On November 24, 1986 was adopted the Council Directive 86/609/EEC, on the approximation of the provisions of laws, regulations and administrative of the Member States regarding the protection of animals used for experimental and other scientific purposes, which aims to harmonise the legislation of the various States members of the EEC in regards to the protection of animals used for these purposes guaranteeing at the same time that the number of animals used in such practices is reduced to a minimum and that, in any case, be granted a treatment that avoids the most prolonged pain, suffering, stress or injury unnecessarily and also encouraging the development of alternative techniques which can provide the same level of information as that obtained in experiments with animals and that they pose a lesser use of these.
In Spanish law there until the present no regulatory legal specific in this matter, although the Royal Circular order of July 31, 1929, updated by order of the Ministry of the Interior from March 1, 1961 establishes the penalties to persons who provide, without justified cause, drug or substance harmful to a harmless animal , or submit to any surgery done without due care or humanity, or consent to the administration of that or the execution of this.
It is necessary, therefore, the enactment of a rule that incorporated into the Spanish legal order provisions of that directive.
By virtue, on the proposal of the Minister of agriculture, fisheries and food, and after deliberation by the Council of Ministers at its meeting of March 11, 1988, available: article 1 the object of this Royal Decree is to ensure the protection of animals used in experimentation and other scientific purposes; that should be granted to such animals adequate care; that does not is cause them unnecessary pain, suffering, stress or injury sustained; to avoid any useless duplication of experiments and the number of animals used is reduced to the minimum.
Article 2 the use of animal testing may only take place when it pursues the following purposes: to) the prevention of diseases, changes in health and other anomalies and their effects, as well as the diagnosis and treatment thereof in man, vertebrate or invertebrate animals or plants; development and manufacture of pharmaceuticals and food products and other substances or products, as well as tests to verify their quality, efficacy and safety.
(b) the assessment, detection, normalization or modification of physiological conditions in man, vertebrate or invertebrate animals or plants.
(c) the protection of the natural environment, in the interests of the health or well-being of man, vertebrate or invertebrate animals or plants.
(d) scientific research.
(e) education and training.
(f) medical research.
Article 3 for the purposes of this Royal Decree, means: to) «Animal» without another qualifier: any being living vertebrate non-human, including autonomous larval forms able to reproduce, with the exception of foetal or embryonic forms.
(b) "experimental animals": animals used or intended to be used in experiments.
(c) ' livestock': animals specially bred for use in experiments in establishments registered with the competent authority.
(d) «experiments»: any use of an animal with experimental or other scientific purposes which may cause pain, suffering, prolonged stress or injury, including any action that intentionally or casual way may give rise to the birth of an animal in the above mentioned conditions. Excluded methods accepted in modern practice (humanitarian methods) for the sacrifice, and identification of the animals. Means that an experiment begins at the moment in which the preparation of an animal for use begins and ends when already it won't be making no further comment to this experiment. He is considered, in addition, experiment the use of animals, even if you eliminate the pain, suffering, injury or stress long, through the use of anaesthesia, analgesia or other methods.
Excluded are non-experimental agricultural practices and Veterinary Clinic.
(e) ' competent person': any person who on the basis of their knowledge is capable, under the aegis of the present Royal Decree, to perform the functions referred to in the same: caregiver: person with training accredited to the proper handling of animals in breeding, supplying and user establishments.
Experimenter: Titled degree medium or greater that possess specific training in protection and animal experimentation.
Manager or specialist: top in experimental sciences titled that, in addition, possess a specific postgraduate training in protection and animal experimentation.
(f) ' authority': the competent bodies responsible for public administrations, in each case, the fulfillment of the rules dictating the present 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 bred for use in experimentation.
(i) ' supplying establishment': any establishment which are not breeding, supply animals for use in experimentation.
(j) «establishment user»: any establishment where animals are used for experimentation.
(k) «properly anaesthetized experimental animals": animals deprived of feelings through the use of local or general anesthesia.
(l) «sacrifice by humanitarian methods»: the sacrifice of an animal less suffering physical and psychological, according to their species.
Article 4th 1. The autonomous communities, in the field of their respective territories, will be responsible for compliance with the provisions of this Royal Decree.
For this purpose, proceed to the register of establishments breeding, suppliers and users as well as the authorization, where appropriate, the use of animals in experiments.
