Changes from plenary report to adopted text

Recital 3: (3) In a number of specific cases, Regulation (EU) No 182/2011 provides for referral to the appeal committee. In practice, particularly in relation to genetically modified organisms, genetically modified food and feed and plant protection products, the appeal committee has been seized in cases where no qualified majority, either in favour or against, was attained within the committee in the context of the examination procedure and thus no opinion was delivered.

Recital 3 a (new): (3a) As a consequence, only a very limited number of cases have been referred to the appeal committee as provided for in Regulation (EU) No 182/2011 and are therefore concerned by this amending act.

Recital 4: (4) Experience has shown that, in the vast majority of cases, the appeal committee repeats the outcome of the examination committee and results in no opinion being delivered. The appeal committee has therefore not helped in providing clarity on Member State positions, or to overcome the absence of opinions in the examination procedure. Regulation (EU) No 182/2011 provides that the Commission may in such cases adopt the draft implementing act, leaving it to the Commission to determine on behalf of the Member States the need and how to ensure the effective implementation of the legislation.

Recital 5: deleted

Recital 6: (6) That discretion is, however, 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 obliged to adopt a decision within a reasonable time and cannot abstain from taking a decision. In this regard, the European Ombudsman pointed out in his decision on case 1582/2014 that the Commission must respect existing legal provisions regarding the deadlines set for the authorisation of genetically modified organisms.

Recital 7: (7) While the Commission has the competence to decide in such cases, due to the particular sensitivity of the issues at stake, Member States should also assume greater responsibility in the decision-making process. Where the basic act concerns the protection of the health or safety of humans, animals or plants, and Member States are not able to reach a qualified majority in favour of the draft implementing act providing for the grant of authorisation for a product or substance, that authorisation should be deemed to have been refused.

Recital 8: (8) In order to increase the added value of the appeal committee its role should therefore be strengthened by providing for the possibility of holding a further meeting of the appeal committee whenever no opinion is delivered. The appropriate level of representation at the further meeting of the appeal committee should be of a sufficiently high political level, such as ministerial level, to ensure a political discussion. To allow the organisation of such a further meeting the timeframe for the appeal committee to deliver an opinion should be extended. However, such extension should be for a short period only.

Recital 10: (10) The Commission should have the possibility, in specific cases, to ask the European Parliament and the Council to indicate their positions and orientation on the wider implications of the absence of an opinion, including the institutional, legal, economic, political and international implications. The Commission should take account of any position expressed by the European Parliament and by the Council within 3 months after the referral. In duly justified cases, for reasons of urgency, the Commission may indicate a shorter deadline in the referral. The positions expressed by the European Parliament and by the Council should also be sent to the European Economic and Social Committee, and to the European Parliament and to the Council as appropriate, without undue delay.

Recital 10 a (new): (10a) Where it appears that it would be difficult to obtain positive opinions from the Member States in relation to several similar draft implementing acts, consideration should be given to reviewing the implementing powers conferred on the Commission in the relevant basic acts.

Recital 11: (11) Transparency on the votes of Member State representatives throughout all stages of the advisory and examination procedures should be increased and the individual Member State representatives' votes should be made public. Where the act concerns particularly sensitive areas, such as the protection of consumers, the health or safety of humans, animals or plants, or the protection of the environment, case-specific detailed reasons for votes and abstentions should be given by each Member State representative. The Commission should also provide information on the composition of committees, including the persons present and the authorities and organisations to which those persons belong, as well as the agendas of the meetings and the documents and drafts of texts being discussed.

Recital 11 a (new): (11a) In order to enhance Union citizens’ awareness and understanding of the procedure and enhance the visibility thereof, reasons should be given by each Member State representative for his or her vote or abstention or for any absence of that representative.

Recital 11 b (new): (11b) The accessibility of the register should be further increased and changes to its content should be made in order to ensure that there is greater transparency concerning the decision-making process, in particular by adding more information as regards that process. Improving the search functions of the register to allow searches by policy area would be an essential element in that regard.

