EUROPEAN COMMISSION Brussels, 17.7.2015 SWD(2015) 137 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 98/34/EC FROM 2011 TO 2013 {COM(2015) 338 final}



TABLE OF CONTENTS – ANNEXES Annex 1 – Procedures for standardisation 1.Information procedure 1.1.Role of ESOs 2.Mandates 2.1.The consultation process 2.2.Role of ESOs 3.Formal objections Annex 2 – Breakdown of new national standardisation activities from notifications

(CEN and CENELEC) in 2011 and 2012 by state Annex 3 – Sectoral breakdown of notifications Annex 4 – Mandates from 2006 to 2012 – total Annex 5 – Commission Decisions on formal objections in 2011 and 2012 Annex 6 – Brief description of the notification procedure Annex 7 – Developments in Court of Justice case-law on the matter 2011-2013 Annex 8 – Application of the procedure between 2011-2013: notifications of technical

regulations submitted by the member states 8.1Volume of notifications during the 2011-2013 period 8.2Breakdown by country 8.3Breakdown by sector 8.4Commission reactions: comments and detailed opinions in 2011, 2012 and 2013

(articles 8(2) and 9(2) of the directive)

8.5Commission reactions: blockages in 2011, 2012 and 2013 (articles 9(3) and 9(4)

of the directive) 8.6Member States reactions 8.7Urgency Procedure (Article 9(7) of the Directive) 8.8Follow-up to Commission reactions Annex 9 – Application of the procedure in 2011-2013: participation of efta countries

signatory to the eea agreement, of switzerland and of turkey Annex 10 – Internet consultations 2011-2013 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 1.2.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. 1.3.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 2011 and 2012 by state Country 2011 2012 Total AT 173 211 384 BE 10 7 17 BG 8 1 9 CH 28 17 45 CY 0 0 0 CZ 34 63 97 DE 343 353 696 DK 2 6 8 EE 15 14 29 ES 184 246 430 FI 16 7 23 FR 231 244 475 GR 0 1 1 HU 57 53 110 IE 8 20 28 IS 0 0 0 IT 99 93 192 LU 0 0 0 LT 30 7 37 LV 7 14 21 MT 0 4 4 NL 35 135 170 NO 18 12 30 PL 21 62 83 PT 0 0 0 RO 25 65 90 SE 22 27 49 SI 2 4 6 SK 23 25 48 UK 131 103 234 Country 2011 2012 Total CEN 1458 1693 3151 CENELEC 64 101 165 EU-15 1476 1765 3241 EFTA 46 29 75 TOTAL 1522 1794 3316 Annex 3 – Sectoral breakdown of notifications 2011 2012 CEN (Subsectors with more than 50 Notifications) Food products 122 Food products 150 Building and construction – Structures 96 Petroleum products 101 Building and construction – Undetermined 67 Building and construction – Structures 93 Petroleum products 59 Fire protection 79 Services - Undetermined 52 Building and construction – Undetermined 73 Mechanical Engineering - Fasteners 51 Shipbuilding and maritime structures 53

2011 2012 CENELEC (Subsectors with more than 5 Notifications) Electrical accessories 16 Telephony, telegraphy for IT 16 Electric cables 9 Electric rotating machines 13 Electrical installations in buildings 7 Electric cables 11 Undetermined 6 Electrical installations in buildings 9 Electrical accessories 6 Undetermined 5



Annex 4 – Mandates from 2006 to 2012 – total Type 2006 2007 2008 2009 2010 2011 2012 After formal objection (New Approach) 4 2 0 0 0 0 1 Amendments (New Approach) 4 0 1 4 0 0 8 New Approach mandates 5 7 2 5 4 5 8 Mandates under other legislation 7 5 9 10 12 9 7 Mandates under Community policy 4 6 6 2 4 5 0 Total 24 20 18 21 20 19 24

