TABLE OF CONTENTS – ANNEXES

Annex 1 ... Procedures for standardisation. …... 2

1............... Information procedure. . 2

1.1............ Role of ESOs. . 2

2............... Mandates. . 2

2.1............ The consultation process. . 2

2.2............ Role of ESOs. . 2

3............... Formal objections. . 3

Annex 2.... Breakdown of new national standardisation activities from notifications (CEN and CENELEC) in 2009 and 2010 by State. . 4

Annex 3.... Breakdown of new national standardisation activities from notifications (CEN and CENELEC) from 1999 to 2010 by group of countries. . 5

Annex 4.... Sectoral breakdown of notifications. . 6

Annex 5.... Mandates from 2006 to 2010 – total 7

Annex 6.... Commission Decisions on formal objections in 2009 and 2010. . 8

Annex 7.... Brief description of the notification procedure. . 10

Annex 8.... Developments in Court of Justice case-law on the matter in 2009 and 2010. . 12

Annex 9.... Application of the procedure in 2009 and 2010: notifications of technical regulations submitted by the member states. . 13

9.1............ Volume of notifications during the 2009-2010 period. . 14

9.2............ Breakdown by country. . 15

9.3............ Breakdown by sector 18

9.4............ Commission reactions: comments and detailed opinions in 2009 and 2010 (Articles 8(2) and 9(2) of the Directive) 20

9.5............ Commission reactions: blockages in 2009 and 2010 (Articles 9(3) and 9(4) of the Directive) 21

9.6............ Member State reactions. . 22

9.7............ Urgency Procedure (Article 9(7) of the Directive) 23

9.8............ Follow-up to Commission reactions. . 25

Annex 10 Application of the procedure in 2009 and 2010: participation of EFTA countries signatory to the EEA Agreement, of Switzerland and of Turkey. . 26

Annex 11 . Internet consultations in 2009 and 2010. . 27

Annex 1 – procedures for standardisation

1. Information procedure 1.1. Role of ESOs

The NSBs, which are members of CEN and CENELEC (including bodies from the EFTA countries), send the necessary information to the CEN Management Centre and the Central Secretariat of CENELEC. The information gathered is sent monthly (except in the summer and over the end of year period) by CEN and quarterly by CENELEC to the Commission (DG Enterprise and Industry), all the members of CEN and CENELEC and to ETSI.

Within the Commission, DG Enterprise and Industry disseminates both the regular returns and the annual reports of CEN and CENELEC to the relevant services.

ETSI takes part in the information procedure, although its role is limited to receiving and examining the information submitted by CEN and CENELEC members via the secretariats of these two bodies.

2. Mandates 2.1. The consultation process

The Commission requests the political and technical endorsement of its policy in a particular area from the Member States. This is achieved by means of a consultation, firstly informally with the standardisation bodies, stakeholders and Member States through sectoral committees or expert groups and then formally with the Member States through the Standing Committee. The consultation process is co-ordinated by DG Enterprise and Industry. The Committee gives its opinion on the draft mandate, an opinion that is fully respected by the Commission services and that is acted upon wherever reasonable and possible. Following this consultation – and any amendment arising from it – the mandates are forwarded to the relevant ESOs for acceptance.

2.2. Role of ESOs

The ESOs may accept the mandate as issued by the Commission services, or indeed not accept it if they so wish, by a decision made at Technical Board level. In practice, as mandates are discussed with the ESOs prior to their being issued, refusal is very rare and mandates are usually only not accepted if the work is outside the scope of the ESO.

The mandates can be addressed to any one of the ESOs, or any combination of them, as the work envisaged requires.

It is common for the ESOs to request co-funding for the mandated work following acceptance – by means of action grants – although the issuance of the mandate itself does not mean funding will necessarily be available and the request for funding must undergo a thorough evaluation process by the Commission services.

3. Formal objections

The procedure begins with the formal objection either being received by the Commission through the Permanent Representation or being launched by the Commission itself. The documents are then circulated to the Committee, and normally a Member State expert group is also consulted for its opinion. Once a draft Commission Decision is ready, the Committee is consulted. After receiving a positive opinion, the Decision is processed further.

