Brussels, 19.12.2017

SWD(2017) 465 final

COMMISSION STAFF WORKING DOCUMENT

Accompanying the document

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE

THE OPERATION OF DIRECTIVE (EU) 2015/1535 FROM 2014 TO 2015

{COM(2017) 788 final}


TABLE OF CONTENTS – ANNEXES

Annex 1 – Brief description of the notification procedure

Annex 2 – Application of the procedure between 2014-2015: notifications of technical regulations submitted by the Member States

2.1Volume of notifications during the 2014-2015 period

2.2Breakdown by country

2.3Breakdown by sector

2.4Commission reactions: comments and detailed opinions in 2014 and 2015 (articles 5(2) and 6(2) of the directive)

2.5Commission reactions: blockages in 2014 and 2015 (articles 9(3) and 9(4) of the directive)

2.6Member States reactions

2.7Urgency Procedure (Article 9(7) of the Directive)

2.8Follow-up to Commission reactions

Annex 3 – Application of the procedure in 2011-2013: participation of efta countries signatory to the EEA Agreement, of Switzerland and of Turkey

Annex 4 – Internet consultations 2011-2013

Annex 1 – Brief description of the notification procedure

This annex gives a general overview of the notification procedure for products and indicates the specific procedural characteristics that apply to Information Society services. For a more detailed description of the procedure, please refer to the information brochure Guide to the procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services, available on the following website: http://ec.europa.eu/growth/tools-databases/tris .

Legal bases

Introduced in 1984 by Directive 83/189/EEC 1 , the notification procedure in the field of technical regulations has gradually been extended to all industrial, agricultural and fishery products. In 1998, Directive 83/189/EEC was repealed and codified by Directive 98/34/EC 2 , which in turn was amended by Directive 98/48/EC 3 in order to extend the notification procedure to Information Society services, with the adaptations needed to take account of the demands of the sector. In 2015, Directive 98/48/EC was repealed and replaced by Directive (EU) 2015/1535 4 with the aim of codifying it after the adoption of Regulation (EU) No 1025/2012 5 .

Obligation to notify and standstill period

Article 5(1) of Directive (EU) 2015/1535 (hereinafter "the Single Market Transparency Directive") stipulates that the Member States shall inform the Commission of any draft technical regulation prior to its adoption. The simple transposition of a European Union act does not require prior notification, unless the national authorities adopt national provisions that go beyond mere compliance with European Union acts and that contain technical regulations within the meaning of the Directive (Article 7 of the Single Market Transparency Directive).

Starting from the date of notification of the draft, a three-month standstill period – during which the notifying Member State cannot adopt the technical regulation in question – enables the Commission and the other Member States to examine the notified text and to respond appropriately. The only derogation to this rule is linked to the nature of the measure in question: for technical specifications linked to fiscal or financial measures, there is no standstill period. This also applies to technical regulations that have to be adopted urgently (see below).

Possible reactions and consequences

Where it emerges that the notified drafts are liable to create barriers to the free movement of goods or to the free provision of Information Society services and freedom of estblishment (Articles 34-36, 49 and 56 of the Treaty on the Functioning of the European Union), the Commission and the other Member States may submit a detailed opinion to the Member State that has notified the draft (Article 6(2) of the Single Market Transparency Directive). The detailed opinion has the effect of extending the standstill period by an additional three months. The Commission and the Member States can also make comments about a notified draft that appears to comply with European Union law but that requires clarification in its interpretation (Article 5(2)). The Commission can also block a draft for a period of 12 months if European Union harmonisation work is due to be undertaken or is already underway in the same field (Article 6(3) to (5)).

In the event of a detailed opinion being issued, the Member State concerned informs the Commission of the action that it intends to take in response to the detailed opinion, and the Commission comments on that reaction (Article 6(2)). With regard to the comments, the Directive does not lay down any legal obligation for the Member State receiving the comments to indicate what follow-up action it intends to take.