Annex 5 – Commission Decisions on formal objections in 2011 and 2012 Standard Directive Decision Date Decision Decision number O.J. Reference decision publication Date of reception Days to close the case (aprox) 1 EN 15947, Pyrotechnic articles - Fireworks, Categories 1, 2 and 3 2007/23/EC Publication of the reference in the OJ with a restriction 28/07/2011 C(2011)5310 L197/23 29.07.2011 20/09/2010 300 2 EN 15947, Pyrotechnic articles - Fireworks, Categories 1, 2 and 3 2007/23/EC Publication of the reference in the OJ with a restriction 28/07/2011 C(2011)5310 L197/23 29.07.2011 27/09/2010 300 Annex 6 – 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, 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, which in turn was amended by Directive 98/48/EC 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: 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 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 7 – Developments in Court of Justice case-law on the matter 2011-2013 During the reporting period the European Court of Justice (ECJ) delivered two important judgements concerning Directive 98/34/EC. The first judgment was rendered on 14 April 2011 in case C-42/10, Vlaamse Dierenartsenvereniging and Janssens. According to the judgement, national provisions concerning the pet passport and its use as proof of identification and registration as well as the use of self-adhesive stickers to amend the identity details of the owner and the animal, on the one hand, and those relating to the determination of a unique number for pets, on the other, do not constitute technical regulations in the meaning of Directive 98/34/EC. The second judgment was rendered on 19 July 2012 in case C-213/11, Fortuna and Others. In this case the ECJ decided that national provisions, which could have the effect of limiting, or even gradually rendering impossible, the running of gaming on low-prize machines anywhere other than in casinos and gaming arcades are capable of constituting ‘technical regulations’ in so far as it is established that those provisions constitute conditions which can significantly influence the nature or the marketing of the product concerned. It should be pointed out that, like the other Court judgments on the notification procedure, these judgments can be consulted on the following website: http://curia.europa.eu/jcms/jcms/Jo1_6308/). Annex 8 – Application of the procedure between 2011-2013: notifications of technical regulations submitted by the member states Annexes 8.1, 8.2 and 8.3 give a statistical overview of the development of the number of draft technical regulations notified by the Member States between 2011 and 2013, 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 .

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 8.4 to 8.6. Annex 8.7 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 8.8 shows the action taken by the Member States in response to the Commission’s reactions. 8.1Volume of notifications during the 2011-2013 period The statistics in Figure 1 show that the Member States notified 675 draft regulations in 2011, 734 draft regulations in 2012 and 705 draft regulations in 2013 to the Commission. 8.2Breakdown by country During the 2011-2013 period, three Member States which notified the highest number of draft technical regulations were Austria (187), Germany (180) and France (169). A group of five other countries (Denmark, Italy, Netherlands, Sweden, Spain and United Kingdom) come next with a total number of notifications of between 103 and 143.



Member States 2011 2012 2013 Austria 65 59 63 Belgium 19 25 27 Bulgaria 11 12 16 Croatia 0 0 1 Cyprus 1 26 2 Czech Republic 22 29 30 Denmark 38 39 34 Estonia 9 16 12 Finland 23 23 29 France 63 57 49 Germany 62 57 61 Greece 13 15 12 Hungary 28 27 38 Ireland 10 6 8 Italy 29 48 34 Latvia 6 3 5 Lithuania 5 9 17 Luxembourg 4 4 16 Malta 5 2 2 Netherlands 41 43 41 Poland 27 37 27 Portugal 5 5 5 Romania 22 41 12 Slovakia 35 28 33 Slovenia 10 8 9 Spain 39 27 47 Sweden 30 40 33 United Kingdom 53 48 42 Total 675 734 705 Table 1 – Number of notifications of technical regulations submitted by the Member States in 2011, 2012 and 2013

