The Treaty on the Functioning of the European Union includes, within the general application provisions, Article 13, the obligation of the Union and the Member States to take full account of the welfare of animals when they formulate and implement certain policies, such as the policy of research, technological development and the internal market. In this area, on 22 September 2010, the European Parliament and the Council adopted Directive 2010 /63/EU on the protection of animals used for scientific purposes, which should be incorporated into the Spanish legal order.

Directive 2010 /63/EU repeals Council Directive 86 /609/EC 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 experimental and other scientific purposes, which was incorporated in our order through Royal Decree 223/1988 of 14 March 1988, which was repealed and replaced by Royal Decree 1201/2005 of 10 October on the protection of animals used for experimental and other purposes scientists.

Furthermore, the European Commission, through Recommendation 2007 /526/EC of 18 June 2007, laid down guidelines for the accommodation and care of animals used for experimentation and other scientific purposes which, on the other hand, had been adopted in the field of the Council of Europe as Appendix A to the European Convention on the protection of vertebrate animals used for experimental or other scientific purposes (ETS 123).

The new directive has made an important step forward in animal welfare, not only because it adapts the minimum general requirements to scientific progress, but also because it extends the scope of the protection rules to cephalopods and certain fetal forms of mammals, and because it establishes as a general principle the promotion and implementation of the "principle of the three errors", that is, the replacement, reduction and refinement of the procedures, encouraging the use of alternative methods to experimentation with live animals.

Although the protection granted by this royal decree cannot be extended today to the new animals until Law 32/2007 is reformed, of 7 November, for the care of animals, in their exploitation, transport, experimentation and sacrifice, this rule is approved in such a way that their protection will be automatically extended as soon as the change provided for in the aforementioned Law is introduced. The same applies to the sanctioning regime, which will now only apply to the infringement of procedures laid down in Law 32/2007 and will be extended as soon as it is reformed.

Animals may only be used when their use is justified by the intended purpose, valuing their opportunity always in terms of their potential benefits. The minimum conditions under which the animals are to be housed and the care to be taken, as well as the minimum requirements for breeders, suppliers and users of experimental animals, all with the main objective of ensuring their welfare to the greatest extent possible are set out in detail. The rules to which projects and procedures should be followed are set out in the same way as they are started until they are completed.

The ultimate objective is the total replacement of animals in the procedures and specific rules are laid down for the use of certain types of animals, such as stray and asilvestrated animals, wild fauna, threatened species and pet animals. In this respect, particularly stringent requirements are laid down in the case of non-human primates.

Relevant changes are also made to the formal control requirements for which the projects and procedures in which live animals are used are to be submitted. In this respect, the rules governing the need for ex-ante evaluation of projects, their retrospective evaluation in certain cases, the obligation to classify procedures according to their degree of severity, the requirements of transparency and information, and many other requirements whose only objective is to ensure the best possible treatment of animals, can be highlighted.

The basic criteria for the training required for certain tasks are also laid down, in line with the results of the consensus between the Member States and the European Commission for the development of guidelines to harmonise the requirements for the recognition of such training and thus facilitate movement between Member States.

Other important developments are the creation of a network of national welfare committees and national focal points for coordination on the implementation of the standards of protection and alternative methods. There is also a requirement for all breeders, suppliers and users to have bodies responsible for animal welfare.

Given the entity of the modifications that are introduced, of which only some have been mentioned in this preamble, for reasons of legal certainty it has been determined the convenience of enacting a new norm that with the rank of royal decree will repeal and replace the Royal Decree 1201/2005, of October 10.

This royal decree is dictated by the development of Law 32/2007, of 7 November, for the care of animals, in their exploitation, transport, experimentation and sacrifice, in the exercise of the regulatory authority which, in general, attributes to the Government Article 97 of the Constitution. Given the markedly technical nature of this provision, its adoption is considered to be adjusted by means of a royal decree.

In the elaboration of this royal decree, the autonomous communities and the sectors affected have been consulted.

In its virtue, on the proposal of the Ministers of Agriculture, Food and Environment and of Economy and Competitiveness, with the prior approval of the Minister of Finance and Public Administrations, in agreement with the Council of State and after deliberation of the Council of Ministers at its meeting of February 1, 2013,

DISPONGO:

CHAPTER I

General provisions

Article 1. Purpose and purpose.

1. The purpose of this royal decree is to lay down the applicable rules for the protection of animals used, reared or supplied for the purpose of experimentation and other scientific purposes, including education and teaching.

To do this, it regulates the following:

(a) The replacement and reduction of the use of animals in procedures and the refinement of breeding, accommodation, care and use of animals in such procedures.

(b) The origin, breeding, marking, care, accommodation and euthanasia of the animals.

c) The activities of breeders, suppliers or users.

(d) The evaluation and authorisation of projects in whose procedures animals are used.

2. This royal decree is intended to ensure such protection, and in particular that:

(a) The number of animals used in the procedures is reduced to a minimum, using alternative methods as far as possible;

b) are not unnecessarily caused pain, suffering, distress or lasting harm;

c) avoid any unnecessary duplication of procedures; and that

(d) the animals used, reared or supplied are given the appropriate care.

Article 2. Scope of application.

1. This royal decree shall apply where animals are used or intended to be used in procedures or when animals are raised specifically to enable their organs or tissues to be used for scientific purposes.

2. This royal decree shall apply until the animals referred to in the first paragraph have been slaughtered, rehoused or reintegrated into a suitable habitat or zootechnical system.

3. All animals used in the procedures shall be understood to be included within the scope of this royal decree, even if the elimination of pain, suffering, distress or lasting damage has been achieved through the satisfactory use of analgesia, anaesthesia or other methods.

4. This royal decree shall apply to the animals referred to in Law 32/2007 of 7 November for the care of animals on their holding, transport, experimentation and slaughter.

It shall also apply to animals at an earlier stage of development if the animal is to be allowed to live beyond that stage of development and as a result of the procedures performed is likely to suffer from pain, suffering, distress or lasting damage after it has reached that stage of development.

5. Excluded from the scope of application:

a) Non-experimental agricultural practices;

b) non-experimental clinical veterinary practices;

(c) the clinical veterinary studies required in the framework of obtaining the marketing authorisation for veterinary medicinal products;

(d) practices carried out for recognised zootechnical purposes;

e) practices performed with the primary objective of identifying an animal;

(f) practices in which pain, suffering, distress or lasting damage equivalent to or greater than those caused by the introduction of a needle in accordance with good veterinary practice is not likely to occur.

6. This royal decree will apply without prejudice to Royal Decree 1599/1997 of 17 October on cosmetic products and their amendments and the legislation of the European Union to replace it.

Article 3. Definitions.

1. For the purposes of this royal decree,

following definitions shall apply:

a) Center or establishment: All installation, building, group of buildings or other premises and mobile facilities, including those not fully enclosed or covered

(b) Breeder: Any natural or legal person who breeds animals of the species listed in Annex I in order to use them in procedures or to use their tissues or organs for scientific purposes, as well as any person who breeds animals of other species primarily for such purposes, with or without profit.

(c) Euthanasia: The interruption of the life of an animal with the least possible suffering, according to its species and state.

(d) Competent Authority: The entities, authorities or administrative units of the autonomous communities and the cities of Ceuta and Melilla competent in each of the matters regulated in this royal decree.

Authority: Public body, or association or private company, authorized and designated by the competent body to perform some of the specific functions established in this royal decree. In this respect, it is appropriate to distinguish the body empowered for the evaluation of projects which, in accordance with the provisions of Article 43, will be provided under free competition, enabling them to carry out other technical measures, which shall be governed by the provisions of the competent body.

e) Primate: Any non-human primate.

(f) Procedure: The use, both invasive and non-invasive, of an animal for experimental or other scientific purposes, the results of which are predictable or unpredictable, or for educational purposes, provided that such use can cause the animal a level of pain, suffering, distress or lasting damage equivalent to or greater than that caused by the introduction of a needle according to good veterinary practice.

In addition, any intervention that intentionally or casually causes, or may cause, the birth of an animal, the hatching of an egg or the creation and maintenance of a line of genetically modified animals in the conditions of pain, suffering, distress or lasting damage mentioned in the previous paragraph is considered.

It is not considered a procedure for the euthanasia of animals when performed with the sole purpose of using their organs or tissues.

A procedure shall be considered to be complete when no further observation is to be made for such a procedure or, in the case of new genetically modified animal lines, where the progeny is not observed or expected to experience pain, suffering, distress or lasting damage equivalent to or greater than that caused by the introduction of a needle.

g) Project: Work programme with a defined scientific objective and in which one or more procedures are carried out.

(h) Supplier: Any person, other than breeder, who acquires or maintains animals for use in procedures or for the use of their tissues or organs for scientific purposes, and supplies such animals with any of these purposes, whether for profit or not.

i) User: Any person who uses animals in procedures, with or without profit.

CHAPTER II

General principles and conditions

Article 4. Principle of replacement, reduction and refinement.

1. It shall be used whenever possible, instead of a scientifically satisfactory procedure, methods or test strategies that do not lead to the use of live animals.

2. The number of animals used shall be reduced to a minimum provided that this does not compromise the objectives of the project.

3. Activities related to breeding, accommodation and care, as well as methods used in procedures, shall be refined as much as possible to eliminate or minimise any potential pain, suffering, distress or lasting damage to animals.

4. As regards the choice of methods, the principle of replacement, reduction and refinement shall apply in accordance with the provisions of Article 24. Where this election results in a procedure, the procedure shall be carried out in accordance with Article 25.

5. The competent bodies shall ensure that the above paragraphs are applied and contribute to the development and validation of alternative approaches which may provide a level of information equal to or higher than that obtained in animal procedures, but which do not use or use fewer animals or involve less painful procedures.

6. The General Administration of the State and the competent bodies shall take the steps they consider appropriate to promote research in this field and shall ensure the promotion of alternative approaches and the dissemination of information on such approaches at national level.

Article 5. Purpose of the proceedings.

The use of animals in the procedures may only take place when they pursue any of the following purposes:

a) Fundamental research.

b) Translational or applied research, and scientific methods with any of the following purposes:

1. The prevention, prophylaxis, diagnosis or treatment of diseases, ill health or other abnormalities or their effects on humans, animals or plants.

2. The assessment, detection, regulation or modification of physiological conditions in humans, animals or plants.

3. The welfare of animals, in particular the improvement of the conditions of production of animals reared for agricultural purposes.

(c) The development and manufacture of pharmaceuticals, food, feed and other substances or products, as well as the testing of their quality, efficacy and safety, with any of the purposes set out in point (b).

d) The protection of the natural environment in the interests of the health or welfare of human beings or animals.

e) Research aimed at the conservation of species.

f) Higher education or training for the acquisition or improvement of professional skills.

g) Legal and forensic medicine.

Article 6. General conditions of accommodation and care of the animals.

1. Breeders, suppliers and users shall comply with the following requirements in relation to the general care and accommodation of animals:

(a) They shall be provided with the accommodation, environment, food, water and care that are appropriate to their species, physiological conditions and health status and ensure their proper general condition.

(b) Any restriction that prevents or limits the animals ' ability to satisfy their physiological and ethological needs shall be reduced as far as possible.

(c) The environmental conditions in which the animals are reared, maintained or used shall be verified on a daily basis.

(d) Media shall be available to ensure that any deficiency that may cause avoidable suffering, pain, distress or lasting damage is eliminated as soon as possible.

e) The working rules and instructions for the use of all elements shall be in writing.

(f) An action plan shall be provided in writing in the event of an emergency or disaster, which shall include measures in relation to the animals housed, which may be integrated with other plans of the establishment and which shall reflect appropriate coordination with the other emergency plans of the centre of work.

2. Establishments or centres must comply with the requirements set out in Annex II, at the latest on the dates specified therein.

3. The competent bodies may grant derogations from the provisions of paragraph 1 (a) and paragraph 2 for scientific, animal welfare or animal health reasons.

Article 7. Methods of euthanasia.

1. The euthanasia of animals shall be carried out:

a) With the least pain, suffering and distress possible.

b) By a trained person.

(c) In an establishment of a breeder, supplier or user, except in the case of a field study or as provided for in paragraph 1 (b) of Annex III.

2. For the animals referred to in Annex III, the appropriate method of euthanasia as set out in that Annex shall be used.

3. The competent authority may grant derogations from the requirement laid down in paragraph 2:

a) To permit the use of another method provided that from scientific evidence it is considered that the method has at least the same absence of cruelty; or

(b) if it is scientifically justified that the purpose of the procedure cannot be achieved using any of the methods of euthanasia referred to in Annex III.

4. Points (b) and (c) of paragraph 1 and paragraph 2 shall not apply where it is necessary to kill an animal in emergency situations on grounds of animal welfare, animal health, public health, public order or environmental protection.

Article 8. Pooling of organs and tissues.

The General Administration of the State and the competent bodies shall encourage, through the committee governed by Article 44, the establishment, between users and other operators, of programmes for the sharing of organs and tissues. These programmes may provide for the creation of shared databases and other measures for collaboration and dissemination of information.

Article 9. Transport of animals.

1. The transport of animals shall be carried out in accordance with the rules in force, in particular on trade, health and animal welfare.

2. The transport containers shall ensure the containment of the animals, while allowing for the freedom of appropriate movements according to their species, age and status. Transport vehicles shall, where appropriate, provide anchorage systems to prevent sudden movements which are detrimental to the welfare of animals.

