The EU Council has published a contribution from Spain and Portugal detailing their positions on the 'One Substance One Assessment' (OSOA) legislative package, which aims to harmonise chemical safety assessments across EU laws. The comments, submitted ahead of upcoming negotiations, include requests for mandatory consultation of medical device experts, concerns over data confidentiality in the proposed Common Data Platform, and calls for adequate resources for the European Chemicals Agency (ECHA).
Document Details
The contribution, dated 2 October 2026, was submitted by Spain and Portugal to the Council's Environment Working Party. It addresses three key legislative proposals: amendments to the RoHS Directive, the POPs Regulation, and the establishment of a Common Data Platform on chemicals. The document is a non-binding input intended to shape the Council's negotiating position.
Policy Orientations and Trade-offs
Spain and Portugal advocate for stronger integration of medical device expertise in chemical assessments, arguing that current procedures lack mandatory consultation of relevant experts. This would increase regulatory coordination but could slow down assessment timelines. On the Common Data Platform, they raise concerns about balancing data confidentiality for businesses with public access to information, highlighting a trade-off between transparency and commercial secrecy. They also stress the need for sufficient funding and staff for ECHA to handle expanded responsibilities, pitting resource allocation against the ambition of the OSOA reforms.
Impact on Stakeholders
- EU regulatory bodies (ECHA): Would face increased workload and need for additional resources, potentially straining budgets if not adequately funded. - Medical device manufacturers: Could benefit from more consistent safety assessments but may face longer approval times due to mandatory expert consultations. - Chemical industry: May experience higher compliance costs from stricter data confidentiality rules on the platform, but also gain from streamlined assessments across legislation. - Civil society and public health groups: Would gain improved access to chemical data, enhancing transparency and oversight, though some data may remain confidential.
Institutional Follow-up
The Council will use these comments to refine its general approach on the OSOA package. The European Parliament is expected to adopt its position in early 2027, followed by trilogue negotiations. The Commission has signalled its intention to finalise the legislation by end of 2027.
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