Animal Testing Under REACH: It's Time to Take 'Last Resort' Seriously

Euractiv

08-07-2025

The European legal framework requires its Member States to pay full regard to animal welfare standards when formulating and implementing policies. Yet, when it comes to chemical safety, the EU's flagship regulation, REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), still relies heavily on animal testing, despite its stated commitment to making this a 'last resort.'
REACH was designed with the core objective to protect people and the environment from dangerous chemicals. At the same time, the regulation claims to support and promote the use of non-animal methods as one of its overarching purposes, as outlined in its first article. In reality, this commitment is not being upheld: almost two decades into its implementation, REACH still relies on often-outdated testing methods, which involve not only significant animal suffering, but questionable scientific reliability.
REACH promotes the use of alternatives 'whenever possible' (Article 13), and Article 25 explicitly states that testing on animals should only occur as a last resort. Yet in practice, these commitments are frequently bypassed. A report[1] published in 2024 by leading scientists and organisations revealed that the last resort requirement isn't always respected in practice. Companies continue to submit animal data on a routine basis, often because such data is perceived as more readily acceptable. Regulators frequently request or accept animal-based studies, even when suitable non-animal methods are available.
The contradictory effects and implications of this approach are evident in the numbers. The scale of animal testing in the EU is staggering. In 2022 alone, over 8.4 million animals were used in scientific procedures across the European Union (EU) and Norway. Of these, more than 1.1 million were used specifically for regulatory testing, including chemical safety assessments.[2] Many of these animals endured moderate to severe suffering. For instance, chemical safety dossiers often include repeated-dose toxicity tests, skin and eye irritation tests on rabbits, and reproductive toxicity tests that use hundreds of animals per chemical.
This reality stands in stark contrast to both the ethical principles and legal goals of REACH, and the situation is worsening. A 2023 review revealed that animal testing under REACH has far exceeded initial projections, with numbers expected to rise further in the coming years (Knight et al. 2023 PMID:37470350). This anticipated increase is partly driven by the potential introduction of new testing requirements, designed to enhance protection of human health and the environment. However, the actual benefit of additional animal testing remains uncertain, and without clear evidence that these new requirements will meaningfully improve safety outcomes, there is a real risk of unnecessarily expanding animal use.
This isn't just an ethical issue, it's also a scientific one. Animal tests are often poor predictors of human outcomes. Numerous studies have demonstrated that non-animal models, including human cell-based assays and computational approaches, can provide more accurate, faster, and cost-effective data. For example, skin sensitisation assessments once relied upon guinea pig and mice tests, but can now be reliably assessed using a combination of cell-based and computational approaches validated by the OECD[3]. Yet, these animal-free methods are still not being utilised to their full potential.
Now is the time to fix this. Nearly two decades after its introduction, REACH is set for a significant revision, offering a critical chance to close this gap between policy and practice. The European Commission has an opportunity to remove regulatory obstacles that slow the adoption of advanced, animal-free safety testing. To truly make animal testing a last resort, not the default, three key reforms should be made: 'No alternative' must truly mean 'no alternative.' Before any animal test is performed, registrants and authorities should publicly document that no equally reliable non-animal method exists. Transparency must be increased.
Animal tests should only be approved if they are scientifically necessary, not just administratively convenient. Too often, testing is driven by regulatory habit rather than safety need.
Ethical and scientific oversight that balances both the necessity and the ethical cost of animal testing must be required. The decision to use live animals must never be taken lightly or hidden behind bureaucratic procedure. The EU has long positioned itself as a global leader in animal welfare and regulatory innovation. But true leadership involves setting high standards and also upholding them. If REACH continues to allow animal testing as a routine fallback, it will undermine both its credibility and its fundamental expression of Europe's broader values and goals. Policymakers now have a chance to align our laws with EU's political agenda and society's technological advancement. Industry, too, stands to benefit from the rapid embrace of non-animal methods that are often faster, cheaper, and more predictive of human outcomes. By shifting the culture around chemical safety testing, we can build a system that protects people, the environment and animals, without compromising our fundamental public health and safety needs.
With REACH under review, it's time to move beyond vague commitments and implement real safeguards to replace animal testing. Let's ensure that the REACH revision reflects not just the best science, but the best of what Europe stands for.
By Dr Giorgia Pallocca and Antigoni Effraimidou, Humane World for Animals.