Council Directive of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (86/609/EEC)

[Text valid from 16-09-2003 to 10-05-2013]

COUNCIL DIRECTIVE

of 24 November 1986

on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes

(86/609/EEC)

Article 1

The aim of this Directive is to ensure that where animals are used for experimental or other scientific purposes the provisions laid down by law, regulation or administrative provisions in the Member States for their protection are approximated so as to avoid affecting the establishment and functioning of the common market, in particular by distorsions of competition or barriers to trade.

Article 2

For the purposes of this Directive the following definitions shall apply:

Article 3

This Directive applies to the use of animals in experiments which are undertaken for one of the following purposes:

Article 4

Each Member State shall ensure that experiments using animals considered as endangered under Appendix I of the Convention on International Trade in Endangered Species of Fauna and Flora and Annex C.I. of Regulation (EEC) No 3626/82 ( 4 ) are prohibited unless they are in conformity with the above Regulation and the objects of the experiment are:

Article 5

Member States shall ensure that, as far as the general care and accommodation of animals is concerned:

For the implementation of the provisions of paragraphs (a) and (b), Member States shall pay regard to the guidelines set out in Annex II.

Article 6

1.  Each Member State shall designate the authority or authorities responsible for verifying that the provisions of this Directive are properly carried out.

2.  In the framework of the implementation of this Directive, Member States shall adopt the necessary measures in order that the designated authority mentioned in paragraph 1 above may have the advice of experts competent for the matters in question.

Article 7

1.  Experiments shall be performed solely by competent authorized persons, or under the direct responsibility of such a person, or if the experimental or other scientific project concerned is authorized in accordance with the provisions of national legislation.

2.  An experiment shall not be performed if another scientifically satisfactory method of obtaining the result sought, not entailing the use of an animal, is reasonably and practicably available.

3.  When an experiment has to be performed, the choice of species shall be carefully considered and, where necessary, explained to the authority. In a choice between experiments, those which use the minimum number of animals, involve animals with the lowest degree of neurophysiological sensitivity, cause the least pain, suffering, distress or lasting harm and which are most likely to provide satisfactory results shall be selected.

Experiments on animals taken from the wild may not be carried out unless experiments on other animals would not suffice for the aims of the experiment.

4.  All experiments shall be designed to avoid distress and unnecessary pain and suffering to the experimental animals. They shall be subject to the provisions laid down in Article 8. The measures set out in Article 9 shall be taken in all cases.

Article 8

1.  All experiments shall be carried out under general or local anaesthesia.

2.  Paragraph 1 above does not apply when:

Anaesthesia should be used in the case of serious injuries which may cause severe pain.

3.  If anaesthesia is not possible, analgesics or other appropriate methods should be used in order to ensure as far as possible that pain, suffering, distress or harm are limited and that in any event the animal is not subject to severe pain, distress or suffering.

4.  Provided such action is compatible with the object of the experiment, an anaesthetized animal, which suffers considerable pain once anaesthesia has worn off, shall be treated in good time with pain-relieving means or, if this is not possible, shall be immediately killed by a humane method.

Article 9

1.  At the end of any experiment, it shall be decided whether the animal shall be kept alive or killed by a humane method, subject to the condition that it shall not be kept alive if, even though it has been restored to normal health in all other respects, it is likely to remain in lasting pain or distress.

2.  The decisions referred to in paragraph 1 shall be taken by a competent person, preferably a veterinarian.

3.  Where, at the end of an experiment:

Article 10

Member States shall ensure that any re-use of animals in experiments shall be compatible with the provisions of this Directive.

In particular, an animal shall not be used more than once in experiments entailing severe pain, distress or equivalent suffering.

Article 11

Notwithstanding the other provisions of this Directive, where it is necessary for the legitimate purposes of the experiment, the authority may allow the animal concerned to be set free, provided that it is satisfied that the maximum possible care has been taken to safeguard the animal's well-being, as long as its state of health allows this to be done and there is no danger for public health and the environment.

Article 12

1.  Member States shall establish procedures whereby experiments themselves or the details of persons conducting such experiments shall be notified in advance to the authority.

2.  Where it is planned to subject an animal to an experiment in which it will, or may, experience severe pain which is likely to be prolonged, that experiment must be specifically declared and justified to, or specifically authorized by, the authority. The authority shall take appropriate judicial or administrative action if it is not satisfied that the experiment is of sufficient importance for meeting the essential needs of man or animal.

