Royal Decree 1201 / 2005 Of 10 October, On The Protection Of Animals Used For Experimental And Other Scientific Purposes.

Original Language Title: Real Decreto 1201/2005, de 10 de octubre, sobre protección de los animales utilizados para experimentación y otros fines científicos.

Read the untranslated law here: https://www.global-regulation.com/law/spain/1447090/real-decreto-1201-2005%252c-de-10-de-octubre%252c-sobre-proteccin-de-los-animales-utilizados-para-experimentacin-y-otros-fines-cientficos.html

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Get a Day Pass for only USD$49.99.
The Directive 86/609/EEC of the Council of 24 November 1986 on the approximation of the laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes, aims to harmonise the legislation of the various States members of the European Union as regards the protection of animals used for these purposes. This directive aims to ensure that the number of animals used in such practices is reduced to a minimum and that, in any case, that are used, be granted treatment that avoids the most pain, suffering or injury, prolonged unnecessarily. Also encourages the development of alternative methods that can provide the same level of information as that obtained in procedures with animals and implying a lesser use of these concepts that are currently included in the 'principle of the three Rs' (reduction, refinement and replacement). On the same date and given the desire to define and limit the use of animals for certain purposes such as scientific research, education and training and the medico-legal investigation, Member States adopted resolution 86/C 331/02.



Council Directive 86/609/EEC was amended by Directive 2003/65/EC of the European Parliament and the Council of 22 July 2003, by which a regulatory Committee is created to ensure the consistency of the annexes to Directive 86/609/EEC with the most recent scientific and technical developments, as well as the results of the research on issues that deal. It is not necessary to transpose this directive into national legislation, since it is limited to the creation of a Committee of EU.
Directive 86/609/EEC of the Council took to the law in Spanish through Royal Decree 223/1988, of 14 March, 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 October 13, 1989, that establish the norms of registration of the breeding suppliers and users of State-owned experimental animals, as well as the authorization for the use of animals in experiments, developing of the Royal Decree 223/1988, of 14 March.
Moreover Spain ratified, on October 25, 1990, the European Convention on the protection of vertebrate animals used for experimental purposes and other scientific purposes (Strasbourg, 18 March 1986), which contains general rules whose aim is to avoid that cause animals that that Convention is applicable them unnecessary pain, suffering or distress as well as the limitation of its use, favoring the use of alternative methods.
Similarly, in the framework of the Council of Europe is adopted, in a series of multilateral consultations, a package of resolutions on the interpretation of certain provisions and expressions of the European Convention on the protection of vertebrate animals used for experimental and other scientific purposes, on the training and education of those who work with animals of laboratory, facilities and care to laboratory animals and on acquisition and transport of these.
The existence of different bodies for the assessment of opportunity practices of research reveals whether to regulate them as an instrument to achieve the purposes set out in the said directive.
The growing concern of society for the protection of animals and the quality of the research, in which observation, control, welfare, the maintenance and care of animals used in experimentation is a basic pillar, as well as changes in the legislation and continued scientific progress, make necessary updating of legislation.
The article 36.2 of the Act 8/2003, 24 April, animal health, says that the basic sanitary conditions which must comply with animal farms will be that set current, and final disposal regulations fifth faculty to the Government to dictate the precise arrangements for the implementation and development of the law. In this Royal Decree law develops as affecting the animal facilities such as farms.
For all of the above, has been considered the need to adapt current legislation, including what's new, and repealing the old one, and so, for the sake of clarity and legal certainty, it has been determined whether to enact a new standard.
In its processing, this Royal Decree has been subjected to consultation of the autonomous communities and the organizations representing the interests of the sector.
By virtue, on the proposal of the Ministers of agriculture, fisheries and food, education and science, health and environment, with the prior approval of the Minister of public administration, in accordance with the Council of State and after deliberation by the Council of Ministers at its meeting of October 7, 2005, D I S P O N G O : Chapter I object, scope and definitions article 1. Object and purpose.



1. the object of this Royal Decree is to establish the rules for the protection of animals used in experimentation and other scientific purposes, including teaching.
2. its purpose is to ensure that protection and, in particular, which are granted to the animals used appropriate care; that does not is cause them unnecessary pain, suffering, distress or injury sustained; to avoid any useless duplication of procedures, and the number of animals used in procedures to be reduced to a minimum by applying alternative methods as far as possible.



Article 2. Scope of application.



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 it pursues the following purposes: to) scientific research, including aspects such as the prevention of diseases, changes in health and other anomalies and their effects, as well as diagnosis and treatment in man, 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, regulation or modification of physiological conditions in man, animals or plants.
(c) the protection of the natural environment, in the interests of the health or welfare of man or animals and maintenance of biodiversity.
(d) education and training.
(e) the medical research.



3 are excluded from the scope of this Royal Decree, non-experimental agricultural practices and Veterinary Clinic.



Article 3. Definitions.



For the purposes of this Royal Decree, means: to) Animal: any being living vertebrate non-human, including the offspring of life or forms of reproduction-breeding, excluding foetal or embryonic forms.



(b) livestock: animals specially bred for use in procedures in establishments approved or registered by the competent authority.
(c) animal experimentation: animals used or intended to be used in procedures.
(d) adequately anesthetized laboratory animals: animals deprived of feelings through the use of effective methods of local or general anesthesia.
(e) Centre or establishment: all installation, building, group of buildings or other premises, including those not fully enclosed or covered, as well as mobile facilities and the whole of personal media and materials organized by their owner for breeding, supply or the use of experimental animals. They are distinguished: 1 breeding centre: any establishment where animals are bred.



2nd supplier Centre: any establishment that provides and maintains experimental animals, not born in the heart.
3rd Center user: any establishment in which experimental animals are used.



(f) fencing: area closed with walls, bars or netting, where one or more animals are kept, and where the freedom of movement of animals depends on the size of the enclosure and the degree of occupation, and that usually 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) compartment: small enclosure from three sides, usually with a feeder and drinker with lateral separations, where can be attached one or more animals.
(i) poultry: area closed with fences, walls, bars or wire mesh located usually on the outside of the buildings, where the animals housed in cages or enclosures can move freely during certain periods of time according to their physiological and Ethological needs.
(j) euthanasia or slaughter by humanitarian methods: the sacrifice of an animal less suffering physical and mental as possible, according to his kind and State.
(k) cage: fixed or mobile socket closed by solid walls and, at least on the one hand, with bars or netting or, in your case, networks, where staying or carry one or more animals.

(l) local accommodation: premises which houses usually animals, good for breeding and maintenance, well during a procedure.
(m) competent person: any person who, depending on their training, is trained legally, under the aegis of this Royal Decree, to perform the functions provided for in it.
n) procedure: any use of an animal for the purposes set forth in article 2 that may cause prolonged pain, suffering, distress or damage, including any action that intentionally or casual way may give rise to the birth of an animal in the above mentioned conditions. He is considered, in addition, 'procedure' the use of animals, even if you eliminate the pain, suffering, injury, distress or damage extended, through the use of anaesthesia, analgesia or other methods. Excluded methods accepted in modern practice (humanitarian methods) for the sacrifice and for the identification of animals. It is understood that a procedure begins at the moment that begins the preparation of an animal for use and ends when already it won't make any further comment for this procedure.
(n) carrier: any natural or legal person who transport experimental animals on their own, on behalf of a third party or by placing available to a third party of a means of transport intended for the transport of laboratory animals, transport must be of a commercial nature and carried out for profit.
(o) competent authority: the competent bodies of the autonomous communities and the competent bodies of the General State administration in their respective areas.
(p) alternative methods: those techniques or experimental strategies that meet the 'principle of the three Rs' (reduction, refinement and replacement): reduction 1: strategy to use the minimum number of animals necessary to achieve the objective proposed in the procedure.



2nd refinement: includes most of those procedures that affect the life of the animal experimentation and allow relieve or reduce the possible pain or discomfort.
3rd replacement: use of alternative techniques which can provide the same level of information as that obtained in procedures with animals and that do not involve the use of these.



Chapter II of the General conditions and article 4 staff. General conditions of accommodation and management.



