1. The issuer of shares admitted to trading on a regulated market shall make public without delay any change in the rights attaching to the various classes of shares, including changes in the rights attaching to derivative securities issued by the issuer itself and giving access to the shares of that issuer.

2. The issuer of securities other than shares, admitted to trading on a regulated market, shall make public without delay any changes in the rights of holders of securities other than shares, including changes in the terms and conditions of these securities which could indirectly affect those rights, resulting in particular from a change in loan terms or in interest rates.

3. The issuer of securities admitted to trading on a regulated market shall make public without delay new loan issues and in particular of any guarantee or security in respect thereof. Without prejudice to Directive 2003/6/EC, the provisions of this paragraph shall not apply to a public international body of which at least one Member State is member.

SECTION II

INFORMATION FOR HOLDERS OF SECURITIES ADMITTED TO TRADING ON A REGULATED MARKET

Article 17

Information requirements for issuers whose shares are admitted to trading on a regulated market

1. The issuer of shares admitted to trading on a regulated market shall ensure equal treatment for all holders of shares who are in the same position.

2. The issuer shall ensure that all the facilities and information necessary to enable holders of shares to exercise their rights are available in the home Member State and that the integrity of data is preserved. Shareholders shall not be prevented from exercising their rights by proxy, subject to the law of the country in which the issuer is incorporated . In particular, the issuer shall:

(a)	provide information on the place, time and agenda of meetings, the total number of shares and voting rights and the rights of holders to participate in meetings;

(b)	make available a proxy form, on paper or, where applicable, by electronic means, to each person entitled to vote at a shareholders meeting, together with the notice concerning the meeting, or on request after an announcement of the meeting;

(c)	designate as its agent a financial institution through which shareholders may exercise their financial rights; and

(d)	publish notices or distribute circulars concerning the allocation and payment of dividends and the issue of new shares, including information on any arrangements for allotment, subscription, cancellation or conversion.

3. For the purposes of conveying information to shareholders, the home Member State shall allow issuers the use of electronic means, provided such a decision is taken in a general meeting and meets at least the following conditions:

(a)	the use of electronic means shall in no way depend upon the location of the seat or residence of the shareholder or, in the cases referred to in Article 10(a) to (h), of the natural persons or legal entities;

(b)	identification arrangements shall be put in place so that the shareholders or, the natural persons or legal entities entitled to exercise or to direct the exercise of voting rights , are effectively informed;

(c)

shareholders or, in the cases referred to in Article 10 (a) to (e), the natural persons or legal entities entitled to acquire, dispose of, or exercise voting rights, shall be contacted in writing to request their consent for the use of electronic means for conveying information and if they do not object within a reasonable period of time, their consent shall be deemed to be given. They shall be able to request, at any time in the future, that information be conveyed in writing ;

(d)	any apportionment of the costs entailed in the conveyance of such information by electronic means shall be determined by the issuer in compliance with the principle of equal treatment laid down in paragraph 1.

4. The Commission shall, in accordance with the procedure provided for in Article 27(2), adopt implementing measures in order to take account of technical developments on financial markets, to take account of developments in information and communication technology and to ensure the uniform application of paragraphs 1, 2 and 3 of this Article. It shall, in particular, specify the types of financial institution through which a shareholder may exercise the financial rights provided for in paragraph 2(c).

Article 18

Information requirements for issuers whose debt securities are admitted to trading on a regulated market

1. The issuer of debt securities admitted to trading on a regulated market shall ensure that all holders of debt securities ranking pari passu receive equal treatment in respect of all the rights attaching to those debt securities.

2. The issuer shall ensure that all the facilities and information necessary to enable debt securities holders to exercise their rights are publicly available in the home Member State and that the integrity of data is preserved. Debt securities holders shall not be prevented from exercising their rights by proxy, subject to the law of the country in which the issuer is incorporated . In particular, the issuer shall:

(a)

publish notices, or distribute circulars, concerning the place, time and agenda of meetings of debt securities holders, the payment of interest, the exercise of any conversion, exchange, subscription or cancellation rights, and repayment, as well as the right of those holders to participate therein;

(b)	make available a proxy form, on paper or, where applicable, by electronic means, to each person entitled to vote at a meeting of debt securities holders, together with the notice concerning the meeting or on request after an announcement of the meeting; and

(c)	designate as its agent a financial institution through which debt securities holders may exercise their financial rights.

3. If only holders of debt securities whose denomination per unit amounts to at least EUR 50 000 or, in the case of debt securities denominated in another currency than Euro, whose denomination per unit is, at the date of the issue, equivalent to at least EUR 50 000 , are to be invited to a meeting, the issuer may choose as venue any Member State, provided that all the facilities and information necessary to enable such holders to exercise their rights are made available in that Member State.

4. For the purposes of conveying information to debt securities holders, the home Member State, or the Member State chosen by the issuer pursuant to paragraph 3, shall allow issuers to use electronic means, provided such a decision is taken in a general meeting and meets at least the following conditions:

(a)	the use of electronic means shall in no way depend upon the location of the seat or residence of the debt security holder or of a proxy representing that holder;

(b)	identification arrangements shall be put in place so that debt securities holders are effectively informed;

(c)

debt securities holders shall be contacted in writing to request their consent for the use of electronic means for conveying information and if they do not object within a reasonable period of time, their consent shall be deemed to be given. They shall be able to request, at any time in the future, that information be conveyed in writing;

(d)	any apportionment of the costs entailed in the conveyance of information by electronic means shall be determined by the issuer in compliance with the principle of equal treatment laid down in paragraph 1.

5. The Commission shall, in accordance with the procedure provided for in Article 27(2), adopt implementing measures in order to take account of technical developments on financial markets, to take account of developments in information and communication technology and to ensure the uniform application of paragraphs 1 to 4 of this Article. It shall, in particular, specify the types of financial institution through which a debt security holder may exercise the financial rights provided for in paragraph 2(c).

CHAPTER IV

GENERAL OBLIGATIONS

Article 19

Home Member State control

1. Whenever the issuer , or any person having requested, without the issuer's consent, the admission of its securities to trading on a regulated market discloses regulated information, it shall at the same time file that information with the competent authority of its home Member State. That competent authority may decide to publish such filed information on its Internet site.

Where an issuer proposes to amend its instrument of incorporation or statutes, it shall communicate the draft amendment to the competent authority of the home Member State and to the regulated market on which its securities have been admitted to trading. Such communication shall be effected without delay, but at the latest on the date of calling the general meeting which is to vote on, or be informed of, the amendment.

2. The home Member State may exempt an issuer from the requirement under paragraph 1 in respect of information disclosed in accordance with Article 6 of Directive 2003/6/EC or Article 12(6) of this Directive.

3. Information to be notified to the issuer in accordance with Articles 9, 10, 11 and 12 shall at the same time be filed with the competent authority of the home Member State.

4. In order to ensure the uniform application of paragraphs 1, 2 and 3 of this Article, the Commission shall, in accordance with the procedure referred to in Article 27(2), adopt implementing measures.

The Commission shall, in particular, specify the procedure in accordance with which an issuer, a holder of shares or other financial instruments, or person referred to in Article 10 , is to file information with the competent authority of the home Member State under paragraphs 1 or 3, respectively, in order to:

(a)	enable filing by electronic means in the home Member State;

(b)	co-ordinate the filing of the annual financial report referred to in Article 4 of this Directive with the filing of the annual information referred to in Article 10 of Directive 2003/71/EC.

Article 20

Languages

1. Where securities are admitted to trading on a regulated market only in the home Member State, regulated information shall be disclosed in a language accepted by the competent authority in the home Member State.

2. Where securities are admitted to trading on a regulated market both in the home Member State and in one or more host Member States, regulated information shall be disclosed:

(a)	in a language accepted by the competent authority in the home Member State; and

(b)	depending on the choice of the issuer, either in a language accepted by the competent authorities of those host Member States or in a language customary in the sphere of international finance.

3. Where securities are admitted to trading on a regulated market in one or more host Member States, but not in the home Member State, regulated information shall, depending on the choice of the issuer , be disclosed either in a language accepted by the competent authorities of those host Member States or in a language customary in the sphere of international finance.

In addition, the home Member State may lay down it its law, regulations or administrative provisions that the regulated information shall, depending on the choice of the issuer, be disclosed either in a language accepted by its authority or in a language customary in the sphere of international finance.

4. Where securities are admitted to trading on a regulated market without the issuer's consent, the obligations under paragraphs 1, 2 and 3 shall be incumbent, not upon the issuer, but upon the person who, without the issuer's consent, has requested such admission.

5. Member States shall allow shareholders and the natural person or legal entity referred to in Articles 9, 10 and 12 to notify information to an issuer under this Directive only in a language customary in the sphere of international finance. If the issuer receives such a notification, Member States may not impose on the issuer to provide for a translation into a language accepted by the competent authorities.

6. By way of derogation from paragraphs 1 to 4, where securities whose denomination per unit amounts to at least EUR 50 000 or, in the case of debt securities denominated in another currency than Euro, equivalent to at least EUR 50 000 at the date of the issue, are admitted to trading on a regulated market in one or more Member States, regulated information shall be disclosed to the public either in a language accepted by the competent authorities of the home and host Member States or in a language customary in the sphere of international finance, at the choice of the issuer or of the person who, without the issuer's consent, has requested such admission.

7. If an action concerning the content of regulated information is brought before a court or tribunal in a Member State, responsibility for the payment of costs incurred in the translation of that information for the purposes of the proceedings shall be decided in accordance with the law of that Member State.

Article 21

Fast access to regulated information

1. The home Member State shall ensure that the issuer, or the person who has applied for admission to trading on a regulated market without the issuer's consent, discloses regulated information in a manner ensuring fast access to such information on a non discriminatory basis and makes it available to the officially appointed mechanism referred to in paragraph 2. The issuer, or the person who has applied for admission to trading on a regulated market without the issuer's consent, may not charge investors any specific cost for providing the information. The home Member State shall require the issuer to use such media as may reasonably be relied upon for the effective dissemination of information to the public throughout the European Union. The home Member State may not impose an obligation to use only media whose operators are established on its territory .

2. The home Member State shall ensure that there is at least one officially appointed mechanism for the central storage of regulated information. These mechanisms should comply with minimum quality standards of security, certainty on the information source, time recording and easy access by end users and shall be aligned with the filing procedure under Article 19(1).

3. Where securities are admitted to trading on a regulated market in only one host Member State, and not in the home Member State, the host Member State shall ensure disclosure of regulated information in accordance with the requirements referred to in paragraph 1.

4. In order to take account of technical developments on financial markets, to take account of developments in information and communication technology and to ensure the uniform application of paragraphs 1, 2 and 3 of this Article, the Commission shall adopt implementing measures in accordance with the procedure referred to in Article 27(2).

The Commission shall, in particular, specify:

(a)	minimum standards for dissemination of regulated information, as referred to in paragraph 1 ;

(b)	minimum standards for the central storage mechanisms as referred to in paragraph 2 .

The Commission may also specify and update a list of media for the dissemination of information to the public.

Article 22

Guidelines

1. The competent authorities of the Member States shall draw up appropriate guidelines with a view to further facilitating public access to information to be disclosed under Directive 2003/6/EC, Directive 2003/71/EC, and this Directive.

The aim of those guidelines shall be the creation of:

(a)

an electronic network to be set up at national level between national securities regulators, operators of regulated markets, and national company registers covered by Council Directive 68/151/EEC of 9 March 1968 on co-ordination of safeguards which, for the protection of the interests of members and others, are required by Member States of companies within the meaning of Article 58 of that Treaty, with a view to making such safeguards equivalent throughout the Community (18); and

(b)	a single electronic network, or a platform of electronic networks, across Member States.

2. The Commission shall review the results achieved under paragraph 1 by 31 December 2006 at the latest and may, in accordance with the procedure referred to in Article 23(2), adopt implementing measures to facilitate compliance with Articles 19 and 21.

Article 23

Third countries

1. Where the registered office of an issuer is in a third country, the competent authority of the home Member State may exempt that issuer from requirements under Articles 4 to 7 and Articles 12(6), 13, 14 and 16 to 18, provided that the law of the third country in question lays down equivalent requirements or such an issuer complies with requirements of the law of a third country that the competent authority of the home Member State considers as equivalent .

However, the information covered by the requirements laid down in the third country shall be filed in accordance with Article 19 and disclosed in accordance with Articles 20 and 21.

2. By way of derogation from paragraph 1, an issuer whose registered office is in a third country shall be exempted from preparing its financial statement in accordance with Article 4 or Article 5 prior to the financial year starting on or after 1 January 2007, provided such issuer prepares its financial statements in accordance with internationally accepted standards referred to in Article 9 of Regulation (EC) No 1606/2002.

3. The competent authority of the home Member State shall ensure that information disclosed in a third country which may be of importance for the public in the Community is disclosed in accordance with Articles 20 and 21, even if such information is not regulated information within the meaning of Article 2(1)(k).

4. In order to ensure the uniform application of paragraph 1, the Commission shall , in accordance with the procedure referred to in Article 27(2), adopt implementing measures stating that, by reason of its domestic law, regulations, administrative provisions, or of the practices or procedures based on international standards set out by international organisations, a third country ensures the equivalence of the information requirements provided for in this Directive.

(a)	setting up a mechanism ensuring the establishment of equivalence of information required under this Directive, including financial statements, and information, including financial statements, required under the law, regulations, or administrative provisions of a third country;

(b)

stating that, by reason of its domestic law, regulations, administrative provisions, or of the practices or procedures based on international standards set out by international organisations, the third country where the issuer is registered ensures the equivalence of the information requirements provided for in this Directive. The Commission shall, in accordance with the procedure referred to in Article 27(2), take the necessary decisions on the equivalence of accounting standards which are used by third country issuers under the conditions set out in Article 30(3) at the latest five years following the date referred to in Article 31. If the Commission decides that the accounting standards of a third country are not equivalent, it may allow the issuers concerned to continue using such accounting standards during an appropriate transitional period.

