On 24 November 1986 Council Directive 86 /609/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the protection of animals was adopted. used for experimental and other scientific purposes, which aims to harmonise the legislation of the various Member States of the EEC in respect of the protection of animals used for such purposes, thereby guaranteeing the number of animals used in this type of practice is reduced to a minimum and that, in all (a) a treatment is granted to avoid maximum pain, suffering, stress or injury prolonged unnecessarily, and also to promote the development of alternative techniques which can provide the same level of information as the obtained in animal experiments and which involve less use of animals.

In Spanish legislation there is no specific legal regulation in this area, although the Royal Order Circular of 31 July 1929, updated by the Order of the Ministry of the Interior of March 1, 1961 provides for penalties for persons who supply, without justified cause, drug or harmful substance to a non-harmful animal, or undergo any surgical intervention made without due care or humanity, or consent to administration of that or running it.

It is therefore necessary to promulgate a rule that incorporates the provisions of the Directive into Spanish law.

In its virtue, on the proposal of the Minister of Agriculture, Fisheries and Food and after deliberation of the Council of Ministers at its meeting on 11 March 1988,

DISPONGO:

Article 1. º

The purpose of this Royal Decree is to ensure the protection of animals used in experimentation and other scientific purposes; that such animals are granted adequate care; that they are not unnecessarily caused prolonged pain, suffering, stress or injury; avoiding any unnecessary duplication of experiments and reducing the number of animals used to the minimum.

Art. 2. º

The use of animals in experimentation may only take place when the following purposes are pursued:

(a) The prevention of diseases, changes in health and other abnormalities or their effects, as well as the diagnosis and treatment of diseases in man, vertebrate or invertebrate animals or plants; development and the manufacture of pharmaceutical and food products and other substances or products, as well as the testing of their quality, efficacy and safety.

(b) The assessment, detection, normalisation or modification of physiological conditions in man, vertebrate or invertebrate animals or plants.

(c) The protection of the natural environment, for the benefit of human health or welfare, vertebrate or invertebrate animals or plants.

d) Scientific research.

e) Education and training.

f) Medical-legal research.

Art. 3. º

For the purposes of this Royal Decree, the following definitions shall

:

(a) "Animal" without another qualifier: Any non-human vertebrate living, including autonomous larval forms capable of reproducing, excluding fetal or embryonic forms.

(b) "Experimental animals" means animals used or intended for use in experiments.

(c) "breeding animals" means animals specially reared for use in experiments in establishments registered by the competent authority.

(d) "Experiments" means any use of an animal for experimental or other scientific purposes which may cause prolonged pain, suffering, stress or injury, including any action which may be intentionally or casually give rise to the birth of an animal under the conditions mentioned above. The methods accepted in modern practice (humanitarian methods) for the slaughter and identification of animals are excluded. It is understood that an experiment starts at the moment when the preparation of an animal is initiated for use and ends when no further observation is to be made to this experiment. The use of animals is also considered, even if the pain, suffering, injury or prolonged stress is eliminated, through the use of anesthesia, analgesia or other methods.

Non-experimental agricultural practices and veterinary clinic practices are excluded.

(e) "Competent Person" means any person who, according to his or her knowledge, is trained under this Royal Decree to perform the functions referred to therein:

Caregiver: Person with accredited training for proper handling of animals in breeding, supply and user establishments.

Experimenter: Titled middle or upper grade with specific training in animal protection and experimentation.

Responsible or Specialist: Senior in Experimental Sciences who additionally has a specific post-graduate training in animal protection and experimentation.

(f) "Authority": The competent bodies of the Public Administrations responsible, in each case, for the compliance with the rules of this Royal Decree.

g) "Establishment": Any installation, building or group of buildings or other premises, including exceptionally places that are not fully fenced or covered, as well as mobile facilities.

h) "breeding establishment": Any facility where animals are reared for use in experimentation.

i) "supplier establishment" means any establishment which, not being farmed, supplies animals for use in experimentation.

j) "User establishment": Any establishment in which the animals are used for experimentation.

k) "Adequately Anesthetized Experimental Animals": The private animals of sensations through the use of anesthesia, local or general.

l) "Sacrifice for Humanitarian Methods": The sacrifice of an animal with the least physical and psychic suffering, according to its species.

Art. 4. º

1. The Autonomous Communities, within the scope of their respective territories, shall be competent to comply with the provisions of this Royal Decree.

For these purposes, they shall proceed to the registration of breeding establishments, suppliers and users, as well as to the authorisation, where appropriate, of the use of animals in the experiments.

Those user establishments that raise animals for their exclusive use will be sufficient to register as user establishments.

