EU member states are debating the proposed Regulation to establish a common data platform on chemicals, a central element of the 'One Substance One Assessment' (OSOA) policy package, according to a Council contribution document published on 2 October 2026. The platform aims to centralise and standardise chemicals data to make it findable, accessible, interoperable, and reusable (FAIR), thereby improving chemical safety assessments and policy coherence across the EU. Key points of contention among member states include the legal procedures for adopting implementing acts, the scope of data inclusion—particularly regarding medicinal products—and the functioning of an early warning system for chemical risks.
Legal procedures and implementing acts
Member states are divided on the legal procedures for adopting implementing acts under Articles 4, 14, and 15 of the proposed Regulation. Some delegations advocate for the use of the examination procedure under Regulation (EU) No 182/2011 (comitology), which gives member states a stronger role in oversight, while others prefer the advisory procedure, which grants the Commission more flexibility. The choice of procedure will affect the balance of power between the Commission and member states in shaping the platform's technical rules, data standards, and operational details.
medicinal products
A significant area of disagreement concerns the inclusion of data on medicinal products in the platform. The current text of Article 3 and the Annexes would require the inclusion of certain data on active pharmaceutical ingredients and excipients. Several member states have raised concerns about potential overlaps with existing EU pharmaceutical legislation and data protection frameworks, arguing that such inclusion could create legal uncertainty and administrative burdens for the pharmaceutical industry. Others support broad data inclusion to ensure comprehensive chemical risk assessment, particularly for endocrine disruptors and persistent pollutants.
Early warning system for chemical risks
Article 19 of the proposal establishes an early warning system for emerging chemical risks, enabling rapid information exchange among member states, the European Chemicals Agency (ECHA), and the Commission. While there is broad support for the system in principle, member states differ on its operational details. Some delegations call for a mandatory notification obligation for all new chemical risks, while others prefer a voluntary approach to avoid overburdening national authorities. The threshold for triggering an alert and the role of ECHA in verifying and disseminating warnings are also under discussion.
Impact on stakeholders
The proposed Regulation will have significant implications for several stakeholder groups. EU regulatory bodies such as ECHA and the European Food Safety Authority (EFSA) will gain access to a centralised, FAIR-compliant data repository, improving the efficiency and consistency of chemical risk assessments. National authorities of EU member states will face new obligations to submit data in standardised formats, potentially requiring investments in IT systems and training. EU chemical producers and downstream users will benefit from reduced duplication of testing and streamlined regulatory submissions, but may incur costs to adapt data management practices to the new platform's requirements. The pharmaceutical industry specifically faces potential additional data-sharing obligations for medicinal products, which could raise concerns about intellectual property and commercial confidentiality.
Expected institutional follow-up
The Council is expected to continue discussions in the Working Party on the Environment, with a view to reaching a general approach in the coming months. The European Parliament is also preparing its position, with the ENVI Committee expected to adopt a report in early 2027. The final Regulation will require approval from both the Council and the Parliament under the ordinary legislative procedure.
← Atlas › News › Environment