On 8 July 2025, the European Commission published its long-awaited proposal for a Regulation on the European Chemicals Agency ("ECHA") – hereinafter "the Proposal".
The Proposal aims to establish a new, autonomous legal framework for ECHA to strengthen its governance, ensure financial sustainability, and reflect its expanding role under existing and forthcoming EU chemicals legislation.
It also amends several other key regulations, including the Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation ("REACH"), the Biocidal Products Regulation ("BPR"), the Prior Informed Consent Regulation ("PIC"), and the Persistent Organic Pollutants Regulation ("POPs"). This article provides an overview of the main changes introduced by the Proposal.
Please contact our EU Regulatory team for further information and assistance: Koen Van Maldegem, Maud Grunchard, Simon Englebert, Maria Beatrice Grassi
Background
The Chemicals Strategy for Sustainability ("CSS"), adopted on 14 October 2020, outlined measures to improve the effectiveness, efficiency, and consistency of safety assessments under the One Substance, One Assessment ("OSOA") approach. As part of this initiative, the European Commission committed to strengthening ECHA's governance and financial model in response to (i) declining and unpredictable fee income following the final REACH registration deadline in 2018 and (ii) plans to re-attribute scientific and technical tasks among EU agencies and improve inter-agency cooperation in the chemicals domain, which culminated in a Commission proposal in December 2023.
Since its establishment in 2007, ECHA has taken on numerous additional responsibilities, which are expected to expand further following the adoption of proposal on re-attribution of tasks among the EU agencies, leading to a growing workload. The Proposal responds to this evolution by creating a stand-alone legal framework to support both current and anticipated functions.
ECHA's Committees
The Proposal significantly enhances the capacity of ECHA's key scientific committees.
- Risk Assessment Committee ("RAC") and Committee for Socio-economic Analysis ("SEAC"):
Member States will be required to nominate two members for both RAC and SEAC and may nominate up to two additional members for each (currently not an obligation). RAC and SEAC will also be granted greater flexibility to co-opt additional members based on workload (currently limited to five). They may also engage external experts where justified (Articles 14, 15, and 16).
- Role of RAC:
The role of RAC is explicitly extended to include the formulation of opinions on Occupational Exposure Limits ("OELs") and related health-based limit values, under the legal frameworks of Directive 98/24/EC, Directive 2004/37/EC, and Directive 2009/148/EC. These tasks, previously carried out under ad hoc agreements, are now formalised (Article 13).
- Socio-economic analysis under BPR:
A new provision (Article 75a BPR) allows SEAC, at the request of the Biocidal Products Committee ("BPC"), to provide input on socio-economic considerations relevant to derogations for active substances meeting the exclusion criteria under Article 5(2) BPR.
- Scientific Committee on Consumer Safety ("SCCS"):
SCCS is recognised as a stand-alone scientific committee focusing on cosmetics. Its members will continue to be selected through open calls for expressions of interest, with terms of office set at five years, renewable once. The Management Board may authorise the co-option of additional members or external experts depending on workload (Article 14).
Organizational structure of ECHA
The governance of ECHA is further strengthened through clearer rules regarding its management bodies.
- Executive Director:
The rules on appointment, performance evaluation, and accountability of the Executive Director are clarified (Article 11). New tasks include preparing the ECHA's financial rules and facilitating coordination between scientific committees in cases of divergent opinions (Article 12).
- Management Board:
Member States exercise oversight via the Management Board, which retains key responsibilities such as appointing the Executive Director, RAC and SEAC members, and the Board of Appeal. The Board will also adopt the Agency's annual activity report and approve the rules of procedure for all ECHA committees and working groups (Articles 7–10).
Financial Provisions
To enhance ECHA's financial sustainability, several changes are proposed:
- Removal of segregated budgets:
The current requirement to maintain separate budgets under Article 78(2) BPR, Article 24(2) PIC, and Article 16(2) POPs is deleted. This consolidation aims to streamline financial management and increase flexibility.
- Periodic evaluations:
The Proposal mandates a first evaluation within two years of entry into force and subsequent evaluations every five years. These reviews will assess the effectiveness and efficiency of ECHA, its working practices, structure, scope of action, and financial implications, while also contributing to public trust.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
