Royal Decree 53/2013, 1 February, By Which Establish The Basic Standards For The Protection Of Animals Used In Experimentation And Other Scientific Purposes, Including Teaching.

Original Language Title: Real Decreto 53/2013, de 1 de febrero, por el que se establecen las normas básicas aplicables para la protección de los animales utilizados en experimentación y otros fines científicos, incluyendo la docencia.

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The Treaty on the functioning of the European Union includes, within the provisions of general application, in article 13, the obligation of the Union and the Member States to take fully into account the welfare of the animals when they formulate and implement some policies, such as research, technological development and internal market policy. Here, on September 22, 2010, the European Parliament and the Council adopted directive 2010/63/EEC on the protection of animals used for scientific purposes, which should be incorporated into the Spanish legal system.

Directive 2010/63/EU repeals Directive 86/609/EC, of the Council of 24 November 1986 on the approximation of the legal, regulatory and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes, which was incorporated to our legal system through the Royal Decree 223/1988 on March 14, which in turn was repealed and replaced by the Royal Decree 1201 / 2005 of 10 October, on the protection of animals used for experimental and other scientific purposes.

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

The new directive has meant an important advance welfare animal, not only because it adapts the minimum general requirements to scientific advances, but also because it expands the scope of application of the rules of protection to cephalopods and foetal forms of mammals, and because it establishes as a general principle the promotion and implementation of the "three Rs principle" i.e. the replacement, reduction and refinement of procedures, encouraging the use of alternative methods to experimenting with live animals.

Although the protection afforded by this Royal Decree not can extend today new animals until it is reformed law 32/2007 of 7 November, for the care of the animals, in its exploitation, transport, experimentation and sacrifice, this standard is approved so that their protection shall extend automatically as soon as it is inserted the change provided for in the Act. The same is true of the penalties that now only applies to breaches of procedures provided for in the law 32/2007 and will be extended as soon as this reform.

Animals can only be used when its use is justified by the aim pursued, valuing its opportunity ever in terms of its potential benefits. Regulate in detail the minimum conditions that have to stay the animals and the care that they have received, as well as the minimum requirements of breeders, suppliers and users of laboratory animals, all with the aim of ensuring their welfare to the greatest extent possible. Likewise establish the norms to which projects and procedures must follow from the start until the end.

He is marked as ultimate goal the total replacement of animals in procedures and specific rules for the use of certain types of animals, are set as the stray animals and feral, wildlife, endangered species and pets. In this sense, are set particularly stringent requirements in the case of non-human primates.

Also relevant changes are introduced into the formal requirements of control which projects and procedures involving live animals should be submitted. The rules governing the need for ex-ante evaluation of projects, retrospective evaluation of them in certain cases, the obligation to classify the procedures according to their degree of severity, the requirements of transparency and information, and other many requirements whose sole purpose is to ensure the best possible treatment of animals can be highlighted in this regard.

Also set the basic criteria in terms of the necessary training couple carrying out certain functions, in line with the results of the consensus between the Member States and the European Commission for the development of guidelines that harmonize the requirements for the recognition of such training and facilitate movement between Member States.

Other news of importance are the creation of a network of national committees of well-being and national contact points of coordination in the field of implementation of standards of protection and alternative methods. Also sets the requirement that all breeders, suppliers and users have of bodies responsible for the welfare of the animals.

Given the entity of the amendments that are being made, that in this preamble alone have been cited some, for reasons of legal certainty it has been determined whether to enact a new standard that with the rank of Royal Decree to repeal and replace the Royal Decree 1201 / 2005 of 10 October.

This Royal Decree is run at development of law 32/2007 of 7 November, for the care of the animals, in its exploitation, transport, experimentation and sacrifice, in the exercise of the regulatory power that generally attributed to the Government Article 97 of the Constitution. Given the character sharply technician of this provision, is considered adjusted its adoption by Royal Decree.

In the elaboration of this Royal Decree have been consulted the autonomous communities and the sectors concerned.

By virtue, on the proposal of the Ministers of agriculture, food and environment and economy and competitiveness, with the prior approval of the Minister of finance and public administration, in accordance with the Council of State and after deliberation by the Council of Ministers at its meeting on February 1, 2013, available: chapter I General provisions article 1. Object and purpose.

1. the object of the present Royal Decree is to establish the rules for the protection of animals used, kept or supplied with experimentation and other scientific purposes, including education and teaching.

To this end, it regulates the following: to) 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 the euthanasia of animals.

(c) the activities of the breeders, suppliers and users.

(d) the evaluation and authorisation of projects whose procedures using animals.

2 Royal Decree aims to ensure such protection, and in particular that: to) the number of animals used in procedures is reduced to a minimum, using as far as possible alternative methods;

(b) not cause them unnecessary pain, suffering, distress or lasting harm;

(c) to avoid any useless duplication of procedures; and d) animals used, kept or supplied be granted the adequate care.

Article 2. Scope of application.

1. this Royal Decree shall apply when they are used or intends to use animals in procedures or when is bred animals specifically so that their organs or tissues may be used for scientific purposes.

2. the present Royal Decree shall apply until the animals referred to in the first paragraph have been slaughtered, relocated or reinstated to a habitat or zootechnical convenient system.

3 shall be included within the scope of the present Royal Decree all animals used in procedures, although he has been achieved the Elimination of pain, suffering, distress or lasting harm by the successful use of analgesia, anaesthesia or other methods.

4. the present Royal Decree shall apply to the animals referred to in law 32/2007 of 7 November, for the care of the animals, in its exploitation, transport, experimentation and sacrifice.

It shall apply also to animals which are in a phase of previous development if it is to allow the animal to live beyond that stage of development and as a result of the procedures performed are likely to suffer pain, suffering, distress or lasting harm after having reached this stage of development.

5 are excluded from the scope of application: to) non-experimental agricultural practices;

(b) the non-experimental clinical veterinary practices;

(c) veterinary clinical studies necessary in the framework of the authorization of marketing of veterinary medicines;

(d) practices conducted with recognized zootechnical purposes;

(e) the practices undertaken with the aim of identifying an animal;

(f) the practices in which it is not likely to be cause them pain, suffering, distress or lasting harm equivalent or superior to those caused by the introduction of a needle according to good veterinary practices.

6. the present Royal Decree shall apply without prejudice to the Royal Decree 1599 / 1997, of October 17, on cosmetic products and their modifications, and the legislation of the European Union that will replace it.

Article 3. Definitions.

1. for the purposes of this Royal Decree, be understood as:


((a) Centre or establishment: any installation, building, group of buildings or other premises and mobile installations, including those not fully enclosed or covered b) breeder: any natural or legal person who breed animals of the species listed in annex I in order to use in procedures or for the use of their tissue or organs for scientific purposes, as well as any person who breed animals of other species mainly for these purposes with or without profit.

(c) euthanasia: disruption of the life of an animal less suffering possible, according to their species and State.

(d) competent authority: the bodies, authorities or administrative units of the autonomous communities and the cities of Ceuta and Melilla competent in each of the matters regulated by this Royal Decree.

Enabled body: public agency, or association or company private, authorized and designated by the competent authority to carry out some of the specific functions that are set in the present Royal Decree. It is important to distinguish, in this respect, the body enabled the evaluation of projects which, pursuant to article 43, shall be given in the regime of free competition, enabling to carry out other technical activities, which will be governed by what effect, provided the competent authority.

(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 are predictable or unpredictable, or educational purposes provided that such use may cause the animal a level of pain, suffering, distress or lasting harm equivalent to or greater than that caused by the introduction of a needle according to good veterinary practices.

Also, any intervention that causes, or may cause, the birth of an animal, hatching from an egg or the creation and maintenance of a line of animals genetically modified the conditions of pain, suffering, distress or lasting harm cited in the previous paragraph, intentionally or casual procedure is considered.

Not considered procedure the euthanasia of the animals when it is done with the sole purpose of using their organs or tissues.

A procedure shall be deemed concluded when already it won't make any further comment for this procedure or, in the case of new animal lines GM, when progeny not to observe it or wait for you to experience pain, suffering, distress or lasting harm equivalent to or greater than that caused by the introduction of a needle.

(g) project: programme of work with a defined scientific objective and that one or more procedures are performed.

(h) supplier: any person, other than the breeder, who acquire or keep animals in order that they be used in procedures or that their tissues or organs will be used for scientific purposes, and provide these animals with any of these purposes, with or without profit.

(i) user: anyone using animals in procedures, with or without profit.

Chapter II principles and conditions general article 4. Principle of replacement, reduction and refinement.

1. will be used whenever possible, rather than a procedure, methods or strategies scientifically satisfactory test that do not involve the use of live animals.

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

3. the activities related to breeding, accommodation and care, as well as the methods used in procedures, refined as much as possible to eliminate or reduce to the minimum any possible pain, suffering, distress or lasting harm to the animals.

4. with regard to the choice of methods, the principle of replacement, reduction and refinement, shall apply in accordance with article 24. Where this election is a procedure, this will take place in accordance with article 25.

5. the competent bodies shall ensure the application of the preceding paragraphs, and will contribute to the development and validation of alternative approaches that can provide a level of information equal to or superior to that obtained in procedures with animals, but not used or use fewer animals or involve less painful procedures.