3. If, in the context of a project, it is necessary to transfer an animal, the animal shall be accompanied by a transfer document issued by the designated veterinarian of the centre of origin, the period of validity of which may not exceed that of the corresponding movement health document and shall contain at least the data set out in Annex IV.

Article 10. Identification of the animals.

All animals belonging to species with already regulated identification systems must be identified in accordance with current regulations.

Article 11. Identification of the containment systems.

The containment systems of the animals must be provided with a system that allows the identification of the animals to be recorded. Unless it is not possible for the circumstances or characteristics of the animals to be confined, the data listed in Annex V shall be specified as a minimum.

Article 12. Records of the animals.

Breeders, suppliers and users shall record at least the data set out in Annex VI. Such data shall be kept for at least five years and be made available to the competent body, when requested by the competent body.

Article 13. Additional requirements for dogs, cats and primates.

1. Dogs, cats and primates must be provided, preferably before their weaning, with an individual and permanent identification mark, performed in such a way as to cause them the least possible pain.

2. Where a dog, cat or primate is moved from a breeder, supplier or user to another person before its weaning and is not possible to mark it in advance, the recipient of the animal shall keep, until the marking is carried out, a register containing at least the data of the mother.

3. The breeder, supplier or user who receives a dog, cat or primate weaned that is not marked, must provide the same, as soon as possible, with an identification mark, individual and permanent, carried out in such a way as to cause the least possible pain.

4. The breeder, supplier or user shall, where appropriate and at the request of the competent authority, justify the reasons why these animals do not have an identification mark.

5. Breeders, suppliers and users should keep, for each dog, cat and primate, the following data:

a) Identity.

b) Place and date of birth, when they are known.

c) If you have been raised for use in procedures.

d) In the case of primates, if they are descendants of primate bred in captivity.

6. Each dog, cat and primate, will have a history that will accompany the animal as long as it is maintained for the purposes of this royal decree. The history shall be established when the animal is born or as soon as possible and shall contain all relevant information on the reproductive, veterinary and ethological aspects of the individual as well as the projects in which it has been used. In the case of rehousing, the veterinary and ethological information of the individual considered to be relevant shall accompany the animal.

7. The information referred to in this Article shall be kept for at least three years following the death or rehoming of the animal and shall be made available to the competent body upon request.

CHAPTER III

breeders, suppliers, and users

Article 14. General requirements.

1. The establishments of the breeders, suppliers and users must have the appropriate facilities and equipment for the species of animals lodged and, if they carry out procedures, for the performance of the same.

2. The design, construction and operation of the installations and equipment referred to in paragraph 1 shall ensure that the procedures are carried out as effectively as possible and shall facilitate the achievement of reliable results using the least number of animals and causing the least degree of pain, suffering, distress or lasting damage.

3. For the purposes of paragraphs 1 and 2, they shall comply with the requirements laid down in Annex II, which apply to them.

4. Each breeder, supplier or user shall designate:

a) At least one responsible animal welfare specialist, who will be responsible in situ for monitoring the welfare and care of animals in the establishment.

(b) At least one veterinarian, hereinafter referred to as the designated veterinarian, or another specialist entitled equivalent, with knowledge and experience in laboratory animal medicine which, irrespective of the other activities which it may develop, shall have advisory functions in relation to the health and treatment of animals, and its professional decisions and opinions shall be taken into consideration by the user, breeder or supplier and by the animal welfare body established in Article 37.

(c) One or more natural persons who are responsible on the spot for compliance with this royal decree, and in particular that the specialists referred to in points (a) and (b) of this paragraph have been appointed, to ensure that the staff dealing with the animals has access to the specific information on the species housed in the establishment and that they are responsible for ensuring that the staff is properly trained, trained, has access to continuous training, and that, while it has not demonstrated such training, it is subject to supervision by trained personnel.

5. The same person may perform several or all of the functions referred to in this article, provided that he meets the different training requirements set out in this royal decree and other applicable regulations in each case.

Article 15. Requirements applicable to staff.

1. Breeders, suppliers and users will have sufficient personnel on site.

2. Persons performing the following functions shall have the appropriate prior training:

a) Care for the animals.

b) Euthanasia of animals.

c) Realization of procedures.

d) Design of projects and procedures

e) Take responsibility for on-site monitoring of animal welfare and care.

f) Assume the duties of designated veterinarian.

3. Staff carrying out the duties referred to in points (a), (b) and (c) of paragraph 2 shall meet the training requirements in accordance with paragraph 6. The competent body may authorise persons who have not yet demonstrated their full training to perform these functions on a temporary basis and under responsible supervision.

4. Personnel carrying out the duties referred to in paragraph 2 (d) shall have received instruction in a scientific discipline relevant to the project or procedure and a specific knowledge of the species involved, in addition to meeting the training requirements in accordance with paragraph 6.

5. Staff carrying out the duties referred to in points (e) and (f) of paragraph 2 shall meet the training requirements in accordance with paragraph 6.

6. The competent bodies shall ensure, by means of authorisation or other appropriate means, the training of staff to carry out the tasks referred to in paragraph 2.

(a) The training of staff may have a modular structure based on guidelines or recommendations published by the European Union, where appropriate.

(b) The minimum requirements for prior or other training shall be expressed, where appropriate, in learning outcomes. For functions (a), (b), (c) and (d), they shall be based on the elements set out in Annex VII.

7. The recognition of training for the performance of the tasks referred to in paragraph 2 by a competent body shall take effect throughout the national territory.

8. The recognition of training for the performance of the tasks referred to in paragraph 2 by the competent authorities of another Member State shall take effect throughout the national territory, in accordance with the principle of reciprocity.

Article 16. Authorisation of breeders, suppliers and users.

1. Breeders, suppliers and users and their establishments must be authorised by the competent body prior to the start of their activities. Such authorisation shall be conditional upon compliance with at least the requirements laid down in this royal decree. Where breeding activities are carried out, even for their own use, supply or use of animals in procedures, authorisation shall be requested for each and every animal.

2. Breeders, suppliers and users shall request the confirmation or renewal of their authorisation:

(a) In view of any significant change in the structure or activities of the breeder, supplier or user who may have negative effects on the welfare of the animals.

b) When they are to breed, supply or use new species.

c) Translate 10 years since the issuance or last renewal of the authorization.

3. The authorisation shall specify the person or persons responsible for ensuring compliance with the provisions of this royal decree, the specialist responsible for the welfare of the animals and the designated veterinarian.

4. If a breeder, supplier or user fails to comply with the requirements set out in this royal decree, the competent authority shall take appropriate corrective action or require that such measures be taken and, where appropriate, suspend or withdraw the authorisation.

5. Where an authorisation is suspended or withdrawn, the competent authority shall ensure that the necessary measures are taken to ensure that the welfare of the animals housed in the establishment is not adversely affected.

Article 17. Register of breeders, suppliers and users.

1. Breeders, suppliers and users must register in the General Register of Livestock Holdings, established and regulated by Royal Decree 479/2004 of 26 March, establishing and regulating the General Register of Livestock Holdings, and, where appropriate, in a specific register for such purposes.

2. Centres integrated by physically independent units shall be registered as a single centre unless they have an independent operation and organisation, or which determines the competence of different competent bodies.

3. Where breeding, supply or use of animals is carried out in procedures, all and each of them shall be specified in the register.

4. Any modification of the data that is entered, derived 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, shall be communicated to the competent organ within the maximum period of one month after such modification has occurred, in order for the corresponding modification to be made in the register. In particular, the change of any of the persons referred to in Article 14 (4) should be communicated.

Article 18. Additional requirements for primate breeders.

Primate breeders should have a strategy to increase the percentage of animals that are descendants of captive-bred primates.

CHAPTER IV

Animals used in procedures

Article 19. Animals reared for use in procedures.

Animals belonging to the species listed in Annex I may only be used in procedures where they have been reared for that purpose. The competent bodies may grant derogations from the foregoing if it is scientifically justified.

Article 20. Animals of endangered species.

1. No animal procedures of the threatened species included in Annex A to Regulation (EC) No 338/97 of the Council of 9 December 1996 on the protection of species of wild fauna and flora by the control of their trade, which are not covered by the provisions of Article 7 of that Regulation, shall be used unless the following two conditions are met:

(a) The procedure has one of the purposes referred to in paragraph (b) (b), (c) or (e) of Article 5 of this royal decree.

(b) It has been scientifically justified that the purpose of the procedure cannot be achieved using animals from other species.

2. The first paragraph shall not apply to any kind of primate, the use of which shall comply with the provisions of Article 21.

Article 21. Primates.

1. Animals of the species Gorilla gorilla (gorilla), Pan troglodytes (chimpanzee), Pan paniscus (bonobo or "chimpanzee pigmeo") and Pongo pygmaeus (orangutan) will not be used in the procedures.

2. Primates of the species listed in Annex A to Regulation (EC) No 338/97 of the Council of 9 December 1996 which are not covered by the provisions of Article 7 (1) of that Regulation shall not be used unless the following two conditions are met:

a) The procedure has one of the purposes indicated in:

1. No. 1 (b) or (c) of Article 5 of this Royal Decree and is carried out in order to prevent, prevent, diagnose or treat disabling diseases or potentially endanger the lives of human beings; or

2. Article 5 (e).

(b) It has been scientifically justified that the purpose of the procedure cannot be achieved using animals other than primates or animals of species not listed in Annex A to Council Regulation (EC) No 338/97 of 9 December 1996.

3. Other primates shall not be used in procedures, unless the following two conditions are met:

(a) It has been scientifically justified that the purpose of the procedure cannot be achieved using non-primate animals;

b) the procedure has one of the purposes indicated in:

1. No. 1 (b) (b) or (c) of Article 5 of this Royal Decree and is carried out for the purposes of prevention, prophylaxis, diagnosis or treatment of disabling diseases or which may endanger the life of human beings; or

2. (a) or (e) of Article 5.

4. A disabling disease, for the purposes of this royal decree, means the pathological process that will heal with a reduction in the normal physical or psychological capacity of a person.

5. The primates listed in Annex VIII, from the dates laid down in Annex VIII, may be used only in procedures if they are the offspring of primate reared in captivity or if they come from self-sustaining colonies. The competent bodies may grant derogations from the foregoing if it is scientifically justified.

For the purposes of this paragraph, "self-sustaining cologne" shall mean the one in which the animals are reared only in the breast or come from other colonies but are not wild-caught animals; and in which the animals are also kept so that they are used to human beings.

Article 22. Animals caught in the wild.

1. Animals caught in the wild shall not be used, unless the competent authority has expressly authorised it, which may grant the scientific justification that the purpose of the procedure cannot be achieved by using animals reared for use in procedures.

2. The capture of animals in the wild shall only be carried out by a competent person with methods which do not cause any lasting pain, suffering, distress or damage. Any animal that is injured or in poor health at the time of its capture or after it must be examined by a veterinarian, or in justified cases, by another trained person, should take the necessary measures to minimize their suffering. Only exceptionally and after scientific justification may the competent authority authorise the failure to take these measures.

Article 23. Wild animals and stray animals of domestic species.

They shall not be used in asilvestrated animal procedures or stray animals of domestic species. The competent authority may exceptionally authorise its use, provided that the following conditions are met:

(a) There is an essential need to conduct studies related to the health and welfare of these animals or with serious threats to the environment or to human or animal health, and

(b) it has been scientifically justified that the purpose of the procedure can only be achieved using stray animals or wild animals.

CHAPTER V

Procedures and projects

Section 1. Procedures

Article 24. Choice of methods.

1. A procedure shall not be carried out if the European Union legislation recognises another method or another test strategy to obtain the result of the result that does not involve the use of live animals.

2. When choosing between different procedures, it will be chosen by those who are most likely to provide satisfactory results and who meet the highest number of the following requirements:

a) Using the least number of animals;

(b) affecting animals with the least capacity to feel pain, suffering, distress or lasting damage;

c) causing less pain, suffering, distress, or lasting damage.

Article 25. General conditions of the proceedings.

1. In order to avoid unnecessary duplication, the competent bodies shall accept data from other Member States obtained by means of procedures recognised by the legislation of the European Union, unless further procedures are to be carried out in relation to such data for the protection of public health, safety or the environment.

2. The procedures may be performed only if they are included within the framework of an approved project in accordance with Section 2. of this Chapter.

3. The procedures shall be performed in such a way as to avoid any unnecessary pain, suffering, distress or lasting damage to the animals.

4. The procedures shall be carried out in approved user centres, with the exception of the competent authority, subject to scientific justification for the need or desirability of being carried out outside such centres.

5. The procedures may only be carried out by persons trained or authorised on a temporary basis under the conditions laid down in Article 15.3 under responsible supervision.

6. As soon as the purpose of the procedure has been achieved, appropriate measures shall be taken to minimise the suffering of the animal.

7. Death as the endpoint criterion of a procedure should be avoided as far as possible and replaced by a more humane completion criterion that can be observed and applied at an earlier point in the procedure. In the event that death cannot be avoided as a endpoint criterion, the procedure shall be designed in such a way that:

a) That the lowest number of animals die; and

b) that the duration and intensity of the animal's suffering be reduced to the minimum possible and, as far as possible, a pain-free death.

Article 26. Anesthesia and analgesia during the procedure.

1. Procedures should be performed with general or local anesthesia, unless it is considered inappropriate because:

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

b) It is incompatible with the purposes of the procedure.

