A proposed modification to the European Union’s REACH rule will significantly refine and minimise animal testing in chemical safety evaluations. This program focusses on Commission Regulation (EC) No 440/2008, which outlines the permitted chemical testing procedures under REACH, the EU’s system for chemical registration, evaluation, authorisation, and restriction.

A draft legislation, which is presently out for public comment, details the inclusion of new and updated testing procedures. These adjustments are intended to match with scientific breakthroughs and the EU’s commitment to minimising animal usage in accordance with Directive 2010/63/EU.

The suggested modifications include three revised in vitro (non-animal) test techniques for detecting eye irritation and skin sensitisation, which are critical for determining possible human health risks. In addition, three novel test techniques for measuring the ecotoxicity of chemicals and their impact on the environment are planned for inclusion.

• In addition to these modifications, the effort takes into account recent revisions to a number of test recommendations that are already included in Regulation 440/2008 that were established by the Organisation for Economic Co-operation and Development (OECD) in 2024. OECD Test Guidelines 403, 442B, 442C, 442E, 492, 492B, and 493 are among them. In addition to removing the out-of-date full explanations for OECD Test Guidelines 403 and 493 from the regulation’s Annex, the update will include these adjustments.
• In addition, the draft act suggests establishing a number of EN standards pertaining to the assessment of dustiness of bulk materials in an effort to better connect with workplace safety rules, particularly Regulation (EC) No 1272/2008 on classification, labelling, and packaging of chemicals and mixtures. These guidelines (EN 17199-2, -3, -4, and -5) offer methods for evaluating possible respiratory risks at work.

The EU’s ongoing efforts to guarantee chemical safety while encouraging moral and cutting-edge scientific testing techniques that lessen dependency on animal experiments are highlighted by this amendment to Regulation 440/2008. The rule will be immediately applicable in every Member State and is anticipated to go into effect twenty days after it is published in the EU’s Official Journal.

Public Feedback Open: Ongoing period for input on draft act until May 1, 2025. Feedback received will be public and factor into the final regulation.

Focus on Reduced Animal Testing: The update to Regulation 440/2008 prioritises ethical, science-based procedures.

Applicability: The new legislation will be binding and effective in all EU member states 20 days after publication.

The European Commission engaged with relevant stakeholders over proposed modifications to chemical testing regulations. Additional input can be provided all over the current feedback period before the initiative is finalised. This initiative ensures chemical safety while reducing animal use.