The European Commission has proposed an update to Regulation (EC) No 440/2008, impacting chemical safety testing across the EU. Published on 3 April 2025, the draft regulation introduces new OECD-aligned test methods under the REACH framework. It aims to modernise chemical assessments, reduce animal testing, and support innovation within manufacturing and supply chains. Stakeholders have until 1 May 2025 to provide feedback.
Industry Relevance: New Standards for Chemical Testing
Manufacturers, especially in sectors dealing with chemicals, coatings, polymers, and electronics, should pay close attention to these changes. The proposal includes in vitro alternatives for eye irritation, skin sensitisation, and acute inhalation toxicity, which are increasingly required during regulatory compliance.
Notably, several revised OECD guidelines—such as Test Guidelines 442C, 442E, 492, and 493—have been integrated. These updates enhance the scientific robustness of safety data and are directly applicable in substance registration and product authorisation under REACH.
Supporting the Transition from Animal Testing
The draft regulation reflects the EU’s strategic goal to phase out animal testing, in line with Directive 2010/63/EU. “Reducing reliance on animal testing while maintaining robust safety standards is a dual objective of this initiative,” the Commission noted. Test methods like OECD TG 492B and TG 496 support this shift by using human cell-based and molecular techniques.
Workplace Safety and Environmental Impact
The update also covers occupational exposure, especially concerning respirable particles from nanomaterials. New EN standards, such as EN 17199-5:2019 (vortex shaker method), are added to evaluate dustiness in workplace environments—critical for safeguarding employee health in manufacturing and logistics facilities.
On the environmental side, OECD TG 321 and TG 253 expand the assessment of endocrine-disrupting properties and bioaccumulation in aquatic species. This could influence product formulation strategies and environmental risk management for industries operating in the EU.
Key Deadlines and Action Points
The feedback window closes on 1 May 2025, and Commission adoption is scheduled for Q3 2025. Businesses should assess their compliance strategies, especially if they rely on outdated test methods or use animal testing by default. Updating internal protocols to align with the new OECD standards will be essential.
