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Animals used for scientific purposes

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Review of Directive 2010/63/EU on the protection of animals used for scientific purposes

Like all recent EU legislation, Directive 2010/63/EU includes a requirement for a review - in this case due by November 2017 (Article 58). Due to the relatively early timing of the review and its partly delayed transposition into certain national legislations of the Member States, there will be only limited experience of the Directive. It is unlikely that the Directive's projected benefits, especially in terms of improved welfare and science, will have fully materialised. The focus of the review is therefore to assess the impacts of the Directive on the basis of preliminary findings in selected targeted areas. Another, more comprehensive, evaluation in line with the Commission Better Regulation programme will be carried out in 2019.

The review process started with targeted stakeholder consultations between 27 May - 31 August 2016 involving the user community (those who breed, supply or use animals), Member State authorities and other EU-level stakeholder organisations. To promote a balanced response, national animal welfare organisations were also invited to contribute in addition to respondents from the user community, both at the establishment as well as at EU level. The Commission has sought to reach out to all relevant stakeholder organisations at EU level.

According to the Directive, the review should take into account advancements in the development of alternative methods not entailing the use of animals, in particular of non-human primates. To that effect, the Commission has requested an update from the Scientific Committee on Health, Environmental and Emerging Risks, SCHEER, to an earlier opinion by its predecessor, SCHER. More information can be found at the SCHEER website. Additional information sources will be used to assess more generally the advancements in the development of alternative methods and approaches, such as EURL ECVAM reports.

The responses to the consultation are being analysed and summarised together with the other relevant information in a draft Commission Review report, scheduled for Q2 2017. There will be a further possibility for stakeholder input before the Commission review report is finalised.

EURL ECVAM Strategy papers

EURL ECVAM strategies typically address different regulatory areas and their related needs. They review the progress made to-date, identify gaps and opportunities in relation to method development and validation, and outline what actions should be taken to deliver solutions that carry Three Rs impact. To ensure robust basis and international alignment to the developed strategies, EURL ECVAM consults with its regulatory and scientific advisory bodies, its stakeholder forum and with international cooperation partners involved in method evaluation, validation and regulatory adoption.

EURL ECVAM Strategy papers cover the following areas - the list expands as new information is published:

  • Acute mammalian systemic toxicity
  • Aquatic toxicity and bioaccumulation
  • Genotoxicity
  • Skin sensitisation
  • Toxicokinetics and systemic toxicity

EURL ECVAM progress report on the development, validation and regulatory acceptance of alternative methods

EURL ECVAM (the European Union Reference Laboratory for Alternatives to Animal Testing) regularly publishes Reports providing updates on the development, validation and regulatory acceptance of alternative methods/approaches.

These include:

ECHA's tri-annual report "The Use of Alternatives to Testing on Animals for the REACH Regulation"

The second report, under Article 117(3) of the REACH Regulation by the European Chemicals Agency, ECHA, on the use of alternative methods has been published. It shows an increase in the use of these methods. Testing on vertebrate animals is only allowed as a last resort under REACH and ECHA's objective is to promote non-animal testing methods and other alternatives. Every three years, ECHA reports to the Commission on how the alternative methods have been used to generate information on intrinsic properties of chemical substances and for the risk assessment. The next report is due in 2017.