On 1 April 2025, the European Parliament adopted the 'one substance, one assessment' chemicals package, a comprehensive initiative to improve the efficiency and transparency of chemical safety assessments in the European Union. The package includes three key legislative proposals aimed at streamlining the assessment processes and improving the accessibility of data on chemical substances.
Towards Simplified and Coherent Chemical Assessments
The initiative aims to streamline the assessment of chemical risks by consolidating scientific and technical assessments under the most appropriate EU agencies. This “one substance, one assessment” approach is expected to reduce duplication, improve consistency, and speed up regulatory decisions under different pieces of EU chemicals legislation.
1. Establishment of a Common Data Platform on Chemicals
A central component of the package is the creation of a common data platform on chemicals. This platform will serve as a “one-stop shop” for accessing information compiled under different EU legislation, including data on:
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Hazard classifications
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Physico-chemical properties
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Chemical presence in the environment
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Emissions and uses
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Environmental sustainability
By consolidating this information, the platform aims to improve the availability and accessibility of chemical data, thereby facilitating more informed decision-making and regulatory processes. The platform will follow the FAIR principles, meaning that the data it contains will be Findable, Accessible, Interoperable, and Reusable. This approach is expected to support higher quality scientific assessments and more efficient regulatory decision-making.
2. Reallocation of Scientific and Technical Tasks Among EU Agencies
The second proposal focuses on optimizing the allocation of scientific and technical tasks related to chemical assessments among EU agencies. By reallocating specific responsibilities, the initiative aims to capitalize the unique expertise of each agency, thereby improving the efficiency and coherence of safety assessment across different legislative frameworks.
3. Amendments to the Restriction of Hazardous Substances in Electrical Equipment (RoHS Directive)
The third proposal involves amending the Directive on the Restriction of Hazardous Substances in Electrical and Electronic Equipment - commonly referred to as the RoHS Directive. This amendment aims at transferring specific scientific and technical tasks to the European Chemicals Agency (ECHA). The objective is to improve the consistency, transparency, and quality of assessments related to hazardous substances covered by this legislation
Next Steps in the Legislative Process
Now that the European Parliament has adopted its position, the 'one substance, one assessment' package will move to negotiations with the Council of the EU. The Council adopted its mandate for these negotiations on 14 June 2024. The final regulation will be agreed upon following these discussions and will form part of the EU’s broader Chemicals Strategy for Sustainability under the European Green Deal.
This new framework aims to strengthen the protection of public health and the environment while promoting innovation and the safer use of chemicals in the European Union.
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