Article 13

1.  On the basis of requests for authorization and notifications received, and on the basis of the reports made, the authority in each Member State shall collect, and as far as possible periodically make publicly available, the statistical information on the use of animals in experiments in respect of:

2.  Member States shall take all necessary steps to ensure that the confidentiality of commercially sensitive information communicated pursuant to this Directive is protected.

Article 14

Persons who carry out experiments or take part in them and persons who take care of animals used for experiments, including duties of a supervisory nature, shall have appropriate education and training.

In particular, persons carrying out or supervising the conduct of experiments shall have received instruction in a scientific discipline relevant to the experimental work being undertaken and be capable of handling and taking care of laboratory animals; they shall also have satisfied the authority that they have attained a level of training sufficient for carrying out their tasks.

Article 15

Breeding and supplying establishments shall be approved by or registered with, the authority and comply with the requirements of Articles 5 and 14 unless an exemption is granted under Article 19 (4) or Article 21. A supplying establishment shall obtain animals only from a breeding or other supplying establishment unless the animal has been lawfully imported and is not a feral or stray animal. General or special exemption from this last provision may be granted to a supplying establishment under arrangements determined by the authority.

Article 16

The approval or the registration provided for in Article 15 shall specify the competent person responsible for the establishment entrusted with the task of administering, or arranging for the administration of, appropriate care to the animals bred or kept in the establishment and of ensuring compliance with the requirements of Articles 5 and 14.

ticle 17

1.  Breeding and supplying establishments shall record the number and the species of animals sold or supplied, the dates on which they are sold or supplied, the name and address of the recipient and the number and species of animals dying while in the breeding or supplying establishment in question.

2.  Each authority shall prescribe the records which are to be kept and made available to it by the person responsible for the establishments mentioned in paragraph 1; such records shall be kept for a minimum of three years from the date of the last entry and shall undergo periodic inspection by officers of the authority.

Article 18

1.  Each dog, cat or non-human primate in any breeding, supplying or user establishment shall, before it is weaned, be provided with an individual identification mark in the least painful manner possible except in the cases referred to in paragraph 3.

2.  Where an unmarked dog, cat or non-human primate is taken into an establishment for the first time after it has been weaned it shall be marked as soon as possible.

3.  Where a dog, cat or non-human primate is transferred from one establishment as referred to in paragraph 1 to another before it is weaned, and it is not practicable to mark it beforehand, a full documentary record, specifying in particular its mother, must be maintained by the receiving establishment until it can be so marked.

4.  Particulars of the identity and origin of each dog, cat or non-human primate shall be entered in the records of each establishment.

Article 19

1.  User establishments shall be registered with, or approved by, the authority. Arrangements shall be made for user establishments to have installations and equipment suited to the species of animals used and the performance of the experiments conducted there; their design, construction and method of functioning shall be such as to ensure that the experiments are performed as effectively as possible, with the object of obtaining consistent results with the minimum number of animals and the minimum degree of pain, suffering, distress or lasting harm.

2.  In each user establishment:

3.  Experiments may, where authorized by the authority, be conducted outside user establishments.

4.  In user establishments, only animals from breeding or supplying establishments shall be used unless a general or special exemption has been obtained under arrangements determined by the authority. Bred animals shall be used whenever possible. Stray animals of domestic species shall not be used in experiments. A general exemption made under the conditions of this paragraph may not extend to stray dogs and cats.

5.  User establishments shall keep records of all animals used and produce them whenever required to do so by the authority. In particular, these records shall show the number and species of all animals acquired, from whom they were acquired and the date of their arrival. Such records shall be kept for a minimum of three years and shall be submitted to the authority which asks for them. User establishments shall be subject to periodic inspection by representatives of the authority.

Article 20

When user establishments breed animals for use in experiments on their own premises, only one registration or approval is needed for the purposes of Article 15 and 19. However, the establishments shall comply with the relevant provisions of this Directive concerning breeding and user establishments.

Article 21

Animals belonging to the species listed in Annex I which are to be used in experiments shall be bred animals unless a general or special exemption has been obtained under arrangements determined by the authority.

Article 22

1.  In order to avoid unnecessary duplication of experiments for the purposes of satisfying national or Community health and safety legislation, Member States shall as far as possible recognize the validity of data generated by experiments carried out in the territory of another Member State unless further testing is necessary in order to protect public health and safety.

