Proposal for a Council Decision on the conclusion of Protocol . . . to the Europe Agreement between the European Communities and their Member States, of the one part, and the Czech Republic, of the other part (97/C 229/01) [COM(97) 173 final - 97/0129 (ACC)]

(Submitted by the Commission on 15 May 1997)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the treaty establishing the European Community, and in particular Article 113 in conjunction with Article 228 (2), first sentence thereof,

Having regard to the Europe Agreement establishing an association between the European Communities and their Member States, of the one part, and the Czech Republic of the other part (1), signed on 4 October 1993,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament,

Whereas in the framework of the negotiations held between the Community and the Czech Republic a stage has been reached whereby an additional protocol now can be concluded bearing in mind that the Annexes will need to be amended regularly, as appropriate; whereas this Protocol will help to develop trade between the Parties by including the application of the principle of regionalization for the main animal diseases and by listing those commodities for which equivalent trade conditions are recognized;

Whereas it is necessary to approve this Protocol . . .;

Whereas it is necessary for reasons of efficiency to lay down a procedure to enable the Annexes to the Protocol to be adapted regularly and, where appropriate, urgently once the Community has taken the internal measures foreseen by the Agreement; whereas it is appropriate to authorize the Commission to conclude the acts that are necessary for the adaptation of the annexes in accordance with the procedures laid down in either Article 13 of Council Directive 64/432/EEC or in Article 16 of Council Directive 77/93/EEC;

HAS DECIDED AS FOLLOWS:

Article 1

Protocol . . . to the Europe Agreement establishing an association between the European Communities and their Member States, of the one part, and the Czech Republic of the other part, is hereby approved on behalf of the European Community.

The text of Protocol . . . is attached to this Decision.

Article 2

The President of the Council is hereby authorized to designate the person empowered to sign the Protocol . . . on behalf of the European Community.

The President of the Council shall give the notification on behalf of the European Community that all necessary procedures have been completed.

Article 3

The Commission is authorized to conclude the adaptations of the Annexes to the Protocol according to the procedure laid down in either Article 13 of Council Directive 64/432/EEC or in Article 16 of Council Directive 77/93/EEC, as appropriate.

(1) OJ No L 360, 31. 12. 1994, p. 1.

ANNEX

PROTOCOL . . . concerning, sanitary, phytosanitary and animal welfare measures in relation to trade

THE EUROPEAN COMMUNITY

(hereinafter referred to as 'the Community`)

on the one part,

and

THE CZECH REPUBLIC

of the other part,

REAFFIRMING that one of the objectives of the Europe Agreement establishing an association between the European Communities and their Member States, of the one part, and the Czech Republic, of the other part, of 4 October 1993 (hereinafter referred to as 'the Europe Agreement`) is to establish progressively, between the Community and the Czech Republic (hereinafter referred to as 'the Parties`), a free trade area and in this context, a Protocol, on sanitary, phytosanitary and animal welfare measures applicable to trade, can contribute to the acceleration of the process by further developing trade between the Parties;

CONSCIOUS that gradual harmonization of sanitary, phytosanitary and animal welfare measures can contribute to the final objective that the Czech Republic becomes a Member of the Community and that pending the completion of this process it is appropriate to conclude a Protocol between the two Parties on sanitary, phytosanitary and animal welfare measures in order to facilitate trade;

DESIRING to facilitate trade and movement between the European Community and the Czech Republic in live animals and animal products while safeguarding public and animal health and animal welfare and meeting consumer expectations in relation to the wholesomeness of food products, and in plants, plant products and other objects while safeguarding plant health;

RESOLVED to take the fullest account of the risk of introduction or spread of disease and pests and the measures put in place to control and/or eradicate such diseases and pests, and in particular to avoid disruptions to trade;

ACCEPTING that their sanitary and phytosanitary measures are intended to provide comparable safeguards against health risks;

WHEREAS given the importance of animal welfare in trade and given its connection with veterinary matters, it is appropriate to include this issue in this Protocol;

CONSIDERING that the recognition of equivalency may be progressive and that technical and financial assistance, as provided for by the Europe Agreement, may be provided, in particular, for issues dealt with in this Protocol, as necessary;

CONSIDERING also that the recognition of equivalency shall take place in accordance with the internal procedures and legislative processes of the Parties and that these procedures are in no way affected by the measures and objectives of the present Protocol;

DESIRING also to give expression to the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures, in particular on recognition of the equivalence of specified sanitary or phytosanitary measures;

HAVE DECIDED to conclude this Protocol and to this end have designated as their plenipotentiaries:

THE EUROPEAN COMMUNITY

THE CZECH REPUBLIC

WHO HAVE AGREED AS FOLLOWS:

CHAPTER I

GENERAL PROVISIONS

Article 1 Objective and scope

1. The objective of this Protocol is to facilitate trade between the Community on the one part and the Czech Republic on the other part in live animals, animal products, plants, plant products and other objects originating within the Parties pending the finalization of the approximation of laws in relation to the scope of this Protocol, referred to in Chapter III of the Europe Agreement.

