Next event: Indicative plenary sitting date, 1st reading 2025/03/31
Progress: Awaiting committee decision
Role | Committee | Rapporteur | Shadows |
---|---|---|---|
Lead | ENVI | TSIODRAS Dimitris ( EPP) | CLERGEAU Christophe ( S&D), TIMGREN Beatrice ( ECR), HOJSÍK Martin ( Renew), PAULUS Jutta ( Greens/EFA), HAZEKAMP Anja ( The Left) |
Former Responsible Committee | ENVI | SPYRAKI Maria ( EPP) | |
Former Committee Opinion | BUDG | ||
Committee for budgetary assessment | BUDG |
Lead committee dossier:
Legal Basis:
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Legal Basis:
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Events
PURPOSE: to amend Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (‘RoHS Directive’) with a view to reattributing certain scientific and technical tasks to the European Chemicals Agency.
PROPOSED ACT: Directive of the European Parliament and of the Council.
ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.
BACKGROUND: the Commission has, in its Communication ‘European Green Deal’, 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.
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.
The reattribution of certain scientific and technical tasks to the European Chemicals Agency is necessary to align processes and levels of scientific scrutiny and digitalisation with current standards and processes of the European Chemicals Agency.
Directive 2011/65/EU of the European Parliament and of the Council contains two procedures related to the assessment of chemicals: the evaluation of economic operators’ applications for granting, renewing or revoking an exemption from the substance restrictions pursuant to Article 5 of that Directive and the review of substances to be added to the list of restricted substances pursuant to Article 6 of that Directive. There is a need to increase transparency by setting detailed procedural steps for the process to review substances for a potential inclusion in the list of restricted substances.
To ensure that the restriction process referred to Article 6 in Directive 2011/65/EU is consistent with the restriction processes under other legislation related to chemicals, in particular with the substance restriction process laid down in Articles 69 to 73 of Regulation (EC) No 1907/2006, it is necessary to amend Directive 2011/65/EU to formally task the European Chemicals Agency with a role in the restriction process.
CONTENT: this proposed regulation aims at amending Articles 5 and 6 of Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment. The amendments allocate a role and specific tasks to ECHA and its scientific committees in the processes for substance restrictions and assessing exemption requests corresponding to the restrictions.
Legislative proposal
PURPOSE: to amend Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (‘RoHS Directive’) with a view to reattributing certain scientific and technical tasks to the European Chemicals Agency.
PROPOSED ACT: Directive of the European Parliament and of the Council.
ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.
BACKGROUND: the Commission has, in its Communication ‘European Green Deal’, 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.
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.
The reattribution of certain scientific and technical tasks to the European Chemicals Agency is necessary to align processes and levels of scientific scrutiny and digitalisation with current standards and processes of the European Chemicals Agency.
Directive 2011/65/EU of the European Parliament and of the Council contains two procedures related to the assessment of chemicals: the evaluation of economic operators’ applications for granting, renewing or revoking an exemption from the substance restrictions pursuant to Article 5 of that Directive and the review of substances to be added to the list of restricted substances pursuant to Article 6 of that Directive. There is a need to increase transparency by setting detailed procedural steps for the process to review substances for a potential inclusion in the list of restricted substances.
To ensure that the restriction process referred to Article 6 in Directive 2011/65/EU is consistent with the restriction processes under other legislation related to chemicals, in particular with the substance restriction process laid down in Articles 69 to 73 of Regulation (EC) No 1907/2006, it is necessary to amend Directive 2011/65/EU to formally task the European Chemicals Agency with a role in the restriction process.
CONTENT: this proposed regulation aims at amending Articles 5 and 6 of Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment. The amendments allocate a role and specific tasks to ECHA and its scientific committees in the processes for substance restrictions and assessing exemption requests corresponding to the restrictions.
