BETA

Activities of Gesine MEISSNER related to 2017/0353(COD)

Shadow opinions (1)

OPINION on the proposal for a regulation of the European Parliament and of the Council laying down rules and procedures for compliance with and enforcement of Union harmonisation legislation on products and amending Regulations (EU) No 305/2011, (EU) No 528/2012, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 and (EU) 2017/1369 of the European Parliament and of the Council, and Directives 2004/42/EC, 2009/48/EC, 2010/35/EU, 2013/29/EU, 2013/53/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU and 2014/90/EU of the European Parliament and of the Council
2016/11/22
Committee: ENVI
Dossiers: 2017/0353(COD)
Documents: PDF(280 KB) DOC(187 KB)

Amendments (9)

Amendment 62 #
Proposal for a regulation
Article 2 – paragraph 1
1. This Regulation applies to all products that are subject: (a) from 1 January 2021 to 31 December 2024, to products subject to legislation requiring a declaration of conformity and which have been aligned with Decision 768/2008; (b) from 1 January2025, to other products covered by Union harmonisation legislation as set out in the Annex to this Regulation (‘Union harmonisation legislation’)delegated acts pursuant to this Regulation. No later than 1 January 2023, the Commission shall review the scope of this Regulation and shall present a report thereon to the European Parliament and to the Council. That report shall be accompanied by a legislative proposal pursuant to point (b), if appropriate.
2018/05/25
Committee: ENVI
Amendment 70 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7 a (new)
(7 a) ‘formal non-compliance’ means any administrative non-compliance that does not lead to a breach of the essential requirements, including but not limited to the non-compliances as defined in Article R34 of the reference provisions in Decision No 768/2008/EC the European Parliament and of the Council1a; _________________ 1aDecision No 768/2008/EC of the European Parliament and of the Council on a common framework for the marketing of products and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
2018/05/25
Committee: ENVI
Amendment 99 #
Proposal for a regulation
Article 5 – paragraph 1
Where Union harmonisation legislation provides for the drawing up of an EU declaration of conformity, manufacturers shall make the declaration publicly available on their website or, in the absence of a website, by any other means that allows the declaration to be readily accessed by the general public in the Unionavailable free of charge.
2018/05/25
Committee: ENVI
Amendment 108 #
Proposal for a regulation
Article 8 – paragraph 3
3. Any exchange of information between market surveillance authorities, the Commission, or the EU Product Compliance Board and businesses or organisations referred to in paragraph 1 for the purposes of preparing or implementing a memorandum of understanding entered into by them under that paragraph shall be deemed not to infringe the requirements of professiontreated in accordance with the requirements of professional secrecy. Any further use of that information shall be subject to the strictest guarantees of confidentiality and of professional and commercial secrecy.
2018/05/25
Committee: ENVI
Amendment 142 #
Proposal for a regulation
Article 14 – paragraph 3 – point i
(i) the power to start investigations or proceedings on their own initiative in order to bring an instance of non-compliance within the territory of the Member State concerned to an end and, where appropriate, to publish information about the investigation through the system referred to in Article 34, subject to the strictest guarantees of confidentiality and of professional and commercial secrecy;
2018/05/25
Committee: ENVI
Amendment 146 #
Proposal for a regulation
Article 14 – paragraph 3 – point n
(n) the power to publish any final decisions, final measures, commitments given by the economic operator or decisions taken or made pursuant to this Regulation, including the publication of the identity of the economic operator who was responsible for the non-compliance, subject to the strictest guarantees of confidentiality and of professional and commercial secrecy.
2018/05/25
Committee: ENVI
Amendment 147 #
Proposal for a regulation
Article 14 – paragraph 4
4. Market surveillance authorities shall publish any commitments given to them by economic operators, details of any corrective action taken by economic operators in their territory, and details of any temporary measures taken by the relevant market surveillance authority pursuant to this Regulation, subject to the strictest guarantees of confidentiality and of professional and commercial secrecy.
2018/05/25
Committee: ENVI
Amendment 152 #
Proposal for a regulation
Article 16 – paragraph 1
Market surveillance authorities shall observe the principle of confidentiality where necessary in order to protectensure the strictest guarantees of confidentiality and of professional and commercial secrets or tocy and shall preserve personal data pursuant to national legislation, subject to the requirement that information be made public to the fullest extent possible in order to protect the interests of end-users in the Union.
2018/05/25
Committee: ENVI
Amendment 172 #
Proposal for a regulation
Article 35 – paragraph 1
1. The Commission may exchange confidential market surveillance related information with regulatory authorities of third countries or international organisations where it has concluded confidentiality arrangements based on reciprocity with those authorities or organisations, subject to the strictest guarantees of confidentiality and of professional and commercial secrecy.
2018/05/25
Committee: ENVI