The Council of the European Union (EU) announced on June 12, 2025, that it reached a provisional agreement with the European Parliament (EP) on the “one substance, one assessment” (OSOA) legislative package, “which aims to streamline assessments of chemicals across relevant EU legislation, strengthen the knowledge base on chemicals, and ensure early detection and action on emerging chemical risks.” The package contains three proposals: a directive concerning the re-attribution of scientific and technical tasks; a regulation aimed at enhancing cooperation among EU agencies in the area of chemicals; and a regulation establishing a common data platform on chemicals. According to the Council, the co-legislators maintain the objectives of the European Commission’s (EC) legislative package but expanded the information available in the common platform to include scientific data submitted voluntarily, clarified the treatment of medical data, and ensured that the content of the platform will be publicly available. The provisional agreement will now be considered by the Council of the EU and the EP for formal adoption.

According to the press release, the OSOA package would create a common platform to integrate existing databases and provide a “one-stop shop” for chemical data from EU agencies and the EC. The platform would allow one legislative area to share knowledge with another and would mandate the systematic collection of human biomonitoring data to inform policymakers about chemical exposure levels. The press release notes that a monitoring and outlook framework “will detect chemical risks early, support fast regulatory responses, and track impacts through an early warning system and indicators.” It would also empower the European Chemicals Agency (ECHA) to generate data when needed and ensure transparency of scientific studies.

Under the agreement, the platform, hosted by ECHA, would provide access to all chemical data generated or submitted as part of the implementation of “about” 70 pieces of EU legislation. The agreement requires ECHA to create and manage a database, inside the common data platform, that lists alternatives to substances of concern. The database should include alternative technologies and materials that do not require such substances of concern. The agreement specifically supports the voluntary submission of scientific data to be included in the platform.

The press release states that the agreement considers that certain categories of newly generated data relating to chemical substances present in medicinal products from the European Medicines Agency (EMA) must also be addressed. According to the press release, the EC will assess whether to add further categories of chemical data related to medicinal products (for instance, other elements than active substances, substances that are now considered non-relevant, or data held by national agencies) in the future. The press release notes that the co-legislators agreed that legacy data from EMA (i.e., data generated and submitted before the entry into force of the regulation) would be gradually integrated into the platform, starting six years after the regulation enters into force.

Under the agreement, the platform would provide access to data that are already public, in line with the rules of the originating legal acts. The press release notes that the OSOA package will help ECHA, and other agencies, to generate studies for multiple purposes. The agreement proposes that four years after the regulation on the common data platform enters into force, ECHA should commission an EU-wide human biomonitoring study to understand better the population’s exposure to chemicals. Human biomonitoring data from the EU and national research programs will also be included in the platform.

Commentary

OSOA is part of the 2020 Chemicals Strategy for Sustainability (the CSS), a key building block of the European Green Deal. As a core element of the European Green Deal’s zero pollution ambition, the CSS aims to strengthen protection for people and the environment while driving innovation toward safer and more sustainable chemicals. One of the goals of the CSS is to simplify and consolidate the EU regulatory framework on chemicals, and OSOA is intended to establish a simpler process for assessing chemical risks and hazards.