Annex 2 Breakdown of new national standardisation activities from notifications (CEN and CENELEC) in 2009 and 2010 by state

Country || 2009 || 2010 || Total

AT || 196 || 205 || 401

BE || 30 || 32 || 62

BG || 12 || 31 || 43

CH || 38 || 24 || 62

CY || 2 || 1 || 3

CZ || 70 || 53 || 123

DE || 424 || 368 || 792

DK || 8 || 1 || 9

EE || 9 || 18 || 27

ES || 208 || 196 || 404

FI || 3 || 0 || 3

FR || 277 || 221 || 498

GR || 0 || 464 || 464

HU || 7 || 7 || 14

IE || 4 || 9 || 13

IS || 0 || 0 || 0

IT || 123 || 265 || 388

LU || 0 || 0 || 0

LT || 3 || 44 || 47

LV || 33 || 11 || 44

MT || 0 || 1 || 1

NL || 59 || 62 || 121

NO || 17 || 15 || 32

PL || 14 || 27 || 41

PT || 0 || 0 || 0

RO || 45 || 2 || 47

SE || 21 || 18 || 39

SI || 11 || 8 || 19

SK || 29 || 26 || 55

UK || 159 || 138 || 297

|| || ||

CEN || 1769 || 2190 || 3959

CENELEC || 99 || 57 || 156

From EU-15 || 1512 || 1979 || 3491

From EU-12 || 235 || 229 || 464

From EFTA || 55 || 39 || 94

TOTAL || 1802 || 2247 || 4049

Annex 3 Breakdown of new national standardisation activities from notifications (CEN and CENELEC) from 1999 to 2010 by group of countries

Annex 4 Sectoral breakdown of notifications

2009 || 2010

CEN

Building and construction – Structures || 183 || Building and construction – Structures || 591

Food products || 70 || Building and construction – Fire protection || 75

Building and construction – Undetermined || 66 || Food products || 62

Mining || 61 || Services - Undetermined || 58

Building and construction – Fire protection || 54 || Health, environment and medical equipment - Undetermined || 56

Road Building and Maintenance || 44 || Water quality and water supply || 51

Non-metallic materials - Undetermined || 42 || Building and construction - Undetermined || 50

Aerospace || 41 || Petroleum products || 46

Optics || 39 || Air quality || 44

Road safety || 38 || Mechanical engineering - Fasteners || 40

Annex 5 Mandates from 2006 to 2010 – total

Type || 2006 || 2007 || 2008 || 2009 || 2010

After formal objection (New Approach) || 4 || 2 || 0 || 0 || 0

Amendments (New Approach) || 4 || 0 || 1 || 4 || 0

New Approach mandates || 5 || 7 || 2 || 5 || 4

Mandates under other legislation || 7 || 5 || 9 || 10 || 12

Mandates under Community policy || 4 || 6 || 6 || 2 || 4

Total || 24 || 20 || 18 || 21 || 20

Annex 6 Commission Decisions on formal objections in 2009 and 2010

|| Standard || Directive || Decision || Date Decision || Decision number || O.J. Reference decision publication || Date of reception || Days to close the case (aprox)

1 || EN 3-9:2006 - Portable fire extinguishers — Part 9: Additional requirements to EN 3-7 for pressure resistance of CO2 extinguishers || 97/23/EC Pressure Equipment || Non publication of the reference in the OJ || 10/02/2009 || C(2009) 666 || L 48/13 19.02.2010 || 06/07/2007 || 574

2 || EN 3-8:2006 - Portable fire extinguishers - Part 8: Additional requirements to EN 3-7 for the construction; resistance to pressure and mechanical tests for extinguishers with a maximum allowable pressure equal to or lower than 30 bar || 97/23/EC Pressure Equipment || Publication of the reference in the OJ || 10/02/2009 || C(2009) 739 || L 40/33 11.02.2010 || 06/07/2007 || 574

3 || EN 12312-9:2005 - Aircraft ground support equipment - Specific requirements - Part 9: Container/Pallet loaders || 2006/42/EC Machinery || publication with a restriction || 11/03/2009 || C(2009) 1551 || L 067/85 12.3.2009 || 19/10/2005 || 1222

