Changes from report parliamentary committee draft to plenary report

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

▸5 unchanged paragraphs

on the proposal for a regulation of the European Parliament and of the Council on the European Chemicals Agency and amending Regulations (EC) No 1907/2006, (EU) No 528/2012, (EU) No 649/2012 and (EU) 2019/1021

(COM(2025)0386 – C100141/2025 – 2025/0207(COD))

(Ordinary legislative procedure: first reading)

The European Parliament,

– having regard to the Commission proposal to Parliament and the Council (COM(2025)0386),

Changed– having regard to Article 294(2) and Article 114114(1) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C100141/2025),

– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

Added– having regard to the budgetary assessment by the Committee on Budgets,

– having regard to the opinion of the European Economic and Social Committee of 23 October 2025,

– having regard to Rules 60 and 58 of its Rules of Procedure,

Changed– having regard to the budgetary assessmentreport byof the Committee on Budgets,the Environment, Climate and Food Safety (A10-0093/2026),

Removed– having regard to the report of the Committee on the Environment, Climate and Food Safety (A100000/2025),

1. Adopts its position at first reading hereinafter set out;

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3. Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Change 1

ChangedRecital 9: (9) The Agency should continue to contribute to the implementation and enforcement of Union legislation and policies related to the hazards, risks, safe use, and environmental sustainability of chemical substances,substances and groups thereof, mixtures and articles in order to achieve a high level of protection of human health and the environment, including the protection of vulnerable groups, the efficient functioning of the internal market and coherence and consistency in chemicals management across the Union, while enhancing competitiveness and innovation, taking into account the specific needs of small and medium-sized enterprises to safeguard and promotingfurther alternativesenhance tooccupational health standards and promoting non-animal approaches.approaches and emerging methodologies. By achieving its objectives and tasks, the Agency will contribute to the full implementation of the objectives of the Treaties and, in particular, pursuant to Article 191(2) TFEU, that environmental policy is to be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay.

Change 2

RemovedThis wording is more consistent with other wording used across chemicals legislation (REACH, OSOA, ...)

AddedRecital 10 a (new): (10a) To reinforce the capacity and contribute to the work of the competent authorities of Member States, the Agency should be able to second officials and other servants in its employment, in the interest of the service and in accordance with Article 37 of the Staff Regulations of Regulation No 31 (EEC), 11 (EAEC)1a and Article 51 of the Conditions of Employment of Other Servants of Regulation No 31 (EEC), 11 (EAEC), to the competent authorities of the Member States or to other public bodies entrusted with tasks related to the Agency’s mandate. / 1a Regulation No 31 (EEC), 11 (EAEC), laying down the Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Economic Community and the European Atomic Energy Community (OJ 45 14.6.1962, p. 1385, ELI: http://data.europa.eu/eli/reg/1962/31(1)/oj).

RemovedRecital 10 a (new): (10a) To reinforce the capacity and contribute to the work of the competent authorities of Member States, the Agency should be able to second officials and other servants in its employment, in the interest of the service and in accordance with Article 37 of Regulation No 31(EEC), 11 (EAEC)1a, to the competent authorities of the Member States or to other public bodies entrusted with tasks related to the Agency’s mandate, for example to help Member States meet their obligations to appoint committee members and thus ensure that the Agency has the number of committee members and experts it needs to do its work properly. / 1a Regulation No 31 (EEC), 11 (EAEC), laying down the Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Economic Community and the European Atomic Energy Community (OJ P 045 14.6.1962, p. 1385, ELI: http://data.europa.eu/eli/reg/1962/31(1)/oj).

RemovedTo perform its tasks and mission the Agency relies heavily on financial and human resources in the Member States in particular for scientific experts. Some Member States may have less resources or competences in the field of chemicals. Where appropriate, the Agency should be able to use to possibility offered by Article 37 of the Staff Regulation to contribute to the capacity building of the expertise of those Member States for example to help them meet their obligations to appoint committee members and thus ensure that the agency has the number of committee members and experts it needs to do its work properly.

Recital 11: (11) The structure of the Agency should be suitable for its tasks and should take into account the experience gained from the Agency’s functioning and performance since its establishment. It is essential to ensure that the Agency is equipped to perform its tasks with high scientific and technical capacities to ensure the highest possible quality.

