The EU Council has published a revised compromise text for a regulation establishing a common data platform on chemicals, a key component of the 'One Substance, One Assessment' (OSOA) initiative. The platform aims to consolidate fragmented chemical data from various EU agencies into a single digital infrastructure to improve human health and environmental protection through more coherent risk assessments. The proposal, part of the European Green Deal and Chemicals Strategy for Sustainability, includes stepwise integration of data on active substances from medicinal products and differentiated access rules for authorities and the public.
Document Details and Scope The document, dated 27 May 2024, is a meeting document under interinstitutional file 2023/0453 (COD). It proposes a regulation of the European Parliament and of the Council. The platform's scope covers data from multiple EU agencies, with a phased approach for including medicinal product data. Access rules distinguish between full access for competent authorities and restricted public access, balancing transparency with confidentiality.
Policy Orientations and Trade-offs The proposal navigates several cleavages: increasing EU regulatory integration vs. national sovereignty, as the platform centralizes data management; consumer protection vs. business competitiveness, as stricter data requirements may impose costs on industry; and transparency vs. privacy, as public access to chemical data must respect commercial confidentiality. The stepwise inclusion of medicinal product data reflects a compromise between comprehensive coverage and practical implementation.
Impact on Stakeholders - EU regulatory bodies: Gain streamlined access to comprehensive data, improving risk assessment efficiency. - Chemical and pharmaceutical industries: Face new compliance costs for data submission and potential disclosure of sensitive information, but benefit from harmonized standards. - National authorities: Must adapt to centralized data sharing, potentially reducing administrative burdens. - Public and NGOs: Gain improved access to chemical information, enhancing transparency and accountability.
Institutional Follow-up The Council will continue negotiations with the European Parliament under the ordinary legislative procedure. The Parliament's ENVI committee is expected to adopt its position, followed by trilogue discussions. The regulation's adoption is anticipated by late 2025, with phased implementation starting in 2026.
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