1 centres or establishments referred to in Royal Decree shall meet the following requirements in relation to the general care and accommodation of animals for experimentation: to) that the animals are them provided adequate conditions of accommodation, environment, degree of freedom of movement, food, drink and care that will ensure their health and well-being.



(b) any restriction that prevents them from satisfying their physiological and Ethological needs is limited to the absolute minimum.
(c) that facilities and environmental conditions in which they are bred, kept, guarded or used experimental animals ensure them an adequate level of well-being, and that it is verified daily.
(d) that is available measures, 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, with the necessary alarms.
(e) labour standards and instructions for use of all the elements contained in writing.
(f) have intended writing a plan of action in case of emergency or disaster.
(g) to prevent access to unauthorised personnel facilities inside.
(h) that the welfare and health of the animals are supervised by competent personnel defined in annex I, to prevent the pain, as well as suffering, distress or lasting damage.



2. establishments or centres must meet the provisions of annex II, as well as the regulations on livestock farms that will be applicable.



3 users centers must have, in addition, adequate facilities for post mortem examinations, sampling and simple diagnostic tests.
4. the management of experimental animals will take place in accordance with annex III, without prejudice to current regulations on conservation of the natural species and wild fauna and flora.



Article 5. Transport of animals.



1. the transport of the animals used or intended to be used in the procedures shall comply with the conditions laid down in the regulations on trade, health and animal welfare.
2 documentation that should protect during transport, the transfer of animals used or intended to be used in the proceedings shall comply with regulations on trade, health and animal welfare.
3. the containers shall ensure the containment of animals and will allow, at the same time, their freedom of movement. Transport vehicles will have an anchoring system, where appropriate, to avoid sudden movements of containers.
4. If during the conduct of a procedure it is necessary to proceed with the transfer of an animal, in addition to the provisions of the preceding paragraphs, shall be accompanied by a movement document issued by the specialist in animal health from the center of origin, which is valid for five days, where shall include, as a minimum, data listed in annex IV. In addition, they be accompanied by clear written instructions on the provision of food and water, and the special care that it shall treat the animals during transport.



Article 6. Identification of the animals.



1. all animals belonging to species with identification systems already regulated should be identified as the current legislation on this matter. The method of identification will be designed so not to falsify, be inviolable, easily readable throughout the life of the animal, which may never be used and does not affect your well-being.
2. specifically, dogs, cats and non-human primates should be identified individually, preferably before your weaning, with a permanent system carried out in such a way that cause you the least possible pain. When a dog, cat or non-human primate is transferred from a centre or establishment to another before their weaning and not possible to identify it previously, receiver establishment or the Centre shall keep a full documentary record, in particular, the data of the mother, and will proceed with identification as soon as possible.
3. when the identification system used can cause pain to the animal, we will provide adequate analgesia or anesthesia.



Article 7. Identification of confined animals.



1. all the cages or confinement of animals systems must be labelled and the identification data of the animals housed there shall be entered on the label. Unless it is not possible by circumstances or characteristics of the animals confined there, shall be specified, as a minimum, the data listed in annex V. 2. Centers users, this label must, in addition, where appropriate, allow their relation to the procedure in which the animal is being used.



Article 8. Record book of animals.



1. workplaces must be a log book approved by the competent authority which shall contain, as a minimum, data that are attached in annex VI. The competent authority shall determine the format of this book of record, which may be carried in manual or computerised form.
2. the record book must be permanently at the Center and at the disposal of the competent authority. The Center shall keep this log book, at least three years from the date of the latest registration.



Article 9. Staff at the centres.



1. persons who carry out procedures or take part in them and the people who are in the care of animals used in procedures, including the monitoring tasks, must have the preparation and the adequate training accredited by the possession of a degree that has been considered adequate for this purpose by the competent authority. This staff will be framed in one of the categories set out in Annex i. 2. In each centre, please designate a person responsible for the care of the animals and of the operation of the equipment.
3. the head of the Centre shall ensure compliance with the provisions of the preceding paragraph.
4. the head of the Center will ensure compliance with the legislation on genetically modified organisms when it is of application.



Article 10. Advisory staff.



1. the centres have specialist staff in animal welfare and animal health.
2. the person in charge of the health of animals is a veterinarian with additional specialized training in experimental animals.
3 the following functions will be assumed by the responsible animal welfare in both responsible for animal health: to) monitoring facilities, welfare, handling and care of animals, in order to detect any existing deficiency.



(b) if it decides at the end of a procedure that the animal is not sacrificed, monitor receive the care appropriate to its state of health under control of a specialist in animal health.

(c) in general, all the tasks of counselling in the field of animal welfare, in order to prevent at all times pain, suffering, distress or lasting harm to the animals.



Chapter III article 11 centres. Obligations of the centers.



1 providers centers may only obtain animals from breeding or supplying centres centres, unless the animal has been legally imported and is not wild or tramp, unless expressly authorized by the competent authority.
2. the centers users, whenever possible, should use livestock. However, can also use animals from facilities providers, another Center user that has given them as part of the scientific exchange or bred for use in their own facilities. In the latter case, shall comply with, the provisions of this Royal Decree for breeding centres. Will provide for the following exceptions: to) the animals of the species listed in annex VII only may be breeding animals, unless it is not possible to have these, and prior authorization from the competent authority.



(b) animals of species other than those listed in annex VII shall be breeding animals or well come from third-party providers establishments, unless that proves that it is not possible to have these, and prior authorization from the competent authority.



3 users centers will have the facilities and equipment appropriate for the species of animal used and for the implementation of the procedures there are carried out; their design, construction and operation should ensure that procedures may be executed with the greatest possible effectiveness, to produce results consistent with the lowest possible number of animals and occurs to animals and the minimum degree of pain, suffering, distress or lasting harm.



Article 12. Registration of breeding centers, providers and users.



1. the centres or private establishments, prior to the start of its operation, must be approved by the competent authority.
2. once obtained all permits, approvals or licenses required by the regulations, no new settlement will begin its activity without being registered and have received the corresponding identification code.
3. the centers or public establishments, prior to the start of its operation, shall be entered in the register approved.
4. There is created in the Ministry of agriculture, fisheries and food registration of suppliers breeding centres and users of animal experiments, of public and informative character, in which shall be entered directly every centre or establishment of State-owned.
5. the autonomous communities shall notify the Ministry data listed in annex VIII, referral centres provided for in paragraphs 1 and 2, for his transfer to such registration.



Article 13. Structure of the registry.



1. the registration of each of the centres will consist at least of the following data: name of the Centre; full address; the Center holder (name and, if applicable, company name and number of CIF / NIF); type of establishment (breeding, supplier, user); registration code; animals that are kept in it, and responsible.
2. you will be assigned a registration code to each centre which will consist of the letters «Is», that identifies to Spain, followed by a numeric code consisting of 12 characters, of which two correspond to the identification of the province, according to the coding of the National Institute of statistics; three, to the identification of the municipality, according to the coding of this Institute, and seven, the identification of the Center. This last code will identify the Center uniquely within the municipality.
3 when already is a settlement registered according to the Royal Decree 479/2004, of March 26, by which establishes and regulates the general register of livestock farms, will keep that registration code, but you must also be included in the register set out in article 12 of this Royal Decree.
4 units of those centres that are integrated by independent units each other physically, unless they have a functioning and independent organization will be registered as different centres.
5. when a centre attained activities of breeding, supplying or user of experimental animals, register each and every one of them, include although when a user facility breed animals for use in their own facilities, it is only necessary to register as a user facility, although it will also comply with all the requirements established in this Royal Decree for breeding centres.



Article 14. Registration in the register of the Ministry of agriculture, fisheries and food.



1. for registration in the register of the Ministry of agriculture, fisheries and food, responsible for State-owned centers must submit his claim to the Directorate General of livestock, accompanied by the documentation referred to in annex IX.
2. any modification of data that are registered, for expansions, reductions, transfers, staff changes or other circumstances, as well as in the case of suspension or cessation of the activity or change in ownership, shall be reported to the Ministry of agriculture, fisheries and food within a maximum of one month since it has been so that the corresponding amendment in the register is made.



