The EU Council has published a meeting document detailing the 'One Substance, One Assessment' (OSOA) policy, which aims to harmonise chemical safety assessments across EU legislation. The document, dated 4 December 2024, outlines proposed amendments to several regulations to re-attribute scientific tasks and enhance cooperation among EU agencies, with the European Chemicals Agency (ECHA) set to take on a more central role. This initiative supports the Chemicals Strategy for Sustainability and the European Green Deal, impacting chemical producers, downstream users, and regulatory bodies.
Document Details and Scope The document, released by the Council, is a meeting document that summarises the legislative proposal to amend Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745, and (EU) 2019/1021. The proposed changes are mandatory and include concrete measures such as consolidating technical work on chemicals within ECHA, introducing new mandates for agencies to cooperate on assessment methodologies and data exchange, and establishing procedures to resolve diverging scientific opinions between agencies.
Policy Orientations and Trade-offs The OSOA policy seeks to increase efficiency and consistency in chemical safety assessments, reducing duplication and conflicting outcomes. However, it also involves a trade-off between centralisation and agency autonomy: while ECHA gains more authority, other agencies like the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA) may see their roles adjusted. This could streamline processes but also raise concerns about over-centralisation and loss of sector-specific expertise.
Impact on Stakeholders - EU chemical producers: May benefit from clearer, faster assessments but could face higher compliance costs if ECHA demands additional data. - EU consumers: Stand to gain from improved safety and transparency of chemical products. - EU regulatory bodies (ECHA, EFSA, EMA): ECHA's role expands, while others may need to adapt to new cooperation frameworks, potentially straining resources. - EU downstream users (e.g., manufacturers using chemicals): Could experience more predictable regulatory outcomes but may face delays during transition.
Expected Institutional Follow-up The Council document is a preparatory step; the legislative proposal will now be discussed by the European Parliament and the Council under the ordinary legislative procedure. The European Commission is expected to present a formal proposal, followed by negotiations among the institutions. The OSOA reform is part of a broader push under the European Green Deal to modernise EU chemicals regulation.
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