EUROPEAN COMMISSION Brussels, 26.2.2016 COM(2016) 92 final REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL ON THE IMPLEMENTATION OF REGULATION (EU) 182/2011



Report FROM THE COMMISSION to the European Parliament and the Council on the implementation of Regulation (EU) 182/2011 1.Introduction The Lisbon Treaty substantially modified the framework for the conferral of powers upon the Commission by introducing a distinction between delegated and implementing powers. Article 291 (3) TFEU foresees that, unlike for delegated acts under Article 290 TFEU, the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of power be laid down in advance in regulations adopted by ordinary legislative procedure. This has led to the adoption of Regulation (EU) 182/2011. Article 15 of Regulation (EU) 182/2011 requires the Commission to report to the European Parliament and the Council on the implementation of the Regulation five years after its entry into force. This report complies with this requirement. In doing so, it concentrates on the elements newly introduced by Regulation (EU) 182/2011 compared to the Council Decision 1999/468/EC, as amended by Council Decision 2006/512/EC, which provided the applicable framework before Regulation (EU) 182/2011. 2. Overall context and functioning of Regulation (EU) 182/2011 Regulation (EU) 182/2011 entered into force on 1 March 2011. It did not require any measures to be taken by the Member States. On the Commission side, the standard rules of procedure for committees referred to in Article 9 of Regulation (EU) 182/2011 were adopted on 8 July 2011 and published in the Official Journal on 12 July 2011 . The rules of procedure of the individual, existing committees were over time adapted to the new standard rules of procedure. The register foreseen in Article 10 of the Regulation already existed since 2002, was thoroughly revamped in 2008 and in 2011 and is being continuously improved. The transitional provisions in Article 13, which provided for an automatic application of the new procedures to existing legislation, and in Article 14, which addressed pending procedures, allowed for an immediate application of Regulation (EU) 182/2011 as from 1 March 2011 and hence a smooth transition. The Commission reports to the European Parliament and the Council in its annual reports on the working of the committees. The table below gives an overall summary of data on the working of the committees since the entry into force of Regulation (EU) 182/2011 and the two preceding years. The annual reports also cover data on the regulatory procedure with scrutiny (RPS), a procedure foreseen under Decision 1999/468/EC, which still applies where foreseen in the basic act. Committees Opinions Measures adopted Positive opinions No opinions Negative opinions 2009 266 2 091 1 808 (131 RPS) 2 003 78 10 2010 259 1 904 1 812 (164 RPS) 1 783 121 0 2011* 268 1 868 1 788 (163 RPS) 1 789 75 4 2012 270 1 923 1 824 (167 RPS) 1 845 78 0 2013 302 1 916 1 887 (171 RPS) 1 845 50 0 2014 287 1 889 1 728 (165 RPS) 1 838 51 0 Table 1, data from the annual reports on the functioning of the committees, the total number of positive opinions delivered by committees may differ from the number of acts adopted by the Commission if opinions are delivered one year but the acts are not adopted until the following year. * Figures relate to the entire year 2011 Overall the figures indicate that the Regulation has allowed a seamless continuation of the system. When comparing the figures since 2011 to the years before the application of Regulation (EU) 182/2011, both the number of committees and their activity has remained stable. The number of committees was at 266 in 2009 and at 287 in 2014. Similarly the number of measures adopted was at 1808 in 2009 and at 1728 in 2014. Building on experience, the Regulation introduced in its Article 3 a number of provisions linked to the working of the committees that reflected common practice, but were not spelled out in the legislation before. This includes provisions on the use of the written procedure, an explicit requirement for the chair to find solutions that command the widest possible support within the committee and the possibility to amend the draft acts prior to the vote to take account of the discussions of the committee. These common provisions continued to be effective and useful in ensuring a proper functioning of the committees. The written procedure is widely used - in 2014 there were 773 committee meetings and 893 written procedures and figures are similar in the years before - and it is an efficient tool. The work of the committees remains consensual: the overwhelming percentage of opinions (well over 90%) are positive opinions, the majority of these adopted by unanimous vote or by consensus of the committee members, and there are hardly any negative and relatively