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Protection of animals used for scientific purposes

EU Directive 2010/63/EU on the protection of animals used for scientific purposes was transposed into Irish law by the European Union (Protection of animals Used for Scientific Purposes) Regulations 2012.This new legislation  applied  from 1 January 2013 and will considerably strengthen the protection of animals still needed for research and safety testing.

The 2012 Regulations introduced significant changes, including a requirement to perform detailed project evaluations before projects using animals can be authorised and higher standards of animal welfare, care and accommodation. The regulations will play a significant role in terms of minimising the number of animals used and require that alternatives to animal testing be utilised where possible. The new laws will also ensure a level playing field for EU industry and enhance the quality of research conducted across all Member States.

The new legislation promotes the principles of the three R’s (replacement of the use of animals to the greatest extent possible with alternative testing methods, refinement of scientific procedures to improve animal welfare, and reduction in numbers of animals used). The European Environment Commissioner has said that the European Union will, once the Directive is transposed, have the highest standards of experimental animal welfare in the world.

The Irish Medicines Board (IMB) has been designated as  the Competent Authority (CA) for the purposes of this legislation from 1 January 2013. The IMB has the relevant expertise in relation to both human and veterinary medicine and in inspecting scientific activities and establishments to undertake this regulatory work. The authorisation of establishments, projects and key individuals involved in those projects is a matter for the IMB. Significant enforcement powers and penalties have also been included in the regulations to support the IMB in implementing this new legislation.

The 2012 Regulations  have been amended by the European Union (Protection of Animals used for Scientific Purposes) (Amendment) Regulations 2013.

It is policy in Ireland not to authorise any scientific procedures using live animals for testing of cosmetics.

It is the practice in Ireland not to authorise scientific procedures involving the use of primates

Correction – 2012 Statistical Report on the use of Animals for Experimental and other Scientific purposes in Ireland

The Department has become aware of an error in the above report whereby an entry of 157,924 was incorrectly inserted in Column 8.2.1.a (Products/substances or devices for human medicine and dentistry and for veterinary medicine) instead of Column 8.2.1.i (Other toxicological or safety evaluations). This has now been rectified.

Download a copy of the amended document here.