2. For this purpose interim measures are set out herein based on the principles of regionalization, the recognition of equivalence and any other measures deemed useful in this context.

3. The scope of this Protocol is limited to the animal, public and plant health conditions and animal welfare measures related to trade between the Parties in items as defined in Article 2.

Article 2 Definitions

For the purposes of this Protocol the following definitions apply:

(a) live animals:

all live animals as set out in Annex I (A) (1) with the exception of family pets accompanying travellers for non-commercial purposes, other than equidae;

(b) animal products:

products of animal origin as set out in Annex I (A) (2);

(c) plants:

living plants and living parts thereof, including seeds, as set out in Annex I (B) (1);

(d) plant products:

products of plant origin, unprocessed or having undergone simple preparation, in so far as these are not plants as set out in Annex I (B) (1);

(e) other objects:

growing medium, packaging other than of plant products and other material as set out in Annex I (B) (2);

(f) pests:

those pests of plants or of plant products which belong to the animal or plant kingdoms or which are bacteria, viruses, mycoplasmas or other pathogens;

(g) trade between the Parties:

export, import and also transit in so far as the veterinary and phytosanitary border controls and checks are carried out and additionally any cross-border movement of items referred to above in points (a) to (e);

(h) sanitary and phytosanitary measures:

measures as defined in Annex A, paragraph 1, of the World Trade Organization (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures (SPS);

(i) responsible Authorities:

as provided for in Annex II;

(j) import and transit procedures:

as provided for in Annex VII;

(k) animal welfare in trade:

as provided for in Annex VIII;

(l) territory of Member States:

as laid down in Annex I of Council Directive 90/675/EEC (Sanitary) and in Article 1 of Council Directive 77/93/EEC (Phytosanitary).

CHAPTER II

PROVISIONS FOR TRADE

Article 3 Diseases or pests

1. (a) Trade between the territory of the Czech Republic and the territory of Member States of the European Community of live animals and products of animal origin are permitted on the condition that none of the diseases listed at Annex III (A) occurs subject to the relevant conditions of Article 7.

The limitations referred to above only concern animals susceptible to a given disease or products representing a risk from such animals.

However where a disease listed at Annex III (A) occurs on the territory of the Czech Republic or the Member States of the European Community then the provisions of Article 4 and Annexes V or VI shall apply.

1. (b) Where one of the Parties considers that it has a special status in total or in parts thereof with respect to a specific disease, it may request recognition of this status. The Party concerned may also request additional or specific guarantees in respect of imports of live animals and animal products appropriate to the agreed status. These guarantees for specific diseases shall be specified in Annex V (A) or VI (A).

2. (a) For the purposes of trade between the Parties in plants, plant products and other objects, the Parties shall certify that such trade is considered to be free from the pests as set out in Annex III (B) subject to the relevant conditions of Article 7.

2. (b) Where one of the Parties considers that it has a special status with respect to specific pests, it may request recognition of this status. The Party concerned may also request additional or specific guarantees in respect of imports of plants, plant products and other objects appropriate to the agreed status. This special status and guarantees for specific pests shall be specified in Annex V (B) or VI (B).

Article 4 Regionalization

(a) Notwithstanding Article 3 exports of live animals and products of animal origin shall be authorized from a 'free` area. Such free areas may be recognized for the diseases listed in Annex III (A), taking account of the recommendations made by the bodies referred to in Article 16, in accordance with the criteria listed in Annex IV and established under the respective legislative process of the Parties. Under the same procedure outlined above countries or areas of low prevalence of disease, as defined by OIE or other international standards, may be recognized.

(b) Trade in plants, plant products and other objects shall also take account of pest-free areas or protected zones. Such pest-free areas and protected zones may be recognized, taking account of the recommendations made by the bodies referred to in Article 16, in accordance with the criteria listed in Annex IV and established under the respective legislative process of the Parties.

Article 5 Equivalence

1. The Parties shall recognize as equivalent those measures, whether or not identical, that provide the same level of health protection and animal welfare in trade. Equivalence shall be applied in relation to legislation, sanitary or phytosanitary measures for sectors, or parts of sectors, systems of inspection, survey, control, testing and certification, parts of these systems, or in relation to specific legislation, inspection and/or hygiene requirements.