5. In order to ensure uniform application of paragraph 3, the Commission may, in accordance with the procedure referred to in Article 27(2), adopt implementing measures defining the type of information disclosed in a third country that is of importance to the public in the Community

6. Undertakings whose registered office is in a third country which would have required an authorisation in accordance with Article 5(1) of Directive 85/611/EEC or, with regard portfolio management under point 4 of section A Directive 2004/39/EC if it had its registered office or (only in the case of an investment firm) its head office within the Community shall also be exempted from aggregating holdings with the holdings of its parent undertaking under the requirements laid down in Articles 12(4) and 12(5) provided that they comply with equivalent conditions of independence as management companies or investment firms.

7. In order to take account of technical developments on financial markets and to ensure the uniform application of paragraph 4, the Commission shall, in accordance with the procedure referred to in Article 27(2), adopt implementing measures stating that, by reason of its domestic law, regulations, or administrative provisions, a third country ensures the equivalence of the independence requirements provided for under this Directive and its implementing measures

CHAPTER V

COMPETENT AUTHORITIES

Article 24

Competent authorities and their powers

1. Each Member State shall designate the central authority referred to in Article 21(1) of Directive 2003/71/EC as central competent administrative authority responsible for carrying out the obligations provided for in this Directive and for ensuring that the provisions adopted pursuant to this Directive are applied. Member States shall inform the Commission accordingly.

2. However, for the purpose of paragraph 5(h) Member States may designate another competent authority, different from the central competent authority as referred to in paragraph 1.

3. Member States may allow their central competent authority to delegate tasks. Except for the tasks referred to in paragraph 5(h) , any delegation of tasks related to the obligations provided for in this Directive and in its implementing measures shall be reviewed five years after the entry into force of this Directive and shall end eight years after the entry into force of this Directive . Any delegation of tasks shall be made in a specific manner stating the tasks to be undertaken and the conditions under which they are to be carried out.

Those conditions shall include a clause requiring the entity in question to be organised in a manner such that conflicts of interest are avoided and information obtained from carrying out the delegated tasks is not used unfairly or to prevent competition. In any case, the final responsibility for supervising compliance with the provisions of this Directive and implementing measures adopted pursuant thereto shall lie with the competent authority designated in accordance with paragraph 1.

4. Member States shall inform the Commission and competent authorities of other Member States of any arrangements entered into with regard to the delegation of tasks, including the precise conditions for regulating the delegations.

5. Each competent authority shall have all the powers necessary for the performance of its functions. It shall at least be empowered to:

(a)	require auditors , issuers, holders of shares or other financial instruments, or persons referred to in Articles 10 or 12 , and the persons that control them or are controlled by them, to provide information and documents;

(b)

require the issuer to disclose the information required under point (a) to the public by the means and within the time limits the authority considers necessary. It may publish such information on its own initiative in the event that the issuer, or the persons that control them or are controlled by them, fail to do so and after having heard the issuer;

(c)

require managers of the issuers and of the holders of shares or other financial instruments, or of persons referred to in Articles 10 or 12 , to notify the information required under this Directive, or under national law adopted in accordance with this Directive, and, if necessary, to provide further information and documents;

(d)

suspend, or request the relevant regulated market to suspend, the trading of securities for a maximum of ten days at one time if it has reasonable grounds for suspecting that the provisions of this Directive, or of national law adopted in accordance with this Directive, have been infringed by the issuer;

(e)	prohibit trading on a regulated market if it finds that the provisions of this Directive, or of national law adopted in accordance with this Directive, have been infringed, or if it has reasonable grounds for suspecting that they would be infringed;

(f)	monitor that the issuer discloses timely information with the objective of ensuring effective and equal access to the public in all Member States where the securities are traded and take appropriate action if that is not the case ;

(g)	make public the fact that an issuer, or a holder of shares or other financial instruments, or a person referred to in Articles 10 or 12 , is failing to comply with its obligations;

(h)	examine that information referred to in this Directive is drawn up in accordance with the relevant reporting framework and take appropriate measures in case of discovered infringements; and

(i)

carry out on-site inspections in its territory in accordance with national law, in order to verify compliance with the provisions of this Directive and its implementing measures. Where necessary under national law, the competent authority or authorities may use this power by applying to the relevant judicial authority and/or in co-operation with other authorities.

6. Paragraphs 1 to 5 shall be without prejudice to the possibility for a Member State to make separate legal and administrative arrangements for overseas European territories for whose external relations that Member State is responsible.

7. The disclosure to competent authorities by the auditors of any fact or decision related to the requests made by the competent authority under Article 24(5)(a) shall not constitute a breach of any restriction on disclosure of information imposed by contract or by any legislative, regulatory or administrative provision and shall not involve such auditors in liability of any kind.

Article 25

Professional secrecy and co-operation between Member States

1. The obligation of professional secrecy shall apply to all persons who work or who have worked for the competent authority and for entities to which competent authorities may have delegated certain tasks. Information covered by professional secrecy may not be disclosed to any other person or authority except by virtue of the laws, regulations or administrative provisions of a Member State.

2. Competent authorities of the Member States shall co-operate with each other, whenever necessary, for the purpose of carrying out their duties and making use of their powers, whether set out in this Directive or in national law adopted pursuant to this Directive . Competent authorities shall render assistance to competent authorities of other Member States.

3. Paragraph 1 shall not prevent the competent authorities from exchanging confidential information. Information thus exchanged shall be covered by the obligation of professional secrecy, to which the persons employed or formerly employed by the competent authorities receiving the information are subject.

4. Member States may conclude cooperation agreements providing for exchange of information with the competent authorities or bodies of third countries enabled by their respective legislation to carry out the tasks (or some of them) assigned by the present Directive to the competent authorities, in accordance with Article 24. Such an exchange of information is subject to guarantees of professional secrecy at least equivalent to those referred to in this Article. Such exchange of information must be intended for the performance of the supervisory task of the authorities or bodies mentioned. Where the information originates in another Member State, it may not be disclosed without the express agreement of the competent authorities which have disclosed it and, where appropriate, solely for the purposes for which those authorities gave their agreement.

Article 26

Precautionary measures

1. Where the competent authority of a host Member State finds that the issuer or the holder of shares or other financial instruments, or the person referred to in Article 10, has committed irregularities or infringed its obligations, it shall refer its findings to the competent authority of the home Member State.

2. If, despite the measures taken by the competent authority of the home Member State or because such measures prove inadequate, the issuer or the security holder persists in infringing the relevant legal or regulatory provisions, the competent authority of the host Member State shall, after informing the competent authority of the home Member State, take, in accordance with Article 3(2), all the appropriate measures in order to protect investors. The Commission shall be informed of such measures at the earliest opportunity.

CHAPTER VI

IMPLEMENTING MEASURES

Article 27

Committee

1. The Commission shall be assisted by the European Securities Committee, instituted by Article 1 of Decision 2001/528/EC.

2. Where reference is made to this paragraph, the regulatory procedure laid down in Article 5 of Decision 1999/468/EC shall apply, in compliance with Article 7 and Article 8 thereof, provided that the implementing measures adopted in accordance with that procedure do not modify the essential provisions of this Directive.

3. The period provided for in Article 5(6) of Decision 1999/468/EC is three months.

4. Without prejudice to the implementing measures already adopted, on the expiry of a four-year period following its entry into force, the application of the provisions of this Directive concerning the adoption of technical rules and decisions in accordance with the procedure referred to in paragraph 2 shall be suspended. On a proposal from the Commission, the European Parliament and the Council may renew the provisions concerned in accordance with the procedure laid down in Article 251 of the Treaty and, to that end, shall review them prior to the expiry of the four-year period.

Article 28

Sanctions

1. Without prejudice to the right of Member States to impose criminal sanctions, Member States shall ensure, in conformity with their national law, that at least the appropriate administrative measures may be taken or civil and/or administrative sanctions imposed in respect of the persons responsible, where the provisions adopted in accordance with this Directive have not been complied with. Member States shall ensure that those measures are effective, proportionate and dissuasive.

2. Member States shall provide that the competent authority may disclose to the public every measure taken or sanction imposed for infringement of the provisions adopted pursuant to this Directive, save where such disclosure would seriously jeopardise the financial markets or cause disproportionate damage to the parties involved.

Article 29

Right of appeal

Member States shall ensure that decisions taken under laws, regulations, and administrative provisions adopted in accordance with this Directive are subject to the right of appeal to the courts.

CHAPTER VII

TRANSITIONAL AND FINAL PROVISIONS

Article 30

Transitional provisions

1. By way of derogation from Article 5(3) of this Directive, the home Member State may exempt from disclosing financial statements in accordance with Regulation (EC) No 1606/2002 issuers referred to in Article 9 of that Regulation for the financial years starting on or after 1 January 2006.

2. Notwithstanding Article 12(2), a shareholder shall notify the issuer at the latest on ... (19) of the proportion of voting rights and capital it holds, in accordance with Articles 9, 10 and 12 , with issuers at that date, unless it has already made a notification containing equivalent information before that date.

Notwithstanding Article 12(6), an issuer shall in turn disclose the information received in those notifications no later than ... (20).

3. Where an issuer is incorporated in a third country, the home Member State may exempt such issuer only in respect of those debt securities which have already been admitted to trading on a regulated market in the European Union prior to 1 January 2005 from drawing up its financial statements in accordance with Article 4 (3) and its management report in accordance with Article 4(5) as long as

(a)	the competent authority of the home Member State acknowledges that annual financial statements prepared by issuers from such a third country give a true and fair view of the issuer's assets and liabilities, financial position and results;

(b)	the third country where the issuer is incorporated has not made mandatory the application of international accounting standards referred to in Article 2 of the Regulation (EC) No 1606/2002; and

(c)

the Commission has not taken any decision in accordance with Article 23(4)(b) as to whether there is an equivalence between the accounting standards referred to in Article 2 of Regulation (EC) No 1606/2002, and

—	the accounting standards laid down in the law, regulations, or administrative provisions of the third country where the issuer is incorporated, or

—	the accounting standards of a third country such an issuer has elected to comply with.

4. The home Member State may exempt issuers only in respect of those debt securities which have already been admitted to trading on a regulated market in the European Union prior to 1 January 2005 from disclosing half-yearly financial report in accordance with Article 5 for 10 years following 1 January 2005, provided that the home Member State had decided to allow such issuers to benefit from the provisions of Article 27 of Directive 2001/34/EC at the point of admission of those debt securities.

Article 31

Transposition

1. Member States shall take the measures necessary to comply with this Directive by ... (21) at the latest. When Member States adopt those provisions they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2. Where Member States adopt measures pursuant to Articles 3(1), 8(2) or (3), 9(6) or 30, they shall immediately communicate those measures to the Commission and to the other Member States.

Article 32

Amendments

With effect from the date specified in Article 31(1), Directive 2001/34/EC is amended as follows:

(1)	In Article 1, points (g) and (h) are deleted;

(2)	Article 4 is deleted;

(3)	In Article 6, paragraph 2 is deleted;

(4)	In Article 8, paragraph 2 is replaced by the following: “2. Member States may make the issuers of securities admitted to official listing subject to additional obligations, provided that those additional obligations apply generally for all issuers or for individual classes of issuers.”

(5)	Articles 65 to 97 are deleted;

(6)	Articles 102 and 103 are deleted;

(7)	In Article 107(3), the second subparagraph is deleted;

(8)

Article 108(2) is amended as follows:

(a)	in point (a), the words ‘periodic information to be published by the companies of which shares are admitted’ are deleted;

(b)	point (b) is deleted,

(c)	in point (c), point (iii) is deleted,

(d)	point (d) is deleted.

References to the deleted provisions shall be construed as references to the provisions of this Directive.

Article 33

Review

The Commission shall by the 30 June 2009 at the latest report on the operation of this Directive to the European Parliament and to the Council including the appropriateness of ending the exemption for existing debt securities after the 10 year period as provided for by Article 30(4) and its potential impact on the European financial markets.

Article 34

Entry into force

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 35

Addresses

This Directive is addressed to the Member States.

Done at ..., on ...

For the European Parliament

The President

For the Council

The President

(1) OJ C...

(2) OJ C...

(3) Poisition of the European Parliament of 30 March 2004.

(4) COM(1999) 232.

(5) OJ L 345, 31.12.2003, p. 64.

(6) OJ L 243, 11.9.2002, p. 1.

(7) OJ L 184, 17.7.1999, p. 23.

(8) OJ L 191, 13.7.2001, p. 45. Decision as amended by Decision 2004/8/EC (OJ L 3, 7.1.2004, p. 33).

(9) OJ L 184, 6.7.2001, p. 1.

(10) OJ L 281, 23.11.1995, p. 31. Directive as amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

(11) OJ L 145, 30.4.2004, p. 1 .

(12) OJ L 96, 12.4.2003, p. 16.

(13) OJ L 375, 31.12.1985, p. 3. Directive as last amended by Directive 2004/39/EC.

(14) OJ L 126, 26.5.2000, p. 1. Directive as last amended by Commission Directive 2004/69/EC (OJ L 125, 28.4.2004, p. 44).

(15) OJ L 204, 21.7.1998, p. 37. Directive as last amended by the 2003 Act of Accession (OJ L 236, 23.9.2003, p. 68).

(16) OJ L 193, 18.7.1983, p. 1. Directive as last amended by Directive 2003/51/EC of the European Parliament and of the Council (OJ L 178, 17.7.2003, p. 16).

(17) OJ L 222, 14.8.1978, p. 11. Directive as last amended by Directive 2003/51/EC.

(18) OJ L 65, 14.3.1968, p. 8. Directive as last amended by Directive 2003/58/EC of the European Parliament and of the Council (OJ L 221, 4.9.2003, p. 13).

(19) Two months after the date in Article 31(1).

(20) Three months after the date in Article 31(1).

(21) 24 months after its entry into force.