Regulation (EU) No 182/2011

Article 1 – paragraph 1 – point 1, Article 3 – paragraph 7 – subparagraph 6: "Where no opinion is delivered in the appeal committee pursuant to the second subparagraph of Article 6(3), the chair or a simple majority of the Member States may decide that the appeal committee shall hold a further meeting, at a sufficiently high political level, such as at ministerial level. In such cases the appeal committee shall deliver its opinion within 3 months of the initial date of referral.";

Regulation (EU) No 182/2011

Article 1 – paragraph 1 – point 2 – point b, Article 6 – paragraph 3a: "3a. Where no opinion is delivered in the appeal committee, the Commission may refer the matter to the European Parliament and to the Council for opinions indicating their positions and orientation on the wider implications of the absence of opinion, including the institutional, legal, economic, political and international implications of the outcome of the vote in the appeal committee. The Commission shall take account of any position expressed by the European Parliament and by the Council within 3 months after the referral. In duly justified cases, for reasons of urgency, the Commission may indicate a shorter deadline in the referral. The positions expressed by the European Parliament and by the Council shall also be sent to the European Economic and Social Committee, and to the European Parliament and to the Council as appropriate, without undue delay.";

Regulation (EU) No 182/2011

Article 1 – paragraph 1 – point 2 – point b a (new), Article 6 – paragraph 4 a (new): (ba) the following paragraph is inserted: / “4a. By way of derogation from paragraph 3, where the basic act concerns the protection of the health or safety of humans, animals or plants and the draft implementing act provides for the grant of authorisation for a product or substance, that authorisation shall only be granted if the vote in accordance with paragraph 1 results in a positive opinion. / The first subparagraph shall be without prejudice to the right of the Commission to propose a modified draft implementing act concerning the same subject matter.”;

Regulation (EU) No 182/2011

Article 1 – paragraph 1 – point 2 – point b b (new), Article 6 – paragraph 4 b (new): (bb) the following paragraph is inserted: / “4b. The Member State representatives shall provide reasons for their vote or abstention under paragraph 1 or for any absence from the vote. / Where the act concerns particularly sensitive areas, such as the protection of consumers, the health or safety of humans, animals or plants, or the environment, the Member State representatives shall provide case-specific detailed reasons for their vote or abstention.”;

Regulation (EU) No 182/2011

Article 1 – paragraph 1 – point 3 – point -a (new), Article 10 – paragraph 1 – point b: (-a) in paragraph 1, point (b) is replaced by the following: / “(b) the agendas of committee meetings, including drafts of the texts to be decided upon and documents to be discussed;”;

Regulation (EU) No 182/2011

Article 1 – paragraph 1 – point 3 – point -a a (new), Article 10 – paragraph 1 – point c: (-aa) in paragraph 1, point (c) is replaced by the following: / “(c) the summary records, together with the lists of the persons present at the meeting and the authorities and organisations to which those persons designated by the Member States to represent them belong;”;

Regulation (EU) No 182/2011

Article 1 – paragraph 1 – point 3 – point a, Article 10 – paragraph 1 – point e: "(e) the voting results, including the votes expressed by each Member State representative and any abstentions, accompanied by the reasons for the vote or abstention as well as reasons for absence from the vote, and, where the act concerns particularly sensitive areas, such as the protection of consumers, the health or safety of humans, animals or plants, or the environment, the accompanying case-specific detailed reasons for the vote or abstention;";

Regulation (EU) No 182/2011

Article 1 – paragraph 1 – point 3 – point a a (new), Article 10 – paragraph 3: (aa) paragraph 3 is replaced by the following: / “3. The European Parliament and the Council shall have access to the information referred to in paragraph 1 in accordance with applicable rules and without undue delay.”;

Regulation (EU) No 182/2011

Article 1 – paragraph 1 – point 3 – point b, Article 10 – paragraph 5: "5. All documents and information referred to in paragraph 1 shall be made public in the register."

Regulation (EU) No 182/2011

Article 1 – paragraph 1 – point 3 – point b a (new), Article 10 – paragraph 5 a (new): (ba) the following paragraph is added: / “5a. The search functions of the register shall enable searches to be made by policy area.”;

Regulation (EU) No 182/2011

Article 1 – paragraph 1 – point 3 a (new), Article 11: (3a) Article 11 is replaced by the following: / “Article 11 / Where a basic act is adopted under the ordinary legislative procedure, either the European Parliament or the Council may at any time indicate to the Commission that, in its view, a draft implementing act exceeds the implementing powers provided for in the basic act, or is in conflict with the objectives of the basic act. In such a case, the Commission shall review the draft implementing act, taking account of the positions expressed, and shall inform the European Parliament and the Council whether it intends to maintain, amend or withdraw the draft implementing act. / In addition, where either the European Parliament or the Council considers it to be appropriate to review the conferral of implementing powers on the Commission in the basic act, it may, at any time, call on the Commission to submit a proposal to amend that basic act.”

Article 2 – paragraph 1: This Regulation shall apply to procedures begun after the date of its entry into force.