New Guidance Released for Minimising Animal Testing Under UK REACH

Highlights from the Guidance

Emphasis on the 3Rs and Testing as a Last Resort

The HSE reiterates that all animal tests under UK REACH must adhere to the 3Rs:

• Reduction: Limiting the number of animals used in testing.
• Refinement: Modifying procedures to minimise animal distress.
• Replacement: Prioritising non-animal testing methods whenever feasible​​.

Testing on vertebrates is strictly controlled under Article 25 of UK REACH, which mandates that these tests are performed only when no alternative methods can meet the data requirements​.

Use of Alternative Approaches

The guidance encourages registrants to apply validated non-animal methodologies, including:

• In vitro methods: Laboratory techniques that simulate biological systems outside a living organism.
• In silico methods: Computational models such as Quantitative Structure-Activity Relationship (QSAR) models to predict chemical properties​​.
• Weight-of-evidence assessments: Combining data from multiple sources to make robust conclusions about a substance's properties​.
• Read-across techniques: Applying data from similar substances to avoid duplicate testing​.

Stepwise Approach to Data Gathering

Registrants are advised to follow a structured process:

1. Compile Existing Data: Gather all available information from existing studies, including data sharing with other registrants through Article 26 inquiries.
2. Evaluate Column 2 Adaptations: Determine if specific adaptations in Annexes 7–10 can address the information requirements without new testing.
3. Utilise OECD Methods: Leverage OECD test guidelines, Integrated Approaches to Testing and Assessment (IATAs), and defined approaches for endpoints such as skin irritation or sensitisation​​.

Regulatory Compliance for Testing Proposals

Registrants planning tests under Annex 9 or 10 (substances exceeding 100 tonnes per year) must submit a testing proposal to the HSE. These proposals must detail:

• Steps taken to explore alternative methods.
• Justifications for why non-animal approaches cannot meet the requirements.
• Plans to employ the least severe tests using the fewest animals​​​.

Implications and Future Outlook

This guidance applies to new substances not previously registered under EU REACH before 1 January 2021. By leveraging innovative methodologies and adhering to strict ethical standards, registrants can ensure regulatory compliance while supporting animal welfare. The HSE’s approach reflects global trends towards reducing animal testing through advances in scientific research and alternative testing strategies​​.