The European Commission answers written question on the high number of regulatory tests still conducted on animals
To the following questions of the European Parliament:
In its report of 5 February 2020 entitled '2019 report on the statistics on the use of animals for scientific purposes, in the Member States of the European Union in 2015-2017', the Commission found that regulatory tests are still being conducted in four key areas where there are validated nonanimal methods accepted in EU legislation. In 2017, a total of 4 120 skin irritation tests, 814 eye irritation tests, 47 341 skin sensitisation tests and 35 172 pyrogenicity tests were conducted.
1. Can the Commission explain why so many of these tests are still being conducted?
2. What it is doing to ensure that the Member States adhere to Article 13(1) of Directive 2010/63/EU, which states 'without prejudice to national legislation prohibiting certain types of methods, Member States shall ensure that a procedure is not carried out if another method or testing strategy for obtaining the result sought, not entailing the use of a live animal, is recognised under the legislation of the Union'?
The Commission replied that the Union legislation recognises alternatives to skin/eye corrosion/irritation and pyrogenicity testing since several years. Alternative methods for skin sensitisation were introduced into the Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) in 2016 .
In some cases, alternative methods have limitations as to the effects they can predict making them unsuitable for some substances/applications. Some results (e.g. for eye) may be inconclusive thus requiring a confirmatory study in vivo and some regulatory areas still require animal tests. For biological products, a successful product specific validation of the alternative method (e.g., in vitro pyrogenicity test) is required before it can be used for regulatory purposes.
In line with Directive 2010/63/EU, before authorising a project the competent authority must be assured that the result sought cannot be obtained using alternatives. Once authorised, each project has a named person responsible for its compliance with the authorisation who should require alternatives to be taken up once recognised by the legislation of the union.
The described limitations may partly explain continued use of animals in these areas. However, the Commission remains concerned, even if the numbers are decreasing in most cases.
The Commission states to be repeatedly reminding Member States of their legal obligations, has issued additional guidance, and encourages collaboration between regulatory authorities. Furthermore, the European Chemicals Agency (ECHA), in the context of testing under REACH, requires justification for using animals as part of the completeness check of dossiers for registered chemicals.