New study reveals 4.2 million animals used in just three test categories for REACH - and numbers are still rising


New study reveals 4.2 million animals used in just three test categories for REACH - and numbers are still rising

28 July 2023
A recently published study, co-authored by the Centre for Alternatives to Animal Testing (CAAT), reveals that 4.2 million animals have been used to date to comply with the REACH Regulation in three test categories: repeated-dose toxicity, developmental toxicity, and reproductive toxicity.

Read the full study here.

The  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals (REACH) Regulation (EC 1907/2006), which came into force across Europe 16 years ago, is the most important piece of EU legislation to protect human health and the environment from the risks that chemicals can pose. It requires the chemical industry to test the safety of all chemicals used in their products. Although animal testing is only allowed as a last resort for safety assessment, i.e. when there is no other non-animal method to obtain the safety information, a large number of animals are still used for this purpose. However, the exact number is neither clear nor publicly available. Therefore, the authors of the study identified the animals used under REACH for the above-mentioned test categories, which represent the majority of animal use under REACH. Based on a direct count of animals in REACH dossiers since 2009, the study shows that approximately 2.9 million animals have been used to date and a further 1.3 million animals are being used in ongoing chemical tests. As compliance checks continue, it is expected that more animal testing will be required.

The study provides clear evidence that the number of animals suffering and dying for chemical testing has been vastly underestimated. The figures for the three test categories analysed to date already far exceed the European Commission’s original estimate of 2.6 million animals that would be used for all test categories as a result of the implementation of the REACH Regulation. The main reason for this difference is that the European Commission’s estimate did not include offspring, although they represent most animals used for REACH. Other reasons include surplus animals to ensure sufficient survival to meet the minimum testing requirements, and additional test animal groups. The authors of the study continue to count all animals used for all test categories in order to obtain a direct estimate of animal use under REACH. Roughly speaking, the number of animals used for other test categories is estimated at between 0.6 and 3.2 million.

The figures are published to coincide with the European Commission’s revision of the REACH Regulation which is likely to expand and increase animal test requirements despite the legal requirement to only use animals as a last resort, the 2021 vote by the European Parliament to phase out such tests in favour of innovative animal-free science, and the well known limitations of animal tests. For instance, an additional 3.5 to 6.9 million animal tests are expected due to the 2022 amendment of REACH. Although the analysis of the use of non-animal test methods was beyond the scope of the study, the authors reported issues with the “read-across” approach (i.e. predicting toxicity by comparison with structurally similar chemicals that have  already been tested). ECHA reports that in 75% of cases, read-across methods were rejected during compliance checks, often  due  to  an  unsatisfactory  justification, triggering the request for animal use to cover the toxicity test.

It is clear the effects of chemicals on human health and the environment are still very poorly understood, with a staggering 70% of EU substances still ‘with poor characterisation of their hazards and exposures’. When we need to communicate or travel, do we resort to antique phones or vintage cars? Of course not. We use the most up-to-date models available, so why is the same not true for chemical safety and research, when such a critical objective- the protection of human health and the environment – is at stake? The implementation and use of non-animal approaches that provide more biologically relevant data is considered by the scientific community to be long overdue and urgently needed to overcome the problems of animal tests, which cannot reliably predict human safety.  

In line with the Commission’s commitment to ultimately move to an animal-free regulatory system under chemicals legislation, it is time for regulators and stakeholders to move beyond rhetoric and leave the old ways behind, by taking action to i) make better use of existing methods and; ii) invest in the development of new scientifically advanced, non-animal approaches to better protect human health and the environment. This can and must be done in a risk-free, measured, intelligent way,  not only to assess - but also to improve - protection levels for human health and the environment.