2. Recognition of equivalence requires an assessment and acceptance of:

- the documented structure of the relevant responsible authority(ies), the command chain, their powers, their modus operandi and the resources available to them,

- the legislation and powers, standards, certification and procedures as well as the programmes in place to allow control and to ensure domestic and importing countries' requirements are met,

- the performance of the relevant responsible authority in relation to the control programme and assurances.

In this assessment, account shall be taken of experience already acquired.

Article 6 Implementation of equivalence

1. The equivalence of the respective sanitary, phytosanitary or welfare measures for the sectors, or parts of sectors listed in Annex V, is recognized. The Parties shall take the necessary legislative/administrative actions, within their responsibilities, to implement this equivalence three months after entry into force of this Protocol.

2. For the sectors, or parts of sectors listed in Annex VI (A) (1) or (B) (1), differences in sanitary, phytosanitary or welfare measures preclude the immediate recognition of equivalence. The actions set out in this Annex shall be taken to enable the assessment of recognition of equivalence by the dates to be determined in accordance with the procedure referred to in Article 16. The Parties shall undertake the necessary legislative/administrative actions, within their responsibilities, to implement this equivalence within three months of the date of recognition.

3. Further consultations shall take place to identify the actions needed to enable the demonstration and recognition of equivalence of the sanitary, phytosanitary or welfare measures for the sectors, or parts of sectors listed in Annex VI (A) (2) or (B) (2).

Article 7 Conditions for trade

1. For the sectors or parts of sectors referred to in Article 6 (1) trade shall take place in accordance with the conditions referred to in Annex V.

2. For the sectors or parts of sectors referred to in Article 6 (2) until equivalence is recognized, trade shall take place in accordance with the respective legislation, conditions or rules in force referred to in Annex VI.

3. For the sectors or parts of sectors referred to in Article 6 (3) until equivalence is recognized and for those not covered by this Protocol, trade shall take place under the conditions required by the countries concerned.

4. Notwithstanding Article 7 (2) and (3), for the purposes of trade between the two Parties, plant health certificates shall only be required for those plants, plant products and other objects listed in Annex 1 (B).

5. The principles and guidelines of veterinary certification may be addressed by the Parties. Any such principles shall be included in Annex V (A) once the relevant measures have been adopted according to the internal procedures of the two Parties.

Article 8 Import checks

1. Veterinary checks at the border inspection posts on imported and transiting live animals shall be carried out on 100 % of consignments. The details of the checks are laid down in Annex VII (A) (1) (i).

2. Veterinary checks at border inspection posts on imported and transiting animal products listed in Annex I (A) (2) shall be set out in Annex VII (A) (1) (ii) and (A) (2). The Parties will take the necessary measures, within their responsibilities, to implement in particular the frequency of these physical checks three months after entry into force of this Protocol.

3. Plant health checks on imports of plants, plant products and other objects covered by this Protocol shall be carried out in accordance with the provisions set out in Annex VII (B) (1). The Parties will take the necessary measures, within their responsibilities, to implement in particular the frequency of these physical checks three months after entry into force of this Protocol.

4. The Parties may amend the frequencies, within their responsibilities, as appropriate as a result of progress made in accordance with Annex VI, or as a result of other measures or consultations provided for in this Protocol.

5. The Parties may address the issue of special import check conditions applicable to local trade within the vicinity of the borders between the two Parties, in accordance with the principles of this Protocol.

Article 9 Inspection fees

1. Where inspection fees are charged for veterinary and phytosanitary checks carried out on imports and transiting of live animals, products of animal origin, plants, plant products and other objects or groups thereof they shall be applied on a uniform basis to consignments of the same nature.

2. These fees shall be equitable in relation to fees charged for similar domestic products and should be no higher than the actual cost of the service.

CHAPTER III

INSPECTION AND VERIFICATION PROCEDURES

Article 10

1. Each Party shall have the right to carry out verification and inspection procedures, which includes:

(a) review of the responsible authorities' compliance/audit programmes;

(b) verification checks of the exporting country or Member State (on-the-spot checks);

(c) periodic assessment of the efficacy of the total control programme in meeting the agreed requirements;

(d) investigations into matters relating to fraud in the veterinary and phytosanitary sectors;

(e) checks on consignments on importation.

2. For the Community:

- the Commission of the European Communities assisted as appropriate by experts from Member States shall carry out the verification procedures provided for in paragraphs 1 (a), (b) (c) and (d),

- the Member States assisted as appropriate by the Commission of the European Communities shall carry out the inspections provided for in paragraphs 1 (d) and (e).

