The EU Council formally adopted the 'One Substance, One Assessment' (OSOA) regulation on 13 May 2024, a legislative package aimed at harmonising chemical safety assessments across multiple EU laws. The regulation consolidates scientific tasks within the European Chemicals Agency (ECHA) and mandates enhanced cooperation between EU agencies, including the European Food Safety Authority (EFSA), the European Medicines Agency (EMA), and the European Environment Agency (EEA). The move is designed to improve efficiency, coherence, and transparency in chemical evaluations, reducing duplication and conflicting scientific opinions.
Key Provisions and Institutional Changes
Regulation (EC) No 178/2002 (General Food Law), (EC) No 401/2009 (EEA founding regulation), (EU) 2017/745 (Medical Devices), and (EU) 2019/1021 (Persistent Organic Pollutants). A central element is the transfer of certain scientific tasks from other agencies to ECHA, which will become the primary hub for chemical hazard assessments. The regulation also establishes new procedures to resolve diverging scientific opinions between agencies, aiming to prevent contradictory hazard classifications that have previously caused regulatory uncertainty. Additionally, it mandates improved data sharing and joint working arrangements among the four agencies.
Policy Orientations and Trade-offs
The regulation strikes a balance between centralisation and agency autonomy. By concentrating expertise in ECHA, the EU aims to achieve greater consistency, but some stakeholders have raised concerns about potential bottlenecks and the loss of sector-specific knowledge at EFSA and EMA. The new dispute resolution mechanism is intended to ensure scientific disagreements are settled transparently, though critics argue it could slow down assessments. The regulation also includes provisions to protect confidential business information while increasing public access to chemical data, reflecting a trade-off between transparency and industry competitiveness.
Impact on Stakeholders
- EU regulatory bodies: ECHA gains expanded responsibilities and resources, while EFSA and EMA lose some chemical assessment tasks, potentially affecting their workload and expertise. The new cooperation requirements may increase administrative burdens. - Chemical industry: Companies face a more streamlined but potentially more stringent assessment process. Harmonised hazard classifications could reduce compliance costs across sectors, but the centralisation may lead to stricter interpretations of chemical risks. - EU consumers and public health: Improved coherence and transparency in chemical safety assessments should enhance protection, as conflicting opinions are resolved and data sharing reduces gaps. However, the transition period may cause temporary delays in new chemical approvals. - Environmental NGOs: The regulation is welcomed for increasing transparency and data access, but some groups argue it does not go far enough in requiring substitution of hazardous chemicals or in strengthening the precautionary principle.
Institutional Follow-up
The regulation will now be published in the EU Official Journal and enter into force 20 days later. Implementation will be phased, with ECHA required to set up new working arrangements within 18 months. The European Commission will monitor the system's performance and report to the European Parliament and Council within five years, potentially proposing further amendments. The Parliament had earlier supported the OSOA approach in a resolution, and the Council's adoption marks the final legislative step.
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