A commitment from Europe to ultimately phase out animal testing
Under the EU REACH regulation, companies must identify and manage the risks of substances they manufacture or market in the EU. REACH sets out requirements for collecting and assessing information on the properties and hazards of chemicals. In most regions of the world, chemical safety assessments require both animal and non-animal testing methods.
Europe has long been committed to the 3 R’s principle—Replacement, Reduction, and Refinement—in animal testing. This principle underpins the EU’s efforts to minimise the use of animals in scientific research by replacing animal tests with alternative methods, reducing the number of animals used, and refining procedures to minimise suffering. Through REACH, alternative methods for hazard and safety assessments – also known as New Approach Methodologies (NAMs) – to reduce the number of tests involving animals are encouraged.
It would be almost impossible to develop one-to-one replacements of animal tests with NAMs for complex end-points. So to advance on this agenda, a next generation safety assessment must be developed, validated and implemented in Europe. In 2023, Europe committed to transform EU chemicals legislations towards ultimately phasing out animal testing for chemical safety assessments (link to communication). The EU Commission is developing a roadmap that outlines milestones and specific actions to be implemented in the short to longer term.
Supporting progress on new approach methodologies
Cefic fully supports the development and use of fit-for-purpose alternative testing methods. Where possible and applicable, the chemical industry uses alternative methods and approaches to assess the safety of substances. These include computational toxicology models, grouping of chemicals and read across, in vitro assays and predictive screenings, and exposure-driven and regulatory relevant concepts in human and environmental toxicology.
Cefic is a longstanding and active member of the European Commission-led Public-Private Partnership, European Partnership for Alternative Approaches to Animal Testing (EPAA). Together with partners, Cefic pools knowledge and resources to accelerate the development, validation and acceptance of alternative approaches to further promote the replacement, reduction and refinement of animal use in regulatory product testing, the 3 R’s principle.
Cefic supports and actively contributes to:
- The development of the EU Commission roadmap outlining short and long-term actions for ultimately phasing out animal testing for chemical safety assessments.
- A roadmap and guiding principles to implement Next-Generation Risk Assessment (NGRA) in EU chemicals legislation led by PARC – Partnership for the Assessment of Risks from Chemicals.
- Initiatives of the European Chemicals Agency (ECHA), including workshops to examine ways to replace animal testing in the hazard assessment of chemicals.
Four actions to accelerate the transition to animal-free regulatory system
Advancements towards an animal free regulatory system have been taken in recent years, yet more must be done to speed up the creation, validation, and implementation of test methods that do not involve animals.
Cefic proposes four actions to achieve progress at EU level:
- As part of the Commission’s roadmap, establish a long-term vision for a new hazard and safety paradigm: Regulators, industry, academia, and NGOs should agree on what can be accomplished in the next two decades and initiate the transition. This can be achieved by identifying the limitations of current hazard and safety frameworks and identifying necessary changes for heading towards next generation safety assessment.
- Establish platforms and processes to gain experience and apply readily-available and robust NAMs: The goal is to gain experience with NAMs and build trust in new type of data and approaches. This can be achieved by promoting the use of alternative approaches to animal testing in existing regulatory processes. Establishing a science discussion platform would also allow for the sharing and discussing insights, interpretations, and experiences with NAMs.
- Secure an internationally-harmonised application of NAM methodologies and Mutual Acceptance of Data (MAD): This will ensure that NAMs are universally accepted across different regions and regulatory systems.
- Enhance the use and availability of exposure information for registered substances: This is crucial for better protection because detailed exposure data can help identify where testing is most needed.