Council Directive 2010/63/EU

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.

The European Union (EU) is an union of twenty-eight independent states based on the European Communities and founded to enhance political, economic and social co-operation. 

In 2010, the EU endorsed the revised Council Directive 2010/63/EU on the protection of animals used for scientific purposes.

The following recitals and articles pertain to the implementation of humane endpoints.

Recitals

(2). Animal welfare is a value of the Union that is enshrined in Article 13 of the Treaty on the Functioning of the European Union (TFEU).

(12). Animals have an intrinsic value which must be respected. There are also the ethical concerns of the general public as regards the use of animals in procedures. Therefore, animals should always be treated as sentient creatures and their use in procedures should be restricted to areas which may ultimately benefit human or animal health, or the environment. The use of animals for scientific or educational purposes should therefore only be considered where a non-animal alternative is unavailable. Use of animals for scientific procedures in other areas under the competence of the Union should be prohibited.

(14). The methods selected should avoid, as far as possible, death as an end-point due to the severe suffering experienced during the period before death. Where possible, it should be substituted by more humane end- points using clinical signs that determine the impending death, thereby allowing the animal to be killed without any further suffering.

(15) The use of inappropriate methods for killing an animal can cause significant pain, distress and suffering to the animal. The level of competence of the person carrying out this operation is equally important. Animals should therefore be killed only by a competent person using a method that is appropriate to the species.

(23) From an ethical standpoint, there should be an upper limit of pain, suffering and distress above which animals should not be subjected in scientific procedures. To that end, the performance of procedures that result in severe pain, suffering or distress, which is likely to be long-lasting and cannot be ameliorated, should be prohibited.

Articles

Art. 6. Methods of killing

1. Member States shall ensure that animals are killed with minimum pain, suffering and distress.
2. Member States shall ensure that animals are killed in the establishment of a breeder, supplier or user, by a competent person.

Article 13. Choice of methods

1. Without prejudice to national legislation prohibiting certain types of methods, Member States shall ensure that a procedure is not carried out if another method or testing strategy for obtaining the result sought, not entailing the use of a live animal, is recognised under the legislation of the Union.

2. In choosing between procedures, those which to the greatest extent meet the following requirements shall be selected:

(a) use the minimum number of animals;
(b) involve animals with the lowest capacity to experience pain, suffering, distress or lasting harm;
(c) cause the least pain, suffering, distress or lasting harm;
(d) and are most likely to provide satisfactory results.

3. Death as the end-point of a procedure shall be avoided as far as possible and replaced by early and humane end-points. Where death as the end-point is unavoidable, the procedure shall be designed so as to:

(a) result in the deaths of as few animals as possible; and
(b) reduce the duration and intensity of suffering to the animal to the minimum possible and, as far as possible, ensure a painless death

Art.14. Anaesthesia

5. As soon as the purpose of the procedure has been achieved appropriate action shall be taken to minimise the suffering of the animal.

Art.17. End of the procedure

2. At the end of a procedure, a decision to keep an animal alive shall be taken by a veterinarian or by another competent person. An animal shall be killed when it is likely to remain in moderate or severe pain, suffering, distress or lasting harm.

Art.24. Specific requirements for personnel

2. Member States shall ensure that persons specified in Article 40(2)(b) shall:
(a) ensure that any unnecessary pain, suffering, distress or lasting harm that is being inflicted on an animal in the course of a procedure is stopped; and (...).

Art.33. Care and accommodation

1. Member States shall, as far as the care and accomodation of animals is concerned, ensure that:

(d) arrangements are made to ensure that any defect or avoidable pain, suffering, distress or lasting harm discovered is eliminated as quickly as possible; and (...)

Legislation on zebrafish

Zebrafish are vertebrates and therefore subject to legislation governing animal testing. Embryos and larvae up to 5 days old are excepted. The legislation criterion is: “independently feeding larval forms ” (Directive 2010/63/EU), in other words; when the larvae are able to move through the water column independently, when their digestive tract is functional, and when they are beginning to hunt for prey.

With respect to zebrafish housing and care, a number of very general rules on fish husbandry apply, that is: housing in a manner appropriate to the species (Directive 2010/63/EU). No well-defined instruction regarding housing, e.g. tank dimensions and enrichment, have been defined (yet). The FELASA guidelines are expected to be presented in the near future.

Specific guidelines are in place regarding the killing of fish, such as the AVMA Guidelines for the euthanasia of Animals: 2013 Edition. Directive 2010/63/EU also contains fish euthanasia guidelines.

ILAR journal volume 53 (2) contains a series of articles and guidelines on various aspects of zebrafish husbandry (IACUC; Guide for the Care and Use of Laboratory Animals).