Council Directive 86 /609/EEC of 24 November 1986 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the protection of animals used for the It is intended to harmonise the legislation of the various Member States of the European Union as regards the protection of animals used for such purposes. This Directive is intended to ensure that the number of animals used in this type of practice is reduced to a minimum and that, in any case, to those used, treatment is granted to avoid maximum pain, suffering or injury, Unnecessarily prolonged. It also encourages the introduction of alternative methods which can provide the same level of information as that obtained in animal procedures and which involve less use of animals, concepts which are currently covered by the "principle of the three errors" (reduction, refinement and replacement). On the same date and given the willingness to define and limit the use of experimental animals for certain purposes such as scientific research, education and training and medical-legal research, the Member States adopted the Resolution 86 /C 331/02.

Council Directive 86 /609/EEC was amended by Directive 2003 /65/EC of the European Parliament and of the Council of 22 July 2003 establishing a Regulatory Committee to ensure the consistency of the Annexes to the Directive 86 /609/EEC with the most recent scientific and technical developments, as well as with the results of the research on the issues they are dealing with. It is not considered necessary to transpose this directive into national law, since it is limited to the setting up of a Community-wide committee. Council Directive 86 /609/EEC transposed the Spanish legal order by means of Royal Decree 223/1988 of 14 March 1988 on the protection of animals used for experimental and other scientific purposes, subsequently developed by Order of the Ministry of Agriculture, Fisheries and Food of 13 October 1989 laying down the rules for the registration of breeding establishments, suppliers and users of state-owned experimental animals, as the authorization for the use of animals in experiments, in the development of the Royal Decree 223/1988 of 14 March 1988. Furthermore, on 25 October 1990 Spain ratified the European Convention on the protection of vertebrate animals used for experimental and other scientific purposes (Strasbourg, 18 March 1986), which contains general rules the purpose of which is to prevent the animals from which the said convention applies to them to be caused unnecessary pain, suffering or distress, as well as the limitation of their use by favouring the use of alternative methods. Within this framework of the Council of Europe, a number of resolutions on the interpretation of certain provisions and expressions of the European Convention on the Protection of Animals were adopted in a series of multilateral consultations. vertebrates used for experimental and other scientific purposes, on the training and education of persons working with laboratory animals, on facilities and care for laboratory animals and on purchase and transport of these. The existence of different bodies for the assessment of the opportunity of research practices reveals the desirability of regulating them as an instrument for achieving the purposes set out in the aforementioned Directive. The growing concern of society for the protection of animals and the quality of research, in which the observation, control, welfare, maintenance and care of animals used in experimentation is a pillar As a result of the changes in legislation and continuous scientific progress, the updating of the existing legislation is necessary. Article 36.2 of Law 8/2003 of 24 April on animal health states that the basic health conditions to be met by animal holdings shall be those laid down by the rules in force and, in their final disposal, the Government to dictate the precise provisions for the application and development of the law. In this royal decree the law is developed in the measure that affects the animalums as farms. For all of the above, the need to adapt the current rules, including the new and repealing the old ones, has been considered, and in the interests of greater clarity and legal certainty, the desirability of enacting a new standard has been determined. In its handling, this royal decree has been submitted to the autonomous communities and the entities representing the interests of the sector. In its virtue, on the proposal of the Ministries of Agriculture, Fisheries and Food, of Education and Science, of Health and Consumption and of the Environment, with the prior approval of the Minister of Public Administrations, in agreement with the State Council and after deliberation by the Council of Ministers at its meeting on 7 October 2005,

D I S P O N G O:

CHAPTER I

Object, application scope, and definitions

Article 1. Purpose and purpose.

1. The purpose of this royal decree is to establish the applicable rules for the protection of animals used in experimentation and other scientific purposes, including teaching. 2. Its purpose is to ensure such protection and, in particular, that the animals used are given adequate care; that they are not unnecessarily caused by pain, suffering, distress or prolonged injury; that any duplication of the number of animals used in the procedures should be reduced to a minimum, using alternative methods as far as possible.

Article 2. Scope.

1. This royal decree applies to animals used in experimentation and other scientific purposes, as well as in teaching. It is applicable throughout the national territory. 2. The use of animals in procedures, teaching or other scientific purposes may only take place when the following purposes are pursued:

a) Scientific research, including aspects such as disease prevention, health disorders and other abnormalities or their effects, as well as their diagnosis and treatment in humans, animals or plants; the development and 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, regulation or modification of physiological conditions in man, in animals or in plants. (c) The protection of the natural environment, in the interests of the health or welfare of man or animals and the maintenance of biodiversity. (d) Education and training. e) Medical-legal research.

3. The non-experimental agricultural practices and the veterinary clinic are excluded from the scope of this royal decree.

Article 3. Definitions.

For the purposes of this royal decree, it is understood by:

(a) Animal: any non-human vertebrate living, including the offspring of its own life or breeding forms in reproduction, excluding fetal or embryonic forms.

(b) breeding animals: animals specially reared for use in procedures in establishments approved or registered by the competent authority. (c) Animal testing: the animals used or intended for use in the procedures. (d) Properly Anesthetized Animals of Experimentation: the private animals of sensations through the use of effective methods of anesthesia, local or general. (e) Centre or establishment: any installation, building, group of buildings or other premises, including those not fully enclosed or covered, as well as mobile facilities and the entire set of personal and material resources organised by their holder for the breeding, supply or use of animals for experimentation. They are distinguished:

1. Center for breeding: any establishment where experimental animals are bred.

2. Supplier Center: any establishment that supplies and maintains animals for experimentation, not born in the same center. 3. "User Centre" means any establishment in which animals are used for experimentation.

f) Cerced: closed area with walls, bars or metal fabric, where one or more animals are kept, and in which the freedom of movement of the animals depends on the size of the enclosure and the degree of occupation, and which normally is less limited than in a cage.

g) CITES: Convention on International Trade in Endangered Species of Wild Fauna and Flora. Washington Convention of 3 March 1973. h) Share: small enclosure of three sides, usually with a feeder and drink with side separations, where one or more animals can be kept tied. (i) 'Corral' means a closed area with fences, walls, bars or metal fabric normally located outside the buildings, where animals housed in cages or enclosures may move freely during certain periods of time according to their physiological and ethological needs. (j) Euthanasia or sacrifice by humanitarian methods: the sacrifice of an animal with the least physical and mental suffering possible, according to its species and state. (k) Jaula: fixed or movable receptacle closed by solid walls and, at least on the one hand, with bars or metal cloth or, where appropriate, nets, where one or more animals are housed or transported. (l) Accommodation premises: premises where the animals are normally housed, either for breeding and maintenance or during the performance of a procedure. (m) "competent person" means any person who, according to his or her training, is legally trained, under this royal decree, to perform the functions provided for therein. (n) "procedure" means any use of an animal for the purposes laid down in Article 2 which may cause prolonged pain, suffering, distress or damage, including any action which may, in an intentional or casual manner, result in the birth of an animal under the conditions mentioned above. The use of animals is also considered to be 'procedure', even if the pain, suffering, injury, distress or prolonged damage is eliminated by the use of anaesthesia, analgesia or other methods. The methods accepted in modern practice (humanitarian methods) for slaughter and for the identification of animals are excluded. It is understood that a procedure begins at the moment when the preparation of an animal is initiated for use and ends when no further observation is to be made for this procedure. (a) either a natural or legal person who carries on the transport of self-employed animals on behalf of a third party or through the provision of a third party to a means of transport for the transport of experimental animals; transport which must be of a commercial nature and be carried out for profit. (o) competent authority shall mean the competent bodies of the autonomous communities and the competent bodies of the General Administration of the State in their respective fields. (p) Alternative methods: those experimental techniques or strategies that meet the "principle of the three errors" (reduction, refinement and replacement):

1. Reduction: strategy to use the minimum number of animals needed to achieve the objective proposed in the procedure.

2. Refining: includes most of those procedures that affect the life of the animal test and allow to alleviate or reduce the possible pain or discomfort. 3. Replacement: use of alternative techniques that can provide the same level of information as that obtained in animal procedures and do not involve the use of animals.

CHAPTER II

From General Conditions and Staff

Article 4. General conditions of accommodation and handling.