Change 3

RemovedMoved to a new recital.

AddedRecital 11 a (new): (11a) The Agency should be central to ensuring that chemicals legislation and the decision-making processes and scientific basis underlying it have credibility with all stakeholders and the general public. The Agency should also play a pivotal role in coordinating communication around chemicals legislation and its implementation. Trust in the Agency by the Union institutions, the Member States, the general public and interested parties is therefore essential. For that reason, it is vital to ensure its independence, high scientific, technical and regulatory capacities, as well as transparency and efficiency. In addition, clear and effective rules should be established to prevent and manage conflicts of interest, and experts should not be appointed to Committees where reasonable concerns about conflicts of interest exist.

RemovedRecital 11 a (new): (11a) The Agency should be central to ensuring that chemicals legislation and the decision-making processes and scientific basis underlying it have credibility with all stakeholders and the general public. The Agency should also play a pivotal role in coordinating communication around chemicals legislation and its implementation. Trust in the Agency by the Union institutions, the Member States, the general public and interested parties is therefore essential. For that reason, it is vital to ensure its independence, high scientific, technical and regulatory capacities, as well as transparency and efficiency.

AddedRecital 13: (13) The Management Board of the Agency should be entrusted with the necessary powers, in particular to appoint the Executive Director, the members of RAC and SEAC and of the Board of Appeal, and to adopt the consolidated annual activity report, the programming document, the annual budget, and the financial rules applicable to the Agency. The Commission, the European Parliament, and the Member States should be represented within the Management Board in order to effectively exercise oversight over it. In the interests of transparency, interested parties without voting rights should be appointed to the Management Board by the Commission and should represent a wide range of relevant fields of expertise.

RemovedConsidering the crucial nature of transparency and efficiency for the Agency, this deserves a separated recital. This recital is based on recital 95 of REACH with modification to give it a more horizontal meaning.

AddedRecital 15 a (new): (15a) The Agency's role as an independent scientific point of reference means that a scientific opinion can be requested not only by the Commission, but also by the European Parliament and the Member States. In order to ensure the manageability and consistency of the process of scientific advice, the Agency should be able to refuse or propose to amend a request, providing justification in the case of a refusal, on the basis of predetermined criteria.

RemovedRecital 15 a (new): (15a) The Agency's role as an independent scientific point of reference means that a scientific opinion can be requested not only by the Commission, but also by the European Parliament and the Member States. In order to ensure the manageability and consistency of the process of scientific advice, the Agency should be able to refuse or amend a request providing justification for that refusal or amendment and on the basis of predetermined criteria.

AddedRecital 16: (16) RAC has, provided scientific opinions on evaluations of Occupational Exposure Limits (‘OELs’), and other aspects relevant to occupational exposure to hazardous chemicals such as biological limit values for hazardous chemicals in the context of Article 3 of Council Directive 98/24/EC11 . Articles 16, 16a and 18a of Directive 2004/37/EC of the European Parliament and of the Council12 and Articles 18c and 22a of Directive 2009/148/EC of the European Parliament and of the Council13 on the basis of an ad hoc agreement between the Commission and the Agency in the past. Since this task has become customary and in order to consolidate that practice, this Regulation should establish that RAC should provide such opinions upon request from the Commission. In addition, RAC should, upon a request from the Commission, the European Parliament or the Member States provide scientific opinions on all other matters related to the hazards, risks and safe use of chemical substances, on their own, in mixtures or in articles as defined in Article 3, paragraphs 1, 2 and 3 of Regulation (EC) No 1907/2006.

RemovedThis is a possibility that is given to the European Parliament or a Member State for EFSA in the General Food Law. This should be mirrored in the ECHA Basic Regulation.

AddedRecital 18: (18) The Management Board should adopt the rules of procedure of RAC, SEAC, MSC, BPC and SCCS, including the procedural arrangements for the Committees’ working groups. In order for the Commission to exercise its oversight, the Commission representatives in the Management Board should be consulted by the Executive Director when preparing the rules of procedure of the RAC, SEAC and SCCS, maintaining the independence of the Committees and their working groups.

