European Chemical Agency (ECHA) report shows that 87% of new animal tests should never have been conducted
The BUAV, secretariat of the European Coalition to End Animal Experiments, is calling on the European Chemicals Agency (ECHA) to do more to prevent animal testing following publication of the Agency’s report on the use of non-animal alternatives for new EU chemicals legislation ‘REACH’.
In an analysis of the ECHA’s new report on ‘The use of alternatives to testing on animals for the REACH Regulation (2011)’, the BUAV found that:
• 107 animal tests have been automatically conducted when they should have initially subjected to a public consultation. This occurred with tests for genotoxicity, long term repeat dose tests, developmental and reproductive toxicity tests and long term toxicity and bioaccumulation tests in fish, which resulted in the deaths of a total of 57,774 animals.
• 323 animal tests have been conducted when in vitro tests should have been used instead. This was for skin and eye irritation tests where alternatives are validated. This resulted in the death of 969 rabbits.
• 343 animal tests were carried out despite an announcement by the ECHA in 2009 that there was no requirement for the 28-day repeated dose and reproductive toxicity screening studies to be conducted if testing proposals for longer term tests were submitted. Yet, it appears that 109 repeated dose and 234 screening studies were still conducted. This resulted in the deaths of 141,324 animals.
In total, the ECHA estimates that 1,849 new animal tests were conducted for the purposes of REACH. Although many companies chose to rely on existing data (these new animal tests were only 2% out of the total test results submitted), the BUAV nonetheless estimates this would still have entailed the use of at least 231,135 animals. However, shockingly, 87% of these animals were used in tests that should not have been conducted according to REACH rules (as listed above).
More encouragingly, the BUAV notes the ECHA has reported that approximately 90% of registrations were joint submissions between companies, indicating that the required data sharing mechanism had worked (thereby reducing the number of animal tests carried out). Also, instead of conducting new animal tests, most chemical companies used existing data (42% of tests) or used the data from similar chemicals to estimate safety (‘read across’ was used for 24% of tests).
However, the BUAV is concerned that the use of ‘alternatives’ was fairly low with approaches such as the use of weight of evidence, QSARs or in vitro tests constituting only 13% of the test results provided. The use of waiving arguments was also lower than expected, only 11% of tests were argued to not be necessary due to the chemical properties of the substance or its likely exposure.
Dr Katy Taylor, the BUAV’s Science Advisor says; “We are encouraged that companies are using existing data and alternative methods to avoid conducting tests on animals. However, there is still a shocking proportion of animal testing taking place that is not required under REACH. Tests are taking place where there are validated alternatives or that should be subject to the required public consultation. This is unacceptable and has resulted in the death of over 200,000 animals. ECHA simply must do more to prevent animal testing.”
1. REACH is the European chemical testing regime. Set up in June 2007, it stands for the Registration, Evaluation and Authorisation of Chemicals. Its purpose is to establish whether an estimated 30,000 chemicals on the market are safe for humans and the environment, and to control the use of those judged to present a risk. Animal testing will be used to establish the safety of these chemicals.
2. The ECHA report, ‘The use of alternatives to testing on animals for the REACH Regulation’, is the first of the reports on this issue that the Agency is obliged to produce under Article 117(3) of REACH. This article asks for reports on the use of alternative methods to meet the requirements of the Regulation to be published every three years starting with the first one by 1 June 2011. The ECHA report was published late on 30 June 2011 and can be found here: http://echa.europa.eu/publications/alternatives_test_animals_2011_en.asp