Article 15. Database of centers of experimental animals.



For informational purposes, shall constitute a database of centres or establishments in the Ministry of agriculture, fisheries and food with the characteristics listed in annex X. This database is nutria communications involved in the autonomous communities and the Ministry itself and shall consist, for each Center, as a minimum, of the data referred to in annex VIII.



Chapter IV procedures article 16. General terms and conditions of the procedures.



1 a procedure shall be not if there are other method satisfactory and scientifically proven, that allow to obtain the desired result without involving the use of animals, except when required by the applicable regulations.
2. the procedures must be performed in such a way that they avoid the anguish and pain or unnecessary suffering to experimental animals.
3. in order to avoid unnecessary duplication of procedures that have the purpose to comply with national or Community legislation in the field of health and safety, the competent authorities should recognize, to the extent possible, the validity of the data obtained through the procedures carried out in the territory of the community, unless further testing is necessary for the protection of public health and safety.
4. the competent authorities should promote research into the development and confirmation of alternative techniques which can provide the same level of information as that obtained in procedures with animals, implying the use of fewer animals or which involve less painful procedures.
5 before the choice between different procedures, will be selected that allows more satisfactory results and that: to) use the lower number of animals.



(b) be done in animals belonging to species whose election has been carefully valued and whose degree of neurophysiological sensitivity is as short as possible.
(c) cause minor pain, suffering, distress or injury to animals.



6. the procedures may only be performed by competent persons, or under the direct responsibility of them, or when are authorized pursuant to the provisions of national legislation.



7. each procedure, for the purposes of the fulfilment of this Royal Decree, will have a single investigator.



Article 17. Prohibited procedures.



1 prohibited procedures involving animals considered endangered under Appendix I of the CITES and Annex A of Regulation (EC) No. 338/97 of the Council of 9 December 1996 on the protection of species of the wildlife through the control of its trade as well as those in the national catalogue of species threatened of law 4/1989, of 27 March, conservation of natural areas and wild flora and fauna, are catalogued as such, unless they conform to the abovementioned regulations and procedure objectives are the research aimed at the protection of the species concerned or essential biomedical purposes When proves that such species are exceptionally suitable only for such purposes, and prior authorization from the competent authority.
2. not may be performed procedures on animals captured in nature or vagabonds, except those made with other animals do not allow to achieve the objectives pursued by the procedure, and prior authorization from the competent authority. Stray cats and dogs may be used in any case.
3 procedures for the purpose of training and education carried out in non-higher education centres, unless it is essential according to the program of training concerned, and prior authorization from the competent authority may not be.



Article 18. Communication and authorization procedures.




1. all settlements users shall be obliged to inform the competent authority procedures which they intend to carry out.
2. to carry out the procedures referred to them in annex XI, will require the prior and express authorization of the competent authority.
3. for communication of the procedure must be presented to the competent authority the documentation listed in annex XII. The validity of the communication of the procedure will match the duration provided for in his memory with a maximum of three years, provided there are no relevant changes in the. The validity of this communication may be extended upon request of the Center user.
4. to obtain the approval of the procedure must be presented to the competent authority documentation that relates in annex XIII.
5. any relevant modification of the descriptive reports listed in annexes XII and XIII of the previously communicated procedures and, where appropriate, authorized shall be communicated to the competent authority. For this purpose, relevant modifications are considered: to) the increase in the number of animals that will 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 that are going to use non-protected species.
(d) the increase of the pain or suffering of the animal.
(e) changes in the place where he is expected to perform the procedure.
(f) that is given any circumstance listed in annex XI.



In the case of relevant modifications in memory of an authorized procedure, it will be necessary to request a new authorization by the competent authority to carry out the procedure.



6. the competent authority shall award a code identifying each of the procedures.
7 State-owned centres shall communicate and, where appropriate, will request the required authorization to the General direction of animal husbandry of the Ministry of agriculture, fishing and food.
8. in the case of authorisations for proceedings by the General Administration of the State, report on the procedure of the National Ethics Committee on animal welfare referred to in article 26 shall be mandatory.



Article 19. Place of performance of the procedures.



1. the procedures will take place in centres registered as users.
2 may be performed procedures outside these centres when its features justify this circumstance, and prior authorization from the competent authority.
3. when necessary for the legitimate purposes of the procedure, that the affected animal is released, provided that appropriate measures are taken to safeguard the welfare of the animals, insofar as permitted by their State of health, there is no danger to animal health, human health or the environment may be permitted , and prior authorization from the competent authority. In any case, when the procedure in which they are used have exclusively the purposes of teaching or training, the animals used may not be released.



Article 20. Anesthesia and analgesia during the procedure.



1 procedures should be performed under general or local anesthesia, unless you consider this: to) is more traumatic to 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 is mandatory.



2. If anaesthesia is not possible, use painkillers or other methods appropriate to ensure, to the extent possible, pain, suffering, distress or injury to be minimal, and, in any case, that the animal does not suffer pain, distress or suffering intense.



3. whenever it is compatible with the purposes of the procedure, where it is expected that an animal will suffer severe or prolonged pain after having recovered from the anesthesia, there will be enough so that it is treated in good time, with adequate means to minimize the pain, or, when this is not possible, it must immediately be sacrificed by humanitarian methods.
4. in any case, and provided that expected that the animal may suffer a serious or prolonged pain, will require the prior authorization of the procedure by the competent authority.
5. in no case an animal may be used more than once in procedures that involve severe pain, distress or equivalent suffering.



Article 21. End of the procedure.



1. at the end of any procedure, will decide if the animal must stay alive or must be sacrificed by a humanitarian method. In any case, not kept alive an animal if, despite having recovered health in all other respects, it is likely to suffer long-lasting pain or suffering. In this regard, such decisions will be taken by the veterinarian responsible for the health of the animals.
2 when at the end of a procedure: 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 4. The supervision of the veterinarian may be suspended when, in his opinion, the animal will not suffer as a result of such suspension.



(b) is necessary for the purposes of the procedure, without prejudice to the other provisions of this Royal Decree, the competent authority may authorize that an animal used in a procedure is returned to their usual environment, and appropriate measures shall be taken to safeguard their welfare, insofar as his health permitted and involves no danger either for the animal health or for public health or for the environment.
(c) Decides to not keep an animal alive, or this not to benefit from the conditions laid down in article 4 relating to their well-being, this must be sacrificed as soon as possible, through a humanitarian method. The disposal of carcasses and by-products, if any, will be held in accordance with the legislation in force.



3. in the case of animals of wild species, in particular endangered species, criteria relating to the disposition of animals set out in resolutions arising from the Convention on international trade in endangered species of wildlife with respect to decision-making on the maintenance in captivity, re-entry into the natural environment or the application of euthanasia to the animals at the end of the procedures shall be taken into account.



Chapter V article 22 animal welfare ethics committees. Creation of the ethics committees of animal welfare.



1. in centres users of State-owned, there will be an Ethics Committee of animal welfare (hereinafter 'the Committee'), which should ensure compliance with the provisions of article 11 and chapter IV.
2. the Committee shall provide itself with an internal regulation that would define and develop, in its scope, its members and its basic operation according to criteria of confidentiality and representativeness, and ensure impartiality in their decisions.



Article 23. Composition.



1. the Committee should be composed of a minimum of three people with the experience and knowledge necessary to ensure the welfare and care of animals. Member that, at a minimum, should be part of these committees shall be as follows: to) specialist in animal welfare from the Centre.



(b) a representative of the unit quality assurance Center, when there is, or, in their absence, a researcher at the Center not directly involved in the procedure which should inform.
(c) a person with expertise in animal welfare that does not have a direct relationship with the Center or the procedure concerned.



2. in any case, they must be constituted by persons other than the evaluated procedure.



3. the members shall respect the principle of confidentiality.
4. when appropriate, seek the advice of experts who do not belong to the Committee, which also respect the principle of confidentiality.



Article 24. Functions.



The functions of the Committee are as follows: to) report on the suitability of each procedure in relation to the objectives of the study, the possibility to reach valid conclusions with the lowest possible number of animals, the consideration of alternatives to the use of animals and the suitability of the selected species.