1. The centres or establishments provided for in this royal decree shall comply with the following requirements in relation to the general care and accommodation of test animals:

(a) The animals are provided with suitable conditions of accommodation, environment, degree of freedom of movement, food, drink and care to ensure their health and well-being.

b) That any restriction that prevents them from satisfying their physiological and ethological needs is limited to the minimum. (c) that the facilities and the environmental conditions in which the test animals are reared, maintained, kept or used ensure an adequate level of welfare and that this is verified on a daily basis. (d) that measures, means and facilities are available to ensure that, as soon as possible, any deficiencies resulting in changes in the health or welfare of the animals are eliminated, with the necessary alarms. (e) that the working rules and instructions for the use of all the elements are in writing. (f) a plan for action in the event of an emergency or a disaster is provided for in writing. (g) to avoid access to the premises of unauthorised personnel. (h) that the welfare and health of the animals are supervised by the competent personnel defined in Annex I, in order to prevent pain, as well as the suffering, distress or lasting damage.

2. Establishments or centres must comply with the provisions of Annex II, as well as the rules in force on farms which are applicable to them.

3. The user centres must also have adequate facilities for the completion of necropsies, sampling and simple diagnostic tests. 4. The management of the experimental animals shall be carried out in accordance with Annex III, without prejudice to the regulations in force for the conservation of natural species and wild fauna and flora.

Article 5. Transport of animals.

1. The transport of the animals used or intended for use in the procedures shall comply with the conditions laid down in the rules in force on trade, health and animal welfare. 2. The documentation to be covered during transport, the movement of animals used or intended for use in the procedures shall comply with the rules in force on trade, health and animal welfare. 3. The transport containers shall ensure the containment of the animals and allow their freedom of movement at the same time. Transport vehicles shall have an anchorage system, where appropriate, in order to prevent the sudden movements of containers. 4. If during the performance of a procedure it is necessary to move an animal, in addition to the provisions set out in the previous paragraphs, it shall be accompanied by a transfer document issued by the animal health specialist in the centre of origin, which shall be valid for a period of five days, where the data set out in Annex IV shall be included as a minimum. In addition, they shall be accompanied by clear written instructions on the supply of water and food, and the special care to be provided to the animals during their transport.

Article 6. Identification of the animals.

1. All animals belonging to species with already regulated identification systems must be identified in accordance with the rules in force in this field. The method of identification shall be designed in such a way that it cannot be forged, that it is inviolable, easily legible throughout the life of the animal, that it cannot be used again and does not affect its well-being. 2. In particular, dogs, cats and non-human primates must be identified individually, preferably before their weaning, with a permanent system performed in such a way as to cause them as little pain as possible. Where a dog, cat or non-human primate is moved from one centre or establishment to another before its weaning and it is not possible to identify it in advance, the receiving centre or establishment shall keep a complete documentary record, in particular, of the mother's data, and will be identified as soon as possible. 3. When the identification system used may cause pain to the animal, appropriate anesthesia or analgesia will be provided.

Article 7. Identification of confined animals.

1. All cages or systems for the containment of animals shall be labelled and the identification data of the animals housed therein shall be entered on the label. Unless it is not possible for the circumstances or characteristics of the animals to be confined, the particulars listed in Annex V. 2. In the user centres shall be specified as a minimum, and this label should also, where appropriate, be specified in Annex V. 2. allow their relationship to the procedure in which the animal is being used.

Article 8. Record book of the animals.

1. The centres must keep a record book approved by the competent authority which shall contain at least the data set out in Annex VI. The competent authority shall determine the format of such a record book, which may be carried out manually or in computerised form. 2. The registration book must be permanently in the centre and at the disposal of the competent authority. The centre shall keep this log book for at least three years from the date of the last registration.

Article 9. Staff of the centres.

1. Persons carrying out or taking part in procedures and persons in care of animals used in procedures, including supervision tasks, shall have the appropriate preparation and training, accredited by the possession of an academic title which has been deemed appropriate for these purposes by the competent authority. This staff shall be in one of the professional categories described in Annex I. 2. Each centre shall be designated as a person responsible for the care of the animals and the operation of the equipment. 3. The person responsible for the centre shall ensure compliance with the provisions of the previous paragraph. 4. The centre responsible shall ensure compliance with the rules on genetically modified organisms where this is applicable.

Article 10. Advisory staff.

1. The centres will have specialist staff in animal welfare and animal health. 2. The animal health officer shall be a veterinarian with complementary training specialised in experimental animals. 3. The following functions may be assumed by both the animal health officer and the animal welfare officer:

a) Oversee facilities, welfare, management and care of animals, in order to detect any existing deficiencies.

b) If you decide at the end of a procedure that the animal is not sacrificed, monitor that you receive the appropriate care to your health status under the control of an animal health specialist. (c) In general, all the tasks of counselling in the field of animal welfare, in order to prevent at all times the pain, suffering, distress or damage to animals.

CHAPTER III

From the centers

Article 11. Obligations of the centres.

1. Supplier centres may only obtain animals from breeding centres or supplying centres, unless the animal has been legally imported and is not wild or stray, unless the competent authority has the express authorisation. 2. The user centres shall, wherever possible, use breeding animals. However, they may also use animals from supplying establishments, from another user centre which has transferred them as part of the scientific exchange or raised for use in their own facilities. In the latter case, they must also comply with the provisions of this royal decree for breeding centres. The following exceptions are provided:

(a) Animals of the species listed in Annex VII may be farmed animals only, unless they are not available, and subject to the authorisation of the competent authority.

(b) Animals of species other than those listed in Annex VII shall be breeding animals or must come from supplying establishments, unless it is established that they are not available, and the authorisation of the competent authority.

3. The user centres shall have the appropriate facilities and equipment for the species of animals used and for the implementation of the procedures to be carried out there; their project, construction and operation shall ensure that the procedures can be carried out as effectively as possible, so that consistent results are obtained with as few animals as possible and animals are produced to the minimum extent of pain, suffering, distress or lasting damage.

Article 12. Registration of breeding centres, suppliers and users.

1. Private establishments or establishments, prior to the commencement of their operation, must be approved by the competent authority. 2. Once all the permits, authorizations or licenses required by the current regulations have been obtained, no new establishment will be able to start its activity without being registered and have received the corresponding identification code. 3. Public establishments or establishments, prior to the commencement of their operation, must be registered in the register enabled for this purpose. 4. The Ministry of Agriculture, Fisheries and Food is hereby established the Register of the breeding centres and users of experimental animals, of a public and informative nature, in which any centre or centre shall be directly registered. establishment of State ownership. 5. The autonomous communities shall communicate to that ministry the data listed in Annex VIII, referred to the centres referred to in paragraphs 1 and 2, for their transfer to that register.

Article 13. Structure of the register.

1. The registration of each of the centres shall consist of at least the following data: name of the centre; full address; centre holder (name and, if applicable, social reason and number of CIF or NIF); type of establishment (breeding, supplier, user); registration code; animal species kept in the, and responsible. 2. A registration code will be assigned to each center that will be composed of the letters "ES", which identifies Spain, followed by a numerical code composed of 12 characters, of which two will correspond to the identification of the province, according to the codification of the National Statistics Institute; three, to the identification of the municipality, according to the codification of that Institute, and seven, to the identification of the center. The latter code will allow the identification of the unique centre within the municipality. 3. Where an establishment is already registered under Royal Decree 479/2004 of 26 March establishing and regulating the General Register of livestock holdings, it shall maintain that registration code, although it must also be included in the the register set out in Article 12 of this royal decree. 4. The units of those centres which are integrated by independent units physically, unless they have an independent operation and organisation, shall not be registered as different centres. 5. Where a centre is involved in breeding, supply or user of experimental animals, all and each of them shall be included in the register, even if a user establishment raises animals for use in their own It will only be necessary for it to be registered as a user establishment, but it will also comply with all the requirements laid down in this royal decree for breeding centres.

Article 14. Registration of the Ministry of Agriculture, Fisheries and Food.

1. For registration of the Ministry of Agriculture, Fisheries and Food, those responsible for the State-owned centers must direct their application to the General Directorate of Livestock, accompanied by the documentation indicated in Annex IX. 2. Any modification of the data entered, arising from extensions, reductions, transfers, changes of the personnel responsible or other circumstances, as well as in the case of suspension or cessation of the activity or of change of ownership, must be notified to the Ministry of Agriculture, Fisheries and Food within the maximum period of one month after it has occurred, for the corresponding amendment to be made to the register.

Article 15. Database of animal centres for experimentation.