P5_TA(2004)0221

Equality of access to and supply of goods and services *

European Parliament legislative resolution on the proposal for a Council directive implementing the principle of equal treatment between women and men in the access to and supply of goods and services (COM(2003) 657 — C5-0654/2003 — 2003/0265(CNS))

(Consultation procedure)

The European Parliament,

—	having regard to the Commission proposal to the Council (COM(2003) 657) (1),

—	having regard to Article 13(1) of the EC Treaty, pursuant to which the Council consulted Parliament (C5-0654/2003),

—	having regard to Rule 67 of its Rules of Procedure,

—

having regard to the report of the Committee on Women's Rights and Equal Opportunities and the opinion of the Committee on Citizens' Freedoms and Rights, Justice and Home Affairs, the Committee on Legal Affairs and the Internal Market, the Committee on Industry, External Trade, Research and Energy and the Committee on Employment and Social Affairs (A5-0155/2004),

1.	Approves the Commission proposal as amended;

2.	Calls on the Commission to alter its proposal accordingly, pursuant to Article 250(2) of the EC Treaty;

3.	Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament;

4.	Asks the Council to consult Parliament again if it intends to amend the Commission proposal substantially;

5.	Instructs its President to forward its position to the Council and the Commission.

TEXT PROPOSED BY THE COMMISSION

AMENDMENTS BY PARLIAMENT

Amendment 1

Title

Council directive implementing the principle of equal treatment between women and men in the access to and supply of goods and services

Council directive implementing equality of women and men in the access to and supply of goods and services

(This amendment applies throughout the text.)

Amendment 2

Recital 2a (new)

(2a) Within the civil rights tradition, the right to equal treatment belongs to a person in his or her capacity as an individual and not in his or her capacity as a member of a racial, sexual, religious or ethnic group. As women and men constitute the two halves of humanity, women are not a minority group and should not be seen or treated as such.

Amendment 3

Recital 2b (new)

(2b) While prohibiting discrimination, it is important to respect other fundamental rights and freedoms.

Amendment 4

Recital 9

(9) Problems are particularly apparent in the area of goods and services. Discrimination based on sex, should therefore be prevented and eliminated in this area. As in the case of Council Directive 2000/43/EC of 29 June 2000 implementing the principle of equal treatment irrespective of racial and ethnic origin, this objective can be achieved by means of Community legislation.

Amendment 5

Recital 10

(10) Such legislation should prohibit discrimination based on sex in the access to and supply of goods and services. Services should be taken to be those which are normally provided for remuneration.

(10) Such legislation should implement the principle of individual rights to equality of women and men. It should prohibit discrimination based on sex and achieve de facto equality of women and men in the access to and supply of all publicly available goods and services. Services should be taken to be those which are normally provided for remuneration. Goods should be taken to be those which have an economic value.

Amendment 6

Recital 10a (new)

(10a) This Directive should not apply to education nor to the content of media and advertising.

Amendment 7

Recital 11

(11) While prohibiting discrimination, it is important to respect other fundamental rights and freedoms, including the protection of private and family life and transactions carried out in that context and the freedom and pluralism of the media. The prohibition of discrimination should therefore apply to access to and supply of goods and services which are available to the public. It should not apply to the content of media or advertising.

Deleted

Amendment 8

Recital 11a (new)

(11a) Differentiation in premiums for or benefits under insurance products based on sex (including the risk of pregnancy) is discriminatory since sex constitutes a factor that may not be influenced and is only attributed to a group on the basis of statistical assumptions; different pricing in relation to differences in risk profile should be attributable to the behaviour and choices of individuals.

Amendment 9

Recital 12

(12) The principle of equal treatment should not preclude differences which are related to goods or services for which men and women are not in a comparable situation because the goods or services are intended exclusively or primarily for the members of one sex, such as private membership clubs, or to skills which are practised differently for each sex.

Deleted

Amendment 10

Recital 14a (new)

(14a) In view of disparities between Member States and the consequent risk of distortion of competition during this transitional period, Member States should annually submit a report to the Commission on the progress made in eliminating the use of actuarial factors related to sex. This constant supervision by the Commission, which should inform the European Parliament and the Council, alongside full transparency in the use of these factors, should limit distortion of competition during the transitional period.

Amendment 42

Article 1, paragraph 1

1. This Directive lays down a framework for combating discrimination based on sex in access to and the supply of goods and services, with a view to putting into effect in the Member States the principle of equal treatment between men and women.

1. This Directive lays down a framework for combating discrimination and achieving equality on the ground of sex in the access to and supply of goods and services, with a view to ensuring in the Member States the equality of women and men .

Amendment 12

Article 1, paragpraph 2

2. Within the limits of the powers conferred upon the Community, this Directive shall apply to all persons in relation to the access to and the supply of goods and services which are available to the public, including housing, as regards both the public and private sectors, including public bodies.

2. Within the limits of the powers conferred upon the Community, this Directive shall apply to all persons in relation to the access to and the supply of all goods and services which are available to the public, as regards both the public and private sectors, including public bodies.

Amendment 13

Article 1, paragraph 3

3. This Directive does not preclude differences which are related to goods or services for which men and women are not in a comparable situation because the goods or services are intended exclusively or primarily for the members of one sex or to skills which are practised differently for each sex.

Deleted

Amendment 14

Article 1, paragraph 4

4. This Directive shall not apply to education nor to the content of media and advertising, in particular advertising and television advertising as defined in Article 1(b) of Council Directive 89/552/EEC.

4. This Directive shall not apply to education nor to the content of media and advertising, except for the advertising of the terms and conditions on which access to goods is granted and services are supplied.

Amendment 15

Article 1, paragraph 4a (new)

(4a) This Directive shall not prejudice the application of Community law in the field of employment, in particular Community provisions in force relating to occupational pension schemes and social security and social assistance matters.

Amendment 16

Article 2, paragraph 1, point (d)

(d)	sexual harassment occurs where unwanted physical, verbal or non-verbal conduct of a sexual nature is exhibited with the purpose or effect of violating the dignity of a person and of creating an intimidating, hostile, degrading, humiliating or offensive environment;

(d)	sexual harassment occurs where unwanted physical, verbal or non-verbal conduct of a sexual nature is exhibited with the purpose or effect of violating the dignity of a person and of creating an intimidating, hostile, degrading or offensive environment either within or outside the workplace ;

Amendment 17

Article 2, paragraph 2

2. Incitement to direct or indirect discrimination on grounds of sex shall be deemed to be discrimination within the meaning of this Directive.

Deleted

Amendment 18

Article 3, Title

Principle of equal treatment

Equality

Amendment 19

Article 3, paragraph 1, points (a) and (b)

(a)	there shall be no direct discrimination based on sex, including less favourable treatment of women for reasons of pregnancy and maternity;

(a)	there shall be no direct discrimination based on sex, including less favourable treatment for reasons of pregnancy, maternity and paternity ;

(b)	there shall be no indirect discrimination based on sex.

(b)	there shall be no indirect discrimination based on sex , in particular on grounds of family or marital status, or for reasons of reconciling family and working life .

Amendment 20

Article 3, paragraph 2a (new)

(2a) Incitement to direct or indirect discrimination on grounds of sex shall also be deemed to be discrimination within the meaning of this Directive.

Amendment 22

Article 4, paragraph 2

2. Member States may defer implementation of the measures necessary to comply with paragraph 1 until [ six years after date referred to in paragraph 1] at the latest.

2. In the event of difficulties encountered in implementing the measures necessary to comply with paragraph 1 , Member States may decide to defer implementation of these measures for a period up to [ four years after date referred to in paragraph 1] at the latest.

In that case, the Member States concerned shall immediately inform the Commission. They shall compile, publish and regularly update comprehensive tables on the mortality and life expectancy of women and men.

In that case, the Member States concerned shall immediately inform the Commission. In addition, they shall regularly submit a report to the Commission on the progress made in overcoming those difficulties. They shall also annually update and publish comprehensive tables on the mortality and life expectancy of women and men.

The Commission shall forward all the abovementioned information to the European Parliament and the Council.

Amendment 43

Article 5

The principle of equal treatment shall not prevent any Member State from maintaining or adopting specific measures to prevent or compensate for disadvantages linked to sex.

With a view to ensuring full equality in practice, the equality of women and men shall not prevent any Member State from maintaining or adopting specific measures to prevent or compensate for disadvantages linked to sex.

Amendment 24

Article 6, paragraph 1

1. Member States may introduce or maintain provisions which are more favourable to the protection of the principle of equal treatment between women and men than those laid down in this Directive.

1. Member States shall maintain provisions , or may introduce new provisions, which are more favourable to the protection of equality of women and men than those laid down in this Directive.

Amendment 25

Article 7, paragraph 2

2. Member States shall introduce into their national legal systems such measures as are necessary to ensure real and compensation or reparation, as the Member States so determine, for the loss and damage sustained by a person injured as a result of discrimination within the meaning of this Directive, in a way which is dissuasive and proportionate to the damage suffered. Such compensation or reparation shall not be restricted by the fixing of a prior upper limit.

2. Member States shall introduce into their national legal systems such measures as are necessary to ensure real and effective compensation or reparation, as the Member States so determine, for the loss and damage sustained by a person injured as a result of discrimination within the meaning of this Directive, in a way which is dissuasive and proportionate to the damage suffered. Such compensation or reparation shall not be restricted by the fixing of a prior upper limit or by excluding an award of interest to compensate for the loss sustained by the recipient of the compensation as a result of the lapse of time until actual payment of the capital sum awarded .

Amendment 44

Article 9

Member States shall introduce into their national legal systems such measures as are necessary to protect persons from any adverse treatment or adverse consequence as a reaction to a complaint or to legal proceedings aimed at enforcing compliance with the principle of equal treatment .

Member States shall introduce into their national legal systems such measures as are necessary to protect any persons , including persons other than the victims, from any adverse treatment or adverse consequence , including unilateral resiliation of a contract by the provider of goods or services, as a reaction to a complaint or to a legal proceeding, or to any other action in support thereof, aimed at ensuring the equality of women and men .

Amendment 45

Article 10

Member States shall engage in dialogue with appropriate nongovernmental organisations which have, in accordance with their national law and practice, a legitimate interest in contributing to the fight against discrimination on grounds of sex with a view to promoting the principle of equal treatment.

Member States shall engage in regular dialogue with appropriate non-governmental organisations and with the social partners which have, in accordance with their national law and practice, a legitimate interest in contributing to the fight against discrimination on grounds of sex with a view to promoting equality.

Amendment 28

Article 11, paragraph 1

1. Member States shall designate and make the necessary arrangements for a body or bodies for the promotion, analysis, monitoring and support of equal treatment of all persons without discrimination on the grounds of sex. These bodies may form part of agencies with responsibility at national level with the defence of human rights or the safeguard of individuals' rights, or bodies with responsibility for implementation of t he principle of equal treatment for men and women as regards access to employment, vocational training and promotion, and working conditions.

1. Member States shall designate and make the necessary arrangements for an independent body or bodies for the promotion, analysis, monitoring and support of equality of women and men and for combating discrimination on the grounds of sex. These bodies may form part of independent agencies with responsibility at national level with the defence of human rights or the safeguard of individuals' rights, or bodies with responsibility for implementation of equality for men and women as regards access to employment, vocational training and promotion, and working conditions.

Amendment 29

Article 11, paragraph 2

2. Member States shall ensure that the competencies of the bodies referred to in paragraph 1 include:

(a)	without prejudice to the rights of victims and of associations, organisations or other legal entities referred to in Article 7(3), providing independent assistance to victims of discrimination in pursuing their complaints about discrimination;

(b)	conducting independent surveys concerning discrimination;

(c)	publishing independent reports and making recommendations on any issue relating to such discrimination.

2. Member States shall ensure that sufficient human and financial resources are available for the bodies referred to in paragraph 1 to exercise effectively their competences, which shall include:

(a)

without prejudice to the rights of victims and of associations, organisations or other legal entities referred to in Article 7(3), bringing legal proceedings whenever necessary to combat discrimination and providing independent assistance to victims of discrimination in pursuing their complaints about discrimination;

(b)	conducting independent surveys concerning discrimination;

(c)	producing statistics broken down by gender, publishing independent reports , making recommendations on any issue relating to such discrimination and reviewing legislation and policy for their impact on the equality of women and men .

Amendment 30

Article 12, introduction

Member States shall take the necessary measures to ensure that the principle of equal treatment is respected in relation to the access to and supply of goods and services within the scope of this directive, and in particular that:

Member States shall take the necessary measures to ensure that equality is respected within the scope of this directive, and in particular that:

Amendment 31

Article 12, point (b)

(b)	any provisions contrary to the principle of equal treatment included in individual or collective contracts or agreements, internal rules of undertakings, and rules governing profit-making or non-profit-making associations are, or may be declared, null and void or are amended.

(b)	any provisions contrary to equality included in contracts or agreements, internal rules of undertakings, and rules governing profit-making or non-profit-making associations are, or may be declared, null and void or are amended.

Amendment 32

Article 13

Penalties

Sanctions

The Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented . The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by the date specified in Article 16(1) at the latest and shall notify it without delay of any subsequent amendment affecting them.

The Member States shall lay down the rules on sanctions applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are applied . The sanctions, which may comprise the payment of compensation to the victim, provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by the date specified in Article 16(1) at the latest and shall notify it without delay of any subsequent amendment affecting them.

Amendment 33

Article 14

Transparency

Dissemination of information

Member States shall ensure that the provisions adopted pursuant to this Directive, together with the relevant provisions already in force, are brought to the attention of the persons concerned by all appropriate means throughout their territory.

Member States shall ensure that the provisions adopted pursuant to this Directive, together with the relevant provisions already in force, are brought to the attention of the persons concerned , in particular to the consumers and to the providers of goods and services, by all appropriate means throughout their territory.

Amendment 34

Article 15, paragraph 1

1. Member States shall communicate all available information concerning the application of this Directive to the Commission, by [ five years after the date of entry into force ] at the latest, and every five years thereafter.

1. Member States shall communicate all available information concerning the application of this Directive to the Commission, including an assessment of the effects, performance and effectiveness of the measures taken, by [ three years after the date of entry into force ] at the latest, and every three years thereafter.

The Commission shall draw up a summary report which it shall submit to the European Parliament and to the Council. Where appropriate, the Commission shall accompany its report with proposals to modify the Directive.

On the basis of the information received, the Commission shall draw up a summary report which it shall submit to the European Parliament and to the Council by [four years after the date of entry into force] at the latest, and every four years thereafter . Where appropriate, the Commission shall accompany its report with proposals to modify the Directive.