(b) inform that each procedure is carried out according to the specification notified or approved to annexes XII and XIII are concerned.
(c) report on the performance of the procedures, in particular to: 1. put the media so that animals do not suffer unnecessarily and so are you provided, when necessary, analgesics, anesthetics, or other methods aimed at eliminating the maximum pain, suffering or distress.



2 methods used for euthanasia appropriate to the animal species and the procedure to be performed.
3. the staff involved in the procedures have adequate training to carry out tasks that are entrusted.



Article 25. Exemption from the creation of committees.



1. the exceptional cases that can be exempt from the creation of these committees shall be established by the General Directorate for livestock.
2. in exempt centers of the creation of the Committee, the functions set out in article 24 shall be undertaken by a Committee recognized by the competent authority.



Article 26. State Ethics Commission of animal welfare.




1. for State-owned centers, will create the State Ethics Commission of animal welfare (hereinafter 'the Commission') as an advisory body in matters of well-being of the animals used for experimentation and other scientific purposes, attached to the Ministry of agriculture, fisheries and food.
2 the Committee shall have the functions of: to) inform in relation to applications for authorization of procedures.



(b) information concerning the requests for exemption from the obligation to establish committees.
(c) advising centers users for compliance with these rules, especially on alternative methods and techniques that avoid repetitive or repetitive procedures.
(d) Act as an advisory body.



3 the Commission shall be composed of the following members: to) President: the General Director of animal husbandry of the Ministry of agriculture, fisheries and food.



(b) first Vice-President: the Director-General of research of the Ministry of education and science.
(c) second Vice-President: the Director-General of Pharmacy and health products of the Ministry of health and consumption.
(d) Secretary: the Chief of service of welfare Animal of the direction General of livestock of the Ministry of agriculture, fisheries and food.
(e) vocal: 1st seven members representing the General Administration of the State, belonging to the following ministries: one on behalf of the Ministry of industry, tourism and trade, with the rank of Assistant Director-general.



One on behalf of the Ministry of agriculture, fisheries and food, with the rank of Assistant Director-general.
One on behalf of the Ministry of health and Consumer Affairs, with the rank of Assistant Director-general.
Two on behalf of the Ministry of education and science, with the rank of Assistant Director-general.
Two on behalf of the Ministry of environment, with the rank of Assistant Director-general.



These vowels shall be designated by the Undersecretary of the Department, and, in case of absence or illness and, in general, when any if other just cause, may be replaced by another person at the service of the unit which depend on, that will be designated in the same way.
2. A vocal representative of national non-governmental organizations which have as one of its main objectives the defence of animal welfare, appointed by the President of the Commission and a proposal from these.



3rd a vocal representative of the professional associations specialized in animals used for experimental and other scientific purposes, appointed by the President of the Commission and a proposal from these.
4th a vocal representative of the General Council of veterinary schools of Spain.



4 they may attend with voice but without vote, representatives of the sectors concerned and the autonomous communities. Upon invitation, when deemed necessary, may also attend independent experts.



5. you may create specific working groups with specific functions.
6. the Commission shall adopt its rules of operation.
7. the Committee shall meet at least every three months.
8. without prejudice to the characteristics provided for in this Royal Decree, the Commission will accommodate its operation to the regime envisaged for the organs members in chapter II of title II of law 30/1992, of 26 November, legal regime of public administrations and common administrative procedure.



Chapter VI supply of information and controls article 27. Provision of information.



1. for the purposes of its communication to the European Commission, centers users must communicate to the competent authority the procedures performed, the species and the number of animals used in each one of them, deadlines and form that establishes the competent authority for each Center. By autonomous communities, such information will be forwarded to the General direction of animal husbandry of the Ministry of agriculture, fishing and food before 31 March of each year with information relating to the previous year, so that by this transfer the same to the European Commission through the corresponding runway.
2 State-owned centers, the communication referred to in paragraph 1 shall be carried out before March 31 of each year with information relating to the previous year.
3 on the basis of requests for authorization and notifications received, and according to the reports, the competent authority will pick up and, to the extent practicable, shall periodically publish statistical information on the use of animals in procedures with respect to the: to) number and species of animals used in procedures.



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



4. the competent authorities shall take all necessary measures to ensure the protection of the confidential nature of the information that a particular commercial interest to communicate in accordance with this Royal Decree.



Article 28. Controls.



1. the control of the compliance with the rules contained in this Royal Decree shall be made by the competent authority; to do so, perform accurate periodic inspections and shall forward to the General direction of animal husbandry of the Ministry of agriculture, fishing and food, before 31 March of each year, a report on the results of inspections carried out the previous year.
2. these inspections, which may be carried out on the occasion of checks made for other purposes, shall be made annually on statistically representative samples of existing centres in the territory of each autonomous community.
3. each Ministry, in the scope of their powers, will prepare an annual plan of controls based on a risk analysis, which may include the determination of the size of the sample which shall be subject to inspection in each autonomous community, as well as the basic criteria for the choice of the sample and, if necessary with the autonomous communities , the list of centres that will be inspected.
4. in the design of the inspection plan, will pay special attention to exempt centers from the obligation of having an own Committee.



Provision additional unique. Human and material resources.



The creation and the operation of the register of breeding centers, providers and users and the State Ethics Commission of animal welfare will be assisted with the human and material resources in the Ministry of agriculture, fisheries and food, without involving increased public expenditure.



First transitional provision. Centers registered in accordance with the Royal Decree 223/1988, of 14 March.



Registered centres to the dispositions in the Royal Decree 223/1988, of 14 March, which are in operation, must communicate the necessary information according to the provisions of this Royal Decree to the competent authority, within a period not exceeding six months, which will adapt the inscriptions records provisions of this Royal Decree.



Second transitional provision. Procedures in processing.



Provisions of article 18 on records of notification and/or approval of the procedures that are in processing or processed within the period of six months from the entry into force of this Royal Decree can be processed in accordance with the Royal Decree 223/1988, of 14 March.



Third transitional provision. Approval of the training.



However under article 9(1), the competent authority may decide, at the request of the person concerned, which must be presented within the six months following the publication of this Decree in the «Official Gazette», waive the possession of the degree corresponding to staff that proved enough come carrying out the tasks and functions provided for in article 9(1) and in annex I for the following periods of time (, according to each category: to) staff category A: two years before the entry into force of this Royal Decree.



(b) category B: staff five years before the entry into force of this Royal Decree.
(c) personal category C: 10 years before the entry into force of this Royal Decree.
(d) personal category D: 10 years before the entry into force of this Royal Decree.



Once granted that derogation, it shall have permanent effects throughout the national territory and shall entitle the applicant to perform the duties corresponding to the category concerned in all Spain.



Sole repeal provision. Repeal legislation.



Are hereby repealed many rules of equal or lower rank is contrary to the provisions of this Royal Decree and, specifically, the Royal Decree 223/1988, of 14 March, on protection of animals used for experimental and other scientific purposes, and the order of 13 October 1989, that establish the norms of registration of the breeding suppliers and users of State-owned experimental animals, as well as the authorization for use of animals in experiments, developing of the Royal Decree 223/1988, of 14 March.



First final provision. Basic character and competence title.



This Royal Decree is basic and is run under the protection of exclusive competences recognised to the State by the Constitution in its article 149.1.13. 2nd in terms of bases and coordination of the general planning of economic activity, and in article 149.1.16. ª in bases and general coordination of the health.




Second final provision. Faculty Development and modification.



1 it allows the Ministers of agriculture, fisheries and food and of education and science to dictate, in the scope of their powers, the provisions necessary for the development and implementation of this Royal Decree and, in particular, to modify the annexes to its adaptation to Community rules or for urgent reasons of protection of animals.
2. specifically, it empowers the Minister of education and science to establish the training of competent personnel to work in the centres.



Third final provision. Entry into force.



This Royal Decree shall enter into force one month after its publication in the "Official Gazette of the State», except for chapter V, that will make it six months after its publication.



Given in Madrid on 10 October 2005.



JUAN CARLOS R.