Urgency procedure

Article 6(7) of the Single Market Transparency Directive describes an urgency procedure, which is designed to allow the immediate adoption of a national draft, subject to a closed list of certain conditions that must be clearly indicated at the time of notification (notably "serious and unforeseeable circumstances relating to the protection of public health or safety, the protection of animals or the preservation of plants, and for rules on [Information Society] services, also for public policy" and "urgent reasons occasioned by serious circumstances relating to the protection of the security and the integrity of the financial system, in particular the protection of depositors, investors and insured persons"). The aim of the urgency procedure is to enable a notifying Member State faced with serious or unforeseeable circumstances to adopt immediately the draft technical regulation or rule on Information Society services, without having to wait for the expiry of the three-month standstill period. The Commission decides on the justification for the urgency procedure as soon as possible. If the request to apply the urgency procedure is accepted by the Commission, the three-month stanstill period does not apply and the notified text can be adopted. Nevertheless, any examination of the substance of the text can subsequently be carried out, including as part of potential infringement proceedings for breach of European Union law.

Communication of final texts

At the end of the notification procedure, the Member States are bound to inform the Commission of final texts as soon as those texts have been adopted and to indicate cases in which the notified draft has been abandoned, in order to allow the procedure to be closed (Article 5(3) of the Single Market Transparency Directive).

‘Technical regulations’ committee

The Standing Committee laid down in Article 2 of the Single Market Transparency Directive consists of representatives appointed by the Member States and is chaired by a representative of the Commission. The Committee meets regularly and constitutes a forum for discussing all issues connected with the application of the Single Market Transparency Directive.

Application of the notification procedure to Information Society services

The notification procedure also applies to Information Society services, with the following adaptations: a) in the event of a detailed opinion being issued, the total standstill period is four months from the date of the communication, instead of the six months stipulated for products; b) the Commission can only block the draft for a maximum of 12 months if the subject of the draft is already covered by an EU Council proposal and if the notified text contains provisions that do not comply with the proposal drafted by the Commission; c) the urgency procedure can be invoked not only under the circumstances stipulated for products ('serious and unforeseeable circumstances') but also 'for urgent reasons ... relating to public safety'. 

The simplified procedure

EFTA countries that are contracting parties to the Agreement on the European Economic Area (‘EEA’), namely Norway, Iceland and Liechtenstein, apply the notification procedure with the necessary adaptations 6 : they notify their drafts via the EFTA Surveillance Authority and can comment on the drafts notified by the 28 Member States. On the other hand the entire European Union can comment on drafts notified by the three countries signatory to the EEA Agreement.

Switzerland (which is part of EFTA, but which does apply the EEA Agreement) also participates in the system.

Turkey, which transposed the Single Market Transparency Directive in 2002, participates in the procedure in the same manner as the EFTA countries. The decision to have Turkey participate in the notification system was taken in 1997 as part of the implementation of the final phase of the Customs Union between Turkey and the European Community.

Annex 2 – Application of the procedure between 2014-2015: notifications of technical regulations submitted by the member states

Annexes 2.1, 2.2 and 2.3 give a statistical overview of the development of the number of draft technical regulations notified by the Member States between 2014 and 2015, and of their breakdown by Member State and by sector. It should be pointed out that, in accordance with Article 8 of the Single Market Transparency Directive, ‘statistics concerning communications received’ as part of the notification procedure are published once a year in the Official Journal, C series 7 .

The reactions to the notified drafts – in the form of comments or detailed opinions from the Commission or the Member States, or of requests to postpone the adoption of the notified draft for 12 or 18 months (Article 6(3)(4) and (5) of the Single Market Transparency Directive) on the part of the Commission – are illustrated in Annexes 2.4 to 2.6.

Annex 2.7 refers to the requests to apply the urgency procedure that the Member States addressed to the Commission pursuant to Article 6(7) of the Single Market Transparency Directive.

