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Brussels, 5 November 2008
Questions and answers on revising the directive for the protection of animals used in scientific experiments
What are the aims of the revision?
The proposal aims to strengthen the protection of animals still used in scientific procedures in line with the European Union's Protocol on Animal Welfare, and ensure a level playing field throughout the EU for industry and the research community Why is a revision needed?
Due to a variety of weaknesses in the current directive on the protection of animals used in scientific experiments (86/609/EEC) some Member States have passed laws with higher welfare standards for experimental animals while others have kept to the minimum European standards. Considering the widening gap in standards in Europe the Commission felt that it was time to rectify this divergence, and that further improvements should be made to the welfare of animals used in scientific procedures. Our knowledge of animals' welfare requirements has increased since 1986 and the research environment has also evolved. Many provisions of the directive currently in force are open to interpretation and some are more political than regulatory in nature. It does not include ethical reviews or requirements to obtain authorisations for experiments. The directive does not explicitly address the internationally recognised Three R concept of Replacement, Reduction and Refinement (Russel and Burch 1959) to minimise the use of experimental animals. Since upholding animal welfare is now integrated in the EU Treaties this must be taken into account in all policy areas.
Revising the directive will strengthen legislation in the area of animal experiments in the EU, reduce the use of experimental animals and ensure that those that are still used in experiments receive appropriate care and humane treatment.
The objectives of the Commission's proposal are to considerably improve the welfare of animals used in scientific procedures, to ensure fair competition for industry, and boost research activities in the European Union.
What is the scope of the proposal?
The proposed directive covers all live non-human vertebrate animals intended for experiments plus certain other species likely to experience pain. The new directive also includes animals specifically bred so that their organs or tissue can be used in scientific procedures.
What is not covered by this proposal?
The proposed directive does not cover behavioural studies carried out on animals kept in zoos or those used in military experiments, or non-experimental, agricultural or clinical veterinary practices and trials. It also does not cover animals used in husbandry or practices for marking an animal.
What are the main benefits of this new proposal?
The objectives of the Commission's proposal are to considerably improve the welfare of animals used in scientific procedures, to ensure fair competition for industry, and boost research activities in the European Union. The proposal is based on the need to replace, reduce, and refine animal testing. The Commission believes strongly in the need to find alternative methods to testing on animals. Where this is not possible the number of animals used must be reduced or the testing methods refined so as to cause less harm to the animals.
Will any animal experiments be banned under this proposal?
The use of non-human primates is subject to restrictions, and the proposal also introduces a ban on the use of great apes – chimpanzees, bonobos, gorillas and orangutans – in scientific procedures. Only when survival of the species itself is at stake, or in the case of an unexpected outbreak of a life-threatening or debilitating disease in human beings, can a Member State exceptionally be granted permission for their use.
The Commission believes that at present it is not possible to ban outright the use of animals for safety testing or biomedical research. This conclusion is backed by the Commission's Scientific Steering Committee (SSC) which stated that there remains a need for non-human primates in biomedical research. The Committee considers that testing on non-human primates should be avoided unless it is justified on a case-by-case basis. For other species the Commission is aware that using animals for biomedical research or regulatory safety testing may sometimes be unavoidable. It is for this reason that the proposal tightens controls on animal use by introducing compulsory ethical evaluations and improving the housing and care provided to experimental animals.
How will the new legislation affect the EU's chemicals law?
Under the EU's chemicals law - Regulation on Registration, Evaluation and Authorisation and Restriction of Chemicals (REACH) - industry is required to safely manufacture, import and use chemicals. To do so sufficient information on hazardous chemicals must be available. However, the hazardous properties of chemicals cannot be sufficiently determined using currently available in vitro (non-animal) testing methods, as noted in a report published by the European Centre for the Validation of Alternative methods (ECVAM). Relying solely on vitro methods can underestimate the potentially hazardous properties of chemicals that could be harmful to humans and the environment.
