The EU Council has published a contribution document dated 2 October 2026, outlining member state positions on the 'One Substance One Assessment' (OSOA) legislative package, which aims to streamline chemicals assessment and data sharing across the bloc. The document details proposals for a common data platform on chemicals and the reattribution of scientific tasks to the European Chemicals Agency (ECHA), with significant input from Denmark, France, and Sweden.
Denmark's Proposal on Medicinal Product Data Denmark has submitted a detailed proposal advocating for the integration of medicinal product data into the common data platform. This would expand the scope of the OSOA package beyond industrial chemicals to include pharmaceuticals, potentially improving cross-sectoral risk assessment but raising concerns about data confidentiality and administrative burden for the pharmaceutical industry.
France's Flexible Implementation Approach France supports flexible implementation timelines and broader data inclusion, arguing that a phased approach would allow member states and industry to adapt without disrupting ongoing operations. This position reflects a trade-off between ambition and pragmatism, aiming to balance public health protection with economic competitiveness.
Sweden's Emphasis on EMA's Role in Biomonitoring Sweden has stressed the need to clarify the European Medicines Agency's (EMA) role in human biomonitoring, suggesting that overlapping responsibilities between ECHA and EMA could lead to inefficiencies. Sweden's intervention highlights a cleavage between expanding EU agency powers and maintaining clear institutional boundaries.
Policy Orientations and Trade-offs The OSOA package represents a significant step toward harmonising chemical assessments, but member state positions reveal tensions between data comprehensiveness and operational feasibility. Denmark's push for pharmaceutical data inclusion could enhance public health protection but may increase costs for drug manufacturers. France's call for flexibility may ease implementation but risks delaying full harmonisation. Sweden's focus on EMA's role underscores concerns about regulatory duplication.
Impact on Stakeholders - EU regulatory bodies (ECHA, EMA): Would gain expanded mandates but face coordination challenges, potentially increasing administrative complexity. - Chemical and pharmaceutical industries: Could face higher compliance costs due to broader data requirements, but may benefit from streamlined assessment processes in the long term. - National authorities: Would need to adapt to new data-sharing obligations, with varying capacities across member states. - EU consumers and civil society: Stand to benefit from improved chemical safety and transparency, though impacts are indirect and long-term.
Expected Institutional Follow-up The Council contribution will feed into ongoing trilogue negotiations with the European Parliament, which has yet to adopt its position. The European Commission is expected to revise its proposals based on member state feedback, with a final vote anticipated in 2027.
← Atlas › News › Environment