(1) Not yet published in the OJ.

P5_TA(2004)0222

Protection of animals *

European Parliament legislative resolution on the proposal for a Council regulation on the protection of animals during transport and related operations and amending Directives 64/432/EEC and 93/119/EC (COM(2003) 425 — C5-0438/2003 — 2003/0171(CNS))

(Consultation procedure)

The European Parliament,

—	having regard to the Commission proposal to the Council (COM(2003) 425) (1)

—	having regard to Article 37 of the EC Treaty, pursuant to which the Council consulted Parliament (C5-0438/2003),

—	having regard to Rule 67 of its Rules of Procedure,

—	having regard to the report of the Committee on Agriculture and Rural Development and the opinion of the Committee on the Environment, Public Health and Consumer Policy and the Committee on Regional Policy, Transport and Tourism (A5-0197/2004),

1.	Approves the Commission proposal as amended;

2.	Calls on the Commission to alter its proposal accordingly, pursuant to Article 250(2) of the EC Treaty;

3.	Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament;

4.	Asks the Council to consult Parliament again if it intends to amend the Commission proposal substantially;

5.	Instructs its President to forward its position to the Council and Commission.

TEXT PROPOSED BY THE COMMISSION

AMENDMENTS BY PARLIAMENT

Amendment 1

RECITAL 5

(5) For reasons of animal welfare the transport of animals over long distances, including animals for slaughter, should be reduced as far as possible.

(5) For reasons of animal welfare the animals should be in the vehicles for as short a time as possible , for which there is a need to have more than one driver, to minimise the travel time and the duration of stops. Accordingly, the use of mobile slaughterhouses should be encouraged, above all in thinly populated and outlying areas.

Amendment 2

RECITAL 10

(10) The unloading and subsequent reloading of animals is more stressful than leaving them resting in the vehicle in good conditions. In addition, contact at staging points between animals from different sources can lead to the spread of infectious disease. Therefore, for animal welfare and animal health reasons the use of staging points should be prevented . Accordingly, Council Regulation (EC) No 1255/97 of 25 June 1997 concerning Community criteria for staging points and amending the route plan referring to in the Annex to Directive 91/628/EEC, should be repealed.

(10) The unloading and subsequent reloading of animals is more stressful than leaving them resting in the vehicle in good conditions. In addition, contact at staging points and markets between animals from different sources can lead to the spread of infectious disease. Therefore, for animal welfare and animal health reasons the use of staging points should be avoided, provided that suitable conditions for the animals can be guaranteed . Accordingly, Council Regulation (EC) No 1255/97 of 25 June 1997 concerning Community criteria for staging points and amending the route plan referring to in the Annex to Directive 91/628/EEC, should be repealed.

Amendment 3

RECITAL 10a (new)

10a. When long-distance journeys are undertaken, stopping areas should continue to be available at which transport vehicles can be refuelled, animals can be fed and watered if supplies for the journey have unexpectedly run out, lactating animals can be milked, and, in emergencies, the assistance of a veterinarian can be sought.

Amendment 4

RECITAL 15a (new)

(15a) Limiting the transport of animals could have serious economic consequences for peripheral regions. This Regulation should therefore specify the exemptions required to prevent the commercial isolation of such regions.

Amendment 5

RECITAL 16

(16) Council Regulation (EEC) No 3820/85 of 20 December 1985 on the harmonisation of certain social legislation relating to road transport provides for maximum driving periods and minimum rest periods for road drivers. It is appropriate that journey times for animals are similarly regulated. Council Regulation (EEC) No 3821/85 of 20 December 1985 on recording equipment in road transport provides for recording equipment to be installed and used to ensure effective checking on compliance with social legislation concerning road transport. It is necessary that such record data be made available and checked so as to enforce travelling time limits under animal welfare legislation.

(16) Council Regulation (EEC) No 3820/85 of 20 December 1985 on the harmonisation of certain social legislation relating to road transport provides for maximum driving periods and minimum rest periods for road drivers. It is appropriate that journey times for animals are similarly regulated. Council Regulation (EEC) No 3821/85 of 20 December 1985 on recording equipment in road transport provides for recording equipment to be installed and used to ensure effective checking on compliance with social legislation concerning road transport. Where animal transport is concerned, a GPS system should be used to monitor travel time, the route and activities of the vehicle during the journey. This could lead to an automated animal transport control system.

Amendment 6

RECITAL 16a (new)

(16a) Owing to their great flexibility and versatility, the application of new satellite positioning and mobile communication technologies to tracking and tracing systems meets the requirements of the new ’animal protection during transport’ policies planned at Community level. These technologies enable animal transport vehicles to be tracked, traced, monitored and controlled. With regard to satellite positioning, the Galileo project launched by the European Union in 2002 (2) is scheduled to provide, as of 2008, services which are optimal for these purposes.

Amendment 7

RECITAL 25a (new)

(25a) In the interests of animal welfare and animal and public health, movements should be kept to the minimum consonant with good farming practice.

Amendment 8

RECITAL 25b (new)

(25b) The slaughter of animals as close as possible to their place of rearing should be given priority, leading to the development of local slaughterhouses and hence employment, in particular in disadvantaged rearing areas,

Amendment 109

ARTICLE 1, PARAGRAPH 2

2. This Regulation shall not apply to the transport of a single animal accompanied by the person who is responsible for it during transport.

2. This Regulation shall not apply to the transport of a single animal accompanied by the person who is responsible for it during transport , for transport in connection with traditional pasturing and transhumance, nor shall it apply to registered equidae being transported for breeding or competition purposes that are identifiable through individual passports. It shall likewise not apply to the transport of animals intended for public performances or shows, cultural, sporting or training activities, restocking or centres exhibiting animal life and the natural world.

The sectors excluded from this Regulation must supply the competent authorities with details of their customary transport practices, in addition to being regularly inspected and demonstrating compliance with the respective specific requirements so as to guarantee the welfare of animals to be transported.

Amendment 10

ARTICLE 1, PARAGRAPH 2a (new)

2a. This Regulation shall not be an obstacle to any stricter national measures, including a total ban on the export of live equidae intended for production or slaughter, aimed at improving the welfare of animals during transport taking place entirely within the territory of a Member State or during transport by sea, departing from the territory of a Member State.

Amendment 11

ARTICLE 2, POINT (aa) (new)

(aa)	‘certified breeding animals’ means animals intended for breeding for which a herd-book certificate has been issued.

Amendment 12

ARTICLE 2, POINT (c)

(c)	‘attendant’ means a person directly in charge of the welfare of the animals who accompanies them during a journey;

(c)	‘attendant’ means a person directly in charge of the welfare of the animals who accompanies them during a journey and during loading and unloading ;

Amendment 121/rev

ARTICLE 2, POINT (h)

(h)	‘journey’ means the entire transport operation from the place of departure to the place of destination, including any unloading, accommodation and loading occurring at intermediate points in the journey;

(h)	‘journey’ means the entire transport operation from the loading of the first animal at the place of departure to the unloading of the last animal at the place of destination, including any unloading, accommodation and loading occurring at intermediate points in the journey;

Amendment 13

ARTICLE 2, POINT (ka) (new)

(ka)	‘journey for slaughter’ means a journey of animals which are slaughtered within one month after arrival at the place of destination after a journey;

Amendment 14

ARTICLE 3a (new)

Article 3a

The slaughter of animals as close as possible to their place of rearing shall be given priority. The development of local slaughterhouses and hence employment in disadvantaged areas shall form part of rural development policy.

In order to minimise the duration of the journey or to obviate the need to transport slaughter animals, the use of mobile slaughterhouses under Regulation (EC) No 1257/1999 (3) on support for rural development shall be encouraged.

Amendment 15

ARTICLE 3b (new)

Article 3b

The Commission shall review the rules on state aid with a view to ensuring that sufficient support can be given to local abattoirs to allow them both to conform with the required standards and be financially viable.

Amendment 115

ARTICLE 3c (new)

Article 3c

The Commission shall examine ways of encouraging and promoting the development and use of more small local abattoirs — and mobile slaughterhouses — and publish a report to that effect before December 2004. The report will in particular examine whether charges for meat hygiene inspections should be calculated on a headage (throughput) basis rather than a set daily charge.

Amendment 16

ARTICLE 6, PARAGRAPH 7

7. Paragraphs 1, 2 and 4 shall not apply to persons transporting animals up to a maximum distance of 50 km counted from the place of departure to the place of destination.

7. Paragraphs 1, 2 and 4 shall not apply to persons transporting animals up to a maximum distance of 100 km counted from the place of departure to the place of destination.

Amendment 17

ARTICLE 7, PARAGRAPH 1

1. No person shall transport animals by road over long-distance journeys unless the means of transport has been inspected and approved under Article 17(1).

1. No person shall transport animals by road over more than 100 km from the place of departure to the place of destination unless the means of transport has been inspected and approved under Article 17(1).

Amendment 18

ARTICLE 9, PARAGRAPH 1a (new)

1a. Operators of assembly centres shall ensure that animals have easy and constant access to fresh, clean water.

Amendment 19

ARTICLE 9, PARAGRAPH 2, POINT (a)

(a)	entrust the handling of animals only to personnel who have followed training courses on the relevant technical rules set out in Annex I;

(a)

entrust the handling of animals only to personnel who have followed training courses on the relevant technical rules set out in Annex I and on animal physiology and drinking and feeding needs, animal behaviour and the factors causing stress, and, in particular, the practical aspects of handling of animals and emergency care for animals .

Amendment 20

ARTICLE 10, TITLE

Authorisations for transporters operating long-distance journeys

Authorisations for transporters transporting animals over a distance of more than 100 km from the place of departure to the place of destination

Amendment 21

ARTICLE 10, PARAGRAPH 1, POINT (e), POINT (i)

(i)	valid training certificates for drivers as provided for in Article 16 (2) for all the drivers intended to operate long distance journeys;

(i)	valid training certificates for drivers as provided for in Article 16(2) for all the drivers intended to operate journeys of more than 100 km or two hours ;

Amendment 22

ARTICLE 10, PARAGRAPH 1, POINT (e), POINT (ii)

(ii)	valid certificates of approval as provided for in Article 17 (2) for all means of transport by road intended to be used for long distance journeys;

(ii)	valid certificates of approval as provided for in Article 17(2) for all means of transport by road intended to be used for journeys of more than 100 km or two hours ;

Amendment 23

ARTICLE 11

Article 11

Authorisations for transporters not operating long distance journeys

1. The competent authority shall grant authorisations to transporters not operating long distance journeys upon application, provided that they comply with points (a) to (d) of Article 10(1).

2. The competent authority shall issue such authorisations in accordance with the specimen set out in Chapter II of Annex III and valid for not more than five years from the date of issue.

Deleted

Amendments 24 and 25

ARTICLE 12, PARAGRAPHS 1-3

1. The competent authority may limit the scope of an authorisation provided for in Article 10(1) or Article 11(1) according to criteria that may be verified during transport.

1. The competent authority may limit the scope of an authorisation provided for in Article 10(1) according to criteria that may be verified during transport.

2. The competent authority shall issue each authorisation provided for in Article 10(1) or Article 11(1) with a number unique in the Member State. The authorisation shall be drawn up at least in one of the official languages of the Member State of issue and two other official languages of the Community.

2. The competent authority shall issue each authorisation provided for in Article 10(1) with a number unique in the Member State. The authorisation shall be drawn up at least in one of the official languages of the Member State of issue and two other official languages of the Community , one of them being English .

3. The competent authority shall record authorisations provided for in Article 10(1) or Article 11(1) in a manner enabling the competent authority to identify transporters rapidly in particular in the event of failure to comply with the requirements of this Regulation.

3. The competent authority shall record authorisations provided for in Article 10(1) in a manner enabling the competent authority to identify transporters rapidly in particular in the event of failure to comply with the requirements of this Regulation.

Amendment 26

ARTICLE 13, POINT (c)

(c)	send details as soon as possible of the intended long distance journey set out in the journey log to the competent authority of the place of destination or of the exit point.

(c)

send details as soon as possible of the intended long distance journey set out in the journey log to the competent authority of the place of destination or of the exit point. For this purpose the competent authority shall notify as soon as possible all transports that it has accepted as being in compliance with this Regulation through the information exchange system referred to in Article 20 of Directive 90/425/EEC.

Amendments 27 and 28

ARTICLE 14

The competent authority shall carry out at any stage of the long distance journey appropriate checks on a random or targeted basis to verify that declared journey times are credible and comply with this Regulation. In particular the competent authority shall verify that travel times and rest periods have complied with the limits set out in Chapter V of Annex I.

The competent authority shall have carried out by qualified representatives at any stage of the long distance journey appropriate official checks on a random or targeted basis concerning aspects which are of relevance to animal welfare to verify that declared journey times are credible and that the journey complies with this Regulation. The number of animals to be checked and the number of checks shall cover at least 20% of journeys, of which at least 10% shall be in the form of a spot check on the road. Member States shall ensure that the relevant inspection authorities have at their disposal sufficient qualified staff to carry out the checks mentioned above.

The use of satellite positioning and mobile communications technologies shall be used for carrying out these checks.

If the checks are delegated to more than one authority, the central authority of the Member State shall ensure that the checks are coordinated, particularly in order to prevent duplication of checks, so as not to delay transport unnecessarily.

The competent authority shall record the outcome of the checks carried out on long distance journeys within the information exchange system referred to in Article 20 of Directive 90/425/EEC.

Amendment 29

ARTICLE 15, paragraph 1a (new)

The training shall be organised within the framework of this Regulation in the Member States on the basis of uniform criteria.

Amendment 30

ARTICLE 16, PARAGRAPH 1

1. Training courses shall be available for personnel of transporters and assembly centres for the purposes of Article 6(4) and Article 9(2)a.

1. Training and further training courses shall be available for personnel of transporters and assembly centres and a certification procedure shall be established for the purposes of Articles 6(4) and 9(2)a.

