Regulatory Developments

EC Opens Call for Evidence on a Proposal for a Basic Regulation for ECHA

September 28, 2022

On September 12, 2022, the European Commission (EC) opened a call for evidence on a proposal for a basic regulation for the European Chemicals Agency (ECHA). According to the EC, this initiative aims to strengthen ECHA governance and adapt it to its future role, as well as streamline the working methods of ECHA bodies and make their financing more sustainable. Responses are due October 10, 2022. The EC plans to adopt a regulation in the second quarter of 2023.

Title X of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation (No. 1907/2006) established ECHA and set out its composition, tasks, and powers, as well as its budget. Since then, ECHA has been entrusted with additional technical, scientific, and administrative tasks arising from other legislation and agreements signed with the EC (e.g., Service Level Agreement for the provision of opinions on occupational exposure limits (OEL)). One of the goals of the EC’s ambitious Chemicals Strategy for Sustainability (CSS), published on October 14, 2020, is to simplify and consolidate the European Union (EU) regulatory framework on chemicals. To coordinate and simplify actions across EU chemical legislation, the CSS calls for the EC to take several actions, including proposing “to strengthen the governance of the European Chemicals Agency and increase the sustainability of its financing model.”

According to the call for evidence, the legal framework of ECHA and its bodies, particularly the Committee for Risk Assessment (RAC), the Committee for Socio-economic Assessment (SEAC), and the Enforcement Forum, need to be clarified to enable ECHA to meet its future obligations and maintain its independence. The call for evidence notes that in the future, RAC will issue scientific opinions on chemical substances based on existing tasks and tasks deriving from initiatives under preparation:

The call for evidence states that a sustainable financial framework for ECHA must also be established, with less administrative burden and more flexibility. ECHA’s resources currently come from three distinct budgets with relatively little flexibility between them: REACH and CLP; the Biocidal Products Regulation (BPR); and the environmental and international conventions. The call for evidence notes that the income from fees has “significantly declined,” in particular the fees collected by ECHA under REACH. Because the fees paid by industry vary substantially year by year, ECHA cannot estimate the need for a balancing contribution from the EU budget, complicating planning budget and work.

The initiative will adjust the mandate and structure of ECHA by simplifying and clarifying the rules under which ECHA operates. It will also improve ECHA’s governance by consolidating ECHA’s purpose, clarifying its expected results, and optimizing and rationalizing how ECHA’s bodies operate. ECHA’s mandate would be adjusted as a result of the adoption of the proposal for a regulation (re)attributing tasks to agencies. This initiative includes the tasks undertaken by ECHA under agreements with the EC that have become structural and need to be part of ECHA mandate. This initiative will also clarify how ECHA works with other agencies that are also involved in chemical safety assessments, including the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA).

The initiative also aims to introduce a sustainable financing model to ensure flexibility and an optimal use of the combined resources of ECHA coming from different parts of the EU budget. According to the call for evidence, ECHA’s income from fees and charges, combined with an EU contribution to balance its budget, should become more stable and cover all of ECHA’s operations. The initiative will consider repealing the provisions in different pieces of legislation to create one budget for ECHA. This budget could be supported by new revenue sources, such as new fee types on certain operations related to the manufacturing, import, or use of chemicals, reflecting the work carried out by ECHA. The call for evidence states that such options are being considered as part of ongoing revisions of legislation, in particular REACH.

The EC is collecting evidence from several sources, including member states and ECHA reports, “in particular the 2021 edition of the report that the Agency must submit every 5 years on the operation of REACH and CLP.” The EC will also study the evidence collected under other initiatives implementing the CSS and entrusting ECHA with tasks.

Commentary

During the 15 years since ECHA was created in 2007, its structure, authority, and funding have not kept pace with the increasing breadth and complexity of its mission. The need for this initiative to strengthen ECHA governance, adapt it to its present and future roles, and streamline the working methods of ECHA bodies has been recognized for many years by the regulators and the regulated community. The ambitious goals of the CSS require improved alignment of ECHA’s scientifically rigorous safety assessments with implementation and enforcement of risk management decisions more quickly, and in a manner that is not only comprehensive and efficient, but consistent and coherent across various EU chemicals regulations.

Maintaining ECHA’s independence while providing an operational structure that facilitates communication among the RAC, SEAC, SCCS, SCHEER, Enforcement Forum, and member states is key to achieving the goals of the CSS, as well as avoiding problems and delays in setting enforceable limits, when appropriate, on the uses of chemicals.

While it is important to provide a more sustainable financing mechanism so that ECHA can perform the broad range of its assigned tasks successfully, a mechanism that is fair and reasonable but does not place undue financial burdens on the regulated community will be challenging.


 
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