2. Analgesics or other appropriate methods should be used to ensure, as far as possible, that pain, suffering, distress or injury are minimal. Its application, where appropriate, must be carried out or supervised by a veterinarian.

3. Procedures involving serious injuries that may cause severe pain will not be performed without anesthesia.

4. No medicinal product shall be supplied to an animal which prevents or restricts its manifestations of pain, unless it has received an adequate dose of anaesthesia or analgesia. Where such medicinal products are supplied, a scientific justification must be provided, accompanied by a description of the treatment by anaesthesia or analgesia, which shall be available to the competent body.

5. Provided that it is compatible with the purposes of the procedure, when it is expected that an animal will suffer pain after having recovered from the anesthesia, it will be applied a preventive and palliative analgesic treatment, or another appropriate method to soothe the pain.

Article 27. Classification of the severity of the procedures.

1. Each and every procedure shall be classified as 'no recovery', 'mild', 'moderate' or 'severe', depending on the classification criteria set out in Annex IX.

2. No procedures shall be performed if they involve a severe level of pain, suffering or distress which is likely to be durable and which cannot be relieved, without prejudice to the use of the safeguard clause set out in the second provision.

Article 28. End of procedure.

1. At the end of any procedure, it shall be decided whether the animals should be kept alive or be slaughtered. The decision shall be taken by a veterinarian, in justified cases, by another trained person.

2. Animals must be euthanised whenever they are likely to suffer from a moderate or severe level of pain, suffering, distress or lasting damage.

3. Where an animal is to be kept alive, the animal must receive the care and accommodation in accordance with its species, physiological conditions and health status.

Article 29. Reuse of animals in procedures.

1. An animal that has already been used in one or more procedures shall not be reused in a new procedure where another animal with which no procedure has been previously performed may be used, unless the following conditions are met:

a) That the actual severity of the above procedures has been classified as "mild" or "moderate".

b) That the overall recovery of the general health and welfare state of the animal has been demonstrated.

c) That the new procedure has been classified as mild, moderate, or without recovery.

d) That you have favorable veterinary advice, carried out taking into account the animal's experiences throughout your life.

2. The competent authority may, in exceptional circumstances and after a veterinary examination, authorise the re-use of an animal even if the provisions of paragraph 1 (a) are not complied with. Such an animal may not have been used more than once in a procedure which has caused severe distress and pain or equivalent suffering.

Article 30. Release and rehoming of animals.

The competent authority may authorise an animal to be given for adoption, rehoused or returned to a habitat, holding or other medium which is suitable for the species concerned. The following conditions must be met:

a) That your health status allows.

b) That it does not pose a danger to public health, animal health or the environment.

c) That appropriate measures have been taken to safeguard the welfare of the animal.

d) That in the case of rehousing or adoption, breeders, suppliers and users have an adequate program to guarantee their socialization.

e) That in the case of the release of wild animals in their habitat, an appropriate adaptation program is available.

Section 2

Article 31. Types of projects.

1. Type I projects: Those projects in which the following three circumstances are met:

a) Implicate exclusively procedures classified as "no recovery", "mild" or "moderate".

b) Do not use primates.

c) They are performed to meet legal or regulatory requirements, or for production or diagnostic purposes by established methods.

Type I projects may be processed by a simplified procedure and not subject to retrospective evaluation.

2. Type II projects: Those projects in which the following circumstances are simultaneously given:

a) Implicate exclusively procedures classified as "no recovery", "mild" or "moderate".

b) Do not use primates.

Type II projects will be subject to the authorisation procedure and may not be subject to retrospective evaluation.

3. Projects of type III: Projects other than types I or II. Without prejudice to the additional authorisations to which certain projects may be subject, all projects of type III shall be subject to the authorisation procedure and shall subsequently be subject to a retrospective evaluation.

Article 32. General conditions of the projects.

1. Type I projects shall be carried out in accordance with the request sent to the competent body, or, in the case of instructions in another sense, in accordance with those requests.

2. Projects of type II and III shall be carried out in accordance with the relevant authorisation.

3. All projects shall have a natural person who shall be responsible for their overall implementation, and in particular:

(a) Ensure that any procedure in which pain, distress, distress or unnecessary lasting damage to an animal in the course of the procedure is inflicted is stopped.

(b) Ensure that the projects are carried out in accordance with paragraphs 1 and 2 of this Article.

(c) Velara because appropriate measures are taken in the event of non-compliance and these measures are recorded.

4. The competent bodies may authorise multiple generic projects carried out by the same user, where they must be carried out to comply with regulatory requirements, or where such projects use animals for production or diagnostic purposes with established methods.

5. No project may be carried out which has not previously been assessed with favourable results by the body authorised under Article 34.

6. Any changes to the project which may have a negative impact on the welfare of the animals will involve a new assessment and, where appropriate, project authorisation.

7. The relevant documentation of the projects, including the authorisations and assessment reports, shall be kept at the disposal of the competent body for at least three years from the date of expiry of the authorisation period or of the time limit laid down in Article 33.4.

8. The documentation of the projects to be submitted to a retrospective evaluation shall be kept until such assessment has been completed, or, where appropriate, until the expiry of the period referred to in paragraph 7 of this Article.

Article 33. Project application and authorization.

1. For the communication and application for authorization of a project the user or the person responsible for the project must submit to the competent body the proposal of the project, accompanied by the report of the ethics committee, copy of the request for evaluation of the project, and at least the corresponding information from among the one that relates in Annex X, and in the case of the projects of type II and III, of the non-technical summary provided for in article 36 of the present royal decree.

The application for an evaluation of the project will be directed to the freely chosen organ chosen by the applicant, among those appearing in the list of authorized organs, except those in whom any of the causes of abstention or recusal provided for in Articles 28 and 29 of Law 30/1992, of 26 November, of legal regime of the Public Administrations and of the Common Administrative Procedure.

The project evaluation request shall contain at least the information or documents listed in paragraphs 4 to 14 of Annex X.

2. The competent bodies shall acknowledge receipt of the applicant for all applications for authorization in accordance with the terms of Article 42.4 of Law No 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Common Administrative Procedure.

In the event of an incomplete or incorrect application, the competent body shall inform the applicant of the need to remedy its application in accordance with Article 71 of Law No 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Common Administrative Procedure, as well as any possible consequences on the applicable period.

3. The body empowered for the assessment of the project shall forward the result of the assessment to the applicant or, at the request of the applicant, to the competent body.

4. The maximum time limit for resolving and notifying the relevant resolution shall be 40 working days. This period includes the evaluation of the project, which should be favourable. In projects type II and III, and where justified by the complexity or multidisciplinary nature of the project, the competent body may extend this period once for an additional period not exceeding 15 working days. The extension and its duration should be duly substantiated and notified to the applicant before the expiry of the initial period.

5. Project authorisations shall be granted for a maximum period of five years.

6. The project authorisation shall specify at least:

a) The user who will perform the project.

b) The person responsible for the project referred to in Article 32.3 of this royal decree.

c) The establishment or, in the case of field work, geographical locations, where it will be carried out.

d) The need, if any, to carry out a retrospective evaluation and, in such a case, the deadline for its submission.

e) Any other specific conditions established by the competent body in the light of the project evaluation.

7. The competent authority may suspend the authorization of a project if the project is not carried out in accordance with the authorization, and withdraw it, subject to a file having been dealt with by the person concerned.

8. If the authorisation of a project is withdrawn, the necessary measures shall be taken to ensure that the welfare of the animals is not adversely affected.

Article 34. Project evaluation.

1. The assessment of each project shall be carried out by the authority with a level of detail appropriate to the type of project and shall consist of verifying that the project meets the following requirements:

a) It is scientifically or educationally justified, or must be carried out by legal or regulatory imposition;

b) its purpose justifies the use of animals; and

(c) is designed in such a way that the procedures are performed as humanely and as environmentally friendly as possible.

2. The project evaluation will include:

(a) An assessment of their purpose, of the scientific benefits to be achieved or of their teaching value;

b) an assessment of their compliance with replacement, reduction, and refinement requirements;

c) an assessment and classification of their procedures according to the degree of severity;

(d) an analysis of the damage and benefits, in order to determine whether the damage, suffering, pain and distress that may be caused to the animals are justified by the expected results, taking into account ethical considerations and the benefits which, in short, the project may entail for humans, animals or the environment;

e) an examination of the situations and exceptions provided for in Articles 6, 7, 9.1, 19, 20, 21, 22, 23, 25.3 and 5, 26 and 29; and

f) a determination as to whether the project should be evaluated retrospectively and, where appropriate, when it should be carried out.

3. Expert advice may be used in the assessment of the project, in particular in the following fields:

a) The areas of scientific application for which animals are to be used, including replacement, reduction and refinement in the respective areas;

b) The experimental design, with statistics, if applicable;

(c) Veterinary practice, in wild animals or in the science of laboratory animals, if appropriate;

d) The zootechnics and the care of the species of animals to be used.

4. The process of evaluating the project must be transparent, being carried out in an impartial manner, being able to integrate the opinion of independent parties.

Article 35. Retrospective evaluation.

1. The body will carry out a retrospective evaluation of projects:

a) In which primates are used.

b) In which procedures classified as "severe" are included.

c) In those contemplated in the additional provision second of this royal decree.

d) In those whose assessment under Article 34 has determined it.

2. Without prejudice to paragraph 1 and unless otherwise decided by the competent authority, type I projects and type II projects in which only procedures classified as 'no recovery' or minor are included shall be subject to retrospective evaluation. Type II projects which include procedures classified as 'moderate' shall be subject to retrospective evaluation where this has been established in the authorisation.

3. The retrospective evaluation will be performed on the basis of the required documentation submitted by the user, and will evaluate the following:

a) If project objectives have been met;

(b) the damage inflicted on the animals, including the number and species of animals used, and the severity of the procedures; and

c) any of the elements that may contribute to a better application of the replacement, reduction and refinement requirement.

Article 36. Non-technical summaries of the projects.

1. The competent bodies shall publish the non-technical summaries of the approved projects and any updates thereof. These summaries, which will be presented by the project managers, will be anonymous and will not contain names or addresses of the users or people, nor any other personal data.

2. Whenever intellectual property and confidential information are protected, the non-technical summary of the project shall include at least the following:

(a) Information on the project's objectives, including the expected damages and benefits, as well as the number and type of animals to be used;

b) The demonstration of compliance with the replacement, reduction, and refinement requirement.

3. The competent bodies may determine that the non-technical summary of the project specifies whether the project should be subject to a retrospective analysis and in what time. In this case, the non-technical summary of the project should be updated with the results of the retrospective analysis.

CHAPTER VI

Organ in charge of animal welfare

Article 37. Establishment of the bodies responsible for animal welfare.

1. Each breeder, supplier and user shall establish an organ in charge of animal welfare, hereinafter referred to as "OEBA". In the users, this organ will be called the ethics committee of animal experimentation.

2. The OEBA shall be provided with an internal regulation defining and developing its composition and its basic functioning according to criteria of confidentiality and representativeness, which ensures impartiality in the decisions taken by it. One-person OEBA shall be exempted from this requirement.

Article 38. Functions of the OEBA.

1. The OEBA shall perform at least the following functions:

(a) Advise staff dealing with animals on issues related to the welfare of animals as regards their purchase, accommodation, care and use.

b) Advise staff on the application of the replacement, reduction and refinement requirement, and keep you informed about technical and scientific progress in applying that requirement.

c) Establish and review internal operational processes with respect to control, communication and monitoring of information related to animal welfare.

d) Advise on rehousing or adoption schemes, including appropriate socialisation of animals to be rehoused or taken up for adoption.

e) In users, it shall also prepare the report referred to in Article 33.1 and monitor the projects taking into account their effect on the animals used as well as determine and evaluate the elements that best contribute to the replacement, reduction and refinement.

2. The ethics committees for animal testing may, in addition, where the competent body so determines, be designated bodies empowered to carry out the assessment and the retrospective evaluation, provided that they comply with the requirements laid down in Articles 39 and 43.

In this case, the empowered body shall forward a detailed annual report of its activities to the competent body, which shall include at least a list of all projects which it has assessed or assessed retrospectively. All documentation shall be made available to the competent body for a minimum period of three years.

3. Records of the recommendations of the OEBA and the decisions taken in relation to those recommendations shall be kept for at least three years. These records shall be made available to the competent body at the request of the competent body.

Article 39. Composition.

1. The OEBA should be made up of people with the expertise and knowledge needed to ensure the welfare and care of animals. It shall consist of at least the following members:

(a) In the case of breeders and suppliers, the OEBA shall be composed of at least the person or persons responsible for the welfare and care of the animals.

(b) In the case of users, the ethical committee for animal testing shall be composed of at least the person or persons responsible for the welfare and care of the animals and for a researcher or other scientific member.

(c) In the event that the ethical committee for animal experimentation acts as an empowered body to carry out the evaluation or retrospective evaluation of the projects, its composition shall also include researchers or other scientific members who are not directly related to the project and a person with experience and knowledge in animal welfare that has no direct relationship with the user or the project.

2. Members shall respect the principle of confidentiality.

3. The OEBA shall receive the advice of the designated veterinarian, and the contributions made by OEBA shall be maintained for at least three years.

4. Where the OEBA considers it appropriate, it shall request expert advice which shall also respect the principle of confidentiality.

