EU member states have expressed widespread concerns about the European Chemicals Agency's (ECHA) capacity and governance under the proposed 'One Substance One Assessment' (OSOA) legislative package, according to a Council contribution document published on 2 October 2026. The package aims to streamline chemical assessments by centralising data and reallocating tasks, but several delegations warn that the increased workload could overwhelm ECHA without a corresponding overhaul of its founding regulation.
The Council document, prepared under the Hungarian Presidency, outlines member state positions on three key legislative files: amendments to the RoHS Directive, a regulation re-attributing tasks to ECHA, and a regulation establishing a common data platform on chemicals. While the overall objective of improving efficiency and consistency in chemical regulation enjoys broad support, significant reservations have emerged regarding ECHA's ability to handle the new responsibilities.
Capacity and Governance Concerns
Several delegations, including Germany and Ireland, have called for a future review clause and a new ECHA founding regulation to address governance and resource issues. They argue that the current proposals do not adequately prepare ECHA for the expanded role, potentially leading to bottlenecks and delays in chemical assessments. The concerns reflect a cleavage between the desire for more integrated EU-level chemical oversight and the practical limitations of existing institutional frameworks.
Technical Amendments on Data and Procedures
In addition to capacity issues, member states have proposed technical amendments on data confidentiality, comitology procedures, and the handling of data for medicinal products within the common platform. These proposals aim to balance transparency with the protection of commercially sensitive information, and to ensure that the platform does not inadvertently compromise intellectual property rights in the pharmaceutical sector. The debate highlights a trade-off between regulatory efficiency and business competitiveness, particularly for industries that rely on proprietary chemical data.
Impact on Stakeholders
The OSOA package, if adopted, would have significant implications for EU regulatory bodies, national authorities, chemical producers, and downstream users. For ECHA, the increased workload could strain resources and require a major governance reform. National authorities may face adjustments in their roles as tasks are reallocated to the EU level. Chemical producers, especially in the pharmaceutical and specialty chemicals sectors, could benefit from more consistent assessments but may also face higher compliance costs related to data sharing and confidentiality protections. Consumers and environmental groups stand to gain from improved chemical safety and transparency, though the pace of implementation may be slower if capacity issues are not resolved.
Next Steps
The Council is expected to continue discussions on the OSOA package in the coming months, with the European Parliament also set to weigh in. The outcome will depend on whether member states can agree on a revised framework that addresses ECHA's capacity concerns while maintaining the package's ambition to streamline chemical regulation across the EU.