RemovedRecital 18: (18) The Management Board should adopt the rules of procedure of RAC, SEAC, MSC, BPC and SCCS, including the procedural arrangements for the Committees working groups. In order for the Commission to exercise its oversight, the Commission representatives in the Management Board should be consulted by the Executive Director when preparing the rules of procedure of the RAC, SEAC and SCCS, without compromising the independence of the Committees and their working groups.

AddedRecital 19: (19) The opinions of RAC and SEAC should be based on the broadest possible scientific and technical expertise available within the Union. To this end and to ensure that RAC and SEAC are fully operational, it is essential that each Member State nominates two members for RAC and SEAC respectively and be entitled to nominate up to two additional members. RAC, SEAC, BPC and SCCS should have the possibility to co-opt members and to rely on the services of experts, taking into account the workload, type of expertise needed, geographical balance and availability of financial resources. Committee members should reflect the expertise required for the proper fulfilment of the tasks allocated to the Agency. The Agency should be able to assist Member States in identifying relevant profiles for membership of the RAC, SEAC and BPC, where Member States so request.

RemovedRecital 19: (19) The opinions of RAC and SEAC should be based on the broadest possible scientific and technical expertise available within the Union. To this end, each Member State should nominate two members for RAC and SEAC respectively and should be entitled to nominate up to two additional members. RAC, SEAC, BPC and SCCS should have the possibility to co-opt members and to rely on the services of experts, taking into account the workload, type of expertise needed and availability of financial resources. Committee members should reflect the expertise required for the proper fulfilment of the tasks allocated to the Agency. The Agency should be able to assist Member States in identifying relevant profiles for membership of the RAC, SEAC and BPC, where Member States so request.

AddedRecital 21 a (new): (21a) The Agency should set up an Assembly of accredited stakeholders which should aim to reinforce the relationship with accredited stakeholders, and facilitate their contribution to the tasks of the Agency while ensuring a balanced representation between industry representatives and civil society representatives.

RemovedRecital 21 a (new): (21a) The Agency should set up a Forum for accreditedstakeholders which should aim to structure and reinforce the relationship with all stakeholders, and allow the members of that forum to contribute to the tasks of the Agency.

AddedRecital 21 b (new): (21b) In order to enhance scientific cooperation and support the Agency’s work, it is necessary to promote the networking of national authorities, agencies and research institutes operating in areas of competence of the Agency’s mandate. This networking aims to foster the exchange of information, coordination of activities, and the development of joint projects, as well as the sharing of expertise and best practices. To achieve this, a list of national authorities, agencies and research institutes designated by the Member States should be drawn up, enabling those national authorities, agencies and research institutes to assist the Agency with tasks such as preparatory work for scientific opinions, data collection, and the identification of emerging risks.

RemovedECHA has had a long standing practice of interaction and exchange with stakeholders and civil society in general, in particular via its accredited stakeholders. The proposal for a Basic Regulation is the opportunity to institutionalise this practice to structure and reinforce the relationship with all stakeholders, and allow its members to contribute to the tasks of the Agency.

RemovedRecital 21 b (new): (21b) In order to enhance scientific cooperation and support the Agency’s work, it is necessary to promote the networking of organisations operating in areas of competence of the Agency’s mandate. This networking aims to foster the exchange of information, coordination of activities, and the development of joint projects, as well as the sharing of expertise and best practices. To achieve this, a list of competent organisations designated by the Member States should be drawn up, enabling these organisations to assist the Agency with tasks such as preparatory work for scientific opinions, data collection, and the identification of emerging risks. The Commission is empowered to adopt delegated acts to establish the criteria for the inclusion of organisations on this list, the quality requirements, and the financial rules governing any financial support that may be provided.

Recital 23 a (new): (23a) Additional workload arising from an increase in tasks and responsibilities allocated to the Agency should be accompanied by the allocation of appropriate funding for staff and other necessary costs. As part of the draft single programming document, the Management Board should conduct an assessment of the adequacy of its financial and human resources to carry out its current and upcoming tasks.

Change 4

RemovedRecital 31: (31) The Agency should continue to play an active role in research and innovation, assisting Member States and the Commission in the promotion of substitution of the most harmful and other hazardous chemicals and in the development of scientific methods, notably non-animal approaches, to assess hazards of chemicals as well as risks and socio-economic impacts of their use. In particular, the Agency should assist and contribute to the research on the links between exposure to hazardous chemicals and negative impacts on health in the field of exposomics, the integrated compilation of all the physical, chemical, biological and psychosocial factors, and their interactions, which have an impact on biology and health.

