12 Amendments of Lynn BOYLAN related to 2023/0455(COD)
Amendment 5 #
Proposal for a regulation
Recital 6
Recital 6
(6) To ensure the coherence and efficiency of assessments related to chemicals across Union legislation, it is also important to enable data interoperability and easy exchange of data between the relevant Union agencies, as well as to encourage cooperation on the development of standard formats and controlled vocabularies. Thus, to facilitate data exchange between agencies, any new data formats defined by the European Food Safety Authority or by the European Environmental Agency should be set in cooperation with other relevant Union agencies working on chemicals. To this end, relevant provisions should be introduced in Regulation (EC) No 401/2009 of the European Parliament and of the Council and, in Regulation (EC) No 178/2002 of the European Parliament and of the Council, existing provisions should be strengthened and, where relevant, new ones be introduced. Similar provisions should also be considered to be proposed for a strengthened mandate of the European Chemicals Agency in its founding regulation, which should be proposed as soon as possible and no later than 31 December 2025.
Amendment 6 #
Proposal for a regulation
Recital 7
Recital 7
(7) To promote the transition towards a toxic-free environment and zero pollution, and the robustness, coherence and efficiency of assessments related to chemicals across Union legislation, steps should be taken by the relevant Union agencies to avoid divergent scientific opinions. Existing cases of divergent opinions have lead to increased uncertainty for operators, as well as to declined public trust in the scientific robustness and coherence of scientific decision making. Proposals to address and strengthen procedures for resolving divergence of scientific opinions concerning the European Medicines Agency with other scientific bodies is proposed as part of the revision of Union pharmaceutical legislation. Similar provisions should also be considered to be proposed for a strengthened mandate of the European Chemicals Agency in its founding regulation, whilst such provisions are not relevant and applicable to the European Environmental Agency, since this agency does not issue scientific opinions on individual chemicals such as to be part in divergent outcomes.
Amendment 8 #
Proposal for a regulation
Recital 8
Recital 8
(8) Correspondingly, this Regulation aims to address the eventual divergence between scientific opinions of the European Food Safety Authority and those of other Union agencies. Regulation (EC) No 178/2002 of the European Parliament and Council already contains provisions establishing a procedure to solve divergent scientific opinions. Those resolution procedures should be reinforced, in that the European Food Safety Authority and the other dissenting agency should be bound to make their best effort to resolve the divergence on general scientific issues, and ooptimising the protection of health and the environment. Diverging scientific opinions and their causes, including in methodological differences, should be duly explained and clarified. Where diverging scientific opinions exist, the most protective opinion from the One Health perspective should be agreed on. Only when they are not able to resolve the divergence, should they refer to risk managers.
Amendment 11 #
Proposal for a regulation
Recital 9
Recital 9
(9) In the more specific case of scientific divergence pertaining to the hazard identification of chemical substances, a new procedure enabling the resolution of the divergence should be established. This procedure should enable the Commission to request the European Chemicals Agency, as the Union agency most equipped with expertise and capacity in hazard assessment, as well as long- standing experience with the harmonised classification and labelling process, to develop a proposal for harmonised classification and labelling, in accordance the Regulation (EC) No 1272/2008 of the European Parliament and Council, moving closer to the ‘one substance, one assessment’ vision as regards uniformity of hazard assessments of chemicals across the Union, optimising the protection of health and the environment. This possibility should be reflected in the relevant provision providing for the resolution of diverging scientific opinions laid down in Regulation (EC) No 178/2002.
Amendment 14 #
Proposal for a regulation
Recital 11
Recital 11
(11) To comply with the obligation laid out in Section 10.4.4. of Annex I to Regulation (EU) 2017/745, the Commission should mandate the relevant scientific committee to prepare guidelines for substances other than phthalates and which are classified as either carcinogenic, mutagenic or toxic to reproduction category 1A or 1B, or which have endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health or the environment and which are identified in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council.
