The European Union is moving towards a new era in chemicals regulation with the implementation of the “One Substance, One Assessment” (OSOA) approach. This initiative, presented as part of the European Green Deal and the Chemicals Strategy for Sustainability, aims to simplify and strengthen the evaluation of chemical substances across Europe by improving coordination between authorities, reducing duplication of work, and increasing access to chemical data.
According to the recent presentation by Dr. Vera Ritz from the German Federal Institute for Risk Assessment (BfR), OSOA will significantly change the way chemical assessments are performed within the EU.
One of the key objectives of OSOA is to consolidate the work carried out by European agencies such as ECHA, EFSA, EMA, and the EEA. The strategy foresees improved cooperation between authorities, redistribution of tasks among agencies, and updates to the founding regulations governing these institutions.
The intention is clear: avoid multiple assessments of the same substance under different regulatory frameworks and ensure that scientific evaluations are shared across all relevant authorities.
This approach is expected to improve efficiency, reduce administrative burden, and support faster regulatory decision-making throughout the EU.
A central pillar of the OSOA strategy is the creation of the Common Data Platform on Chemicals (CDPC), which will be established and managed by the European Chemicals Agency (ECHA).
The CDPC will act as a central repository integrating multiple databases and information systems related to chemicals, including:
- Monitoring data platforms such as IPCHEM (future Post to be published on this)
- Databases on regulatory processes
- Study notification databases
- Information on chemicals in products and articles
- Data on alternatives to substances of concern
- Environmental sustainability information
- Reference values and standardised vocabularies
The platform aims to improve data sharing and facilitate access to chemical information across regulatory sectors.
The proposed framework establishes differentiated access rights depending on the type of user. European institutions, EU agencies, and Member State competent authorities will be able to access both public and confidential data to support the implementation and development of chemicals legislation and policy.
At the same time, confidentiality protections from the original legislation will remain fully respected through the so-called “originator principle.” Confidentiality flags attached to submitted data will continue to apply when information is transferred or reused through the CDPC.
Importantly, the use of shared data will not replace the legal obligations of companies or duty holders, meaning that the burden of proof remains with industry.
The implementation of the CDPC will take place progressively over the next decade. According to the proposed timeline:
- The regulation entered into force on 2 January 2026
- ECHA must establish the CDPC and dedicated services within the first years
- A minimum viable product (MVP) integrating key datasets is expected within approximately three years
- Full integration of all data into the platform is foreseen by 2036
Additional measures include the creation of a database for study notifications and a database containing environmental sustainability-related data.
The OSOA initiative reflects the EU’s broader ambition to modernise chemicals regulation through greater transparency, digitalisation, and cooperation between authorities.
As highlighted during the presentation, the future European system will rely on:
- Shared assessment results
- Centralised data access
- Risk-based evaluations
- Increased use of new scientific methodologies (NAMs)
For companies operating in the chemical, biocidal, biostimulant, and related sectors, these developments will likely reshape regulatory strategies and data management practices in the coming years.
