Subject matter and scope

1. This Directive establishes measures for the protection of animals used for scientific or educational purposes.

To that end, it lays down rules on the following:

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;

the origin, breeding, marking, care and accommodation and killing of animals;

the operations of breeders, suppliers and users;

the evaluation and authorisation of projects involving the use of animals in procedures.

2. This Directive shall apply where animals are used or intended to be used in procedures, or bred specifically so that their organs or tissues may be used for scientific purposes.

This Directive shall apply until the animals referred to in the first subparagraph have been killed, rehomed or returned to a suitable habitat or husbandry system.

The elimination of pain, suffering, distress or lasting harm by the successful use of anaesthesia, analgesia or other methods shall not exclude the use of an animal in procedures from the scope of this Directive.

3. This Directive shall apply to the following animals:

live non-human vertebrate animals, including:

independently feeding larval forms; and

foetal forms of mammals as from the last third of their normal development;

live cephalopods.

4. This Directive shall apply to animals used in procedures, which are at an earlier stage of development than that referred to in point (a) of paragraph 3, if the animal is to be allowed to live beyond that stage of development and, as a result of the procedures performed, is likely to experience pain, suffering, distress or lasting harm after it has reached that stage of development.

5. This Directive shall not apply to the following:

non-experimental agricultural practices;

non-experimental clinical veterinary practices;

veterinary clinical trials required for the marketing authorisation of a veterinary medicinal product;

practices undertaken for the purposes of recognised animal husbandry;

practices undertaken for the primary purpose of identification of an animal;

practices not likely to cause pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice.

6. This Directive shall apply without prejudice to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products ( 8 ) .

DIRECTIVE 2010/63/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2010 on the protection of animals used for scientific purposes ANNEX I ANNEX II ANNEX III ANNEX IV ANNEX V ANNEX VI ANNEX VII ANNEX VIII