Those establishments users who bred animals for their exclusive use, is sufficient to register as user establishments.
2 they are excluded from the provisions of the preceding paragraphs establishments breeding, suppliers and users of State ownership, which will be competent the Ministry of agriculture, fisheries and food for your registration and, where appropriate, authorise the use of animals in experiments.
3. in any case, establishments users will be obliged to notify the competent authority quarterly experiments which they intend to carry out.
Article 5 the autonomous communities, for the purposes of the protection of animals, they shall communicate quarterly to the Ministry of agriculture, fisheries and food the registration of establishments, mention expresses its name and address, type of establishment, description, capacity, species and number of animals which are bred, provide or use, as appropriate, and name and title of the competent person; the experiments, with a description of the fundamental aspects of the same, species and number of animals used, final destination and, where applicable, method of humanitarian sacrifice used, as well as the exceptions granted in the scope of their respective competencies.
Article 6 1. Establishments breeding and supplying establishments shall be required to have: to) a book of registry entries, in which shall be entered the number and species of animals acquired, with an indication of their origin, or born in the establishment, with an indication of the date in both cases.
(b) a log book of outputs, in which shall be entered the number and species of animals sold or supplied, the date of sale or supply, the name and address of the recipient and the number and species of the animals died during their stay in the establishment of breeding or supplying establishment in question.
These records shall be kept for at least three years from the date of the last entry and shall be subject to periodic inspection carried out by the competent authority.
2 providers establishments may only obtain animals from breeding, of other providers establishments or establishments imports from these categories of establishments duly authorized in the country of origin. The exceptions to this rule may only be agreed by the competent authority.
3. user establishments shall be obliged to have a log book in which providing evidence of all the animals used, as well as of the number and species of animals acquired and acquisition settlements and the fate of those, once finished the experiment. This record must be kept, at least three years from the date of the last entry and shall be subject to periodic inspection carried out by the competent authority.
4 into the corresponding register of each establishment must be given specific details relating to the identity and origin of any dog, cat or non-human primate, in accordance with article 9.
5. user establishments may be used only animals of the species listed in annex I of the present Royal Decree, from breeding or suppliers. Not be used in the experiments, stray domestic animals. The exceptions to this rule may only be granted with particular character by the competent authority.
Article 7th so that the establishments referred to in this Royal Decree can be registered must meet the following requirements in order to the general care and accommodation of experimental animals: to) that animals will provide them with adequate conditions of accommodation, environment, food and drink, as well as some degree of freedom of movement and any restriction that prevents them from satisfying their physiological and Ethological; needs is limited to the minimum necessary These conditions should be checked daily.
(b) that the well-being and State of health of the animals are supervised by a competent person with higher qualifications.
(c) that is available means and facilities that ensure the elimination, in the shortest possible time, of any deficiency that may cause alterations in the State of health or welfare of the animals; labour standards and instructions for use of all the elements indicated in writing.
Article 8 1. User establishments must have installations and equipment, both human and material, appropriate species to use and experiments to be done, ensuring that they can run with the greatest possible effectiveness, in such a way that the results pursued with the fewest possible animals and producing them the minimum degree of pain suffering, stress or injury sustained. At the head of the establishment should be a responsible person administratively the care of animals and the operation of the equipment.
2. also, you need to have is with veterinary advice for the control of all aspects related to the health of animals and with a veterinarian or other competent person to take care of the welfare of the animals.
Article 1-9th. Establishments breeding, suppliers or users, to any dog, cat or non-human primate, is shall provide, before its weaning, a brand of individual identification made in such a way that it causes the least possible harm.
2 when a dog, cat or non-human primate is transferred from an establishment to another which are cited in the preceding paragraph, before their weaning, and it has not been possible to identify it previously, the receiving establishment shall keep a full documentary record, with identification, in particular, the data of the mother, until it is identified.
Prohibited experiments involving animals considered endangered, listed in Appendix I of the Washington Convention of 3 March 1973 on international trade in endangered species of Fauna and Flora Silvestres, modified on October 22, 1987; in Annex C, part 1, of Regulation (EEC) number 3626/1982, amended by Regulation (EEC) number 3143/1987 and the Royal Decrees 1497 and 3181/1980 / 1986, unless they conform to the provisions of these regulations and the objectives of the experiment are: research aimed at the protection of the species concerned or essential biomedical purposes When proves that such species are exceptionally suitable for these purposes only.