3. For the Czech Republic, the Czech authorities shall carry out the verification and inspection procedures provided for in paragraph 1.

4. Arrangements for carrying out the verification and inspection provisions will be discussed by the bodies (referred to in Article 16) and all necessary assistance, access to establishments and documents shall be ensured by the responsible authorities concerned in order that the checks and verifications as provided for in paragraph 1 above may be efficiently and satisfactorily carried out. It may be agreed to undertake joint sanitary border inspection checks.

CHAPTER IV

NOTIFICATION AND SAFEGUARD PROVISIONS

Article 11

1. The Parties shall notify each other of:

(a) - significant changes in health status such as the presence and evolution of diseases in List A of OIE with 24 hours,

- outbreaks in their territory, other than those already referred to in the first indent, of any zoonoses, diseases or other causes likely to constitute a serious hazard to animal or human health,

- any additional measures beyond the basic requirements of their respective sanitary measures taken to control and/or eradicate disease, and any changes in vaccination policy,

(b) - significant changes in plant health status such as the presence of pests and the development of pests which are set out in Annex III (B) without delay,

- findings of plant health concern with respect to new pests considered to be quarantine pests, in accordance with the definition in Article II.2 of the International Plant Protection Convention, which are not covered by this Protocol without delay,

- any change in the phytosanitary measures applied beyond the basic requirements of their respective phytosanitary measures taken to control and/or eradicate pests,

(c) - information relating to matters concerning fraud provided that such information is not sub judice; in this case information in general terms should be provided,

(d) - changes to agreed lists of establishments authorized for export by the relevant authorities, if appropriate.

2. The notifications referred to in paragraph 1 shall be made in writing to the established contact points in accordance with Article 15 paragraph 3. However to achieve the optimum notification of serious diseases or pests the Community informatics systems, in particular, 'ADNS` and 'Europhyt` will be extended to include the Czech Republic as soon as possible and, when implemented, shall supersede the need for the relevant written notification.

3. In cases of serious and immediate concern for one of the Parties with respect to public/animal health or to trade, and with respect to plant health, oral notification shall be made by this concerned Party to the established contact points and written confirmation should follow within 24 hours. In such cases each Party, should take immediately all appropriate control and protective measures in accordance with its legislation or any other measures deemed necessary.

4. Where either Party has serious concerns regarding a risk to animal or public health, or regarding a risk to plant health, consultations regarding the situation shall, on request of either Party, take place as soon as possible, and in any case within 14 days. Each Party shall endeavour in such situations to provide all the information necessary to avoid a disruption in trade, and to reach a mutually acceptable solution.

Article 12 Safeguard provisions

Without prejudice to Article 11 and in particular paragraph 4, either Party may, on serious public or animal health grounds, or on serious plant health grounds, take interim protective measures according to their own procedures with regard to the introduction into their territory of live animals or animal products or to the introduction into their territory of plant, plant products or other objects directly related to the risk. These measures shall be notified without delay to the other Party and, on request, consultations regarding the situation shall be held within 14 days of notification. The Parties shall, within their competencies, take the necessary measures taking due account of the results of the consultations.

CHAPTER V

Article 13 Financial and technical assistance

Technical and financial assistance, as referred to in the Europe Agreement, may be provided for issues dealt with in this present Protocol, as necessary.

CHAPTER VI

FINAL AND INSTITUTIONAL PROVISIONS

Article 14

1. The principles of this Protocol shall be applied to address outstanding issues concerning sanitary or phytosanitary measures affecting trade between the Parties in live animals and animal products or in plants, plant products and other objects including inter alia the issues listed in Annex VI.

2. The Parties shall provide for the submission of scientific papers or data to the relevant scientific forums to substantiate their views/claims. Such evidence shall be subjected to a risk assessment by the relevant scientific forums in due time, and the results of that examination shall be made available.

Article 15

1. The Parties shall exchange information on a uniform and systematic basis, to provide assurance, engender mutual confidence and demonstrate the efficacy of the control programmes.

2. The information exchange on changes in their respective sanitary and phytosanitary measures, and other relevant information, shall include:

- opportunity to consider proposals for changes in regulatory requirements which may affect this Protocol in advance of their finalization. Where either party considers it necessary, proposals may be discussed in accordance with Article 16,

- briefing on current developments affecting trade in live animals, animal products, plants, plant products and other objects,

- information on the results of frontier checks on live animals, animal products, plants, plant products and other objects.

