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Friday, December 12, 2025European Commission

Implementation of the “One substance, one assessment” package

Mise en place du pack "Une substance, une évaluation"

On December 12, 2025, two Regulations and a Directive were published in the Official Journal of the European Union. This marks the implementation of the “One Substance, One Assessment” initiative, with the creation of a common data platform on chemicals and the reallocation of scientific and technical tasks to ECHA.

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The initiative “One substance, one assessment” is a commitment by the European Commission, expressed in the European Green Deal in 2009 and detailed in the Chemicals Strategy for Sustainable Development.
Its aim is to de synchronise and coordinate regulatory measures and safety assessments as far as possible, to have the tasks carried out by the parties best placed to make the best use of available resources and expertise, and to make methodologies consistent and harmonised. All this is achieved by applying the FAIR (Findable, Accessible, Interoperable, and Reusable) principle to data.
The three texts published on December 12, 2025, are the result of this process.

Regulation (EU) 2025/2455
It establishes a common data platform on chemicals, lays down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlooks framework for chemicals.
It is intended to bring together all their data on chemicals currently held by the Commission and European agencies. This platform and its specialized services will be managed by ECHA and must be established by January 2, 2029, at the latest.

Regulation (Eu) 2025/2457
It amends Regulations (EC) No.178/2002 (on food law and EFSA), (EC) No.401/2009 …

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