For information purposes, a database of the centres or establishments in the Ministry of Agriculture, Fisheries and Food shall be established with the characteristics set out in Annex X. This database shall be the communications carried out by the autonomous communities and the ministry itself, and shall comprise at least the data set out in Annex VIII.

CHAPTER IV

Of the procedures

Article 16. General conditions of the proceedings.

1. A procedure shall not be carried out if another scientifically satisfactory and contrasting method is available to enable the result to be obtained without involving the use of animals, except where the implementing rules so require. 2. Procedures shall be carried out in such a way as to avoid unnecessary distress and pain or suffering to experimental animals. 3. In order to avoid unnecessary duplication of procedures which are intended to comply with the provisions of national or Community legislation on health and safety, the competent authorities shall, in so far as they are the validity of the data obtained through the procedures carried out on the territory of the Community, unless further proof is necessary for the protection of public health and safety. 4. The competent authorities should encourage research on the development and confirmation of alternative techniques which may provide the same level of information as that obtained in animal procedures, which involve the use of less animals or involving less painful procedures. 5. Before the choice between different procedures, the one that allows to obtain the most satisfactory results will be selected and that:

a) Use the least number of animals.

(b) Be carried out in animals belonging to species whose choice has been carefully assessed and whose degree of neurophysiological sensitivity is as low as possible. c) Cause the least pain, suffering, distress or injury to the animals.

6. The procedures may only be carried out by persons competent or under the direct responsibility of them, or where they are authorised in accordance with the provisions of national legislation.

7. Each procedure, for the purposes of compliance with this royal decree, will have a single responsible investigator.

Article 17. Prohibited procedures.

1. The procedures for the use of animals deemed to be endangered in accordance with Appendix I to CITES and Annex A to Council Regulation (EC) No 338/97 of 9 December 1996 on the use of animals shall be prohibited. protection of species of wild fauna and flora through the control of their trade, as well as those in the National Catalogue of Endangered Species of Law 4/1989, of March 27, of conservation of the natural and flora and flora and wild fauna, they are catalysed as such, unless they conform to the said regulations and that the objectives of the the procedure shall be the research aimed at the protection of the species concerned or essential biomedical purposes, where it is established that such species are exceptionally unique for such purposes and subject to prior authorisation of the competent authority. 2. Procedures may not be carried out with animals caught in the wild or in vagrants, unless those carried out with other animals do not allow the objectives pursued by the procedure to be achieved and the authority has been authorised. competent. In no case can stray dogs or cats be used. 3. Procedures shall not be carried out for the purposes of training and education carried out in institutions of higher education, unless it is essential in accordance with the training programme concerned, and subject to the authorization of the competent authority.

Article 18. Communication and authorisation of procedures.

1. All user establishments shall be obliged to communicate to the competent authority the procedures they intend to carry out. 2. In order to be able to carry out the procedures referred to in Annex XI, prior and express approval of the competent authority shall be required. 3. The documentation listed in Annex XII shall be submitted to the competent authority for the communication of the procedure. The validity of the communication of the procedure shall correspond to the intended duration of the procedure for a maximum of three years, provided that there is no relevant amendment to it. The validity of this communication may be extended upon request of the user centre. 4. The documentation referred to in Annex XIII shall be submitted to the competent authority to request the authorisation of the procedure. Any relevant changes to the descriptive reports listed in Annexes XII and XIII to previously communicated procedures and, where appropriate, authorised shall be communicated to the competent authority. For these purposes, they are considered relevant modifications:

(a) The increase in the number of animals to be used, in the case of protected species.

b) The use of a new protected species. (c) The significant increase in the number of animals to be used for non-protected species. d) The increase in the pain or suffering of the animal. (e) Changes in the place where the procedure is intended to be carried out. (f) Any circumstances listed in Annex XI are to be found.

In the case of relevant changes in the memory of an authorised procedure, it is necessary to request a new authorisation from the competent authority in order to carry out the procedure.

6. The competent authority shall award an identification code to each of the procedures. 7. The State-owned centres shall communicate and, where appropriate, request the necessary authorization from the General Directorate of Livestock of the Ministry of Agriculture, Fisheries and Food. 8. In the case of authorisation of procedures by the General Administration of the State, the report on that procedure of the national ethical animal welfare committee referred to in Article 26 shall be required.

Article 19. Place of completion of the procedures.

1. The procedures shall be carried out in centres registered as user centres. 2. Procedures may be carried out outside these centres where their characteristics justify this, and subject to the authorisation of the competent authority. 3. Where it is necessary for the legitimate purposes of the procedure, the animal concerned may be allowed to be released, provided that appropriate measures have been taken to safeguard the animal's welfare, in so far as its the health status so permits, that there is no danger to animal health, public health or the environment, and subject to the authorisation of the competent authority. In any case, where the procedure in which they are used has exclusively educational or training purposes, the animals used may not be released.

Article 20. Anesthesia and analgesia during the procedure.

1. The procedures must be performed with general or local anaesthesia, unless it is considered to be:

a) It is more traumatic for the animal than the procedure itself.

b) It is incompatible with the purposes of the procedure; in this case, the prior authorization of the competent authority will be required.

2. If anaesthesia is not possible, analgesics or other appropriate methods should be used to ensure, as far as possible, that pain, suffering, distress or injury are minimal and, in any case, that the animal does not suffer. pain, distress or intense suffering.

3. Provided that it is compatible with the purposes of the procedure, when it is expected that an animal will suffer severe or prolonged pain after having recovered from the anesthesia, it will have the necessary time to be treated in advance. sufficient, with adequate means to minimize pain, or, where this is not possible, must be immediately sacrificed by humanitarian methods. 4. In any case, and provided that the animal is expected to suffer severe or prolonged pain, prior authorisation of the procedure by the competent authority shall be necessary. 5. In no case may an animal be used more than once in procedures involving severe pain, distress or equivalent suffering.

Article 21. End of procedure.

1. At the end of any procedure, it shall be decided whether the animal should be kept alive or be slaughtered by a humane method. In any case, an animal will not be kept alive if, despite 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 veterinarian responsible for the health of the animals. 2. When at the end of a procedure:

(a) An 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 4. The veterinary surveillance may be suspended when, in its opinion, the animal is not suffering as a result of such suspension.

(b) It is necessary for the purposes of the procedure, without prejudice to the other provisions of this royal decree, the competent authority may authorise an animal used in a procedure to be returned to its usual means, and appropriate measures shall be taken to safeguard their welfare, in so far as their state of health so permits and does not endanger animal health, public health or the environment. (c) It is decided not to keep an animal alive, or the animal cannot benefit from the conditions laid down in Article 4 concerning its welfare, the animal must be slaughtered as soon as possible, by means of a humanitarian method. The disposal of carcasses and by-products, if any, will be carried out in accordance with existing legislation.

3. In the case of animals of wild species and in particular threatened species, the criteria for the disposal of animals laid down in the resolutions resulting from the Convention on trade shall be taken into account. international species of endangered species of wild fauna and flora with regard to decision-making on captive maintenance, re-introduction into the natural environment or the application of euthanasia to animals at the end of the procedures.

CHAPTER V

Ethical animal welfare committees

Article 22. Creation of the ethical committees for animal welfare.

1. An ethical committee on animal welfare (hereinafter referred to as 'the committee') shall be established in the State-owned centres, which shall ensure compliance with the provisions of Article 11 and Chapter IV. 2. The committee shall be provided with a regulation. internal defining and developing, in its field, its members and its basic functioning according to criteria of confidentiality and representativeness, and which guarantees impartiality in its decisions.

Article 23. Composition.

1. The committee should be composed of a minimum of three people with the expertise and knowledge needed to ensure the welfare and care of the animals. Members who, at least, must be members of these committees shall be as follows:

a) The animal welfare specialist of the centre.

(b) A representative of the quality assurance unit of the centre, where there is, or, failing that, a researcher at the centre not directly involved in the procedure to be informed. (c) A person with experience and knowledge in animal welfare who has no direct relationship with the centre or the procedure in question.

2. In any case, they must be made up of persons other than the assessed procedure.

3. Members shall respect the principle of confidentiality. 4. When deemed appropriate, they shall request the advice of experts who do not belong to the committee, who shall also respect the principle of confidentiality.

Article 24. Functions.

