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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. Another, more comprehensive, evaluation in line with the Commission Better Regulation programme has been proposed for 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 preliminary findings from the different consultations were presented and discussed at a stakeholder meeting, open to any interested parties to participate, on 31 March 2017. On the basis of all the consultations, and other relevant information, the Commission will now prepare the Review Report by 10 November 2017. It will be accompanied by a more detailed Staff Working Document.

Article 10 feasibility study under Directive 2010/63/EU on the protection of animals used for scientific purposes

According to the Directive a feasibility study must be conducted by November 2017 to consider progress towards the requirement to restrict the use of non-human primates to those animals which are offspring of parents which themselves were bred in captivity or obtained from a self-sustaining colony (Article 10 of the Directive).  The process for the feasibility study started in summer 2016 by convening a stakeholder meeting covering Member States where non-human primates are used, users and breeders/suppliers of non-human primates both from academia and industry, specialised stakeholder organisations and NGOs for animal welfare. The meeting discussed the scope of the study. On the basis of the scoping meeting, information on the current and future use and supply as well as animal health and welfare information relevant to the transitional period were collected from EU and non-EU countries.
The preliminary findings from these fact-finding surveys were presented at a stakeholder meeting, open to any interested parties to participate, on 30 March 2017.

The final study report will be published by 10 November 2017. Any policy proposals arising from the study will be incorporated in the above mentioned Review Report.

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.