14 Amendments of Beatrice TIMGREN related to 2023/0454(COD)
Amendment 3 #
Proposal for a directive
Recital 1
Recital 1
(1) The Commission has, in its Communication ‘European Green Deal’2 , set an objective that chemical safety assessments should move towards a process of ‘one-substance, one- assessment’, calling for more transparent and simpler risk assessment processes in order to reduce the burden on all stakeholders, accelerate decision-making, as well as to increase consistency and predictability of scientific decisions and opinions. The Commission, in its Communication on Chemicals Strategy for Sustainability3 concludes that, in order to achieve that objective, part of the scientific and technical work on chemicals performed at Union level in support of Union legislation needs to be reattributed to the most suitable Union agencies. This would simplify the current set-up, improve quality and coherence of safety assessments across Union legislation, and ensure more efficient use of existing resources. This approach is also expected to promote cost-effectiveness and competitiveness by simplifying regulatory procedures and reducing administrative burdens, ensuring that businesses can adapt efficiently to evolving regulatory frameworks. _________________ 2 Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal (COM (2019) 640 final of 11 December 2019). 3 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Chemicals Strategy for Sustainability Towards a Toxic-Free Environment (COM (2020) 667 final of 14 October 2020).
Amendment 3 #
Proposal for a directive
Recital 1
Recital 1
(1) The Commission has, in its Communication ‘European Green Deal’2 , set an objective that chemical safety assessments should move towards a process of ‘one-substance, one- assessment’, calling for more transparent and simpler risk assessment processes in order to reduce the burden on all stakeholders, accelerate decision-making, as well as to increase consistency and predictability of scientific decisions and opinions. The Commission, in its Communication on Chemicals Strategy for Sustainability3 concludes that, in order to achieve that objective, part of the scientific and technical work on chemicals performed at Union level in support of Union legislation needs to be reattributed to the most suitable Union agencies. This would simplify the current set-up, improve quality and coherence of safety assessments across Union legislation, and ensure more efficient use of existing resources. This approach is also expected to promote cost-effectiveness and competitiveness by simplifying regulatory procedures and reducing administrative burdens, ensuring that businesses can adapt efficiently to evolving regulatory frameworks. _________________ 2 Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal (COM (2019) 640 final of 11 December 2019). 3 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Chemicals Strategy for Sustainability Towards a Toxic-Free Environment (COM (2020) 667 final of 14 October 2020).
Amendment 4 #
Proposal for a directive
Recital 2
Recital 2
(2) The reattribution of certain scientific and technical tasks to the European Chemicals Agency is necessary in order to align processes and levels of scientific scrutiny and digitalisation with current standards and processes of the European Chemicals Agency. This is also necessary in order to ensure a consistent standard of scientific quality, transparency, data searchability and interoperability, in line with the ‘one-substance, one- assessment’ ambition. Moreover, digitalization and streamlined processes will reduce duplicative efforts and administrative delays, providing significant cost savings and efficiency gains for both Member States and economic operators.
Amendment 4 #
Proposal for a directive
Recital 2
Recital 2
(2) The reattribution of certain scientific and technical tasks to the European Chemicals Agency is necessary in order to align processes and levels of scientific scrutiny and digitalisation with current standards and processes of the European Chemicals Agency. This is also necessary in order to ensure a consistent standard of scientific quality, transparency, data searchability and interoperability, in line with the ‘one-substance, one- assessment’ ambition. Moreover, digitalization and streamlined processes will reduce duplicative efforts and administrative delays, providing significant cost savings and efficiency gains for both Member States and economic operators.
Amendment 5 #
Proposal for a directive
Recital 4
Recital 4
(4) Data and information held by the European Chemicals Agency in the context of regulatory processes under Titles VII and VIII of Regulation (EC) No 1907/2006 of the European Parliament and of the Council5 can be usefully deployed for the assessment of potential substance restrictions and for assessing applications for exemption under Directive 2011/65/EU. Established structures and procedures can help to build on the existing knowledge base, maximise synergies, and make the best use of available expertise and resources. Utilising these established structures not only enhances efficiency but also reduces compliance costs for businesses, ensuring that regulatory processes support innovation and competitiveness in Union industries. _________________ 5 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC - OJ L 396 30.12.2006, p. 1.
Amendment 5 #
Proposal for a directive
Recital 4
Recital 4
(4) Data and information held by the European Chemicals Agency in the context of regulatory processes under Titles VII and VIII of Regulation (EC) No 1907/2006 of the European Parliament and of the Council5 can be usefully deployed for the assessment of potential substance restrictions and for assessing applications for exemption under Directive 2011/65/EU. Established structures and procedures can help to build on the existing knowledge base, maximise synergies, and make the best use of available expertise and resources. Utilising these established structures not only enhances efficiency but also reduces compliance costs for businesses, ensuring that regulatory processes support innovation and competitiveness in Union industries. _________________ 5 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC - OJ L 396 30.12.2006, p. 1.
Amendment 6 #
Proposal for a directive
Recital 5 a (new)
Recital 5 a (new)
(5 a) The information submitted as part of the confidential version of an exemption application should be subject to an assessment by the European Chemicals Agency. Such assessment should comply with Union law concerning confidential data and protection of personal data, in particular regarding dissemination and confidentiality criteria established under Regulation (EC) No 1907/2006.
Amendment 6 #
Proposal for a directive
Recital 5 a (new)
Recital 5 a (new)
(5a) The information submitted as part of the confidential version of an exemption application should be subject to an assessment by the European Chemicals Agency. Such assessment should comply with Union law concerning confidential data and protection of personal data, in particular regarding dissemination and confidentiality criteria established under Regulation (EC) No 1907/2006.
Amendment 7 #
Proposal for a directive
Recital 5 b (new)
Recital 5 b (new)
(5 b) Most exemption requests are expected to require the expertise of the Committee for Socio-economic Analysis set up pursuant to Article 76(1), point (d) of Regulation (EC) No 1907/2006. The Members States’ representatives should be consulted by the Commission when adopting guidelines on the involvement of the Committee for Risk Assessment.
Amendment 7 #
Proposal for a directive
Recital 5 b (new)
Recital 5 b (new)
(5b) Most exemption requests are expected to require the expertise of the Committee for Socio-economic Analysis set up pursuant to Article 76(1), point (d) of Regulation (EC) No 1907/2006. The Members States’ representatives should be consulted by the Commission when adopting guidelines on the involvement of the Committee for Risk Assessment.
Amendment 9 #
Proposal for a directive
Recital 8
Recital 8
(8) For amending procedural provisions under Directive 2011/65/EU, a transitional period of 124 months is necessary to allow for appropriate resource and task allocation for the European Chemicals Agency. That timeframe is considered sufficient to allow potential applicants or Member States to adjust to the modified procedural steps under that Directive.
Amendment 9 #
Proposal for a directive
Recital 8
Recital 8
(8) For amending procedural provisions under Directive 2011/65/EU, a transitional period of 124 months is necessary to allow for appropriate resource and task allocation for the European Chemicals Agency. That timeframe is considered sufficient to allow potential applicants or Member States to adjust to the modified procedural steps under that Directive.
Amendment 41 #
Proposal for a directive
Article 2 – paragraph 1
Article 2 – paragraph 1
The provisions under this Directive shall be applicable from [OJ: 124 months after the publication of this Directive].
Amendment 41 #
Proposal for a directive
Article 2 – paragraph 1
Article 2 – paragraph 1
The provisions under this Directive shall be applicable from [OJ: 124 months after the publication of this Directive].