Amendment 31

ARTICLE 16, PARAGRAPH 2

2. The training certificate for drivers of road vehicles transporting domestic equidae or domestic animals of bovine, ovine, caprine, porcine species or poultry as referred to in Article 6(5) shall be granted in accordance with Annex IV. The training certificate shall be drawn up in at least one of the official languages of the Member State where it is issued and of two other official languages of the Community. The training certificate shall be issued by the competent authority or body designated for this purpose by the Member States and in accordance with the specimen set out in Chapter III of Annex III.

2. The training certificate for drivers of road vehicles transporting animals as referred to in Article 6(5) shall be granted in accordance with Annex IV. The training certificate shall be drawn up in at least one of the official languages of the Member State where it is issued and in two other official languages of the Community. One of these languages shall be English. The training certificate shall be issued by the competent authority or body designated for this purpose by the Member States and in accordance with the specimen set out in Chapter III of Annex III. A certificate of completion of the regular course at an agricultural college or similar training shall be deemed to constitute a training certificate as referred to in Annex IV.

Amendment 32

ARTICLE 16, PARAGRAPH 2a (new)

2a. The scope of the training certificate may be limited to a specific species, subgroup, transport time or period of time.

Amendment 33

ARTICLE 16, PARAGRAPH 2b (new)

2b. The personnel responsible shall update their knowledge at suitable intervals to include further scientific developments in animal handling.

Amendment 34

ARTICLE 17, PARAGRAPH 1, INTRODUCTION

1. The competent authority or body designated by Member State shall grant a certificate of approval for means of transport by road used for long-distance journeys upon application provided that the means of transport:

1. The competent authority or body designated by the Member State shall grant a certificate of approval for means of transport by road used for journeys of more than 100 km between the place of departure and the place of destination upon application provided that the means of transport:

Amendment 35

ARTICLE 17, PARAGRAPH 1, POINT (b)

(b)	have been favourably inspected by the competent authority regarding the requirements of Chapters II and VI of Annex I applicable to the design, the construction and the maintenance of means of transport by road used for long distance journeys.

(b)	have been favourably inspected by the competent authority regarding the requirements of Chapter II of Annex I and , for means of transport by road for long distance journeys, Chapter VI of Annex I applicable to the design, construction and maintenance of means of transport by road.

Amendment 36

ARTICLE 17, PARAGRAPH 2

2. The competent authority or body designated by Member State shall issue each certificate with a number unique in the Member State and in accordance with the specimen set out in Chapter IV of Annex III. The certificate shall be drawn up in at least one of the official languages of the Member State of issue and two other official languages of the Community. Certificates shall be valid for a period of not more than five years from the date of issue and shall be renewed any time the means of transport is modified or refitted.

2. The competent authority or body designated by Member State shall issue each certificate with a number unique in the Member State and in accordance with the specimen set out in Chapter IV of Annex III. The certificate shall be drawn up in at least one of the official languages of the Member State of issue and two other official languages of the Community , one of them being English . Certificates shall be valid for a period of not more than three years from the date of issue and shall become invalid as soon as the means of transport is modified or refitted.

Amendment 41

ARTICLE 17, PARAGRAPH 2a (new)

2a. All vehicles in each Member State shall be licensed for the species of animal they will be allowed to carry. The weight and size of the animals will also affect the number of animals the individual vehicle will be allowed to carry. Each vehicle shall be ‘plated’ with the relevant information so that the provisions of this Regulation can be enforced throughout the European Union.

Amendment 37

ARTICLE 17, PARAGRAPH 2b (new)

2b. The competent authority shall record the certifications of the approval of the means of transport in an electronic database in a manner enabling competent authorities in all Member States to identify a means of transport rapidly, in particular in the event of failure to comply with the requirements of this Regulation.

Amendment 38

ARTICLE 18, PARAGRAPH 1, POINT (a)

(a)	regularly operated from the Member State where the application is made;

(a)	operated from the Member State where the application is made;

Amendment 39

ARTICLE 18, PARAGRAPH 2

2. The competent authority or body designated by Member State shall issue each certificate with a number unique in the Member State. The certificate shall be drawn up in at least one of the official languages of the Member State of issue and two other official languages of the Community. Certificates shall not be valid for a period of more than five years from the date of issue and shall be renewed any time the livestock vessel is modified or refitted.

2. The competent authority or body designated by Member State shall issue each certificate with a number unique in the Member State. The certificate shall be drawn up in at least one of the official languages of the Member State of issue and two other official languages of the Community , one of them being English . Certificates shall not be valid for a period of more than five years from the date of issue and shall be renewed any time the livestock vessel is modified or refitted.

Amendment 40

ARTICLE 18, PARAGRAPH 3

3. The competent authority shall record approved livestock vessels in a manner enabling them to be rapidly identified in particular in the event of failure to comply with this Regulation.

3. The competent authority shall record approved livestock vessels in an electronic database in a manner enabling them to be rapidly identified in particular in the event of failure to comply with this Regulation.

Amendment 42

ARTICLE 19, PARAGRAPH - 1 (new)

- 1. Before loading begins, the transporter shall complete fully and correctly the ‘journey plan for livestock vessels’ as provided for in Chapter IVa of Annex III, after which the route plan shall be submitted to the competent authority.

Amendment 43

ARTICLE 19, PARAGRAPH 1, INTRODUCTION

1. The competent authority shall inspect livestock vessels before any loading of animals in order to verify in particular that:

1. The competent authority shall inspect livestock vessels before any loading of animals in order to verify the correctness of the ‘journey plan for livestock vessels’ and in particular that:

Amendment 44

ARTICLE 20, PARAGRAPH 1, INTRODUCTION

1. Without prejudice to the checks provided for in Article 2 of Regulation (EC) No 639/2003 where animals are presented at exit points or border inspection posts , official veterinarians of the Member States shall check that the animals are transported in compliance with this Regulation and in particular:

1. Without prejudice to the checks provided for in Article 2 of Regulation (EC) No 639/2003, official veterinarians of the Member States shall check at exit points and border inspection posts that the animals are transported in compliance with this Regulation and in particular:

Amendment 45

ARTICLE 20, PARAGRAPH 1, POINT (fa) (new)

(fa)	that, in the case of imports and exports, transporters have provided evidence that the journey from the place of departure to the place of destination indicates compliance with the journey times laid down in Chapter V of Annex I.

Amendment 46

ARTICLE 20, PARAGRAPH 2

2. In the case of long distance journeys for domestic equidae and domestic animals of bovine, ovine, caprine and porcine species official veterinarians of exit points and border inspection posts shall perform and record the checks listed in the Section 3 ‘Place of destination’ of Annex II. Records of those checks and the check provided for in paragraph 1shall be kept by the competent authority for a period of at least five years from the date of the checks including a copy of the corresponding record sheet or printing as referred to in Annex I or Annex IB to Regulation (EEC) No 3821/85 if the vehicle is covered by that Regulation.

2. In the case of long distance journeys or journeys for the slaughter of domestic equidae and domestic animals of bovine, ovine, caprine and porcine species official veterinarians of exit points and border inspection posts shall perform and record the checks listed in the Section 3 ‘Place of destination’ of Annex II. Records of those checks and the check provided for in paragraph 1shall be kept by the competent authority for a period of at least five years from the date of the checks including a copy of the corresponding record sheet or printing as referred to in Annex I or Annex IB to Regulation (EEC) No 3821/85 if the vehicle is covered by that Regulation.

Amendment 47

ARTICLE 20, PARAGRAPH 3

3. Where the competent authority considers that animals have been neglected or maltreated during the journey and are therefore not fit to complete their journey, they shall be unloaded, watered, fed and rested.

3. Where the competent authority considers that animals have been neglected or maltreated during the journey or are not fit to continue their journey, they shall be unloaded, watered, fed and rested for a period of at least 24 hours, and, if necessary, action shall be taken in accordance with Article 22 .

Amendment 48

ARTICLE 20, PARAGRAPH 3a (new)

3a. If, in the case of imports, animals are not transported in compliance with this Regulation and in particular with the provisions of paragraph 1(a), (b), (c), (d), (f), or (fa), or paragraphs 2 or 3, the competent authority shall refuse the animals entry into the territory of the European Union.

Amendment 49

ARTICLE 20, PARAGRAPH 3b (new)

3b. All animals imported for slaughter shall be unloaded at or near the border inspection post and rested for a period of 24 hours, with the provision of food and water, unless their journey to the slaughterhouse can be completed within two hours. This provision would not apply if the countries of origin and transit have transposed Community welfare legislation into their own legislation and the imported animals meet all the requirements of this Regulation.

Amendment 50

ARTICLE 20, PARAGRAPH 3c (new)

3c. If, in the case of exports, animals are not transported in compliance with this Regulation and in particular with provisions laid down in 1(a), (b), (c), (d), (f) or (fa), or paragraphs 2 or 3, the competent authority shall prohibit the animals from leaving the territory of the European Union.

Amendment 51

ARTICLE 21, PARAGRAPH 2a (new)

2a. The competent authority shall ensure that the official checks required pursuant to Article 14 are organised and performed in such a way that the journeys can continue immediately. The duration of a check should not exceed 30 minutes.

Amendment 52

ARTICLE 22, PARAGRAPH 2, POINT (d)

(d)	returning the animals to their place of departure by the most direct route;

(d)	returning the animals to their place of departure by the most direct route, or allowing the animals to continue to their place of destination by the most direct route, whichever would be the most humane ;

Amendment 53

ARTICLE 22, PARAGRAPH 2a (new)

2a. The competent authority of each Member State shall identify a sufficient number of suitable unloading premises and notify the Commission thereof at regular intervals.

Amendment 54

ARTICLE 23, PARAGRAPH 2

2. Each Member State shall communicate details of a contact point for the purposes of this Regulation to the Commission, including, where available, an electronic address , within three months of the date of entry into force of this Regulation as well as any update of such data. The Commission shall forward details of the contact point to the other Member States within the framework of the Standing Committee on the Food Chain and Animal Health.

2. Each Member State shall communicate details of a contact point for the purposes of this Regulation to the Commission, including an electronic address. The Commission shall create, by ... (4), a central electronic database to which all information shall be sent pursuant to Article 25(7) by the contact point determined by each Member State pursuant to Article 23(2). The Commission shall be responsible for the management of this database within the framework of the Standing Committee on the Food Chain and Animal Health.

Amendment 55

ARTICLE 24

The Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions, as well as provisions for the application of Article 25, to the Commission by dd/mm/yy [insert 18 months after the date of publication at the latest and shall notify it without delay of any subsequent amendment affecting them.

The Member States shall lay down the rules on penalties which shall be uniform throughout the EU, applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions, as well as provisions for the application of Article 25, to the Commission by dd/mm/yy [insert 18 months after the date of publication] at the latest and shall notify it without delay of any subsequent amendment affecting them. In the event of negligent or deliberate infringements causing severe suffering to animals, the transporter's authorisation shall be withdrawn for one year and all employees shall be required to undergo appropriate training. In case of negligent or deliberate infringements causing severe suffering to animals, penalties must include the possibility of a prison sentence of up to two years.

Amendment 56

ARTICLE 25, PARAGRAPH 2

2. Where a competent authority establishes that a transporter has not observed, or a means of transport does not comply with this Regulation, it shall notify without delay the competent authority that granted the authorisation to the transporter or the certificate of approval of the means of transport. Any relevant data and documents shall accompany such notification.

2. Where a competent authority establishes that a transporter has not observed, or a means of transport does not comply with this Regulation, it shall notify without delay the competent authority that granted the authorisation to the transporter or the certificate of approval of the means of transport and, where the driver is involved in the failure to observe this Regulation, the competent authority that issued the driver's training certificate. Any relevant data and documents shall accompany such notification.

Amendment 57

ARTICLE 25, PARAGRAPH 4a (new)

4a. In the event of three infringements of this Regulation within one year, the competent authority shall suspend or withdraw the authorisation of the transporter and, if appropriate, the certificate of approval of the means of transport concerned for at least one year.

Amendment 58

ARTICLE 25, PARAGRAPH 5

5. In the case of infringement of this Regulation by a driver holding a training certificate as provided for in Article 16 (2), the competent authority may suspend or withdraw the training certificate, in particular if the infringement shows that the driver lacks sufficient knowledge or awareness to transport animals in compliance with this Regulation.

5. In the event of infringement of this Regulation by a driver holding a training certificate as provided for in Article 16(2), the competent authority shall suspend or withdraw the training certificate, in particular if the infringement shows that the driver lacks sufficient knowledge or awareness to transport animals in compliance with this Regulation unless the infringement is minor and did not impair the animals' welfare, or there are particular circumstances which indicate that the infringement was outside the driver's control.

Amendment 59

ARTICLE 25, PARAGRAPH 6

6. In the case of repeated or serious infringements of this Regulation, a Member State may temporarily prohibit the transporter or means of transport concerned from transporting animals on its territory, even if the transporter or the means of transport is authorised by another Member State, provided that all the possibilities afforded by mutual assistance and exchange of information as provided for in Article 23 have been exhausted.

6. In the event of infringements of this Regulation, a Member State may , depending on the seriousness of the offence, temporarily or entirely prohibit the transporter or means of transport concerned from transporting animals on its territory, even if the transporter or the means of transport is authorised by another Member State, provided that all the possibilities afforded by mutual assistance and exchange of information as provided for in Article 23 have been exhausted.

Amendment 60

ARTICLE 25, PARAGRAPH 7

7. Member States shall ensure that all the contact points as provided for in Article 23(2) are notified without delay of any decision taken under paragraph 4 (c), or paragraphs 5 or 6.

7. Member States shall ensure that the electronic database provided for in Article 23(2) is updated in the light of any decision taken under paragraph 4(c), or paragraphs 5 or 6.

Amendment 61

ARTICLE 26, PARAGRAPH 1

1. The competent authority shall check that the requirements of this Regulation have been complied with, by carrying out non-discriminatory inspections of animals, means of transport and accompanying documents. Such inspections must be carried out on an adequate proportion of the animals transported each year within each Member State, and may be carried out at the same time as checks for other purposes. The proportion of inspections shall be increased where it is established that the provisions of this Regulation have been disregarded. The above proportions shall be determined in accordance with the procedures referred to in Article 30(2).

