A new study by the European Commission's Joint Research Centre (JRC) outlines a transformative approach to chemical safety testing, advocating for the phase-out of animal testing. The study introduces a roadmap for transitioning towards non-animal methods, also known as New Approach Methodologies (NAMs), which promise enhanced efficiency, reduced costs, and improved safety assessments for both human health and the environment.
The Call for Chemicals 2.0
The European Union (EU) chemical regulatory framework is under pressure to evolve. Recent developments have highlighted the need to improve current testing practices to protect human health and the environment better. The study proposes "Chemicals 2.0," a new regulatory model focused on minimising unnecessary testing and improving efficiency through the adoption of NAMs. These methods would eventually replace traditional animal tests, in line with the EU's long-standing commitment to reduce animal testing.
The research emphasises that animal testing is no longer the only reliable option for ensuring chemical safety. Innovative technologies and biological reasoning now offer robust non-animal alternatives that can meet regulatory standards.
Pathways to Adoption
The study highlights five key pathways towards the acceptance of non-animal testing strategies:
- Augmenting: Introducing NAMs to address gaps where no animal or required tests exist.
- Complementing: Using NAMs alongside animal tests to boost confidence in results.
- Repurposing: Reassigning non-animal methods from one legislative context to another.
- Replacing: Fully replacing animal tests where non-animal methods prove sufficient.
- Rebuilding: Overhauling the regulatory framework to prioritise non-animal testing at all levels.
The report acknowledges that the transition to non-animal testing faces several socio-technical barriers, including resistance to changing established practices and concerns about the readiness of non-animal methods.
Regulatory and Technological Challenges
One of the main challenges for regulators is adapting the EU’s Globally Harmonised System (GHS) for classifying and labelling chemicals. Current GHS criteria are heavily reliant on data from animal testing. The study suggests revising these criteria to accommodate the growing body of evidence from NAMs.
Furthermore, there are concerns about whether non-animal methods can effectively address complex health and environmental issues, such as chronic toxicity. The authors propose a tiered testing approach, ensuring proportionality in testing requirements and cost-effectiveness.
The Future of Risk Assessment
The study proposes a hybrid system that integrates animal and non-animal methods while the transition progresses. The eventual goal is to adopt a fully non-animal testing framework. With post-market surveillance and advanced monitoring techniques, the study envisions a system where the most hazardous chemicals are prioritised, ensuring continued safety and sustainability.
The study marks a significant step in transforming chemical safety assessments in Europe, advocating for a gradual but determined shift towards non-animal testing. As NAMs continue to improve, this twin transition could herald a new era of more efficient, humane, and scientifically advanced toxicology practices.