2. Breeding establishments, suppliers and users of State ownership, for which the Ministry of Agriculture, Fisheries and Food shall be responsible for their registration, shall be excluded from the provisions of the preceding paragraphs. their case, authorising the use of animals in experiments.

3. In any case, the user establishments shall be obliged to notify the competent authority on a quarterly basis of the experiments they intend to carry out.

Art. 5. º

The Autonomous Communities, for the purposes of the protection of animals, shall inform the Ministry of Agriculture, Fisheries and Food on a quarterly basis, with the express reference of their name and Address, type of establishment, description, capacity, species and number of animals raised, supplied or used, as appropriate, and name and title of the competent person; the experiments carried out, with a description of the aspects fundamental of the same, species and number of animals used, destination (i) final of the same and, where applicable, method of humanitarian slaughter used, as well as derogations granted in the field of their respective powers.

Art. 6. º

1. Breeding establishments and supplying establishments shall be required to have:

(a) A record book of entries, in which the number and species of animals acquired, with indication of their origin, or born in the establishment itself, with indication of the date in both cases, shall be recorded.

(b) A book for the registration of exits, in which the number and species of animals sold or supplied, the date of sale or supply, the name and address of the consignee and the number and species of the animals shall be recorded. dead animals during their stay in the breeding establishment, or in the supplying establishment in question.

Such records shall be kept for at least three years from the date of the last registration and shall be subject to periodic inspection by the competent authority.

2. Supplying establishments may only obtain animals from breeding establishments, other suppliers ' establishments or imports from these categories of establishments duly authorised in the country of origin. origin. Exceptions to this rule may only be agreed by the competent authority.

3. The user establishments shall be required to have a record book in which all the animals used, as well as the number and species of animals acquired and the acquiring establishments and the final destination of the animals, are kept on record. those, once the experiment is finished. This register shall be kept for at least three years from the date of the last registration and shall be subject to periodic inspection by the competent authority.

4. Details of the identity and origin of any dog, cat or non-human primate shall be included in the relevant log book of each establishment in accordance with Article 9.

5. User establishments may only use animals of the species listed in Annex I to this Royal Decree from breeding establishments or suppliers. They shall not be used in experiments, stray animals of domestic species. Derogations from this rule may be granted only on a special basis by the competent authority.

Art. 7. º

In order for the establishments referred to in this Royal Decree to be registered they must comply with the following requirements in order to the general care and accommodation of the animals of experimentation:

(a) Animals are provided with suitable conditions of accommodation, environment, food and drink, as well as a certain degree of freedom of movement and are limited to the minimum necessary any restrictions on them. to prevent its physiological and ethological needs; these conditions should be verified daily.

b) That the welfare and health of the animals be supervised by a competent person with higher qualifications.

(c) provision of facilities and facilities to ensure that any deficiencies resulting in changes in the health or welfare of animals are eliminated as soon as possible; and instructions for use of all elements shall be written in writing.

Art. 8. º

1. The user establishments must have facilities and equipment, both human and material, appropriate for the species to be used and the experiments to be carried out, ensuring that the same can be executed as effectively as possible, the results achieved with the lowest possible number of animals and producing at least the minimum degree of pain, suffering, stress or prolonged injury. At the front of the establishment there shall be a person administratively responsible for the care of the animals and the operation of the equipment.

2. Veterinary advice shall also be provided for the control of all aspects relating to the health of the animals and to a veterinarian or other person competent to take care of the welfare of the animals.

Art. 9. º

1. In breeding establishments, suppliers or users, any dog, cat or non-human primate must be provided, before its weaning, with an individual identification mark carried out in such a way as to cause the least damage to it.

2. Where a dog, cat or non-human primate is moved from one establishment to another of those referred to in the previous paragraph, before its weaning, and it has not been possible to identify it in advance, the receiving establishment must retain a complete documentary record, with identification, in particular, of the mother's data, until it is identified.

Art. 10.

The experiments in which animals considered to be endangered are used shall be prohibited, as listed in Appendix I to the Washington Convention of 3 March 1973 on International Trade in Species Threatened by Wild Fauna and Flora, as amended on 22 October 1987; in Part 1 of Annex C to Regulation (EEC) No 3626/1982, as amended by Regulation (EEC) No 3143/1987 and in the Royal Decrees 3181/1980 and 1497/1986, unless it is In accordance with the above rules and the objectives of the experiment, they are: for the protection of the species concerned or essential biomedical purposes, where it is established that such species are exceptionally unique to such species.