Legislative proposal
Documents
- Amendments tabled in committee: PE766.687
- Committee draft report: PE763.254
- Contribution: COM(2023)0781
- Contribution: COM(2023)0781
- ESC: CES5710/2023
- Legislative proposal: COM(2023)0781
- Legislative proposal: Go to the pageEur-Lex
- Document attached to the procedure: Go to the pageEur-Lex
- Document attached to the procedure: SWD(2023)0850
- Legislative proposal published: COM(2023)0781
- Legislative proposal published: Go to the page Eur-Lex
- Committee draft report: PE763.254
- Amendments tabled in committee: PE766.687
- Legislative proposal: COM(2023)0781 Go to the pageEur-Lex
- Document attached to the procedure: Go to the pageEur-Lex SWD(2023)0850
- Contribution: COM(2023)0781
- Contribution: COM(2023)0781
- ESC: CES5710/2023
Amendments | Dossier |
78 |
2023/0454(COD)
2024/12/09
ENVI
39 amendments...
Amendment 10 #
Proposal for a directive Recital 8 a (new) (8 a) In order to ensure that this Directive is coherent with any future amendment of Regulation (EC) No 1907/2006, or of other future Union law concerning sustainability criteria for hazardous substances and chemicals, the Commission should assess whether an amendment of Articles 5 and 6 of this Directive is required. Where appropriate, the Commission should propose amendments to this Directive in a future regulation amending Regulation (EC) No 1907/2006 or in other future Union law concerning sustainably criteria for hazardous substances and chemicals.
Amendment 11 #
Proposal for a directive Article 1 – paragraph 1 – point 1 – point -a (new) Directive 2011/65/EU Article 5 – paragraph 2 Amendment 12 #
Proposal for a directive Article 1 – paragraph 1 – point 1 – point a Directive 2011/65/EU Article 5 – paragraph 4 – point c (c) if necessary, request the applicant to complete the application, and provide an appropriate deadline; and shall, whenever appropriate, set up a meeting of applicants and/or interested parties particularly if contradictory information is received during the procedural step under paragraph 4, point (f)
Amendment 13 #
Proposal for a directive Article 1 – paragraph 1 – point 1 – point a Directive 2011/65/EU Article 5 – paragraph 4 – subparagraph 2 Where the applicant does not complete the application with the missing elements identified by the Agency in compliance with Annex V within the deadline provided in accordance with the first subparagraph, point (c), the Agency
Amendment 14 #
Proposal for a directive Article 1 – paragraph 1 – point 1 – point b Directive 2011/65/EU Article 5 – paragraph 4a – subparagraph 2 – point a a (new) (a a) shall publish the draft opinions referred to in point (a) on its website without delay and invite interested parties to provide their comments on the draft opinion for a period no shorter than 60 days after its publication;
Amendment 15 #
Proposal for a directive Article 1 – paragraph 1 – point 1 – point b Directive 2011/65/EU Article 5 – paragraph 4a – subparagraph 2 – point a a (new) (a a) shall publish the draft opinions on its website without delay and invite interested parties to provide their comments on the draft opinion no later than 60 days from its publication;
Amendment 16 #
Proposal for a directive Article 1 – paragraph 1 – point 1 – point b Directive 2011/65/EU Article 5 – paragraph 4a – subparagraph 3 Each Committee shall take into account any information submitted by interested parties in accordance with the second subparagraph, point (aa), and submitted by third parties in accordance with the second subparagraph, point (c).
Amendment 17 #
Proposal for a directive Article 1 – paragraph 1 – point 1 – point b Directive 2011/65/EU Article 5 – paragraph 4a – subparagraph 3 Each Committee shall take into account any information submitted
Amendment 18 #
Proposal for a directive Article 1 – paragraph 1 – point 1 – point b Directive 2011/65/EU Article 5 – paragraph 4a – subparagraph 5 The Agency shall identify which parts of its opinions and of any attachments thereto should be made publicly available on its website and shall make those parts publicly available on its website, together with any requests made in accordance with the second subparagraph, point (c).