few no opinions. Regulation (EU) 182/2011 provides a comprehensive and exhaustive legal framework for the Commission's exercise of implementing powers. The outcome of the negotiations on the Interinstitutional Agreement on Better Law-Making foresees a commitment by the institutions to refrain from adding, in Union legislation, procedural requirements which would alter the mechanisms for control established by Regulation (EU) 182/2011. In the framework of the Communication on Better Regulation the Commission committed to several measures intended to improve the mechanisms to listen more closely to citizens and stakeholders, and be open to their feedback, at every stage of the policy making process. In relation to implementing acts the Commission committed that important implementing acts which are subject to committee opinion will be made public for four weeks, allowing stakeholders to submit comments before any vote by Member States in the relevant committee. This will significantly increase the transparency for implementing acts in the phase before the committee vote. 3. Main changes 3.1 The reduction of the number of committee procedures One of the objectives of Regulation (EU) 182/2011 was to simplify the system by reducing the number of committee procedures. The old regulatory and management procedures were replaced by the examination procedure, while the advisory procedure was maintained. The reduction of the number of procedures has not raised particular issues.

3.2 The creation of the appeal committee The appeal committee was a novelty introduced by Regulation (EU) 182/2011. It was introduced to create a second layer to address issues on which the committee could not find agreement. Referral to the appeal committee is a rather exceptional step in the procedure. It is a possibility to move ahead in case of a negative opinion or a no opinion with a blocking effect if the implementing act is deemed necessary. The appeal committee adopted its rules of procedure on 29 March 2011. The Commission already made in accordance with Article 14 of the rules of procedure (the review clause) a first evaluation how these rules of procedure operate in practice. The outcome of this review was included in the 2013 Annual Report on the working of the committees. Overall number of Appeal Committees referrals DGs/policy areas concerned Appeal committee positive Appeal committee negative Appeal committee no opinion Measures adopted in case of no opinion 2011 8 Plant protection products, medicinal products 2 1 5 5 2012 6 Genetically modified food and feed 0 0 6 6 2013 9 Genetically modified food and feed, plant protection products, biocidal products, community customs code 0 0 9 8 2014 13 Genetically modified food and feed, rules and standards on ship inspections 2 0 11 11 Total 36 4 1 31 30 Table 2, data from the Comitology Register and the annual reports So far the appeal committee has mainly been convened in relation to one policy area, namely health and consumer protection, and more specifically in relation to genetically modified food and feed and plant protection products. In these cases the appeal committee has so far confirmed the no opinion outcome of the committee. The Commission Communication 'Reviewing the decision-making process on genetically modified organisms (GMOs) ' provides a detailed analysis of the decision-making process in the area of genetically modified food and feed. Overall the referral to the appeal committee has taken place with a comparable frequency to the earlier referrals to the Council, which are no longer permitted under the new institutional framework. Those referrals occurred in similar policy areas and with similar outcomes. On the practical side, experience shows that Member States were so far in nearly all cases represented by members of the Permanent Representation. 3.3 The flexibility for the Commission to adopt in case of a no opinion (examination procedure) Regulation (EU) 182/2011 introduced more flexibility for the Commission in case there is no qualified majority in favour or against the draft (referred to as a no opinion) in the committee in the examination procedure. Previously, both the management and the regulatory procedure foresaw that in case of a no opinion in the committee, respectively if the Council did not act, the Commission 'shall' adopt the measure. Regulation (EU) 182/2011 provides that the Commission 'may' adopt, either in case of a no opinion in the committee, or in the appeal committee. Increased flexibility was introduced to enable the Commission to reconsider draft measures and to be in a position to decide whether or not to adopt the draft measures or to present an amended draft to the committee, taking account inter alia of positions expressed within the committee. This increased flexibility is subject to a number of exceptions listed in Article 