Brussels, [Insert Date] — In a major step toward modernizing the European Union’s chemicals policy, the Council of the EU and the European Parliament have reached a provisional agreement on the so-called “One Substance One Assessment” (OSOA) package , aimed at simplifying chemical risk assessments, enhancing transparency, and improving data sharing across EU agencies.
The deal marks a significant milestone in the EU’s broader effort to protect human health and the environment from harmful chemical exposures while promoting innovation in safer and more sustainable substances.
A Unified Approach to Chemical Safety
At the heart of the agreement is the creation of a centralized digital platform that will serve as a comprehensive repository for chemical data collected under approximately 70 pieces of EU legislation. Hosted by the European Chemicals Agency (ECHA) , this “one-stop shop” will integrate existing databases, eliminate duplication of efforts, and allow for better coordination among EU agencies and institutions.
“This agreement will help us move beyond fragmented assessments,” said one EU official involved in the negotiations. “With ‘one substance, one assessment,’ we ensure efficiency, consistency, and faster action when risks are identified.”
Key Features of the Agreement
1. Common Data Platform
The new platform will:
- Collect and centralize chemical data from across the EU.
- Include voluntarily submitted scientific data.
- Ensure public access to non-confidential information, in line with EU transparency laws (Regulation (EC) No 1049/2001).
- Provide systematic access to human biomonitoring data , offering real-time insights into population exposure to chemicals.
2. Alternatives Database
A key innovation is the establishment of a publicly accessible database of alternatives to substances of concern — chemicals that pose potential risks to health or the environment. The database will include alternative materials, technologies, and processes that can replace hazardous substances, supporting the EU’s transition to a circular and green economy.
3. Enhanced Risk Detection and Response
The agreement introduces a Monitoring and Outlook Framework designed to:
- Detect emerging chemical risks early.
- Enable rapid regulatory responses through an early warning system.
- Track progress using measurable indicators.
This framework empowers ECHA to generate its own scientific data when necessary, increasing the EU’s capacity to act swiftly in the face of new threats.
4. Integration of Medicinal Product Data
For the first time, the agreement addresses the inclusion of chemical data related to medicinal products . While active pharmaceutical ingredients were already part of discussions, the co-legislators agreed to explore whether other elements — such as excipients or previously overlooked substances — should also be included in the future.
Legacy data from the European Medicines Agency (EMA) will begin to be integrated six years after the regulation comes into force.
5. Human Biomonitoring Study
Four years after the regulation enters into force, ECHA will conduct a Union-wide human biomonitoring study to assess the general population’s exposure to chemicals. This initiative will incorporate data from both EU and national research programs, providing critical insights for policymaking.
Background: Why It Matters
The OSOA package is a core component of the Chemicals Strategy for Sustainability , launched in October 2020 as part of the European Green Deal. With global chemical production projected to double by 2030 , according to the UN Environment Programme, the need for robust, coordinated, and forward-looking regulation has never been greater.
By streamlining assessments and ensuring that scientific knowledge is shared efficiently across sectors, the EU aims to:
- Strengthen consumer and environmental protection.
- Reduce administrative burdens on industry.
- Encourage innovation in safer, sustainable chemicals.
Next Steps
The provisional agreement now awaits formal endorsement by both the Council and the European Parliament. Once adopted, it will set a new standard for chemical governance in Europe — one that is more agile, transparent, and responsive to the challenges of the 21st century.
As the world moves toward a greener and more sustainable future, the EU’s commitment to safe chemicals and informed decision-making is clearer than ever.
Council and Parliament strike provisional deal on the OSOA (one substance one assessment) package.
