The European Commission has published a report analysing the implementation of the Directive on the protection of animals used for scientific purposes in the Member States between 2018 and 2022.
The report is based on data sent in by the Member States, which are required to submit information on the implementation of the Directive every five years.
In its report, the European Commission summarises the highlights of the implementation of the Directive:
- Education and training: Responsibility for education and training lies primarily with the Member States, in accordance with the framework established by the Commission to define training requirements. Although mutual acceptance of training between States reduces duplication, specific training remains necessary due to national differences. In this context, the European Commission points out that an e-learning module on skills assessment is currently being developed.
- Project evaluation and authorisation: When assessing projects, applications must be examined carefully to ensure that the use of animals is justified and that the 3Rs principles (Replacement, Reduction and Refinement) are properly applied. Most Member States ensure the transparency of the process, but there are variations in the consistency and speed of decisions between Member States, including the assessment of the competence of project evaluators.
- Animals bred for use in scientific procedures: A reduction of 29% has been observed for these animals, but there is still a surplus. In this context, the European Commission mentions that initiatives to reduce the surplus of animals have been identified such as seminars and training programmes as well as guidance on surplus prevention developed at national level.
- The ‘3Rs’ principle: The directive requires the systematic application of the ‘3Rs’ principle (referring to : Replacement, Reduction and Refinement) in animal testing. Several Member States have reported improvements over the last five years, thanks in particular to better sharing of knowledge.
- Authorisation of breeders, suppliers and users: There are differences of interpretation between ‘establishment’ and ‘user’, ‘breeder’ and/or ‘supplier’. The European Commission has noted that some Member States may grant several authorisations to an establishment, either for each of the types listed, or for a combination of them, or several authorisations of the same type may be granted within the same premises, company or educational establishment.
- Withdrawal of authorisations for establishments and projects, and penalties: The European Commission reports that penalties and fines vary considerably from one Member State to another.
- Inspections: While most Member States have complied with the requirement to inspect one third of their user establishments each year, the COVID-19 pandemic has posed challenges for some Member States, which have encountered staffing problems.
For the proper implementation of the directive, three new guidance documents have been developed by the European Commission, covering genetically modified animals, non-technical project summaries and the results of retrospective assessments. On the basis of this analysis report, the European Commission mentions that training tools are currently being developed. Thirteen additional e-learning modules will be available in 2025, aimed at ensuring the competence of personnel involved in the care and use of animals throughout the EU.
The European Commission has also committed to developing a roadmap for phasing out animal testing for chemical safety assessments in response to the citizens' initiative on ending animal testing for cosmetics.
The roadmap should be finalised at the start of the new European Commission's term of office.
Finally, in terms of transparency on the use of animals in science, the European Commission recalls the launch of two public databases on annual statistics on the use of animals and non-technical summaries of projects (“ALURES”).