1. The competent authority shall check that the requirements of this Regulation have been complied with, by carrying out non-discriminatory inspections of animals, means of transport and accompanying documents. Such inspections must be carried out on an adequate proportion of at least 10% of the animals transported each year within each Member State, and may be carried out at the same time as checks for other purposes. The proportion of inspections shall be increased where it is established that the provisions of this Regulation have been disregarded. The above proportions shall be determined in accordance with the procedures referred to in Article 30(2).

Amendment 62

ARTICLE 26, PARAGRAPH 2

2. The competent authority shall submit to the Commission by 30 June each year an annual report of the previous year on the inspections provided for in paragraph 1. The report shall be accompanied by an analysis of the major deficiencies detected , an action plan to address them and documentation on the sanction measures taken by the authorities. The report shall be made available to the European Parliament and the Member States on request .

Amendment 63

ARTICLE 27

Veterinary experts from the Commission may, in collaboration with the authorities of the Member State concerned and, in so far as it is necessary to ensure uniform application of this Regulation, make on-the-spot checks in accordance with the procedures laid down in Commission Decision 98/139/EC.

Amendment 64

ARTICLE 28

Guides to good practice

Member States shall encourage the development of guides to good practice which shall include guidance on compliance with this Regulation and in particular with Article 10(1).

Guides to good practice and certification schemes

1. Member States shall develop guides to good practice and certification schemes which shall include guidance on compliance with this Regulation and in particular with Article 10(1). Such guides shall be drawn up at national level, among a number of Member States, or at Community level. Dissemination and use of national and Community guides shall be encouraged. However, their use shall be optional.

2. Certification schemes for transporters carrying out long distance journeys shall include guidance on compliance with this Regulation and ensure animal welfare standards that exceed the minimum standards laid down in this Regulation.

Participation in a certification scheme is obligatory for certain long distance transporters, as specified in Annex I.

Amendment 65

ARTICLE 29, PARAGRAPH 1

1. The Annexes may be amended in accordance with the procedure referred to in Article 30(2).

1. The Annexes to this Regulation shall be amended by the Council acting by a qualified majority on a proposal from the Commission and after consultation of the European Parliament, except as regards Annexes III, IV, V and VI, which may be amended in accordance with the procedure referred to in Article 30(2).

Amendment 66

ARTICLE 29, PARAGRAPH 6a (new)

6a. The Commission shall draw up a report, which it shall forward to the European Parliament, making it possible to assess the impact of this Regulation on all sectors affected by the tightening of rules on animal welfare during transport. Any further amendment of the rules contained in the Annexes to this Regulation and which may result from the application of Article 29(1) shall form the subject of a prior impact assessment, which shall also be forwarded to the European Parliament.

Amendment 67

ARTICLE 30a (new)

Article 30a

Acute-phase protein

Since the impact of this Regulation on animal welfare needs to be demonstrated scientifically, the Commission shall submit, by ... (5), a report on the development of acute-phase protein research, if necessary accompanied by proposals to revise this Regulation.

Amendment 68

ARTICLE 32, POINT 2

Article 12, paragraph 1, point (b), point (i) (Directive 64/432/EEC)

(i)	have appropriate cleaning and disinfection facilities approved by the competent authority, including facilities for storing litter and dung; or

(i)	make available to transporters the facilities needed to clean and disinfect vehicles. These facilities shall be approved by the competent authority, including facilities for storing litter and dung; or

Amendment 69

ARTICLE 33

Annex A, Part II, paragraph 3 (Directive 93/119/EC)

3. Animals must be moved with care. Passageways must be so constructed as to minimise the risk of injury to animals, and so arranged as to exploit their gregarious tendencies. Instruments intended for guiding animals must be used solely for that purpose, and only for short periods.

Amendment 70

ARTICLE 34, PARAGRAPH 2

It shall apply from dd/mm/yy [insert 18 months after the date of publication].

It shall apply from dd/mm/yy [insert 24 months after the date of publication].

Amendment 71

ANNEX I, CHAPTER I, PARAGRAPH 2, POINT (e)

(e)	they are pigs of less than four weeks , lambs of less than one week and calves of less than two weeks of age unless they are transported less than 100 km ;

(e)	they are pigs of less than three weeks , lambs of less than one week and calves of less than two weeks of age;

Amendment 72

ANNEX I, CHAPTER I, PARAGRAPH 3, INTRODUCTION

3.	However, ill or injured animals may be considered fit for transport if they are:

3.	However, ill or injured animals may be considered fit for transporting for short distances if they are:

Amendment 73

ANNEX I, CHAPTER II, PARAGRAPH 1.1, POINT (ha) (new)

(ha)	be equipped, from 2008 onwards, with the appropriate satellite navigation equipment, allowing for recording and transmission of positioning information to the competent authorities.

Amendment 74

ANNEX I, CHAPTER II, PARAGRAPH 1.1, POINT (hb) (new)

(hb)	provide external and internal ramps that are not steeper than 30% on the horizontal level, equipped with cleats with intervals at a maximum of 30 centimetres.

Amendment 112

ANNEX I, CHAPTER II, PARAGRAPH 1.4

1.4	Partitions shall be strong enough to withstand the weight of animals. Fittings shall be designed for quick and easy operation.

1.4

To prevent animals being thrown about during transport, partitions shall be fitted and used to subdivide large groups of animals or subdivide an area which contains fewer animals than its normal capacity. Partitions shall be strong enough to withstand the weight of animals. Fittings shall be designed for quick and easy operation. Partitions shall be constructed and fitted in such a way that animals are not caused injury by their legs being trapped between the bottom of the partition and the vehicle floor or between the bars of the partition.

Amendment 75

ANNEX I, CHAPTER II, PARAGRAPH 1.5

1.5.	Piglets of less than 10 kg, lambs of less than 20 kg, calves of less than six months and foals of less than four months of age shall be provided with appropriate bedding material. It shall be sufficient to allow the animals to lie down without being in direct contact with the floor.

1.5.	All animals shall be provided with adequate and appropriate bedding material which shall be sufficient to allow the animals to lie down without being in direct contact with the floor. This material has to ensure adequate absorption of urine and faeces.

Amendment 76

ANNEX I, CHAPTER III, PARAGRAPH 1.4

1.4.	Ramps shall not be steeper than 33,3% on the horizontal level for pigs, calves and horses and than 50% for sheep and cattle other than calves provided that ramps are equipped with cleats with intervals at a maximum of 30 centimetres.

1.4.	External and internal ramps shall not be steeper than 30% for pigs, calves , horses , sheep and cattle and shall be equipped with cleats with intervals at a maximum of 30 centimetres.

Amendment 77

ANNEX I, CHAPTER III, PARAGRAPH 1.11, POINT (fa) (new)

(fa) sexually mature male and female animals.

Amendment 78

ANNEX I, CHAPTER IV, PARAGRAPH 9a (new)

9a.	A satellite navigation system should be used to record on a continuous basis journey positioning information, as well as transmission of such data on request to the competent authorities.

Amendment 79

ANNEX I, CHAPTER V, INTRODUCTORY PARAGRAPH, POINT (b)

(b)	‘travel time’means a period during a journey which is not interrupted by a minimum rest period as provided for in points (d) and (e) of paragraph 1.1 of section 1.

(b)

‘travel time’ means a period during a journey which is not interrupted by a minimum rest period as provided for in points (d) and (e) of paragraph 1.1 of section 1. In the interests of animal welfare, transport may be extended by two hours in the event of unforeseeable delays (traffic jams, breakdown, accident, diversions, force majeure, etc.), taking account in particular of the proximity of the destination or the resting place envisaged in the transport plan.

Amendment 80

ANNEX I, CHAPTER V, PARAGRAPH - 1 (new)

- 1.

Journeys by road and rail for slaughter of animals such as domestic equidae and domestic animals of bovine, ovine, caprine and porcine species are only permitted if travel times do not exceed nine hours. This restriction shall not apply if there are not at least two slaughterhouses available within a radius of 500 km from the place of departure. Member States may apply shorter transport periods for transport within their own territory or ban exports of certain species for moral reasons.

Amendment 81

ANNEX I, CHAPTER V, PARAGRAPH 1.1, POINT (da) (new)

(da)

for transport by road, certified in accordance with Article 28(2), travel times do not exceed travel times for drivers as laid down in Regulation (EEC) No 3820/85. Sequences of travel times may be repeated during a journey. In the interest of the animals the maximum journey time may be extended by a maximum of two hours taking into account the proximity of the final destination.

Amendment 82

ANNEX I, CHAPTER VI, PARAGRAPH 1.2

1.2. Equidae shall have permanent access to hay.

1.2.	Equidae shall have access to hay and water every nine hours .

Amendment 83

ANNEX I, CHAPTER VI, PARAGRAPH 1.7

1.7.	Animals shall not be tied during movements of the means of transport. This provision does not apply for registered equidae as referred to in Directive 90/426/EEC.

1.7.

Animals shall not be tied during movements of the means of transport. This provision does not apply for registered equidae as referred to in Directive 90/426/EEC. However, tying shall be permitted, exceptionally, if this is necessary on grounds of animal welfare and/or occupational health and safety and adequate feed and water are provided.

Amendment 84

ANNEX I, CHAPTER VI, PARAGRAPH 1.9a (new)

1.9a.

Bovines should be transported in a group of maximum 8 adult cattle or 15 calves; pigs in a group of maximum 15 pigs/young sows, 60 piglets (< 10 kg), 32 young pigs (10-30 kg), sheep and goats in groups of maximum 30 animals.

Amendment 85

ANNEX I, CHAPTER VI, PARAGRAPH 3.1

3.1.

Ventilation systems on road vehicles shall be designed, constructed and maintained in such way that, at any time during the journey, whether the vehicle is stationary or moving, they are capable of maintaining the temperature adjusted for humidity in the vehicle between the maximum and minimum temperatures set out in Table 1 ;

3.1.	Ventilation systems on road vehicles shall be designed, constructed and maintained in such way as to ensure that a temperature range between 5 and 30 °C is maintained for all animals inside the vehicle, with a tolerance of + 5 °C depending on the outside temperature ;

Amendment 86

ANNEX I, CHAPTER VI,

TABLE 1

The table is deleted.

Amendment 87

ANNEX I, CHAPTER VII, PARAGRAPH 1.2a (new)

1.2a.

In the case of long distance transport by sea, an additional 10% shall be given to pregnant females in the last third of gestation, non-castrated bulls and bovines shipped to destinations south of the 30th parallel for the minimum floor area set out in Tables 1, 2 and 3.

Amendment 88

ANNEX I, CHAPTER VII, PARAGRAPH 1.7a (new)

1.7a.

The height of the compartments must permit all animals to stand upright naturally, with sufficient space above the highest part of the body to allow adequate ventilation. The internal height of the compartment must be at least 10 cm more than the height of the withers of the largest animal.

Amendment 89

ANNEX I, CHAPTER VII, TABLE 1, EQUIDAE

Average weight in kg	Area A1 per animal in m2
50	0,488
100	0,625
150	0,763
200	0,900
250	1,038
300	1,175
350	1,313
400	1,450
450	1,588
500	1,725
550	1,863
600	2,000
650	2,125
700	2,250
750	2,375
800	2,500

Average weight in kg	Area A1 per animal in m2
50	0,50
100	0,60

200	0,90

300	1,20

400	1,50

500	1,70

600	1,90

700	2,00

Amendment 110

ANNEX I, CHAPTER VII, TABLE 1, BOVINE ANIMALS

Average weight in kg	Area A1 per animal in m2	Area A2 per animal in m2
50	0,289	0,439
100	0,459	0,563
150	0,603	0,686
200	0,731	0,810
250	0,849	0,934
300	0,959	1,058
350	1,064	1,181
400	1,163	1,305
450	1,259	1,429
500	1,351	1,553
550	1,440	1,676
600	1,526	1,800
650	1,610	1,913
700	1,692	2,025
750	1,772	2,138
800	1,851	2,250

Average weight in kg	Area A1 per animal in m2	Area A2 per animal in m2
50	0,300	0,350
100	0,400	0,500

200	0,700	0,800

300	1,000	1,100

400	1,100	1,150

500	1,300	1,400

600	1,500	1,600

700	1,700	1,800

Amendment 90

ANNEX I, CHAPTER VII, TABLE 2, SHEEP AND GOATS

Average weight in kg	Area A1 or A2 per animal in m2
20	0,240
30	0,265
40	0,290
50	0,315
60	0,340
70	0,390
80	0,440

Average weight in kg	Area A1 or A2 per animal in m2
20	0,25


50	0,30

70	0,40
80	0,50

Amendment 91

ANNEX I, CHAPTER VII, TABLE 3, PIGS, H1 (cm) FORCED VENTILATION

Average weight in kg	H1 (cm) forced ventilation
20	66
30	70
40	74
50	77
70	84
90	90
100	92
110	95
130	99
150	103
170	106
190	109

210	111
230	112

Average weight in kg	H1 (cm) forced ventilation
20	60
30	60

50	70
70	80

100	90


150	100


200	110

Amendment 92

ANNEX I, CHAPTER VII, TABLE 3, PIGS, H2 (cm) PASSIVE VENTILATION

Average weight in kg	H1 (cm) passive ventilation
20	81
30	85
40	89
50	92
70	99
90	105
100	107
110	110
130	114
150	118
170	121
190	124

210	126
230	127

Average weight in kg	H1 (cm) passive ventilation
20	70
30	70

50	80
70	90

100	100


150	120


200	130

Amendment 93

ANNEX 1, CHAPTER VII, TABLE 3, AREA A1 WT IN KG M2/ANIMAL

Average weight in kg	Area A1 Wt in kg m2/animal

20	0,143
30	0,187
40	0,227
50	0,264
70	0,331
90	0,391
100	0,420
110	0,448
130	0,501
150	0,551
170	0,599
190	0,646

210	0,691
230	0,734

Average weight in kg	Area A1 Wt in kg m2/animal
	< 4 hours	> 4 hours
20	0,119	0,15
30	0,156	0,20
40	0,189
50	0,220	0,30
70	0,276	0,35
90	0,326
100	0,350	0,45
110	0,373
130	0,417
150	0,460	0,55
170	0,499
190	0,538
200		0,70
210	0,575
230	0,612

Amendment 94

ANNEX II, POINT 3, POINT (d)

(d)	ensure that the journey log accompanies the animals during the journey until the point of destination or, in case of export to a third country at least until the exit point .