REACH limits animal testing to a bare minimum by requiring the sharing of information resulting from tests where vertebrate animals were used. This data becomes publicly available 12 years after it has been submitted to the European Chemicals Agency (ECHA). Those wishing to perform tests must indicate to the agency the tests they propose, for which they must then obtain approval before carrying them out. Under the chemicals law lab animal testing is to be avoided in favour of alternative methods. Laboratory testing is to be used as a last resort.
Will the use of non-human primates be phased out?
The Commission does not believe it is possible to phase out the use of non-human primates in the immediate foreseeable future. Non-human primates are currently used for a number vital research programmes on infectious diseases such as HIV, malaria, hepatitis, and SARS. The Commission is closely monitoring scientific developments in this area and examines them carefully should possibilities for phasing out the testing on non-human primates arise.
How will the revision affect research in the European Union?
The Commission's proposal is based on a cost and benefit analysis of action or lack thereof with respect to the economic and social development of the European Union as a whole. The results of this analysis complement the views expressed during a public consultation on animal testing organised in the summer of 2006.
The proposal strikes a balance between promoting research and competitiveness while ensuring that animal welfare is upheld. Under the revised directive research activities in the EU are enhanced due to measures that reduce the bureaucratic burden and that foster a non-competitive approach to research inside the European Union. It is hoped the revision will greatly improve the quality of scientific research, boost innovation and promote the development of alternative methods.
The animal welfare measures and practices included in the proposal are already in place in countries like the United States, Canada and Australia while a number of other countries are improving their animal welfare standards. Such practices must be firmly anchored in European legislation.
How many animals would be saved under the proposed directive?
The actual reduction in the number of animals used in experiments as a direct result of the new directive would be difficult to quantify. Such reductions would be influenced by factors such as research investments, health priorities, large-scale projects and use of alternative methods to replace and reduce animals.
The overall reduction would be driven by the introduction and use of alternative methods to animal testing in scientific procedures. The proposal foresees the creation of a network of national reference laboratories that would take part in the validation of alternative methods. But the proposal should not be seen in isolation. Other research initiatives and programmes will also contribute to the validation efforts within the EU and internationally. The European Partnership for Alternatives to Animal Testing also plays an important role. The full application of the Three Rs through compulsory ethical evaluations will significantly improve the welfare of animals used.
Will the new directive prevent duplication of experiments?
The duplication of experiments will be significantly reduced by the sharing of non-confidential data derived from experiments.
The Commission believes that the most pragmatic approach to reducing the use of animals in experiments is by introducing alternative methods that would eventually replace animal testing. This is known as the Three Rs principle of replacement, reduction and refinement. Replacement refers to replacing procedures which involve live animals with alternatives not using sentient animals. Reduction refers to reducing to a minimum the use of animals in procedures without compromising the quality of results. Refinement refers to using methods that avoid pain, suffering or distress or lasting harm to a bare minimum. This last 'R' also includes improving the care, treatment and living conditions of animals.
What is the EPAA (European Partnership for Alternative Approaches to Animal Testing)?
The Commission and industry have set up the European Partnership for Alternative Approaches to Animal testing (EPAA). The aim of the EPAA is to promote the development of new ‘3R’ methods - refinement, reduction, and replacement - as alternative approaches to the use of animals in safety assessment.
The 7th amendment to the Cosmetics Directive (76/768/EEC) foresees a testing and marketing ban on cosmetics tested on animals. The directive on animal testing (86/609/EEC) does not amend the rules provided for in other pieces of EU legislation. It lays down how testing on animals can be carried out when it does happen.
The testing ban on cosmetics will fully apply in 2009 when testing will be prohibited irrespective of alternatives to animal testing being available. The marketing ban will apply unconditionally to all human health effects with the exception of three toxicological effects such as repeated-dose toxicity, reproductive toxicity and toxicokinetics. The year 2013 is foreseen as the deadline for a ban on these specific health effects.
The development and availability of alternative methods is being closely monitored.
European Chemicals Agency:
European Partnership for Alternative Approaches to animal testing