The functions of the committee are as follows:

(a) Inform the appropriateness of each procedure in relation to the objectives of the study, the possibility of reaching valid conclusions with the smallest possible number of animals, the consideration of alternative methods to the use of the animals and the suitability of the species selected.

b) Report that each procedure is carried out in accordance with the notified or approved description referred to in Annexes XII and XIII. (c) Report on the implementation of the procedures, in particular that:

1. The means are put in place to ensure that animals do not suffer unnecessarily and to be provided, where necessary, with painkillers, anaesthetics or other methods designed to eliminate the pain, suffering or distress to the maximum.

2. Appropriate methods of euthanasia are used for the animal species and for the procedure to be performed. 3. The personnel involved in the procedures have the appropriate training to carry out the tasks assigned to them.

Article 25. Exemption from the creation of committees.

1. The exceptional cases in which the establishment of these committees may be exempted shall be established by the Directorate-General for Livestock. 2. In the centres exempted from the establishment of the committee, the tasks set out in Article 24 shall be taken into account. by a committee recognised by the competent authority.

Article 26. State ethical animal welfare commission.

1. For the State-owned centres, the State Ethics Commission for Animal Welfare (hereinafter referred to as 'the Commission') shall be established as an advisory body for the welfare of animals used for experimental and other scientific purposes, attached to the Ministry of Agriculture, Fisheries and Food. 2. The Commission shall have the functions of:

a) Report on procedures authorization requests.

b) Report on requests for exemption from the obligation to set up committees. (c) Advise the user centres for compliance with this legislation, especially on alternative methods and techniques that avoid repetitive or repetitive procedures. d) Act as a consultative body.

3. The Commission shall be composed of the following members:

(a) President: the Director General of Livestock, Ministry of Agriculture, Fisheries and Food.

b) First Vice-President: the Director-General of Research at the Ministry of Education and Science. (c) Second Vice-President: the Director-General of Pharmacy and Health Products of the Ministry of Health and Consumer Affairs. (d) Secretary: the Head of Animal Welfare Service of the General Directorate of Livestock, Ministry of Agriculture, Fisheries and Food. e) Vocals:

1. Seven vowels representing the General Administration of the State, belonging to the following ministries: One representing the Ministry of Industry, Tourism and Commerce, with the rank of deputy director-general.

One on behalf of the Ministry of Agriculture, Fisheries and Food, with the rank of deputy director-general. One on behalf of the Ministry of Health and Consumer Affairs, with the rank of deputy director-general. Two on behalf of the Ministry of Education and Science, with the rank of deputy director-general. Two on behalf of the Ministry of the Environment, with the rank of deputy director general.

Such vowels shall be designated by the Deputy Secretary of the department concerned, and, in cases of absence or disease, and in general, where there is another justified cause, they may be replaced by another person. service of the unit from which they are dependent, which shall be designated in the same way. 2. A vocal representative of non-governmental organizations of a national character who have as one of their main objectives the defense of animal welfare, designated by the President of the Commission and on a proposal from them.

3. A vocal representative of professional associations specializing in animals used for experimentation and other scientific purposes, designated by the President of the Commission and on a proposal from them. 4. A vocal representative of the General Council of Veterinary Colleges of Spain.

4. Representatives of the sectors concerned and of the autonomous communities may be present with a voice, but without a vote. Independent experts may also be present at the invitation, where deemed necessary.

5. Specific task forces may be set up with specific functions. 6. The Commission shall adopt its operating rules. 7. The Commission shall meet at least every three months. 8. Without prejudice to the peculiarities provided for in this royal decree, the Commission shall adjust its operation to the arrangements provided for in Chapter II of Title II of Title II of Law No 30/1992 of 26 November 1992. Public administrations and the Common Administrative Procedure.

CHAPTER VI

Providing information and controls

Article 27. Provision of information.

1. For the purposes of their communication to the European Commission, the user centres must communicate to the competent authority the procedures performed, the species and the number of animals used in each of them, in the time limits and the manner in which they are used. each centre establishes the competent authority. For the autonomous communities, this information shall be forwarded to the General Directorate of Livestock of the Ministry of Agriculture, Fisheries and Food before 31 March of each year with the data relating to the previous year, in order to ensure that It will be transferred to the European Commission via the appropriate channel. 2. For State-owned centres, the communication referred to in paragraph 1 shall be made before 31 March of each year with the data relating to the previous year. 3. On the basis of the applications for authorisation and the notifications received, and in accordance with the reports drawn up, the competent authority shall collect and, as far as possible, publish the statistical information on the Use of animals in procedures with regard to:

(a) Number and species of animals used in the procedures.

(b) Number of animals, by selected categories, used in the procedures referred to in Article 2. (c) Number of animals, by selected categories, used in the procedures required by the legislation.

4. The competent authorities shall take all necessary measures to ensure the protection of the confidential nature of information which is of particular commercial interest to be communicated in accordance with this royal decree.

Article 28. Controls.

1. The control of compliance with the rules contained in this royal decree shall be carried out by the competent authority; for this purpose, it shall carry out the necessary periodic inspections and transmit to the General Directorate of Livestock of the Ministry of Agriculture, Fisheries and Food, before 31 March each year, a report on the outcome of the inspections carried out in the previous year. 2. These inspections, which may be carried out on the occasion of checks carried out for other purposes, shall be carried out annually on samples statistically representative of the centres existing in the territory of each Autonomous Community. 3. Each ministry, within the scope of its powers, shall draw up an annual plan of checks with the autonomous communities in accordance with a risk analysis, which may include determining the size of the sample to be the subject of inspection in each autonomous community, as well as the basic criteria for the selection of the sample and, where appropriate, the list of the centres to be inspected. 4. In the design of the inspection plan, special attention shall be paid to the centres exempted from the obligation to have a committee of their own.

Single additional disposition. Human and material resources.

The creation and operation of the Register of breeding centres, suppliers and users and the state ethical animal welfare commission will be met with the human and material resources existing in the Ministry of Education. Agriculture, Fisheries and Food, without any increase in public expenditure.

First transient disposition. Registered centres in accordance with Royal Decree 223/1988 of 14 March.

The centers registered under the provisions of Royal Decree 223/1988, of March 14, that are in operation, must communicate the necessary supplementary information as provided in this royal decree to the competent authority, within a period not exceeding six months, which shall adapt the registrations in the registers to the provisions of this royal decree.

Second transient disposition. Procedures for processing.

The provisions of Article 18 on cases of notification and/or authorization of procedures that are in the process or are dealt with within six months of the entry into force of this royal decree may be be dealt with in accordance with Royal Decree 223/1988 of 14 March 1988.

Transitional provision third. Approval of the training.

By way of derogation from Article 9.1, the competent authority may decide, at the request of the person concerned, to be submitted within six months of the publication of this royal decree in the Official Journal of the European Communities. "State" shall not require the possession of the academic title corresponding to the staff who have sufficient evidence to carry out the tasks and duties provided for in Article 9.1 and Annex I during the following periods of time, depending on each category:

(a) Category A staff: two years before the entry into force of this royal decree.

b) Category B personnel: five years before the entry into force of this royal decree. c) Staff of category C: 10 years before the entry into force of this royal decree. (d) Category D personnel: 10 years before the entry into force of this royal decree.

Once this derogation has been granted, it will have permanent effects throughout the national territory and will empower the person concerned to carry out the duties corresponding to the category concerned throughout Spain.

Single repeal provision. Regulatory repeal.

As many rules of equal or lower rank are repealed, they oppose the provisions of this royal decree and, specifically, Royal Decree 223/1988 of 14 March on the protection of animals used for experimentation and other scientific purposes, and the Order of 13 October 1989 laying down the rules for the registration of breeding establishments, suppliers and users of experimental animals of state ownership, as well as those for authorisation for the use of animals in experiments, in the development of Royal Decree 223/1988 of 14 March.

Final disposition first. Basic character and competence title.

This royal decree is of a basic nature and is dictated by the exclusive competences recognized by the State of the Constitution in its article 149.1.13. economic activity, and in Article 149.1.16. in the field of basic and general health coordination.

Final disposition second. Faculty of development and modification.

1. The Ministers for Agriculture, Fisheries and Food and Education and Science are empowered to lay down, in the field of their powers, the provisions necessary for the development and implementation of this royal decree and, in particular, to amend its annexes for adaptation to Community legislation or for urgent reasons for the protection of animals. 2. Specifically, the Minister of Education and Science is empowered to establish the training of competent staff to work in the centres.

Final disposition third. Entry into force.