5. The competent bodies may exceptionally authorise, in small breeders, suppliers and users, the tasks set out in Article 38 (1) to be carried out by an OEBA of another breeder, supplier or authorised user. In no case shall breeders, suppliers or users of primates be eligible for this exceptional authorisation.

CHAPTER VII

Information, controls, committee and sanctioning regime

Article 40. Inspections or controls.

1. The competent or empowered bodies shall carry out regular checks or inspections on breeders, suppliers and users, including their establishments, in order to verify compliance with this royal decree. An adequate proportion of inspections must be carried out without warning.

2. The competent bodies shall adapt the frequency of inspections or controls, which may be carried out on the occasion of checks carried out for other purposes, in the light of a risk analysis which takes into account:

a) The species and quantity of animals housed;

b) the compliance or default history by the breeder, supplier, or user;

c) for users, quantity, and project types.

d) any data that may indicate a possible default.

3. The competent or empowered bodies shall inspect each year at least once:

a) To all breeders, suppliers and users of primates.

b) A third of other users.

4. The competent bodies which have designated bodies authorised in accordance with Article 38.2 shall carry out regular checks on those bodies.

5. The records of the inspections shall be kept for at least five years.

Article 41. Coordination, the duty of information and publicity of information.

1. Breeders, suppliers and users shall communicate to the competent bodies, within the time limits and in the form they establish, the data necessary to enable them to comply with the obligations laid down in national and European Union legislation.

2. The Ministry of Agriculture, Food and Environment is the contact point for the implementation of this royal decree and for the purposes of advising on the relevance of regulations and the appropriateness of the alternative approaches proposed for their validation, which establish, respectively, Articles 59.2 and 47.5 of Directive 2010 /63/EU, of 22 September, concerning the protection of animals used for scientific purposes.

3. The autonomous communities and cities of Ceuta and Melilla will establish a contact point for the fulfillment of this royal decree, which they will communicate to the Ministry of Agriculture, Food and the Environment.

4. The contact points set out in the previous paragraph, for the purpose of fulfilling the obligation to communicate information to the European Commission, shall draw up reports on the frequency, format and content of the Ministry of Agriculture, Food and Environment in coordination with the autonomous communities and cities of Ceuta and Melilla. These reports shall be sent annually by 31 March at the latest to the said Ministry.

5. With the information provided, the Ministry of Agriculture, Food and the Environment will draw up the relevant reports for their forward referral to the European Commission via the appropriate channel.

6. The Ministry of Agriculture, Food and the Environment shall publish annually, in the format established by the European Commission, statistical information on the use of animals, including information on the actual severity of the procedures, and on the species and origin of the primates used in the procedures.

7. The Ministry of Agriculture, Food and Environment will coordinate with the competent bodies the necessary actions for the implementation of this royal decree.

Article 42. Controls by the European Commission.

1. The competent bodies shall provide the experts of the European Commission with all the assistance and assistance they need to carry out the checks on the infrastructure and the operation of the national inspections provided for in Article 40. In these controls, the representatives of the Ministry of Agriculture, Food and the Environment will be able to accompany the experts of the European Commission and the representatives of the competent bodies of the autonomous communities and cities of Ceuta and Melilla.

2. The competent bodies and the Ministry of Agriculture, Food and the Environment shall establish the corresponding mechanisms for coordination and cooperation of the actions relating to the performance and results of these controls.

3. The competent bodies shall take the necessary measures to take account of the results of checks and inspections.

Article 43. Bodies empowered.

1. Only those bodies of which there has been a record of evidence that:

a) Possess the technical knowledge and means necessary for the performance of the functions and

b) There is no conflict of interest to perform the functions.

2. In particular, they can only be enabled to perform control and inspection functions to organs under the following conditions:

a) The tasks that the enabled organ can perform and the conditions in which it can be performed are accurately described;

(b) The enabled body works and is accredited in accordance with UNE-EN ISO/IEC 17020 "General criteria for the operation of the various types of bodies carrying out the inspection" or with another rule that is most relevant to the delegated tasks concerned;

(c) The competent authority shall, on a regular basis and subject to the latter's request, communicate to the competent body the results of the checks carried out. If the results of the checks reveal or cause suspicion of non-compliance, the competent authority shall immediately inform the competent authority thereof;

d) There is effective and effective coordination between the competent body and the body.

e) The competent body carries out audits or inspections of the authorised bodies.

3. The bodies authorised for the evaluation of projects shall be appointed by the competent bodies in accordance with a watered-down procedure guaranteeing the free competition of all those who fulfil the requirements laid down in the preceding paragraphs. The list of authorised bodies should be kept up to date, and should be sent to the Ministry of Economy and Competitiveness, to the sole purpose of their advertising through their electronic headquarters.

Article 44. Spanish committee for the protection of animals used for scientific purposes.

1. In accordance with Article 49 of Directive 2010 /63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes, the Spanish Committee for the Protection of Animals used for Scientific Purposes is hereby established as an inter-departmental body, which shall be the body responsible for advising the General Administration of the State, the Autonomous Communities and the cities of Ceuta and Melilla and the animal welfare bodies provided for in the Chapter. VI, in matters relating to the acquisition, rearing, accommodation, care and use of animals in procedures, as well as to ensure that best practices are shared, and for proper coordination.

The Committee will exchange information with the National Committees of the other Member States on the functioning of the bodies responsible for animal welfare and project evaluation, and share best practices in the European Union.

The Committee will be attached to the Ministry of Agriculture, Food and the Environment through the Directorate General of Agricultural Productions and Markets.

2. The Committee shall be composed of

following members:

(a) President: The head of the General Directorate of Agricultural Productions and Markets in the Ministry of Agriculture, Food and the Environment.

b) Vice President, who will replace the president in case of vacancy, absence or illness: The head of the General Secretariat of Livestock Products of the Ministry of Agriculture, Food and Environment.

c) Vocals:

1. On the part of the General Administration of the State:

By the competent ministries: An official, with level at least of the Head of Service, of the Health and Animal Hygiene and Traceability of the Ministry of Agriculture, Food and Environment; a representative, with level at least of Head of Service in both cases, from the Ministry of Economy and Competitiveness and the Ministry of Health, Social Services and Equality, appointed by their respective Undersecretaries.

By the public research organizations: A representative, with at least the Head of Service, of the public research organizations attached to the General Administration of the State, designated by the Secretariat of State for Research, Development and Innovation.

By the Council of Universities: A representative appointed by the Council.

When aspects relating to medicinal products are to be addressed, a representative, with at least the Head of Service, of the State Agency for Medicines and Health Products, designated by its Director, shall be included as a voice.

When topics related to cosmetic products are to be discussed, a representative of the unit of the Ministry of Health, Social Services and Equality, with competence in cosmetic products, will be integrated as a voice, with at least the Head of Service, appointed by its Undersecretary.

When topics related to education, training or training of staff are to be addressed, a representative of the Ministry of Education, Culture and Sport with competence in education, with at least the Head of Service, appointed by its Assistant Secretary, will be included as a voice.

2. By the Autonomous Communities and the cities of Ceuta and Melilla: a representative of each of them who agree to join this Section.

3. By non-governmental organizations of a national character that have as one of their main objectives the defense of animal welfare of the animals of experimentation: a representative, appointed by the president of the Committee, on a proposal of those.

4. " By professional associations specialized in animals used for scientific purposes of a national nature: a representative, appointed by the president of the Committee, on a proposal from those.

5. On the part of national organizations that have as one of their main objectives the development and promotion of alternative methods to animal experimentation: a representative, appointed by the president of the Committee, on the proposal of those.

6. A representative of the General Council of Veterinary Colleges of Spain appointed by the President of the Committee on a proposal from the President of the Council.

7. On the part of the scientific professional associations of a national nature: a representative, appointed by the president of the Committee, on the proposal of those.

d) Secretary: An official with the minimum level of head of service of the General Secretariat of Livestock Products of the Ministry of Agriculture, Food and the Environment.

3. Independent experts may attend, at the invitation of the President, with a voice but without a vote.

4. The Committee may set up working groups in accordance with Article 40.3 of Law 6/1997 of 14 April of the Organization and the Functioning of the General Administration of the State.

5. The Committee may approve its own operating rules. The provisions of Chapter II of Title II of Law No 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Common Administrative Procedure shall apply in all cases not provided for therein.

6. The Committee shall meet by a call from its President or at the request of one third of its members.

7. The functioning of the Committee will not increase public expenditure and will be met with the material and personnel resources available in the Ministry of Agriculture, Food and the Environment.

The costs of compensation for the performance of services, allowances and displacements arising from the participation in meetings of the members of the Committee shall be on behalf of their respective administrations or organizations of origin.

Article 45. Sanctioning regime.

The regime of sanctions and violations of what is foreseen in this royal decree will be governed by the provisions of Law 32/2007 of 7 November 2007 on the protection of animals in their exploitation, transport, experimentation or slaughter, and on the autonomous rules of application, without prejudice to the civil, criminal or other responsibilities that may arise.

Additional disposition first. Human and material resources.

The records provided for in this royal decree will be taken into account with the human and material resources available in the Ministry of Agriculture, Food and the Environment, without its creation and operation assuming an increase in public spending. Likewise, the provisions of this royal decree will in no way imply an increase in the amount of appropriations, salaries, or other personnel costs.

Additional provision second. Safeguard clause.

1. The competent authority may take provisional measures to allow exceptionally:

(a) The use of primates for purposes other than to prevent, prevent, diagnose or treat debilitating or potentially life-threatening clinical conditions, provided that such purpose cannot be achieved using other animal species, where it has scientifically-founded reasons to consider its use as essential.

(b) The performance of a procedure even if it involves severe pain, suffering or distress for the animals and it is likely that these effects will be long-lasting and cannot be alleviated, when, for exceptional and scientifically justified reasons, it is considered necessary to carry out such a procedure.

2. The competent body which decides to adopt such a provisional measure shall immediately inform the animal welfare body of the Ministry of Agriculture, Food and the Environment, justifying its decision and providing evidence of the situation which has led to the adoption of that measure.

3. The Ministry of Agriculture, Food and the Environment shall act accordingly and shall immediately inform the Commission and the other Member States of the information and documentation.

4. The Ministry of Agriculture, Food and the Environment shall immediately inform the competent authority of the decision taken by the European Commission. The competent body shall immediately take the necessary measures to comply with the content of that decision.

First transient disposition. Breeders, suppliers and registered users in accordance with Royal Decree 1201/2005 of 10 October on the protection of animals used for experimental and other scientific purposes.

The breeders, suppliers and users registered under the provisions of Royal Decree 1201/2005 of 10 October on the protection of animals used for experimental and other scientific purposes, which are in operation, shall communicate to the competent bodies, within a period not exceeding six months after the publication of this royal decree, the necessary supplementary information as provided for therein.

Second transient disposition. Projects and procedures in processing.

1. The provisions of Section 2 of Chapter V shall not apply to procedures which have been approved before 1 January 2013 and which are finalised before 1 January 2018.

2. Projects approved before 1 January 2013 and ending after 1 January 2018, shall obtain an authorisation in accordance with this royal decree for completion by 1 January 2018 at the latest.

3. The administrative procedures in processing at the time of the entry into force of this royal decree, will be resolved in accordance with the regulations in force at the time of the beginning of the same.

Transitional provision third. Pre-existing reporting models.

As long as the European Commission does not establish new reporting models for compliance with the provisions of Article 54 of Directive 2010 /63/EU of the European Parliament and of the Council of 22 September 2010, for the purposes of compliance with the duty of information, communication and publicity set out in Article 41 of this Royal Decree, the competent authorities and the Ministry of Agriculture, Food and Environment shall continue to prepare the reports in accordance with Article 27 of Royal Decree 1201/2005 of 10 October.

Transitional disposition fourth. Categories recognised under Royal Decree 1201/2005 of 10 October.

The persons empowered by the competent bodies to carry out the functions corresponding to the categories established in accordance with the provisions of the repealed Royal Decree 1201/2005 of 10 October shall retain that power in reference to those functions, without prejudice to the requirements for adaptation to the new rules which may be adopted by those bodies.

Transient disposition fifth. Trained staff to carry out the duties referred to in Article 15.

Within 12 months of the publication of this royal decree, the Ministry of Economy and Competitiveness, after a report from the Ministries of Education, Culture and Sport, and Agriculture, Food and Environment, will develop the training requirements for the staff referred to in Article 15. To this end, a working group, established within the framework of the Committee established in Article 44, may be assisted in the field of education, training and training of staff. As soon as the above requirements are not developed:

1. They are considered to be qualified to perform the functions of Article 15.2.a) to staff recognised or approved as category A as set out in Annex I to Royal Decree 1201/2005 of 10 October.

2. They are qualified to perform the functions of Article 15.2.b) to the staff recognised or approved as category A, B, and D2 as set out in Annex I to Royal Decree 1201/2005 of 10 October.

3. They are qualified to perform the functions of Article 15.2.c) to the staff recognised or approved as category B and C as set out in Annex I to Royal Decree 1201/2005 of 10 October. In the latter case staff are required to have received instruction in a scientific discipline relevant to the procedure performed and have specific knowledge of the species involved.

4. They are qualified to perform the functions of article 15.2.d) to the staff recognized or approved as category C as set out in Annex I to Royal Decree 1201/2005 of 10 October and in addition they have received an instruction in a scientific discipline relevant to the work done and have a specific knowledge of the species involved.

