Question to the EC: Animal experiments: regulatory testing

See the joint question by MEPs Francisco Guerreiro, Anja Hazekamp, Eleonora Evi, Pascal Durand, Petras Auštrevičius, Tilly Metz, Sirpa Pietikäinen and David Cormand to the European Commission and the written answer on animal experiments and regulatory testing.

Subject: Animal experiments: regulatory testing

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 non-animal 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’?

Answer in writing

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)(1) in 2016(2).

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(3), 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(4) 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 is 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.

(1)       Commission Regulation (EU) 2016/1688 of 20 September 2016 amending Annex VII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards skin sensitisation (Text with EEA relevance), OJ L 255, 21.9.2016, p. 14‐16.

(2)       Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

(3)       Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes, OJ L  276 20.10.2010, p. 33.

(4)       Article 40(2)(b) of Directive 2010/63/EU.

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