3. The Parties shall inform each other of the contact points for this exchange of information and any changes thereof.

Article 16

The Parties agree that, in the framework of the bodies established by the Europe Agreement, their representatives shall meet to discuss the implementation of this Protocol, in particular:

- to see to the proper functioning of the Protocol,

- to seek to resolve differences on issues,

- to address claims for updating the Annexes of this Protocol. The Annexes shall be amended by common agreement once the relevant measures have been taken by the Parties according to their internal procedures,

- to decide, when circumstances require, to establish ad hoc working groups or scientific groups. Membership of such groups is not necessarily restricted to representatives of the Parties.

Issues may also be addressed by correspondence.

Article 17

The Annexes attached to this Protocol shall form an integral part thereof.

Article 18

This Protocol is concluded for an unlimited period, however either Party may denounce it provided that at least six months' notice is given. In this latter event the Protocol shall come to an end on the expiry of the period of notice.

Article 19

This Protocol shall apply, on the one hand, to the territories in which the Treaty establishing the European Communities is applied and under the conditions laid down in that Treaty and, on the other hand, to the territory of the Czech Republic.

Article 20

This Protocol is drawn up in duplicate in Danish, Dutch, English, Finnish, French, German, Greek, Italian, Portuguese, Spanish, Swedish and Czech languages, each of these texts being equally authentic.

Article 21

1. This Protocol shall enter into force on the 30th day following the date on which the Parties notify each other of the completion of the procedures necessary for that purpose.

2. The Parties shall implement the commitments and obligations arising from this Protocol in accordance with their own internal procedures, and shall amend the Annexes hereto accordingly.

3. The Annexes to this Protocol shall be amended following agreement between the two Parties.

Done at . . .

For the European Community

For the Czech Republic

ANNEX I

ITEMS COVERED

A: SANITARY PART

1. Main live animal categories

I. Equidae (1)

II. Bovine animals

III. Ovine and caprine animals

IV. Porcine animals

V. Poultry (2)

VI. Live fish

VII. Crustaceans

VIII. Molluscs

IX. Eggs and gametes of live fish

X. Hatching eggs

XI. Semen - ova - embryos

XII. Other mammals

XIII. Other birds

XIV. Reptiles

XV. Amphibians

XVI. Other vertebrates

XVII. Invertebrates

Full details of the ANIMO codes are laid down in Commission Decisions 93/70/EEC and its amendment 94/295/EC.

2. Products of animal origin

Main product categories

I. Fresh meat of domestic species and game, including offal and blood for human consumption.

II. Meat products and other products of animal origin for human consumption.

III. Liquid milk.

IV. Milk products.

V. Fishery products for human consumption.

VI. Eggs for consumption, egg products, products produced by bees.

VII. Snails and frogs' legs.

VIII. Hides or skins of hoofed animals, wool, hair, bristles, feathers, down, or parts of feathers, game trophies.

IX. Bones, horns, hooves and their by-products (gelatins) other than meals.

X. Blood, blood products, amniotic fluid for use in the pharmaceutical industry or for technical use other than in animal feeding stuffs, pathogenic agents.

XI. Other animal waste: high-risk untreated matter, low-risk raw materials for the pharmaceutical industry, or technical use or for use in feeding stuffs.

XII. Pet food - processed animal protein for use in feeding stuffs (meals and greaves).

XIII. Liquid manure for use as fertilizer.

XIV. Small consignments of products for private individuals, products in the possession of the travelling public and commercial samples.

XV. Fresh meat for exhibition purposes, specific study or analysis.

XVI. Fresh meat and meat products supplied exclusively to international organizations.

Full details of the ANIMO codes are laid down in Commission Decisions 93/70/EEC and its amendment 94/295/EC.

B: ITEMS COVERED

1. Plants and plant products

a. Plants and plant products which are potential carriers of pests of relevance to both parties

1. Plants, intended for planting, other than seeds or aquarium plants, but including seeds of Capsicum spp., Helianthus annuus L., Lycopersicon lycopersicum (L.) Karsten ex Farw., Medicago sativa L., Prunus L., Rubus L., Oryza spp., Zea mais L., Allium cepa L., Allium porrum L., Allium schoenoprasum L., and Phaseolus L.

2. Parts of plants, other than fruits and seeds of:

- Castanea Mill., Dendranthema (DC) Des. Moul., Dianthus L., Pelargonium l'Herit ex Aid, Phoenix spp., Populus L., Quercus L.,

- conifers (Coniferales).

3. Tubers of Solanum tuberosum L.

4. Isolated bark of:

- conifers (Coniferales)

- Acer saccharum Marsh., Castanea Mill., Populus L.; and Quercus L. other than Quercus suber L.