5. It is considered to be capable of performing the functions of Article 15.2.e) to staff recognised or approved as category D1 as set out in Annex I to Royal Decree 1201/2005 of 10 October.

6. It is considered to be capable of performing the functions of Article 15.2.f) to staff recognised or approved as category D2 as set out in Annex I to Royal Decree 1201/2005 of 10 October.

Transitional disposition sixth. Stricter provisions.

The competent bodies may maintain provisions aimed at ensuring greater protection for animals within their territory, provided that they are already in force on 9 November 2010, which are compatible with the general principles of the Treaty on the Functioning of the European Union and which are communicated to the European Commission as soon as possible. For these purposes, the competent bodies of the autonomous communities and cities of Ceuta and Melilla shall communicate before 1 December 2012 to the General Directorate-General for Animal Welfare of the General Administration of the State the provisions which they have decided to maintain, in order to communicate it to the European Commission for the time being.

Transitional disposition seventh. Enablement.

The autonomous communities shall authorize and designate, within the maximum period of six months, in accordance with the provisions of Article 43, the bodies authorized for the evaluation of projects, and shall send, for the sole purposes of their publicity, the relationship thereof to the Ministry of Economy and Competitiveness, which shall make such a list public through its electronic headquarters, and shall keep it duly updated at the disposal of the persons concerned.

They shall be entitled to an interim rating as long as the list of authorised bodies referred to in the preceding paragraph is not advertised, the animal experimentation ethics committees, which shall comply with the provisions of Article 43.1.

Single repeal provision. Regulatory repeal.

At the entry into force of this royal decree, they are repealed:

(a) Royal Decree 1201/2005 of 10 October on the protection of animals used for experimental and other scientific purposes.

(b) Article 11 of Royal Decree 751/2006 of 16 June on the authorisation and registration of carriers and means of transport of animals and establishing the Spanish Committee on the Welfare and Protection of Animals of Production.

Final disposition first. Basic character and competence title.

This royal decree is of a basic nature and is dictated by the powers recognized by the Constitution in its article 149.1.13. ª, 15. and 16. the Constitution, which attributes to the State exclusive competence in the field of bases and coordination of the general planning of economic activity, the promotion and general coordination of scientific and technical research, and of bases and general coordination of health.

Final disposition second. Incorporation of Community law.

By this royal decree, Directive 2010 /63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes is incorporated into our legal order.

Final disposition third. Right of amendment.

The head of the Ministry of Agriculture, Food and the Environment is empowered to modify the annexes of this royal decree, in order to adapt them to the Community or international regulations.

Final disposition fourth. Entry into force.

This royal decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid, on February 1, 2013.

JOHN CARLOS R.

The Vice President of the Government and Minister of the Presidency,

SORAYA SAENZ DE SANTAMARIA ANTON

ANNEX I

Species referred to in Article 19

1. Mouse (Mus musculus).

2. Rat (Rattus norvegicus).

3. Cobaya (Cavia porcellus).

4. Syrian Hamster (dorado) (Mesocricetus auratus).

5. Chinese Hamster dwarf (Cricetulus griseus).

6. Mongolia's Jerbo (Ointiculatus Merions).

7. Rabbit (Oryctolagus cuniculus).

8. Dog (Canis familiaris).

9. Cat (Felis catus).

10. All non-human primate species.

11. Frog [Xenopus (laevis, tropicalis), Rana (temporaria, pipiens)].

12. Zebrafish (Danio rerio).

ANNEX II

Requirements for establishments and accommodation and care for animals

Section A: General Section

1. Installations.

1.1 Functions and overall design.

(a) All installations must be constructed in such a way as to ensure an environment which takes into account the physiological and ethological needs of the species housed therein. They should also be designed and managed with a view to preventing unauthorised access and entry or flight of animals.

(b) The establishments must implement an active maintenance programme in order to avoid and repair any defects in the buildings or the material.

1.2 Accommodation premises.

(a) The establishments must have an efficient program of regular cleaning of the premises and maintain a satisfactory hygienic level.

(b) The walls, ceilings and floors must be covered with impermeable material when necessary and resistant to the great wear and tear caused by the animals and the cleaning operations. Such coating material should not be harmful to the health of the animals or cause the animals to be harmed. Devices or accessories should be specially protected to prevent animals from spoiling or injuring them.

(c) Species that are incompatible, such as predators and prey, or animals that need different environmental conditions, should be housed in different premises and, in the case of predators and their prey, out of the reach of their sight, smell or hearing.

1.3 Locals for general and special purposes for performing procedures.

(a) The establishments should, where appropriate, have laboratory facilities available for simple diagnostic tests, necropsies, or for samples to be submitted to wider laboratory investigations elsewhere. Premises for carrying out procedures for general or special purposes should be available for situations where it is not advisable to carry out procedures or observations in accommodation premises.

(b) Facilities should be available to allow the isolation of newly acquired animals until their health status is determined and the potential health risk to other animals is assessed and minimised.

c) Local should be available to accommodate sick or injured animals separately.

1.4 Service Locals.

(a) Storage premises should be designed, used and maintained in such a way as to preserve the quality of feed and bedding. Those premises should be as far as possible to test for parasites and insects. Materials of other type, which may be contaminated or pose a danger to animals or personnel, must be stored separately.

b) Cleaning and washing facilities should be large enough to accommodate the facilities needed to decontaminate and clean the used material. The cleaning process should be arranged in such a way that the flows of clean and dirty materials are kept separate in order to avoid contamination of the freshly cleaned material.

c) The establishments should take measures for the safe disposal and disposal of the carcasses and residues of the animals under satisfactory hygiene conditions.

d) When surgical procedures are necessary in aseptic conditions, one or more duly equipped rooms, as well as facilities for post-operative recovery, shall be available.

2. The environment and its control.

2.1 Ventilation and temperature.

(a) The insulation, heating and ventilation of the accommodation premises shall ensure that air circulation, dust levels and gas concentrations are maintained within limits that are not harmful to the animals being housed.

(b) The temperature and relative humidity in the accommodation premises must be adapted to the species and age groups of the animals being housed. The temperature should be measured and recorded daily.

(c) Animals should not be required to remain in external areas under climatic conditions which may be potentially harmful or may cause distress to them.

2.2 Lighting.

(a) When natural light does not guarantee an adequate cycle of light-dark, a controlled lighting system must be provided to meet the biological needs of the animals and provide a suitable means of work.

b) Lighting should be suitable for handling and inspection of animals, without this being a stress for animals

c) Regular photoperiods should be provided, with a light intensity adapted to the species.

d) If you have albino animals, the lighting must be adapted to take into account your special sensitivity to light.

2.3 Noise.

(a) Noise levels, including ultrasounds, should not adversely affect animal welfare.

(b) The establishments must have alarm systems which, if they are acoustic, emit sounds outside the sensitive audible spectrum of the animals, when this does not interfere with their audibility for humans.

(c) Accommodation premises should, where appropriate, be provided with insulation materials and sound absorption.

2.4 Emergency and alarm systems.

(a) Establishments that rely on mechanical or electrical devices for the control and regulation of environmental conditions should have alternative systems that ensure that essential services and emergency lighting devices continue to operate, and that they prevent the alarm systems themselves from operating.

(b) The heating and ventilation systems must be equipped with control and alarm devices.

c) Clear instructions on the actions to be developed in the event of an emergency should be displayed.

3. Care for animals.

3.1 Health.

(a) The establishments should have a strategy to ensure the maintenance of an animal health condition that ensures their well-being and meets the scientific requirements. This strategy should include regular health monitoring, a microbiological surveillance programme and action plans in the face of health problems, the definition of health parameters and protocols for the introduction of new animals.

b) A trained person must perform at least once a day a control of the animals. Such checks should ensure that any sick or injured animal is detected and receives the necessary care.

3.2 Animals caught in the wild.

(a) In the places of capture, where it is necessary to transfer the animals for examination or treatment, containers and means of transport adapted to the species concerned should be available.

(b) Special consideration should be given and appropriate measures taken for acclimatisation, quarantine, accommodation, zootechnics, care of animals caught in the wild and, where appropriate, provisions for their release at the end of the proceedings.

3.3 Accommodation and enrichment.

a) Accommodation.

Animals, except those that are by their solitary nature, should be housed in stable groups of compatible individuals. Where the individual accommodation is permitted in accordance with Article 6.3, its duration should be limited to the minimum necessary, and a visual, auditory, olfactory and/or tactile contact should be maintained. The introduction or reintroduction of animals into established groups should be monitored carefully in order to avoid problems of incompatibility or a disturbance in social relations.

b) Environmental enrichment.

All animals should have a sufficient space of complexity to allow them to express a wide range of normal behaviors. They must have a certain degree of control and choice of their environment, in order to reduce the behaviors induced by stress. Establishments should have adequate enrichment techniques that extend the range of activities within the range of the animal and develop their capacity to adapt, such as physical exercise, food search and manipulation and exploration activities, depending on the species. The environmental enrichment of the animal enclosure must be adapted to the individual's needs and to the species ' own needs. The enrichment strategies of the establishments should be reviewed and updated regularly.

c) Animal enclosures.

Enclosures should be manufactured with materials that are not harmful to animal health. They must be designed and constructed in such a way as to avoid injury. If they are not disposable, they must be manufactured with materials resistant to cleaning and decontamination techniques. The design of the floors of the enclosures must be adapted to the species and age of the animals and facilitate the disposal of excrement.

3.4 Power.

(a) The form, composition and presentation of feed or other food must be in response to the nutritional and behavioural needs of the animal.

b) Diet should be appetising and not contaminated. In the selection of raw materials and in the production, preparation and presentation of food for animals, establishments should take measures to minimise chemical, physical and microbiological contamination.

(c) Packaging, packaging, transport and storage of feed should be planned in such a way as to avoid contamination, deterioration or destruction. All feeders, hoppers and other utensils used for feeding must be cleaned regularly and, if necessary, sterilised.

(d) Each animal must have access to the food and have sufficient space to limit competition with other animals.

3.5 Water.

(a) All animals must permanently dispose of uncontaminated drinking water.

(b) Where automatic water supply systems are used, their operation should be subject to periodic inspection, maintenance and cleaning in order to avoid accidents. If compact floor cages are used, the risk of flooding should be minimised.

c) The necessary measures should be taken to adapt the water supply of the aquariums and terrariums to the needs and limits of tolerance of each species of fish, amphibians and reptiles.

3.6 Rest zones.

(a) Animals should always be provided with rest structures or bed materials adapted to the species, as well as nesting structures or materials for breeding animals.

b) In the animal enclosure, according to the needs of each species, a solid and comfortable resting surface must be provided for all animals. All sleeping areas should be kept clean and dry.

3.7 Handling.

Establishments should develop appropriate acclimation and learning programmes for the animals, procedures and duration of the project.

Section B: Specific Sections

1. Mice, rats, jerbos, hamsters and guinea pigs.

In the following tables on mice, rats, jerbos, hamsters and guinea pigs, the "height of the enclosure" means the vertical distance between the floor and the upper part of the enclosure; this height must be available in more than 50 percent of the minimum surface of the floor of the enclosure before the introduction of enrichment elements.

When planning procedures, account should be taken of the potential growth of animals in order to ensure adequate space for them (as shown in Tables 1.1 to 1.5) throughout the study.

Table 1.1 Ratons

	Body weight (g)	Minimum enclosure dimension (cm²)	Soil surface by animal (cm²)	Minimum enclosure height (cm)	Date referred to in Article 6.2
In reserve and during procedures.	Up To 20. From more than 20 to 25. From more than 25 to 30. More than 30.	330 330 330 330	60 70 80 100	12 12 12 12	1 January 2017
.		330 For a monogamous (non-consanguine/consanguinee) or a trio (consanguineum) pair. For each additional female and your litter must be added another 180 cm²		12
In reserve on breeders *.	Less than 20.	950	40	12
standby in breeders *.	Less than 20.	1,500	30	12

* Mice weaned, and until dispatch, and provided that their weight is less than 20 grams, and the enclosure has a minimum surface of 950 cm² can be maintained at a density of up to 40 cm²/animal, or 30 cm²/animal if the enclosure surface is at least 1,500 cm².They will also not be able to keep to these higher densities if there is some well-being, such as increased aggressiveness, morbidity or mortality, stereotyping, other behavioral abnormalities, weight loss, or other physiological or behavioral responses to stress.

Table 1.2 Rats

	Body weight (g)	Minimum enclosure dimension (cm²)	Soil surface by animal (cm²)	Minimum enclosure height (cm)	Date referred to in Article 6, paragraph 2
	In reservation and during procedures *.	Up to 200. From more than 200 to 300. From more than 300 to 400. From more than 400 to 600. More than 600.	800 800 800 800 1,500	200 250 350 450 600	18 18 18 18 18	1 January
.		800 Mother and litter. For each additional adult animal, permanently introduced into the enclosure, another 400 cm² must be added		18
Reserve in breeders * *. The enclosure dimension 1 500 cm².	Up to 50. From more than 50 to 100. Over 100 to 150. From more than 150 to 200.	1,500 1,500 1,500 1,500	100 125 150 175	18 18 18 18
Reserve in breeders * *. The enclosure dimension 2 500 cm².	Up to 100. Over 100 to 150. From more than 150 to 200.	2,500 2,500 2,500	100 125 150	18 18 18

* In long-term studies, if the minimum space available for each animal is lower than that indicated above towards the end of these studies, priority should be given to maintaining stable social structures.