This royal decree will enter into force one month after its publication in the "Official Gazette of the State", except for Chapter V, which will do so six months after its publication.

Given in Madrid, on October 10, 2005.

JOHN CARLOS R.

First Vice-President of the Government and Minister of the Presidency, MARIA TERESA FERNÁNDEZ DE LA VEGA SANZ

ANNEX I

Competent staff to work in the centers

Four professional categories are defined, which are classified as follows: A. Staff of category A: personnel for the care of animals. The teaching programmes for this category shall include at least: 1. Basic concepts relating to the ethical and normative aspects of care provided to experimental animals.

2. Handling and maintenance of animals:

(a) Environment, equipment, cages and accessories in animal facilities: description, use and maintenance.

b) Manipulation and containment of animals. c) Basic knowledge on the methods of humanitarian euthanasia of the affected species. (d) General elements of physiology and behaviour of the animal species used for experimental purposes. (e) Maintenance of the animals and, if necessary, rearing of the animals. (f) Verification of environmental conditions in animals.

3. Recognition of the state of health and disease:

a) Hygiene and disease control.

b) Elements of general physiology and behaviour of animal species used for experimental purposes.

4. Recognition of pain, suffering and distress.

5. Regulations concerning the safety, administration, transport, reception, supply of animals and the disposal of dead bodies. 6. Specific training, if necessary, for any assistance work during the procedures.

B. Category B staff: personnel carrying out the procedures. The teaching programmes for this category shall include at least:

1. Appropriate basic knowledge on the maintenance of animals and the rules on safety, administration, transport, reception and supply of animals and the disposal of dead bodies.

2. Basic concepts relating to the ethical and normative aspects of care provided to experimental animals. 3. Handling and basic principles of animal maintenance:

(a) Biological characteristics, in particular physiological and behavioural characteristics, of species, breeds and lines of animals, in accordance with the tasks to be performed.

b) Manipulation and containment of animals. c) Methods of humanitarian euthanasia of the affected species.

4. Recognition of the state of health and diseases: practical aspects of the monitoring of the state of health and diseases.

5. Implications of the microbiological status of animals. 6. Recognition of pain, suffering and distress. 7. Appropriate training for the completion of the procedures. To the extent necessary for the tasks to be performed:

a) Appreciation of the elements to be taken into account from the conception of a procedure, including refinement, reduction and replacement.

b) Importance of the housing system and the immediate environment of the animals for the procedures. c) Anatomy of animals used for experimental purposes. (d) Anesthesia, analgesia and appreciation of the need to put an end to the procedure to reduce the suffering of the animal as much as possible. e) Appropriate techniques and surgical interventions.

The category B staff training programme must have an important practical component, which will be carried out under the supervision of a person with extensive experience in the aspects studied. C. Staff of category C: responsible staff to lead or design the procedures. Scientists responsible for the design and management of procedures shall be deemed to be competent when:

1. Be graduates with a level equivalent to a bachelor's degree in a discipline such as Biology (animal), Medicine, Veterinary or other discipline with adequate training in zoology, anatomy and physiology.

2. Have participated in a basic course on the science of laboratory animals in order to develop an appropriate level of responsibility for the use of animals in accordance with high level scientific standards, the programme of which includes at least:

a) Ethical aspects and legislation.

b) Biology and maintenance of experimental animals. c) Microbiology and diseases. d) Design of procedures with animals. e) Anesthesia, analgesia and experimental procedures. f) Alternatives to the use of animals. g) Analysis of the appropriate scientific literature.

D. Category D personnel: specialist in animal science personnel for experimentation with advisory functions on the welfare of animals.

1. Specialist animal welfare staff: a person with a higher university degree in the area of Health Sciences, who is responsible for supervising and advising all aspects related to animal welfare. 2. Specialist animal health personnel: a person licensed in veterinary medicine with complementary training specialized in experimental animals, responsible for supervising and advising all aspects related to the health of the animals.

ANNEX II Guidelines for the accommodation of animals

1. Installations.

1.1 Functions and overall project. 1.1.1 The facilities shall be constructed in such a way as to provide a suitable environment for the species housed therein and shall be designed to prevent unauthorised access.

1.1.2 Facilities that are part of a larger building will be protected by building regulations and provisions limiting the number of accesses and preventing the movement of unauthorized persons. 1.1.3 The existence of a maintenance programme for installations is recommended in order to avoid any failure of the equipment.

1.2 Accommodation premises.

1.2.1 All necessary measures will be taken to ensure the regular and effective cleaning of the premises, as well as the maintenance of a satisfactory hygienic level. The ceilings and walls will be resistant, with smooth, waterproof and easily washable surfaces. Special attention shall be given to the joints with doors, ducts, tubes and cables. Doors and windows, where appropriate, shall be constructed or protected in such a way as to prevent the access of animals outside the establishment. The floors shall be smooth, waterproof, non-sliding and easily washable and shall bear the weight of the shelves or other heavy materials. In case there are sinks, they will be adequately covered and will have a barrier that will prevent the access of animals from outside the centre.

1.2.2 The areas where the animals move freely will have walls and floors with a particularly resistant coating to withstand the great wear and tear caused by these and the cleaning operations. Such material shall not be harmful to the health of the animals or may cause injury to the animals. In these areas, the sinks are advisable. Equipment and accessories must be specially protected to prevent animals from spoiling or injuring them. 1.2.3 The rules governing farm animals are to be complied with by the premises intended for the lodging of farm animals (cattle, sheep, goats, pigs, horses, poultry, etc.). 1.2.4 Incompatible species shall not be housed together. 1.2.5 Accommodation premises may be provided with facilities for carrying out minor procedures or manipulations, where appropriate.

1.3 Laboratories and experimentation premises for general and special purposes.

1.3.1 Breeding establishments or suppliers shall have adequate facilities to prepare for the dispatch of animals.

1.3.2 All establishments shall have at least facilities for simple diagnostic tests, necropsies and/or collection of samples for wider investigations. 1.3.3 Measures should be taken on the reception of animals for the establishment of quarantines. 1.3.4 There will be room for experimentation for general and special purposes, provided that it is not appropriate to carry out the procedures or observations in the accommodation premises. 1.3.5 Local accommodation shall be available to accommodate sick or injured animals separately. 1.3.6 Where appropriate, it shall be available in one or more rooms which are suitably equipped for the performance of surgical experiments under aseptic conditions. It is also appropriate to have facilities for the post-operative period when necessary.

1.4 Service Locals.

1.4.1 The premises for the storage of food and/or beds must be fresh, dried and tested for parasites and insects. Other materials that may be contaminated or present danger will be stored in a different location.

1.4.2 Local storage of cages, instruments and any other clean material will be available. 1.4.3 Cleaning and washing facilities will be extensive enough to accommodate the facilities needed to decontaminate and clean the used material. The cleaning process should be arranged in such a way as to separate the clean material circuit from the dirty material to avoid contamination of the freshly cleaned material. The walls and floors should be coated with a suitable resistant material and the ventilation system should have sufficient capacity to remove excess heat and moisture. 1.4.4 Provisions for the storage and disposal of carcasses and residues of animals in satisfactory hygienic conditions shall be adopted. Measures will be taken to eliminate these remains with safety guarantees and in accordance with the current regulations. Special precautions shall be taken with very toxic or radioactive waste. 1.4.5 The project and construction of the circulation areas will be in line with the rules laid down for accommodation premises. The corridors are advised to be quite wide to allow for the easy circulation of the mobile material.

2. Environmental conditions in the accommodation premises and their control.

2.1 Ventilation. 2.1.1 The accommodation premises shall have an adequate ventilation system which satisfies the requirements of the host species. The purpose of the ventilation system is to provide clean air and maintain low levels of odours, noxious gases, dust and infectious agents of any kind. It will also eliminate excess heat and moisture.

2.1.2 The local air will be refreshed with frequent intervals. Under normal conditions the ventilation system should be 15 to 20 air renewals per hour. 2.1.3 The ventilation system shall be designed in such a way as to avoid air currents.

2.2 Temperature.

2.2.1 Table 1 shows the recommended temperature margins. The figures refer only to normal adult animals. The temperature of the premises shall be adjusted in accordance with any changes in the thermal regulation of the animals, which may be due to special physiological conditions or to the effects of the procedure.

2.2.2 An air conditioning system will be available that can both heat and cool the air it supplies. 2.2.3 There is a need for precise temperature control of accommodation premises in user establishments, as the ambient temperature is a physical factor that profoundly affects the metabolism of all animals.

