EUROPEAN COMMISSION 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, 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 In 1998, Directive 83/189/EEC was repealed and codified by Directive 98/34/EC, which in turn was amended by Directive 98/48/EC in order to extend the notification procedure to Information Society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. In 2015, Directive 98/48/EC was repealed and replaced by Directive (EU) 2015/1535 with the aim of codifying it after the adoption of Regulation (EU) No 1025/2012. 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: 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 . 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. 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