** The rats, once weaned, can remain with those higher occupancy densities in the short period between weaning and expedition, provided that they are housed in larger enclosures with adequate enrichment and these housing conditions do not produce any welfare loss such as increased aggressiveness, morbidity or mortality, stereotyping and other behavioral abnormalities, weight loss, or other physiological or behavioral responses to stress.

Table 1.3 Jerbos

	Body weight (g)	Minimum enclosure dimension (cm²)	Soil surface by animal (cm²)	Minimum enclosure height (cm)	Date referred to in Article 6, paragraph 2
	In reserve and during procedures.	Up to 40. Over 40.	1,200 1,200	150 250	18 18	January 1, 2017
.		1,200 Monogamous pair or trio with offspring.		18

Table 1.4 Hamsters

	Body weight (g)	Minimum enclosure dimension (cm²)	Soil surface by animal (cm²)	Minimum enclosure height (cm)	Date referred to in Article 6, paragraph 2
	In reserve and during procedures.	Up to 60. From more than 60 to 100. More than 100.	800 800 800	150 200 250	14 14 14	January 1, 2017
.		800 Mother or partner monogamous with litter		14
standby in breeders *.	Less than 60.	1,500	100	14

* Hamsters, once weaned, can remain with those higher occupancy densities, in the short period between weaning and expedition, provided that they are housed in larger enclosures with adequate enrichment and these conditions of accommodation do not produce any well-being, such as increased aggressiveness, morbidity or mortality, stereotyping and other behavioral abnormalities, weight loss, or other physiological or behavioral responses to stress.

Table 1.5 Cobayas

	Body weight (g)	Minimum enclosure dimension (cm²)	Soil surface by animal (cm²)	Minimum enclosure height (cm)	Date referred to in Article 6, paragraph 2
	In reserve and during procedures.	Up to 200. From more than 200 to 300. From more than 300 to 450. From more than 450 to 700. Over 700.	1,800 1,800 1,800 2,500 2,500	200 350 500 700 900	23 23 23 23 23
.		2,500 Partner with litter. For each additional breeding female, another 1,000 cm² should be added.		23

2. Rabbits. In the framework of an agricultural research, where the objective of the project is to ensure that the animals are kept in a similar condition to those of animals from commercial holdings, the animal housing must comply with at least the standards set out in Royal Decree 348/2000 of 10 March, incorporating Directive 98 /58/EC on the protection of animals on livestock farms.

A platform must be provided within the enclosure. That platform has to allow the animal to lie down, sit and move easily underneath, but it should not cover more than 40 per cent of the ground. Where, for reasons of a scientific or veterinary nature, a platform cannot be used, the enclosure must be 33 per cent greater for a rabbit alone, and 60 per cent greater for two rabbits. Where a platform is provided for rabbits less than 10 weeks of age, the surface of such a platform must be at least 55 x 25 cm and its height in relation to the soil must be suitable for use by the animals.

Table 2.1 Over 10-Week Conejos

Table 2.1 refers to both cages and fences. The additional floor area is at least 3 000 cm² per rabbit for the third, fourth, fifth and sixth animals, while at least 2 500 cm² should be added for each rabbit that is placed above six.

	body weight (kg)	Minimum soil surface for one or two socially harmonious animals (cm²)	Minimum height (cm)	Date referred to in Article 6, paragraph 2
than 3. Between 3 and 5. More than 5.	3 500 4 200 5 400	45 45 60	January 1, 2017

Table 2.2 With litter

Weight of the eyebrow

(kg)

Minimum enclosure surface (cm²)	Supplement for nest boxes (cm²)	Minimum height (cm)	Date referred to in Article 6 (2
Less than 3. Between 3 and 5. More than 5.	3,500 4,200 5,400	1,000 1,200 1,400	45 45 60	January 1 de.2017

Table 2.3 Counts of less than 10 weeks

Table 2.3 refers to both cages and fences.

	Minimum enclosure surface (cm²)	Minimum floor area per animal (cm²)	Minimum height (cm)	Date referred to in Article 6, paragraph 2
Between weaning and 7 weeks.	4,000	800	40	January 1, 2017
7 and 10 weeks.	4,000	1,200	40

Table 2.4 Conejos: optimal dimensions of the platforms for enclosures having the dimensions indicated in Table 2.1

in weeks

Final body weight (kg)	Optimal dimension (cm x cm)	Optimal height from enclosure floor (cm)	Date referred to in Article 6, paragraph 2
More than 10.	Less than 3.	55 x 25	25	January 1, 2017
	Between 3 and 5.	55 x 30	25
	More than 5.	60 x 35	30

3. Cats. Cats should not be individually housed more than 24 hours in a row. Cats that are repeatedly aggressive towards other cats should only be housed individually if a compatible partner cannot be found. The social stress of all individuals housed by couples or groups should be monitored at least once a week. Females in the last two weeks of gestation or with offspring of less than four weeks may be individually housed.

Table 3. Cats

The minimum space in which you can keep a cat and your litter is that of a cat alone, gradually increasing in such a way that when the pups are four months old, they have been rehoused in accordance with the space requirements indicated for the adults.

Zones for food and for sanitary trays should not be at a distance of less than 0.5 meters and should not be exchanged.

	Soil * (m²)	Platforms (m²)	Height (m)	Date referred to in Article 6, paragraph 2
Minimum for an adult animal.	1.5	0.5	2	January 1, 2017
each additional animal.	0.75	0.25	-

* Surface area with exclusion of platforms.

4. Dogs. Dogs must be moved when possible to an outside area where they can exercise. The individual accommodation should not be prolonged for more than four hours.

The inner enclosure size must not be less than 50 per cent of the minimum space available for dogs as detailed in Table 4.1.

The dimensions of available space indicated in the following tables are based on the needs of the Beagle, so the giant races such as the San Bernardo or the Irish lob must have a considerably larger space than the one indicated in Table 4.1. For races other than the Beagle of experimentation, the available space needs should be decided with advice from the veterinary staff.

Table 4.1 Dogs

Dogs housed in pairs or groups may be confined, each, to half of the total space provided (2 m² for a dog of less than 20 kg, 4 m² for one of more than 20 kg), while undergoing the procedures defined in this royal decree, if such isolation is essential for scientific purposes. The time during which the dog is subject to these limitations should not be prolonged for more than four hours.

A lactating dog and its litter must have the same space as a single dog of equivalent weight. The breeding grounds must be designed in such a way that the dog can move to an attached compartment or a separate platform of the puppies.

Weight

(kg)

Minimum enclosure dimension (m²)	Minimum floor area for one or two animals (m²)	For each additional animal, add a minimum of (m²)	Minimum Height (m)	Date referred to in article 6, paragraph 2
to 20. More than 20.	4 8	4 8	2 4	2 2	1 January 2017

Table 4.2 Dogs: Space available after weaning

	weight (kg)	Minimum enclosure dimension (m²)	Minimum floor/animal surface area (m²)	Minimum height (m)	Date referred to in Article 6, paragraph 2
	5.	4	0.5	2	January 1, 2017
more than 5 to 10.	4	1.0	2
more than 10 to 15.	4	1.5	2
more than 15 to 20.	4	2	2
20.	8	4	2

5. Ferrets.

Table 5. Ferrets

	Minimum enclosure dimension (cm²)	Minimum floor area per animal (cm²)	Minimum height (cm)	Date referred to in Article 6, paragraph 2
up to 600 g.	4,500	1,500	50	1.de.January de.2017
over 600 g.	4,500	3,000	50
Machos.	6,000	6,000	50
and litter.	5,400	5,400	50

6. Primates. Young primates should not be separated from their mother before they reach, depending on the species, an age of six to twelve months.

The environment should allow primates to develop a complex daily program of activities. The enclosure should allow primates to adopt as wide a repertoire of conduct as possible, give them a sense of security and provide a complex enough environment for them to run, ride, climb and jump.

Table 6.1 Tities and Tamarins

	Minimum enclosure floor area for 1 * or 2 animals, plus pups up to 5 months (m²)	Minimum volume per additional animal over 5 months (m³)	Minimum enclosure height (m) * *	Date referred to in Article 6, paragraph 2
Tities.	0.5	0.2	1.5	January 1, 2017
Tamarinos.	1.5	0.2	1.5

* Animals will only be housed individually in exceptional circumstances.

** The upper limit of the enclosure must be at least 1.8 m from the floor.

Young tities and tamarins should not be separated from the mother before the age of eight months.

Table 6.2 Saimiris

floor space for 1 * or 2 animals (m²)	Minimum volume for each additional animal over 6 months (m³)	Minimum enclosure height (m)	Date referred to in Article 6, paragraph 2
2.0	0.5	1.8	1 January

* Animals will only be housed individually in exceptional circumstances.

Young tities and tamarins should not be separated from the mother before the age of six months.

Table 6.3 Macaques and Green Monkeys *

	Minimum enclosure dimension (m²)	Minimum enclosure volume (m³)	Minimum volume per animal (m³)	Minimum enclosure height (m)	Date referred to in Article 6, paragraph 2
Animals less than 3 years of age * *.	2.0	3.6	1.0	1.8	January 1, 2017
from 3 years of age * **.	2.0	3.6	1.8	1.8
for Playback * ***.			3.5	2.0

* Animals will only be housed individually in exceptional circumstances.

** In an enclosure of the minimum dimensions, up to three animals can be accommodated.

*** In an enclosure of the minimum dimensions you can accommodate up to two animals.

**** In the breeding colonies there is no need for extra space/volume for young animals up to 2 years of age with their mother.

Young macaques and green monkeys should not be separated from the mother before the age of eight months.

Table 6.4 Baboons *

	Minimum enclosure dimension (m²)	Minimum enclosure volume (m³)	Minimum volume per animal (m³)	Minimum enclosure height (m)	Date referred to in Article 6, paragraph 2
Animals * * less than 4 years of age.	4.0	7.2	3.0	1.8	January 1, 2017
* * from 4 years of age.	7.0	12.6	6.0	1.8
for Playback * **.			12.0	2.0

* Animals will only be housed individually in exceptional circumstances.

** In an enclosure of the minimum dimensions you can accommodate up to 2 animals.

*** In the breeding colonies there is no need for extra space/volume for young animals up to 2 years of age with their mother.

Young baboons should not be separated from the mother before the age of eight months.

7. Other farm animals. In the context of an agricultural investigation, where the objective of the project is to ensure that the animals are kept in a similar condition to those of the animals of the commercial holdings, the accommodation of the animals must comply with at least the rules laid down in Royal Decree 348/200 of 10 March, incorporating Directive 98 /58/EC on the protection of animals in livestock holdings, in Royal Decree 1047/1994 of 20 May 1994 on minimum standards for the protection of calves and on the Royal Decree 1135/2002 of 31 October concerning minimum standards for the protection of pigs.

Table 7.1 Bovine cattle

	weight (kg)	Minimum enclosure dimension (m²)	Minimum soil/animal surface area (m2/animal)	Feeder length for bovines ad libitum feed (m/animal)	Length of feedlot for the restricted feeding of uncorned bovines (m/animal)	Date referred to in Article 6 (2
to 100.	2.50	2.30	0.10	0.30	January 1, 2017
more than 100 to 200.	4.25	3.40	0.15	0.50
over 200 to 400.	6.00	4.80	0.18
over 400 to 600.	9.00	7.50	0.21
more than 600 to 800.	11.00	8.75	0.24
800.	16.00	10.00	0.30	1.00

Table 7.2 Owines and goats

	weight (kg)	Minimum enclosure dimension (m²)	Minimum soil/animal surface area (m2/animal)	Minimum height of enclosures between enclosures (m)	Power-feeder length ad libitum (m/animal)	The feed length for restricted power (m/animal)	Date referred to in Article 6, paragraph 2
than 20.	1.0	0.7	1.0	0.10	0.25	January 1, 2017
more than 20 to 35.	1.5	1.0	1.2	0.10
more than 35 to 60.	2.0	1.5	1.2	0.12
60.	3.0	1.8	1.5	0.12	0.50

Table 7.3 dwarf pigs and pigs

weight (kg)	Minimum enclosure dimension * (m²)	Minimum floor area per animal (m2/animal)	Minimum resting zone per animal (in thermally neutral conditions) (m2/animal)	Date referred to in the article 6, paragraph 2
to 5.	2.0	0.20	0.10	January 1, 2017
more than 5 to 10.	2.0	0.25
more than 10 to 20.	2.0	0.35
more than 20 to 30.	2.0	0.50	0.24
more than 30 to 50.	2.0	0.70
over 50 to 70.	3.0	0.80
more than 70 to 100.	3.0	1.00
more than 100 to 150.	4.0	1.35
150.	5.0	2.50
Verracs (conventional).	7.5

pigs may be confined in smaller enclosures for a short period of time, for example by dividing the main enclosure by separators, when justified by veterinary or experimental reasons, such as when individual food consumption is required.

Table 7.4 Equals

The shorter side must measure at least 1.5 times the height of the animal's cross. The height of the inner enclosures must be such that the animals can stand on their hind legs.

Height to cross (m)

Minimum floor/animal surface (m2/animal)			Minimum enclosure height (m)	Date referred to in Article 6, paragraph 2
each animal hosted individually or in groups of 3 animals at most	For each animal hosted in groups of 4 animals or more	Breeding/mare with
to 1.40.	9.0	6.0	16	3.00	January 1, 2017
more than 1.40 to 1.60.	12.0	9.0	20	3.00
than 1.60.	16.0	(2 x AC) ² *	20	3.00

* In order to ensure sufficient space, the minimum space needs for each individual animal must be calculated according to the height of the cross (AC).

