EU Commission Unveils 'One Substance, One Assessment' Proposal

Streamlining Chemical Assessments for Enhanced Safety

The new legislative proposals are designed to streamline the assessment processes of chemicals across various EU legislations. The reform will reallocate significant tasks among four key EU agencies - the European Chemicals Agency, the European Food Safety Authority, the European Environment Agency, and the European Medicines Agency. This restructuring aims to ensure coherent and transparent safety assessments of chemicals in diverse products, ranging from medical devices and toys to food, pesticides, and biocides.

Benefits for Citizens, Companies, and Authorities

The reform promises multiple benefits:

• Simplified and Transparent Access: Both the public and industries will gain easier access to comprehensive information about chemicals.
• Harmonised Processes: By aligning methodologies and timelines, the process of chemical assessment will become more predictable and harmonised across different legislations.
• Swift Regulatory Actions: The new measures are set to reduce the time between identifying potential risks and implementing necessary regulatory responses, thereby enhancing the protection of public health and the environment.

Key Features of the Proposal

1. Strengthened Cooperation: The proposals aim to consolidate scientific work on chemicals, improving cooperation among the involved agencies.
2. Common Data Platform: A ‘one-stop shop’ for data on chemicals will be established, encompassing data on hazards, uses, and regulatory processes.
3. Human Biomonitoring Data: Systematic collection of data on chemical levels in humans will inform policymakers about exposure levels.
4. Monitoring and Outlook Framework: This will enable early detection of chemical risks and fast regulatory responses.
5. Empowered European Chemicals Agency: The agency will have the authority to generate necessary data.
6. Transparency in Scientific Studies: Studies on chemicals, including those commissioned by companies, will be made transparent.

The legislative proposals will now undergo scrutiny and potential amendments by the European Parliament and the Council, following the ordinary legislative procedure.

Background and Significance

With global chemical production projected to double by 2030, the EU's chemical laws are more critical than ever. The Chemicals Strategy for Sustainability, part of the European Green Deal, underscores the need for safer and sustainable chemical innovations while ensuring the protection of citizens and the environment.

Virginijus Sinkevičius, Commissioner for Environment, Oceans and Fisheries, highlighted the significance of these proposals, stating, "These proposals are a breakthrough in how we collect data on chemicals and assess their safety. They will simplify, expedite, and enhance the transparency of regulatory action, allowing us to protect Europeans and the environment more effectively from hazardous chemicals, including emerging risks."