6. the General Administration of the State and the bodies will give the steps deemed appropriate to encourage research in this field and shall ensure the promotion of alternative approaches and the dissemination of information about these at the national level.

Article 5. Purpose of the procedures.

The use of animals in procedures may only take place when it pursues any of the following purposes: to) fundamental research.

(b) translational or applied research, and the scientific method with any of the following purposes: 1 prevention, prophylaxis, diagnosis, or treatment of disease, ill-health or other anomalies or its effects on humans, animals or plants.

2nd assessment, detection, regulation or modification of physiological conditions in human beings, animals or plants.

3rd the well-being of animals, in particular the improvement of the production conditions of animals reared for agricultural purposes.

((c) the development and manufacture of pharmaceutical products, foods, animal feed and other substances or products, as well as testing to check their quality, efficacy and safety, with any of the purposes set forth in point b).

(d) the protection of the natural environment in the interests of the health or welfare of humans or animals.

(e) research aimed at preservation of the species.

(f) higher education or training for the acquisition or improvement of skills.

(g) legal and forensic medicine.

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

1 the breeders, suppliers and users must meet the following requirements in relation to the general care and accommodation of animals: to) be provided accommodation, environment, food, water and care which are appropriate to their species, physiological conditions and State of health and ensure their adequate general condition.

b) shall be reduced as far as possible any restrictions that prevent or limit the possibilities of their physiological and Ethological needs animals.

c) will be verified daily environmental conditions in which they are bred, kept or used animals.

(d) there will be media that ensure the elimination in the shortest possible time of any deficiency that may cause avoidable suffering, pain, distress or lasting harm that are discover.

(e) labour standards and instructions for use of all the elements indicated in writing.

f) will be available in writing an action plan in case of emergency or disaster, which will include measures relating to the hosted animals, which can be integrated with other plans of the establishment and which will reflect the proper coordination with the rest of emergency plans for the center of work 2. Establishments or centres must meet the provisions of annex II, at the latest on the dates indicated therein.

(3. the competent authorities may grant exceptions to the provisions of paragraph 1.a) and in paragraph 2, for scientific reasons, welfare or animal health.

Article 7. Methods of euthanasia.

1 the euthanasia of the animals will be held: to) with less pain, suffering and distress as possible.

(b) by a qualified person.

((c) in a settlement of a breeder, supplier or user, unless in the case of a field study or that applicable provisions of paragraph 1.b) of annex III.

2. in relation to the animals referred to in annex III be used the appropriate method of euthanasia as set out in that annex.

3 the competent authority may grant derogations from the requirement laid down in paragraph 2: to) to allow the use of another method always from scientific evidence deemed that the method has at least the same absence of cruelty; either b) if scientifically justified that the purpose of the procedure cannot be achieved using any of the euthanasia methods referred to in annex III.

4 the letters b)) and (c) of paragraph 1 and paragraph 2 shall not apply where it is necessary to kill an animal emergency for reasons of animal welfare, animal health, public health, public order, or environmental.

Article 8. Sharing of organs and tissues.

The General Administration of the State and the competent bodies shall encourage, through the regulated Committee in article 44, the establishment, between users and other operators, programs for sharing organs and tissues. These programs may provide the creation of shared databases and other measures of collaboration and dissemination of information.

Article 9. Transport of animals.

1. the transport of animals shall be in accordance with current legislation, in particular, trade, health and animal welfare.

2. the containers shall ensure containment of animals, while allowing them freedom of movement right depending on their species, age, and State. Transport vehicles shall provide, where appropriate, of anchorage systems to avoid harmful jerking for the welfare of the animals.


3. If in the framework of a project it is necessary to proceed with the transfer of an animal, this must be accompanied by a document of transfer issued by the veterinarian designated Center of origin, whose period of validity may not exceed the corresponding movement health document and which must appear, at a minimum, the data listed in annex IV.

Article 10. Identification of the animals.

All animals belonging to species with identification systems already regulated should be identified as the current legislation on this matter.

Article 11. Identification of confinement systems.

Confinement of animals must be fitted with a system that allows you to enter data for identification of the animals housed there. Unless it is not possible by circumstances or characteristics of the animals confined there, specify minimum data listed in annex V.

Article 12. Records of the animals.

Breeders, suppliers and users should at least record the data which are set in annex VI. These data must be kept for at least five years and be at the disposal of the competent authority, when this article 13 requests it. Additional requirements for dogs, cats and primates.

1. dogs, cats and primates must be provided, preferably before your weaning, a brand identification, individual and permanent, carried out in such a way that cause you the least possible pain.

2 when a dog, cat, or primate is transferred from a breeder, supplier or user to another before their weaning and not possible previously to mark it, the receiver of the animal shall keep, until it is appropriate to the markup, a register containing at least the data of the mother.

3. the breeder, supplier or user who receives a dog, cat, or weaned primate that is not marked, shall provide, as soon as possible, a brand identification, individual and permanent, carried out in a way that will cause the least possible pain.

4. the breeder, supplier or user shall justify, where appropriate and when prompted the competent organ, the reasons why these animals have no identification mark.

5 the breeders, suppliers and users should preserve, about each dog, cat and primate, the following data: to) identity.

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

c) if it has been bred for use in procedures.

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

6. each dog, cat and primate, will have a record that will accompany the animal while it is maintained for the purposes of this Royal Decree. History will be created when the animal is born, or as soon as possible and will contain all relevant information on reproductive, veterinary and Ethological aspects of the individual, as well as the projects in which it has been used. For rehousing, veterinary and Ethological individual deemed pertinent information will accompany the animal.

7. the information referred to in this article will be retained for at least three years after the death or the rehousing of the animal and will be made available by the competent authority, on request of the same.

Chapter III breeders, suppliers and users article 14. General requirements.

1. the establishments of breeders, suppliers and users should have the facilities and equipment suitable for the species of animals housed and, if carried out procedures for carrying them out.

2. the design, construction and operation of installations and equipment referred to in paragraph 1 shall ensure that the procedures are carried out with the maximum possible efficiency, and promote the obtaining of reliable results using fewer animals and causing the lowest degree of pain, suffering, distress or lasting harm.

3. for the purposes of paragraphs 1 and 2, shall meet the requirements set out in annex II, that apply to them.

4 each breeder, supplier or user shall appoint: to) at least one responsible animal welfare specialist, who will be responsible for on-site monitoring of the welfare and care of the animals in the establishment.

(b) at least one veterinarian, hereinafter the designated veterinarian, or other specialist entitled equivalent, with knowledge and expertise in medicine of laboratory animals that will have, regardless of other activities that can develop, advisory functions in relation to the State of health and treatment of the animals, and their decisions and professional opinions must be taken into account by the user , breeder or supplier and by the body responsible for animal welfare laid down in article 37.

(((c) one or more natural persons that are responsible for on-site compliance of this Royal Decree, and in particular that have been designated specialists indicated in letters a) and b) of this section, ensuring that the staff dealing with animals have access to specific information on the species housed in the establishment and that they are responsible for ensuring that personnel are adequately trained is trained, have access to training continues, and that, while you have not shown such training, is subject to supervision by trained personnel.

5. one person may perform several or all functions which is referenced in this article, provided that they meet the different training requirements of this Royal Decree and other regulations applicable in each case.

Article 15. Requirements applicable to personnel.

1. the breeders, suppliers and users will benefit from sufficient staff on-site.

2 persons who perform the following functions must have adequate prior training: to) care of the animals.

(b) animal euthanasia.

(c) performance of the procedures.

((d) design of procedures and projects e) responsible for the in situ supervision of the welfare and care of the animals.

(f) assume the functions of designated veterinarian.

3 the personnel who perform the functions indicated in the letters to), b), c) of paragraph 2 shall meet the training requirements in accordance with paragraph 6. The competent authority may authorize persons who have not yet demonstrated their total training to perform those functions temporarily and under the responsible supervision.

(4 staff who perform the functions indicated in the letter d) of paragraph 2 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 requirements of training in accordance with paragraph 6.

5 staff who perform the functions indicated in the letters 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 authorization or other appropriate means, the training of personnel to carry out the functions listed in paragraph 2.

(a) the training of personnel may have a modular structure based on his case, in guides, guidelines or recommendations issued by the European Union.

(b) the minimum requirements of prior training or otherwise shall be expressed, in his case, in learning outcomes. For functions a), b), c) and d) is, be based on the elements set out in annex VII 7. Recognition of the training to carry out the functions listed in paragraph 2 by a competent authority shall have effect throughout the national territory.

8. the recognition of the training to carry out the functions listed in paragraph 2 the competent authorities of another Member State shall be valid throughout the country, in accordance with the principle of reciprocity.

Article 16. Authorisation of breeders, suppliers and users.

1. the breeders, suppliers and users and their establishments shall be authorized by the competent authority prior to the beginning of its activities. Such authorization will be conditioned to the fulfillment of, at least, the requirements of this Royal Decree. When breeding activities, is simultaneen even for their own use, supply or use of animals in procedures, it must request authorization for each and every one of them.