Annex 2.8 shows the action taken by the Member States in response to the Commission’s reactions.

2.1Volume of notifications during the 2014-2015 period

Figure 1: Number of Notifications

The statistics in Figure 1 show that the Member States notified 655 draft regulations in 2014, and 727 draft regulations in 2015 to the Commission.

2.2Breakdown by country

During the 2014-2015 period, three Member States which notified the highest number of draft technical regulations were United Kingdom (143), France (118) and Germany (111). A group of six other countries (Netherlands, Austria, Finland,Sweden, Denmark and the Czech Republic) come next with a total number of notifications of between 63 and 103.


Member States

2014

2015

Austria

38

43

Belgium

20

20

Bulgaria

6

13

Croatia

10

4

Cyprus

14

3

Czech Republic

26

37

Denmark

29

39

Estonia

18

17

Finland

34

37

France

49

69

Germany

50

61

Greece

7

8

Hungary

24

22

Ireland

6

2

Italy

29

20

Latvia

15

21

Lithuania

4

8

Luxembourg

2

1

Malta

5

1

Netherlands

59

44

Poland

25

36

Portugal

7

22

Romania

24

17

Slovakia

23

35

Slovenia

8

6

Spain

21

30

Sweden

38

32

United Kingdom

64

79

Total

655

727

Table 1 – Number of notifications of technical regulations submitted by the Member States in 2014 and 2015

Member States

2014

2015

Austria

5.8%

5.9%

Belgium

3.1%

2.8%

Bulgaria

0.9%

1.8%

Croatia

1.5%

0.6%

Cyprus

2.1%

0.4%

Czech Republic

4.0%

5.1%

Denmark

4.4%

5.4%

Estonia

2.7%

2.3%

Finland

5.2%

5.1%

France

7.5%

9.5%

Germany

7.6%

8.4%

Greece

1.1%

1.1%

Hungary

3.7%

3.0%

Ireland

0.9%

0.3%

Italy

4.4%

2.8%

Latvia

2.3%

2.9%

Lithuania

0.6%

1.1%

Luxembourg

0.3%

0.1%

Malta

0.8%

0.1%

Netherlands

9.0%

6.1%

Poland

3.8%

5.0%

Portugal

1.1%

3.0%

Romania

3.7%

2.3%

Slovakia

3.5%

4.8%

Slovenia

1.2%

0.8%

Spain

3.2%

4.1%

Sweden

5.8%

4.4%

United Kingdom

9.8%

10.9%

Table 2 – Percentage of notifications submitted by the Member States in 2014 and 2015

2.3Breakdown by sector

Table 3: Breakdown by sector of the drafts notified by the Member States of the European Union in 2014

M

Figure 3: Percentage of the sectors of the drafts notified by the Member States of the European Union in 2014

Sectors

2014

Construction

143

Agriculture, Fisheries and Foodstuffs

127

Telecoms

52

Transport

48

Mechanics

47

Environment

41

Energy, Minerals, Wood

38

Goods and Miscellaneous Products

37

Domestic and Leisure Equipment

36

Chemicals

31

98/48/EC Information Society Services

25

Pharmaceuticals and Cosmetics

23

Health, Medical Equipment

7

Total

655

Table 4: Breakdown by sector of the drafts notified by the Member States of the European Union in 2015

sector of the e M

Figure 4: Percentage of the sectors of the drafts notified by the Member States of the European Union in 2015

2.4Commission reactions: comments and detailed opinions in 2014 and 2015 (Articles 5(2) and 6(2) of Directive (EU) 2015/1535)

Figure 5: Commission Reactions to Notifications in 2014 and 2015

The number of comments made by the Commission increased from 161 in 2014 to 191 in 2015.

The number of detailed opinions issued by the Commission increased between 2014 and 2015: 60 detailed opinions in 2014 on the total number of 655 notifications (9.1%) and 81 in 2015 on the total number of 725 notifications (11.2%).