AddedRecital 25: (25) The Agency has experienced difficulties to accurately predict the income from fees and charges even with the most advanced statistical techniques due to the paucity of information on the drivers of demand from duty holders. The Agency commits to continuously improve its forecasting methods. This impacts the operations of the Agency and requires recurrent amendments to the budget by the Management Board. Therefore, the Agency should be allowed to create a reserve from the surplus of its revenues from fees and charges, subject to the conditions set out in this Regulation. This will allow the Agency to mitigate the consequences of large fluctuation in income from fees and charges. Specifically, the creation of such reserve will allow the Agency to increase the sustainability of its financing model without prejudice to the annual Union contribution and multiannual financial programming. The detailed rules on the parameters, the calculation and the operation of the reserve should be laid down in the Agency’s financial rules and should include the requirements set out in this Regulation. The calculation of the amount of the annual contribution to the reserve or of the amount made available from the reserve, to be included in the draft budget of the Agency, should follow a methodology mechanically applied by the Agency every year. The establishment of such a reserve for a partially self-financed EU agency operating under the universal budgetary model is a unique case and does n…

RemovedSubstitution effort should not be limited to the most harmful substances. This amendment also outlines research on exposome as one of the key priorities to which the Agency should contribute.

AddedRecital 26: deleted / (deleted)

RemovedRecital 31 a (new): (31a) Strengthened collaboration between Union agencies can play a critical role by ensuring that scientific evidence is aligned, making knowledge more accessible to all relevant stakeholders, providing strategic direction to Union research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between the Agency, the European Food Safety Authority (EFSA), the European Medicines Agency (EMA), the European Centre for Disease Prevention and Control (ECDC) and the European Environment Agency (EEA), established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five Union agencies in order to help them to better address challenges to human, animal, plant and environmental health and successfully contribute to the implementation of the One Health approach in Europe. As that initiative is to end in 2026, this Regulation should establish a more permanent and established form of transdisciplinary cooperation with a permanent task force aiming to build on the work of the One Health task force and to broaden the scope of its work to other approach, such as exposome. The Agencies composing the task force should outline a common vision and objectives for that task force, working toward a more permanent and established form of transdisciplinary cooperation between the Union agencies. They should be able to plan coordinated actions and to broaden the scope of their cooperati…

AddedRecital 31: (31) The Agency should continue to play an active role in research and innovation, assisting Member States and the Commission in the promotion of substitution of the most harmful chemicals and other hazardous chemicals and groups thereof and in the development of scientific methods, notably non-animal approaches and emerging methodologies, to assess hazards of chemicals and groups of chemicals as well as risks and socio-economic impacts of their use. Where appropriate, the Agency should contribute to research on the links between exposure to hazardous chemicals and negative impacts on health in the field of exposomics, the integrated compilation of all the physical, chemical, biological and psychosocial factors, and their interactions, which have an impact on biology and health.

RemovedArticle 4 – paragraph 1: 1. The Agency shall contribute to the implementation and enforcement of Union legislation and policies related to the hazards, risks, safe use, and environmental sustainability of chemical substances, mixtures and articles, provide scientific opinions and advice and independent information on all matters within that field, monitor emerging chemical risks and generate data on chemicals, and communicate on those matters.

AddedRecital 31 a (new): (31a) Strengthened collaboration between Union agencies can play a critical role by ensuring that scientific evidence is aligned, making knowledge more accessible to all relevant stakeholders, providing strategic direction to Union research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force established in 2023 by the Agency, the European Food Safety Authority (EFSA), the European Medicines Agency (EMA), the European Centre for Disease Prevention and Control (ECDC) and the European Environment Agency (EEA), has proven to be a successful initiative to strengthen transdisciplinary cooperation among those five Union agencies in order to help them to better address challenges to human, animal, plant and environmental health and successfully contribute to the implementation of the One Health approach in Europe. As that initiative is to end in 2026, this Regulation should establish a more permanent and established form of transdisciplinary cooperation with a permanent task force aiming to build on the work of the One Health task force and to broaden the scope of its work to other approaches, such as exposome encompassing also the One System framework, providing for a holistic, systems-based approach towards environmental risk assessment of chemicals. EU-OSHA should also be included in this permanent framework. The agencies composing the task force should outline a common vision and objectives for that task force…

RemovedThe 'One Substance One Assessment' package tasks ECHA to collect data on the environmental sustainability of chemicals (Article 13 of the Common Data Platform on Chemicals), this needs to be reflected in the objectives and tasks of the Agency.