The first Vice-President of the Government and Minister of the Presidency, MARÍA TERESA FERNÁNDEZ DE LA VEGA SANZ annex I competent personnel to work in the centres are defined four occupational categories, which are classified in the following way: A. personnel category A: personal care of the animals. The programmes for this category shall include as a minimum: 1. basic concepts relating to the ethical and regulatory aspects of the care provided to experimental animals.



2 handling and maintenance of animals: to) environment, equipment, cages and accessories in animal facilities: description, use and maintenance.



(b) handling and containment of animals.
(c) basic knowledge about methods of humanitarian euthanasia of the affected species.
(d) General elements of Physiology and behavior of animals used for experimental purposes.
(e) maintenance of the animals and, if necessary, breeding of these.
(f) verification of the environmental conditions in the animal facilities.



3 recognition of the State of health and diseases: to) hygiene and disease control.



(b) elements of general physiology and behavior of animals used for experimental purposes.



4. recognition of the pain, suffering and anguish.



5. regulations concerning security, administration, transportation, reception, sourcing of animals and the disposal of corpses.
6. specific training, if necessary, for all work of assistance during the proceedings.



B. staff of the category B: personal carrying out procedures. The programmes for this category shall include as a minimum: 1. basic knowledge appropriate about the keeping of the animals and the rules on security, administration, transport, reception and the supply of animals and the removal of corpses.



2. basic concepts relating to the ethical and regulatory aspects of the care provided to experimental animals.
3 handling and basic principles of the maintenance of the animals: a) biological characteristics, in particular, physiological and behavior, species, breeds and lines of the animals, in accordance with the tasks that are going to meet.



(b) handling 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 monitoring of the State of health and diseases.



5. implications of the microbiological status of animals.
6. recognition of pain, suffering, and anguish.
7. training appropriate for the performance of the procedures. En_la_medida_en_que it is necessary for the tasks they will perform: to) appreciation of the elements to be taken into account from the design of a procedure, including the refinement, reduction and replacement.



(b) importance of the accommodation and the immediate environment of animals for the procedures.
(c) the anatomy of animals used for experimental purposes.
(d) anaesthesia, analgesia and appreciation of the need to put an end to the procedure to reduce as much as possible the suffering of the animal.
(e) appropriate techniques and surgical interventions.



The programme of training of the staff of category B must be an important practical component, this last aspect that will take place under the supervision of a person with extensive experience in the studied aspects.
C. staff of category c staff responsible for directing or designing procedures. Shall be considered that the scientists responsible for the design and handling proceedings are competent when: 1. are graduates with level equivalent to a Bachelor's degree in a discipline such as biology (animal), medicine, veterinary medicine or other discipline with proper training in zoology, Anatomy and physiology.



2 participated in a basic course on the science of laboratory animals, in order to develop a level of responsibility appropriate for the use of animals in accordance with scientific standards of high level, whose program includes as a minimum: a) legislation and ethical aspects.



(b) biology and maintenance of experimental animals.
(c) microbiology and diseases.
(d) design of procedures with animals.
(e) anaesthesia, analgesia and experimental procedures.
(f) alternatives to the use of animals.
(g) analysis of the appropriate scientific literature.



D. category D: staff specialist staff in Sciences of the animal experimentation with functions of advice on the welfare of animals.



1. personal animal welfare specialist: person with a university degree in the area of Health Sciences, responsible for overseeing and advising all aspects related to the welfare of the animals.
2. personal animal health specialist: person a degree in veterinary medicine with complementary training specializing in experimental animals, responsible for overseeing and advising all aspects related to the health of animals.



Annex II guidelines relating to the accommodation of the animals 1. Facilities.



1.1 functions and overall project.
1.1.1. the facilities will be built in such a way that they provide a suitable environment for the species housed in them and will be designed to prevent access by unauthorized persons.



1.1.2. the installations that form part of one greater building shall be protected by building regulations and provisions that limit the number of accesses and prevent unauthorised circulation.
1.1.3 the existence of a facilities maintenance program. it is recommended to avoid any failure of your equipment.



1.2 local accommodation.



1.2.1 will be taken all appropriate measures to ensure regular and effective cleaning of premises, as well as the maintenance of a satisfactory hygienic level. The ceilings and walls will be tough, with smooth, waterproof and easily washable surfaces. Special attention will be paid to joints with doors, ducts, pipes and cables. Doors and windows, if any, will be constructed or protected in such a way that they prevent access by animals outside the establishment. Floors shall be smooth, impervious, not sliding, easily washable and will support the weight of the shelves or other heavy materials. In the event that there are sinks, they are covered properly and have a barrier that prevents the access of animals outside the Centre.



1.2.2. the areas where animals move freely will have walls and floors with a particularly resistant coating to withstand the heavy wear caused by these and cleaning operations. This material will not be detrimental to the health of the animals or which may cause injury to the animals. Sinks are recommended in these areas. Equipment and accessories must be protected especially to prevent animals spoil them or hurt them.
1.2.3. the premises intended for the accommodation of experimental farm animals (cattle, sheep, goats, pigs, horses, poultry, etc.) shall comply with the regulations in force concerning farm animals.
1.2.4. not together incompatible species will stay.
1.2.5. the premises of accommodation may provide facilities to perform procedures or manipulations under, in their case.



1.3 laboratories and premises of experimentation for General and special purposes.



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



1.3.2. all establishments will have, at least, facilities for testing simple diagnosis, necropsies, or collection of samples for more extensive research.
1.3.3 steps should be taken to the reception of the animals for the establishment of quarantine.
1.3.4 will dispose of local experimentation with General and special purposes, provided that it is not convenient perform procedures or observations in the local accommodation.
1.3.5 will be available of premises to accommodate separate sick or injured animals.
1.3.6 is available, where appropriate, of one or more rooms suitably equipped for surgical experiments under aseptic conditions. It is also desirable to have facilities for the postoperative period when necessary.



1.4 local service.



1.4.1. the premises for the storage of food or beds should be cool, dry, and resistant parasites and insects. Other materials which may be contaminated or present danger should be stored in a different location.




1.4.2 will have premises for storage cages, instruments and any other clean material.
1.4.3. the premises of cleaning and washing will be large enough to accommodate the installations necessary to decontaminate and clean used material. The cleaning process should be organized so that separate circuit clean dirty material material, to prevent contamination of the newly cleaned material. Walls and floors should be covered with a suitable waterproof material and the ventilation system should have sufficient capacity to remove excess heat and humidity.
1.4.4. you shall take measures for the storage and disposal of dead bodies and waste of animals under satisfactory hygienic conditions. Measures for the Elimination of such remains shall be taken with security guarantees and in accordance with the regulations in force. It shall take special precautions with very toxic or radioactive waste.
1.4.5. the design and construction of circulation areas adapt to the standards established for the premises of accommodation. It is recommended that aisles are pretty wide to allow easy circulation of rolling-stock.



2. environmental conditions on the premises of accommodation and its control.



2.1 ventilation.
2.1.1. the premises of accommodation will have a proper ventilation system that meets the requirements of the species housed. The ventilation system aims to provide clean air and keep under the level of odours, harmful gases, dust and any infectious agents. It will also eliminate excess heat and humidity.



2.1.2. the air in the room will be renewed at frequent intervals. Under normal conditions the ventilation system should be 15 to 20 air renewals per hour.
2.1.3. the ventilation system will be screened so as to prevent air currents.



2.2 temperature.



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



2.2.2 there will be an air conditioning system that is able to both heat and cool the air supplied.
2.2.3. in establishments users is necessary the precise accommodation premises temperature control, because the ambient temperature is a physical factor that profoundly affects the metabolism of all animals.



2.3 moisture.



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



2.4 lighting.



In premises which are devoid of windows, it is necessary to have a system of controlled lighting both for biological animal needs to provide a satisfactory working environment. It is also necessary to control the intensity and light-dark cycle.



2.5 noise.



Noise can be an important cause of discomfort to the animals. Local accommodation and experimentation must be insulated foci of sounds of audible and higher frequencies, in order to avoid disturbances in behaviour and the physiology of animals.



2.6. alarm systems.