2 breeders, suppliers and users must apply for renewal of its authorization or confirmation: to) before any significant change of the structure or of the activities of the breeder, supplier or user that may have negative effects on the welfare of animals.

(b) when will breed, supply or use new species.

(c) period of 10 years from the issue or last renewal of the authorization.

3. in the permit specify the person or persons responsible for ensuring compliance with the provisions of this Royal Decree, the specialist responsible for the welfare of animals and the designated veterinarian.

4 If a breeder, supplier or user fails to comply with the requirements of this Royal Decree, the competent authority shall take appropriate corrective action or shall require that such measures and, where appropriate, suspend or withdraw its authorization.

5 when suspend or remove an authorization, the competent authority shall ensure that the necessary measures are taken so that is not affected negatively the welfare of the animals housed in the establishment.


Article 17. Register of breeders, suppliers and users.

1. the breeders, suppliers and users must register in the General Register of livestock farms, created and regulated by Royal Decree 479/2004, of March 26, by which establishes and regulates the General Register of livestock farms, and, where appropriate, in a specific register for this purpose.

2 centers composed of physically separate units together will be recorded as a single Center, unless they have a functioning and independent organization, or that it determines the competence of different competent bodies.

3. when breeding activities are simultaneen, supply or use of animals in procedures, the registration shall be specified in each and every one of them.

4. any modification of the data appearing for expansions, reductions, transfers, changes of staff or other circumstances, as well as in the case of suspension or cessation of the activity, or change in ownership, registered, shall be notified to the competent authority within a maximum of one month since such modification has occurred, for making the corresponding changes in the register. In particular must communicate the change of any of the persons referred to in article 14.4.

Article 18. Additional requirements for breeders of primates.

Breeders of primates must have a strategy to increase the percentage of animals that are descendants of primates bred in captivity.

Chapter IV animals used in procedures article 19. Animals bred for use in procedures.

Animals belonging to the species listed in annex I can only be used in procedures when they have been bred for this purpose. The competent authorities may grant exceptions to the above if it is scientifically justified.

Article 20. Animals of endangered species.

1. not be used in animal procedures of threatened species included in Annex A of Regulation (EC) No. 338/97 of the Council of 9 December 1996 on the protection of species of wild through control of their trade, the fauna and flora that are not referred to in the cases of article 7 of that regulation ((((, unless the following conditions are met: a) the procedure has one of the purposes indicated in number 1 of subparagraph (b)), paragraph c) or paragraph e) of article 5 of this Royal Decree.

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

2. the paragraph first does not apply to any species of primate, whose use shall be subject to the provisions of article 21.

Article 21. Primates.

1. not be used in procedures of Gorilla species animals gorilla (gorilla), Pan troglodytes (chimpanzee), Pan paniscus (bonobo or "Pygmy Chimpanzee") and Pongo pygmaeus (orangutan).

2 are not used primates of the species listed in Annex A of Regulation (EC) No. 338/97 of the Council of 9 December 1996, which are not referred to in the case of article 7, paragraph 1, of that regulation, unless the following conditions are met: a) the procedure has one of the purposes indicated in: 1 number 1 of paragraph b) or in paragraph c) of article 5 of the present Royal Decree and It is done in order to avoid, prevent, diagnose or treat disabling diseases or that potentially can jeopardize the lives of human beings; (or 2nd paragraph e) of article 5.

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

3 the rest of primates shall not be used in procedures, except if the following two conditions are met: to) 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 number 1 of subparagraph (b)) .or in subparagraph (c)) of article 5 of the present Royal Decree and carried out for the purpose of prevention, prophylaxis, diagnosis, or treatment of disabling diseases or which could endanger the life of human beings; ((or 2nd paragraphs to) or e) of article 5.

4. it is understood by disabling disease, for the purposes of this Royal Decree, the disease process that curse with a reduction of the normal physical or psychological capacity of a person.

5. the primates included in annex VIII, from the dates set therein, can only be used in procedures if they are descendants of primates bred in captivity or if they come from colonies becomes self-fulfilling. The competent authorities may grant exceptions to the above if it is scientifically justified.

For the purposes of this paragraph, be understood as "self-sustaining colony" that in which animals are bred only in the bosom of the same or come from other colonies but are not animals caught in the wild; and which in addition are kept animals so they are accustomed to humans, article 22. Animals captured in nature.

1. not be used in procedures animals captured in the wild, unless expressly authorized by the competent authority, which may be granted it following scientific justification that the purpose of the procedure cannot be achieved using animals bred for use in procedures.

2. the capture of animals in nature only shall be made by a competent person with methods that do not cause pain, suffering, distress or lasting harm that can be avoided. Any animal that is injured or in poor health at the time of their capture or after this should be examined by a veterinarian, or in cases justified, by another qualified person, and take measures to minimize their suffering. Only exceptionally and prior scientific justification may be the competent body authorised that these measures are not taken.

Article 23. Feral animals and domestic species stray animals.

Or stray domestic species of animals shall not be used in feral animal procedures. The competent body may exceptionally authorize its use, provided that the following conditions are met: a) there is an essential need for studies related to the health and welfare of these animals or serious threats to the environment or to human or animal health, and b) has been scientifically justified that the purpose of the procedure can only be achieved by using animals stray or feral animals.

Chapter V procedures and projects section procedures article 24 1. Choice of methods.

A procedure, shall be 1 if the regulations of the European Union recognizes another method or another trial strategy to get the desired result that does not involve the use of live animals.

2 when you can choose between different procedures, will opt for those who have the more likely to provide satisfactory results and which comply with the highest number of the following requirements: to) which use fewer animals;

(b) that it will affect animals with the least ability to feel pain, suffering, distress or lasting harm;

(c) that it will cause less pain, suffering, distress or lasting harm.

Article 25. General terms and conditions of the procedures.

1. with the aim of avoid unnecessary duplication, competent bodies must accept data from other Member States obtained by procedures recognised by the legislation of the European Union, unless are to be other additional procedures in relation to such data for the protection of public health, safety or the environment.

2 procedures may only be made if they are included within the framework of a project authorized in accordance with section 2 of this chapter.

3. the procedures must be performed so as to prevent animals any pain, suffering, distress or lasting harm that are unnecessary.

4. procedures will take place in centres authorized users, unless authorised by the competent authority, following scientific justification of the necessity or desirability that occur outside these centres.

5. proceedings may only be performed by persons trained or authorised on a temporary basis under the conditions laid down in article 15.3 low responsible for supervision.

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

7 death as the end-point of a procedure criteria should be avoided as far as possible and replaced by a more humanitarian completion criteria who can observe and apply in the procedure earlier. En_caso_de_que you can not avoided death as the end-point criteria, the procedure shall be designed in such a way: to) that die the less possible number of animals; and (b) reducing to the minimum the duration and intensity of the suffering of the animal and, to the extent possible, to ensure a death without pain.

Article 26. Anesthesia and analgesia during the procedure.

1 procedures should be performed under general or local anesthesia, unless deemed to be inappropriate because: to) is more traumatic to the animal than the procedure itself.

(b) it is incompatible with the purposes of the procedure.


2 use painkillers or other methods appropriate to ensure, to the extent possible, that pain, suffering, distress or injury are minimal. Their application, where appropriate, should be performed or supervised by a veterinarian.

3. the procedures that involve serious injuries that can cause severe pain not be conducted without anesthesia.

4 will be provided an animal any medication that would prevent or restrict its manifestations of pain, unless you have received a proper dose of anesthesia or analgesia. It should be supplied such medicines be provided a scientific justification accompanied by a description of the treatment by anesthesia or analgesia, that will be available to the competent authority.

5. whenever it is compatible with the purposes of the procedure, where it is expected that an animal will suffer pain after having recovered from the anesthesia, be charged an analgesic treatment preventive and palliative, or another suitable method to soothe the pain.

Article 27. Classification of severity of procedures.

1. each and every one of the procedures are classified as «without recovery», «mild», «moderate» or «severe», according to the classification criteria set out in annex IX.

2 procedures there will be no if they involve a severe level of pain, suffering or distress is likely going to be lasting and that cannot be relieved, without prejudice to the use of provisions of the safeguard laid down in the second additional provision clause.

Article 28. End of the procedure.

1. at the end of any procedure will decide if animals must stay alive or be slaughtered. The decision will be made by a veterinarian, in justified cases, by another qualified person.

2 you must opt for euthanasia of animals whenever it is likely that they will suffer a moderate or severe level of pain, suffering, distress or lasting harm.

3. When you go to keep alive an animal, this should receive care and accommodation appropriate to their species, physiological conditions and State of health.

Article 29. Re-use of animals in procedures.

1 an animal that has already been used in one or more procedures, shall not be re-used in a new procedure when in place could be used other animal to receive previously any procedure, unless the following conditions are met: to) that the actual severity of the previous procedures has been classified as "mild" or "moderate".

(b) that has been shown the full recovery of the State of general health and well-being of the animal.

(c) that the new procedure is classified as mild, moderate or no recovery.

(d) that it has veterinary advice, made taking into account the experiences of the animal throughout its life.