2.5Commission reactions: requests to postpone the adoption of the notified draft for 12 months in 2014 and 2015 (articles 6(3) and 6(4) of Directive (EU) 2015/1535)

During the 2014-2015 period, the Commission requested a 12-month postponement of the adoption of 12 draft regulations notified by the Member States, because they concerned a subject on which Union harmonisation work had already been announced or was underway.

Table 5

Year

Standstills (Blockages)

Total

Announcement of a Community text (Article 9(3))

Presentation to the Council of a Community text (Article 9(4))

2014

0

2

2

2015

0

1

1

2.6Member States reactions

Table 6 - Comments and detailed opinions issued by the Member States in 2014 and 2015 (Articles 5(2) and 6(2) of Directive (EU) 2015/1535)

2014

2015

Comments

Detailed Opinions

Comments

Detailed Opinions

Austria

8

9

9

5

Belgium

0

1

1

1

Bulgaria

1

2

3

3

Croatia

4

0

1

0

Cyprus

0

0

0

0

Czech Republic

0

6

5

4

Denmark

1

1

4

0

Estonia

1

0

2

1

Finland

3

0

2

1

France

10

5

8

2

Germany

17

0

33

6

Greece

0

2

0

3

Hungary

2

2

5

3

Ireland

1

1

2

0

Italy

8

4

7

6

Latvia

0

0

0

0

Lithuania

0

1

0

2

Luxembourg

0

0

0

0

Malta

3

5

1

2

Netherlands

3

1

0

0

Poland

15

6

12

2

Portugal

0

2

0

5

Romania

3

2

1

2

Slovakia

2

6

6

6

Slovenia

6

0

2

0

Spain

9

8

9

11

Sweden

3

0

5

0

UK

12

0

7

2

Total

112

64

125

67

Table 7 – Number of reactions (comments and detailed opinions) issued by Member States between 2014 and 2015 by sector

2.7Urgency Procedure (Article 6(7) of Directive (EU) 2015/1535)

Table 8 - Requests to apply the urgency procedure received in 2014 and 2015

2014

2015

Requests

Favourable
opinion

Requests

Favourable
opinion

Austria

0

0

0

0

Belgium

4

1

1

1

Bulgaria

0

0

1

1

Croatia

1

0

0

0

Cyprus

0

0

0

0

Czech R.

0

0

1

0

Denmark

0

0

0

0

Estonia

3

3

4

4

Finland

10

10

4

4

France

1

1

2

2

Germany

1

1

3

3

Greece

0

0

0

0

Hungary

5

5

5

5

Ireland

0

0

0

0

Italy

1

0

0

0

Latvia

0

0

3

2

Lithuania

0

0

3

0

Luxembourg

0

0

0

0

Malta

0

0

0

0

Netherlands

1

1

0

0

Poland

3

1

1

1

Portugal

0

0

0

0

Romania

1

0

1

1

Slovakia

0

0

1

1

Slovenia

1

0

0

0

Spain

1

0

0

0

Sweden

6

6

6

6

UK

1

0

0

0

Total

40

29

36

31

Table 8 provides an overview of the number of requests to apply the urgency procedure, by Member State and by year; it also shows the number of requests to which the Commission gave a favourable opinion.

Table 9 - Breakdown by sector of the requests to apply the urgency procedure in 2014 and 2015

BE

BG

CZ

EE

FI

FR

DE

HR

HU

IT

LT

LV

NL

PL

RO

SI

SK

ES

SE

UK

R

F

R

F

R

F

R

F

R

F

R

F

R

F

R

F

R

F

R

F

R

F

R

F

R

F

R

F

R

F

R

F

R

F

R

F

R

F

R

F

98/48/EC Information Society Services

0

0

0

0

0

0

0

0

0

0

3

3

0

0

0

0

0

0

0

0

2

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Agr. Fisheries and Foodstuffs

0

0

0

0

0

0

0

0

0

0

0

0

1

1

0

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

1

0

0

0

1

0

1

1

0

0

Chemical

1

1

0

0

0

0

6

6

14

14

0

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

5

5

0

0

Construction

1

1

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1

1

0

0

0

0

0

0

0

0

0

0

1

1

0

0

Domestic and Leisure Equip.