2.3 Humidity.

The optimal relative humidity in the accommodation premises will be 55% +/-10%. Indices of less than 40% and above 70% relative humidity should be avoided for long periods.

2.4 Lighting.

In premises that lack windows, it is necessary to have a controlled lighting system both to meet the biological needs of the animals and to provide a satisfactory working environment. It is also necessary to control the intensity and the light-dark cycle.

2.5 Ruids.

Noises can be an important cause of discomfort for animals. Accommodation and experimentation premises must be isolated from pockets of loud noise from audible and higher frequencies, in order to avoid disturbances in the conduct and physiology of animals.

2.6 Alarm systems.

2.6.1 When the health and welfare of animals are dependent on an artificial system, appropriate emergency systems must be provided to ensure that the appropriate environmental conditions are maintained, and must be alarm systems warning in case of failure.

2.6.2 Both alarm and emergency systems should be reviewed regularly, and a record of such reviews shall be maintained. 2.6.3 Clear instructions on emergency and alarm procedures shall be provided, in the case of a visible location. 2.6.4 The operation of the systems will be ensured as much as possible to the animals.

3. Caged.

3.1 The guidelines suggested for cages, fencing, pens and stables are found in tables 2 to 12.

3.2 In figures 1 to 7, supplementary indications are found on the minimum surface of the cages. 3.3 In figures 8 to 12, the corresponding indications are presented for the estimation of the level of occupancy of the cages. 3.4 Cages and pens must be made of materials which are not harmful to the health of animals. 3.5 They shall be designed in such a way that the animals cannot be injured and, unless they are disposable, of material resistant to cleaning and decontamination. 3.6 Cage and fenced floors shall be suitable for the species and age of the animals and shall be designed to facilitate the disposal of excrement. 3.7 The fencing shall be designed with the welfare of the animals present. It is appropriate to allow for the satisfaction of certain ethological needs (e.g. the need to climb, hide or temporarily protect themselves) and to facilitate their cleaning, while avoiding contact with other animals when it is estimated required.

Cat

Poultry

1 Guidelines for ambient temperature (animals housed in cages or fenced)
or groups of species	Optimal zone at
Primates of the New non-human world	20-28
20-24
Rata	20-24
20-24
Syrian Hamster	20-24
Jerbo	20-24
Cobaya	20-24
Non-human Old World Primates	20-24
Codornish	20-24
	15-21
15-21
Dog	15 -21
Huron	15-21
15-21
Paloma	15-21
Porcin	10-24
Caprine	10-24
Ovina	10-24
Bovine	10-24
	10-24

TABLE 2

Guidelines for the caging of small rodents and rabbits (in reserve and during procedures)

3 kg

Rabbit 5 kg

	Minimum cage floor surface on cm2	Height minimum cage in cm
	180	12
Rata	350	14
Hamster	180	12
Cobaya	600	18
1 kg	1,400	30
2,000		30
2,000
2,500	35
3,000	3,000	40
40	40
: "cage height" means the vertical distance between the cage floor and the top horizontal portion of the lid or cage.

When planning procedures, it is appropriate to take into account the potential growth of the animals, in order to always have sufficient space according to this table in all phases of experimentation. See also Figures 1 to 5 and 8 to 12.

3 Guidelines for the caging of small rodents during breeding

Species

Minimum surface cage floor per mother and its prole in cm2

Minimum Height

. Rat................. . Hamster............... Cobaya.................

200 800 6,500 1,200

12 14 12 18

Cobaya in collectivities. .

1,000 per adult

18

Note: View the note in Table 2 for the definition of "cage height".

TABLE 4

Guidelines for rabbit caging during breeding

Weight of

the

in kg

2

Surface minimum of the cage floor by eyebrow and its prole in m2	Minimum height of the cage in cm	Minimum Surface of the nest floor in m2
	0.30	30	0.1
0.35	30	0.1
3	0.40	35
	4	0.45	40
		0.50	40

Note: For the definition of "cage height", see Table 2.

The minimum surface of the cage floor by eyebrow and its prole already includes the surface of the nest soil. See also Figure 6.

4-5

5 Guidelines for hosting cats (during procedures and breeding)
Weight of the cat in kg	Minimum surface area of cage by cat in m2	Minimum cage height in cm	Minimum floor surface of the cage by gata and its prole in m2	Minimum surface of the fenced by gata and its prole on m2
0.5-1	0.2	50	-	-
-3	0.3	50	0.58	2
3-4	0.4	50	0.58	2
0.6	50	0,58	2

Note: The enclosure of cats should be kept to a minimum in cages. Cats held in this way should be able to exercise at least once a day, provided that this does not hinder the procedure. It is advisable that the fenced for cats are equipped with trays for the depositions, ample space in shelves for rest and objects that allow to climb and sharpen the claws. 'cage height' means the distance between the highest point of the floor and the lowest point of the cage roof. The area of the ledges may be included when calculating the minimum floor area. The minimum surface of the cage floor per cat and its prole includes the area of 0.18 m2 of the box for deliveries. See also Figure 7.

6 Guidelines for enclosure dogs in cages (during the performance of the procedures)
-in-cm-level dog height	Minimum floor area	Minimum Height of the cage in cm
30 70 75	0.75 1.00 1.75	60 60 140

Note: dogs should only remain in cages for the time strictly necessary for the purposes of the procedure. It is advisable to release caged dogs to exercise once a day, provided that this is not incompatible with the purpose of the procedure. It is recommended to limit the seclusion of dogs without providing daily exercise. It is of interest that the areas for the exercise are large enough for the dog to have freedom of movement. It is not advisable to use grating floors in dog cages, unless required by the procedure. Considering the large differences in height and the low ratio between height and weight in various breeds of dogs, the height of the cage should be based on the height of the body at the animal's cross level. As a general rule, the minimum height of the cage is advised to be double the height of the cross. For the definition of "cage height", see the note in Table 5.

7 Guidelines for enclosure dogs in fenced (in reserve and during experimentation and breeding)
Weight of the dog in kg	Minimum surface of the fenced floor Dog-table_izq"> per m2	Minimum adjacent surface for exercise per dog
		Up to three dogs per m2	More than three dogs per m2
< 6 6-10 10-20 20-30 30	0.5 0.7 1.2 1.7 2.0	0.5 (1, 0) 1.4 (2, 1) 1.6 (2, 8) 1.9 (3, 6) 2.0 (4, 0)	0.5 (1, 0) 1,2 (1, 9) 1.4 (2, 6) 1.6 (3, 3) 1.8 (3, 8)

Note: the figures in parentheses indicate the total area per dog, i.e. the surface of the fenced floor plus the adjacent surface for exercise. Dogs permanently housed in the open air should have access to a covered place to protect themselves from weathering. When dogs are housed on grating soil, it is advised that they have a smooth sleeping surface. It is not recommended to use grating floors unless the procedure so requires. The divisions between fencing will prevent dogs from herthering each other. The fencing shall have an appropriate drainage system.

TABLE 8

Guidelines for non-human primate accommodation (in reserve and during procedures and breeding)

Preliminary note: due to the great diversity of primate sizes and characteristics, it is especially important to adapt the shape and the internal fittings, as well as the dimensions of their cages to their particular needs. The total volume of the cage is as important to the primates as the surface of the soil. As a general principle, height should be the largest dimension of the cage, at least for anthropomorphs and other apes. The cages shall have sufficient height at least for the animals to stand. It is recommended that the minimum height of the cage for the animals that move suspended is sufficient to allow them to be fully balanced without reaching the floor of the cage with the feet. Where appropriate, the hangers shall be arranged so that the primates can use the upper part of the cage.

Two compatible primates can be housed in the same cage. When they cannot be put in pairs, it is appropriate to place the cages so that they can see each other, but also that there is the possibility of avoiding it when necessary. Taking into account these observations, the following table provides a general orientation for the caging of the most commonly used groups (superfamilies "Ceboidea" and "Cercopitheidea").

Weight in kg

Minimum cage floor surface for one or two animals in m2	Minimum height of the cage in cm
< 1 3-5 3-5 3-5 5-7 7-9 9-15 15-25	0.25 0,35 0.50 0,70 0,90 1.10 1.50	60 75 80 85 80 90 125 125

Note: For the definition of "cage height" see the note in Table 5.

