The Council of the European Union has published a contribution from Austria on the 'One Substance, One Assessment' (OSOA) legislative package, dated 2 October 2026. The document outlines Austria's general support for the Presidency's compromise text while raising specific concerns on delegated acts, medicinal product scope, and internal company data.
Background and General Position The OSOA package, proposed by the European Commission in 2023 (proposals 2023/0453-0455 COD), seeks to centralise chemical safety evaluations to improve efficiency and consistency. Austria broadly endorses the Presidency's compromise text, signalling a constructive approach to advancing the legislation. However, the contribution highlights several areas where further adjustments are needed.
Key Concerns Raised by Austria Austria emphasises the importance of Member State involvement in delegated acts, advocating for a stronger role for national experts in shaping implementing rules. This reflects a tension between EU-level harmonisation and national sovereignty, as some Member States seek to retain influence over technical decisions. On scope, Austria questions the inclusion of medicinal products, arguing that existing sector-specific regulations may already address safety assessments adequately. Additionally, Austria supports excluding certain internal company data from notification requirements, citing concerns over administrative burden and business confidentiality.
Trade-offs and Stakeholder Impact The OSOA package presents several trade-offs. For EU regulatory bodies, centralisation could improve efficiency but may reduce flexibility. National authorities face potential loss of control over delegated acts, while gaining access to more consistent data. For pharmaceutical companies, inclusion of medicinal products could increase compliance costs, but exclusion may leave gaps in oversight. Chemical producers benefit from reduced notification burdens for internal data, but may face stricter harmonised standards. Environmental and health NGOs may welcome streamlined assessments but could criticise any exemptions that limit transparency.
Next Steps The OSOA package will continue to be discussed in the Council's working parties, with the European Parliament also expected to adopt its position. The Austrian contribution will inform further negotiations, aiming for a final agreement under the current or next Presidency.
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