4 || EN ISO 4869-4:2000 Acoustics - Hearing protectors - Part 3: Measurement of insertion loss of ear-muff type protectors using an acoustic test fixture || 89/686/EEC Personal Protective Equipment || Presumption of conformity withdrawn || 18/03/2010 || C(2010) 1599 || L 69/20 19.3.2010 || 05/11/2008 || 493

5 || EN 353-1:2002 Personal protective equipment against falls from height – Part 1: Guided type fall arresters including a rigid anchor line || 89/686/EEC Personal Protective Equipment || non-withdrawal of the reference of standard || 19/03/2010 || C(2010)1619 final || L 75/27 23.3.2010 || 29/10/2008 || 500

6 || EN 71-1:2005 – 5.12 Fillings (rembourrage) || 88/378/EEC Toys || non-withdrawal of the reference of standard || 09/06/2010 || C(2010)3571 final || non published || 15/05/2006 || 1464

7 || EN 71-8:2003/A2:2005 – Swings || 88/378/EEC Toys || Presumption of conformity partially withdrawn || 24/06/2010 || C(2010)4156 final || non published (but mentioned in the list published on OJEU C 236/3 01.09.2010) || 19/04/2006 || 1505

Annex 7 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/enterprise/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.

Obligation to notify and standstill period

Article 8(1) of Directive 98/34/EC (hereinafter "the 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 10 of the 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 (Articles 34-36, 49 and 56 of the Treaty on the Functioning of the European Union) or to secondary legislation, the Commission and the other Member States may submit a detailed opinion to the Member State that has notified the draft (Article 9(2) of the 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 8(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 9(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 9(2)). With regard to the comments, even though 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, the Member States are inclined to respond, thus making the procedure a genuine instrument of dialogue.

Urgency procedure

Article 9(7) of the 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 (‘serious and unforeseeable circumstances relating to the protection of public health or safety, the protection of animals or the preservation of plants'). The aim of the urgency procedure is to enable a notifying Member State faced with serious or unforeseeable circumstances immediately to adopt the draft technical regulation, 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-monthe 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, as part of infringement proceedings for breach of European Union law.

Communication of final texts

At the end of the 98/34 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 98/34 procedure to be closed (Article 8(3) of the Directive).

‘Technical standards and regulations’ committee

The Standing Committee laid down in Article 5 of the Directive consists of representatives appointed by the Member States and is chaired by a representative of the Commission. In its ‘Technical standards and regulations’ configuration, the Committee meets regularly and constitutes a forum for discussing all issues connected with the application of the Directive.

Application of the 98/34 procedure to Information Society services

The 98/34 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 98/34 procedure with the necessary adaptations[4]: they notify their drafts via the EFTA Surveillance Authority and can comment on the drafts notified by the 27 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 not apply the EEA Agreement) also participates in the system. This country applies the 98/34 procedure on a voluntary basis following an informal agreement to exchange information in the field of technical regulations: it submits its drafts to the Commission and can make and receive comments on the notified drafts.

Turkey, which transposed the 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 8 Developments in Court of Justice case-law on the matter in 2009 and 2010

During the 2009-2010 period one Court of Justice judgment has been delivered on Directive 98/34/EC.

In the case Lars Sandström (Judgment of 15 April 2010, Case C-433/05, OJ C 148 of 5 June 2010, p.2) the Court of Justice clarifies the concept of significant alteration of the draft for the purposes of the third subparagraph of Article 8.1 of the Directive.

It stated that "an amendment made to a draft technical regulation already notified to the European Commission, pursuant to the first subparagraph of that provision, and which contains, in relation to the notified draft, merely a relaxation of the conditions of use of the product in question and which, therefore, reduces the possible impact of the technical regulation on trade, is not a significant alteration of the draft for the purposes of the third subparagraph of that provision and need not be notified beforehand to the Commission".

It should be pointed out that, like other Court of Justice judgments on the notification procedure, this judgment can be consulted on the following website:

http://curia.europa.eu/jcms/jcms/Jo1_6308/).

