The Council of the European Union on 13 May 2024 adopted a regulation establishing a common data platform on chemicals, aiming to implement the 'one substance, one assessment' approach and improve coherence and transparency of chemical safety assessments across the EU. The decision will impact chemical producers, importers, and downstream users, as well as national authorities and EU regulatory bodies, by centralising data submission and access.
The regulation (Interinstitutional file 2023/0453 (COD)) was adopted by the Council as a legislative act, making it mandatory for all EU member states. It sets concrete requirements for data sharing, including differentiated access rights: authorities will have full access, including to confidential information, while public access will be restricted to non-confidential data. A stepwise approach will be used to include data from medicinal products, starting with active substances and later expanding to other components.
Policy orientations and trade-offs
The regulation balances transparency with protection of confidential business information. Granting authorities full access enhances regulatory oversight and risk assessment capabilities, supporting the Chemicals Strategy for Sustainability and the European Green Deal. However, restricting public access may limit scrutiny by civil society and researchers, raising concerns about accountability. The stepwise inclusion of medicinal product data addresses industry concerns about intellectual property and competitive sensitivity, but delays full integration of health-related chemical data.
Impact on stakeholders
- EU chemical producers and importers: Will face new data submission obligations, increasing compliance costs, but benefit from streamlined, harmonised assessment procedures across member states, reducing duplication.
- National authorities: Gain comprehensive access to chemical data, improving their ability to assess risks and enforce regulations, but must manage the technical and administrative burden of the new platform.
- EU consumers and civil society: Indirectly benefit from more coherent safety assessments, but limited public access to confidential data may reduce transparency and trust.
- Pharmaceutical industry: Subject to a phased inclusion of medicinal product data, which protects sensitive information initially but may lead to future obligations.
Expected institutional follow-up
The regulation will now be published in the Official Journal and enter into force 20 days later. The European Commission will be responsible for developing the technical platform and implementing the stepwise data inclusion. The European Parliament and Council will monitor implementation, with potential for further refinement as the platform evolves.