9 Guidelines for pigs caging (in reserve and during experimentation)
Weight the pig in kg	Minimum surface area of the cage by pig in m2	Minimum height of the cage in cm
5-15 15-25 25-40	0.35 0.55 0,80	50 60 80

Note: This table would also apply to piglets. It is not recommended to keep pigs caged unless it is essential for the purpose of the procedure and in such a case only for the minimum time.

For the "cage height" definition, see the note in Table 5.

TABLE 10 Guidelines for hosting farm animals in fenced (in reserve and during experimentation in user establishments)

Species and weights in kg

3

Bovine 60-100

Bovine 100-150

Minimum surface area of fenced in m2	Minimum fenced length in m	Minimum height of fenced in m	Minimum fenced floor surface for groups on m2 per animal	Minimum feedlot length per head in m
Porcin 10-30	2	1.6	0.8	0.2	0.20
Porcin 30-50	2	1.8	1.0	0.3	0.25
2.1	1.2	0,30	0,30
Porcin 100-150	5	2.5	1.4	1,2
150	5	2.5	1.4	2.5
	Ovina < 70	1.4	1.8	1.2	0,35	0,35
Caprine < 70	1.6	1.8	2.0	0,8	0,35
		1.1	1.0	0,8
2.2	1.8	1.0	1.0
2.4	1.8	1,0	1,2	0,35
	Bovine 150-200	2.5	2.0	1.2	1.4
Bovine 200-400	2.6	2.2	1.4	1.6
400	2.8	2.2	1.4	1.8
(adults)	13.5	4.5	1.8	-	-

TABLE 11 Guidelines for hosting farm animals in compartments (in reserve and during experimentation in user establishments)

Species and weights in kg

Minimum compartment surface in m2	Minimum compartment length in m	Minimum height of the divisions in m
Porcin 100-150	1.2	2.0	0.9
150	2.5	2.5	1.4
Ovina < 70	0.7	1.0	0.9
Caprine < 70	0.8	1.0	0.9
Bovine 60-100	0.6	1.0	0.9
100-150	0.9	1.4
150-200	1.2	1.1.6	1.4
	200-350	1.8	1.8
	350-500	2.1	1.9	1.4
> 500	2.6	2.2	1.4
	Caballar (adults)	4.0	2.5	1.6
Note: The compartments should be wide enough to allow the animal to lie comfortably.

Codorices

12 Guidelines for bird caging (in reserve and during experimentation in establishments users)
Species and weights in g		Minimum surface per bird in cm2	Surface minimum for two birds in cm2 per bird	Minimum surface for three or more birds in cm2 per bird	Minimum cage height in cm	Minimum feedlot length per bird in cm
Pollos	100-300	250	200	150	25
			300-600	500	400	300	35	7
	600-1,200	1,000	600	450	45	10
	1.200-1,800	1,200	700	550	45
		1.800-2,400	1,400	850	650	45	12
(adult Machos)	> 2,400	1,800	1,200	1,000	60	15
120-140	350	250	200	15	4
For the definition of "cage height", see the note in Table 5. The openings of the meshes in the floors The grid will not exceed 10 x 10 mm for chicks, and 25 x 25 mm for older chickens and adults. The thickness of the wire should be at least 2 mm. The slope of the ground should not pass from 14% (8 °). It is advisable that the drinkers have the same length as the feeders. If you use teat or cup drinkers, it is convenient for each bird to have access to two. The cages should be equipped with hangers and allow the birds housed in individual cages to see each other.

Here are several images in the original. See the PDF document for this disposition.

ANNEX III

Animal care guidelines

1. Catch: Wild animals will be captured only by humanitarian methods and with the intervention of experts who possess a deep understanding of the customs and habitat of the animals that it is interested to catch. If any anesthetic or other drug should be used in the capture operation, a veterinarian will administer it. Any animal that was seriously injured should be subjected to the care of a veterinarian as soon as possible. If, in the opinion of the veterinarian, the animal can only continue to live with suffering or injury, it should be sacrificed immediately by a humanitarian method. In the absence of a veterinarian, any animal suffering from serious injury should be killed immediately by a humanitarian method.

2. Reception and unpacking.

2.1 Animal shipments will be received and unpacked, avoiding any delay.

2.2 After inspecting, the animals will be housed in clean cages or fenced and given food and water according to their needs. 2.3 Animals that are sick or ill will be kept for any other cause under observation and apart from others. 2.4 A veterinarian shall examine them as soon as possible and, if necessary, treat them. 2.5 Animals that do not have any chance of recovery will be killed immediately by means of a humanitarian method. 2.6 All animals received shall be identified and registered in accordance with the rules in force. 2.7 The boxes used for transport, if they cannot be decontaminated properly, will be destroyed immediately.

3. Quarantine, isolation and acclimatisation.

3.1 Separate facilities will be available to isolate animals which, by presenting symptoms or being suspected of ill health, may pose a danger to humans or other animals.

3.2 Even when animals are in good health, it is appropriate to submit them to an acclimatisation period before using them in a procedure (see Table 1). The time required depends on several factors, such as the stress to which the animal has been subjected, which in turn depends on several factors, such as the length of transport and the age of the animal. A competent person shall decide on the duration of that period.

4. Power.

4.1 Food processing will be in line with current regulations. Feeders, drinkings and other utensils used for food shall be cleaned regularly and, where appropriate, sterilised. If wet food is used or easily contaminated with water, urine, etc., your daily cleaning will be necessary.

4.2 Although the food distribution process may vary according to the species, it must be performed in a way that satisfies the physiological needs of the animal. All animals will be able to access the food.

5. Water.

5.1 All animals will always have uncontaminated drinking water.

5.2 The bottles will be made of transparent material to allow the control of their contents. They should be wide-mouthed to facilitate their cleaning and, if plastic material is used, they will not release soluble substances. Caps, plugs and tubes will be sterilizable and easy to clean. The bottles and accessories shall be removable and cleaned and sterilised at regular intervals. 5.3 Automatic drinking systems will be monitored, checked and cleaned regularly to prevent accidents and the spread of infections. If smooth soil cages are used, measures should be taken to reduce the risk of flooding. Periodic bacteriological control of the system is also necessary to ensure water quality. 5.4 Water from the public network contains micro-organisms which are generally considered safe unless they are used for microbiological definition animals. In these cases water should be treated. Public water is often chlorinated to reduce the growth of microorganisms. Such chlorination is not always sufficient to prevent the growth of some potential pathogenic germs, such as the Pseudomonas spp. As a complementary measure, the chlorine level of the water can be raised or acidified to achieve the desired effect. 5.5 In fish, amphibians and reptiles, tolerance to acidity, chlorine and many other chemicals varies widely according to species. Therefore, it is necessary to take the necessary measures to adapt the water supply of the aquariums and nurseries to the needs and limits of tolerance of each species.

6. Bed: The bed will be absorbent, free of dust, non-toxic and free of infectious agents, parasites or any other form of contamination. Special care shall be taken to avoid the use of sawdust or other chemically treated wood-derived bed material.

7. Exercise and manipulation.

7.1 Any opportunity for animals to exercise will be used.

7.2 The behavior of an animal during a procedure depends to a great extent on its confidence in the people to be developed. It is recommended to maintain frequent contact for animals to become accustomed to human presence and activity.

8. Cleaning.

8.1 The quality of an installation depends largely on good hygiene. Clear instructions will be given to change the bed of cages and fencing.

8.2 A suitable programme for cleaning, washing, decontamination and, where necessary, sterilisation of cages, accessories, bottles and any other material shall be established. It is also appropriate to maintain a high degree of cleanliness and order in accommodation, washing and storage facilities. 8.3 The material covering the soil of cages, pens and pens shall be periodically renewed to prevent them from becoming a source of infection or parasite infestation.