2 the competent authority, in exceptional circumstances and prior veterinary examination, may allow re-use of an animal while non-observance within the meaning to) of paragraph 1. That animal cannot have been used more than once in a procedure that caused severe pain and distress or equivalent suffering.

Article 30. Start freedom and re-homing of animals.

The competent authority may authorize that an animal can be given up for adoption, relocated, or returned to a habitat, exploitation or other medium that is suitable for the species concerned. To do this you must meet the following conditions: to) that his State of health allows it.

(b) that it does not suppose a danger to public health, animal health or the environment.

(c) that adequate measures are taken to safeguard the well-being of the animal.

(d) in the case of re-homing or adoption, breeders, suppliers and users have an appropriate programme that will ensure his socialization.

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

Section 2 projects article 31. Types of projects.

1 projects of type I: those projects in which the three following circumstances occur simultaneously: to) involve only procedures classified as «recovery», «mild» or «moderate».

(b) do not use primates.

c) are performed to meet legal or regulatory, or for purposes of production or diagnosis by established methods.

Type I projects will be handled by a simplified procedure and not be subjected to retrospective evaluation.

2 type II projects: those projects where the following circumstances occur simultaneously: to) involve only procedures classified as «recovery», «mild» or «moderate».

(b) do not use primates.

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

3. projects of type III: different types I or II projects. Without prejudice to the additional authorizations that certain projects may be conditioned, all type III projects will be subject to the authorisation procedure and will then undergo a retrospective assessment.

Article 32. General terms and conditions of the project.

1 type I projects will be conducted in accordance with the application sent to the competent body, or, in the case that this give instructions in another sense, in accordance with the same.

2 type II and III projects, will be made pursuant to the authorization.

3 all projects will have an individual who will be responsible for overall implementation, and in particular: to) ensure that he stops any procedure that is inflicting pain, suffering distress or lasting unnecessary damage to an animal in the course of the procedure.

b) will ensure that the projects are carried out in accordance with paragraphs 1 and 2 of this article.

(c) ensure because in case of non compliance will take appropriate measures and these measures are recorded.

4. the competent authorities may authorise multiple generic projects carried out by the same user, when undertaken to meet regulatory requirements, or when these projects using animals for purposes of production or diagnostic with established methods.

5. cannot be any project that has not been previously evaluated with favorable results for the organ in accordance with article 34-enabled.

6. any change to the project that may have a negative impact on the welfare of animals will mean a new assessment and, where appropriate, approval of the project.

7. the documentation of the projects, including authorisations and evaluation reports, will be retained at the disposal of the competent authority for at least three years from the date of expiry of its period of authorization or of the period specified in article 33.4.

8. the documentation of the projects that must undergo a retrospective evaluation will be retained until it has been completed the assessment, or, in his case, until the expiry of the period indicated in paragraph 7 of this article.

Article 33. Application and approval of projects.

1. for communication and a project authorization request user or the person responsible for the project must present to the competent organ project proposal, accompanied by the report of the Ethics Committee, copy of the application for evaluation of the project, and at least information corresponding among which relates in annex X, and in the case of type II and III projects the non-technical summary provided for in article 36 of the present Royal Decree.

The evaluation of the project application must be directed to the enabled body freely chosen by the applicant from among those included in the listing of authorized bodies, except those who comply with any of the causes for abstention or objection provided for in articles 28 and 29 of the law 30/1992, of 26 November, legal regime of public administrations and common administrative procedure.

Request for evaluation of the project will contain, at least, the information or documents listed in paragraphs 4 to 14 of annex X.

2. the competent bodies will accuse receipt to the applicant of all requests for authorization under the terms provided for in article 42.4 of the law 30/1992, of 26 November, legal regime of public administrations and common administrative procedure.

In the case of an incomplete or incorrect application, the competent authority shall inform the applicant of the need to remedy your request in accordance with article 71 of the law 30/1992, of 26 November, legal regime of public administrations and common administrative procedure, as well as of any possible consequence over the applicable period.

3 body enabled the evaluation of the project, shall transmit to the applicant, or, at the request, to the competent authority, the results of the assessment.

4. the maximum period to resolve and to notify the corresponding resolution shall be 40 days. This period includes the evaluation of the project, which should be favourable. In the project types II and III, and when justified by the complexity or the multi-disciplinary nature of the project, the competent authority may extend this term once for an additional period not exceeding 15 days. The extension and its duration should motivate yourself properly and shall be notified to the applicant before the expiration of the initial period.

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


6 in the project authorization shall specify, at least: to) the user who will execute the project.

(b) the head of the project indicated in article 32.3 of this Royal Decree.

(c) the establishment or, in the case of field work, geographical locations, where will take place.

(d) the need, where appropriate, carry out a retrospective evaluation and, if so, the deadline for its submission.

(e) any other specific conditions that establish the competent authority in the light of the evaluation of the project.

7. the competent authority may suspend the approval of a project if it is not performed in accordance with the authorization, and remove, prior record filed with the interested audience.

8. If withdraws the approval of a project, necessary measures shall be taken so that the welfare of the animals is not affected negatively.

Article 34. Evaluation of projects.

1 the evaluation of each project will be made in the body with a level of detail appropriate to the type of project and will be to verify that the project meets the following requirements: to) is justified from the point of view of scientific or educational, or must be done by the imposition by law or regulation;

(b) its purpose to justify the use of animals; and (c) is designed so that procedures be performed as the most humane and respectful with the environment that it is possible.

2 the evaluation of the project will include: to) an assessment of the purpose of the scientific benefits that are expected to reach or educational value;

(b) an assessment of its conformity with the requirements of replacement, reduction and refinement;

(c) an assessment and classification of their procedures based on the degree of severity;

(d) an analysis of harms and benefits, to determine if the damage, suffering, pain and distress that may be caused to animals are justified by the expected results, taking into account ethical considerations and benefits that, ultimately, can assume the project for human beings, animals or the environment;

(e) a review 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 retrospective should be assessed in a way and, if necessary, should be done when.

3 in the evaluation of the project may have recourse to the advice of experts, in particular in the following fields: a) the scientific application areas for which are to be used with animals, including the replacement, reduction and refinement in the respective areas;

(b) the experimental design, statistics, if necessary;

(c) the veterinary practice, wild animals or the science of laboratory animals, if applicable;

(d) animal husbandry and care of the animals that will be used.

4. the project evaluation process must be transparent, making impartial way, being able to integrate the opinion of independent parties.

Article 35. Retrospective evaluation.

1 the enabled body will make an evaluation retrospective of those projects: to) that primates are used.

(b) on the inclusion of procedures classified as "severe".

(c) in those referred to in the second additional provision of this Royal Decree.

(d) in those whose assessment according to article 34 thus determined it.

2. without prejudice to the above paragraph 1 and unless decided otherwise by the competent authority, they are exempt subject to retrospective evaluation type I projects and projects type II that included only procedures classified as "no recovery" or mild. Type II projects involving procedures classified as "moderate" shall be subject to retrospective evaluation when it is thus set to authorization.

3 the evaluation retrospective will be done on the basis of the mandatory documentation submitted by the user, and will evaluate the following: a) if achieved the objectives of the project;

(b) the harm inflicted on animals, including the number and species of animals used, and the severity of the procedures; and (c) any of the elements that can contribute to a better implementation of the requirement of replacement, reduction and refinement.

Article 36. Non-technical summaries of the projects.

1. the competent bodies shall publish the non-technical summaries of authorised projects and any updates. These summaries, which will be presented by those responsible for projects, will be anonymous and will not contain names or addresses of users or of persons, or any other personal information.

2 provided that the intellectual property and confidential information are protected, summary not technician of the project shall include at least the following: to) information on the objectives of the project, including damages and the expected benefits, as well as the number and type of animals to be used;

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

3. the competent authorities may determine that the summary not technician of the project specify if this should undergo a retrospective analysis and in what timescale. In this case, the non-technical summary of the project should be updated with the results of retrospective analysis.

Chapter VI organ responsible for the welfare of animals article 37. Creation of bodies responsible for the welfare of the animals.

1. each breeder, supplier and user shall establish a body responsible for the welfare of animals, hereinafter "OEBA". In users, this organ is referred to as animal experimentation Ethics Committee.

2. the OEBA shall provide itself with an internal regulation that would define and develop, its composition and its basic operation according to criteria of confidentiality and representativity, which ensures impartiality in decisions made by the same. They will be exempted from this requirement the one-person OEBA.

Article 38. The OEBA functions.

1 the OEBA will perform at least the following functions: to) advise the staff dealing with animals on matters related to the welfare of animals in terms of their acquisition, accommodation, care and use.

(b) advise staff on the application of the requirement of replacement, reduction and refinement and keep it informed of the technical and scientific advances in the application of this requirement.

(c) establish and review internal operational processes with respect to the control, the communication and tracking of information related to the welfare of the animals.

(d) advise on schemes of re-homing or adoption, including the proper socialization of animals that go to relocate it or giving it up for adoption.

(e) in the users, also prepare the report referred to in article 33.1 and will track projects taking into account their effect on the animals used as well as determine and assess the elements that best contribute to the replacement, reduction and refinement.

