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EU OSOA Chemical Safety Assessment Rules Overhauled to Streamline Compliance

General
17
April 2025
•
400
Dr Steven Brennan
EU chemical safety assessment rules overhauled to streamline compliance. Learn what it means for your business and how to prepare.
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The European Parliament has approved a major overhaul of EU chemical safety assessment rules, including a central data platform, new early warning systems, and reallocation of agency responsibilities. Trilogues with the Council will shape the final text. Manufacturers should act now to evaluate risks and ready compliance systems.

What is the new EU chemicals data platform and why does it matter?

The new platform centralises data on chemical hazards, uses, and emissions, reducing duplication and easing compliance. It offers manufacturers better visibility into regulatory risks and safer alternatives, helping them stay ahead of EU chemical policy developments.

What are the next steps for the EU chemical safety reforms?

Now that the European Parliament has adopted its position, trilogue negotiations with the Council of the EU will begin. These talks will determine the final legislation, likely later in 2025. Businesses should track progress and start adapting internal systems to anticipated changes.

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On 1 April 2025, the European Parliament adopted three key legislative proposals to reform EU chemical safety assessment rules. Aimed at simplifying compliance and enhancing transparency, the new framework will significantly impact manufacturers and their supply chain partners by introducing a centralised chemicals data platform, reallocating agency tasks, and boosting early risk detection.

New Chemicals Data Platform Set to Transform Access

A centrepiece of the reform is the establishment of a common data platform to serve as a “one-stop shop” for information on chemical substances. The system will consolidate data across EU laws on hazards, uses, emissions, and environmental presence. This is expected to support industry by reducing duplication, enabling better exposure assessments, and simplifying access to data on safer alternatives.

Parliament further strengthened the proposal by requiring the inclusion of data on chemicals in products and making publicly funded research submissions mandatory. Dimitris Tsiodras (EPP, EL), rapporteur for the legislation, stated: “These three pieces of legislation will ensure the relevant regulatory actions will be faster, simpler and more transparent.”

Improved Detection of Chemical Risks

A key goal of the reforms is to enable earlier identification of emerging chemical threats. The legislation mandates the use of new data sources, including biomonitoring information such as levels of chemicals found in blood or breast milk, to flag risks more effectively. This proactive approach will help stakeholders across the value chain prepare for regulatory changes with fewer surprises and greater agility.

Agency Roles Reallocated to Avoid Duplication

To improve efficiency, the reforms redistribute scientific and technical responsibilities across major EU agencies, including the European Chemicals Agency (ECHA), European Food Safety Authority (EFSA), European Environment Agency (EEA), and European Medicines Agency (EMA). This shift is designed to reduce administrative burdens, streamline assessments, and ensure consistent outcomes across overlapping regulations—particularly relevant for manufacturers in sectors where chemical safety intersects with food, environment, and health standards.

Next Steps for Legislators and Industry

Following the adoption of the Parliament's position, trilogue negotiations with the Council of the EU will begin. These interinstitutional discussions aim to reach a final agreement on the legislative texts. If consensus is reached, formal adoption by both institutions could follow later in 2025. Until then, amendments may still be introduced, and the scope of obligations could evolve.

Industry stakeholders should monitor developments closely, consult legal and compliance experts, and begin preparing internal systems for anticipated data submission and reporting requirements. Early alignment with the direction of travel can offer strategic advantages.

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