The assessment of these exceptions and the authorisation, where appropriate, shall be the responsibility of the competent authority, in accordance with the provisions of Article 4., at the request of the user establishment, which shall accompany it with a descriptive of the experiment and objectives to be pursued with it.

Art. 11.

1. Experiments may only be carried out by competent persons (experimenter, responsible or specialist) or under the direct responsibility thereof.

2. An experiment shall not be carried out if another scientifically satisfactory and contrasting method is available to enable the same conclusions to be obtained without involving the use of animals.

Before the choice between different experiments, they will be selected to obtain the most satisfactory results and that: a) Use the least number of animals; b) be treated animals with the least degree of sensitivity neurophysiologic, and c) Cause the least prolonged pain, suffering, stress, or injury.

3. Experiments on wild animals or vagrants may not be carried out unless those carried out with other animals do not allow the attainment of the objectives pursued by the experiment.

4. In exceptional cases, experiments outside the user establishments may be carried out by the competent authority, subject to authorisation.

Art. 12.

1. Experiments must be carried out with general or local anaesthesia, unless it is considered to be:

a) It's more traumatic for the animal than the experiment itself.

b) Is incompatible with the purpose of the experiment.

When it is foreseen that in an experiment some of the two circumstances outlined in the previous paragraph are to be given and in order to ensure that it is not carried out unnecessarily, it will be expressly mentioned in the notification to the competent authority as provided for in Article 4., for the purpose of the authorisation of the experiment.

2. Without prejudice to the provisions of the preceding paragraph, where any of the exceptions provided for therein are provided, analgesics or other suitable methods must be used to ensure, as far as possible, that pain, suffering, stress or session are minimal.

3. Provided that it is compatible with the purpose of the experiment, an animal that will suffer severe and prolonged pain after having recovered from the anesthesia must be treated on time, with adequate means to calm the pain or, when this is not possible, it must be immediately sacrificed by humanitarian methods.

Art. 13.

1. At the end of every experiment, it will be necessary to decide whether the animal should be kept alive or be sacrificed through a humanitarian method. In any case, an animal will not be kept alive if, having recovered health in all other aspects, it is likely to have lasting pain or suffering. In this respect, such decisions shall be taken by the person responsible for the experiment.

2. When at the end of an experiment:

(a) A animal must be kept alive, the animal must be properly cared for, be subjected to the supervision of a veterinarian and maintained in accordance with the requirements of Article

.

Without prejudice to the other provisions of this Royal Decree, where necessary for the purposes of the experiment, the competent authority may authorise an animal used in experimentation to be returned to its environment. (a) customary, taking appropriate measures to safeguard the welfare of the same, to the extent that its state of health so permits and does not pose a risk to public health or the environment.

(b) It is decided not to keep an animal alive, the animal must be slaughtered as soon as possible by means of a humanitarian method.

Art. 14.

In any experiment in which the animals may suffer severe pain, the person responsible for the experiment must present a supporting memory to the competent authority, at least 30 days in advance at the beginning of the experiment, where the species and the number of animals to be used are recorded, as well as the absence of alternative procedures. The competent authority shall, where appropriate, authorise such an experiment.

In no case may an animal be used more than once in experiments involving severe pain, stress or suffering.

Art. 15.

The Ministry of Agriculture, Fisheries and Food will publish annually the information received from the Autonomous Communities regarding the use of animals in experimentation, with the necessary precautions for ensure that the confidential nature of the information which is of particular commercial interest is safeguarded.

ADDITIONAL DISPOSITION

The criteria laid down in Annex II to Council Directive 86 /609/EEC relating to the accommodation and care of animals must be taken into account in any experiment with animals and related establishments. with the same.

TRANSIENT PROVISIONS

First.

After a period of eighteen months, counted from the entry into force of this Royal Decree, it will be necessary to have registered in the corresponding register, the breeding establishment, supplier or user, for the exercise of your activity.

Second.

Every experiment, in order to be performed, must conform to what is stated in this Royal Decree, after eighteen months, counted from its entry into force.

ADDITIONAL PROVISIONS

First.

The Ministry of Agriculture, Fisheries and Food is empowered to dictate implementing rules of this Royal Decree.

Second.

This Royal Decree will enter into force the day after its publication in the "Official State Gazette".

Dado en Madrid a 14 de marzo de 1988.

JOHN CARLOS R.

The Minister of Agriculture, Fisheries and Food,

CARLOS ROMERO HERRERA

ANNEX

.	Mus musculus.
.	Cobaya.
	Cavia porcellus.
	Hamster gold.	Mesoricetus auratus.
Orytolagus cuniculus.
-human Primates.
Dog.	Canis familiaris.
.	Felis catus.
Codornish.	Coturnix coturnix