2 animal experimentation ethics committees may, in addition, when so determined by the competent authority, be appointed enabled bodies to carry out the assessment and retrospective assessment, provided that they meet the requirements laid down in articles 39 and 43.

In this case, enabled organ must send a detailed annual report on its activities to the competent authority, which shall include as a minimum a relationship of all projects assessed or evaluated retrospectively. All documentation should be available to the competent authority for a minimum period of three years.

3. will be retained, at least for three years, records the OEBA recommendations and the decisions taken with regard to those recommendations. These records shall be made available to the competent authority, at the request of this.

Article 39. Composition.

1. the OEBA should be composed of people with experience and expertise to ensure the well-being and care of animals. It shall consist at least of the following members: a) in the case of breeders and suppliers, the OEBA will be formed as a minimum by the person or persons responsible for the welfare and care of the animals.

(b) in the case of users, the animal experimentation Ethics Committee will be formed as a minimum by the person or persons responsible for the welfare and care of the animals and by a researcher or other scientific member.

c) in the event of the animal experimentation Ethics Committee acting as body enabled to carry out the evaluation or the retrospective evaluation of projects, its composition will include also researchers or other scientific members who are not directly related to the project and a person with expertise in animal welfare that does not have a direct relationship with the user or the project.

2. members shall respect the principle of confidentiality.

3. the OEBA will receive advice from the designated veterinarian, and should be kept for at least three years contributions wiil.

4 when the OEBA sees fit, it shall request the advice of experts which also respect the principle of confidentiality.

5. the competent authorities may authorise exceptionally on small breeders, suppliers and users the functions set out in paragraph 1 of article 38 are assumed by an OEBA from another breeder, supplier or authorized user. In any case the breeders, suppliers or users of primates may benefit from this exceptional authorization.

CHAPTER VII


Information, checks, and regime Committee sanctioning article 40. Inspections or controls.

1-enabled or competent bodies shall carry out controls or regular inspections to the breeders, suppliers and users, including their establishments, to verify the compliance of this Royal Decree. An appropriate proportion of inspections shall be unannounced.

2 the competent bodies will adapt the frequency of inspections or controls, which may be carried out on the occasion of checks made for other purposes, on the basis of a risk analysis which takes into consideration: to) the species and the number of animals housed;

(b) the history of compliance or non-compliance by the breeder, supplier or user;

(c) in the case of users, the amount and types of projects.

(d) any data that could indicate a possible breach.

3-enabled or competent bodies shall inspect each year, at least once: to) to all breeders, suppliers and users of primates.

(b) to one-third of other users.

4 the competent bodies which have designated bodies in accordance with article 38.2-enabled shall carry out regular checks to those authorized bodies.

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

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

1. the breeders, suppliers and users shall communicate to the competent bodies, deadlines and form that they establish, the necessary data so that it can comply the obligations laid down in the national legislation and the European Union.

2. the Ministry of agriculture, food and environment is the point of contact for the purpose of the fulfilment of this Royal Decree and for the purpose of advising on policy relevance and appropriateness of the alternative approaches proposed for validation, which set out, respectively, the articles 59.2 and 47.5 of the 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 shall provide a point of contact for the purpose of the fulfilment of this Royal Decree, which communicated to the Ministry of agriculture, food and environment.

4. the contact points set out in the preceding paragraph, for the purposes of compliance with the obligation of communication of information to the European Commission, to draw up reports with the frequency, format and content established the Ministry of agriculture, food and environment in coordination with the autonomous communities and cities of Ceuta and Melilla. These reports will be sent annually by March 31 to the aforementioned Ministry.

5. with this information, the Ministry of agriculture, food and environment will produce relevant reports for their remission time the European Commission through the appropriate channel.

6. the Ministry of agriculture, food and environment will be published annually, on the model established by the European Commission, statistical information relating to the use of animals, which will include information on the actual severity of the procedures, and the species and the origin of primates used in procedures.

7. the Ministry of agriculture, food and environment will coordinate with the competent bodies the precise actions for the implementation of this Royal Decree.

Article 42. The European Commission checks.

1. the competent bodies shall provide the experts from the European Commission all the help and assistance that they need to carry out controls of the infrastructure and operation of national covered by article 40 inspections. In these controls, the representatives of the Ministry of agriculture, food and environment may accompany experts from 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 environment shall establish appropriate mechanisms of coordination and collaboration of the actions related to the implementation and results of these controls.

3. the competent bodies shall take appropriate measures to take into account the results of controls and inspections.

Article 43. Authorized bodies.

1 can only be designated as eligible bodies those agencies which have evidence of that: to) they possess the technical expertise and the necessary means for carrying out the functions and b) there is no conflict of interest for the performance of functions.

2 in particular, only it can enable to perform functions of control and inspection bodies under the following conditions: to) describes accurately the tasks enabled body can carry out and the conditions in which it can perform them;

(b) the enabled body works and is accredited in accordance with standard UNE-EN ISO/IEC 17020 "General criteria for the operation of various types of bodies performing inspection" or with another standard which is more relevant to the delegated tasks in question;

(c) the enabled body informs the competent authority on a regular basis and whenever the latter request, the results of the checks carried out. If the results of the checks reveal or suspect a breach, the enabled body shall inform immediately the competent organ;

(d) there is an effective and efficient coordination between the competent body and the enabled body.

(e) the competent authority carries out audits or inspections of the authorized organs.

3. the bodies enabled the evaluation of projects shall be designated by the competent bodies in accordance with a regulated procedure that ensures the free competition of all those who meet the requirements provided for in the preceding paragraphs. The relationship of authorized bodies, shall keep up-to-date, must send copy to the Ministry of economy and competitiveness, for the sole purpose of advertising through its electronic office.

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

1. in accordance with the provisions of article 49 of Directive 63/2010/EU of the European Parliament and of the Council, of 22 of September of 2010, concerning the protection of animals used for scientific purposes, creates the Spanish Committee for the protection of animals used for scientific purposes, hereinafter the Committee as a collegiate body, of inter-departmental character that will be the body responsible for advising the General Administration of the State, the autonomous communities and the cities of Ceuta and Melilla and the bodies responsible for the welfare of animals laid down in chapter VI, on issues related to the acquisition, breeding, accommodation, care and use of animals in procedures, as well as ensuring that best practices are shared , and for proper coordination.

The Committee exchanged information with the national committees of the other Member States about the functioning of the bodies responsible for the welfare of the animals and the evaluation of projects, and share best practices in the European Union.

The Committee shall be attached to the Ministry of agriculture, food and environment through the General Directorate of agricultural markets and production.

2 the Committee shall consist of the following members: to) President: the holder of the General direction of production and agricultural markets of the Ministry of agriculture, food and environment.

(b) Vice-President, who shall replace the President in case of vacancy, absence or illness: the owner of the General Sub-Directorate of livestock products of the Ministry of agriculture, food and environment.

(c) vocal: 1 by the General Administration of the State: by the competent ministries: an official, with at least level head, of the Subdirectorate of health and Animal hygiene and traceability of the Ministry of agriculture, food and environment; a representative with at least level head of service in both cases, the Ministry of economy and competitiveness, the Ministry of health, social services and equality, appointed by their respective Secretaries.

By public research organizations: A representative, with at least level head, of the public research institutions attached to the General Administration of the State, designated by the Secretary of State for research, development and innovation.

The Council of universities: A representative appointed by the same.

When they will deal with issues relating to drugs, a representative, will be part of vocal with at least level head, of the State Agency of medicines and health products, designated by its Director.

When you go to discuss issues relating to cosmetic products, a representative of the Ministry of health, social services and equality unit, will be part of vocal competition in cosmetic products, with at least Service Chief, appointed by its Undersecretary level.

When they will discuss issues relating to education, training or staff training, will be part of vocal a representative of the unit of the Ministry of education, culture and sport with competition in education, with at least Service Chief, appointed by its Undersecretary level.


2nd by part of the autonomous communities and the cities of Ceuta and Melilla: a representative of each of which agreed to integrate into this section.

3rd part of national non-governmental organizations which have as one of its main objectives the defence of animal welfare of experimental animals: a representative, appointed by the Chairman of the Committee, on a proposal from those.

4th by the professional associations specialized in animals used for scientific purposes of national character: a representative, appointed by the Chairman of the Committee, on a proposal from those.

5 by the national organizations which have as one of its main objectives the development and promotion of alternative methods to animal testing: a representative, appointed by the Chairman of the Committee, on a proposal from those.

6 a representative of the General Council of veterinary colleges of Spain appointed by the Chairman of the Committee on the proposal of the President of the Council.

7th by professional scientific associations of national character: a representative, appointed by the Chairman of the Committee, on a proposal from those.

(d) Secretary: an official with minimum level of head of service of the General Sub-Directorate of livestock products of the Ministry of agriculture, food and environment.

3 may attend, upon invitation by the Chair, with voice but without vote, independent experts.

4. the Committee may establish working groups pursuant to article 40.3 of the law 6/1997, of 14 April, of organization and functioning of the General Administration of the State.

5. the Committee may approve its own rules of operation. In everything not foreseen therein, shall apply the provisions of chapter II of title II of law 30/1992, of 26 November, legal regime of public administrations and common administrative procedure.

