Background

Directive 2010/63/EU of the European parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposesprovides for administrative and technical conditions for protection of animals used in scientific procedures (animals in experiments).This complex and extensive piece of European legislation is based on the principles of the replacement and reduction of the use of animals in procedures and the refinement of the breeding, accommodation, care and use of animals in procedures. Its purpose is to protect animals in processes of breeding, marking, care and accommodation and killing. It lays down rules on the operations of breeders, suppliers and users and the evaluation and authorisation of projects involving the use of animals in procedures.

Albeit the use of animals in experiments is regulated separately from farm animals, implementation and enforcement of this part of animal welfare legislation often shows the need for discussion and guidelines. It would therefore be highly beneficial for the industry and indeed for the competent authorities in the region to have the opportunity to harmonise procedures and provide technical support on issues stemming from implementation and enforcement of the directive.

What is in place

DG ENVI has created a good and efficient system in order to keep all stakeholders involved in the process of implementation, enforcement, and training. Alas, contrary to DG SANCO, DG ENVI cannot organise training events (e.g. ‘Better training for safer food’ initiative) to disseminate the knowledge and good practice, as there is no legal base and consequently no funding foreseen.

In addition to regular semestral meetings of working group of national contact points for the use of animals in scientific procedures, there are several sub-groups which can be summoned ad hoc:

  • Training and education
  • Inspections and enforcement
  • Severity assessment
  • Animal welfare bodies and National committees
  • 3R
  • Project evaluation

To facilitate easier implementation, the Commission has produced several documents which have been endorsed by the national contact points. These documents are legaly non-binding guidelines and are recommended to be used in all member states:

  • Education and training framework with a modular Learning Outcome-based training structure, principles and criteria for supervision, competence assessment, continued professional development and for a mutual approval/accreditation of courses
  • The principles of creation, establishment and maintenance of genetically altered animal lines and how these are considered within project authorisation and statistical reporting
  • Guidance on the drafting and publication of non-technical project summaries
  • Guidance for performance of Project Evaluation
  • The severity assessment framework
  • Q&A on various articles in the Directive

Possible future activities for the RAWC

    1. To create and provide training courses for users of animals, competent staff, and inspectors;
    2. To propose, evaluate and assist in validation process for alternative methods used instead of the ones including animals;
    3. To prepare severity classification tool to be used in severity assessment framework;
    4. To propose and evaluate possible methods of euthanasia of species used in scientific procedures;