A contribution document published by the EU Council on 2 October 2026 reveals that member states, led by Denmark and Germany, are demanding greater involvement in the 'One Substance, One Assessment' (OSOA) package, which aims to harmonise chemical safety evaluations across EU legislation. The document shows delegations seeking a formal role in selecting chemicals for monitoring and commissioning studies under the European Chemicals Agency (ECHA), while raising concerns about capacity, budget, and legal clarity.
The OSOA package, proposed by the European Commission in 2023 (proposals 2023/0453-0455 COD), seeks to streamline scientific assessments of chemicals across regulatory frameworks for industrial chemicals, food safety, and medical devices. The current Council contribution reflects ongoing negotiations among member states before the package proceeds to interinstitutional talks.
Key member state positions Denmark and Germany, supported by several other delegations, have submitted detailed comments requesting stronger member state control over ECHA's new tasks. This reflects a tension between centralised EU-level efficiency and national sovereignty over chemical risk management. Several delegations also questioned whether ECHA has sufficient capacity and budget to handle the additional workload, suggesting the Commission should provide a detailed impact assessment and secure adequate funding.
Calls for legal clarity and transition periods The contribution highlights demands for clearer legal text to avoid ambiguities in the amended regulations. Some member states requested extended transition periods to allow national authorities and industry to adapt to new requirements. This indicates a split between those prioritising swift implementation of harmonised assessments and those concerned about administrative burden and compliance costs.
Impact on stakeholders - EU regulatory bodies (ECHA): The agency would gain new responsibilities but faces scrutiny over its capacity and budget. Member state demands for oversight could slow decision-making but also enhance legitimacy. - National authorities of EU countries: They would have a stronger say in chemical prioritisation and study commissioning, but may face increased workload and resource demands. - EU chemical industry: Companies may benefit from streamlined assessments and reduced duplication, but could face higher costs from new data requirements and longer transition periods if adopted. - EU consumers and civil society: Harmonised assessments could improve chemical safety and transparency, but delays due to extended transitions or capacity constraints might postpone health and environmental benefits.
Next steps The Council is expected to continue discussions on the OSOA package in the coming months, aiming to reach a general approach before entering trilogue negotiations with the European Parliament. The Commission will need to address member state concerns on budget, capacity, and legal clarity to secure adoption.
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