9. Slaughter with humane methods of animals.

9.1 Every human method of animal slaughter requires knowledge that can only be acquired through appropriate training.

9.2 The removal of dead bodies should not be allowed before rigor mortis is overcome.

Table 1

5-15

	Days
5-15
-15	5-15
5-15		5-15
	5-15
Hamster	5-15
Rabbit	20-30
	20-30
Dog	20-30
Non-human Primates	40-60

ANNEX IV Minimum data to be recorded in the transfer document issued by the animal health specialist

a) Sender: name of its holder, registration number and address.

b) Recipient: name of the center, registration number, and address. (c) Place of loading, or place of catch in the case of wild animals. (d) Type of means of transport and identification of the means of transport. (e) Carrier, specifying its approval number for the transport of live animals. (f) Species transported. (g) Number of animals. (h) Individual identification, if applicable. (i) the health status of the animals to be moved, in accordance with the rules affecting the species moved. (j) First name, number of the national identity card and signature of the animal health specialist extending the document. (k) Date. (l) In the case of wild animals, the permit to catch the competent authority shall be indicated. (m) It shall be indicated whether they are animals of derogation according to Article 3.1.b) 2. of Royal Decree 1041/1997 of 27 June 1997 laying down rules on the protection of animals during their transport. (n) Justification of the assumptions of Article 5.4, if any. n) Cause of the exception, description of the situation, instructions for handling and care during transport. o) Day and time of the load. (p) Estimated duration of transport. q) The expected day and time of the download.

ANNEX V

Minimum data for identification in cages or systems of confinement

a) Species. (b) Race (if applicable). (c) Cepa (if applicable). (d) Sex. (e) Date of birth. f) Date of crossing (if they are pairs). (g) Number of animals. (h) In the user centres, where appropriate, the investigator responsible for the procedure in which the animals are being used, the department to which the animals are attached and the identification code of the procedure. (i) Remarks.

ANNEX VI Minimum data from the animal registration book in the centres

All centers must keep a record of the animals in which the following data must be recorded:

a) The name and record number of the center.

(b) The number of animals present in the centre at the time of opening this register, indicating the species or species to which they belong. (c) the entries of the animals, the date on which they are produced, indicating the species, the births and the purchases, stating their origin (with reference to the name and address of the breeding or supplier centre). (d) the departure of the animals, the date on which they are produced and the species, stating their consignee (with reference to the name and address of the consignee). (e) the animals slaughtered or killed not used in procedures, and their causes, and, where appropriate, the method of slaughter used. (f) The animals used in procedures, indicating which procedure they are intended for. (g) the observations made during the quarantine period of the animals coming from outside the centre. (h) The results of the health examinations carried out on the animals. i) The results of the necropsies performed. (j) Cases of disease and treatments administered. (k) In the case of animals reared, supplied or used in procedures, of species in which it is established, the individual identification of each animal shall be recorded. (l) Data concerning the origin and individual identification of dogs, cats and non-human primates shall be recorded. (m) In centres which breed livestock of livestock species for which the existence and maintenance of a registration book is compulsory, the rules in force in this field shall apply.

ANNEX VII List of animal species to which the provisions of Article 15 apply

Mouse: "Mus musculus".

Rat: "Rattus norvegicus". Cobaya: "Cavia porcellus." Golden hamster: "Mesocricetus auratus." Rabbit: 'Oryctolagus cuniculus'. Non-human primates. Dog: "Canis familiaris." Cat: "Felis catus." Quail: " Coturnix coturnix".

ANNEX VIII Minimum data for centres entered into the national database of animal testing

a) Record number.

b) The name of the establishment. (c) Full address. (d) telephone number, fax number, e-mail address. (e) Type of establishment. (f) Animal species present in the establishment. (g) Responsible for the centre (natural or legal person).

ANNEX IX Minimum documentation required for registration of the centers in the registry

1. Request containing the following data:

a) Name of the center.

b) Full address. c) Holder of the center, name and, if applicable, social reason and number of tax identification code or tax identification number. (d) Type of establishment (breeding, supplier or user).

2. Report containing at least:

(a) descriptive and drawings or drawings of the situation, distribution of the buildings, facilities and dependencies, as well as the capacity in number of animals and activities that they are expected to develop.

b) Health-hygiene programme providing for all the control measures established by the current legislation. (c) a description of the essential aspects of the procedures to be carried out, species and number of animals reared, supplied or used. (d) Technical and health reports. The health report shall be signed by the animal health specialist. (e) Identification of the administrative officer of the centre. f) Identification of the person responsible for animal welfare. (g) Identification of the veterinarian responsible for animal health. (h) The relationship of specialised staff, with a specification of their training, qualifications and experience. In the case of university user centres and public research centres, only the relationship of the staff for the care of the animals, the specialist animal welfare staff and the animal health specialist will be entered. (i) In the case of a State-owned user centre, the composition of the committee shall also be entered.

ANNEX X Record Characteristics

Unit responsible for the declaration and registration of the file: Directorate General of Livestock of the Ministry of Agriculture, Fisheries and Food.

Purpose: registration of breeding establishments and users of experimental animals, in compliance with the provisions of Council Directive 86 /609/EEC of 24 November 1986. Uses: control, by means of the competent authority, of compliance with the current regulations. Persons and groups concerned: any supplier, breeding or user centre for animals of experimentation which radiating in Spain. Procedures for the collection of data: they shall be provided by the person concerned to the competent authorities of the competent authorities. Basic structure of the file and description of the types of personal data included in the file: data of the identification of the person responsible, of the person or persons specialists in animal welfare or animal health of the center: name, national identity card, training. Transfers of personal data and international transfers of data: to the autonomous communities in the field of their competences. Responsible organ: General Directorate of Livestock of the Ministry of Agriculture, Fisheries and Food and Autonomous Communities. Body to which the rights of access, rectification and cancellation may be exercised: competent authorities referred to in Article 3 (o). Safety measures with indication of the level required: basic level.

ANNEX XI Procedures requiring prior and express authorisation from the competent authority

(a) The use of animals of the species listed in Annex VII which have not been born or have been expressly raised in officially recognised centres.

(b) The use of animals of species not included in Annex VII which do not come from breeding or supply centres. c) The execution of procedures outside the user centers. (d) The release of the animals during the procedure. (e) the use of wild animals caught in the wild, from stray animals, from animals coming from official animal protection centres or from protected or endangered animals, if permitted by the specific rules of protection, provided that the objectives of the procedure are the research which is intended to protect these species or other essential biomedical purposes and that the said species are exceptionally the only ones suitable for the the purpose that is intended. The scientific activities related to the ring, marking, and sampling for routine analysis are excluded. (f) The execution of procedures for teaching purposes in non-higher education institutions. (g) performing procedures in which no anesthesia, analgesia or other methods are used to eliminate the pain, suffering or distress to the maximum, as they are incompatible with the results of the procedure or by be contraindicated. (h) the execution of procedures in which the animal may suffer severe or prolonged pain. (i) In those procedures in which animals caught in the wild have been used, the release to the medium originating from these animals, after the completion of those animals.

ANNEX XII Minimum documentation for procedure communication

1. A descriptive memory of the procedure, in which it will be stated:

a) The name of the procedure to be performed.

b) The objectives that are pursued. c) The methodology of the procedure. Where the guidelines of a procedure are officially published or have been officially validated, this shall be deemed to be completed, provided that a copy of the relevant publication or validation is provided. d) Justification of the need to use animals to obtain the results pursued with the procedure. (e) The species and number of animals to be used. (f) the duration of the procedure and the frequency of implementation. (g) Expected start date and expected date of completion of the procedure. (h) Final destination of the animals and, in the case of slaughter, the method used. (i) The identification of the investigating staff responsible for the procedure. (j) the data of the centre responsible for the establishment of the animals during the procedure, including its corresponding registration number. Any change of location of the animals to another registered centre shall be reflected in the book of registration of the animals.

2. In the State owned centers, report of the ethical committee of animal welfare of the animals used in the procedures. A copy of the report will need to be forwarded to the appropriate user centre.

ANNEX XIII Documentation for the application for prior and express authorization of procedures

1. Description of the procedure, in which it shall be stated:

a) The name of the procedure to be performed.

b) The objectives that are pursued. c) The methodology of the procedure. Where the guidelines of a procedure are officially published or have been officially validated, this shall be deemed to be completed, provided that a copy of the relevant publication or validation is provided. d) Justification of the need to use animals to obtain the results pursued with the procedure. (e) The species and number of animals to be used. (f) the duration of the procedure and, where appropriate, the frequency of the planned performance. (g) Expected date of commencement and intended date of completion of the procedure (h) Final destination of the animals and, in the case of slaughter, the method used. (i) The identification of the investigating staff responsible for the procedure. (j) the data of the centre responsible for the establishment of the animals during the procedure, including its corresponding registration number. Any change of location of the animals to another registered centre shall be reflected in the book of registration of the animals.

2. The State-owned centers will submit an ethics committee report.

3. Circumstance by which the prior and express authorisation of the competent authority is required, and their justification.