3

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Environment

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2

0

0

0

0

0

0

0

0

0

3

3

0

0

Goods & Misc. Products

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1

1

0

0

0

0

0

0

Mechanics

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Pharmac. and Cosmetics

0

0

1

1

0

0

1

1

0

0

0

0

3

3

0

0

10

10

0

0

1

0

2

2

0

0

2

2

2

1

0

0

0

0

0

0

2

2

0

0

Telecoms

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1

0

Transport

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Total

5

2

1

1

1

0

7

7

14

14

3

3

4

4

1

0

10

10

1

0

3

0

3

2

1

1

4

2

2

1

1

0

1

1

1

0

12

12

1

0

 

R: Requests F: Favorable Opinions

Table 9, which gives a sectoral breakdown of the requests to apply the urgency procedure received by the Commission during the 2014-2015 period, shows that the application of this exceptional procedure was invoked mainly in the pharmaceutical and cosmetics sector (29 requests) and in the chemicals sector (23).

2.8Follow-up to Commission reactions

Table 10 shows the number of detailed opinions issued by the Commission in 2014-2015, the number of replies to detailed opinions by Member States and the number of replies that were deemed satisfactory. The table also shows the number of notifications that were closed. 8

 Table 10

Year

Detailed Opinions

Responses from the MS

Satisfactory

Closures

2014

60

62

28

3

2015

81

69

35

6

Table 11

Year

Comments

Responses from MS

2014

161

101

2015

191

132

Table 11 shows the number of comments issued by the Commission in 2014-2015 and the number of replies to comments by Member States.

Annex 3 – Application of the procedure in 2014-2015: participation of efta countries signatory to the eea agreement, of switzerland and of turkey

Table 12 – Number of notifications from EFTA countries and comments issued to them by the European Union

2014

2015

Notifications

Comments

Notifications

Comments

EFTA

Iceland

4

2

2

0

Liechtenstein

0

0

3

2

Norway

17

5

18

5

Table 13 – Number of notifications submitted by Switzerland and Turkey and comments issued to them by the Commission or the Member States

2014

2015

Notifications

Comments

Notifications

Comments

Switzerland

9

3

10

5

Turkey

6

2

16

2

Table 14 – Number of comments from EFTA, Switzerland and Turkey regarding the notifications from the Member States

2014

2015

EFTA

0

0

Switzerland

0

0

Turkey

0

0



Annex 4 – Internet consultations 2014-2015

Note: Internet consultations available only after August 2014 due to the roll-out of the new website and new statistical analysis algorithm.

(1)    Directive of 28 March 1983, OJ L 109/8 of 26.4.1983
(2)    OJ L 204/37 of 21.7.1998, p. 37-48.
(3)    OJ L 217/18 of 5.8.1998, p. 18-26.
(4)      Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services, OJ L 241, 17.9.2015, p. 1.
(5)

     Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council Text with EEA relevance, OJ L 316, 14.11.2012, p. 12–33.

(6)    Annex II, Chapter XIX, point 1 to the EEA Agreement.
(7)      For 2014: OJ C 174, 28.5.2015, p. 2–6.
(8)      The number of replies by Member States to detailed opinions and comments refers to the replies sent during each of the two years considered. These replies do not necessarily refer to the detailed opinions issued in the same year (for instance, some of the replies sent in 2014 concern detailed opinions issued in 2013). This explains why the number of replies to detailed opinions by Member States in 2014 is higher than the number of detailed opinions issued in the same year.