Member States 2011 (%) 2012 (%) 2013 (%) Austria 9.6% 8.0% 8.9% Belgium 2.8% 3.4% 3.8% Bulgaria 1.6% 1.6% 2.3% Croatia 0.0% 0.0% 0.1% Cyprus 0.1% 3.5% 0.3% Czech Republic 3.3% 4.0% 4.3% Denmark 5.6% 5.3% 4.8% Estonia 1.3% 2.2% 1.7% Finland 3.4% 3.1% 4.1% France 9.3% 7.8% 7.0% Germany 9.2% 7.8% 8.7% Greece 1.9% 2.0% 1.7% Hungary 4.1% 3.7% 5.4% Ireland 1.5% 0.8% 1.1% Italy 4.3% 6.5% 4.8% Latvia 0.9% 0.4% 0.7% Lithuania 0.7% 1.2% 2.4% Luxembourg 0.6% 0.5% 2.3% Malta 0.7% 0.3% 0.3% Netherlands 6.1% 5.9% 5.8% Poland 4.0% 5.0% 3.8% Portugal 0.7% 0.7% 0.7% Romania 3.3% 5.6% 1.7% Slovakia 5.2% 3.8% 4.7% Slovenia 1.5% 1.1% 1.3% Spain 5.8% 3.7% 6.7% Sweden 4.4% 5.4% 4.7% United Kingdom 7.9% 6.5% 6.0% Table 2 – Percentage of notifications submitted by the Member States in 2011, 2012 and 2013 8.3Breakdown by sector Table 3: Breakdown by sector of the drafts notified by the Member States of the European Union in 2011 M Figure 3: Percentage of the sectors of the drafts notified by the Member States of the European Union in 2011 Sectors 2011 Construction 166 Agriculture, Fishing and Foodstuffs 113 Transport 66 Telecoms 58 Environment 42 Mechanics 41 Goods and Miscellaneous Products 40 Energy, Minerals, Wood 33 98/48/EC Services 32 Domestic and Leisure Equipment 32 Chemicals 28 Pharmaceuticals and Cosmetics 15 Health, Medical Equipment 9 Total 675 Table 4: Breakdown by sector of the drafts notified by the Member States of the European Union in 2012 sector of the e M Figure 4: Percentage of the sectors of the drafts notified by the Member States of the European Union in 2012 Table 5: Breakdown by sector of the drafts notified by the Member States of the European Union in 2013 Tab3: Breakdown by sector of the drafts notified by the M Figure 5: Percentage of the sectors of the drafts notified by the Member States of the European Union in 2013 8.4Commission reactions: comments and detailed opinions in 2011, 2012 and 2013 (articles 8(2) and 9(2) of the directive)

The number of comments made by the Commission increased from 130 in 2011 to 145 in 2012 and to 150 in 2013. The number of detailed opinions issued by the Commission during the period in question increased between 2011 and 2012: 51 detailed opinions in 2011 on the total number of 675 notifications (7.5%) and in 2012, 64 detailed opinions on the total number of 734 notifications (8.7%). The percentage of detailed opinions increased to the level of 13.1% in 2013 (93 detailed opinions were issued by the Commission on the total number of 705 notifications).

8.5Commission reactions: blockages in 2011, 2012 and 2013 (articles 9(3) and 9(4) of the directive) During the 2011-2013 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 6 Year Standstills (Blockages) Total Announcement of a Community text (Article 9(3)) Presentation to the Council of a Community text (Article 9(4)) 2011 2 1 3 2012 2 2 4 2013 4 1 5

8.6Member States reactions Table 7 - Comments and detailed opinions issued by the Member States 2011, 2012 and 2013 (Articles 8(2) and 9(2)) 2011 2012 2013 Comments Detailed Opinions Comments Detailed Opinions Comments Detailed Opinions Austria 6 5 7 9 5 11 Belgium 1 0 2 2 0 1 Bulgaria 0 0 2 1 0 0 Croatia 0 0 0 0 6 0 Cyprus 0 0 0 0 0 0 Czech Republic 7 1 23 6 6 6 Denmark 2 0 1 1 2 0 Estonia 0 0 0 0 0 0 Finland 4 0 3 1 2 0 France 12 7 17 11 15 5 Germany 34 1 57 4 27 2 Greece 0 3 0 2 1 0 Hungary 1 1 7 1 0 1 Ireland 0 1 1 1 2 0 Italy 16 5 23 10 14 9 Latvia 0 0 0 0 0 0 Lithuania 2 0 0 0 0 1 Luxembourg 0 0 0 1 0 0 Malta 3 10 1 5 2 6 Netherlands 4 4 3 2 1 8 Poland 4 0 6 1 10 1 Portugal 3 4 4 2 1 1 Romania 4 0 5 2 7 1 Slovakia 15 1 11 2 3 6 Slovenia 5 0 9 0 3 0 Spain 11 3 22 16 13 9 Sweden 1 0 1 0 2 0 UK 11 2 4 5 8 4 Total 146 48 209 85 130 72 8.7Urgency Procedure (Article 9(7) of the Directive) Table 8 - Requests to apply the urgency procedure received in 2011, 2012 and 2013 2011 2012 2013 Requests Favourable