5. Wood only in so far as it retains all or part of its natural round surface, with or without bark, or as it is in the form of chips, particles, sawdust, wood waste or scrap and also where it is in the form of dunnage, spacers, pallets or packaging material which are actually in use in the transport of objects of all kinds, provided that it presents a plant health risk and where it:

(i) has been obtained in whole or part from one of the order, genera or species as described hereafter:

- Castanea Mill.,

- Platanus, including wood which has not kept its natural round surface,

- Pinus L., including wood which has not kept its natural round surface;

and

(ii) meets one of the following descriptions laid down in Part II of Annex I to Regulation (EEC) No 2658/87.

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b. Plants and plant products which are potential carriers of pests of relevance to certain protected zones

Without prejudice to the plants, plant products and other objects listed in Annex I (B) (1) (a).

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Wood only in so far as it retains all or part of its natural round surface, with or without bark, or as it is in the form of chips, particles, sawdust, wood waste or scrap and also where it is in the form of dunnage, spacers, pallets or packaging material which are actually in use in the transport of objects of all kinds, provided that it presents a plant health risk and where it:

(a) has been obtained in whole or part from conifers (Coniferales), other than Pinus L., originating in the Czech Republic,

and

(b) meets one of the following descriptions

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Additional protected zones are detailed in Annex III (B) (1) (b) and III (B) (2) (b).

c. Plants and plant products which are potential carriers of pests of relevance to certain pest free areas

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d. Plants and plant products which are potential carriers of pests of relevance for one or part of one of the parties

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2. Other objects

a. Other objects which are potential carriers of pests of relevance to both parties

Soil and growing medium as such, which consists in whole or in part of soil or solid organic substances such as part of plants, humus including peat or bark, other than that composed entirely of peat.

b. Other objects which are potential carriers of pests of relevance to certain protected zones

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c. Other objects which are potential carriers of pests of relevance to certain pest free areas

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d. Other objects which are potential carriers of pests of relevance for one or part of one Party

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(1) Equidae (including zebras) or asinine species or the offspring of crossings of those species.

(2) Fowl, turkeys, guinea fowl, ducks, geese.

ANNEX II

RESPONSIBLE AUTHORITIES

(i) The Czech Republic - controls in veterinary or phytosanitary affairs are shared between the Ministry of Agriculture of the Czech Republic and the Ministry of Health together with the State Veterinary Administration of the Czech Republic and/or State Phytosanitary Administration of the Czech Republic.

- The Ministry of Agriculture of the Czech Republic is responsible for overall co-ordination, monitoring, inspections/audits and the necessary legislative action to ensure uniform application of veterinary and phytosanitary measures within the Czech Republic,

- the Ministry of Health of the Czech Republic is responsible for laying down the measures in relation to public health,

- in terms of exports to the Community, the State Veterinary Administration and State Phytosanitary Administration of the Czech Republic are responsible for controlling the production circumstances and requirements, and issuing certification attesting to the agreed animal health, public health and animal welfare measures, or issuing plant health certification attesting to the agreed plant health measures.

(ii) The European Community - responsibility for veterinary and plant health affairs is shared between the services for veterinary or plant health protection in the individual Member States and the Commission of the European Communities. In this respect the following shall apply:

- the Commission of the European Communities is responsible for overall coordination, monitoring, inspections/audits and the necessary legislative action to ensure uniform application of animal health, public health, animal welfare and phytosanitary measures within the Community,

- in terms of exports to the Czech Republic, the Member States are responsible for controlling the production circumstances and requirements, and issuing certification attesting to the agreed animal health, public health and animal welfare measures, or issuing plant health certification attesting to the agreed plant health measures.

ANNEX III

LIST OF DISEASES AND PESTS

A: DISEASES FOR WHICH REGIONALIZATION APPLIES

Foot and mouth disease

Vesicular stomatitis

Swine vesicular disease

Rinderpest

Peste des petits ruminants

Contagious bovine pleuropneumonia

Lumpy skin disease

Bluetongue

Epizootic haemorrhagic disease

Sheep pox and goat pox

African horse sickness

African swine fever

Classical swine fever

Porcine enterovirus encephalitis (Teschen)

Fowl plague (highly pathogenic avian influenza)

Newcastle disease

Equine encephalomyelitis of all types including Venezuelan

Rift Valley fever

Vesicular exanthema

With respect to diseases of fish, bivalve molluscs and crustaceans and their products, these will be examined later.

