C_202600070EN.000101.fmx.xml

Opinion of the European Economic and Social Committee

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) 386 final – 2025-207-COD)

(C/2026/70)

Rapporteur-General:

Maciej Dawid KUNYSZ

Advisor	Frank ALLEN
Legislative procedure	EU Law Tracker
Referral	European Parliament, 6.10.2025 Council of the European Union, 26.9.2025
Legal basis	Article 114 of the Treaty on the Functioning of the European Union
European Commission documents	COM(2025) 386 final – 2025-207-COD Summary of COM(2025) 386 final – 2025-207-COD
Relevant Sustainable Development Goals (SDGs)	SDG 16 – Peace, Justice and Strong Institutions SDG 3 – Good Health and Well-being SDG 12 – Responsible Consumption and Production
Section responsible	Agriculture, Rural Development and the Environment
Adopted at plenary session	23.10.2025
Plenary session No	600
Outcome of vote (for/against/abstentions)	197/4/8

1. RECOMMENDATIONS

The European Economic and Social Committee (EESC)

1.1.

welcomes the proposed European Chemicals Agency (ECHA) regulation which will create an independent legal framework to help ECHA manage its growing duties efficiently with a view to protecting human health and the environment. The EESC has already called for this development in the NAT/911 opinion (1).

1.2.

believes that scientific assessments of chemicals should note the needs of vulnerable groups as part of the decision-making process. Vulnerable groups are at heightened risk of poor health, harm or exploitation due to factors such as socioeconomic status, age, health or social marginalisation. Common vulnerable groups include children, the elderly, people with disabilities, migrants and refugees, racial and ethnic minorities and those experiencing homelessness or poverty. The use of some chemical substances can pose particular problems for such groups. The EESC urges the Agency to integrate the One Health perspective into its chemical assessments in order to both better address risks that disproportionately affect vulnerable groups and strengthen inclusive, transparent and coordinated governance (2).

1.3.

notes that the key to the future success of the Agency lies in ensuring that it is independent and seen to be so in the exercise of its duties and responsibilities. All committee members must be seen to be independent and have the necessary public acceptance of independence. The issue of conflicts of interest must also be a central consideration in order to ensure widespread acceptance of scientific opinions.

1.4.

recommends that the new proposals ensure the widest possible access to all documents containing chemical data and all other sources of information on chemical data. This will ensure the best possible input for scientific opinions. Independent academic data is essential, and a mechanism is needed to ensure that such data is taken into account.

1.5.

considers that the Board of Appeal, consisting of a chairperson and two members, is far too narrow and restricted to deal adequately with the various appeals that will arise. The EESC considers that the Board of Appeal must have a broader membership to ensure fairness and transparency in the appeals system.

1.6.

underlines that the precautionary principle must apply in order to protect public health and the environment in the event of failure to remedy diverging scientific opinions. The regulatory framework must always give priority to public health and the environment.

1.7.

calls for adequate resources to be provided for the ECHA committees and for timeliness indicators and service standards to be introduced. All of these elements must be reported in the Single Programming Document and the annual report.

1.8.

recommends establishing a permanent Civil Society Advisory Panel (CSAP) to the ECHA Management Board, with its opinions and minutes published.

1.9.

calls for the proactive publication of non-confidential inputs and plain-language summaries of opinions, decisions and reports (in English and in the languages of relevant Member States), along with FAIR metadata and an API for data re-use. The EESC is also in favour of giving eligible non-profit organisations the right to address the Board of Appeal, and of granting fee waivers or reductions for such organisations.

2. EXPLANATORY NOTES

Arguments in support of recommendation 1.2

2.1.

Independent academic evidence. To improve transparency and trust, the Management Board should ensure systematic screening of peer-reviewed academic studies for each relevant opinion and the publication of a short public feedback statement explaining how independent evidence has been used or why it has not been retained.

2.2.

Vulnerable groups and cumulative exposure. The EESC highlights disproportionate risks faced by children, pregnant and breastfeeding persons, immune-compromised individuals and high-exposure workers, including cumulative exposure. The Commission notes that children, pregnant women, and the elderly are particularly sensitive to certain hazardous properties, while consumers and workers face wide exposure across products and workplaces (3). Extending the generic approach to risk management aims to ensure more consistent protection of vulnerable groups (4).