Amendment 19 #
Proposal for a directive Article 1 – paragraph 1 – point 1 – point b Directive 2011/65/EU Article 5 – paragraph 4a – subparagraph 5 The Agency shall identify which parts of its opinions and of any attachments thereto should be made publicly available on its website and shall make those parts publicly available on its website, including any requests made in accordance with the second subparagraph, point (c) .
Amendment 20 #
Proposal for a directive Article 1 – paragraph 1 – point 1 – point b a (new) Directive 2011/65/EU Article 5 – paragraph 5 Amendment 21 #
Proposal for a directive Article 1 – paragraph 1 – point 1 – point b a (new) Directive 2011/65/EU Article 5 – paragraph 5 Amendment 22 #
Proposal for a directive Article 1 – paragraph 1 – point 1 – point b a (new) Directive 2011/65/EU Article 5 – paragraph 5 Amendment 23 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point a Directive 2011/65/EU Article 6 – paragraph 1 – subparagraph 1 With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and an amendment of the list of restricted substances in Annex II shall be considered by the Commission periodically and at least every 30 months on its own initiative or following the submission of a restriction dossier prepared by a Member State containing the information referred to in paragraph 2.;
Amendment 24 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point c Directive 2011/65/EU Article 6 – paragraph 2 – subparagraph 1 The review and amendment of the list of restricted substances, or a group of substances, in Annex II shall be based on restriction dossiers prepared by the Agency at the request of the Commission or prepared by a Member State.
Amendment 25 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point c Directive 2011/65/EU Article 6 – paragraph 2 – subparagraph 1 The review and amendment of the list of restricted substances, or group of substances, in Annex II shall be based on restriction dossiers prepared by the Agency at the request of the Commission or prepared by a Member State.
Amendment 26 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point c Directive 2011/65/EU Article 6 – paragraph 2 – subparagraph 1 The review and amendment of the list of restricted substances or group of substances in Annex II shall be based on restriction dossiers prepared by the Agency at the request of the Commission or prepared by a Member State.
Amendment 27 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point c Directive 2011/65/EU Article 6 – paragraph 2 – subparagraph 2 The Agency or a Member State shall take into account any available information and any relevant
Amendment 28 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point c Directive 2011/65/EU Article 6 – paragraph 2 – subparagraph 2 The Agency or a Member State shall take into account any available information and any relevant
Amendment 29 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point c Directive 2011/65/EU Article 6 – paragraph 2 – point –a (new) (-a) The identity of the substance;
Amendment 3 #
Proposal for a directive 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.
Amendment 30 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point c Directive 2011/65/EU Article 6 – paragraph 2 – point –a a (new) (-a a) a precise and clear wording of the entry of the proposed restriction in Annex II;
Amendment 31 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point c Directive 2011/65/EU Article 6 – paragraph 2 – point –a b (new) (-a b) references and scientific evidence for the restriction;
Amendment 32 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point c Directive 2011/65/EU Article 6 – paragraph 2 – point b a (new) (b a) information on possible alternatives, their availability and suitability;
Amendment 33 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point c Directive 2011/65/EU Article 6 – paragraph 2 – point b a (new) (b a) information on possible suitable alternatives and their availability;
Amendment 34 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point c Directive 2011/65/EU Article 6 – paragraph 2 – point b b (new) (b b) justification for considering a Union-wide restriction as the most appropriate measure.
Amendment 35 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point c Directive 2011/65/EU Article 6 – paragraph 2 – point b c (new) (b c) socioeconomic assessment.
Amendment 36 #
Proposal for a directive Article 1 – paragraph 1 – point 4 Directive 2011/65/EU Article 6a – paragraph 4 a (new) 4a. The Agency, working in cooperation with the Commission, shall draw up and implement an international cooperation mechanism for the exchange of information and statistics on chemical substances, with a view to increasing the transparency and safety of their use worldwide.