Amendment 15 #
Proposal for a regulation
Recital 13
Recital 13
(13) Taking account of the new hazard classes and criteria for classification, labelling and packaging of substances introduced by Commission Delegated Regulation (EU) 2023/707 of 19 December 20227 , reference to endocrine disruptors for human health or the environment, of Category 1, should be specified in 10.4.1., point (b) of Annex I of Regulation (EU) 2017/745 in light of the relevance of that hazard class to the type of substances in medical devices. _________________ 7 Commission Delegated Regulation (EU) 2023/707 of 19 December 2022 amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures (OJ L 93, 31.3.2023, p. 7–39).
Amendment 21 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 178/2002
Article 30 – paragraph 2 – subparagraph 2
Article 30 – paragraph 2 – subparagraph 2
The Authority and the body concerned shall cooperate to resolve the divergence, with the aim of optimising the protection of health and the environment, prioritising the most protective opinion. If the Authority and the body concerned are not able to resolve the divergence, they shall draw up a joint report. The report shall clearly outline the contentious scientific issues and, identify the relevant uncertainties in the data and the possible causes for the diverging opinions, including on methodological differences and be made publicly available.
Amendment 25 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 178/2002
Article 30 – paragraph 3
Article 30 – paragraph 3
3. Where relevant, and where the divergence concerns conflicting scientific opinions of the Authority and another Union body or agency on whether a substance fulfils the criteria laid out in Annex I of Regulation (EC) No 1272/2008 of the European Parliament and of the Council11 , the Commission may request the European Chemicals Agency to prepare a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for revision thereof following the procedure laid out in Article 37 of Regulation (EC) No 1272/2008, with the aim of optimising the protection of health and the environment. The Authority and the Union body or agency concerned shall co-operate with the European Chemicals Agency in developing that proposal.. _________________ 11 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. OJ L 353 31.12.2008, p. 1 – 1355.
Amendment 27 #
Proposal for a regulation
Article 2 – paragraph 1 – point 1 a (new)
Article 2 – paragraph 1 – point 1 a (new)
Regulation (EC) No 401/2009
Article 15 – paragraph 4
Article 15 – paragraph 4
Amendment 28 #
Proposal for a regulation
Article 2 – paragraph 1 – point 2
Article 2 – paragraph 1 – point 2
Regulation (EC) No 401/2009
Article 15 – paragraph 5
Article 15 – paragraph 5
5. The Agency shall cooperate with other scientific bodies established under Union law, notably the European Chemicals Agency, the European Food Safety Authority, and the European Medicines Agency, on the exchange of data and information on chemicals, including the possible establishment of related data formats and controlled vocabularies to facilitate such an exchange, and on the development of scientific methodologies for the assessment of chemicals. This cooperation shall aim to support the development of innovative methods and tools, notably non animal approaches and aim to ensure that animal testing takes place only as last resort.
Amendment 29 #
Proposal for a regulation
Article 3 – paragraph 1 – point 1
Article 3 – paragraph 1 – point 1
Regulation (EU) 2017/745
Annex I – Section 10.4.1 – point b
Annex I – Section 10.4.1 – point b
(b) substances which are identified as endocrine disruptors for human health or the environment, of Category 1, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council12 andor substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health or the environment and which are identified in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council or substances having endocrine disrupting properties relevant to human health or the environment identified in accordance with Regulation (EU) No 528/2012. _________________ 12 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006( OJ L 353 31.12.2008, p. 1 ).
Amendment 31 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3
Article 3 – paragraph 1 – point 3
Regulation (EU) 2017/745
Annex I – Section 10.4.3
Annex I – Section 10.4.3
When deemed appropriate based on the latest scientific evidence, but at least every 53 years, the Commission shall request the European Chemicals Agency (ECHA) to update guidelines on the benefit-risk assessment of the presence of phthalates which belong to either of the groups of substances referred to in Section 10.4.1., points (a) and (b). The benefit-risk assessment shall consider the intended purpose and context of the use of the device, as well as any available alternative substances and alternative materials, designs or medical treatments