Adopted text, 1 April 2025

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

Document TA-10-2025-0046 · P10_TA(2025)0046 · PE763.254

Adopted in plenary on Tuesday, 1 April 2025 · Passed 482 for, 110 against, 81 abstained · See the decision →
Where the law stands · dossier 2023/0454 →

AI:In short

Parliament's amended version of the proposed directive re-attributing scientific and technical tasks to the European Chemicals Agency (ECHA) under Directive 2011/65/EU on hazardous substances in electrical and electronic equipment. It sets rules for applications, renewals, reviews, and restrictions. The amendments require ECHA to reject incomplete applications, make opinions public including requests, set deadlines for renewal decisions, and mandate periodic reviews of restricted substances at least every 36 months. Restriction dossiers must include identity, wording, evidence, alternatives, justification, socio-economic assessment, and consider other legislation. The Commission must consult member state experts before delegated acts and monitor ECHA resources.

Key points

The re-attribution aims to align processes with ECHA standards, support 'one-substance, one-assessment', and improve quality, coherence, and efficiency.
The list of restricted substances in Annex II should be reviewed at least every 36 months, considering market, technical, and scientific progress.
The transitional period for procedural amendments is extended from 12 to 18 months.
ECHA shall reject applications not completed within the deadline and must communicate the date when an application is considered complete.
ECHA must make public its opinions and attachments, including requests made under the specified provision.
Renewal applications must be made no later than 18 months before exemption expiry; the Commission shall decide within six months of receiving ECHA opinions, and the exemption remains valid until then.
Reviews and amendments of the restricted substances list shall be based on dossiers prepared by ECHA or a Member State, covering the whole life cycle including waste phase.
Restriction dossiers must include substance identity, precise wording, scientific evidence, alternatives, justification for Union-wide restriction, and socio-economic assessment.
Before adopting delegated acts, the Commission shall consult experts designated by each member state.
The Commission shall monitor ECHA's resources and scientific committees' workload and, if necessary, propose legislation to address needs.

Who is affected

Applicants for exemptions under Directive 2011/65/EU: must meet deadlines or face rejection; renewals must be filed 18 months before expiry.
European Chemicals Agency: gains tasks, must reject incomplete applications, publish opinions, and prepare restriction dossiers.
Member States: can submit restriction dossiers and provide information; their experts must be consulted before delegated acts.
Manufacturers and users of restricted substances: face periodic reviews and potential new restrictions.

Figures and deadlines

36 months: review period for the list of restricted substances.
18 months: transitional period and deadline for renewal applications before exemption expiry.
Six months: time for the Commission to decide on renewal applications after receiving ECHA opinions.

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Full text

Jump to an amendment (19)

Amendment 1
Amendment 2
Amendment 3
Amendment 4
Amendment 5
Amendment 6
Amendment 7
Amendment 8
Amendment 9
Amendment 10
Amendment 11
Amendment 12
Amendment 13
Amendment 14
Amendment 15
Amendment 16
Amendment 17
Amendment 18
Amendment 19

Text 107 paragraphs

Committee on the Environment, Climate and Food Safety

Amendments adopted by the European Parliament on 1 April 2025 on the proposal for a directive of the European Parliament and of the Council amending Directive 2011/65/EU of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks to the European Chemicals Agency (COM(2023)0781 – C9-0448/2023 – 2023/0454(COD))

(Ordinary legislative procedure: first reading)

Amendment 1

Proposal for a directive

Recital 1

Text proposed by the Commission	Amendment
Text proposed by the Commission(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(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 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.
Text proposed by the Commission2 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).	Amendment2 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).
Text proposed by the Commission3 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).	Amendment3 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 2

Proposal for a directive

Recital 2

Text proposed by the Commission	Amendment
Text proposed by the Commission(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.

Text proposed by the Commission

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.

Amendment 3

Read the rest (95 paragraphs)

Proposal for a directive

Recital 6 a (new)

Text proposed by the Commission	Amendment
Text proposed by the Commission	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.

Text proposed by the Commission

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.

Amendment 4

Proposal for a directive

Recital 8

Text proposed by the Commission	Amendment
Text proposed by the Commission(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.

