The EU Council has advanced the 'One Substance, One Assessment' (OSOA) legislative package, aiming to streamline chemical assessments for a more efficient regulatory framework. The proposals, published on 2 October 2026, focus on establishing a common data platform for chemicals, with the Council Presidency proposing compromises on personal data protection, Member State governance, medicinal product data scope, and animal testing provisions.
The discussion took place during a Council meeting on 13 May 2024, resulting in a meeting document that outlines the Presidency's proposed orientations. The OSOA package consists of three Commission regulations (2023/0453-0455 COD) designed to harmonise data sharing and assessment procedures across EU agencies.
Key Policy Orientations and Trade-offs The Presidency's proposals address several contentious issues. On personal data protection, the Council seeks to balance transparency with privacy, potentially limiting access to certain data. Member State involvement in governance is strengthened, giving national authorities more say in the platform's operation. The scope of medicinal product data is narrowed, excluding some pharmaceutical information to avoid duplication with existing frameworks. Provisions on animal testing aim to reduce redundancy, though critics argue they may not go far enough.
Impact on Stakeholders - EU chemical industry: Faces new compliance costs for data submission but benefits from streamlined assessments and reduced duplication. - National regulatory authorities: Gain enhanced governance roles, increasing their influence but also administrative burden. - Animal welfare NGOs: Welcome reduced animal testing but may push for stricter bans. - Pharmaceutical sector: Excluded from some data-sharing requirements, reducing regulatory overlap but potentially slowing cross-sector chemical safety insights.
Expected Institutional Follow-up The Council will continue negotiations with the European Parliament, which is expected to propose amendments on data access and animal testing. Trilogue discussions are anticipated in early 2027, with adoption possible by mid-2027.
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