Arguments in support of recommendation 1.3

2.3.

Independence and conflict of interest. The EESC stresses that independence must be demonstrable. The conflict-of-interest guidelines should set minimum criteria, including a 24-month cooling-off period after employment with economic operators assessed by the Agency, public disclosure of interests at least 14 days before meetings, and recusal rules. These rules must cover members, co-opted members, advisers and external experts involved in drafting or reviewing opinions. The European Court of Auditors found that ECHA’s conflict-of-interest policies and procedures were incomplete and less precise, and recommended clear, objective criteria for assessing declarations of interest and addressing post-employment risks (5).

2.4.

Management Board and civil society. The Management Board should include at least one voting member from civil society organisations active in public health, environment or consumer protection, selected through an open and non-discriminatory procedure with term limits. A permanent Civil Society Advisory Panel (CSAP) should issue opinions on the Single Programming Document, transparency policy, conflict-of-interest rules and timeliness indicators. CSAP opinions and minutes should be published.

Arguments in support of recommendation 1.4

2.5.

Transparency and re-use of data. The Agency should proactively publish non-confidential inputs and plain-language summaries of opinions, decisions and reports in English and in the languages of relevant Member States. Datasets should include FAIR metadata and be made available through an API to enable independent analysis and re-use.

Arguments in support of recommendation 1.5

2.6.

Capacity and timeliness. Given the Agency’s expanding remit, the EESC calls for adequate resources to be provided for RAC/SEAC and other committees and for timeliness indicators and service standards to be introduced (e.g. percentage of opinions delivered on time, median processing time and a quarterly early-warning pipeline). Results should be reported in the Single Programming Document and the annual report. The European Parliament calls for a new stable financing model for ECHA and adequate staffing levels to deliver the Green Deal and the Chemicals Strategy (6).

2.7.

Board of Appeal – effects of appeals. To safeguard legal certainty and the public interest, appeals should not have automatic suspensive effect. The Board of Appeal may grant suspension only where a prima facie case of serious and irreparable harm is shown, after a balance-of-interests assessment. The EESC is also in favour of giving eligible non-profit organisations the right to act as intervenors or amicus curiae, and of granting fee waivers or reductions for such organisations.

2.8.

Public consultation standard. For key committee opinions and draft guidance, the Agency should conduct public consultations lasting at least eight weeks and publish a public feedback statement summarising inputs and the Agency’s responses. The Commission’s Better Regulation Guidelines require mandatory internet-based public consultations (minimum 12 weeks) for initiatives with IAs, and the publication of a short factual summary of key issues within 8 weeks of closure (7).

2.9.

Budget for participation and transparency. The EESC recommends a ringfenced budget heading for civil society participation, covering translations, plain-language summaries, consultations and the participation of non-profit experts, so as to ensure that transparency and engagement are consistently deliverable.

3. PROPOSED AMENDMENTS TO THE LEGISLATIVE PROPOSAL OF THE EUROPEAN COMMISSION

Amendment 1

linked to recommendation 1.2

Text proposed by the European Commission	EESC amendment
Article 4(2)	Article 4(2)
In the fulfilment of its objectives, the Agency shall aim to contribute to a high level of protection of human health and the environment, to the free circulation of substances in the internal market and coherence and consistency in chemicals assessment and management across the Union, while enhancing 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 enterprises and promoting alternatives to animal testing.	In the fulfilment of its objectives, the Agency shall aim to contribute to a high level of protection of human health and the environment , including the protection of vulnerable groups, to the free circulation of substances in the internal market and coherence and consistency in chemicals assessment and management across the Union, while enhancing 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 enterprises and promoting alternatives to animal testing.

Reason

Vulnerable groups such as children need special protection as they may not be fully aware of the risks associated with the chemical contents of particular products.

