EU Parliament Adopts ‘One Substance, One Assessment’ Package to Streamline Chemical Regulation (Updated)

Update 13 November 2025:
The Council of the European Union has today formally approved the One Substance, One Assessment (OSOA) legislative package, marking the final political step before publication in the Official Journal. Once published, the three acts will enter into force 20 days later. The package introduces a harmonised assessment process across EU chemicals legislation and foresees the creation of a common data platform, which must become operational within three years of entry into force.

Original News:

On 21 October 2025, the European Parliament adopted three legislative resolutions forming the core of the One Substance, One Assessment (OSOA) initiative. The package aims to simplify and harmonise the evaluation of chemicals across the EU by improving data accessibility, strengthening coordination among EU agencies, and transferring certain scientific and technical tasks to the European Chemicals Agency (ECHA).

Common Data Platform on Chemicals

The first regulation (P10_TA(2025)0235) establishes a common data platform on chemicals to consolidate information on hazard properties, uses, emissions, presence in the environment, and human exposure. The platform will also include data on safer alternatives and will apply the FAIR principles (findable, accessible, interoperable, and reusable) to ensure consistency and transparency in chemical data. It also establishes a monitoring and outlook framework to support the early identification of emerging chemical risks.

Re-attribution of Tasks to ECHA

The second act (P10_TA(2025)0236) reallocates specific scientific and technical tasks from the European Commission and other bodies to ECHA. These include assessing exemption requests under the Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU, coordinating technical reviews, and publishing non-confidential application information. A twenty-month transition period is foreseen to enable the transfer of responsibilities and resources.

Strengthened Inter-Agency Cooperation

The third text (P10_TA(2025)0237) amends several existing EU regulations to strengthen cooperation among EU agencies involved in chemical safety, food safety, environmental protection, and product regulation. These include:

• Regulation (EC) No 178/2002 (General Food Law Regulation)
• Regulation (EC) No 401/2009 (European Environment Agency Regulation)
• Regulation (EU) 2017/745 (Medical Devices Regulation)
• Regulation (EU) 2019/1021 (Persistent Organic Pollutants Regulation)

The amendments introduce mechanisms for data exchange, coordinated scientific assessments, and the resolution of divergent scientific opinions.

Next Steps

These measures aim to eliminate the duplication of chemical assessments, improve regulatory efficiency, and enhance the scientific coherence of EU chemicals legislation. This is in line with the objectives of the Chemicals Strategy for Sustainability and the zero-pollution ambition of the European Green Deal.

Following Parliament’s approval, the package awaits formal adoption by the Council of the European Union before entering into force. Each act will enter into force following publication in the Official Journal of the European Union, typically twenty days after publication, unless otherwise specified.