Friday, 22 October 2010 15:35

Revised EU-Directive on the protection of animals used for scientific purposes now published in the Official Journal of the European Union. To increase the use of alternative approaches is necessary. Featured

The Directive will enter into force on 9th Nov. 2010. Using animals should only be considered where a non-animal alternative is unavailable. To promote the principle of reduction, Member States should facilitate the establishment of programmes for sharing organs and tissues. Availability of alternative methods is dependent on the progress of the research into the development of alternatives. There is an increasing need for new methods to be developed and proposed for validation. Community programmes provide increasing funding for projects which aim to replace, reduce and refine the use of animals.

After agreement of the Council of 3rd June 2010 and adoption by the EU-Parliament in second reading on 8th September 2010, the Directive 2010/63/EU of 22th September 2010, that will replace Directive 86/609/EEC of 1986, will enter into force on 9th November 2010. Member States shall adopt and publish, by 10th November 2012, the laws, regulations and administrative provisions necessary to comply with the Directive. They shall apply those provisions from 1th January 2013.

Below you will find the main points concerning alternative methods which are appointed in the official reasons of the Directive. Some text passages are highlighted by InVitroJobs with bold text:

The Directive states, that it is "necessary to improve the welfare of animals used in scientific procedures by raising the minimum standards for their protection in line with the latest scientific developments." (Directive 2010/63/EU, Reasons, 6)[1] "Animals have an intrinsic value which must be respected. There are also the ethical concerns of the general public as regards the use of animals in procedures. Therefore, animals should always be treated as sentient creatures and their use in procedures should be restricted […]. The use of animals for scientific or educational purposes should therefore only be considered where a non-animal alternative is unavailable. Use of animals for scientific procedures in other areas under the competence of the Union should be prohibited." (12)

"Animal tissue and organs are used for the development of in vitro methods. To promote the principle of reduction, Member States should, where appropriate, facilitate the establishment of programmes for sharing the organs and tissue of animals that are killed." (27)

"To manage risks to human and animal health and the environment, the legislation of the Union provides that substances and products can be marketed only after appropriate safety and efficacy data have been submitted. Some of those requirements can be fulfilled only by resorting to animal testing, hereinafter referred to as ‘regulatory testing’. It is necessary to introduce specific measures in order to increase the use of alternative approaches and to eliminate unnecessary duplication of regulatory testing. For that purpose Member States should recognise the validity of test data produced using test methods provided for under the legislation of the Union." (42)

"The availability of alternative methods is highly dependent on the progress of the research into the development of alternatives. The Community Framework Programmes for Research and Technological Development provided increasing funding for projects which aim to replace, reduce and refine the use of animals in procedures. In order to increase competitiveness of research and industry in the Union and to replace, reduce and refine the use of animals in procedures, the Commission and the Member States should contribute through research and by other means to the development and validation of alternative approaches." (46)

"The European Centre for the Validation of Alternative Methods, a policy action within the Joint Research Centre of the Commission, has coordinated the validation of alternative approaches in the Union since 1991. However, there is an increasing need for new methods to be developed and proposed for validation, which requires a reference laboratory of the Union for the validation of alternative methods to be established formally. This laboratory should be referred to as the European Centre for the Validation of Alternative Methods (ECVAM). It is necessary for the Commission to cooperate with the Member States when setting priorities for validation studies. The Member States should assist the Commission in identifying and nominating suitable laboratories to carry out such validation studies. For validation studies that are similar to previously validated methods and in respect of which a validation represents a significant competitive advantage, ECVAM should be able to collect charges from those who submit their methods for validation. Such charges should not be prohibitive of healthy competition in the testing industry." (47)

[1] DIRECTIVE 2010/63/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22th September 2010 on the protection of animals used for scientific purposes, published in the Official Journal of the European Union L 276/33 (20.10.2010). Accentuation by InVitroJobs.

Here you can download the Directive (Official Journal of the European Union, 20.10.2010).