2.6.1. when the health and well-being of animals dependent on an artificial system, appropriate emergency systems that guarantee the maintenance of the appropriate environmental conditions must be provided, and you need to have with alarm systems that warn in case of breakdown.



2.6.2 both alarm systems and emergency should be reviewed regularly, and will keep a record of such revisions.
2.6.3 there will be clear instructions, exposed in a visible location, alarm and emergency procedures.
2.6.4 will ensure the functioning of systems to disturb as little as possible to animals.



3 caged.



3.1. in tables 2 to 12 are the guidelines suggested for cages, enclosures, corrals and stables.



3.2. in figures 1 to 7 are supplementary indications on the minimum size of the cages.
3.3 figures 8 to 12, presents the corresponding signs for the estimation of the level of occupation of the cages.
3.4. the cages and enclosures must be non-harmful materials for the health of the animals.
3.5. be screened so that animals could not injure, and unless they are disposable, resistant to cleaning and decontamination materials.
3.6. the floors of cages and enclosures shall be appropriate to the species and age of the animals and will be projected in such a way that it facilitate the removal of excreta.
3.7. be designed fences bearing in mind the welfare of the animals. Allow the satisfaction of certain Ethological needs (for example, the need to climb, hide or shelter temporarily) and to facilitate cleaning, avoiding, in addition, contact with other animals when it deems necessary should.




TABLE 1 guidelines for ambient temperature (animals housed in cages or enclosures) species or groups of species optimum area in ° C Primates of the new world nonhuman 20-28 mouse 20-24 rat 20-24 Syrian Hamster 20-24 gerbil 20-24 Guinea pig 20-24 Primates of the old world nonhuman 20-24 quail 20-24 rabbit 15-21 cat 15-21 dog 15-21 15-21 15-21 Paloma poultry Huron





15-21 swine 10-24 Caprina 10-24 lamb 10-24 Bovina 10-24 Caballar 10-24 Note: in special cases, for example, when it comes to very young animals or without hair, can be necessary temperatures exceeding the specified environment.











TABLE 2 guidelines for the caged small rodents and rabbits (in reserve and during procedures) species minimum area of the floor of the cage in cm2 minimum height from cm 180 12 350 14 Syrian Hamster rat mouse cage 180 12 Guinea pig 600 18 Rabbit 1 1,400 30 rabbit 2 2,000 30 rabbit 3 kg kg kg 2500 35 rabbit 4 kg 3,000 40 rabbit 5 4 3600 kg 0 Note: «cage height» means the vertical distance between the floor of the cage and the upper horizontal part of the lid or cage.











Planning procedures, should take into account the potential growth of the animals, to always have sufficient space according to this table in all phases of experimentation.
See also figures 1 to 5 and 8 to 12.




TABLE 3 guidelines for the caged in small rodents during breeding species minimum surface of the floor of the cage by mother and their offspring in cm2 minimum height in cm mouse cage...

Rata . . . . . . . . . . . . . . . . . . . .

Hámster . . . . . . . . . . . . . . . .

Cobaya . . . . . . . . . . . . . . . . .





200 800 6,500 1,200 12 14 12 18 Guinea pig in communities. .





1,000 per adult 18 Note: see the note in table 2 for the definition of «cage height».



TABLE 4 guidelines for the caged rabbits for breeding weight of the DOE kg minimum surface of the floor of the cage by DOE and their offspring in m2 minimum height of cage in cm minimum from the nest in 1 m2 soil surface of 0.30 30 0.1 2 0.35 30 0.1 3 0.40 35 0.12 4 0.45 40 0.12 5






0.50 40 0.14 Note: for the definition of «cage height» see note in table 2.



The minimum area of the floor of the cage by DOE and their offspring includes the surface of the floor of the nest.
See also Figure 6.




TABLE 5 guidelines for housing of cats (during procedures and breeding) weight of the cat in kg minimum area of the floor of the cage by cat in m2 minimum height of cage in cm minimum from the floor of the cage by gata and its offspring in m2 minimum surface area of the soil of fencing by gata and its offspring in m2 0.5 - 1 0.2 50 - 1-3 0.3 50 0.58 2 3 - 4 0.4 50 0.58





2 4-5 0.6 50 0.58 2 Note: the accommodation of cats should be limited to the minimum in cages. Cats confined in this way should leave to exercise at least once per day, provided that this not difficult procedure. It is advisable that the fencing for cats are fitted with trays for bowel movements, of ample space on shelves to rest and objects that allow climbing and sharpened claws.
«Cage height» means the distance between the highest point of the ground and the lowest point of the roof of the cage.
The area of shelves may be included when calculating the minimum area of land. The minimum area of the floor of the cage by gata and its offspring includes the surface of 0,18 m2 of the case for deliveries.
See also Figure 7.




TABLE 6 guidelines for housing dogs in cages (during the performance of the procedures) height of the dog at the level of the cross in cm minimum surface of the floor of the cage by dog in m2 minimum height of cage in 30-70-75 cm 0.75 1.00 1.75 60 60 140 Note: dogs should only remain in cages the time strictly necessary for the purposes of the procedure. We recommend releasing the caged dogs to make exercise once a day, provided that this is not incompatible with the purpose of the procedure. It is recommended to limit the detention of dogs without providing daily exercise. It is interesting that the zones for the exercise are large enough so that the dog has freedom of movement. He is not recommended to use grid floors in the cages of dogs, unless required by the procedure.
Taking into account the differences in height and the little relationship between height and weight in different breeds of dogs, the height of the cage should be based on the height of the body at the level of the cross of the animal. As a general rule, it is recommended that the minimum height of the cage is double with respect to the height of the cross.
For the definition of «cage height» see note in table 5.




TABLE 7 guidelines for housing dogs in enclosures (in reserve and during experiments and breeding) weight dog kg minimum surface of fencing by dog in m2 adjacent minimum area for exercise by dog up to three dogs per m2 more than three dogs per m2 < 6 6 - 10 10 10-20-20 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 : figures in parentheses indicate the total area per dog, i.e., the surface of the soil of fencing more adjacent surface to exercise. The dogs housed permanently outdoors should have access to a covered place to protect from the elements. When dogs are housed on grid flooring, it is advisable that you have a smooth surface to sleep. Using grid floors unless required by the procedure is not recommended. Divisions between fences will prevent dogs to injure each other.
The fences will have a proper drainage system.



TABLE 8 guidelines for the accommodation of non-human primates (in reserve and during procedures and breeding) preliminary note: due to the great diversity of sizes and characteristics of primates, it is particularly important to adapt the shape and internal accessories as well as the dimensions of their cages to their particular needs. The total volume of the cage is as important to primates as the surface of the soil. As a general principle, the height should be the greatest dimension of the cage, at least for the anthropomorphs and other apes. The cages will be high enough at least so that the animal can stand up. It is recommended that the minimum height of the cage for animals that move suspended sufficient so they can balance extended completely unless they come to touch the floor of the cage with his feet. Where appropriate, spars shall be provided so that primates can use the top of the cage.



Two compatible primates may stay in the same cage. When they can not be put in pairs, it is convenient to place the cages so they can see each other, but also to be able to avoid it when necessary.
Taking into account these observations, the following table provides a general orientation to the caged in groups of species most commonly used (superfamilies «Ceboidea» and «Cercopitheoidea»).




Primate in kg minimum surface of the floor of the cage for one or two animals in m2 minimum height of cage in cm weight < 1 1 1-3-3 3-5 5-7 5-7 7-9 9 9-15-15 15-25 0.25 0.35 0.50 0.70 0.90 1.10 1.50 60 75 80 85 90 125 125 Note: for the definition of «cage height» see note in table 5.




TABLE 9 guidelines for the caged of pigs (in reserve and during experimentation) weight of the pig in kg minimum cage floor area per pig m2 minimum height of cage in 5-15 5-15 15-25 cm 25-40 0.35 0.55 0.80 50 60 80 Note: this table would also apply to piglets. He is not recommended to keep the caged pigs unless it is essential for the purpose of the procedure and in this case only for the minimum time.



For the definition of «cage height» see note in table 5.


