Activities of Daniel BUDA related to 2017/0035(COD)
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) No 182/2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers
Amendments (15)
Amendment 14 #
Proposal for a regulation
Recital 2
Recital 2
(2) TWhile the system established by Regulation (EC) No 182/2011 has, overall, proven to work well in practice and struck an appropriate institutional balance as regards the roles of the Commission and the other actors involved. T, it has not effectively provided any concrete added value in the form of a better decision- making process, having encountered a number of regulatory hitches regarding the functioning of the appeal committee. The key components of that system should therefore continue to function unchanged except for certain necessary targeted amendments concerning specific aspects of procedure at the level of the appeal committee. These amendments are intended to ensure wider political accountability and ownership of politically sensitive implementing acts without, however, modifying the legal and institutional responsibilities for implementing acts as organised by Regulation (EU) No 182/2011.
Amendment 17 #
Proposal for a regulation
Recital 2
Recital 2
(2) The system established by Regulation (EC) No 182/2011 has, overall, proven to work well in practice and struck an appropriate institutional balance as regards the roles of the Commission and the other actors involved. T, although some minor hitches have been experienced in the workings of the appeal committee. It follows that the key components of that system should therefore continue to function unchanged except for certain targeted amendments concerning specific aspects of procedure at the level of the appeal committee. These amendments are intended to ensure wider political accountability and ownership of politically sensitive implementing acts as well as an evidence-based approach that does not undermine confidence in EU risk assessors or their scientific integrity, without, however, modifying the legal and institutional responsibilities for implementing acts as organised by Regulation (EU) No 182/2011.
Amendment 17 #
Proposal for a regulation
Recital 4
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 and so far has provided only limited added value, leaving the Commission to decide on behalf of the Member States in a 'no opinion' situation.
Amendment 19 #
Proposal for a regulation
Recital 5
Recital 5
(5) Regulation (EU) No 182/2011 provides that the Commission may in such cases adopt the draft implementing act, thus giving the Commission discretion regarding the need to ensure the effective implementation of the legislation.
Amendment 24 #
Proposal for a regulation
Recital 4
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, leaving it to the Commission’s discretion to decide on behalf of the Member States in a 'no opinion' situation.
Amendment 25 #
Proposal for a regulation
Recital 8
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 high- level meeting of the appeal committee whenever no opinion is delivered. The appropriate level of representation at the further meeting of the appeal committee should therefore be 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 albeit for a reasonable period only.
Amendment 26 #
Proposal for a regulation
Recital 5
Recital 5
(5) Regulation (EU) No 182/2011 provides that the Commission may in such cases adopt the draft implementing act, thus giving the Commission discretion when it comes to ensuring the effective implementation of the legislation.
Amendment 31 #
Proposal for a regulation
Recital 10
Recital 10
(10) The Commission should have the possibility, in specific cases, to ask the Council to indicate its views and orientation on the wider implications of the absence of an opinion, including the institutional, legal, political and international implications. The Commission should take account of any position expressed by the Council within 3 months after the initial referral. or, failing that no more than one month after the referral. In duly justified cases, the Commission may indicate a shorter deadline in the referral.
Amendment 32 #
Proposal for a regulation
Recital 7
Recital 7
(7) While the Commission is empowered to decide in such cases, due to the particular sensitivity of the issues at stake, Member States should also fully assume their responsibility in the decision- making process. This, however, is not the case when Member States are not able to reach a qualified majority, due to, amongst others, a significant number of abstentions or non-appearances at the moment of the vote.
Amendment 35 #
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) Risk assessors should take into account a socio-economic analysis of product authorisations, since any amendments proposed during the vote in the appeal committee can delay the decision-making process, especially in highly sensitive cases.
Amendment 44 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU) No 182/2011
Article 3 – paragraph 7 – subparagraph 6
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 ministerial level. In such cases the appeal committee shall deliver its opinion within no more than 3 months of the initial date of referral. ";
Amendment 51 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU) No 182/2011
Article 3 – paragraph 7
Article 3 – paragraph 7
"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 Member State representatives may decide that the appeal committee shall hold a further meeting, at ministerial level. In such cases the appeal committee shall deliver its opinion within no more than 3 months of the initial date of referral. "; (https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32011R0182&from=fr)Or. ro
Amendment 51 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Regulation (EU) No 182/2011
Article 6 – paragraph 3 a
Article 6 – paragraph 3 a
"3a. Where no opinion is delivered in the appeal committee, the Commission may refer the matter to the Council for an opinion indicating its views and orientation on the wider implications of the absence of opinion, including the institutional, legal, political and international implications. The Commission shall take account of any position expressed by the Council within 3 months after the initial referral or, where that is not possible, no more than one month after the referral. In duly justified cases, the Commission may indicate a shorter deadline in the referral.
Amendment 60 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point a
Article 1 – paragraph 1 – point 3 – point a
Regulation (EU) No 182/2011
Article 10 – paragraph 1 – point e
Article 10 – paragraph 1 – point e
Amendment 66 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point a
Article 1 – paragraph 1 – point 3 – point a
Regulation (EU) No 182/2011
Article 10 – paragraph 1 – point e
Article 10 – paragraph 1 – point e
(e) "(e) the voting results including, in the case of the appeal committee, the votes expressed by the representative of each Member State; (https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32011R0182&from=fr), explanations of vote, abstentions and absences; Or. ro