8. Birds. In the context of agricultural research, where the objective of the project is to establish that the animals are kept in similar conditions to those of animals from commercial farms, the accommodation of the animals must comply with at least the standards set out in Royal Decree 348/2000 of 10 March, which incorporates Directive 98 /58/EC on the protection of animals in livestock holdings, in Royal Decree 2/2002 of 1 January laying down minimum standards for the protection of laying hens and the Royal Decree of 10 March 2000. Decree 692/2010 of 20 May 2010 laying down minimum standards for the protection of chickens intended for the production of meat and amending Royal Decree No 1047/21994 of 20 May 1994 on minimum standards for the protection of calves.

Table 8.1 Gallins

If for scientific reasons these minimum dimensions cannot be provided, the experimenter must justify the duration of the confinement, in consultation with the veterinary staff. In those circumstances, birds can be housed in smaller, conveniently enriched enclosures and with a minimum floor area of 0.75 m².

	Mass (g)	Minimum enclosure dimension (m²)	Minimum surface per bird (m²)	Minimum height (cm)	Minimum feedlot length (cm)	Date referred to in article 6, paragraph 2
to 200.	1.00	0.025	30	3	January 1, 2017
over 200 to 300.	1.00	0.03	30	3
more than 300 to 600.	1.00	0.05	40	7
over 600 to 1 200.	2.00	0.09	50	15
more than 1 200 to 1 800.	2.00	0.11	75	15
more than 1 800 to 2 400.	2.00	0.13	75	15
More than 2 400.	2.00	0.21	75	15

Table 8.2 Domestic Paves

All sides of the enclosure must measure at least 1.5 m long. If, for scientific reasons, these minimum dimensions cannot be provided, the experimenter must justify the duration of the confinement, in consultation with the veterinary staff. In those circumstances, birds may be housed in smaller, suitably enriched enclosures and with a minimum floor area of 0,75 m² and a minimum height of 50 cm in the case of birds of less than 0,6 kg, 75 cm in the case of birds of less than 4 kg, and 100 cm in the case of birds of more than 4 kg. These enclosures can be used to accommodate small groups of birds according to the minimum available space indicated in Table 8.2.

	Mass (kg)	Minimum enclosure dimension (m²)	Minimum surface per bird (m²)	Minimum height (cm)	Minimum feedlot length (cm)	Date referred to in article 6, paragraph 2
to 0.3.	2.00	0.13	50	3	January 1, 2017
more than 0.3 to 0.6.	2.00	0.17	50	7
more than 0.6 to 1.	2.00	0.30	100	15
more than 1 to 4.	2.00	0.35	100	15
more than 4 to 8.	2.00	0.40	100	15
more than 8 to 12.	2.00	0.50	150	20
12 to 16.	2.00	0.55	150	20
more than 16 to 20.	2.00	0.60	150	20
than 20.	3.00	1.00	150	20

Table 8.3 Codorices

	Masa (g)	Minimum enclosure dimension (m²)	Couple-hosted bird surface (m²)	Group-hosted additional bird surface (m²)	Minimum height (cm)	Minimum feedlot length (cm)	Date referred to in article 6, paragraph 2
to 150.	1.00.	0.5	0.10	20	4	January 1, 2017
150.	1.00.	0.6	0.15	30	4

Table 8.4 Patos and ocas

If for scientific reasons these minimum dimensions cannot be provided, the experimenter must justify the duration of the confinement, in consultation with the veterinary staff. In those circumstances, birds can be housed in smaller, conveniently enriched enclosures and with a minimum floor area of 0.75 m². These enclosures can be used to accommodate small groups of birds according to the minimum available space indicated in Table 8.4.

	Mass (g)	Minimum enclosure dimension (m²)	Surface by bird (m²) *	Minimum height (cm)	Minimum feedlot length (cm)	Date referred to in Article 6, paragraph 2
					Patos					1 January 2017
to 300.	2.00	0.10	50	10
over 300 to 1 200 * *.	2.00	0.20	200	10
more than 1 200 to 3 500.	2.00	0.25	200	15
More than 3 500.	2.00	0.50	200	15
					Ocas
to 500.	2.00	0.20	200	10
over 500 to 2 000.	2.00	0.33	200	15
More than 2 000.	2.00	0.50	200	15

* This surface must include a pond with at least a surface of 0.5 m² per 2 m² of enclosure and a minimum depth of 30 cm. The pond can occupy up to 50 per cent of the minimum area of the enclosure.

** Birds that do not yet have feathers can be housed in enclosures with a minimum height of 75 cm.

Table 8.5 Patos and ocas: Minimum ponds of ponds *

	Surface (m²)	Depth (cm)
Patos.	0.5	30
Ocas.	0.5	Between 10 and 30

* These dimensions correspond to 2 m² of enclosure. The pond can occupy up to 50 per cent of the minimum area of the enclosure.

Table 8.6 Palomes

The enclosures must be long and narrow (for example, 2 m per 1 m), rather than squares, so that birds can make short flights.

	size	Minimum enclosure dimension (m²)	Minimum height (cm)	Minimum feedlot length (cm)	Minimum length of perch per bird	Date referred to in article 6, paragraph 2
to 6.	2	200	5	30	1 January 2017
	Between 7 and 12.	3	200	5		30
By additional bird beyond 12.	0.15		5	30

Table 8.7 Mandarin Diamonds

The enclosures must be long and narrow (for example, 2 m per 1 m) so that the birds can make short flights. For reproduction studies, couples can be accommodated in smaller enclosures, suitably enriched, with a minimum floor area of 0.5 m² and a minimum height of 40 cm. The experimenter must justify the duration of the confinement, in consultation with the veterinary staff.

	size	Minimum enclosure dimension (m²)	Minimum height (cm)	Minimum number of feeders	Date referred to in Article 6, paragraph 2
to 6.	1.0	100	2	January 1, 2017
Between 7 and 12.	1.5	200	2
13 and 20.	2.0	200	3
By additional bird beyond 20.	0.05		1 for every 6 birds

9. Amphibians.

Table 9.1 Aquatic

Body length *

(cm)

Minimum water surface (cm²)	Minimum water surface per additional animal-hosted group (cm²)	Minimum water depth (cm)	Date referred to in Article 6 (2)
To 10.	262.5	50	13	January 1, 2017
more than 10 to 15.	525	110	13
more than 15 to 20.	875	200	15
more than 20 to 30.	1.837.5	440	15
30.	3.150	800	20

* Measure from the front end of the head to the sewer.

Table 9.2 Water Anides *

length ** (cm)	Minimum water surface (cm²)	Minimum water surface per additional animal-hosted group (cm²)	Minimum water depth (cm)	Date referred to in Article 6 (2)
than 6.	160	40	6	January 1, 2017
Between 6 and 9.	300	75	8
more than 9 to 12.	600	150	10
More than 12.	920	230	12.5

* These conditions apply to maintenance aquariums, but for reasons of effectiveness they do not apply to aquariums used for natural mating and superovulation, since these last procedures require smaller aquariums. The minimum spaces in the table correspond to adults of the indicated sizes; young animals and tadpoles must be kept apart or the dimensions of the aquarium should be modified proportionally to the size scale.

** Measure from the front end of the head to the sewer.

Table 9.3 Semi-aquatic anides

Body length *

(cm)

Minimum enclosure dimension * * (cm²)	Minimum area per additional animal-hosted group (cm²)	Minimum enclosure height * ** (cm)	Minimum water depth (cm)	Date referred to in article 6, paragraph 2
to 5.0.	1,500	200	20	10	January 1, 2017
more than 5.0 to 7.5.	3,500	500	30	10
More than 7.5.	4,000	700	30	15

* Measure from the front end of the head to the sewer.

** One third of land and two thirds of water where the animals can be submerged.

*** Measure from the surface of the ground area to the inside of the roof of the terrarium; in addition, the height of the enclosures must be adapted to the interior equipment.

Table 9.4 Semi-terrestrial Anides

Body length *

(cm)

Minimum enclosure dimension * * (cm²)	Minimum area per additional animal-hosted group (cm²)	Minimum enclosure height * ** (cm)	Minimum water depth (cm)	Date referred to in article 6, paragraph 2
to 5.0.	1,500	200	20	10	January 1, 2017
more than 5.0 to 7.5.	3,500	500	30	10
More than 7.5.	4,000	700	30	15

* Measure from the front end of the head to the sewer.

** Two-thirds of the land and a third of the water where the animals can be submerged.

*** Measure from the surface of the ground area to the inside of the roof of the terrarium; in addition, the height of the enclosures must be adapted to the interior equipment.

Table 9.5 Arboricultural Anides

Body length *

(cm)

Minimum enclosure dimension * * (cm²)	Minimum area per additional animal-hosted group (cm²)	Minimum enclosure height * ** (cm)	Date referred to in Article 6 (2)
to 3.0.	900	100	30	January 1, 2017
More than 3.0.	1,500	200	30

* Measure from the front end of the head to the sewer.

** Two-thirds of the land and a third of the water where the animals can be submerged.

*** Measure from the surface of the ground area to the inside of the roof of the terrarium; in addition, the height of the enclosures must be adapted to the interior equipment.

10. Reptiles.

Picture 10.1 Aquatic Turtles

Body length *

(cm)

Minimum water surface (cm²)	Minimum water surface per additional animal-hosted group (cm²)	Minimum water depth (cm)	Date referred to in Article 6 (2)
To 5.	600	100	10	January 1, 2017
more than 5 to 10.	1,600	300	15
more than 10 to 15.	3,500	600	20
more than 15 to 20.	6,000	1,200	30
more than 20 to 30.	10,000	2,000	35
30.	20,000	5,000	40

* A straight line measure from the front to the rear of the shell.

Table 10.2 Terrestrial Serpents

Body length *

(cm)

Minimum floor area (cm²)	Minimum area per additional animal-hosted group (cm²)	Minimum enclosure height * * (cm)	Date referred to in Article 6, paragraph 2
Up to 30.	300	150	10	January 1, 2017
more than 30 to 40.	400	200	12
more than 40 to 50.	600	300	15
more than 50 to 75.	1,200	600	20
75.	2,500	1,200	28

* Measure from the front end of the head to the queue.

** Measure from the surface of the ground area to the inside of the roof of the terrarium; in addition, the height of the enclosure must be adapted to the interior equipment.

11. Fish.

11.1 Supply and quality of water.

A proper supply of water of the right quality should be provided at all times. The flow of water in the recirculation or filtering systems in the tanks should be sufficient to maintain the parameters of water quality at acceptable levels. The water supplied must be filtered or treated in order to remove the harmful substances for fish, where necessary. Water quality parameters should always be within the range acceptable for the physiology and normal activity of the species concerned and their stage of development. The water flow should be suitable to allow the fish to swim properly and maintain their normal behavior. Fish should be given adequate time for their acclimation and adaptation to changes in water quality conditions.

11.2 Oxygen, nitrogenous compounds, pH and salinity.

The oxygen concentration must be adequate for the species and the environment in which the fish are maintained. If necessary, the aeration of the tank water should be supplemented. Concentrations of nitrogenous compounds should be kept low.

The pH level should be adapted to the needs of the species and kept as stable as possible. The salinity must be adapted to the needs of the species concerned and to the life of the fish. Any change of salinity should be done gradually.

11.3 Temperature, lighting, noise.

The temperature must be kept within the optimal range for the species concerned and as stable as possible. Any changes should occur gradually. The appropriate photoperiod should be provided to the fish. The noise level must be reduced to a minimum, and as far as possible, equipment that causes noise or vibration, such as electrical generators or filtration systems, must be separated from the tanks where the animals are housed.

11.4 Density of occupancy and complexity of the environment.

Density of occupancy must be based on the totality of the needs of the fish as far as the conditions of the environment, health and welfare are concerned. Fish should have a sufficient volume of water to allow them to swim normally, taking into account their size, age, health status and the feeding system used. Fish should be provided with adequate environmental enrichment, such as hiding places or background substrate, unless their behavioural patterns suggest that it is not necessary.

11.5 Power and handling.

Fish will be fed with a proper diet and in adequate quantity and frequency. Special attention should be paid to feeding the larvae when it is passed from live food to artificial diets. Fish handling should be reduced to the minimum possible.

ANNEX III

Animal euthanasia methods

1. For the euthanasia of animals, the methods listed in the table in point 3 shall be used.

However, other methods other than those listed in the table in point 3 may be used:

a) If the animals are unconscious, provided that they do not regain consciousness before they die.

(b) If the animals are used in the framework of an agricultural research, where the objective of the project is to ensure that the animals are kept in a similar condition to those of the animals of the commercial holdings, in which case they may be slaughtered in accordance with the requirements laid down in Annex I to Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of slaughter.

2. The euthanasia of animals should be completed by one of the following methods:

(a) Confirmation of the permanent cessation of movement.

b) Destruction of the brain.

c) Cervical luxation.

d) Disanglement.

e) Confirmation of the beginning of rigor mortis.

