18 Amendments of Pierre JOUVET related to 2023/0455(COD)
Amendment 4 #
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2a) To improve further the cooperation among Union agencies in the area of chemicals, and to increase coherence and efficiency of assessments related to chemicals across Union legislation, it is necessary to lay the foundation for a common approach to hazard assessment of chemicals across Union legislation. This Regulation should establish a forum for Agencies to improve sharing and re-use of chemicals data, exchange best practices, and foster cooperation in the hazard assessment of chemicals.
Amendment 9 #
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 only when they are not able to resolve the divergence, should they refer to risk managers. Differences in assessment methodologies resulting in divergent opinions, particularly with regards to the protection of vulnerable groups, should be duly clarified. In such instances, priority should be given to the most protective opinion to safeguard the most vulnerable populations.
Amendment 12 #
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 withe 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. 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 17 #
Proposal for a regulation
Article -1 (new)
Article -1 (new)
Article -1 Forum on Hazard Assessment 1. The Commission shall, by means of an implementing decision, establish and manage a Forum on Hazard Assessment ('the Forum') which shall include representatives from each of the Agencies, the Commission, Member states and the European Parliament. 2. The Forum shall establish a work programme to (a) foster cooperation in the area of hazard assessment of chemicals; (b) improve the sharing and re-use of data between agencies; (c) establish a strategy toward the common hazard assessment of chemicals across Union legislation in the area of chemicals. 2. The forum shall meet and update its work programme regularly. 3. The Forum shall draw up an annual report, compiling and analysing the advancement and conclusions of its work programme referred to in paragraph 2. The first report shall be prepared by [OP: please insert date: 1 year after the end of the first calendar year after entry into force of this Regulation]. The Forum shall present this report to the Commission, relevant Union agencies and Member State competent authorities, the European Parliament and the Council for consideration of the need for regulatory or policy action related to the conclusion of this report
Amendment 19 #
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 3
Article 30 – paragraph 2 – subparagraph 3
Where the Authority identifies a potential source of divergence, it shall contact the body concerned in order to ensure that all relevant scientific or technical information is shared and in order to identify the potentially contentious scientific or technical issues. Difference in assessment methodologies resulting in divergent opinions shall be duly justified, especially regarding the protection of vulnerable groups.
Amendment 22 #
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. Priority shall be given to the opinion that affords the highest level of protection in order to safeguard the most vulnerable groups. 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 be made publicly available.
Amendment 26 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2 a (new)
Article 1 – paragraph 1 – point 2 a (new)
Regulation (EC) No 178/2002
Article 30 – paragraph 3 a (new)
Article 30 – paragraph 3 a (new)
In article 30, the following paragraph is added 3a. In cases where a divergence is identified, and the Authority requests additional information from the other Union or Member State authority, the period by when the relevant authorities are required to adopt their respective output, or the joint output referred to in paragraph 2, may be extended. After consulting the body concerned, the Authority shall lay down a period within which this information shall be provided and shall inform the Commission of the additional period needed. The Commission shall inform the concerned business operator(s) and the Member States of the extension.
Amendment 30 #
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 identclassified as endocrine disruptors for human health, 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 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 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 33 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
Regulation (EU) 2019/1021
Article 8 – paragraph 1a – point a
Article 8 – paragraph 1a – point a
(a) as appropriate, information on human health and environmental impacts of waste consisting of, containing or contaminated with POPs, including impacts on waste management;
Amendment 34 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
Regulation (EU) 2019/1021
Article 8 – paragraph 1a – subparagraph 2
Article 8 – paragraph 1a – subparagraph 2
The Agency shall, as soon as it receives the request referred to in the first subparagraphArticle 8(1), point (i), publish on its website a notice that a report on a possible amendment of Annex IV or V will be prepared inviting all interested parties, including waste operators and users of recycled materials, to submit comments within 8 weeks. The Agency shall publish those comments on its website.
Amendment 35 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
Regulation (EU) 2019/1021
Article 8 – paragraph 1a – subparagraph 3
Article 8 – paragraph 1a – subparagraph 3
At the latest 9 months following the submission of that report referred to in Article 8(1), point (i), the Committee for Socio-economic Analysis of the Agency, set up pursuant to Article 76(1), point (d), of Regulation (EC) No 1907/2006 shall adopt an opinion on the report and on the concentration limit values proposed therein. For the purpose of adopting an opinion on the report, Article 87 of Regulation (EC) No 1907/2006 shall apply mutatis mutandis.
Amendment 36 #
Proposal for a regulation
Article 4 – paragraph 1 – point 4
Article 4 – paragraph 1 – point 4
Regulation (EU) 2019/1021
Article 15 – paragraph 2
Article 15 – paragraph 2
2. The Commission is empowered to adopt delegated acts in accordance with Article 18, to amend Annexes IV and V to adapt them to the changes to the list of substances set out in the Annexes I, II or III to Regulation(EU) 2019/1021, or the Annexes to the Convention or the Protocol or to adapt them to scientific and technical progress.
Amendment 38 #
Proposal for a regulation
Article 4 – paragraph 1 – point 5 – point c
Article 4 – paragraph 1 – point 5 – point c
Regulation (EU) 2019/1021
Article 18 – paragraph 6
Article 18 – paragraph 6
6. A delegated act adopted pursuant to Articles 4(3), 10(2) and 15 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period may be extended by two months at the initiative of the European Parliament or of the Council’.
Amendment 39 #
Proposal for a regulation
Article 4 – paragraph 1 – point 5 – point c
Article 4 – paragraph 1 – point 5 – point c
Regulation (EU) 2019/1021
Annex IV – Table 1 – Row 5 Present text
Annex IV – Table 1 – Row 5 Present text
Amendment 40 #
Proposal for a regulation
Article 4 – paragraph 1 – point 5 – point c
Article 4 – paragraph 1 – point 5 – point c
Regulation (EU) 2019/1021
Annex IV – Table 1 – Row 12 Present text
Annex IV – Table 1 – Row 12 Present text
Amendment 41 #
Proposal for a regulation
Article 4 – paragraph 1 – point 5 – point c
Article 4 – paragraph 1 – point 5 – point c
Regulation (EU) 2019/1021
Annex IV – Table 1 – Row 30
Annex IV – Table 1 – Row 30
Amendment 42 #
Proposal for a regulation
Article 4 – paragraph 1 – point 5 – point c
Article 4 – paragraph 1 – point 5 – point c
Regulation (EU) 2019/1021
Annex IV – Table 1 – Row 27 Present text
Annex IV – Table 1 – Row 27 Present text
Amendment 43 #
Proposal for a regulation
Article 4 – paragraph 1 – point 5 – point c
Article 4 – paragraph 1 – point 5 – point c
Regulation (EU) 2019/1021
Annex IV – Table 1 – Row 31 Present text
Annex IV – Table 1 – Row 31 Present text