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Parliamentary questions
PDF 109kWORD 29k
5 September 2014
Answer given by Mr Potočnik on behalf of the Commission
Question reference: E-006155/2014

Non-animal methods are increasingly used for testing the safety of chemicals, the quality and safety of drugs as well as in biomedical research. However, in many areas, non-animal alternatives are not yet available(1). High-throughput in vitro approaches like ‘toxicity testing in the 21st century’ (with which EU-funded projects cooperate(2)) are promising but not yet ready to be used for safety assessment in regulated business sectors (e.g. pharmaceuticals). Therefore, limited animal testing is still needed to ensure an adequate level of protection against harmful chemicals and for developing new safe therapies for the benefit of the citizens.

Directive 2010/63/EU(3) sets the principle that the use of experimental animals is limited to the necessary minimum, i.e. to cases where no scientifically satisfactory alternatives are available. REACH contains extensive provisions to minimise animal testing and to promote the use of alternative approaches. This has shown to be effective in keeping the number of animal testing required for REACH well below the initial estimates(4).

The Commission is highly committed to promote the use of alternative methods, through funding of dedicated research (200 million EUR for animal-free toxicology projects under Framework Programme 7(5) and further research foreseen under Horizon 2020), coordination with industry (e.g. EPAA(6)) and a leading role of the Commission's Joint Research Centre (JRC) to the development, validation and promotion of alternative methods. In this context, the JRC hosts a comprehensive database on alternative methods(7) with information, among others, on their status of regulatory acceptance.

(1)Joint Research Centre, European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM). EURL ECVAM, status report on the development, validation and regulatory acceptance of alternative methods and approaches (2013-April 2014), http://ihcp.jrc.ec.europa.eu/our_labs/eurl-ecvam/eurl-ecvam-2014-report-alternative-methods
(3)Directive 2010/63/EU of the European Parliament and of the Council of 22.9.2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
(4)The Use of Alternatives to Testing on Animals for the REACH Regulation. Second report under Article 117(3) of the REACH Regulation http://echa.europa.eu/documents/10162/13639/alternatives_test_animals_2014_en.pdf
(5)see e.g. http://axlr8.eu/assets/axlr8-progress-report-2012.pdf, http://www.seurat-1.eu/
(6)European Partnership for Alternatives Approaches to Animal Testing, http://ec.europa.eu/enterprise/epaa/
(7)EURL ECVAM DataBase service on ALternative Methods to animal experimentation (DB-ALM), http://ihcp.jrc.ec.europa.eu/our_databases/db-alm

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