The EU Council has published a contribution document detailing member state comments on the 'One Substance One Assessment' (OSOA) initiative, which seeks to harmonise chemical assessments across EU regulatory frameworks. The document, dated 2 October 2026, includes proposals led by Denmark for clarifications on data platform governance, confidential information handling, and procedural timelines for chemical evaluations.
The contribution stems from discussions within the Council's Working Party on the Environment, focusing on three legislative proposals (2023/0453-0455 COD) to establish a common data platform for chemicals, as well as amendments to Directive 2011/65/EU on hazardous substances in electrical equipment (RoHS). The OSOA initiative aims to streamline chemical safety assessments, reduce duplication, and improve data sharing among EU agencies and member states.
Key policy orientations and trade-offs
Delegations, notably Denmark, have submitted detailed comments seeking to refine the proposals. Key issues include governance of the common data platform, where some member states advocate for stronger central oversight to ensure data quality, while others prioritise flexibility for national authorities. On confidential information, there is a push to balance transparency for public health with protection of business-sensitive data. Procedural timelines for assessments are also contested: some delegations favour shorter deadlines to accelerate regulatory decisions, while others warn of administrative burdens and insufficient resources.
Impact on stakeholders
The OSOA reforms will have significant implications for several groups:
- EU chemical producers face potential new compliance costs from harmonised data requirements and shorter assessment timelines, but may benefit from reduced duplication across member states.
- National regulatory authorities will need to adapt to a common platform and potentially tighter deadlines, requiring investment in IT systems and training.
- EU consumers and environmental NGOs stand to gain from improved transparency and faster identification of hazardous substances, enhancing public health protection.
- EU institutions (ECHA, EFSA, EEA) will see expanded roles in data management and assessment coordination, requiring additional resources and staff.
Expected institutional follow-up
The Council's contribution will inform ongoing trilogue negotiations between the Council, European Parliament, and European Commission. The Parliament is expected to adopt its position in early 2027, with final adoption of the OSOA package likely by late 2027. The RoHS amendment may follow a separate timeline.