B.1 QUARANTINE PESTS RECOGNIZED BY BOTH PARTIES

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B.2 QUARANTINE PESTS RECOGNIZED ONLY BY THE EUROPEAN COMMUNITY

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B.3 QUARANTINE PESTS RECOGNIZED ONLY BY THE CZECH REPUBLIC

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ANNEX IV

CRITERIA FOR REGIONALIZATION

1. The criteria for the definition of an area or zone should take into account appropriate international standards and include:

- the geographical conditions,

- the epidemiological situation,

- patterns of trade,

- the meteorological conditions,

- the distribution of vectors and alternative or secondary hosts,

- administrative boundaries,

- effective control of movement across the boundaries of the area,

- effective control (1) and surveillance measures within the non-free area, zone and free area as appropriate,

- the eco-system including the agronomy and the environment.

2. A protected zone, as defined in Council Directive 77/93/EEC, Article 2 (1) (h) (2) shall be considered as a zone where there is effective control on plants, plant products and other objects moving into or within the zone and effective surveillance measures as detailed in Commission Directive 92/70/EEC (3), within the zone

- in which one or more pests, which are established in one or more parts, are not endemic or established, despite favourable conditions for them to become established therein,

- in which there is a danger that certain pests will establish themselves, given propitious ecological conditions, for particular crops, despite the fact that these pests are not endemic or established.

(1) With respect to plant health, control means here suppression, containment or eradication of a pest population.

(2) OJ No L 26, 31. 1. 1977, p. 20.

(3) OJ No L 250, 29. 8. 1992, p. 37.

ANNEX V

A. SANITARY MEASURES RECOGNIZED EQUIVALENT: LIVE ANIMALS, SEMEN, OVA AND EMBRYOS

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B. PHYTOSANITARY MEASURES RECOGNIZED EQUIVALENT

1. General measures

(a) For the purpose of trade between the Parties in plants, plant products and other objects, the Parties shall certify that such trade is considered to be free from the pests as set out in Annex III (B) of this Protocol.

(b) The Parties shall take account of pest-free-areas and of protected zones for the purpose of trade between the Parties in plants, plant products and other objects.

2. Additional measures

For the following additional measures, detailed below, both Parties recognize them to be equivalent:

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3. The conditions of trade for those specified plants, plant products and other objects for which both the general measures (point 1) and all applicable additional measures (point 2) are completely recognized as being equivalent are laid down in Annex VII (B).

ANNEX VI

A.1 SANITARY MEASURES NOT RECOGNIZED EQUIVALENT FOR WHICH EQUIVALENCY MAY BE OBTAINED: LIVE ANIMALS, SEMEN, EMBRYOS AND OVA

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A.2. SANITARY MEASURES NOT RECOGNIZED EQUIVALENT FOR WHICH FURTHER CONSULTATIONS ARE NEEDED LIVE ANIMALS, SEMEN, EMBRYOS AND OVA

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B.1. PHYTOSANITARY MEASURES NOT RECOGNIZED EQUIVALENT FOR WHICH EQUIVALENCE MAY BE OBTAINED

A. Negotiations on the necessity for plant health certificates for the plants, plant products and other objects listed in Annex I (B) (1) (d) and I (B) (2) (d) with a view to the elimination, as appropriate, of this requirement within one year.

B. Negotiations on the recognition of pests which are currently only recognized by one Party, as listed in Annex III (B) (2) and III (B) (3); with a view to either their elimination from that Annex or their incorporation into Annex III (B) (1), as appropriate, within one year.

C. Negotiations on additional measures as laid down in the following list, with a view to a determination of equivalency for such additional measures following appropriate modifications within one year.

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B.2. PHYTOSANITARY MEASURES NOT RECOGNIZED EQUIVALENT FOR WHICH FUTHER CONSULTATIONS ARE NECESSARY

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ANNEX VII

IMPORT AND TRANSIT PROCEDURES

A. SANITARY PART

The Parties recognize the distinction between documentary, identity and physical checks carried out on imports of live animals and animal products.

1. Import checks

(i) Live animals

1. Documentary checks

Documentary checks will be carried out on 100 % of consignments. It means that veterinary certificates or veterinary documents required by the legislation have to be controlled to confirm that the form and the content are fulfilling the legal requirements.

2. Identity checks

Identity checks will be carried out on all consignments to confirm the correspondence between the documents referred to in paragraph 1 and the consignment itself.

3. Physical checks

The aim of the physical checks is to ensure that the animals meet the guarantees mentioned on the documents referred to in paragraph 1 and that they are clinically healthy. The guarantee of origin certified by the third country must accordingly be verified as well as the transport and the animal welfare conditions. In principle every animal of a consignment should be physically checked. This physical check may include sampling and testing procedures.

In principle the physical check must include, in particular, a clinical examination of all the animals.

