The EU Council has published a meeting document detailing the 'One Substance, One Assessment' (OSOA) initiative, which aims to harmonise chemical safety assessments across EU legislation. The proposal seeks to amend several regulations—(EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745, and (EU) 2019/1021—to re-attribute scientific tasks and improve cooperation among EU agencies. This initiative is part of the EU's Chemicals Strategy for Sustainability and impacts chemical producers, downstream users, and regulatory bodies.
The document, dated 27 May 2024, is a meeting document from the Council of the European Union. It outlines legislative proposals to consolidate technical work on chemicals within the European Chemicals Agency (ECHA), establish stronger mandates for agencies to develop common assessment methodologies and data formats, and introduce new procedures to resolve diverging scientific opinions between agencies.
Policy orientations and trade-offs The OSOA initiative aims to increase efficiency and consistency in chemical safety assessments, reducing duplication and conflicting results. However, it may centralise authority in ECHA, potentially reducing the role of other agencies like the European Food Safety Authority (EFSA) or the European Medicines Agency (EMA). This trade-off between harmonisation and agency autonomy is a key point of discussion.
Impact on stakeholders - EU chemical producers: May benefit from clearer, more consistent assessment procedures, reducing compliance costs and uncertainty. However, they could face increased scrutiny if ECHA adopts stricter standards. - EU consumers: Likely to gain from improved chemical safety and transparency, as harmonised assessments could lead to better protection from hazardous substances. - EU regulatory bodies (ECHA, EFSA, EMA): ECHA's role would expand, while EFSA and EMA may lose some scientific tasks, potentially leading to internal restructuring and resource reallocation. - EU civil society and NGOs: May welcome increased transparency and consistency, but could criticise any perceived weakening of precautionary approaches if harmonisation leads to lower standards.
Expected institutional follow-up The document is a basis for further discussion within the Council. The European Parliament will also need to consider the proposals under the ordinary legislative procedure. Stakeholders are expected to provide input during the legislative process, with the aim of finalising the reforms in the coming years.
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