Amendment 37 #
Proposal for a directive Article 1 – paragraph 1 – point 4 Directive 2011/65/EU Article 6a – paragraph 6 a (new) 6a. The Agency shall facilitate the exchange of information and access to statistics on chemical substances, including by developing links to relevant international databases, so as to ensure a comprehensive analysis of their risks and of alternatives.
Amendment 38 #
Proposal for a directive Article 1 – paragraph 1 – point 4 a (new) Directive 2011/65/EU Article 20 – paragraph 1 Amendment 39 #
Proposal for a directive Article 1 – paragraph 1 – point 4 b (new) Directive 2011/65/EU Article 20 – paragraph 1 b (new) (4 b) In Article 20, the following paragraph 1a is inserted: “1a. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.”
Amendment 4 #
Proposal for a directive 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 40 #
Proposal for a directive Article 1 – paragraph 1 – point 4 a (new) Directive 2011/65/EU Article 24 – paragraph 2a (new) (4 a) In Article 24 , the following paragraph is added: “(2 a). The Commission shall monitor the situation regarding the resources of the European Chemicals Agency and tasks, workload and remit of the scientific committees of the European Chemicals Agency and present, where necessary, a legislative proposal to reflect any needs of the Eureopan Chemicals Agency stemming from tasks introduced by this Regulation and to improve governance of its scientific committees. "
Amendment 41 #
Proposal for a directive Article 2 – paragraph 1 The provisions under this Directive shall be applicable from [OJ:
Amendment 5 #
Proposal for a directive 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.
Amendment 6 #
Proposal for a directive 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 7 #
Proposal for a directive 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 8 #
Proposal for a directive Recital 6 a (new) (6 a) The list of restricted substances Directive 2011/65/EU should be periodically reviewed to ensure a high level of protection of human health, the environment and consumer safety. It is considered appropriate to set the review period by taking into account market developments and technical and scientific progress and in view of the fact that restriction dossiers can be submitted by Member States at any time and horizontal restriction measures can be initiated and adopted by Regulation (EC) No 1907/2006, Regulation (EU) 2019/1021 or other Union law concerning sustainably criteria for hazardous substances and chemicals.
Amendment 9 #
Proposal for a directive Recital 8 (8) For amending procedural provisions under Directive 2011/65/EU, a transitional period of
source: 766.687
2024/12/11
ENVI
39 amendments...
Amendment 10 #
Proposal for a directive Recital 8 a (new) (8a) In order to ensure that this Directive is coherent with any future amendment of Regulation (EC) No 1907/2006, or of other future Union law concerning sustainability criteria for hazardous substances and chemicals, the Commission should assess whether an amendment of Articles 5 and 6 of this Directive is required. Where appropriate, the Commission should propose amendments to this Directive in a future regulation amending Regulation (EC) No 1907/2006 or in other future Union law concerning sustainably criteria for hazardous substances and chemicals.