6. the Committee shall meet by call of its Chairman or at the request of one third of its members.

7. the functioning of the Committee does not imply increasing public spending and will be dealt with material means and personnel in the Ministry of agriculture, food and environment.

Expenditure on compensation for the performance of services, diets and displacements resulting from noncompliance with the participation at meetings of the members of the Committee, shall be borne by their respective administrations or organisations of origin.

Article 45. Sanctioning regime.

The regime of sanctions and infringements of the provisions of this Royal Decree shall be governed by the provisions in law 32/2007 of 7 November, for the protection of animals in its exploitation, transport, experimentation, or sacrifice, and in the autonomous rules of application, without prejudice of responsibilities in civil, criminal or other who could attend.

First additional provision. Human and material resources.

The records provided for in Royal Decree will be treated with the human and material resources in the Ministry of agriculture, food and environment, while its creation and operation involving increased public expenditure. In addition, provisions of this Royal Decree does not imply in any case increase allocations, or fees, or other staff costs.

Second additional provision. Safeguard clause.

1 the competent authority may take interim to allow exceptional measures: to) the use of primates for purposes that are not the prevent, prevent, diagnose or treat debilitating clinical conditions or that potentially can endanger life, whenever not achievable that purpose using other species of animals, when you have reasons scientifically founded to consider as essential use.

(b) the completion of a procedure although involves severe pain, suffering or distress for the animals and is likely that these effects are long-lasting and not can be alleviated, when exceptional and scientifically well-founded reasons deemed necessary the realization of that procedure.

2. the competent body that decides to adopt a provisional measure of this kind shall immediately inform the organ with competence in animal welfare of the Ministry of agriculture, food and environment, justifying its decision and giving evidence of the situation which led to the adoption of that.

3. the Ministry of agriculture, food and environment will act accordingly and will immediately transfer to the Commission and to the other Member States of the abovementioned information and documentation.

4. Likewise, the Ministry of agriculture, food and environment shall immediately inform the competent authority of the decision which, in his case, take the European Commission. The competent body shall immediately take measures to comply with the contents of the above-mentioned decision.

First transitional provision. Breeders, suppliers and users registered in accordance with the 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 on the basis of provisions of the Royal Decree 1201 / 2005, on 10 October, on the protection of animals used for experimental and other scientific purposes, which are in operation, shall be notified to the competent bodies, in a period not exceeding six months from the publication of the present Royal Decree supplementary information according to the provisions of the same.

Second transitional provision. Projects and processing procedures.

1 shall not apply as provided in section 2 of chapter V to procedures that have been approved before 1 January 2013 and that end before January 1, 2018.

2. the projects approved before January 1, 2013 and are completed after January 1, 2018, must obtain an authorization in accordance with this Royal Decree for implementation, later than January 1, 2018.

3 administrative procedures in processing at the time of the entry into force of this Royal Decree, shall be resolved in accordance with the legislation in force at the time of the beginning of the same.

Third transitional provision. Models of pre-existing reports.

While the European Commission do not set new models of reports for compliance with the provisions of article 54 of Directive 2010/63/EU of the European Parliament and of the Council of September 22, 2010, for the purposes of fulfillment of the duty of information, communication and advertising laid down in article 41 of the present Royal Decree users and the competent bodies and the Ministry of agriculture , Food and environment continue to preparing reports pursuant to article 27 of the Royal Decree 1201 / 2005 of 10 October.

Fourth transitional provision. Categories recognised in accordance with the Royal Decree 1201 / 2005 of 10 October.

The persons empowered by the competent bodies to carry out the duties corresponding to the categories established in accordance with the provisions of the repealed Royal Decree 1201 / 2005, of 10 October, will keep that power in reference to the above functions, without prejudice to the requirements of adaptation to the new legislation to be adopted by these bodies.

Fifth transitional provision. Staff trained to perform the functions listed in article 15.

Within the period of 12 months from the publication of the present Royal Decree, the Ministry of economy and competitiveness, prior report of the ministries of education, culture and sport and agriculture, food and environment will develop the requirements for the training of personnel referred to in article 15. For such purposes may attend a working group, established in the framework of the Committee set up in article 44, in the field of education, training and personnel training. En_tanto as the above-mentioned requirements do not develop: 1. are considered qualified to perform the functions of article 15.2. at) staff recognized or approved as category A as set out in annex I of Royal Decree 1201 / 2005, of 10 October.

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

3 are considered qualified to perform the functions of article 15.2. c) staff recognized or approved as category B and C as set out in annex I of Royal Decree 1201 / 2005 of 10 October. In the latter case requires that staff has received training in a relevant scientific discipline for the procedure performed and has a specific knowledge of the involved species 4. They are considered qualified to perform the functions of article 15.2. d) staff recognized or approved as category C as set out in annex I of Royal Decree 1201 / 2005 of 10 October and in addition they have received instruction in a scientific discipline relevant to the work carried out and has a specific knowledge of the species involved.

5 is considered qualified to perform the functions of article 15.2. e) staff recognized or approved as a category D1 as set out in annex I of Royal Decree 1201 / 2005 of 10 October.


6 is considered qualified to perform the functions of article 15.2. f) staff recognized or approved as a category D2 as set out in annex I of Royal Decree 1201 / 2005 of 10 October.

Sixth transitional provision. More stringent provisions.

The competent bodies may maintain provisions whose purpose is to ensure greater protection to animals within its territory, provided that they were already in force on November 9, 2010, that are consistent with the principles General of Treaty of functioning of the European Union and which communicate to the European Commission in the shortest possible time. For this purpose, the competent bodies of the autonomous communities and cities of Ceuta and Melilla shall communicate before the 1 of December 2012 to the competent Directorate-General animal welfare General Administration of the State provisions that have decided to maintain, for its communication by this time the European Commission.

Seventh transitional provision. Habilitation.

The autonomous communities shall authorize and shall designate, within a maximum period of six months, in accordance with the provisions of article 43, to authorized bodies for the evaluation of projects, and forward, to the sole purpose of advertising, the relationship of these to the Ministry of economy and competitiveness, which will make public the list through its electronic office , and keep it properly updated available to interested parties.

They will have provisional authorization as not is publicize the list of enabled bodies referred in the previous paragraph, animal ethics committees, which in its action shall comply with the provisions of article 43.1.

Sole repeal provision. Repeal legislation.

The entry into force of this Royal Decree shall be repealed: to) the Royal Decree 1201 / 2005 of 10 October, on the protection of animals used for experimental and other scientific purposes.

(b) article 11 of the Royal Decree 751/2006, of June 16, on authorization and registration of carriers and means of transport of animals and by establishing the Spanish Committee for welfare and protection of farm animals.

First final provision. Basic character and competence title.

This Royal Decree is basic and is run under cover of the competences recognized to the State by the Constitution in its article 149.1.13., 15th and 16th of the Constitution, which attributes to the State the exclusive competence in matters of bases and coordination of the general planning of economic activity, promotion and general coordination of scientific and technical research , and bases and general coordination of the health.

Second final provision. Incorporation of Community law.

It joins our legal system the Directive 63/2010/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes by this Royal Decree.

Third final provision. Faculty of modification.

It empowers the titular person of the Ministry of agriculture, food and environment to amend annexes of this Royal Decree, to its adaptation to community or international legislation.

Fourth final provision. Entry into force.

This Royal Decree shall enter into force the day following its publication in the "Official Gazette".

Given in Madrid on February 1, 2013.

JUAN CARLOS R.

The Vice-President of the Government and Minister of the Presidency, SORAYA SAENZ DE SANTAMARIA ANTON annex I species which is referenced in the article 19 1. Mouse (Mus musculus).

2 rat (Rattus norvegicus).

3 Guinea pig (Cavia porcellus).

4. Syrian hamster (gold) (Mesocricetus auratus).

5. Chinese dwarf hamster (Cricetulus griseus).

6. Mongolia gerbil (Meriones unguiculatus).

7 rabbit (Oryctolagus cuniculus).

8 dog (Canis familiaris).

9 cat (Felis catus).

10. all species of non-human primates.

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

12 zebra fish (Danio rerio).

Annex II requirements relating to settlements and the accommodation and care of animals section A: general section 1. Facilities.

1.1 functions and general design.

(a) all facilities must be built in so as to ensure an environment that takes into account the physiological and Ethological needs of the species housed in them. They must also designed and managed with a view to prevent access by unauthorized persons and the entry or the escape of animals.

(b) establishments must apply an active program of maintenance in order to avoid and repair any buildings or material defect.

1.2 local accommodation.

(a) establishments should have an efficient program of periodic cleaning of the premises and maintain a satisfactory hygienic level.

(b) the walls, ceilings and floors must be covered with a waterproof material when necessary and resistant to great wear and tear caused by the animals and cleaning operations. The lining material should not be detrimental to the health of the animals or lead which animals are hurt. Devices or accessories must be protected especially to prevent animals spoil them or injury.

(c) the species which are incompatible, as predators and prey, or animals requiring different environmental conditions, must be housed in separate locations and, in the case of predators and their prey, out of his sight, smell, or hearing.

