Brussels, 9 September 2010
Questions and answers on the new directive for the protection of animals used for scientific purposes
What are the aims of the new directive?
The main objectives are to considerably improve the welfare of animals used in scientific procedures, to ensure fair competition for industry, and foster research activities in the European Union. The directive is based on the need to Replace, Reduce, and Refine animal testing – the Three Rs principle. 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.
Why was it necessary to revise Directive 86/609/EEC?
Legislation on the protection of animals used in scientific experiments (86/609/EEC) had a variety of weaknesses, and a number of Member States have passed laws that have led to a widening gap in standards. The Commission felt it was necessary to address these issues whilst ensuring further improvements were made to the welfare of animals used in scientific procedures. Our knowledge of animal welfare requirements and their capacity to experience pain, suffering and distress 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. In addition, EU legislation has never before explicitly addressed the internationally recognised Three R concept of Replacement, Reduction and Refinement (Russell and Burch 1959) which aims 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 has strengthened the legislation in the area of animal experimentation in the EU. The aim is to reduce the use of animals in scientific experiments and ensure that those that are still used receive appropriate care and humane treatment.
How does the new directive differ from the old directive?
The revised directive will make it compulsory to carry out ethical evaluation and require that experiments where animals are used be subject to authorisation;
It will widen the scope of the directive to include under its protection specific invertebrate species and foetuses in their last trimester of development as well as animals used for the purposes of basic research, education and training;
It will set minimum housing and care requirements;
The revised directive requires that only non-human primates of second or higher generation be used, subject to transitional periods, to avoid taking animals from the wild for animal welfare and environmental reasons;
More clarity has been introduced into the requirement to replace the use of animals by non-animal methods. Member States will be required to improve breeding, accommodation and care measures as well as methods used in procedures to eliminate or reduce to a minimum any possible pain, suffering, distress or lasting harm caused to animals. These measures are based on the Three Rs principle: Replacing, Reducing and Refining the use of animals in experiments;
There will be an 'Animal welfare body' in each establishment to foster a climate of care and ensure a systematic application of the current Three Rs methods and techniques as well as to ensure the uptake of the new, emerging ones;
Non-technical summaries will be prepared for each project to be published by the Member States to improve transparency and understanding and a retrospective assessment of projects with high concern will be conducted;
Significant focus has been put on correct application and enforcement for example through systematic controls including unannounced inspections.
How will the revision affect research in the European Union?
The directive 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.
How many animals would be saved under the new directive?
The actual reduction in the number of animals used in experiments as a direct result of the new directive is 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 directive foresees the creation of a network of national reference laboratories that would take part in the validation of alternative methods. But the directive 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 (EPAA) also plays an important role. The full application of the Three Rs through compulsory project (ethical) evaluations will significantly improve the welfare of animals used.
What is the scope of the directive?
The directive covers all live non-human vertebrate animals intended for experiments plus certain other species likely to experience pain. It also includes animals specifically bred so that their organs or tissue can be used in scientific procedures, foetuses of mammals in the last trimester of development as well as animals used in basic research, education and training.
What is not covered by the directive?
The 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 practices used in recognised husbandry or for marking an animal, or non-invasive research practices.
Will any animal experiments be banned under the new legislation?
The use of non-human primates is subject to restrictions, and the revised directive introduces a ban on the use of great apes – chimpanzees, bonobos, gorillas and orangutans – for scientific purposes. 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 directive tightens controls on animal use by introducing compulsory ethical evaluations and improving the housing and care provided to experimental animals.
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 foreseeable future. Non-human primates are currently used for a number of vital research programmes on infectious diseases such as HIV, malaria, hepatitis, and SARS. The Commission is closely monitoring scientific developments in this area and examining them carefully in case possibilities for phasing out the testing on non-human primates arise. Periodic thematic reviews of the 3Rs will be conducted by the Commission paying specific attention to the use of non-human primates.
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 and through systematic ethical evaluation assessing the project proposals.
What is the view of the Commission on alternative methods?
The Commission believes that the most practical approach to reducing the use of animals in experiments is the introduction of 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 number of animals in procedures without compromising the quality of results. Refinement refers to using methods that attempt to avoid pain, suffering or distress, or lasting harm. This last 'R' also includes improving the care, treatment and living conditions of animals.
Why has the obligation to use alternatives where practicably available been removed from the revised text?
Directive 86/609/EEC states in Article 7 that 'an experiment [involving an animal] should not be performed if another scientifically satisfactory method, not entailing the use of an animal, is reasonably and practicably available'. This lead to misinterpretation and ambiguity resulting in court cases in various Member States. The new text obliges users to choose an alternative method should it be recognised by Community legislation (Article 13).
