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EU Directives

Dáil Éireann Debate, Tuesday - 6 March 2012

Tuesday, 6 March 2012

Questions (534)

Seán Kyne


589 Deputy Seán Kyne asked the Minister for Health if he will consider, within the context of the transposition of EU Directive 2010/63/EU, introducing an obligation to use the new non-animal alternatives (details supplied) for the testing of chemicals, for which the EU granted approval last month. [12834/12]

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Written answers (Question to Minister for Health)

Directive (2010/63/EU) on the protection of animals used for scientific purposes will strengthen the protection of animals still needed for research and safety testing. The Directive will also play a significant role in minimising the number of animals used and require alternatives to be used where possible, whilst ensuring a level playing field for EU industry and enhancing the quality of research conducted in the EU. The "Three Rs" principle of replacing, reducing, and refining animal testing is firmly anchored in the new legislation and this is something that I strongly support.

I am pleased to be able to inform the Deputy that the IMB has advised the Department that a new non-animal cell-based test method has been approved for the testing of Botox. The test replaces the animal-based LD50 assay for testing of botulinum neurotoxins, an assay method which has been the standard up to now. They further advise that the new test has been validated for use to determine the potency of product for release onto the market and in stability studies and it will result in a significant reduction in the use of animals in testing of Botox. The change in test methods is in line with the overall ‘3Rs' principles of replacement, refinement and reduction in the use of animals in research testing which is enshrined in the Directive.