Amendment 11 #
Proposal for a directive Article 1 – paragraph 1 – point 1 – point -a (new) Directive 2011/65/EU Article 5 – paragraph 2 Amendment 12 #
Proposal for a directive Article 1 – paragraph 1 – point 1 – point a Directive 2011/65/EU Article 5 – paragraph 4 – point c (c) if necessary, request the applicant to complete the application, and provide an appropriate deadline; and shall, whenever appropriate, set up a meeting of applicants and/or interested parties particularly if contradictory information is received during the procedural step under paragraph 4, point (f)
Amendment 13 #
Proposal for a directive Article 1 – paragraph 1 – point 1 – point a Directive 2011/65/EU Article 5 – paragraph 4 – subparagraph 2 Where the applicant does not complete the application with the missing elements identified by the Agency in compliance with Annex V within the deadline provided in accordance with the first subparagraph, point (c), the Agency
Amendment 14 #
Proposal for a directive Article 1 – paragraph 1 – point 1 – point b Directive 2011/65/EU Article 5 – paragraph 4a – subparagraph 2 – point a a (new) (aa) shall publish the draft opinions referred to in point (a) on its website without delay and invite interested parties to provide their comments on the draft opinion for a period no shorter than 60 days after its publication;
Amendment 15 #
Proposal for a directive Article 1 – paragraph 1 – point 1 – point b Directive 2011/65/EU Article 5 – paragraph 4a – subparagraph 2 – point a a (new) (aa) shall publish the draft opinions on its website without delay and invite interested parties to provide their comments on the draft opinion no later than 60 days from its publication;
Amendment 16 #
Proposal for a directive Article 1 – paragraph 1 – point 1 – point b Directive 2011/65/EU Article 5 – paragraph 4a – subparagraph 3 Each Committee shall take into account any information submitted by interested parties in accordance with the second subparagraph, point (aa), and submitted by third parties in accordance with the second subparagraph, point (c).
Amendment 17 #
Proposal for a directive Article 1 – paragraph 1 – point 1 – point b Directive 2011/65/EU Article 5 – paragraph 4a – subparagraph 3 Each Committee shall take into account any information submitted
Amendment 18 #
Proposal for a directive Article 1 – paragraph 1 – point 1 – point b Directive 2011/65/EU Article 5 – paragraph 4a – subparagraph 5 The Agency shall identify which parts of its opinions and of any attachments thereto should be made publicly available on its website and shall make those parts publicly available on its website, together with any requests made in accordance with the second subparagraph, point (c).
Amendment 19 #
Proposal for a directive Article 1 – paragraph 1 – point 1 – point b Directive 2011/65/EU Article 5 – paragraph 4a – subparagraph 5 The Agency shall identify which parts of its opinions and of any attachments thereto should be made publicly available on its website and shall make those parts publicly available on its website, including any requests made in accordance with the second subparagraph, point (c) .
Amendment 20 #
Proposal for a directive Article 1 – paragraph 1 – point 1 – point b a (new) Directive 2011/65/EU Article 5 – paragraph 5 Amendment 21 #
Proposal for a directive Article 1 – paragraph 1 – point 1 – point b a (new) Directive 2011/65/EU Article 5 – paragraph 5 Amendment 22 #
Proposal for a directive Article 1 – paragraph 1 – point 1 – point b a (new) Directive 2011/65/EU Article 5 – paragraph 5 Amendment 23 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point a Directive 2011/65/EU Article 6 – paragraph 1 – subparagraph 1 With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and an amendment of the list of restricted substances in Annex II shall be considered by the Commission periodically and at least every 30 months on its own initiative or following the submission of a restriction dossier prepared by a Member State containing the information referred to in paragraph 2.;
Amendment 24 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point c Directive 2011/65/EU Article 6 – paragraph 2 – subparagraph 1 The review and amendment of the list of restricted substances, or a group of substances, in Annex II shall be based on restriction dossiers prepared by the Agency at the request of the Commission or prepared by a Member State.
Amendment 25 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point c Directive 2011/65/EU Article 6 – paragraph 2 – subparagraph 1 The review and amendment of the list of restricted substances, or group of substances, in Annex II shall be based on restriction dossiers prepared by the Agency at the request of the Commission or prepared by a Member State.
Amendment 26 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point c Directive 2011/65/EU Article 6 – paragraph 2 – subparagraph 1 The review and amendment of the list of restricted substances or group of substances in Annex II shall be based on restriction dossiers prepared by the Agency at the request of the Commission or prepared by a Member State.
Amendment 27 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point c Directive 2011/65/EU Article 6 – paragraph 2 – subparagraph 2 The Agency or a Member State shall take into account any available information and any relevant
Amendment 28 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point c Directive 2011/65/EU Article 6 – paragraph 2 – subparagraph 2 The Agency or a Member State shall take into account any available information and any relevant
Amendment 29 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point c Directive 2011/65/EU Article 6 – paragraph 2 – point –a (new) (-a) The identity of the substance;
Amendment 3 #
Proposal for a directive 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.