(d)	ensure that the journey log accompanies the animals during the journey until the point of destination.

Amendment 95

ANNEX II, POINT 7a (new)

7a.	Satellite navigation data records shall be provided to the competent authority upon its request and in the format required by that authority.

Amendment 96

ANNEX III, CHAPTER IVa (new)

Chapter IVa

Journey plan for livestock vessels

1. Ship's details

Name of Ship:

Ship's flag:

IMO number:

Classification society:

ISM issuing authority:

ISM operator:

Full contact details of shipowner/manager

Captain's name:

Full contact details of authorised transporter:

Authorisation number:

Date and place of issue:

Full contact details of issuing authority:

2. Ship's livestock particulars

Total area available for livestock, excluding ramps/alleyways/storage (inm2)

Fresh water capacity, excluding ballast water (in tons):

Possible daily fresh water production at sea (in tons):

3. Voyage particulars

Loadport:

Intended date and time of sailing from loadport:

Discharge port:

Intended date and time of arrival at discharge port:

Duration of voyage (in hours/days):

Distance between load port and discharge ports (in sea miles):

Cargo details (types of animals, number, weight):

Number of pregnant animals:

Number of non-castrated bulls:

Total area required for the animals (in m2);

Total tons of fodder required for the sea voyage + safety margin:

Total tons of water required for the sea voyage + safety margin:

Total tons of fodder available on board upon sailing:

Total tons of water available on board upon sailing:

4. Signatures

Signature ship master:

Signature for approval of competent authority:

Amendment 97

ANNEX IV, PARAGRAPH 1

1.	Road drivers as referred to in Article 6(4) and Article 16 (1) shall have successfully completed the training as provided for in paragraph 2 and have passed an examination approved by the competent authority, which shall ensure that examiners are independent.

Road drivers as referred to in Article 6(4) and Article 16(1) shall have successfully completed the training provided for in paragraph 2 and have passed an examination approved by the competent authority, which shall ensure that the examiners are independent. Previous training and experience may be assessed and taken into account by the examiner.

(1) Not yet published in OJ.

(2) Council Regulation (EC) No 876/2002 of 21 May 2002 setting up the Galileo Joint Undertaking (OJ L 138, 28.5.2002, p. 1).

(3) Council Regulation (EC) No 1257/1999 of 17 May 1999 on support for rural development from the European Agricultural Guidance and Guarantee Fund (EAGGF) and amending and repealing certain Regulations (OJ L 160, 26.6.1999, p. 80).

(4) Six months after the entry into force of this Regulation.

(5) Five years after the entry into force of this Regulation.

P5_TA(2004)0223

Fight against fraud and protection of the financial interests of the Communities (2002)

European Parliament resolution the protection of the financial interests of the Communities and the fight against fraud — Annual report 2002 (COM(2003) 445 — C5-0593/2003 — 2003/2248(INI))

The European Parliament,

—	having regard to the Commission's annual report for 2002 on the protection of the financial interests of the Communities and the fight against fraud (COM(2003) 445 — C5-0593/2003),

—	having regard to the report of the European Anti-Fraud Office (OLAF) for the year ending June 2003 (1),

—	having regard to the annual report of the European Court of Auditors concerning the financial year 2002 (2),

—	having regard to its resolution of 4 December 2003 on the Commission report on the evaluation of the activities of the European Anti-Fraud Office (OLAF) (3),

—	having regard to the proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 1073/1999 concerning investigations conducted by the European Anti-Fraud Office (OLAF) (COM(2004) 103),

—	having regard to Article 276(3) and Article 280(5) of the EC Treaty,

—	having regard to Rule 47(2) and Rule 163 of its Rules of Procedure,

—	having regard to the report of the Committee on Budgetary Control (A5-0135/2004),

whereas the number of cases of fraud and irregularity reported in 2002 has risen by 13% and the established amounts by 35,8 %; whereas, compared with the previous year, the number of cases relating to traditional own resources has increased by 13% and those in the agricultural sector by 36 %;whereas the number of cases relating to structural actions has more than quadrupled, which is a reflection of the conclusion of the programmes for the period 1994-1999 and whereas the number of cases detected relating to direct expenditure rose by 21% (see Annexes 1 to 4 to report A5-0135/2004),

whereas the total volume of cases of irregularity and fraud listed in the Commission's annual report for 2002 amounted to just under EUR 2,12 billion, EUR 1,18 billion of which was reported by the Member States and EUR 0,94 billion by OLAF; the cases reported by the Member States can be broken down as follows:

— own resources:	EUR 324 544 459	(2001: EUR 238 908 883)
— EAGGF Guarantee Section:	EUR 198 079 000	(2001: EUR 140 685 000)
— structural actions:	EUR 614 094 000	(2001: EUR 201 549 000)
— direct expenditure:	EUR 42 605 000	(2001: EUR 42 548 000),

whereas, in the period covered by the report, in the sphere of traditional own resources cases involving a total of EUR 324,54 million, in the sphere of the EAGGF Guarantee Section cases involving a total of EUR 171,58 million and in the sphere of structural policy measures cases involving a total of EUR 368,29 million were reported with a view to recovery, and whereas, in the sphere of traditional own resources, a sum of EUR 80,6 million, i.e. 24,8% of the amounts established in 2002, was recovered,

D.	whereas, in 2002, OLAF opened investigations into 415 cases and concluded 652 cases; whereas the amounts implicated in the cases concluded in that period was an estimated EUR 937 million,

whereas the Community completed the financial year 2002 with a budget surplus of EUR 7,4 billion (2001: EUR 15,0 billion, 2000: EUR 11,6 billion), which was chiefly attributable to the Member States having overestimated their Structural Fund expenditure by EUR 4,8 billion, but also to the over-estimation by EUR 1,8 billion of planned expenditure involving resources directly administered by the Commission,

Reporting of irregularities and fraud by the Member States

Regrets the fact that, in the wake of the Eurostat affair, the Commission lacked the determination and strength to overcome the resistance within its administration and make the necessary revisions to its policy of decentralising responsibility for financial management; notes that, in the absence of independent and effective balancing checks, this decentralisation will pose serious risks to the Community's financial interests;

Recalls that in 1999 the Commission came into office trumpeting a policy of zero tolerance as regards fraud and corruption, but notes that it will bequeath to its successors in the fight against irregularities and fraud an unprecedented welter of sometimes contradictory rules and newly established units and bodies, making turf wars and mutual buck-passing inevitable;

3.	Expects that one member of the future Commission will be exclusively responsible for budgetary control in order to underline the importance of this task and to avoid any possible conflict of interest from the start;

4.	Notes with great concern that numerous Member States do not take communication, reporting and follow-up of irregularities and fraud seriously; points out that, in not doing so, those Member States are acting contrary to the law;

5.	Notes that only a small part of national inspection services and investigative departments are assigned to fighting combat fraud and calls on the Member States to reconsider their position in this respect;

Is frustrated that progress in this area is still totally unsatisfactory after numerous years. As the Commission states: ‘The practices of the national administrations still vary despite the efforts made at harmonisation. The data communicated by the Member States is often incomplete, in particular a number of cases do not include any mention of the amounts or of references to the identification of the products concerned. Also the distinction between “frauds” and other irregularities remains due to the fact that the Member States do not always have the same view of “criminal risk”. Consequently, communications refrain, in a not insignificant proportion, from identifying the case as a fraud or a simple irregularity’ (4);

Notes that Germany, Greece and Spain are in breach of current law (5) and do not communicate irregularities in the agricultural sector to OLAF in digital form, whereas Germany and Spain are responsible for 52% of the total number of communications; calls on the Member States concerned to send their communications in digital format;

8.	Notes, as regards traditional own resources (total implicated amount of EUR 324 544 459), that goods put into free circulation (cigarettes, bananas, sugar, aluminium) are particularly affected by irregularities;

9.	Notes with incredulity that, in the agricultural sector (total implicated amount EUR 198 079 000), the product concerned could not be identified in 50% of cases; in addition, most irregularities occurred in relation to fruit and vegetables;

10.	Notes, as regards structural actions (total implicated amount EUR 614 094 000), that the main causes of irregularities were billing for ineligible expenditure, failure to complete the measure and missing or incomplete supporting documents;

11.	Emphasises that the recovery of monies unduly paid does not represent a penalty and that on grounds of deterrence alone it is vital that the Commission and OLAF should urge the competent national authorities to initiate criminal proceedings when instances of attempted fraud occur;

Recovery of amounts paid in excess or in error (6)

12.

Notes that almost EUR 2,2 billion are to be recovered from the areas below:

—	Own resources: EUR 243 981 821 from 2002 (EUR 1,24 billion from 1998 to 2001 (7)); in 2002, the irregularities were mainly attributable to Germany, the Netherlands and Italy;

—	Structural actions: EUR 368 287 000 from 2002 (EUR 337 656 000 from previous years); in 2002, the irregularities were mainly attributable to Germany;

13.	Asks OLAF to clarify by the end of March 2004 whether a Tempus-Phare training seminar for senior Romanian civil servants, which was organised by the Université Libre de Bruxelles and scheduled to be held in Bucharest in 2002, duly took place;

14.

Notes the Commission's statement (answer to Written Question E-3812/03) that OLAF has resumed its investigations of the case involving Tempus training seminars for senior Romanian civil servants; emphasises that the Université Libre de Bruxelles must be called on to pay back the funding allocated for this programme should no adequate evidence be provided that senior civil servants did indeed take part in the relevant seminars;

15.

Notes, further, in connection with this case, the Commission's statement (answer to Written Question E-3812/03) that the relevant allegations were initially the subject of an anti-fraud audit conducted by a private auditing firm, whose findings OLAF then used as the basis for its investigation; looks to OLAF to include, in its next activity report, a list of all the cases in which it has agreed to audits by private firms instead of immediately initiating its own investigations;

16.

Welcomes the fact that the Commission reviewed the procedural systems for reporting and following up irregularities under the Structural Funds in November 2002 and January 2003 and came to the following conclusions which should be translated into practice in the next few months (8):

—	systematic and immediate reporting of all irregularities should be the norm;

—	there should be systematic monitoring of the follow-up of irregularities and their reporting, enabling OLAF to update the communications;

—	the information contained in the notification should be accurate and complete;

—	at national level, coordinating measures should be taken or consolidated to ensure harmonised interpretation and procedures;

—	at national level, instructions should be drawn up for dealing with irregularities, they should be worded more clearly and expanded;

—	electronic data transfer to the Commission should be introduced as quickly as possible;

—	updated systems descriptions should be forwarded to OLAF in order to implement Regulation (EC) 1681/94 (9) (Article 2);

—	an accounts receivable register should be established; the paying agencies should start to forward the necessary reports on recovery of payments and take these into account in the statements of expenditure;

European Agricultural Guidance and Guarantee Fund (10)

17.	Notes that on 1 December 2003 (11), the total amount to be recovered under the EAGGF — Guarantee Section was EUR 2,08 billion, and that EUR 657 million of that sum originated in irregularities already reported in the period before 1995;

18.	Notes that the Commission has made some progress in clearing the backlog of such cases;

19.

Notes, in this context, Commission Decision 2003/481/EC of 27 June 2003 (12) on the financial implications of irregularities committed by economic operators, according to which of a total irrecoverable amount of EUR 73,6 million, only EUR 5,6 million (i.e. 7,6 %) were attributable to Member States' negligence, while the remainder was charged to the Community budget;

20.	Asks the Court of Auditors, in anticipation of further decisions of this type, to examine whether the Commission may have been too lenient with the Member States in its above decision of 27 June 2003, and to submit a special report on the subject as soon as possible;

21.	Notes that more than two thirds (EUR 1,40 billion) of the total amount of EUR 2,08 billion to be recovered was attributable to Italy alone;

22.

Points to the case-law of the European Court of Justice which, in its judgment of 11 October 1990 (Case C-34/89, Republic of Italy v. the Commission) (13) recalled the obligation of general diligence placed on the Member States, by virtue of which Member States must take steps to rectify irregularities promptly as, otherwise, there is a risk that it will become difficult or impossible to recover sums paid in excess;

Export refunds for live cattle intended for Lebanon

23.

Notes that, in 2002, 226 867 live cattle were exported to Lebanon, resulting in the payment of more than EUR 52 million in export refunds; 121 026,6 tonnes of live cattle were thus exported to Lebanon; Doubts that the Lebanese market can absorb such a high volume of beef and veal imports and doubts, therefore, that Lebanon is the sole destination of the live cattle; Calls on the Commission, therefore, immediately to halt the payment of export refunds for live cattle intended for Lebanon until it has been established that the export refunds in question are not being misused;

24.	Calls on OLAF to embark on an investigation into the obvious irregularities in connection with export refunds for live animals intended for Lebanon;

25.

Calls on the Commission to take prompt measures to abolish the system of export refunds, which is prone to abuse; looks to the Commission to put forward a timetable for this process; calls on the Council to support Parliament in its efforts to secure the abolition of export refunds, in the interests of the public;

26.

Welcomes the measures taken by the Commission in the agricultural sphere to halt the use of export refunds to support the legal, but ethically unacceptable, practice of importing agricultural products into one of the 10 new Member States and transporting those products back to their country of origin following the accession of those Member States;

OLAF's annual activities report and its information policy

27.

Is disappointed with OLAF's annual activity report for the year ending June 2003, because, although it contains a large number of tables and diagrams and some examples of specific cases, it does not facilitate an overall assessment of the results and the success of the investigations carried out by the Anti-Fraud Office;

28.	Regrets, in particular, that probably the most important case during the reporting period — the Eurostat case — was actually expressly omitted from the report;

29.

Criticises the fact that the reporting period selected, from mid-year to mid-year, makes it unnecessarily difficult to gain an overall comparative view in conjunction with the Commission's annual report on the protection of the Community's financial interests; calls therefore for the reporting periods to be brought into line with each other;

30.	Recalls the fact that Parliament had called on OLAF to inform it about internal and external investigations on a quarterly basis (14); criticises the fact that this was not done in 2003;

31.