2.  To that end, Member States shall, where practicable and without prejudice to the requirements of existing Community Directives, furnish information to the Commission on their legislation and administrative practice relating to animal experiments, including requirements to be satisfied prior to the marketing of products; they shall also supply factual information on experiments carried out in their territory and on authorizations or any other administrative particulars pertaining to these experiments.

3.  The Commission shall establish a permanent consultative committee within which the Member States would be represented, which will assist the Commission in organizing the exchange of appropriate information, while respecting the requirements of confidentiality, and which will also assist the Commission in the other questions raised by the application of this Directive.

Article 23

1.  The Commission and Member States should encourage research into the development and validation of alternative techniques which could provide the same level of information as that obtained in experiments using animals but which involve fewer animals or which entail less painful procedures, and shall take such other steps as they consider appropriate to encourage research in this field. The Commission and Member States shall monitor trends in experimental methods.

2.  The Commission shall report before the end of 1987 on the possibility of modifying tests and guidelines laid down in existing Community legislation taking into account the objectives referred to in paragraph 1.

Article 24

This Directive shall not restrict the right of the Member States to apply or adopt stricter measures for the protection of animals used in experiments or for the control and restriction of the use of animals for experiments. In particular, Member States may require a prior authorization for experiments or programmes of work notified in accordance with the provisions of Article 12 (1).

Article 24a

The measures necessary for the implementation of this Directive relating to the subject matters referred to below shall be adopted in accordance with the regulatory procedure set out in Article 24b(2):

Article 24b

1.  The Commission shall be assisted by a Committee.

2.  Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3.  The Committee shall adopt its rules of procedure.

Article 25

1.  Member States shall take the measures necessary to comply with this Directive by 24 November 1989. They shall forthwith inform the Commission thereof.

2.  Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive.

Article 26

At regular intervals not exceeding three years, and for the first time five years following notification of this Directive, Member States shall inform the Commission of the measures taken in this area and provide a suitable summary of the information collected under the provisions of Article 13. The Commission shall prepare a report for the Council and the European Parliament.

Article 27

This Directive is addressed to the Member States.

ANNEX I

LIST OF EXPERIMENTAL ANIMALS COVERED BY THE PROVISIONS OF ARTICLE 21

ANNEX II

GUIDELINES FOR ACCOMMODATION AND CARE OF ANIMALS

(Article 5 of the Directive)

INTRODUCTION

DEFINITIONS

In this Annex, in addition to the definitions contained in Article 2 of the Directive:

1.   THE PHYSICAL FACILITIES

1.1.   Functions and general design

1.2.   Holding rooms

1.3.   Laboratories and general and special purpose experiment rooms

1.4.   Service rooms

2.   THE ENVIRONMENT IN THE HOLDING ROOMS AND ITS CONTROL

2.1.   Ventilation

2.2.   Temperature

2.3.   Humidity

Extreme variations in relative humidity (RH) have an adverse effect on the health and well-being of animals. It is therefore recommended that the RH level in holding rooms should be appropriate to the species concerned and should ordinarily be maintained at 55 % ± 10 %. Values below 40 % and above 70 % RH for prolonged periods should be avoided.

2.4.   Lighting

In windowless rooms, it is necessary to provide controlled lighting both to satisfy the biological requirements of the animals and to provide a satisfactory working environment. It is also necessary to have a control of the intensity and of the light-dark cycle. When keeping albino animals, one should take into account their sensitivity to light (see also 2.6).

2.5.   Noise

Noise can be an important disturbing factor in the animal quarters. Holding rooms and experiment rooms should be insulated against loud noise sources in the audible and in the higher frequencies in order to avoid disturbances in the behaviour and the physiology of the animals. Sudden noises may lead to considerable change in organ functions but, as they are often unavoidable, it is sometimes advisable to provide holding and experiment rooms with a continous sound of moderate intensity such as soft music.

2.6.   Alarm systems

A facility housing a large number of animals is vulnerable. It is therefore recommended that the facility is duly protected by the installation of devices to detect fires and the intrusion of unauthorized persons. Technical defects or a breakdown of the ventilation system is another hazard which could cause distress and even the death of animals, due to suffocation and overheating or, in less serious cases, have such negative effects on an experiment that it will be a failure and have to be repeated. Adequate monitoring devices should therefore be installed in connection with the heating and ventilation plant to enable the staff to supervise its operation in general. If warranted, a stand-by generator should be provided for the maintenance of life support systems for the animals and lighting in the event of a breakdown or the withdrawal of supply. Clear instructions on emergency procedures should be prominently displayed. Alarms for fish tanks are recommended in case of failure of the water supply. Care should be taken to ensure that the operation of an alarm system causes as little disturbance as possible to the animals.

