Back in 2004, the European Commission estimated that chemical safety tests prompted by the introduction of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation would use 2.6 million animals. Eighteen years later, things look set to get a lot worse following the publication in 2020 of the Commission’s far-reaching Chemicals Strategy for Sustainability (CSS), which lays out a raft of provisions aiming to better protect humans and the environment from the harmful effects of chemicals.
The CSS states that “animals are still required to be used systematically for testing in the field of chemicals”, and Cruelty Free Europe estimates that increased requirements that will be brought in under the CSS will result in millions more animals suffering and dying in new tests for REACH. Registration of selected polymers alone under REACH could use over 1.5 million animals, and we estimate that, at the very least, 3.6 million animals will be used in new tests attempting to identify and characterize endocrine disruptors. Our worst-case estimate is considerably higher. Options recently considered by the Commission for amending REACH information requirements to enable detection of critical hazards at all production volumes would see an additional two million animals used in new tests for substances already registered under REACH.
These figures show that the Commission must act urgently to change course. To begin with, the Commission should propose adding the goal of ending reliance on animal testing firmly to the REACH regulation itself, signaling that this really is a priority for the EU. As requested by the European Parliament in September last year, it should develop a strategy for achieving this goal. The Commission could also propose enhancing the European Chemicals Agency’s mandate to give it a more central role in promoting non-animal methods, bringing the agency into alignment with the European Medicines Agency and the European Food Safety Authority, both of which are proactively steering away from animal tests. Crucially, it could include in revised REACH a mechanism to ensure that non-animal replacement methods are adopted into REACH and their use actively encouraged as soon as they become available, rather than the current system, which is slow and bureaucratic. Importantly, it could laser-focus funding and other resources on developing and adding to the growing toolbox of new non-animal approaches.
Protecting humans and the environment is fundamental and non-negotiable — we too want a toxic-free environment — and that’s exactly why we need to move away from animal tests.
Tests cause immense suffering for 10 million animals in EU laboratories each year and short-change all of us. Many of the animal test methods in use today are decades old and have never been validated to modern standards, in other words, their fitness for purpose has never been demonstrated. Unsurprisingly, they often generate untrustworthy, misleading data that provide a poor foundation for regulatory decision-making. In contrast, modern non-animal methods are demonstrably reliable and relevant. This is evidenced in the field of skin sensitization, where non-animal approaches predict human outcomes with up to 85 percent accuracy, compared to the most widely used animal test, which is just 74 percent accurate.
Being faster and cheaper than animal tests, non-animal methods also enable many more chemicals and mixtures to be tested than would be possible with animals. Scientists and regulators are racing to develop and implement a non-animal approach to developmental neurotoxicity — a critical hazard highlighted by the CSS — because testing all chemicals with the available animal tests would cost too much time and money to be feasible.
The EU is, in theory, committed to fully replacing animal testing, with this ‘ultimate goal’ enshrined in the directive governing the use of animals in research and testing. While this goal is echoed by rhetoric within the CSS itself, its defined actions do not tell the same story. Promises made by the CSS set Europe on course to use millions of animals in new chemicals tests and, regrettably, the Commission is showing little interest in changing tack. Its REACH revision public consultation survey was littered with biased and leading questions that, without justification, presented increased use of non-animal methods as detrimental to identifying and characterizing critical hazards, international harmonization and competitiveness, the latter despite industry support for increased use of non-animal methods.
Regardless of how you feel about the ethics of using millions of animals in new tests, it is an inescapable truth that trying to achieve the aims of the CSS with animal tests that are unfit for purpose jeopardizes the goal of realizing a toxic-free environment. We urge the Commission, Parliament and Council to use the revision of REACH under the CSS as an opportunity to demonstrate the EU’s commitment much more clearly to humane and human-relevant science — not just for the sake of animals in laboratories, but to ensure the best possible methods are being used to protect humans and the environment from the harmful effects of chemicals
 Van Der Jagt K, Munn S, Torslov J, De Bruijn J. Alternative Approaches Can Reduce the Use of Test Animals under REACH. EUR 21405 EN. EC; 2004. JRC29111
 European Commission. Chemicals Strategy for Sustainability: Towards a Toxic-Free Environment. 2020. Available at: https://ec.europa.eu/environment/pdf/chemicals/2020/10/Strategy.pdf
 Calculations available upon request.
 European Parliament. Plans and actions to accelerate a transition to innovation without the use of animals in research, regulatory testing and education. 16 September 2021. Available at: https://www.europarl.europa.eu/doceo/document/TA-9-2021-0387_EN.html
 European Commission. Animals used for scientific purposes – EU statistical reports on the use of animals for scientific purposes. Available at: https://ec.europa.eu/environment/chemicals/lab_animals/reports_en.htm
 Kleinstreuer NC, et al. Non-animal methods to predict skin sensitization (II): an assessment of defined approaches. Crit Rev Toxicol. 2018;48(5):359-374.
 Fritsche E, Grandjean P, Crofton KM, et al. Consensus statement on the need for innovation, transition and implementation of developmental neurotoxicity (DNT) testing for regulatory purposes. Toxicol Appl Pharmacol. 2018;354:3-6. doi:10.1016/j.taap.2018.02.004