The control over the use of animals for scientific purposes falls primarily on the competent bodies of the Autonomous Communities and is carried out in different forms of authorization and inspection regulated by Royal Decree 53/2013 (boe.es), of 1 February, which establishes the applicable basic rules for the protection of animals used in experimentation and other scientific purposes, including teaching, recently modified by Royal Decree 1083/2025, of 2 December. The activity of researchers using experimental animals must conform to the procedures established within a project that must be evaluated favourably by an authorized organ (OH) for it. In addition, the user center must also be authorized and have a Body specifically In Charge of Animal Welfare (OEBA). Animal breeders and suppliers must also be authorised for testing and all personnel involved in the system must have specific training and training.
The Ministry of Science, Innovation and Universities, for the purposes of transparency, keeps the list of qualified bodies of each Autonomous Community updated for the evaluation of research projects that include the use of animals. These authorized bodies are designated by the respective Autonomous Communities and the cities of Ceuta and Melilla, according to a regulated procedure that guarantees the free concurrence of all those who meet the requirements established in the regulations.
Their authorization makes them responsible for verifying that each project meets the established requirements and, in particular, based on the technical review of the project carried out by the OEBA, evaluates,
- its purpose, the scientific benefits expected to be achieved;
- its compliance with replacement, reduction and refinement requirements;
- that there are no alternative methods to using animals to achieve the objectives of the project;
- its procedures, regulated according to the degree of severity;
- and an analysis of damages and benefits, taking into account ethical considerations;
The European Commission has published a document on the project evaluation system: Caring for animals towards better science – Directive 2010/63/EU on the protection of animals used for scientific purposes – Framework Document for Education and Training, Publications Office, 2018, https://data.europa.eu/doi/10.2779/07581.
For the sake of transparency, the competent bodies of the Autonomous Communities shall publish the non-technical summaries of the projects authorised which are in turn integrated into a Commission database, EU NTS Database on the use of animals for scientific purposes under Directive 2010/63/EU – ALURES – Animal Use Reporting – EU System, open access.
In order to make it possible to keep the list of qualified bodies up to date, the competent bodies of the Autonomous Communities are invited to inform this Ministry of Science, Innovation and Universities of any high or low results that are caused by bodies qualified for the evaluation of projects in their territory.