The appreciation of these exceptions and the authorization, if any, shall be the competent authority, in accordance with the provisions of the article 4th, at the request of the user establishment, that it be accompanied by a descriptive report of the experiment and objectives that will be pursued with the same.
1. experiments may be made only by competent persons (experimenter, Manager or specialist) or under the direct responsibility of them.
2 an experiment must be not if another scientifically satisfactory and proven method that allow to obtain the same conclusions, without involving the use of animals is available.
Before the choice between different experiments, will be selected those that allow to obtain the most satisfactory results and that: to) use fewer animals; b) case of animals with the lowest degree of sensitivity Neuropsychological), and (c) cause minor pain, suffering, stress or injury sustained.
3 they may carry out experiments with wild animals or vagabonds, except those made with other animals do not allow to achieve the aims of the experiment.
4. exceptionally and prior authorization from the competent authority may carry out experiments outside user establishments.
1 experiments must be carried out under general or local anesthesia, unless it is considered that this: to) is more traumatic to the animal than the experiment itself.
(b) it is incompatible with the purposes of the experiment.
When it is expected that in an experiment they will give any of the two circumstances outlined in the preceding paragraph and to ensure to not unnecessarily perform, it shall state expressly in the notification to the competent authority envisaged in the 4th article, that is authorized by the experiment.
2. without prejudice to the provisions of the preceding paragraph, where any of the exceptions provided for therein, shall be used analgesics or other methods appropriate to ensure, to the extent possible, pain, suffering, stress, or the session minimum.
3 provided that it is compatible with the aims of the experiment, an animal that will suffer intense and prolonged pain after having recovered from the anesthesia, should be treated in time, with adequate means to alleviate pain or, where this is not possible, must be sacrificed immediately by humanitarian methods.
1. at the end of any experiment must decide if the animal must stay alive or be sacrificed by a humanitarian method. In any case, not kept alive an animal if, having recovered health in all other respects, is likely to suffer long-lasting pain or suffering. In this regard, such decisions shall be adopted by the person in charge of the experiment.
2 when at the end of an experiment: to) is going to keep alive an animal, it shall receive the care appropriate to its state of health, be subjected to surveillance of a veterinarian and maintained in conditions consistent with the requirements of article 7th without prejudice to the other provisions of this Royal Decree, when it is necessary for the purposes of the experiment the competent authority may authorise an animal used in experiments to be returned to its usual means, adopting appropriate measures to safeguard the well-being of the same, as his health permitted and involves no risk to human health or the environment.
(b) Decides to not keep alive an animal, this must be slaughtered as soon as possible, through a humanitarian method.
In any experiment in which animals can suffer intense pain, responsible for the experiment shall provide to the competent authority a report justifying, at least for thirty days at the beginning of the experiment, where is it recorded the species and number of animals to be used, as well as the absence of alternative procedures. The competent authority shall, if necessary, authorize this experiment.
In any case an animal may be used more than once in experiments involving pain, stress or suffering intense.
By the Ministry of agriculture, fisheries and food will be published annually the information received from the autonomous communities, relative to the use of animals in experimentation, with the guarantees necessary to ensure the safeguarding of the confidentiality of the information that a particular commercial interest.
The additional provision criteria set out in annex II of the Council Directive 86/609/EEC, relating to the accommodation and care of animals, must be taken into account in all experiment with animals and related establishments.
TRANSITIONAL provisions first.
After a period of eighteen months, from the entry into force of this Royal Decree, it is indispensable to have registered in the corresponding register, establishment of breeding, supplying or user, for the exercise of their activity.
All experiment, to be able to be carried out must comply with as set out in the present Royal Decree, once after eighteen months from its entry into force.
ADDITIONAL provisions first.
It empowers the Ministry of agriculture, fisheries and food to enact rules in development of this Royal Decree.
This Royal Decree shall enter into force the day after its publication in the «Official Gazette».
Given in Madrid on March 14, 1988.
JUAN CARLOS R.
The Minister of agriculture, fisheries and food, CARLOS ROMERO HERRERA annex mouse.