By way of derogation to the clinical examination the following shall apply:

(a) animals for fattening, 10 % of animals in a consignment with a minimum of 10 animals;

(b) animals for direct slaughtering: visual examination;

(c) poultry, birds, aquaculture animals including fish, rodents including lagomorphs, bess and other insects, reptiles, other invertebrates, dangerous zoo animals: examination of the general health status and behaviours or of a representative of animals;

(d) pathogens free animals: physical examination should take place only in case of presence of a risk of an irregularity.

4. Transits

Similar checks as laid down above shall apply for transits of live animals.

(ii) Products of animal origin

1. Documentary checks

Documentary checks will be carried out on 100 % of consignments, veterinary certificates, veterinary documents or other documents required by the legislation have to be controlled to confirm that the form and the content are fulfilling the legal requirements.

2. Identity checks

Identity checks will be carried out on consignments to confirm the correspondence between the documents referred to in paragraph 1 and the consignment itself.

3. Physical checks

The aim of the physical check is to ensure that the products still meet the purpose mentioned on the documents referred to in paragraph 1. The guarantees of origin certified by the third country must accordingly be verified while ensuring that the subsequent transport of the products has not altered their original conditions. In the light of the inspections and controls undertaken by the exporting country and the experience gained, the following factors will be applied to the rates of checking frequencies set out in Annex I to Commission Decision 94/360/EC, it being understood that the resulting rates are to be considered as maximum rates. This physical check may include sampling and testing procedures.

Groups of products and the frequencies of checks to be applied by the contracting parties for products where equivalent trade conditions have been agreed and lists of 'approved` establishments (animal health and public health) have been laid down where necessary, are listed in Annex VII (A) (2).

Notwithstanding the agreed checks and the reduced frequencies laid down in this Protocol additional checks may be carried out in cases of suspicion.

4. Transits

The checks as laid down in paragraphs 1 above shall apply. Identity and/or physical checks may be carried out in cases of suspicion.

2. Reduced frequencies of checks

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The rates of physical checks for animal products mentioned above which are not harmonized (i.e. listed in Annex V) or not marked with an asterisk will be those set out in Annex I to Commission Decision 94/360/EC, however the rates indicated above shall apply following harmonization.

The rates of physical checks for animal products not mentioned above will be those set out in Annex I to Commission Decision 94/360/EC.

The rates of sampling for all animal products must be 1 % of consignments presented (except if noted otherwise).

For the purposes of this Protocol, 'consignment` means a quantity of products of the same type, covered by the same health certificate or document, conveyed by the same means of transport, consigned by the same consignor, and originating from the same exporting country or part of the same country.

3. Inspection fees

For the Czech Republic:

Pending the Czech Republic's review of it's system of veterinary fees on importations from the Community and for the health inspections carried out in establishments approved to export to the Community, to be achieved by 1 January 1998 in order to implement the principles of Council Directive 85/73/EEC as amended, the following importation fees will be applied on a standard basis to consignments as an interim measure:

Live animal consignments:

- one animal: CZK (Czech crowns) 100

- more than one animal: CZK 200

Animal product consignments;

- per consignment: CZK 200

As from 1 January 1998 the same fees as those for the Community shall apply.

That part of the fees exceeding the real costs shall be allocated to a special veterinary fund intended to strengthen the veterinary services in order to allow them to react more effectively to any appearance of exotic diseases.

For the Community the fees will be as follows:

(a) animal product consignment inspections: ECU 3 per tonne;

(b) live animals: ECU 5 per tonne;

with a minimum of ECU 30 and a maximum of ECU 350 per consignment, except where the actual costs are greater than this maximum.

B. PHYTOSANITARY PART

Import procedures

General procedures

The Parties shall not require any additional declaration on the plant health certificates.

Specific procedures

Only those plants, plant products and other objects are considered, for which all applicable specific measures are recognized to be equivalent. According to Annex V (B) these are the following plants, plant products and other objects detailed below.

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The Parties have agreed that for these commodities:

1. Documentary checks

The documentary checks shall be carried out for 100 %.

2. Identity checks

The identity checks shall be carried out for 100 %.

3. Physical checks

The frequency of physical checks shall not be higher than 50 % and shall be further reduced according to experience and upon recommendation by the Committee with the eventual aim of reducing these checks to zero wherever possible.

ANNEX VIII

ANIMAL WELFARE AND OTHER SUBJECTS

SCOPE:

1. Council Directive 91/628/EEC (as last amended) of 19 November 1991 on the protection of animals during transport and amending Directives 90/425/EEC and 91/496/EEC.

2. Council Directive 93/119/EEC on the protection of animals at slaughter.

(Details to be completed during further negotiations; the parties may agree to widen the scope to other welfare considerations or other subjects).