Amendment 5

Proposal for a directive

Article 1 – paragraph 1 – point 1 – point a

Directive 2011/65/EU

Article 5 – paragraph 4 – subparagraph 2

Text proposed by the Commission	Amendment
Text proposed by the CommissionWhere 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.	AmendmentWhere 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.

Text proposed by the Commission

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

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.

Amendment 6

Proposal for a directive

Article 1 – paragraph 1 – point 1 – point b

Directive 2011/65/EU

Article 5 – paragraph 4a – subparagraph 5

Text proposed by the Commission	Amendment
Text proposed by the CommissionThe 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.	AmendmentThe 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.

Amendment 7

Proposal for a directive

Article 1 – paragraph 1 – point 1 – point b a (new)

Directive 2011/65/EU

Article 5 – paragraph 5

Present text	Amendment
Present text	Amendment(ba) paragraph 5 is replaced by the following:
Present text5. 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"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."

Amendment 8

Proposal for a directive

Article 1 – paragraph 1 – point 3 – point a

Directive 2011/65/EU

Article 6 – paragraph 1 – subparagraph 1

Text proposed by the Commission	Amendment
Text proposed by the CommissionWith 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.;	AmendmentWith 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.;

Text proposed by the Commission

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 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.;

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.;

Amendment 9

Proposal for a directive

Article 1 – paragraph 1 – point 3 – point c

Directive 2011/65/EU

Article 6 – paragraph 2 – subparagraph 1

Text proposed by the Commission	Amendment
Text proposed by the CommissionThe 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.	AmendmentThe 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 10

Proposal for a directive

Article 1 – paragraph 1 – point 3 – point c

Directive 2011/65/EU

Article 6 – paragraph 2 – subparagraph 2

Text proposed by the Commission	Amendment
Text proposed by the CommissionThe 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.	AmendmentThe 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.

Text proposed by the Commission

Amendment

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.

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.

Amendment 11

Proposal for a directive

Article 1 – paragraph 1 – point 3 – point c

Directive 2011/65/EU

Article 6 – paragraph 2 – subparagraph 3 – point -a (new)

Text proposed by the Commission	Amendment
Text proposed by the Commission	Amendment(-a) the identity of the substance;

Amendment 12

Proposal 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)

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

Amendment 13

Proposal 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)

Text proposed by the Commission	Amendment
Text proposed by the Commission	Amendment(-ab) references and scientific evidence for the restriction;

Amendment 14

Proposal 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)

Text proposed by the Commission	Amendment
Text proposed by the Commission	Amendment(ba) information on possible alternatives, their availability and suitability;

Amendment 15

Proposal 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)

Text proposed by the Commission	Amendment
Text proposed by the Commission	Amendment(bb) justification for considering a Union-wide restriction as the most appropriate measure.

Amendment 16

Proposal 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)

Text proposed by the Commission	Amendment
Text proposed by the Commission	Amendment(bc) a socio-economic assessment.

Amendment 17

Proposal for a directive

Article 1 – paragraph 1 – point 4 a (new)

Directive 2011/65/EU

Article 20 – paragraph 1 a (new)

Text proposed by the Commission	Amendment
Text proposed by the Commission	Amendment(4a) In Article 20, the following paragraph is inserted:
Text proposed by the Commission	Amendment“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 18

Proposal for a directive

Article 1 – paragraph 1 – point 4 b (new)

Directive 2011/65/EU

Article 24 – paragraph 2 a (new)

Text proposed by the Commission	Amendment
Text proposed by the Commission	Amendment(4b) In Article 24 , the following paragraph is added:
Text proposed by the Commission	Amendment“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. "

Text proposed by the Commission

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. "

Amendment 19

Proposal for a directive

Article 2 – paragraph 1

Text proposed by the Commission	Amendment
Text proposed by the CommissionThe provisions under this Directive shall be applicable from [OJ: 12 months after the publication of this Directive].	AmendmentThe provisions under this Directive shall be applicable from [OJ: 18 months after the publication of this Directive].

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

AIAI:In short

Key points

Who is affected

Figures and deadlines

Full text

Amendment 1

Amendment 2

Amendment 3

Amendment 4

Amendment 5

Amendment 6

Amendment 7

Amendment 8

Amendment 9

Amendment 10

Amendment 11

Amendment 12

Amendment 13

Amendment 14

Amendment 15

Amendment 16

Amendment 17

Amendment 18

Amendment 19

AI:In short