There is a strong public interest in the issue of animal welfare, and many people have concerns about some of the methods used in animal testing.
The protection and welfare of animals is an issue covered by a wide range of EU legislation, such as the protection of wildlife, zoo animals, farm animals, animals in transport and animals used for scientific and cosmetic purposes.
Animals used for scientific purposes
In order to protect animals while allowing research to continue, the EU has laid down specific legislation limiting animal testing and setting minimum requirements for accommodating and caring for animals.
The EU rules on this issue are stipulated in Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes.
The main objectives of the directive are to improve the welfare of animals still needed to be used in scientific procedures, guarantee a level playing field for industry and enhance the quality of research in the EU. The directive is based on the principle of replacement, reduction and refinement of the use of animals in procedures (also known as the ‘Three Rs’ principle).
Detailed information on the directive, its objectives and scope is available in the Commission’s ‘questions and answers’ of 9 September 2010.
The European Citizens’ Initiative ‘Stop Vivisection’
‘Stop Vivisection’ was the third European Citizens’ Initiative (ECI), submitted to the European Commission on 3 March 2015. The main objectives of this initiative were ‘to abrogate Directive 2010/63/EU on the protection of animals used for scientific purposes and put forward a new proposal aimed at phasing out the practice of animal experimentation, making compulsory the use – in biomedical and toxicological research – of data directly relevant for the human species’.
The initiative was registered in June 2012, and collected 1 173 130 signatures until its closing on 1 November 2013. It was discussed during a public hearing hosted by the European Parliament on 11 May 2015, and was answered by the European Commission on 3 June 2015.
In its communication, the Commission welcomed the mobilisation of citizens in support of animal welfare and stated that the EU shares the initiative’s conviction that animal testing should be phased out, which is also the main aim of EU legislation. It underlined that, while working towards the ultimate goal of full replacement of animals, for the time being animal experimentation remains important for protecting human and animal health, and for maintaining an intact environment. For this reason, Directive 2010/63/EU, considered by the Commission as the right legislation to achieve the underlying objectives of the initiative, was needed to ensure a high level of protection of the animals used in research.
At the same time the Commission stressed that it will continue to promote the development and implementation of alternative approaches, encourage cooperation and knowledge sharing across sectors, validate new methods and facilitate their regulatory approval. More details are available in the Commission’s press release of 3 June 2015.
In the context of Action 1 of the Commission’s communication, the Joint Research Centre’s European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) conducted a public survey to solicit input from individuals and organisations on public knowledge of the ‘Three Rs’ and how it could be disseminated.
The EUR-Lex summary on the protection of laboratory animals, as well as the Commission’s webpage on animals used for scientific purposes, which also contains details of EU action to identify alternative approaches, may also be of interest.
Cosmetics and household products
Cosmetic products are regulated at European level to ensure consumer safety and to secure an internal market for cosmetics. EU legislation also ensures the existence of a ban on animal testing for cosmetic purposes, i.e. it prohibits testing cosmetic ingredients and finished products on animals, and marketing products that were tested on animals in the EU.
Cosmetic products cannot be placed on the market if the finished product or its ingredients have undergone animal testing, unless the testing was carried out to meet the obligations of other legislation such as the REACH Regulation.
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (Cosmetics Regulation) provides the current regulatory framework in this regard.
Further to the ban on animal testing, MEPs have addressed a number of written questions to the Commission on the issue of extending the ban to animal testing for household product (E-009062-15), as well as the marketing of household products tested on animals (P-012055-15).
The Commission, in its answer of 23 December 2014, referred to the REACH Regulation and to the regulation on classification, labelling and packaging of substances and mixtures and stated that testing on animals is only done as a last resort. The Commission promotes the use of alternatives, however ‘regarding substances in household products, alternatives have not yet been validated for all toxicological effects hence the Commission is currently not in a position to ban all animal experiments while ensuring safe products’.
In addition, in its reply of 10 March 2016, the Commission reiterated its position and underlined its intention of following the EU-ToxRisk project and reviewing its results with respect to current legal provisions on testing methods. This project started in January 2016 and is ‘charged to develop more tools and strategies to ultimately allow an animal-free risk assessment of chemicals. At mid-term, the project is expected to deliver a limited set of animal-free procedures that could be used in the context of REACH. However, the full replacement of animals in safety testing of chemicals is unlikely to be achievable within the next decade’.
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