On 5 June 2019 the European Parliament and the Council adopted Regulation (EU) 2019/1010 on the alignment of reporting obligations in the field of legislation related to the environment amending inter alia Directive 2010/63/EU. The Regulation aims at improving the evidence base for EU policies, increasing transparency for the public and simplifying reporting to reduce administrative burden. Besides Directive 2010/63/EU it covers nine other pieces of environmental legislation.
In relation to Directive 2010/63/EU, the Regulation amends articles 43 and 54 of the Directive. With these amendments the Directive will become a front runner in the world in improving transparency of animal use in research, testing, education and training.
As recommended in the Directive Review report, Commission will establish a central, searchable, open-access database for non-technical project summaries. The non-technical project summaries will continue to be written in national languages but the use of modern IT tools should allow searching the database in all community languages. Since the majority of Member States have included the obligation to update the non-technical project summaries 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 any updates to these. Similarly, Member State annual statistical data on animal use will be made publicly available through an open access, searchable EU database. The databases should be operational from January 2021.
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 Regulation does not change any of the rules as to when non-technical project summaries or retrospective assessments are required – these remain unchanged.
The European Parliament has provided additional funds for the Commission to promote the use of alternatives to animal testing in the EU through information sharing and education activities. This pilot project will play a pivotal role for the implementation of the Directive by actively promoting existing alternatives, facilitating development and validation of new alternatives, fostering exchanges of information, knowledge and best practices and providing tools for education and training to facilitate the application of the principle of Three Rs in line with the Directive.
Three separate, identifiable pillars of action were agreed with the EP:
To develop six open access (on-line) eLearning modules of which two will focus on on non-animal alternatives on “how to search for non-animal alternatives” and to facilitate “the development of non-animal alternatives with a view to their use in regulatory context”; the other four modules will focus on the implementation of the Three Rs under the Directive covering “project design” (levels I and II), “project evaluation” and “application of severity assessment framework”. It is expected that these modules will provide much needed consistency across the EU on some of the key elements crucial for the correct application of the legislation.
To support the Education and Training Platform for Laboratory Animal Science (ETPLAS), which pools together Member State authorities, course providers and course accreditors, as a one-stop-shop in the EU for provision of information on available training and assessment tools for those tasked with evaluation of Learning Outcomes and competence assessment. ETPLAS will also host the above mentioned six eLearning modules.
To develop guidance that targets decision-makers in educational organisations to facilitate the incorporation of the Three Rs into their curricula at three levels of education, i.e., high schools, universities and professional education; and the production of at least three of the proposed resources that can be used in programmes to teach the principles of the Three R. This work is co-ordinated by EURL ECVAM in the Joint Research Centre (JRC) of the Commission.
All the activities have started and are expected to be completed by the end of 2020. For more information, please contact through the functional mailbox.
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