Table 10 guidelines for housing farm animals in enclosures (in reserve and during experimentation in user establishments) species and in kg minimum surface area of the soil of fencing in m2 minimum length of fencing in m minimum height of the divisions of fencing in m minimum surface from the soil of fencing for groups in m2 per animal minimum length of trough per head in m swine 10 - 30 2 1.6 0.8 0.2 0.20 swine 30 - 50





2





1,8





1,0





0,3





0,25






Porcina 50 - 100





3





2,1





1,2





0,8





0,30






Porcina 100 - 150





5





2,5





1,4





1,2





0,35






Porcina > 150





5





2,5





1,4





2,5





0,40






Ovina < 70





1,4





1,8





1,2





0,7





0,35






Caprina < 70





1,6





1,8





2,0





0,8





0,35






Bovina < 60





2,0





1,1





1,0





0,8





0.30 Bovina 60-100 2.2






1.8 1.0 1.0 0.30 Bovina 100-150 2.4 1.8 1.0 1.2 0.35 Bovina 150-200 2.5 2.0 1.2 1.4 0.40 Bovina 200-400 2.6 2.2 1.4 1.6 0.55 Bovina > 400 2.8 2.2 1.4 1.8 0.65 Caballar (adults) 13.5 4.5 1.8 - table 11 guidelines for housing farm animals in compartments (in reserve and for experimentation in the estab lecimientos users) species and in kg minimum surface of the compartment in m 2 minimum length of compartment in m minimum height of the divisions of the compartments in swine 100-150 m 1.2 2.0 0.9 > 150 2.5 2.5 1.4 lamb < 70 0.7 1.0 0.9 Caprina < 70 0.8 1.0 0.9 Bovina 60-100 0.6 1.0 0.9 100-150 0.9 1.4 0.9






150-200 1.2 1.6 1.4 200-350 1.8 1.8 1.4 350-500 2.1 1.9 1.4 > 500 2.6 2.2 1.4 Caballar (adults) 4.0 2.5 1.6 Note: agrees that compartments are wide enough so that the animal can lie down comfortably.












TABLE 12 guidelines for the caged bird (in reserve and during experimentation in user establishments) species and weights g minimum area per bird in cm2 minimum for two birds in cm2 per bird minimum area for three or more birds in cm2 per bird minimum height of cage in cm minimum length of trough per bird in cm chickens 100-300 250 200 150 25 3 300-600 500 400 300 35 7 600-1,200





1,000 600 450 45 10 1,200-1,800 1,200 700 550 45 12 1,800-2,400 1,400 850 650 45 12 (adult males) > 2,400 1,800 1,200 1,000 60 15 quail 120 - 140 350 250 200 15 4 Note: 'surface' means the product of the length by the width of the cage measures horizontally on the inside, and not the product of the length by the width of the floor.

For the definition of «cage height» see note in table 5.

The openings of the mesh grid floors will not exceed 10 x 10 mm for chicks, and 25 x 25 mm for older children and adults chickens. The thickness of the wire should be at least 2 mm. The inclination of the ground should not exceed 14% (8 °). It is advisable that drinkers have the same length as the feeders. If with nipple drinkers or cups are used, it is convenient that every bird has access to two. It is appropriate that cages are equipped with perches and allow birds housed in individual cages to see each other.











Here are several images in the original. See the PDF document of this provision.


Annex III guidelines relating to the care of animals 1. Screenshot: The wild animals will be captured only by humanitarian methods and with the intervention of experts who have a deep knowledge of the habits and habitat of animals that want to catch. If I had to use an Anaesthetic or any other drug in the capture operation, a veterinarian will administer it. Any animal that was seriously injured must be submitted as soon as possible to the care of a veterinarian. If, in the opinion of the veterinarian, the animal can only continue living with suffering or injury, it should be immediately sacrifice it for a humanitarian method. In the absence of veterinarian, any animal that suffers serious injury is suitable to immediately sacrifice it for a humanitarian method.



2 reception and unpacking.



2.1. will they be received and unpacked consignments of animals by avoiding any delay.



2.2 after inspecting them, will be staying to animals in cages or enclosures clean and given food and water according to their needs.
2.3 will keep animals that are sick or ill for any reason in observation and apart from the others.
2.4. a veterinarian will examine them as soon as possible and, if necessary, try them.
2.5. animals that have no chance of recovery will be immediately killed by a humanitarian method.
2.6. all received animals will be identified and registered in accordance with the regulations.
2.7. the boxes used to transport, if not you can decontaminate properly, will be destroyed immediately.



3 quarantine, isolation and acclimatization.



3.1 will be available in separate facilities to isolate animals who have symptoms or be suspected of ill-health, can represent a danger for man or other animals.



3.2. even when the animals present good health, is suitable to undergo a period of acclimatisation prior to use in a procedure (see table 1). The time required depends on several factors, such as stress which has been subjected to the animal, which in turn depends on several factors, such as the duration of the transport and the age of the animal. A competent person shall decide the duration of that period.



4 power.



4.1 food processing shall be subject to the regulations in force. Feeders, troughs and other utensils used for feeding be cleaned so regular and, where appropriate, they must be sterilised. If you use moist foods or they are easily contaminated with water, urine, etc., daily cleaning will be necessary.



4.2 Although the food distribution process may vary depending on the species, it should be in such a way that it meets the physiological needs of the animal. All animals have access to food.



5. water.



5.1. all animals will always have clean drinking water.



5.2. the bottles will be transparent material to allow control of your content. It is important that they are wide mouth for easy cleaning and, if plastic is used, they will not release soluble substances. Caps, plugs and pipes will be Sterilizable and easy to clean. The bottles and accessories shall be removable and are cleaned and sterilized at regular intervals.
5.3 automatic drinking systems be controlled, reviewed and cleaned regularly to avoid accidents and the spread of infections. If smooth soil cages are used, you should take steps to reduce the risk of flooding. Regular bacteriological monitoring of the system is also necessary to ensure the quality of the water.
5.4. water from the public network contains microorganisms that are generally considered harmless, unless you are working with animals of microbiological definition. In these cases would have to treat the water. Public supply water is usually chlorinated to reduce the growth of microorganisms. Such chlorination not always enough to prevent the growth of certain potential pathogens, as, for example, the «Pseudomonas spp.'. As a complementary measure, it should be raise the level of chlorine from the water or make it to get the desired effect.

5.5. in fish, amphibians and reptiles, tolerance to acidity, chlorine and many other chemical substances varies widely according to the species. It is therefore necessary to take measures to adapt the water of aquariums and nurseries supply the needs and tolerances of each species.



6 bed: The bed will be absorbent, dust-free, non-toxic and free of infectious agents, parasites or any other form of contamination. It will be especially careful to avoid the use of sawdust or other bed material derived from chemically-treated lumber.



7 exercise and manipulation.



7.1 any chance will take advantage to make the animals exercise.



7.2. the behavior of an animal during a procedure depends largely on your confidence in people that need to be developed. It is recommended to keep frequent contacts animals become accustomed to the presence and human activity.



8. cleaning.



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



8.2 will be established an appropriate programme for the cleaning, washing, decontamination and, where necessary, sterilization of bottles, cages, accessories and any other material. It is also important to maintain a high degree of cleanliness and order on the premises of accommodation, washing and storage.
8.3. the material that covers the floor of the cages, enclosures and pens will be renewed periodically to avoid that they become a focus of infection or infestation by parasites.



9. with humanitarian methods of animal sacrifice.



9.1. all human method of slaughter of animals requires knowledge that only can be purchased through adequate training.



9.2 the removal of corpses. not be allowed until rigor mortis occurrence.



Table 1 species days mouse 5-15 rat 5-15 gerbil 5-15 Guinea pig 5-15 Syrian Hamster 5-15 rabbit 20-30 cat dog 20-30-40-60 non-human Primates 20-30 Annex IV data minimum to enter in the movement document issued by the animal health specialist to) sender: name of its owner, number of registration and address.