1.3. local purposes General and special procedures.

(a) establishments should have, when appropriate, of laboratory facilities to perform simple diagnostic tests, post-mortem examinations, or to take samples which must be subject to laboratory research in somewhere else. Premises for the performance of procedures for General or special purposes must be available for situations where it is not advisable to carry out procedures or observations on the premises of accommodation.

(b) should there be facilities to allow the isolation of the newly acquired animals until they determine their State of health and evaluates and minimizes the potential health risk to other animals.

c) must have premises to accommodate separate sick or injured animals.

1.4 local service.

(a) storage premises should be designed, used and kept so to preserve the quality of feed and bedding. These premises should be as far as possible to test for parasites and insects. The materials of another type, which may be contaminated or present a hazard to animals or staff, should be stored separately.

(b) the premises of cleaning and washing must be large enough to accommodate the installations necessary to decontaminate and clean used material. The cleaning process should be organised so that remain separate flows of clean and dirty materials to prevent contamination of the newly cleaned material.

(c) the establishments must take measures for storage and safe disposal of carcasses and waste of animals under satisfactory hygienic conditions.

(d) when it is necessary to carry out surgical procedures under aseptic conditions, will have one or more rooms duly equipped, as well as facilities for post-operative recovery.

2. the environment and its control.

2.1 ventilation and temperature.

(a) insulation, heating and ventilation of the premises of accommodation ensure that air circulation, dust levels and gas concentrations remain within limits which are not harmful for the animals housed.

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

(c) animals must not be forced to remain in outdoor areas under climatic conditions which can be potentially harmful or likely to cause distress.

2.2 lighting.

a) when natural light does not ensure an appropriate light/dark cycle, must have a controlled lighting system to meet the biological needs of animals and provide a suitable working environment.

b) lighting should be adequate to carry out the management and inspection of animals, to stress to animals c) photoperiods must be regular, with an intensity of light adapted to the species.

(d) If you are albino animals, the lighting must adapt to take into account their special sensitivity to light.

2.3 noise.

a) noise levels, including ultrasounds, they should not affect negatively animal welfare.

(b) establishments should have systems of alarm that, if they are acoustic, emitting sound outside the sensitive animals audio spectrum, as it does not interfere with their audibility to human beings.

(c) the premises of accommodation must have, in your case, insulation and sound absorption materials.

2.4. emergency and alarm systems.

(a) establishments that rely on electrical or mechanical devices for the control and regulation of environmental conditions must have alternative systems that ensure that will operate essential services and emergency lighting devices, and to avoid own alarm systems to become inoperable.


(b) heating and ventilation systems must have control and alarm devices.

c) be exposed in a visible location clear instructions on actions to develop in case of emergency.

3. care of the animals.

3.1 health.

(a) establishments must have a strategy to ensure the maintenance of a State of health of the animals that guarantees their welfare and meets scientific requirements. This strategy should include periodic health checks, a microbiological surveillance and program action plans address the health problems, the definition of health parameters and protocols for the introduction of new animals.

(b) a qualified person should check at least once a day the animals. Such controls must ensure that any sick or injured animal is detected and receive the necessary care.

3.2 animals captured in nature.

(a) in places of capture, where it is necessary to move the animals for examination or treatment, you must have containers and means of transport adapted to the species considered.

(b) it must be given special consideration and take appropriate measures for acclimatisation, quarantine, animal husbandry, care of the animals captured in nature and, where appropriate, provisions for their release at the end of the procedures.

3.3 accommodation and enrichment.

(a) accommodation.

Animals, except those who are by nature solitary, must be accommodated in stable groups of compatible individuals. When permitted pursuant to article 6.3 individual accommodation, their duration should be limited to the minimum necessary, and must be a visual, auditory, olfactory and/or tactile contact. The introduction or reintroduction of animals in established groups must be carefully monitored to avoid problems of incompatibility or a disturbance of social relations.

(b) environmental enrichment.

All animals must have a space of sufficient complexity to allow them to express a wide range of normal behavior. They must have some level of control and choice of their environment, to reduce stress-induced behaviors. Establishments must have appropriate enrichment techniques that expand the range of activities available to the animal and develop its capacity for adaptation, such as physical exercise, the search for food and activities of manipulation and exploration according to the species. The animal enclosure environmental enrichment must adapt to individual needs and those of the species. Strategies of enrichment of the establishments inspected and updated on a regular basis.

(c) animal enclosures.

Enclosures should be constructed with materials not harmful to the health of the animals. They must be designed and constructed so as to avoid causing injury. If they are not disposable, they should be constructed with materials resistant to cleaning and decontamination techniques. The design of the soils of the enclosures must be adapted to the species and age of the animals and facilitate the removal of excreta.

3.4 power.

(a) the form, composition and the presentation of feed or other food must respond to nutritional needs and behavior of the animal.

(b) the diet must be palatable and not contaminated. In the selection of raw materials and production, preparation and presentation of the animal food establishments must take steps to minimise chemical, physical and microbiological contamination.

(c) packaging, packaging, transport and storage of feedingstuffs must plan so to prevent their contamination, deterioration or destruction is. All feeders, hoppers and other utensils used for feeding must be cleaned regularly and if necessary sterilized.

(d) each animal must have access to food and have enough space to limit competition with other animals.

3.5 water.

(a) all animals must have permanently non-contaminated drinking water.

(b) when using automatic systems of water intake, your operation should be subject to periodic inspection, maintenance and cleaning to avoid accidents. If compact soil cages are used, you must minimize is the risk of flooding.

c) must take the necessary measures to adapt the water of aquariums and terrariums supply the needs and tolerances of each species of fish, amphibians and reptiles.

3.6. resting areas.

(a) the animals must always have resting structures or bed materials adapted to the species, as well as structures or for breeding animals nesting materials.

(b) in the vicinity of animals, according to the needs of each species, must provide a solid and comfortable sleep surface for all animals. All sleeping areas must be kept clean and dry.

3.7 management.

Establishments should develop acclimatization and learning programmes suitable for animals, the procedures and the duration of the project.

Section B: sections specific 1. Mice, rats, gerbils, hamsters and Guinea Pigs.

In the following tables on mice, rats, gerbils, hamsters and Guinea pigs, "enclosure height" means the vertical distance between the ground and the upper part of the enclosure; It must be this height by more than 50 per cent of the minimum area of the floor of the enclosure before introducing elements of enrichment.

When planning the procedures should take into account the potential growth of the animals in order to ensure them adequate space (as shown in tables 1.1 to 1.5) throughout the study.

Table 1.1 mice weight body (g) minimum size of the enclosure (cm²) soil surface per animal (cm²) minimum height of the enclosure (cm) date referred to in article 6(2) in reserve and during procedures.





Up to 20.

More than 20 to 25.

More than 25 to 30.

More than 30.





330 330 330 330 60 70 80 100 12 12 12 12 1 2017 January playlist.





 





330. for a monogamous pair (not consanguineous / inbred) or a trio (SIB). Other 180 12 cm² should be added for each additional female and her litter on reservation at breeders *.





Less than 20.





950 40 12 in book at breeders *.





Less than 20.





1,500 30 12 * weaned mice, and even issue, and provided that their weight is less than 20 grams, and the compound has a minimum surface of 950 cm² can maintain at a density of up to 40 cm2 per animal, or 30 cm2/animal if the surface of the enclosure is at least 1500 cm2. Not be able to stay at these higher densities if there is any loss of welfare, as for example, increased aggressiveness, morbidity or mortality, stereotypic movements, other abnormalities of behavior, weight loss or other physiological responses or behavioral stress.

Table 1.2 rats weight body (g) minimum size of the enclosure (cm²) soil surface per animal (cm²) minimum height of the enclosure (cm) date referred to in article 6, paragraph 2 in reserve and during procedures *.





Up to 200.

More than 200 to 300.

More than 300 to 400.

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 2017 January playlist.





 





800 mother and litter. Other 400 cm² 18 reservation at breeders should be added for each additional adult animal, introduced permanently in the enclosure, *.

Enclosure dimension 1 500 cm².





Up to 50.

More than 50 to 100.

More than 100 to 150.

More than 150 to 200.





1,500 1,500 1,500 1,500 100 125 150 175 18 18 18 18 reserve at breeders *.

Dimension of the enclosure 2 500 cm².





Up to 100.

More than 100 to 150.

More than 150 to 200.





2,500 2,500 2,500 100 125 150 18 18 18 * in long-term studies, if the minimum available space for each animal is less than indicated above towards the end of these studies, should be prioritized to maintaining stable social structures.


* Rats, once weaned, can stay with these higher densities of occupation in the short period between weaning and the expedition, provided that they are housed in larger enclosures with adequate enrichment, those conditions of accommodation do not produce any decline of welfare as, for example, increased aggressiveness, morbidity or mortality, stereotypic movements and other abnormalities of behavior weight loss or other physiological responses, or behavioral stress.

Table 1.3 gerbils weight body (g) minimum size of the enclosure (cm²) soil surface per animal (cm²) minimum height of the enclosure (cm) date referred to in article 6, paragraph 2 in reserve and during procedures.





Up to 40.

More than 40.