5(4) of Regulation (EU) 182/2011, i.e. in certain policy areas (taxation, financial services, the protection of the health or safety of humans, animals or plants, or definitive multilateral safeguard measures), if the basic act provides that the draft implementing act may not be adopted where no opinion is delivered (no opinion clause) or if a simple majority of the component members of the committee opposes it. In these cases the Commission is prevented from adopting the draft. If the act is nevertheless deemed necessary the chair can submit an amended version of the implementing act to the committee or refer it to the appeal committee. The inclusion of a no opinion clause in the basic act must respond to a specific need and must be justified by the legislator. Since the entry into force of Regulation (EU) 182/2011 the Commission has made statements in that sense in about 30 cases in response to the legislator which had introduced such clauses in basic legal acts without providing justifications for doing so. The majority of actual no opinion votes have so far, however, taken place in areas that are either already covered by the specific policy areas listed in Article 5(4), and where the Commission cannot adopt without going to the appeal committee, or in areas (notably customs, agriculture, development cooperation and trade) in which none of the three exceptions apply and the Commission could adopt the act anyhow without having to seize the appeal committee. No opinions in examination procedure Commission adopted measure Commission did not adopt measure 2011 67 63 4 2012 73 70 3 2013 49 47 2 2014 45 42 3 Total 234 222 12 Table 3, data extracted from the Comitology Register (excluding the appeal committee), data may differ from that in the annual report The data above shows that the Commission does not frequently use the possibility to not adopt the act in case of no opinion. In practice the Commission's flexibility is significantly reduced in cases relating to the authorisation of products or substances, such as in the area of genetically modified food and feed, as the Commission is required to adopt a decision (authorising or prohibiting the placing on the market) within a reasonable amount of time. It cannot abstain from taking a position. In these cases the Commission is also prevented from adopting the draft act in case of no opinion of the committee, to do so it must first refer the draft act to the appeal committee. This also partially explains why the appeal committee was so far mainly convened in this policy area. To address the particular situation in the field of genetically modified food and feed, and following the solution found for cultivation authorisations, the Commission adopted in April 2015 a proposal to amend the legislative framework. While the authorisation process is maintained, the proposal foresees that Member States may restrict or prohibit the use of genetically modified food or feed on their territory. The use of this possibility has to be based on grounds other than those related to risks to human and animal health and to the environment, which are addressed at EU level. The newly granted flexibility for the Commission to decide whether to adopt a draft implementing act in the case of no opinion is useful. Even though used so far in few cases, it allowed the Commission to reassess the draft measure after the voting results and the discussion in the committee had shown that it did not enjoy the widest possible support within the committee. 3.4 The criteria for the choice between the procedures Regulation (EU) 182/2011 sets out the criteria for the choice of procedures. Article 2(2) establishes a number of cases in which the examination procedure is generally assumed to apply. The advisory procedure applies in principle to all cases to which the examination procedure does not apply. The criteria for the choice of the examination procedure are similar to those provided for in the 1999 Comitology Decision. Overall, the choice of procedure appears to have been uncontroversial. One notable exception is the case of the conciliation committee discussing mainly about the choice of procedure (relating to Macro-financial assistance to Georgia). Acts adopted under examination procedure Acts adopted under the advisory procedure 2011 1 311 77 2012 1 591 121 2013 1 579 143 2014 1 437 122 Table 4, data extracted from the Comitology Register, data may differ from that in the annual report The examination procedure is clearly the procedure applicable in the majority of cases, only about 10% of the opinions are adopted by advisory procedure. This reflects largely the split of management/regulatory versus advisory procedure under the previous regime. 3.5 The scrutiny right for the European Parliament and the Council in case of basic acts adopted under the ordinary legislative procedure