Comparative analysis of the revised Directive 2010/63/EU for the protection of laboratory animals with its predecessor 86/609/EEC - a t4 report.

On 8th September 2010 the long process of revising the EU Directive for the protection of laboratory animals was concluded. Here a comparative evaluation of the new and old Directive is provided. While its ultimate goal is to replace the use of animals, the new Directive acknowledges that animals, including nonhuman primates, are still needed for scientific purposes today. Importantly, animals have an intrinsic value, which must be respected. There are some major advances for animal welfare, many of which had however already been common practice in the more progressive Member States. The new Directive prohibits new, more progressive legislation if not already in place and thus harmonises but also freezes the 27 Member States at a relatively high level. The revision was an important opportunity for the European Commission, on the one side to demonstrate its commitment to improve human health and safety by enabling animal testing and on the other side to improve animal health and welfare by setting minimum standards. By this Directive Europe is again taking a leading role in research and development for new non-animal tests and technologies by introducing a series of measures that strengthen the evaluation of the need of animal use in each case. It also represents a formal implementation of the 3Rs principle (Replacement, Reduction and Refinement of animal tests) put forward by Russel and Burch 1959.