EU Phasing out Animal Testing in
Chemical Safety Assessments
EU NAMs
How to align with the EU’s roadmap towards phasing out animal testing for chemical safety assessments, presented June 2026, delivered under the REACH framework and Chemicals Action Plan, launched July 2025.
The challenge you're facing
The EU Commission’s “Phasing out animal testing” strategy signals structured deadlines for moving away from in vivo as the default approach for chemical safety assessment. Focused on harmonised EU legislation, the long-term plan pushes organisations towards a validated, animal-free regulatory system.
What do you need to do?
You will need to demonstrate the use and integration of NAMs to generate scientifically robust, validated evidence which justifies chemical safety decision making without relying on animals.
The EU Commission expects organisations to support regulatory-quality safety decisions with validated non-animal evidence.
Integrate EU non-animal evidence in two stages:
Predict
1. Build in silico workflows
Identify potential safety risks before experimental testing using modern in silico approaches.
QSAR
Mechanistic integration
Read across
Leverage
2. Use existing evidence first
Start every safety assessment by leveraging existing data before generating new experimental evidence.
Datasets
Weight of evidence / Context of use
Data integration & collaboration
Regulatory Requirements
Context of Use:
expectations from the EMA
The EMA is focused on achieving regulatory aligned 3Rs testing approaches, specifying Context of Use as essential to evidence robust, reliable and fit-for-purpose non-animal based pathways for regulatory acceptance. Their request is harmonised efforts towards qualifying scientifically sound, biologically relevant NAMs.
Organisations that can clearly define their testing model’s Context of Use, specifically how NAM data will be used in the context of regulatory decision making, will be well positioned to meet the increasing regulatory requirements now and in the next 5-10 years.
Context of Use doesn’t rely on one standalone model, its built by leveraging human-relevant evidence to safely predict mechanistic risk.
Meeting EMA guidance:
Define the boundaries of your Context of Use, specifically what it is intended to demonstrate and the regulatory question it addresses.
Combine computational, experimental and existing evidence using Integrated Approaches to Testing and Assessment (IATA) and Weight of Evidence principles.
Engage in early dialogue through the Innovation Task Force (ITF) and other pathways to reduce regulatory uncertainty. Evidence, validation and justifications are needed to outline credible new approaches.
The EMA framework judges new approaches on whether they are scientifically robust enough to inform a decision within a defined Context of Use. Organisations are expected to set out the method protocol, demonstrate its reliability, and show its relevance to that context alongside existing evidence.
International harmonisation
Bridging global regulatory change
using the ICH guidelines
The EU is not evolving in isolation. Regulatory agencies across the globe are increasingly recognising the value of predictive, human-relevant safety assessment. Discover the UK Roadmap and US Strategy.
The ICH guidelines provide an international framework for aligning non-clinical requirements across multiple regions, including the UK, EU, US and Japan.
By integrating chemical databases, computational modelling and mechanistic human biology, organisations can build evidence packages which align closely with multiple regulatory markets and their individual development programme
Navigating global change:
A well-integrated evidence package should be mapped against the relevant ICH safety guidelines.
A safety strategy should be designed around ICH expectations so that evidence generated meets other ICH regions.
A clearly articulated Context of Use improves confidence during regulatory review and provides transparent rationale.
The organisations best positioned to navigate evolving ICH guidelines will be those that build scientifically robust, internationally transferable evidence packages aligned with harmonised non-clinical expectations, rather than developing separate safety strategies for each regulatory market.