3.   CARE

3.1.   Health

3.2.   Capture

Wild and feral animals should be captured only by humane methods and by experienced persons who have a thorough knowledge of the habits and habitats of the animals to be caught. If an anaesthetic or any other drug has to be used in the capturing operation, it should be administered by a veterinarian or other competent person. Any animal which is seriously injured should be presented as soon as possible to a veterinarian for treatment. If the animal, in the opinion of the veterinarian, can only go on living with suffering or pain it should be killed at once by a humane method. In the absence of a veterinarian, any animal which may be seriously injured should be killed at once by a humane method.

3.3.   Packing and transport conditions

All transportation is undoubtedly, for the animals, a stressful experience, which should be mitigated as far as possible. Animals should be in good health for transportation and it is the duty of the sender to ensure that they are so. Animals which are sick or otherwise out of condition should never be subjected to any transport which is not necessary for therapeutic or diagnostic reasons. Special care should be exercised with female animals in an advanced state of pregnancy. Female animals which are likely to give birth during the transport or which have done so within the preceding forty-eight hours, and their offspring, should be excluded from transportation. Every precaution should be taken by sender and carrier in packing, stowing and transit to avoid unnecessary suffering through inadequate ventilation, exposure to extreme temperatures, lack of feed and water, long delays, etc. The receiver should be properly informed about the transport details and documentary particulars to ensure quick handling and reception in the place of arrival. It is recalled that, as far as international transport of animals is concerned, Directives 77/489/EEC and 81/389/EEC apply; strict observance of national laws and regulations as well as of the regulations for live animals of the International Air Transport Association and the Animal Air Transport Association is also recommended.

3.4.   Reception and unpacking

The consignments of animals should be received and unpacked without avoidable delay. After inspection, the animals should be transferred to clean cages or pens and be supplied with feed and water as appropriate. Animals which are sick or otherwise out of condition should be kept under close observation and separately from other animals. They should be examined by a veterinarian or other competent person as soon as possible and, where necessary, treated. Animals which do not have any chance to recover should be killed at once by a humane method. Finally, all animals received must be registered and marked in accordance with the provisions of Articles 17, 18, 19 (5) of the Directive. Transport boxes should be destroyed immediately if proper decontamination is impossible.

3.5.   Quarantine, isolation and acclimatization

3.6.   Caging

3.7.   Feeding

3.8.   Water

3.9.   Bedding

Bedding should be dry, absorbent, non-dusty, non-toxic and free from infectious agents or vermin, or any other form of contamination. Special care should be taken to avoid using sawdust or bedding material derived from wood which has been treated chemically. Certain industrial by-products or waste, such as shredded paper, may be used.

3.10.   Exercising and handling

3.11.   Cleaning

3.12.   Humane killing of animals

TABLE 1

Guidelines for room temperature

(animals kept in cages, pens or indoor runs)

Note:

In special cases, for example when housing very young or hairless animals, higher room temperatures than those indicated may be required.

TABLE 2

Guidelines for local quarantine periods

Introductory note:

For imported animals, all quarantine periods should be subject to the Member States' national regulations. In regard to local quarantine periods, the period should be determined by a competent person according to circumstances, normally a veterinarian appointed by the establishment.

TABLE 3

Guidelines for caging small rodents and rabbits

(in stock and during experiments)

Note:

‘Cage height’ means the vertical distance between the cage floor and the upper horizontal part of the lid or cage.

When designing experiments, consideration should be given to the potential growth of the animals to ensure adequate room according to this table in all phases of the experiments.

See also Figures 1 to 5 and 8 to 12.

TABLE 4

Guidelines for caging small rodents in breeding

Note:

For definition of ‘cage height’ see note to Table 3.

TABLE 5

Guidelines for caging breeding rabbits

Note:

For definition of ‘cage height’ see note to Table 3.

The minimum cage floor area per doe and litter includes the area of the nest box floor.

See also Figure 6.

TABLE 6

Guidelines for housing cats

(during experiments and breeding)

Note:

The housing of cats in cages should be strictly limited. Cats confined in this way should be let out for exercising at least once a day, where it does not interfere with the experiment. Cat pens should be equipped with dirt trays, ample shelf room for resting and objects suitable for climbing and claw-trimming.