AddedRecital 37 a (new): (37a) The implications of this Regulation for the Union budget have been assessed1a pursuant to Article 310(4) of the Treaty on the Functioning of the European Union. Sufficient financial and human resources should be provided for its implementation, while considering the impact of the financing on other Union programmes or policies and ensuring its compatibility with the multiannual financial framework, the system of own resources and the corresponding interinstitutional agreement, as well as with the budgetary principles laid down in Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council1b. / 1a Pro memoria: Budgetary assessment of the European Parliament’s Committee on Budgets of (XX) 2026 on the proposal for a Regulation of the European Parliament and of the Council on the European Chemicals Agency and amending Regulations (EC) No 1907/2006, (EU) No 528/2012, (EU) No 649/2012 and (EU) 2019/1021 (COM(2025)0386). / 1b Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council of 23 September 2024 on the financial rules applicable to the general budget of the Union (OJ L, 2024/2509, 26.9.2024, ELI: http://data.europa.eu/eli/reg/2024/2509/oj).

RemovedArticle 4 – paragraph 2 – subparagraph 1: In the fulfilment of its objectives, the Agency shall aim to contribute to ensuring a high level of protection of human health and the environment, including the protection of vulnerable groups. The Agency shall aim to deliver quality, coherence and consistency in chemicals assessment and management across the Union which is key to ensure the free circulation of substances in the internal market, while contributing to enhancing the competitiveness and innovation, taking into account the specific needs of small and medium-sized enterprises (‘SMEs’) as defined in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises26 and promoting the development and use of non-animal approaches.

AddedArticle 3 – paragraph 1: The Agency shall have its seat in Helsinki, Finland. / (deleted)

RemovedThe first and foremost objective of the agency should remain the ensuring a high level of protection of health and the environment. A particular attention should be given to vulnerable groups in alignment with the text adopted in the OSOA Package (Proposal on the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals). It is also key to base the objectives of this Regulation in alignment with the general principles of the Treaties regarding protection of health and the environment.

AddedArticle 4 – paragraph 1: 1. The Agency shall contribute to the implementation and enforcement of Union legislation and policies related to the hazards, risks, safe use and environmental sustainability of chemical substances, mixtures and articles, provide scientific opinions and advice and independent information on all matters within that field, monitor emerging chemical risks and collect or generate data on chemicals, and communicate on those matters.

RemovedArticle 4 – paragraph 2 – subparagraph 1 a (new): As a body based on scientific and technical expertise, the Agency shall also contribute to ensuring that Union policy on chemicals is based on the principles enshrined in Article 191(2) TFEU.

AddedArticle 4 – paragraph 2: 2. In the fulfilment of its objectives, the Agency shall contribute to ensuring a high level of protection of human health and the environment, including the protection of vulnerable groups. The Agency shall aim to deliver quality, coherence and consistency in chemicals assessment and management across the Union which is key to ensuring the free circulation of substances in the internal market, while contributing to enhancing the competitiveness and innovation, taking into account the specific needs of small and medium-sized enterprises (‘SMEs’) as defined in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises26 and promoting and strengthening expertise in the substitution of harmful chemicals and groups of harmful chemicals as well as the development, and use of non-animal approaches and emerging methodologies.

Change 5

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Change 6

RemovedArticle 4 – paragraph 5 – point b: (b) provide technical and scientific support, guidance, IT tools and digital infrastructure for the development, implementation and enforcement of this Regulation and sectoral Union legislation taking into account the objectives of ensuring a high level of protection of health and the environment, the specific needs of SMEs and the goal of replacing animal testing with non-animal approaches where scientifically possible;

RemovedProtection of health and the environment should remain the principal compass of the Agency, together with contributing to the competitiveness of the industry and replacing animal testing.