Annex 9 Application of the procedure in 2009 and 2010: notifications of technical regulations submitted by the member states

Annexes 9.1, 9.2 and 9.3 give a statistical overview of the development of the number of draft technical regulations notified by the Member States in 2009 and 2010, and of their breakdown by Member State and by sector. It should be pointed out that, in accordance with Article 11 of the Directive, ‘statistics concerning communications received’ as part of the notification procedure are published once a year in the Official Journal, C series[5].

The reactions to the notified drafts – in the form of comments or detailed opinions from the Commission or the Member States, or of blockages on the part of the Commission – are illustrated in Annexes 9.4 to 9.6.

Annex 9.7 refers to the requests to apply the urgency procedure that the Member States addressed to the Commission pursuant to Article 9(7) of the Directive.

Annex 9.8 shows the action taken by the Member States in response to the Commission’s reactions.

9.1 Volume of notifications during the 2009-2010 period

Figure 1

2009

2010

The statistics in figure 1 show that the Member States notified to the Commission 708 draft regulations in 2009 and 817 in 2010.

9.2 Breakdown by country

Figure 2

During the 2009-2010 period, the two Member States which notified the most draft technical regulations were France (155) and Germany (120). A group of three other countries (Netherlands, United Kingdom and Spain) come next with a total number of notifications of between 100 and 117.

Table 1 – Number of notifications of technical regulations submitted by the Member States in 2009 and 2010

Member States || 2009 || 2010

Austria || 43 || 48

Belgium || 51 || 31

Bulgaria || 8 || 5

Cyprus || 1 || 6

Czech Republic || 26 || 26

Denmark || 34 || 45

Estonia || 15 || 5

Finland || 31 || 34

France || 56 || 99

Germany || 64 || 56

Greece || 9 || 7

Hungary || 20 || 10

Ireland || 8 || 9

Italy || 31 || 41

Latvia || 15 || 12

Lithuania || 9 || 8

Luxembourg || 1 || 63

Malta || 9 || 12

Netherlands || 67 || 50

Poland || 20 || 42

Portugal || 9 || 7

Romania || 14 || 41

Slovakia || 16 || 14

Slovenia || 14 || 7

Spain || 52 || 47

Sweden || 31 || 40

United Kingdom || 54 || 52

Total || 708 || 817

Table 2 – Percentages of notifications submitted by the Member States in 2009 and 2010

Member States || 2009 || 2010

Austria || 6.1% || 5.9%

Belgium || 7.2% || 3.8%

Bulgaria || 1.1% || 0.6%

Cyprus || 0.1% || 0.7%

Czech Republic || 3.7% || 3.2%

Denmark || 4.8% || 5.5%

Estonia || 2.1% || 0.6%

Finland || 4.4% || 4.2%

France || 7.9% || 12.1%

Germany || 9.0% || 6.9%

Greece || 1.3% || 0.9%

Hungary || 2.8% || 1.2%

Ireland || 1.1% || 1.1%

Italy || 4.4% || 5.0%

Latvia || 2.1% || 1.5%

Lithuania || 1.3% || 1.0%

Luxembourg || 0.1% || 7.7%

Malta || 1.3% || 1.5%

Netherlands || 9.5% || 6.1%

Poland || 2.8% || 5.1%

Portugal || 1.3% || 0.9%

Romania || 2.0% || 5.0%

Slovakia || 2.3% || 1.7%

Slovenia || 2.0% || 0.9%

Spain || 7.3% || 5.8%

Sweden || 4.4% || 4.9%

United Kingdom || 7.6% || 6.4%

9.3 Breakdown by sector

Figure 3

Building and construction are constantly increasing and represent the sector with the highest number of notifications during the period in question (354 notifications). They are followed by the foodstuffs and agricultural products sector (224 notifications). In 2009 and 2010, the transport sector grew (178 notifications). Information Society services represent on average 5.5% of the total number of notifications.