‘Cage height’ means the vertical distance between the highest point on the floor and the lowest point in the top of the cage.

For the purpose of calculating the minimum floor area, the shelf area may be included. The minimum cage floor area per queen and litter includes the 0,18 m2 area of the kittening box.

See also Figure 7.

TABLE 7

Guidelines for housing dogs in cages

(during experiments)

Note:

Dogs should not be kept in cages any longer than is absolutely necessary for the purpose of the experiment. Caged dogs should be let out for exercise at least once a day unless it is incomptabile with the purpose of the experiment. A time-limit should be set beyond which a dog should not be confined without daily exercise. Exercise areas should be large enough to allow the dog freedom of movement. Grid floors should not be used in dog cages unless the experiment requires it.

In the light of the great differences in height and the limited interdependence of height and weight of various breeds of dogs, the cage height should be based on the body height to the shoulder of the individual animal. As a general rule the minimum cage height should be twice the height to the shoulder.

For definition of ‘cage height’, see note to Table 6.

TABLE 8

Guidelines for housing dogs in pens

(in stock and during experiments and breeding)

Note:

Figures in brackets give the total area per dog, that is, the pen floor area plus the adjacent exercise area. Dogs kept permanently outdoors should have access to a sheltered place to find protection against unfavourable weather conditions. Where dogs are housed on grid floors, a solid area should be provided for sleeping. Grid floors should not be used unless the experiment requires it. Partitions between pens should be such as to prevent dogs from injuring each other.

All pens should have adequate drainage.

TABLE 9

Guidelines for caging non-human primates

(in stock and during experiments and breeding)

Introductory note:

Because of the wide variations in sizes and characteristics of primates, it is especially important to match the shape and internal fittings as well as the dimensions of their cages to their particular needs. The total volume of the cage is just as important to primates as the floor area. As a general principle, the height of a cage, at least for apes and other simians, should be its greatest dimension. Cages should be high enough at least to allow the animals to stand up erect. The minimum cage height for brachiators should be such as to allow them to swing in full extension from the ceiling without their feet touching the cage floor. Where appropriate, perches should be fitted to allow the primates to use the upper part of the cage.

Compatible primates may be kept two to a cage. Where they cannot be kept in pairs, their cages should be so placed that they can see one another, but it should also be possible to prevent this when required.

Subject to these observations, the following table constitutes a general guideline for caging the groups of species most commonly used (superfamilies Ceboidea and Cercopithecoidea).

Note:

For definition of ‘cage height’ see note to Table 6.

TABLE 10

Guidelines for caging pigs

(in stock and during experiments)

Note:

The table would also apply to piglets. Pigs should not be kept in cages unless absolutely necessary for the purpose of the experiment and then only for a minimum period of time.

For definition of ‘cage height’ see note to Table 6.

TABLE 11

Guidelines for accommodating farm animals in pens

(in stock and during experiments in user establishments)

TABLE 12

Guidelines for accommodating farm animals in stalls

(in stock and during experiments in user establishments)

Note:

Stalls should be sufficiently wide to allow an animal to lie comfortably.

TABLE 13

Guidelines for caging birds

(in stock and during experiments in user establishments)

Note:

‘Area’ means the product of cage length and cage width measured internally and horizontally. Not the product of the floor length and floor width.

For definition of ‘cage height’ see note to Table 6.

Mesh size in grid floors should not be greater than 10 × 10 mm for young chicks, and 25 × 25 mm for pullets and adults. The wire thickness should be at the least 2 mm. The sloping gradient should not exceed 14 % (8°). Water troughs should be of the same length as the feed troughs. If nipples or cups are provided, each bird should have access to two. Cages should be fitted with perches and allow birds in single cages to see each other.

FIGURE 1

FIGURE 2

FIGURE 3

FIGURE 4

FIGURE 5

FIGURE 6

FIGURE 7

FIGURE 8

FIGURE 9

FIGURE 10

FIGURE 11

FIGURE 12

( 1 ) OJ No C 351, 31. 12. 1985, p. 16.

( 2 ) OJ No C 255, 13. 10. 1986, p. 250.

( 3 ) OJ No C 207, 18. 8. 1986, p. 3.

( 4 ) OJ No L 384, 31. 12. 1982, p. 1.