3. Table.

	, Observations/methods	Ffish	amphibians	reptiles	Birds	rodents	rabbits	Dogs, cats, ferrets and foxes	Large mammals	Primates
anesthetic overdose.	(1)	(1)	(1)	(1)	(1)	(1)	(1)	(1)	(1)
piercing plug's Pistola.			(2)
dioxide.					(3)
Cervical Dislocation.				(4)	(5)	(6)
Conmotion of the brain/blunt strike on the head.				(7)	(8)	(9)	(10)
Decapitation.				(11)	(12)
Aturment.	(13)	(13)		(13)		(13)	(13)	(13)
inert gases (Ar, N2).								(14)
with appropriate rifles, pistols, and ammunition.			(15)				(16)	(15)

Requirements:

1) It should be used, where appropriate, after sedation of the animal.

2) Only in large reptiles.

3) Only with gradual release of gas. Do not use in rodent fetuses and in neonates.

4) Only for birds of less than 1 kg. Birds over 250 g must be sedated.

5) Only for rodents of less than 1 kg. Rodents over 150 g should be sedated.

6) Only for rabbits of less than 1 kg. Rabbits over 150 g should be sedated.

7) Only for birds of less than 5 kg.

8) Only rodents of less than 1 kg.

9) Only for rabbits of less than 5 kg.

10) Only in neonates.

11) Only for birds of less than 250 g.

12) Only if other methods cannot be used.

13) Requires special material.

14) Only in pigs.

15) Only in field conditions by expert shooters.

16) Only in field conditions by expert shooters, if other methods cannot be used.

ANNEX IV

Minimum data to be recorded in the transfer document referred to in Article 9.3

a) Sender: identification of the source center.

(b) Recipient: registration number, in the case of a centre of the European Union.

c) Species: number and identification of animals.

d) Clear instructions on the provision of water, food and special care to animals during their transport.

e) Carrier: number of authorisations for the transport of live animals.

f) Type and identification of means of transport.

g) Expected place, day and time of departure.

h) Estimated duration of the trip.

i) Signature and date of issue.

(j) Where applicable, authorisation of the competent body of the place of destination.

ANNEX V

Minimum data for identification in cages or confinement systems

a) Species.

b) Race (if applicable).

c) Cepa (if applicable).

d) Sex.

e) Date of birth.

f) Date of crossover (if they are pairs).

g) Number of animals.

h) In the user centers, project code or other means to permit the identification of the procedure and the person responsible for the procedure.

i) Remarks.

ANNEX VI

Minimum data on animals to be maintained by breeders, suppliers or users

a) The name and record number of the center.

(b) Number of animals present in the centre at the time of opening of 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 destination and consignee (with reference to the name and address of the consignee).

(e) Animals to which the anesthesia or death not used in procedures has been applied, the causes of death, when known, or, where appropriate, the method of euthanasia used.

f) Animals used in procedures, indicating the project.

g) Where appropriate, the observations made during the quarantine period.

h) The results of the health tests performed on the animals.

i) The results of the necropsies performed.

j) Cases of disease.

k) The treatments administered.

(l) Individual identification data for dogs, cats, primates and other animals for which individual identification is required by national or European Union legislation.

m) The data that correspond, in the case of the production species for which the regulation requires the existence and maintenance of a record book or other requirements for reasons of public health or animal health.

ANNEX VII

Elements to establish minimum requirements for staff education and training

1. National legislation in force related to the acquisition, zootechnics, care and use of animals for scientific purposes.

2. Ethical principles of the relationship between human beings and animals, intrinsic value of life and arguments for and against the use of animals for scientific purposes.

3. Fundamental and adjusted biology to each species in relation to anatomy, physiological aspects, reproduction, genetics and genetic modifications.

4. Ethology, zootechnics and environmental enrichment.

5. Methods for the management of each of the species and procedures, where appropriate.

6. Management of the health and hygiene of animals.

7. Recognition of the distress, pain and suffering characteristic of the most common species of laboratory animals.

8. Anesthesia, methods for calming pain and euthanasia

9. Use of humanitarian endpoints.

10. Requirements for replacement, reduction and refinement.

11. Design of procedures and projects, where appropriate.

ANNEX VIII

Species and dates referred to in Article 21.5

	Date
Titi (Callithrix jacchus).	January 1, 2013
Macaco (Macaca fascicularis)	5 years from the publication of the feasibility study referred to in the fourth subparagraph of Article 10 (1) of Directive 2010/63 of 22 September, provided that the study does not recommend a period of time.
Macaco Rhesus (Macaca mulatta).	5 years from the publication of the feasibility study referred to in the fourth subparagraph of Article 10 (1) of Directive 2010/63 of 22 September, provided that the study does not recommend a period of time.
Other non-human primate species.	5 years from the publication of the feasibility study referred to in the fourth subparagraph of Article 10 (1) of Directive 2010/63 of 22 September, provided that the study does not recommend an extended period.

ANNEX IX

Classification of the severity of the procedures

The severity of a procedure will be determined by the degree of pain, suffering, distress, or lasting damage that an animal is expected to experience individually during the procedure.

Section I: Severity categories

No recovery: Procedures that are performed in their entirety under general anesthesia from which the animal does not regain consciousness, should be classified as "without recovery."

Mild: Procedures as a result of which animals are likely to experience mild pain, suffering or mild distress, as well as procedures without significant alteration of the welfare or general condition of the animals, should be classified as 'mild'.

Moderate: Procedures as a result of which animals are likely to experience moderate, or mild but long-lasting moderate pain, suffering or distress, as well as procedures that may cause a moderate alteration of the welfare or general condition of the animals, should be classified as "moderate".

Severe: The procedures as a result of which animals are likely to experience severe or moderate but lasting pain, suffering or distress, as well as procedures that may cause a serious disturbance to the welfare or general condition of the animals, should be classified as "severe".

Section II: Classification Criteria

The classification of the severity category will take into account any intervention or manipulation of an animal in a given procedure. It will be based on the most severe effect an animal can experience after applying all appropriate refinement techniques.

In the assignment to a procedure of a particular category, the type of procedure and many other factors must be taken into account, which must be considered on a case by case basis.

The factors relating to the procedure must include:

-Types of handling and handling.

-Nature of pain, suffering, distress or lasting damage caused by all elements of the procedure, as well as its intensity, duration, frequency and the multiplicity of techniques employed.

-Cumulative suffering in the procedure.

-Impairment of expressing natural behavior, including restrictions on the standards of accommodation, zootechnics, and care of animals.

Section III sets out the types of procedures attributed to each category of severity on the basis of the factors relating to the type of procedure concerned. They shall provide the first indication of the classification which would be most appropriate for a given type of procedure.

However, for the purposes of the final severity classification of the procedures, the following additional factors are to be considered, assessed on a case by case basis:

-Type of species and genotype.

-Maturity, age and gender of the animal.

-Degree of learning of the animal for the procedure.

-If the animal is reused, the actual severity of the above procedures.

-Methods used to reduce or suppress pain, suffering and distress, including refinement of the conditions of accommodation, zootechnical and care of animals.

-Use of humanitarian endpoints.

Section III: Types of procedure attributed to each severity category on the basis of factors relating to the type of procedure

1. Mild:

a) Administration of anesthesia, except for the sole purpose of euthanasia.

b) Pharmacokinetic study where a single dose is administered and a limited number of blood samples are collected (totaling < 10 per cent of the circulating volume) and the substance is not expected to cause any detectable harmful effects.

c) Non-invasive imaging techniques in animals (e.g. magnetic resonance imaging) with sedation or appropriate anesthesia.

d) Surface procedures, for example ear and tail biopsies, non-surgical subcutaneous implantation of mini-pumps and transponders.

e) Application of external telemetry devices that only cause the animal a minor weakening or minor interference with normal activity and behavior.

f) Administration of substances subcutaneously, intramuscularly, intraperitoneal, by gastric and intravenous tube through the superficial blood vessels, where the substance has only a mild effect on the animal, and the volumes are within appropriate limits for the size and species of the animal.

g) Induction of tumours, or spontaneous tumours, which do not cause any perceptible clinical harmful effects (e.g. small, subcutaneous, non-invasive nodules).

h) Cria of genetically modified animals that is expected to result in a phenotype with mild effects.

i) Food with modified diets, which do not cover the nutritional needs of all animals and are expected to cause a mild clinical anomaly in the study period.

j) Short-term confinement (< 24h) in metabolic cages.

k) Studies involving short-term deprivation of social partners, short term solitary caged of rats or adult mice of gregarious strains.

l) Models that expose the animal to harmful stimuli that are briefly associated with pain, suffering, or mild distress, and that the animal can avoid.

m) A combination or accumulation of the following examples may result in a slight classification:

1. Evaluation of body composition through non-invasive measurements and minimal restriction.

2. ° ECG monitoring with non-invasive techniques with minimal or no restriction on habituated animals.

3. Application of external telemetry devices that are not expected to cause any impediment to socially adapted animals that do not interfere with normal activity and behavior.

4. Cria of genetically modified animals that are not expected to have any clinically perceptible adverse phenotype.

5. Addition to the diet of inert markers to follow the step of digesting.

6. Disposal of the diet for a period of less than 24h in adult rats.

7. Open field trials.

2. Moderate:

a) Frequent application of test substances that produce moderate clinical effects, and extraction of blood samples (> 10 per cent of circulating volume) in a conscious animal within a few days without volume replacement.

b) Studies of determination of the dose range causing acute toxicity, chronic toxicity/carcinogenicity tests, with non-lethal endpoints.

c) Surgery under general anesthesia and appropriate analgesia, associated with post-surgical pain or suffering or post-surgical alteration of the general condition. Examples include: thoracotomy, craniotomy, laparotomy or orchiectomy, lymphodenectomy, thyroidectomy, orthopaedic surgery with effective stabilization and wound care, organ transplantation with effective treatment of rejection, surgical implantation of catheters, or biomedical devices (e.g. telemetry transmitters, mini-pumps, etc.).

d) Models of tumor induction, or spontaneous tumors, that are expected to cause moderate pain or distress or moderate interference with normal behavior.

e) Irradiation or chemotherapy with a sublethal dose, or with a dose that would otherwise be lethal, but with reconstitution of the immune system. The harmful effects could be expected to be mild or moderate and ephemeral (< 5 days).

f) Cria of genetically modified animals expected to result in a phenotype with moderate effects.

g) Production of genetically modified animals by surgical procedures.

h) Use of metabolic cages involving a moderate restriction of movement for a lasting period (up to 5 days).

i) Studies on modified diets that do not cover the nutritional needs of all animals and are expected to cause a moderate clinical anomaly in the study period.

j) Withdrawal from feeding for 48 hours in adult rats.

k) Provocation of escape and avoidance reactions when the animal cannot escape or avoid stimulus, and which is expected to result in moderate distress.

3. Severe:

(a) Test of toxicity in which death is the final point, or in which deaths are predicted and severe physiopathological states are caused. For example, single dose acute toxicity testing (see OECD guidelines on trials).

b) Testing of devices in which failure can cause severe pain or distress or the death of the animal (e.g. cardiac resuscitation devices).

c) The potency test of a vaccine characterized by persistent alteration of the state of the animal, progressive disease causing death, associated with pain, distress or lasting moderate suffering.

d) Irradiation or chemotherapy with a lethal dose without reconstitution of the immune system, or reconstitution with the production of graft-versus-host disease;

e) Models with tumor induction, or with spontaneous tumors, expected to cause progressive fatal disease associated with pain, distress, or long-lasting moderate suffering. For example, tumors that cause cachexia, invasive bone tumors, tumors that result in metastatic spread, and tumors that are allowed to be ulcerated.

f) Surgical and other interventions in animals under general anesthesia that are expected to result in severe or persistent moderate or severe postoperative pain, suffering or distress, or a severe and persistent alteration of the general condition of the animal. Production of unstable fractures, thoracotomy without adequate analgesia, or trauma to produce the multi-organ failure.

g) organ transplantation where the organ rejection is likely to cause distress or severe alteration of the general condition of the animal (e.g., xenotransplantation).

h) Reproduction of animals with genetic disorders expected to undergo a severe and persistent alteration of their general condition, e.g. Huntington's disease, muscular dystrophy, recurrent chronic neuritis models.

i) Use of metabolic cages involving a severe restriction of movements for a lasting period.

j) Unmissable electrical discharge (e.g. to produce learned helplessness);

k) Full isolation during long periods of gregarious species, e.g. dogs and primates.

l) Immobilization tension to induce gastric ulcers or heart failure in rats.

m) Forced swimming or exercise tests with exhaustion as an endpoint.

ANNEX X

Elements referred to in Article 33.1

1. Identification of the user and establishment in which the project procedures will be carried out.

2. Responsible for the project indicated in article 32.3 of this royal decree.

3. OK from the user's administrative officer.

4. Relevance and justification for the following:

(a) Use of animals, including their origin, estimated number, species and stages of life.

b) Procedures.

5. Application of methods to replace, reduce and refine the use of animals in procedures.

6. Use of anesthetics, analgesics, and other means to relieve pain.

7. Measures to reduce, avoid and alleviate any form of animal suffering throughout their lifetime, where appropriate.

8. Use of humanitarian endpoints.

9. Experimental or observational strategy and statistical model to minimise the number of animals used, pain, suffering, distress and environmental impact, where appropriate.

10. Reuse of animals and their cumulative effect on the animal.

11. Proposal for the classification of procedures according to their severity.

12. Measures to avoid unjustified repetition of procedures, where appropriate.

13. Accommodation, zootechnical and animal care conditions.

14. Methods of euthanasia.

15. Training of the people involved in the project.