Furthermore, in the areas of basic research and applied research in which test methods are not detailed in EU legislation, Article 4(1) provides that “Member States shall ensure that, wherever possible, a scientifically satisfactory method or testing strategy, not entailing the use of live animals, shall be used instead of a procedure”. This obligation is strong and a decision not to use an available scientifically satisfactory alternative method would need to be clearly justified.
Would it be obligatory to use alternative methods involving human embryonic stem cells if these present themselves as alternatives to animal tests?
The directive is not designed to regulate research using human embryonic stem cells. It also does not define what an ethically acceptable alternative replacement method is. Neither of these subject matters falls within the scope of the directive.
The use of human embryonic stem cells raises a number of ethical questions on which positions between, and often within, Member States differ. Bearing in mind this ethical dimension and the principle of subsidiarity, the Commission believes these issues are best regulated at Member State level. It considers that EU legislation should neither impose the use of human embryonic stem cells on Member States that find their use ethically unacceptable, nor prevent others from resorting to their use.
The use of human embryonic stem cells was discussed during the revision process. During the co-decision procedure, amendments tabled by the European Parliament at the first reading led to changes in the text. Member States and the European Parliament considered that the agreed wording sufficiently addresses the problem. The Commission shares this view. Even if a Member State does not have national rules that prohibit the use of human embryonic stem cells, under the revised directive the use of such a testing method would only be obligatory if it was recognised by EU legislation. No such legislation exists, nor is its adoption to be expected in the light of the above considerations. In this context it should be remembered that the requirement to use alternative methods in place of an animal method is not a new requirement introduced through the revision of the directive, but a legal obligation that has been in place since 1986. Should a Member State introduce national legislation prohibiting the use of human embryonic stem cells, the wording of Articles 4 and 13 ensures that the revised directive cannot overrule any such national prohibitions.
What is the European Partnership for Alternative Approaches to Animal Testing (EPAA)?
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.
Will there be a ban on animal testing for cosmetics?
The 7th amendment to the Cosmetics Directive (76/768/EEC) establishes a testing and marketing ban on cosmetics tested on animals. The directive on animal testing does not amend the rules provided for in other pieces of EU legislation, it simply lays down how testing on animals can be carried out when it is necessary.
The testing ban on cosmetics has existed since 2009 when testing was prohibited irrespective of alternatives to animal testing being available. The marketing ban applies unconditionally to all human health effects with the exception of three toxicological effects. 2013 is foreseen as the deadline for a ban on testing for these three specific health effects.
The development and availability of alternative methods is being closely monitored.
How will the new legislation affect the EU's chemicals law?
Under the EU's chemicals law REACH (Registration, Evaluation and Authorisation and restriction of CHemicals), 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, an issue highlighted in a report published by the European Centre for the Validation of Alternative methods (ECVAM). Relying solely on in 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 which tests they propose and must obtain approval before carrying them out. Under EU chemicals law, laboratory animal testing is to be avoided in favour of alternative methods and is only to be used as a last resort.
This directive is fully in line with the general principles of REACH. Under the directive, testing required by REACH or other product-related legislation will be subject to the same measures as any other testing. In other words, testing carried out for REACH will need to be carried out in compliance with the provisions of this directive.
Will the new legislation be reflected in the ongoing revision of the Biocides Directive?
The reduction of animal testing is one of the objectives of the ongoing revision of the Biocides Directive. In light of this, the proposed Regulation, which will replace the Biocides Directive, requires that testing on vertebrate animals is undertaken only as a last resort. In the future, it will not be possible to repeat animal testing for the purposes of the proposed Regulation. If animal tests are carried out under the proposed Regulation, they will have to comply with the relevant requirements of this Directive.
In line with the recent developments under REACH and the Plant Protection Products Regulation, mandatory sharing of data involving animal tests has been introduced. Furthermore, in order to avoid situations where unnecessary testing is carried out, the proposed Regulation strengthens the provisions on data waiving. Member States will be obliged to inform companies about the possibility to request an adaptation of data requirements, the grounds for data waiving and, where possible, provide assistance in preparing the data adaptation requests.
Application of the new law
The Member States will have 24 months to adopt and publish national legislation which will transpose the provisions of this Directive. The new Directive will take effect on 1 January 2013.
European Chemicals Agency: http://echa.europa.eu/
European Partnership for Alternative Approaches to animal testing: