Re-attribution of scientific and technical tasks to the European Chemicals Agency

Amendments tabled for the plenary sitting on this text, in their own numbering series. This is a different set from the committee amendments tracked elsewhere on AmendEU, and is not counted in any of the site’s amendment totals.

1. Amendment 1Proposal for a directive · Recital 1
   Current text

   (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 m…

   Amendment

   (1) The Commission has, in its Communication ‘European Green Deal2 , 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 mo…

   Excerpt — full text in the official PDF.
   official amendment document ↗
2. Amendment 2Proposal for a directive · Recital 2
   Current text

   (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.

   Amendment

   (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, digitalisation and streamlined processes will reduce duplicative efforts and administrative delays, providing significant cost savings and efficiency gains for both Member States and economic operators.

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3. Amendment 3Proposal for a directive · Recital 6 a (new)
   Amendment

   (6a) The list of restricted substances referred to in 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 appropriate to set a review period of at least 36 months, taking into account market developments and technical and scientific progress, and the fact that restriction dossiers can be submitted by Member States at any time and horizontal restriction measures can be initiated and adopted under Regulation (EC) No 1907/2006, Regulation (EU) 2019/1021 or other Union law concerning sustainability criteria for hazardous substances and chemicals.

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4. Amendment 4Proposal for a directive · Recital 8
   Current text

   (8) For amending procedural provisions under Directive 2011/65/EU, a transitional period of 12 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

   (8) For amending procedural provisions under Directive 2011/65/EU, a transitional period of 18 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.

   official amendment document ↗
5. Amendment 5Proposal for a directive · Article 1 – paragraph 1 – point 1 – point a · Directive 2011/65/EU · Article 5 – paragraph 4 – subparagraph 2
   Current text

   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 may reject such application. The Agency shall establish and communicate to the applicant without undue delay the date when the application is considered complete.

   Amendment

   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 shall reject such application. The Agency shall establish and communicate to the applicant without undue delay the date when the application is considered complete.

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6. Amendment 6Proposal for a directive · Article 1 – paragraph 1 – point 1 – point b · Directive 2011/65/EU · Article 5 – paragraph 4a – subparagraph 5
   Current text

   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.

   Amendment

   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 point (c) of the second subparagraph.

   official amendment document ↗
7. Amendment 7Proposal for a directive · Article 1 – paragraph 1 – point 1 – point b a (new) · Directive 2011/65/EU · Article 5 – paragraph 5
   Current text

   5. An application for renewal of an exemption shall be made no later than 18 months before the exemption expires. The existing exemption shall remain valid until a decision on the renewal application is taken by the Commission.

   Amendment

   (ba) paragraph 5 is replaced by the following: "5. An application for renewal of an exemption shall be made no later than 18 months before the exemption expires. The Commission shall adopt the decision on the application within six months of receipt of the opinions from the Agency. The existing exemption shall remain valid until a decision on the renewal application is taken by the Commission."

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8. Amendment 8Proposal for a directive · Article 1 – paragraph 1 – point 3 – point a · Directive 2011/65/EU · Article 6 – paragraph 1 – subparagraph 1
   Current text

   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 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

   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 36 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.;

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9. Amendment 9Proposal for a directive · Article 1 – paragraph 1 – point 3 – point c · Directive 2011/65/EU · Article 6 – paragraph 2 – subparagraph 1
   Current text

   The review and amendment of the list of restricted 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

   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.

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10. Amendment 10Proposal for a directive · Article 1 – paragraph 1 – point 3 – point c · Directive 2011/65/EU · Article 6 – paragraph 2 – subparagraph 2
    Current text

    The Agency or a Member State shall take into account any available information and any relevant risk assessment submitted for the purposes of other Union legislation covering the life cycle of the substance used in EEE, in particular the waste phase. To this end, other bodies established under Union law and carrying out a similar task shall, on request, provide information to the Agency or Member State concerned.

    Amendment

    The Agency or a Member State shall take into account any available information and any relevant assessment submitted for the purposes of other Union legislation covering any part of the life cycle of the substance used in EEE, in particular the waste phase. To this end, other bodies established under Union law and carrying out a similar task shall, on request, provide information to the Agency or Member State concerned.

    official amendment document ↗
11. Amendment 11Proposal for a directive · Article 1 – paragraph 1 – point 3 – point c · Directive 2011/65/EU · Article 6 – paragraph 2 – subparagraph 3 – point -a (new)
    Amendment

    (-a) the identity of the substance;

    official amendment document ↗
12. Amendment 12Proposal for a directive · Article 1 – paragraph 1 – point 3 – point c · Directive 2011/65/EU · Article 6 – paragraph 2 – subparagraph 3 – point -a a (new)
    Amendment

    (-aa) a precise and clear wording for the entry of the proposed restriction in Annex II;

    official amendment document ↗
13. Amendment 13Proposal for a directive · Article 1 – paragraph 1 – point 3 – point c · Directive 2011/65/EU · Article 6 – paragraph 2 – subparagraph 3 – point -a b (new)
    Amendment

    (-ab) references and scientific evidence for the restriction;

    official amendment document ↗
14. Amendment 14Proposal for a directive · Article 1 – paragraph 1 – point 3 – point c · Directive 2011/65/EU · Article 6 – paragraph 2 – subparagraph 3 – point b a (new)
    Amendment

    (ba) information on possible alternatives, their availability and suitability;

    official amendment document ↗
15. Amendment 15Proposal for a directive · Article 1 – paragraph 1 – point 3 – point c · Directive 2011/65/EU · Article 6 – paragraph 2 – subparagraph 3 – point b b (new)
    Amendment

    (bb) justification for considering a Union-wide restriction as the most appropriate measure.

    official amendment document ↗
16. Amendment 16Proposal for a directive · Article 1 – paragraph 1 – point 3 – point c · Directive 2011/65/EU · Article 6 – paragraph 2 – subparagraph 3 – point b c (new)
    Amendment

    (bc) a socio-economic assessment.

    official amendment document ↗
17. Amendment 17Proposal for a directive · Article 1 – paragraph 1 – point 4 a (new) · Directive 2011/65/EU · Article 20 – paragraph 1 a (new)
    Amendment

    (4a) In Article 20, the following paragraph 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.”

    official amendment document ↗
18. Amendment 18Proposal for a directive · Article 1 – paragraph 1 – point 4 b (new) · Directive 2011/65/EU · Article 24 – paragraph 2 a (new)
    Amendment

    (4b) In Article 24 , the following paragraph is added: “2a. The Commission shall monitor the situation regarding the resources of the European Chemicals Agency and the 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 the governance of its scientific committees. "

    official amendment document ↗
19. Amendment 19Proposal for a directive · Article 2 – paragraph 1
    Current text

    The provisions under this Directive shall be applicable from [OJ: 12 months after the publication of this Directive].

    Amendment

    The provisions under this Directive shall be applicable from [OJ: 18 months after the publication of this Directive].

    official amendment document ↗
20. Amendment 20ENVIProposal for a directive

    Replaces or inserts a longer passage — full text in the official document.

    official amendment document ↗