Amendment 2

linked to recommendation 1.3

Text proposed by the European Commission	EESC amendment
Article 14(1)	Article 14(1)
Each Member State shall nominate two candidates for membership of RAC and may nominate up to two additional candidates.	Each Member State shall nominate two candidates for membership of RAC and may nominate up to two additional candidates. The European Commission shall issue clear guidelines for assessing the independence and conflicts of interest of all members, co-opted members, advisers and experts.

Reason

All members of ECHA committees must be seen to be independent so that their decisions will be seen to be fair and reasonable and not beholden to vested interests. Conflicts of interest must be dealt with in a transparent manner so that the public can have confidence in the decisions reached by the committees.

Amendment 3

linked to recommendation 1.4

Text proposed by the European Commission	EESC amendment
Article 16(1)	Article 16(1)
The Agency may rely on the services of experts to serve in a working group of the committees, of the Forum, or of other working groups of the Agency or for the performance of other tasks set out in this Regulation or sectoral Union legislation, where it is justified by the scientific and technical context, or the high level of expertise required. The procedure for and the scope of the use of experts shall be adopted by a decision of the Management Board.	The Agency may rely on the services of experts to serve in a working group of the committees, of the Forum, or of other working groups of the Agency or for the performance of other tasks set out in this Regulation or sectoral Union legislation, where it is justified by the scientific and technical context, or the high level of expertise required. The procedure for and the scope of the use of experts shall be adopted by a decision of the Management Board.
	Provision must be made for making full use of the valuable insights of independent research, such as peer-reviewed academic studies which are relevant for regulatory purposes.

Reason

Independent data can make a significant contribution to the regulatory process.

Amendment 4

linked to recommendation 1.5

Text proposed by the European Commission	EESC amendment
Article 20(1)	Article 20(1)
The Board of Appeal shall be composed of a Chairperson and two other members.	The Board of Appeal shall be composed of a Chairperson and four other members.

Reason

The membership of the proposed Board of Appeal is far too narrow to deal with the potential appeals that will arise in the future.

Amendment 5

linked to recommendation 1.6

Text proposed by the European Commission	EESC amendment
Article 45(3)	Article 45(3)
The Agency and the body concerned shall cooperate to resolve the divergence. If the Agency and the body concerned are not able to resolve the divergence, they shall draw up a joint report. The report shall clearly outline the contentious scientific issues, identify the relevant uncertainties in the data and the underlying reasons for the diverging opinions, including on methodological differences, and be made publicly available. Where the body concerned is a Union agency or a scientific committee, the Agency shall present the joint report to the Commission.	The Agency and the body concerned shall cooperate to resolve the divergence. If the Agency and the body concerned are not able to resolve the divergence, they shall draw up a joint report. The report shall clearly outline the contentious scientific issues, identify the relevant uncertainties in the data and the underlying reasons for the diverging opinions, including on methodological differences, and be made publicly available. Where the body concerned is a Union agency or a scientific committee, the Agency shall present the joint report to the Commission. In the event of serious scientific divergences, the precautionary principle shall apply in order to protect public health and the environment.

Reason

Failure to remedy diverging scientific opinions is a serious issue and therefore the precautionary principle must apply until such matters can be resolved.

Brussels, 23 October 2025.

The President

of the European Economic and Social Committee

Séamus BOLAND

(1) Opinion of the European Economic and Social Committee – Proposal for a regulation of the European Parliament and of the Council establishing a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals and – Proposal for a regulation of the European Parliament and of the Council amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021 of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals and – 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 (OJ C, C/2024/3381, 31.5.2024, ELI: http://data.europa.eu/eli/C/2024/3381/oj).

(2) Opinion of the European Economic and Social Committee – Healthy planet for healthy people: towards a comprehensive ‘One Health’ approach (own-initiative opinion) (OJ C, C/2026/16, 16.1.2026, ELI: http://data.europa.eu/eli/C/2026/16/oj).

(3) European Commission, COM(2020) 667, sec. 2.2.1.

(4) European Commission, COM(2020) 667, sec. 2.2.1.

(5) European Court of Auditors, Special Report No 15/2012.

(6) European Parliament, Discharge 2020: European Chemicals Agency, 4 May 2022, P9_TA(2022)0174.

(7) European Commission – Better Regulation Guidelines (SWD(2021) 305 final), 3 November 2021.