In 2004, the European Commission estimated that the chemical safety tests prompted by the introduction of the REACH regulation (Registration, Evaluation, Authorization and Restriction of Chemicals) would use 2.6 million animals. Eighteen years later, things are set to get worse after the publication in 2020 of the Commission’s broad Chemicals Strategy for Sustainability (CSS), which provides a set of provisions aimed at better protecting man and the environment from the harmful effects of chemical products.
The CSS states that “animals should always be used routinely for chemical testing”, and Cruelty Free Europe estimates that the increased requirements that will be introduced under the CSS will result in the suffering and death of millions of additional animals in new tests. for REACH. Registration of selected polymers under REACH alone could use more than 1.5 million animals, and we estimate that at least 3.6 million animals will be used in new tests to identify and to characterize endocrine disruptors. Our worst-case estimate is considerably higher. Options recently considered by the Commission to modify the information requirements of REACH to allow the detection of critical hazards at all production volumes would result in the use of two million additional animals in new tests for substances already registered under REACH.
These figures show that the Commission needs to act urgently to change course. As a start, the Commission should propose to firmly add the objective of ending the use of animal testing to the REACH regulation itself, signaling that this is indeed a priority for the EU. As requested by the European Parliament in September last year, it should develop a strategy to achieve this goal. The Commission could also propose to strengthen the mandate of the European Chemicals Agency to give it a more central role in the promotion of non-animal methods, aligning the agency with the European Medicines Agency and the European food safety, both of which are proactively moving away from animal testing. Basically, it could include in revised REACH a mechanism to ensure that alternative non-animal methods are adopted in REACH and their use is actively promoted as they become available, rather than the current system, which is slow and bureaucratic. Above all, it could focus funding and other resources on developing and adding to the growing toolbox of new, non-animal approaches.
The protection of 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 testing.
Testing causes immense suffering to 10 million animals in EU labs every year and bypass us all. Many methods of animal testing used 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 unreliable and misleading data that provides a poor basis for regulatory decision-making. In contrast, modern non-animal methods are demonstrably reliable and relevant. This is evidenced in the area of skin sensitization, where non-animal approaches predict human outcomes with up to 85% accuracy, compared to the most widely used animal test, which is only accurate to 74%.
Being faster and cheaper than animal testing, non-animal methods also allow 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 danger highlighted by CSS — because testing all chemicals with available animal tests would cost too much. time and money to be feasible.
The EU has, in theory, pledged to replace animal testing entirely, with that ‘ultimate goal’ enshrined in the directive governing the use of animals in research and experimentation. While this goal is echoed in rhetoric within CSS itself, its defined actions don’t tell the same story. The promises made by the CSS have put Europe on the right track to use millions of animals in new chemical tests and, unfortunately, the Commission shows little interest in changing tack. Its public consultation survey on the REACH review was peppered with biased and leading questions that, without justification, presented the increased use of non-animal methods as detrimental to critical hazard identification and characterization, international harmonization and competitiveness, the latter despite industry support for increased use of non-animal methods. – animal methods.
Regardless of what you think about the ethics of using millions of animals in new tests, it is an inescapable truth that trying to achieve the goals of CSS with animal testing that is not suitable to the goal undermines the goal of achieving a toxic-free environment. We urge the Commission, Parliament and Council to use the SSC review of REACH as an opportunity to demonstrate much more clearly the EU’s commitment to humane and relevant science for humans — not only for the benefit of animals in laboratories, but to ensure the best possible methods are 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 may reduce the use of test animals under REACH. 21405 EUR FR. THIS ; 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 on 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 for predicting skin sensitization (II): an evaluation 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 testing (DNT) for regulatory purposes. Toxicol Appl Pharmacol. 2018;354:3-6. doi:10.1016/j.taap.2018.02.004