Amendment 30 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point c Directive 2011/65/EU Article 6 – paragraph 2 – point –a a (new) (-aa) a precise and clear wording of the entry of the proposed restriction in Annex II;
Amendment 31 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point c Directive 2011/65/EU Article 6 – paragraph 2 – point –a b (new) (-ab) references and scientific evidence for the restriction;
Amendment 32 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point c Directive 2011/65/EU Article 6 – paragraph 2 – point b a (new) (ba) information on possible alternatives, their availability and suitability;
Amendment 33 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point c Directive 2011/65/EU Article 6 – paragraph 2 – point b a (new) (ba) information on possible suitable alternatives and their availability;
Amendment 34 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point c Directive 2011/65/EU Article 6 – paragraph 2 – point b b (new) (bb) justification for considering a Union-wide restriction as the most appropriate measure.
Amendment 35 #
Proposal for a directive Article 1 – paragraph 1 – point 3 – point c Directive 2011/65/EU Article 6 – paragraph 2 – point b c (new) (bc) socioeconomic assessment.
Amendment 36 #
Proposal for a directive Article 1 – paragraph 1 – point 4 Directive 2011/65/EU Article 6a – paragraph 4 a (new) 4a. The Agency, working in cooperation with the Commission, shall draw up and implement an international cooperation mechanism for the exchange of information and statistics on chemical substances, with a view to increasing the transparency and safety of their use worldwide.
Amendment 37 #
Proposal for a directive Article 1 – paragraph 1 – point 4 Directive 2011/65/EU Article 6a – paragraph 6 a (new) 6a. The Agency shall facilitate the exchange of information and access to statistics on chemical substances, including by developing links to relevant international databases, so as to ensure a comprehensive analysis of their risks and of alternatives.
Amendment 38 #
Proposal for a directive Article 1 – paragraph 1 – point 4 a (new) Directive 2011/65/EU Article 20 – paragraph 1 Amendment 39 #
Proposal for a directive Article 1 – paragraph 1 – point 4 b (new) Directive 2011/65/EU Article 20 – paragraph 1 b (new) (4b) In Article 20, the following paragraph 1a is inserted: “1a. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.”
Amendment 4 #
Proposal for a directive 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 40 #
Proposal for a directive Article 1 – paragraph 1 – point 4 a (new) Directive 2011/65/EU Article 24 – paragraph 2a (new) (4a) In Article 24 , the following paragraph is added: “(2 a). The Commission shall monitor the situation regarding the resources of the European Chemicals Agency and tasks, workload and remit of the scientific committees of the European Chemicals Agency and present, where necessary, a legislative proposal to reflect any needs of the European Chemicals Agency stemming from tasks introduced by this Regulation and to improve governance of its scientific committees. "
Amendment 41 #
Proposal for a directive Article 2 – paragraph 1 The provisions under this Directive shall be applicable from [OJ:
Amendment 5 #
Proposal for a directive 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.
Amendment 6 #
Proposal for a directive 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) (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 8 #
Proposal for a directive Recital 6 a (new) (6a) The list of restricted substances Directive 2011/65/EU should be periodically reviewed to ensure a high level of protection of human health, the environment and consumer safety. It is considered appropriate to set the review period by taking into account market developments and technical and scientific progress and in view of the fact that restriction dossiers can be submitted by Member States at any time and horizontal restriction measures can be initiated and adopted by Regulation (EC) No 1907/2006, Regulation (EU) 2019/1021 or other Union law concerning sustainably criteria for hazardous substances and chemicals.
Amendment 9 #
Proposal for a directive Recital 8 (8) For amending procedural provisions under Directive 2011/65/EU, a transitional period of
source: 766.687
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