P10_TA(2025)0046 – Re-attribution of scientific and technical tasks to the European Chemicals Agency – 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)
Date: 2025-04-01
Institutions: Committee on Budgets, Committee on the Environment, Climate and Food Safety, European Parliament
Subjects: European Chemicals Agency, chemical product, chemicals legislation, dangerous substance, electrical equipment, electronic equipment, operation of the Institutions, scientific report




C_202504377EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/4377


9.9.2025






P10_TA(2025)0046

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


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))
             (1)


(Ordinary legislative procedure: first reading)

(C/2025/4377)


Amendment 1


Proposal for a directive


Recital 1








Text proposed by the Commission




Amendment











(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 Sustainability (3) 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.












(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 Sustainability (3) 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.



















Amendment 2


Proposal for a directive


Recital 2








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.












(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


Proposal for a directive


Recital 6 a (new)








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











(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.












(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





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





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.


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
.





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





 










(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 existing exemption shall remain valid until a decision on the renewal application is taken by the Commission.




‘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





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





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.


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 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





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





 










(-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





 










(-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





 










(-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





 










(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





 










(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





 










(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





 










(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.’








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





 










(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





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


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






(1)  The matter was referred back for interinstitutional negotiations to the committee responsible, pursuant to Rule 60(4), fourth subparagraph (A10-0019/2025).

(2)  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).

(2)  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).

(3)  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).

(3)  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).


ELI: http://data.europa.eu/eli/C/2025/4377/oj
ISSN 1977-091X (electronic edition)