Also criticises the fact that the summary tables are constantly changing format, which makes it impossible to follow cases over several reporting periods; makes it clear therefore that, in future, the summary tables must show the following columns: CMS (Case Management System) number and date of entry, organisation/company concerned, allegation/suspicion, evaluation: beginning-end, investigation: beginning-end, current status, possible financial loss; recommended follow-up: disciplinary proceedings/criminal proceedings/recovery; actual follow-up and result;

32.

Notes that internal OLAF information was passed to the press on several occasions; also notes that OLAF published a press release on 27 March 2002 which, among other things, explained that an internal investigation was being launched and that ‘it is not excluded that payment may have been made to somebody within OLAF ... for these documents’ (15); a journalist working for a German weekly magazine, in which several articles concerning OLAF cases had appeared, felt that he had been libelled and lodged a complaint with the European Ombudsman;

33.

Notes that OLAF's opinion has proved to be an untenable assertion, which prompted the Ombudsman to recommend in June 2003 that ‘OLAF should consider withdrawing the allegations of bribery that were published and that were likely to be understood as directed at the complainant’ (16); regrets the fact that OLAF has not acted on that recommendation, but instead has repeated, in a press release dated 30 September 2003, that there is suspicion of bribery, stating merely that no evidence had come to light ‘thus far’;

34.

Points out that OLAF may open investigations only in cases where suspicions are properly founded and that, pursuant to Article 6 of the OLAF regulation, such investigations must be conducted continuously over a period proportionate to the circumstances; calls on the OLAF Supervisory Committee to deliver an opinion as to whether these provisions have been breached in this case and as to whether the investigation may have been misused to exert pressure on or intimidate journalists;

Revision of the OLAF Regulation (EC) No 1073/1999 (17)

35.

Points out that the President of the Commission announced on 18 November 2003 that legislative proposals would be forthcoming which could be adopted by Parliament and the Council before the European elections, thereby contributing to restoring public confidence, which was destroyed by the Eurostat affair;

36.

Recalls its abovementioned resolution of 4 December 2003 on evaluating OLAF's work, in which it supported the Commission President's announcement of giving greater priority to OLAF's core tasks, improving the flow of information between OLAF and the institutions, doing more to safeguard the rights of defence of persons under investigation and enhancing the role of the OLAF Supervisory Committee;

37.

Cannot understand that the Commission has forwarded the progress report pursuant to Article 15 of the OLAF Regulation more than one year late and, following the adoption of Parliament's abovementioned resolution of 4 December 2003, that the Commission took over two months to adopt a package of proposals on 10 February 2004 (COM(2004) 103); notes that this delay has made it impossible to improve the OLAF Regulation before the European elections;

38.

Notes that the legislative proposals submitted by the Commission point to some extent in the right direction but that the following points are totally unacceptable and must almost be regarded as provocation;

(a)

instead of stipulating that OLAF should finally carry out to the full extent its long-neglected core task of internal investigations, the Commission's proposal expressly offers OLAF the possibility of not opening internal investigations even when there is sufficiently strong suspicion that acts of fraud or corruption or other illegal acts have been committed to the detriment of the financial interests of the Community;

(b)

instead of assigning the secretariat of the OLAF Supervisory Committee administratively to the secretariat of the European Parliament, the Commission now proposes that the secretariat should be administratively assigned to the Commission, thereby calling into question the independence of the Supervisory Committee;

(c)

instead of strengthening the rights of persons subject to an internal investigation, they are to be deprived of the possibility hitherto provided by the OLAF Regulation to appeal to the European Court of Justice, if OLAF, in the course of its investigations, acts in a way which adversely affects them; this would open the floodgates to abuses of power (e.g. opening an investigation without sufficient grounds, inordinately long investigations) as such offences would no longer be subject to the scrutiny of a court;

39.

Notes, moreover, that the Commission proposal puts forward changes relating to Regulation (Euratom, EC) No 2185/96 (18) concerning on-the-spot checks and inspections, which could delay its prompt adoption by the Council; takes the view that the shortcomings revealed in the application of the above Regulation should be remedied by directly amending that Regulation and not indirectly by amending the OLAF Regulation;

40.	Emphasises that during the intervening period the current provisions of the OLAF regulation must be strictly applied;

41.

Emphasises in particular, in that connection, that Article 10 of the OLAF regulation explicitly requires the Director of OLAF to forward to the judicial authorities information liable to result in criminal proceedings; stresses once again that the regulation does not confer any discretionary powers on the Director in this regard (paragraph 16 of its resolution of 4 December 2003 on the evaluation of the activities of OLAF), but leaves the decision entirely in the hands of the competent national judicial authorities;

42.

Emphasises once again the substance of paragraph 18 of its resolution of 4 December 2003, which states that priority must be given to investigations in those areas where the national authorities have no particular interest or no powers, that is to say investigations within the institutions and agencies and in connection with activities administered directly by the Commission; stresses that investigations in those areas must, as a matter of principle, be conducted in accordance with the strict rules governing internal investigations, because in such cases possible involvement or negligence on the part of EU employees has to be investigated;

43.

Points out that the budgetary authority appended the following remark to the OLAF establishment plan, which authorises a total of 329 posts for 2004: ‘Of which 80 posts for internal investigations pursuant to Article 4 of Regulation (EC) No 1073/1999. These investigators are to be grouped together within a special directorate’; looks to OLAF to complete the requisite internal reorganisation by July 2004 at the latest;

44.	Points out that OLAF sometimes makes headlines with investigations outside the Community (e.g. on the possible misuse of aid payments to the Palestinian National Authority); calls for this matter to be dealt with as part of the proposed revision of the OLAF regulation;

45.

Takes note of a tendency on the part of the Court of First Instance, in its rulings, to reject actions brought by officials and other servants against OLAF as inadmissible if the relevant OLAF investigations have not led to the imposition of disciplinary penalties; points out that Article 14 of the OLAF regulation explicitly provides for judicial review of measures taken by OLAF as part of an internal investigation, without laying down specific conditions governing such a review; calls on the Commission to point out clearly in future proceedings before the Court of First Instance that it had been the intention of the legislator to offer to persons concerned a reliable protection under the rule of law already during the period of investigation;

46.	Asks the newly elected Parliament to make the revision of the OLAF Regulation a matter of priority as of September 2004;

Combating fraud in the European Central Bank and the European Investment Bank

47.	Recalls the judgments of the Court of Justice of the European Communities of 10 July 2003 (Cases C-11/00 and C-15/00), ruling that the OLAF Regulation (EC) No 1073/1999 is applicable to the European Central Bank and the European Investment Bank;

48.	Calls on both banks, without delay, to take the decisions provided for in Article 4 of the OLAF Regulation concerning internal OLAF investigations and to implement the standard decision on internal investigations;

49.	Draws attention to the fact that, even without such a decision on internal OLAF investigations, both banks are required, pursuant to Article 7 of the OLAF Regulation, to forward to OLAF without delay any information relating to possible cases of fraud or corruption or any other illegal activity;

50.

Takes the view that both banks must, without delay, make the notifications they have so far failed to do, so that OLAF obtains a comprehensive picture of all cases of irregularity and fraud which have occurred in the banks since OLAF was set up in 1999; expects OLAF to submit a report on this subject by September 2004 at the latest;

51.	Takes the view that the judgments of the Court of Justice apply, mutatis mutandis, to the European Investment Fund as well; calls on the Investment Fund to take the requisite decisions;

Contracts with external firms

52.

Notes that, between 1998 and the first half of 2003, the Commission paid a sum of almost EUR 115 million to the five most important international consultancies; two of these five companies received more than EUR 77 million, i.e. more than two thirds of the money; points out that these figures clearly relate only to expenditure directly administered by the Commission; calls on the Commission to compile statistics which also contain details of payments involving Community expenditure not directly administered by the Commission, in particular under the Structural Funds;

53.	Recalls the bad impression left by the award in 2002 of a contract to the ASCII consortium with a total value of EUR 23 million because a Commission spokesman, who at the time was an official granted leave of absence ‘on personal grounds’, had profited therefrom (19);

54.

Calls on the Commission to reconsider its policy of outsourcing Commission activities in the light of such high sums for consultant contracts and the negative experience of awarding contracts to external firms in the past; notes that contracting external firms to carry out work on behalf of the Commission should only be done in exceptional cases;

55.

Recalls Title V (Article 89) of the New Financial Regulation which states that ‘all public contracts ... shall comply with the principles of transparency, proportionality, equal treatment and non-discrimination’ and that all procurement contracts shall, as a rule, ‘be put out to tender on the broadest possible base’; points out that, according to experts, the failure to issue or the manipulation of invitations to tender in respect of public contracts can lead to substantial additional costs to the European taxpayer;

56.

Looks to the Director of OLAF to report all instances of breaches of the rules governing tender procedures to the competent judicial authorities and no longer to accept the explanation that such breaches were the result of ignorance or incompetence or were not committed with a view to personal enrichment;

57.

Points out that Article 314 of the Belgian Criminal Code is also applicable to invitations to tender issued by the European institutions which have their seat in Brussels: on that basis, the mere fact of using fraudulent means to exclude potential tenderers from participation in a tender procedure constitutes a criminal offence, with no need to meet the generally difficult requirement to prove the size of the resulting loss or that corruption and personal enrichment were involved;

Other remarks

58.	Welcomes the Commission's detailed account of the form in which the accession countries were involved in the policy of preventing and fighting fraud;

59.

Welcomes the opening of the OLAF investigation into the financing of Parliament's buildings in Brussels including all payments between the developer, SA Forum Léopold, and WestLB (which provided the financing) and possible payments to third parties; expects that, if necessary, the competent judicial authorities will provide all necessary assistance should the parties under investigation invoke banking secrecy;

60.	Asks the Commission to inform the competent Parliament committee in writing of the measures to stem cigarette smuggling, including the complaints pending before the US courts, together with measures to protect the euro and intellectual property;

61.

Calls for clarification of the status of negotiations with Switzerland concerning the combating of fraud; calls for clarification in particular as to whether:

—	Switzerland continues to refuse to carry out administrative checks on economic operators resident in Switzerland;

—	Switzerland is prepared to adopt the Council of Europe standards for judicial cooperation in the field of customs and tax offences, and

—	Switzerland continues to regard the laundering of profits from tax fraud through Swiss financial institutions as a legal activity;

62.

Stresses once again (20) that an 80-page list of new national provisions to achieve the aims of Article 280 of the EC Treaty is of little value as long as it is not analysed by the Commission with a view to highlighting any shortcomings in the protection of the Community's financial interests; calls for the annual report for 2003 to contain a section which undertakes such an analysis and in which the Commission highlights the areas still in need of urgent action;

63.

Notes that Commissioner Solbes forwarded the Eurostat action plan for 2004 to the chair of the Committee on Budgetary Control on 21 January 2004; takes the view that an independent administrative and management audit of the new Eurostat structure should be carried out once OLAF's investigations are complete;

64.	Calls on the Commission to ensure that the spirit of preferential trading schemes with neighbouring states is not undermined by support for exports to an accession country of certain goods which should, in fact, remain in the European Union;

* *

65.	Instructs its President to forward this resolution to the Council, the Commission, the European Court of Justice, the European Court of Auditors, the European Central Bank, the European Investment Bank, the European Investment Fund, the OLAF Supervisory Committee and OLAF.

(1) http://europa.eu.int/comm/anti_fraud/reports/index_en.html

(2) OJ C 286, 28.11.2003, p. 1.

(3) P5_TA(2003)0551.

(4) COM(2003) 445, Title III, point 10.1. See also point 11.

(5) OJ L 67, 14.3.1991, p. 11.

(6) See also Annexes 5 to 7 to report A5-0135/2004.

(7) It is unclear whether parts of these amounts have already been recovered for these years.

(8) Commission, DG Regional Policy and OLAF, summary report on the review of the systems and procedures for the reporting and follow-up of irregularities in the context of the Structural Fund of 19 December 2003.

(9) OJ L 178, 12.7.1994, p. 43.

(10) Letter of 30 January 2004 from Commissioner Schreyer to the rapporteur.

(11) Letter D (2004) 3541 of 30 January 2004 from Commissioner Schreyer.

(12) OJ L 160, 28.6.2003, p. 83.

(13) ECR 1990, I-3603.

(14) Paragraphs 140 and 142 of Parliament's resolution of 8 April 2003 containing the comments accompanying the decision concerning discharge in respect of the implementation of the general budget of the European Union for the 2001 financial year (Commission) (OJ L 148, 16.6.2003, p. 21).

(15) http://europa.eu.int/comm/anti_fraud/press_room/pr/2002/2002_03_en.html

(16) http://www.europarl.ep.ec/ombudsman/recommen/en/021840.html

(17) OJ L 136, 31.5.1999, p. 1.

(18) OJ L 292, 15.11.1996, p. 2.

(19) According to information published by Agence Europe, 30 September 2002, point 29.

(20) Paragraph 56 of the European Parliament resolution of 13 March 2003 on the protection of the financial interests of the communities and the fight against fraud — Annual report (2001) (OJ C 61 E, 10.3.2004, p. 392); see also the European Parliament resolution of 29 November 2001 on this subject (OJ C 153 E, 27.6.2002, p. 325).

+	adopted
-	rejected
↓	lapsed
W	withdrawn
RCV (..., ..., ...)	roll-call vote (for, against, abstentions)
EV (..., ..., ...)	electronic vote (for, against, abstentions)
split	split vote
sep	separate vote
am	amendment
CA	compromise amendment
CP	corresponding part
D	deleting amendment
=	identical amendments
§	paragraph
art	article
rec	recital
MOT	motion for a resolution
JT MOT	joint motion for a resolution
SEC	secret ballot

Subject	RCV, etc.	Vote	RCV/EV — remarks
single vote		+

Subject	RCV, etc.	Vote	RCV/EV — remarks
single vote	RCV	+	307, 1, 20

Subject	RCV, etc.	Vote	RCV/EV — remarks
single vote		+

Subject	RCV, etc.	Vote	RCV/EV — remarks
approval without vote		+

Subject	Amendment No	Author	RCV, etc.	Vote	RCV/EV — remarks
single vote				+