On 31 May 2018 the Commission adopted a Proposal for a Regulation on the alignment of reporting obligations in the field of environment policy. The alignment proposal’s objectives are to improve the evidence base for implementing EU policy, increase transparency for the public and simplify reporting with a view to reducing administrative burden. Besides 2010/63/EU it covers 10 pieces of environmental legislation.
In relation to Directive 2010/63/EU, the proposal includes amendments to articles 43, 54 and 57. As recommended in the Directive Review report, Commission proposes to establish a central, searchable open-access database for non-technical project summaries. The non-technical project summaries will continue to be written in the language of the Member State. Since the majority of Member States have included the obligation to update these with the results of retrospective assessment in their national legislation, the database will need to be able to host both the original non-technical project summaries and their updates. In respect to the harmonisation aims of the Directive, the proposal aligns the updating obligation to the remaining Member States.
These amendments will significantly improve access to information on animal use in the EU - both prospectively and retrospectively. Centrally available data provides an opportunity for EU-wide analyses of current animal use to inform policy as well as to identify areas in need of alternative strategies to help Replace, Reduce, and Refine animal use in areas with the highest impact. It is important to note that the proposal does not amend any of the rules as to when non-technical project summaries or retrospective assessments are required – these remain unchanged. The remaining amendments are mainly to accelerate the availability of data and to reduce administrative burden in relation to reporting.
The idea of streamlining environment reporting was triggered by the Better Regulation Package of May 2015. Also The Fitness Check Evaluation on environmental reporting (Commission Work Programme in 2016) covered reporting and monitoring as a way to better support implementation.
The Fitness Check Evaluation on environmental reporting aimed to develop a more modern, efficient and effective regulatory monitoring and reporting, building on past successes and supporting the following specific objectives:
In the Fitness Check Evaluation the Commission screened 64 pieces of environment legislation, evaluated 58 of them, identified 181 reporting obligations of which 78 result in formal Commission reports. A number of stakeholder consultations were conducted ensuring a solid evidence base for the Commission proposal. The alignment proposal has been prepared on the basis of the evidence in the Fitness Check evaluation, and incorporating recommendations, where appropriate, from other relevant evaluations and reviews that were carried out on sectoral legislation, including the review of Directive 2010/63/EU on the protection of animals used for scientific purposes.
More information: Reporting and monitoring of environment legislation.
Like all recent EU legislation, Directive 2010/63/EU includes a requirement for a review - in this case by 10 November 2017 (Article 58). Due to the relatively early timing of the review and the Directive's partly delayed transposition into certain national legislations of the Member States, there is only limited experience with the Directive's implementation. Its projected benefits, especially in terms of improved welfare and science, have not yet fully materialised. The focus of the review was therefore to assess the impacts of the Directive on the basis of preliminary findings.
The Directive has three key objectives: to ensure efficient functioning of the EU internal market and enhance competitiveness and innovation of the EU research industry through the creation of a level playing field; to ensure high standards of welfare for animals still used for scientific purposes; and to improve transparency to the general public on the use of live animals for scientific purposes in the EU. The review was assessing the progress towards these three goals. The Directive's framework is generally considered to be a sound foundation for the regulation of animals used for scientific purposes. There are indications that the impact of the Directive varies among Member States. However, this is largely due to the differences in national legislation in place prior to the Directive. Some aspects of the Directive are developing and working well, for example Animal Welfare Bodies which are already contributing positively to animal use and care practices. Other positive effects include raising standards in research practice, improved Three Rs awareness, promotion of culture of care, growing recognition within the research community of the link between animal welfare and good science, and increasing transparency. At the same time, areas have been identified as needing further attention and progress. These include the efficiency and consistency of project evaluation and authorisation processes as well as access to, and quality of information on the use of animals. Finally, the Review Report incorporates the findings from the feasibility study on the 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 Review Report COM(2017) 631 is accompanied by a Commission Staff Working Document SWD(2017) 353 providing more insight into the review finding. The Staff Working Document also contains a number of recommendations for different stakeholders to take up, as appropriate, with the common aim of improving the attainment of Directive objectives.
The review process started with targeted stakeholder consultations during 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 for participation to any interested parties, on 31 March 2017.
The capture of non-human primates from the wild gives rise to animal welfare, health, and ethical issues. To end the capturing of animals from the wild for both scientific and breeding purposes, the Directive has set as one of its aims to allow, after an appropriate transition period, only the use of non-human primates that are the offspring of animals which have themselves been bred in captivity, or that are sourced from self-sustaining colonies. According to the Directive, a feasibility study must be conducted by 10 November 2017 to consider progress towards this aims (Article 10 of the Directive).
Considering the current and projected demand and supply of the non-human primate species used, and impacts on the animal welfare and health, the conclusions of the Feasibility Study do not support altering the dates set out in the Directive. The main species of concern is the Cynomolgus macaque. Their global availability in second (or higher) generation captive-bred exceeds the current and projected EU demand already today. However, the additional five years (2017-2022), as embedded in the Directive, are required to further facilitate the complete transition to Herpes B-virus free Cynomolgus macaques from those suppliers in Mauritius who are not yet able to fully meet demand. This would allow continuity of supply and allay scientific concerns on, for example availability of historical data/results from previous studies, should animals be required to be sourced elsewhere. To facilitate accurate reporting, Commission Implementing Decision 2012/707/EU should be adjusted to obtain annual information on the generation of animals supplied from self-sustaining colonies as this is currently not recorded.
The conclusions of the feasibility study are incorporated in the above-mentioned Review Report.
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 through targeted surveys. 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 survey questionnaires:
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:
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.
ECHA's tri-annual report "The Use of Alternatives to Testing on Animals for the REACH Regulation"
In line with Article 117(3) of the REACH Regulation, the European Chemicals Agency, ECHA, submits a report on the use of alternatives to testing on animals for the REACH Regulation. 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.
ECHA submitted the first report of this kind in June 2011, the second in June 2014 and the third one in June 2017