(b) recipient: name of school, address and registration number.
(c) place of loading, or place of capture in the case of wild animals.
(d) means of transport and identification of this type.
(e) carrier, with specification of your authorization number for the transport of live animals.
(f) species transported.
(g) number of animals.
(h) individual identification, if appropriate.
(i) State health of animals subject to transfer, in accordance with the regulations affecting the species moved.
(j) the name, surname, number of the national identity document and signature of the specialist in animal health that extends the document.
(k) date.
l) if it's wild animals, indicate the permission of capture of the competent authority.
((m) will indicate if they are animals of exception according to article 3.1. b) 2 of the Royal Decree 1041 / 1997 of 27 June, is establishing the rules concerning the protection of animals during transport.
(n) justification of the assumptions of article 5.4, if any.
(n) the cause of the exception, description of the situation, instructions for use and care during transport.
(o) date and time of the load.
(p) the estimated duration of the transport.
q) day and estimated time of discharge.



Annex V data minimum for identification in cages or containment systems to) species.
(b) race (in your case).
(c) strain (in your case).
(d) sex.
(e) date of birth.
(f) date of crossing (if couples).
(g) number of animals.
(h) in the centers users, where appropriate, research manager of the procedure in which they are being used animals, Department to which it is attached and identification code of the procedure.
(i) observations.



Annex VI data minimum from the book of registration of animals in the centres all centres must keep a record of animals in which the following data should be noted: a) the name and the registration number of the Centre.



(b) the number of animals present in the Centre at the time of open this log, indicating the species or species to which they belong.
(c) the entries of the animal, the date in which they are produced, indicating the species, births and purchases, stating its origin (with mention of the name and address of the breeder or supplier).
(d) outputs of the animals date as they occur, the species, stating its recipient (with mention of the name and address of the recipient).
(e) animals slaughtered or killed not used in procedures, and its causes, and, where appropriate, the method of slaughter used.
(f) animals used in procedures, indicating to which procedure are intended.
(g) the observations made during the period of quarantine for animals coming from the outside of the Center.
(h) the results of medical tests carried out the animals.
(i) the results of the necropsies performed.
(j) cases of disease and administered treatments.
(k) in the case of animals bred, supplied or used in procedures, species in which is statutorily established, it shall contain the individual identification of each animal.
l) shall set forth the data concerning the origin and the individual identification of dogs, cats and non-human primates.
(m) in the centers that bred livestock animals for which the existence and maintenance of a log book is required, shall apply the regulations in force in this area.



Annex VII list of animal species to which apply the provisions of article 15 mouse: «Mus musculus ".



Rat: "Rattus norvegicus".
Guinea pig: «Cavia porcellus».
Golden Hamster: «Mesocricetus auratus».
Rabbit: «Oryctolagus cuniculus ".
Non-human primates.
Dog: "Canis familiaris".
Jack: "Felis catus".
Quail: «Coturnix coturnix».



Annex VIII data minimum of centres enrolled in the national database of centers of experimental animals to) registration number.



(b) the name of the establishment.
(c) full address.
(d) number of phone, fax No., e-mail address.
(e) type of establishment.
(f) animal species present in the establishment.
(g) the head of the Center (physical or legal person).



Annex IX minimum documentation required for the registration of the centers in the register 1. Application containing the following information: a) name of the Centre.



(b) full address.
(c) owner of the Center, name and, if applicable, company name and tax identification number or tax identification code number.
(d) type of establishment (breeding, supplier or user).



2 report that contains, as a minimum: a) descriptive report and drawing or sketch of situation, distribution structures, installations and units, as well as capacity in number of animals and activities that it is expected that they will develop.



(b) hygiene program which provides all the control measures established by the regulations in force.
(c) specification of the fundamental aspects of the procedures that will be carried out, species and number of animals which are bred, they supply or use.
(d) technical and medical reports. The health report will be signed by the specialist in animal health.
(e) identification of the administrative head of the Center.
(f) identification of the person responsible for the welfare of the animals.
(g) identification of the veterinarian responsible for the health of the animals.
(h) list of qualified personnel, with specification of their training, certification and experience. Centers University users and public research centres, the ratio of staff to care for the animals, the specialist staff in animal welfare and animal health specialist shall only be recorded.
i) when a Center is State-owned user, shall be recorded, in addition, the composition of the Committee.



Annex X features of the registry unit responsible for the Declaration and registration of the file: address General of animal husbandry of the Ministry of agriculture, fisheries and food.



Purpose: registration of providers establishments breeding and users of laboratory animals, in accordance with the provisions of Directive 86/609/EEC of the Council of 24 November 1986.
Applications: control, by the competent authority, in compliance with current regulations.
People and groups affected: all supplier Center, breeding or user of experimental animals which lies in Spain.
Data collection procedures: will be provided by the person concerned before the competent bodies of the competent authorities.
Basic structure of the file and description of the types of personal information contained in it: call sign data of the person responsible, the person or persons specialists in animal welfare or animal health: name, national document of identity formation.
Transfers of data of a personal nature and international data transfers: to the autonomous communities in the field of its competences.

Responsible authority: Directorate General of animal husbandry of the Ministry of agriculture, fisheries and food and autonomous communities.
Body to which the rights of access, rectification and cancellation can be exercised: competent authorities referred to in the 3rd article).
Safety with indication of the required level: basic level.



Annex XI procedures that need prior written authorization by the competent authority to) the use of animals of the species listed in annex VII were not born nor have expressly been servants in officially approved centres.



(b) the use of animals of the species not listed in annex VII which do not come from breeding or supply centers.
(c) the execution of procedures outside the users.
(d) the release of animals during the procedure.
(e) the use of wild animals caught in the wild, stray animals, animals from animal protection centers official or protected animals or endangered, permitting the specific protection legislation, provided that the objectives of the procedure are the research that tends to protect these species or other essential biomedical purposes and check that these species are exceptionally suitable only for the purpose it is intended to. The scientific activities related to banding, marking, and the taking of samples for routine analysis are excluded.
(f) the implementation of educational measures in non-higher education centers.
(g) the performance of procedures that don't use anaesthesia, analgesia or other methods designed to eliminate the most pain, suffering or distress, for being incompatible with the results pursued by the procedure or be contraindicated.
(h) the execution of procedures in which the animal may suffer a serious or prolonged pain.
(i) in those procedures in which animals have been captured in the wild, the release to the environment from these animals, once completed those.



Annex XII minimum documentation for the communication of procedures 1. A descriptive report of the procedure, which shall contain: a) the name of the procedure to perform.



(b) the objectives pursued.
(c) the methodology of the procedure. In the event that a procedure guidelines are published with official character or have been officially validated, shall be deemed completed this end, provided that a copy of the publication or corresponding validation contribution.
(d) justification of the need to use animals for the results pursued with the procedure.
(e) the species and number of animals which are expected to use.
(f) the duration of the procedure and frequency of preparation provided.
(g) expected date of start and expected date of completion of the procedure.
(h) final destination of animals and, in the case of sacrifice, the method used.
(i) the identification of the researchers responsible for the procedure.
(j) data of the Center responsible for the confinement of animals during the procedure, stating their corresponding registration number. Any relocation of the animals to another registered Center will be reflected in the record of this book.



2. in State-owned centers, report of the Ethics Committee of animal welfare of the animals used in procedures. A copy of the report must be forwarded to the Centre for user.



Annex XIII documentation for prior and express authorization of procedures 1. Descriptive report of the procedure, which shall contain: a) the name of the procedure that will be carried out.



(b) the objectives pursued.
(c) the methodology of the procedure. In the event that a procedure guidelines are published with official character or have been officially validated, shall be deemed completed this end, provided that a copy of the publication or corresponding validation contribution.
(d) justification of the need to use animals for the results pursued with the procedure.
(e) the species and number of animals which are expected to use.
(f) the duration of the procedure and, where applicable, frequency of planned preparation.
g) date scheduled home and date planned completion of the procedure h) final destination of animals and, in the case of sacrifice, the method used.
(i) the identification of the researchers responsible for the procedure.
(j) data of the Center responsible for the confinement of animals during the procedure, stating their corresponding registration number. Any relocation of the animals to another registered Center will be reflected in the record of this book.



2 State-owned centers shall submit a report of the Ethics Committee.



3. circumstances that the previous and express authorization of the competent authority, and its justification is needed.

Related Laws