Tables 3 and 4 – Breakdown by sector of the drafts notified by the Member States of the European Union in 2009 and 2010

Sectors || 2009 || || Sectors || 2010

Building and construction || 132 || 18.6% || || Building and construction || 222 || 27.2%

Foodstuffs and agricultural products || 105 || 14.8% || || Foodstuffs and agricultural products || 119 || 14.6%

Chemicals || 21 || 3.0% || || Chemicals || 19 || 2.3%

Pharmaceuticals || 23 || 3.2% || || Pharmaceuticals || 23 || 2.8%

Domestic and leisure equipment || 23 || 3.2% || || Domestic and leisure equipment || 47 || 5.8%

Mechanical engineering || 39 || 5.5% || || Mechanical engineering || 46 || 5.6%

Energy, ores, wood || 40 || 5.6% || || Energy, ores, wood || 35 || 4.3%

Environment, packaging || 62 || 8.8% || || Environment, packaging || 47 || 5.8%

Health, medical equipment || 9 || 1.3% || || Health, medical equipment || 5 || 0.6%

Transport || 114 || 16.1% || || Transport || 64 || 7.8%

Telecommunications || 70 || 9.9% || || Telecommunications || 86 || 10.5%

Miscellaneous products || 39 || 5.5% || || Miscellaneous products || 51 || 6.2%

Information Society services || 31 || 4.4% || || Information Society services || 53 || 6.5%

9.4 Commission reactions: comments and detailed opinions in 2009 and 2010 (Articles 8(2) and 9(2) of the Directive)

Table 7

Year || Comments || Detailed opinions

2009 || 154 || 57

2010 || 108 || 48

The number of detailed opinions issued by the Commission during the period in question decreased: 57 detailed opinions in 2009 on a total number of 708 notifications (8.05%) and in 2010, 48 detailed opinions on a total number of 817 notifications (5.87%).

The number of comments made by the Commission also decreased: from 154 in 2009 to 108 in 2010.

Figure 4

9.5 Commission reactions: blockages in 2009 and 2010 (Articles 9(3) and 9(4) of the Directive)

During the 2009-2010 period, the Commission requested a 12-month postponement of the adoption of 11 draft regulations notified by the Member States, because they concerned a subject on which Community harmonisation work had already been announced or was underway.

Table 8

Year || Standstills || Total

Announcement of a Community text (Article 9(3)) || Presentation to the Council of a Community text (Article 9(4))

2009 || 3 || 3 || 6

2010 || 2 || 3 || 5

9.6 Member States reactions

Table 9 – Comments and detailed opinions issued by the Member States in 2009 and 2010 (Articles 8(2) and 9(2))

|| 2009 || 2010

|| Com. || D.O. || Com. || D.O.