opinion Requests Favourable

opinion Requests Favourable

opinion Austria 4 4 0 0 0 0 Belgium 0 0 3 0 1 0 Bulgaria 0 0 1 0 0 0 Croatia 0 0 0 0 0 0 Cyprus 0 0 0 0 0 0 Czech R. 1 0 2 2 8 2 Denmark 1 1 0 0 0 0 Estonia 0 0 1 1 1 1 Finland 1 1 7 6 1 1 France 1 0 1 1 1 1 Germany 0 0 1 1 1 1 Greece 1 0 5 2 0 0 Hungary 3 1 2 2 2 2 Ireland 1 1 0 0 0 0 Italy 1 1 0 0 0 0 Latvia 0 0 0 0 1 0 Lithuania 0 0 0 0 0 0 Luxembourg 0 0 0 0 0 0 Malta 0 0 0 0 0 0 Netherlands 2 2 2 0 2 1 Poland 2 2 1 0 0 0 Portugal 0 0 1 0 1 1 Romania 1 1 0 0 2 1 Slovakia 2 0 0 0 0 0 Slovenia 0 0 0 0 0 0 Spain 2 1 0 0 1 0 Sweden 3 3 8 8 4 4 UK 0 0 0 0 0 0 Total 26 18 35 23 26 15

Table 8 provides an overview of the number of requests to apply the emergency 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 2011, 2012 and 2013 AT BE BG CZ DK EE FI FR DE EL HU IE IT LV NL PL PT RO SK ES SE 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 R F 98/48/EC Services 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 0 0 Agr. Fishing and Foodstuffs 0 0 0 0 1 0 4 3 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 1 0 4 2 0 0 0 0 0 0 0 0 1 0 0 0 Chemical 3 3 3 0 0 0 3 0 1 1 1 1 1 1 0 0 0 0 0 0 1 1 1 1 0 0 0 0 1 0 0 0 0 0 2 2 0 0 0 0 6 6 Construction 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 0 0 1 1 0 0 0 0 0 0 2 0 0 0 0 0 Domestic and Leisure Equip. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 Energy, Min, Wood 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 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 0 0 0 0 0 0 0 0 1 0 0 0 0 0 3 3 Goods & Misc. Products 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 0 0 2 2 0 0 0 0 1 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 Health, Medi. Equipment 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 0 0 Mechanics 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 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Pharmac. and Cosmetics 1 1 0 0 0 0 3 1 0 0 1 1 8 7 0 0 2 2 0 0 4 4 0 0 0 0 0 0 0 0 2 2 1 1 0 0 0 0 1 1 6 6 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 0 0 0 0 Transport 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Total 4 4 4 0 1 0 11 4 1 1 2 2 9 8 3 2 2 2 6 2 7 5 1 1 1 1 1 0 6 3 3 2 2 1 3 2 2 0 3 1 15 15 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 2011-2013 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). 8.8Follow-up to Commission reactions Table 10 shows that, in 2011, the recipient Member States responded to 47 of the 51 detailed opinions issued by the Commission (92,1%) and that 23 responses were deemed satisfactory by the Commission (46%). In 2012, they responded to 59 of the 64 detailed opinions (92.1%); 27 were satisfactory (45.7%). In 2013, they responded to 73 of the 93 detailed opinions (75.2); 39 were satisfactory (53,4 %). Table 10 Year Detailed Opinions Responses from the MS Satisfactory Closures 2011 51 47 23 9 2012 64 59 27 6 2013 93 73 39 7

Table 11 Year Comments Responses from MS 2011 130 83 2012 145 93 2013 150 79 Table 11 shows that, in 2011, the recipient Member States responded to 83 of the 130 comments issued by the Commission (63,8 %) and in 2012, they responded to 93 of the 145 (64.1 %). In 2013 they responded to 79 of the 150 (52.6 %). Annex 9 – Application of the procedure in 2011-2013: 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 2011 2012 2013 Notifications Comments Notifications Comments Notifications Comments EFTA Iceland 6 4 4 1 3 1 Liechtenstein 1 0 2 2 0 0 Norway 6 6 4 0 13 5