CHAPTER II

PROVISIONS ON THE USE OF CERTAIN ANIMALS IN PROCEDURES

Endangered species
Article 7
1
Specimens of those endangered species listed in Annex A to Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein , which do not fall within the scope of Article 7(1) of that Regulation, shall not be used in procedures, with the exception of those procedures meeting the following conditions:
a
the procedure has one of the purposes referred to in points (b)(i), (c) or (e) of Article 5 of this Directive; and
b
there is scientific justification to the effect that the purpose of the procedure cannot be achieved by the use of species other than those listed in that Annex.
2
Paragraph 1 shall not apply to any species of non-human primates.

Non-human primates
Article 8
1
Subject to paragraph 2, specimens of non-human primates shall not be used in procedures, with the exception of those procedures meeting the following conditions:
a
the procedure has one of the purposes referred to in
1. points (b)(i) or (c) of Article 5 of this Directive and is undertaken with a view to the avoidance, prevention, diagnosis or treatment of debilitating or potentially life-threatening clinical conditions in human beings; or
2. points (a) or (e) of Article 5;
and
b
there is scientific justification to the effect that the purpose of the procedure cannot be achieved by the use of species other than non-human primates.
A debilitating clinical condition for the purposes of this Directive means a reduction in a person’s normal physical or psychological ability to function.
2
Specimens of non-human primates listed in Annex A to Regulation (EC) No 338/97, which do not fall within the scope of Article 7(1) of that Regulation, shall not be used in procedures, with the exception of those procedures meeting the following conditions:
a
the procedure has one of the purposes referred to in:
1. points (b)(i) or (c) of Article 5 of this Directive and is undertaken with a view to the avoidance, prevention, diagnosis or treatment of debilitating or potentially life-threatening clinical conditions in human beings; or
2. Article 5(e);
and
b
there is scientific justification to the effect that the purpose of the procedure cannot be achieved by the use of species other than non-human primates and by the use of species not listed in that Annex.
3
Notwithstanding paragraphs 1 and 2, great apes shall not be used in procedures, subject to the use of the safeguard clause in Article 55(2).

Animals taken from the wild
Article 9
1
Animals taken from the wild shall not be used in procedures.
2
Competent authorities may grant exemptions from paragraph 1 on the basis of scientific justification to the effect that the purpose of the procedure cannot be achieved by the use of an animal which has been bred for use in procedures.
3
The capture of animals in the wild shall be carried out only by competent persons using methods which do not cause the animals avoidable pain, suffering, distress or lasting harm.
Any animal found, at or after capture, to be injured or in poor health shall be examined by a veterinarian or another competent person and action shall be taken to minimise the suffering of the animal. Competent authorities may grant exemptions from the requirement of taking action to minimise the suffering of the animal if there is scientific justification.

Animals bred for use in procedures
Article 10
1
Member States shall ensure that animals belonging to the species listed in Annex I may only be used in procedures where those animals have been bred for use in procedures.
However, from the dates set out in Annex II, Member States shall ensure that non-human primates listed therein may be used in procedures only where they are the offspring of non-human primates which have been bred in captivity or where they are sourced from self-sustaining colonies.
For the purposes of this Article a ‘self-sustaining colony’ means a colony in which animals are bred only within the colony or sourced from other colonies but not taken from the wild, and where the animals are kept in a way that ensures that they are accustomed to humans.
The Commission shall, in consultation with the Member States and stakeholders, conduct a feasibility study, which shall include an animal health and welfare assessment, of the requirement laid down in the second subparagraph. The study shall be published no later than 10 November 2017. It shall be accompanied, where appropriate, by proposals for amendments to Annex II.
2
The Commission shall keep under review the use of sourcing non-human primates from self-sustaining colonies and, in consultation with the Member States and stakeholders, conduct a study to analyse the feasibility of sourcing animals only from self-sustaining colonies.
The study shall be published no later than 10 November 2022.
3
Competent authorities may grant exemptions from paragraph 1 on the basis of scientific justification.

Stray and feral animals of domestic species
Article 11
1
Stray and feral animals of domestic species shall not be used in procedures.
2
The competent authorities may only grant exemptions from paragraph 1 subject to the following conditions:
a
there is an essential need for studies concerning the health and welfare of the animals or serious threats to the environment or to human or animal health; and
b
there is scientific justification to the effect that the purpose of the procedure can be achieved only by the use of a stray or a feral animal.
OJ L 61, 3.3.1997, p. 1.