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At the end of 2025, the European Union finalised a series of legislative measures under the One Substance, One Assessment (OSOA) framework, marking a significant shift in EU chemicals governance. Adopted in November and December 2025, the reforms enter into force at the start of 2026, moving from legislation to implementation. The European Chemicals Agency (ECHA) will take on an expanded operational role in this process.

Common Data Platform on Chemicals Becomes Operational Focus

A central element of the OSOA package is the establishment of a common data platform on chemicals, which will be operated by ECHA. The platform is intended to function as a one-stop shop for chemicals data, centralising regulatory, monitoring, and study-related information that is currently dispersed across EU legislation and authorities. It will support early warning and monitoring functions, facilitate data reuse, and improve transparency for regulators, industry and the public.

ECHA will develop and manage the platform in close cooperation with other EU bodies, including the European Food Safety Authority (EFSA), the European Environment Agency (EEA), the European Medicines Agency (EMA) and the European Agency for Safety and Health at Work (EU-OSHA), under a governance framework adopted by the European Commission.

Scientific and Technical Tasks Reassigned to ECHA

In parallel, the OSOA reforms reallocate several scientific and technical responsibilities to ECHA, thereby strengthening consistency across EU product and chemicals legislation. These include the preparation of restriction proposals and assessment of exemption requests under the RoHS Directive, the setting and review of limit values for persistent organic pollutants in waste, and updates to benefit–risk assessment guidance under the Medical Devices Regulation. Transitional arrangements apply, with several of these changes taking effect from 2027.

Governance Reforms Supporting ECHA’s Expanded Mandate

Alongside the OSOA package, EU institutions have proposed a standalone regulation for ECHA, which aims to align the agency’s governance, mandate and financing with its expanding responsibilities across EU chemicals legislation. Together, these measures are intended to support more coherent, efficient and science-based chemical safety assessments across the EU.