
EFSA Seeks Feedback on Overhaul of Weight of Evidence and Biological Relevance Guidance
EFSA launches consultation on updating its Weight of Evidence and Biological Relevance guidance, aiming to streamline chemical risk assessment practices.


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.
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.”
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.
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.
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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