Austria || 10 || 1 || 4 || 1

Belgium || 3 || 3 || 8 || 3

Bulgaria || 1 || 0 || 1 || 0

Cyprus || 0 || 0 || 3 || 1

Czech Republic || 6 || 0 || 15 || 1

Denmark || 3 || 1 || 12 || 0

Estonia || 6 || 0 || 3 || 0

Finland || 9 || 1 || 6 || 1

France || 22 || 23 || 14 || 7

Germany || 12 || 8 || 10 || 8

Greece || 11 || 4 || 0 || 0

Hungary || 6 || 0 || 2 || 0

Ireland || 0 || 0 || 4 || 1

Italy || 24 || 18 || 14 || 14

Latvia || 8 || 1 || 10 || 3

Lithuania || 1 || 0 || 3 || 0

Luxembourg || 0 || 0 || 2 || 0

Malta || 1 || 4 || 2 || 0

Netherlands || 7 || 0 || 4 || 0

Poland || 4 || 3 || 15 || 2

Portugal || 5 || 0 || 2 || 0

Romania || 4 || 1 || 9 || 3

Slovakia || 8 || 4 || 1 || 0

Slovenia || 3 || 0 || 2 || 0

Spain || 16 || 1 || 13 || 2

Sweden || 4 || 0 || 10 || 1

United Kingdom || 9 || 1 || 2 || 8

Total || 183 || 74 || 171 || 56

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

Table 10 – Requests to apply the urgency procedure received in 2009 and 2010

YEAR || 2009 || 2010

COUNTRY || Requests || Favourable opinion || Requests || Favourable opinion

Austria || 2 || 2 || 2 || 2

Belgium || 1 || 0 || 2 || 2

Bulgaria || 0 || 0 || 0 || 0

Cyprus || 0 || 0 || 0 || 0

Czech Rep. || 0 || 0 || 0 || 0

Denmark || 0 || 0 || 1 || 1

Estonia || 0 || 0 || 0 || 0

Finland || 1 || 0 || 1 || 1

France || 0 || 0 || 4 || 2

Germany || 2 || 2 || 1 || 1

Greece || 0 || 0 || 0 || 0

Hungary || 0 || 0 || 0 || 0

Ireland || 0 || 0 || 2 || 2

Italy || 0 || 0 || 0 || 0

Latvia || 0 || 0 || 0 || 0

Lithuania || 1 || 0 || 0 || 0

Luxembourg || 0 || 0 || 0 || 0

Malta || 0 || 0 || 1 || 0

Netherlands || 0 || 0 || 0 || 0

Poland || 0 || 0 || 2 || 2

Portugal || 3 || 0 || 0 || 0

Romania || 2 || 0 || 4 || 2

Slovakia || 0 || 0 || 0 || 0

Slovenia || 0 || 0 || 0 || 0

Spain || 3 || 0 || 6 || 0

Sweden || 5 || 5 || 6 || 5

United Kingdom || 0 || 0 || 0 || 0

Total || 20 || 9 || 32 || 20

Table 10 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 (29 out of the 52 made during the entire 2009-2010 period).

Table 11 – Breakdown by sector of the requests to apply the urgency procedure in 2009 and 2010.

Table 11, which gives a sectoral breakdown of the requests to apply the urgency procedure received by the Commission during the 2009-2010 period, shows that the application of this exceptional procedure was invoked mainly in the pharmaceutical and cosmetics sector (15 requests) and in the goods and miscellaneous products sector (5).

9.8 Follow-up to Commission reactions

Table 12 shows that, in 2009, the recipient Member States responded to 51 of the 57 detailed opinions issued by the Commission (89.5%) and that 20 responses were deemed satisfactory by the Commission (39.2%). In 2010, they responded to 40 of the 48 detailed opinions (83.3%), 10 were satisfactory (25%).

Table 12*

Year || Detailed opinions || Responses from the Member States || Satisfactory || Closures

2009 || 57 || 51 || 20 || 4

2010 || 48 || 40 || 10 || 4

*Data at 04/06/2011

Table 13

Year || Observations COM || Responses from the Member States

2009 || 154 || 105

2010 || 108 || 67

Table 13 shows that, in 2009, the recipient Member States responded to 105 of the 154 observations issued by the Commission (68.2 %) and in 2010, they responded to 67 of the 108 (62 %).

Annex 10 Application of the procedure in 2009 and 2010: participation of EFTA countries signatory to the EEA Agreement, of Switzerland and of Turkey

Table 13 – Number of notifications from EFTA countries and comments issued to them by the European Union

|| 2009 || 2010

Notifications || Com. EU || Notifications || Com. EU

EFTA || Norway || 8 || 5 || 10 || 0

Liechtenstein || 6 || 4 || 8 || 0

Iceland || 1 || 1 || 1 || 0

Table 14 – Number of notifications submitted by Switzerland and Turkey and comments issued to them by the Commission or the Member States

|| 2009 || 2010

Notifications || Com. || Notifications || Com.

|| Switzerland || 9 || 1 || 5 || 0

|| Turkey || 3 || 2 || 2 || 2

Table 15 – Number of comments from EFTA, Switzerland and Turkey regarding the notifications from the Member States

|| 2009 || 2010

|| EFTA || 0 || 0

|| Switzerland || 0 || 0

|| Turkey || 0 || 0

Annex 11 – Internet consultations in 2009 and 2010

Figure 5

[1] Directive of 28 March 1983, OJ L 109/8 of 26.4.1983

[2] O L 204/37 of 21.7.1998.

[3] O L 217/18 of 5.8.1998.

[4] Annex II, Chapter XIX, point 1 to the EEA Agreement, which includes Article 8(2) of the Directive

[5] For 2009: OJ C 164/3 of 24.06.2010; for 2010: OJ C 147/07 of 18 May 2011