1,200 1,200 150 250 18 18 1 2017 January playlist.





 





1200 monogamous pair or trio with offspring.





 





18 table 1.4 hamsters weight body (g) minimum size of the enclosure (cm²) soil surface per animal (cm²) minimum height of the enclosure (cm) date referred to in article 6, paragraph 2 in reserve and during procedures.





Up to 60.

More than 60 to 100.

More than 100.





800 800 800 150 200 250 14 14 14 1 2017 January playlist.





 





800 mother or monogamous pair with litter 14 in reserve at breeders *.





Less than 60.





1,500 100 14 * hamsters, once weaned, can stay with these higher densities of occupation, in the short period between weaning and the expedition, provided that they are housed in more spacious with adequate enrichment facilities, accommodation conditions do not produce any loss of welfare, as, for example, increased aggressiveness, morbidity or mortality, stereotypic movements and other abnormalities of behavior weight loss or other physiological responses, or behavioral stress.

Table 1.5 Guinea Pigs weight body (g) minimum size of the enclosure (cm²) soil surface per animal (cm²) minimum height of the enclosure (cm) date referred to in article 6, paragraph 2 in reserve and during procedures.





Up to 200.

More than 200 to 300.

More than 300 to 450.

More than 450 to 700.

More than 700.





1,800 1,800 1,800 2,500 2,500 200 350 500 700 900 23 23 23 23 23 1 2017 January playlist.





 





2500 pair with litter. For each additional breeding female, other 1,000 cm² should be added.





 





23





2. Rabbits. Within the framework of an investigation of agricultural nature, where the objective of the project available to keep animals in conditions similar to the animals of commercial farms, the accommodation of the animals must meet at least the standards referred to in the Royal Decree 348/2000, of March 10, which is incorporated into the legal system Directive 98/58/EC concerning the protection of animals kept for farming.

A platform within the enclosure should be envisaged. This platform must allow the animal to tip over, feels and moves easily under, but should not cover more than 40 percent of the soil. When, for scientific or veterinary reasons, not able to use a platform, the enclosure must be a 33rd hundred wholesale for a single rabbit and 60 100 wholesale for two rabbits. When it is expected a platform for rabbits of less than 10 weeks of age, the surface of the platform must be, at least 55 x 25 cm and its height above the ground must be adequate so that animals use it.

Table 2.1 rabbits for more than 10 weeks table 2.1 refers both to the cages and fences. Supplementary soil surface is less than 3 000 cm2 per rabbit for the third, the fourth, the fifth and the sixth animal, while they should be added, as a minimum, 2 500 cm2 for each rabbit introduced above six.




Weight body end (kg) minimum area of land for one or two socially harmonious animals (cm²) minimum height (cm) date referred to in article 6, paragraph 2 less of 3.

Between 3 and 5.

More than 5.





3 500 4 200 5 400 45 45 60 1 January 2017 box 2.2 rabbits with litter weight of the DOE (kg) minimum surface of the enclosure (cm²) supplement for boxes nest (cm²) minimum height (cm) date referred to in article 6, paragraph 2 less of 3.

Between 3 and 5.

More than 5.





3,500-4,200-5,400 1,000 1,200 1,400 45 45 60 1 January de.2017 table rabbits of less than 10 weeks 2.3 table 2.3 refers both cages and fences.




Age minimum surface of the enclosure (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 1 January 2017 between 7-10 weeks.





4,000 1,200 40 box 2.4 Rabbits: optimal dimensions of pallets for enclosures having the dimensions indicated in table 2.1 age in weeks final body weight (kg) optimal Dimension (cm x cm) optimum height from the floor of the enclosure (cm) date referred to in article 6, paragraph 2 of 10.





Less than 3.





55 x 25 25 1 2017 January between 3 and 5.





55 x 30 25 of 5.





60 x 35





30





3. Cats. Cats should not be housed individually more than 24 hours at a time. Cats that are displayed repeatedly aggressive toward other cats only should be accommodated individually if a compatible companion cannot be found. The social stress of all individuals staying in pairs or in groups must be checked at least once a week. Females in the last two weeks of gestation or with calves of less than four weeks can be housed individually.

Table 3. Cats minimal space in which it can keep a cat and their pups is a single cat, gradually increasing so that when you broods them have four months of age, they have been relocated to the space requirements for adults.

Areas for food and sanitary trays must not be less than 0,5 metres away and must not be interchanged.




 





Soil * (m²) platforms (m²) height (m) date referred to in article 6, paragraph 2 minimum for an adult animal.





1.5 0.5 1 2 January 2017 for each additional animal.





0.75 0.25 - * floor with the exception of pallets.

4 dogs. Dogs must be transferred whenever possible to an outdoor area in which to exercise. Individual accommodation should not be extended for more than four hours.

Indoor enclosure size must not be less than 50 per cent of the minimum space for the dogs, as detailed in table 4.1.

The dimensions of the available space shown in the following tables are based on the needs of the Beagle, so giant, like the St. Bernard or Irish Wolfhound races must have a space considerably greater than indicated in table 4.1. For races other than the Beagle of experimentation, the needs of space must decide with advice from the veterinary staff.

Table 4.1 dogs


Dogs housed in pairs or in a group can be confined, each one of them, 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 being subjected to the procedures defined in the present Royal Decree, if the insulation is essential for scientific purposes. The time during which the dog is subject to such limitations should not extended more than four hours at a time.

A nursing bitch and her litter should have the same space as a single bitch of equivalent weight. Breeding enclosure must be designed in such a way that the bitch can move to an adjacent compartment or a platform separate from the puppies.




Weight (kg) minimum size of the enclosure (m²) minimum floor area for one or two animals (m²) for each animal in addition, add a minimum of (m²) minimum height (m) date referred to in article 6, paragraph 2 up to 20.

More than 20.





4 8 4 8 2 4 2 2 1 January 2017 box 4.2 dogs: space available after weaning weight of dog (kg) minimum size of the enclosure (m²) minimum surface of soil/animal (m²) minimum height (m) date referred to in article 6, paragraph 2 up to 5.





4 0.5 2 1 2017 January more than 5 to 10.





4





1,0





2






De más de 10 a 15.





4





1,5





2






De más de 15 a 20.





4





2





2






De más de 20.





8





4





2





5. Ferrets.

Table 5. Ferrets minimum size of the enclosure (cm²) minimum floor area per animal (cm²) minimum height (cm) date referred to in article 6, paragraph 2 animals up to 600 g.





4,500 1,500 50 1.de.enero de.2017 animals of more than 600 g.





4,500 3,000 50 adult males.





6,000 6,000 50 female 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.

Environment must allow primates to develop a complex daily activities program. The enclosure must allow the primates adopt a code of conduct the broadest possible, give them a sense of security and provide a sufficiently complex environment so that they can run, walk, climb and jump.

Table 6.1 marmosets and tamarins minimum area of land of enclosures for 1 * or 2 animals, more offspring up to 5 months (m²) minimum volume per additional animal over 5 months (m) minimum height of the enclosure (m) * date referred to in article 6, paragraph 2 marmosets.





0.5 0.2 1.5 January 1, 2017 tamarins.





1.5 0.2 1.5 * animals are only individually accommodated in exceptional circumstances.

* The upper limit of the enclosure should be at least 1.8 m from the ground.

Young marmosets and tamarins not must be separated from the mother before eight months of age.

Table 6.2 Saimiris minimum area of land for 1 * or 2 animals (m²) minimum volume for each additional animal over 6 months (m3) minimum height of the enclosure (m) date referred to in article 6, paragraph 2 2.0 0.5 1.8 1 January 2017 * animals are only individually accommodated in exceptional circumstances.

Young marmosets and tamarins not must be separated from the mother before six months of age.

Table 6.3 macaques and green monkeys * minimum size of the enclosure (m²) minimum volume of the enclosure (m3) minimum volume per animal (m3) minimum height of the enclosure (m) date referred to in article 6, paragraph 2 animals less than 3 years of age *.





2.0 3.6 1.0 1.8 1 January 2017 animals from 3 years of age *.





2.0 3.6 1.8 1.8 animals for reproduction *.





 





 





3.5 2.0 * animals are only individually accommodated in exceptional circumstances.

 * In an enclosure of minimum dimensions are can accommodate up to three animals.

An enclosure of minimum dimensions can accommodate up to two animals.

In reproductive colonies does not lack additional space/volume for young animals up to 2 years housed with their mother.

Young macaques and green monkeys not must be separated from the mother before 8 months of age.

Table 6.4 baboons * minimum size of the enclosure (m²) minimum volume of the enclosure (m3) minimum volume per animal (m3) minimum height of the enclosure (m) date referred to in article 6, paragraph 2 animals * of less than 4 years of age.





4.0 7.2 3.0 1.8 1 January 2017 animals * from 4 years of age.





7.0 12.6 6.0 1.8 animals for reproduction *.





 





 





12.0 2.0 * animals are only individually accommodated in exceptional circumstances.

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

In reproductive colonies does not lack additional space/volume for young animals up to 2 years housed with their mother.

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

7. other farm animals. Within the framework of an investigation of agricultural nature, where the objective of the project available to keep animals in conditions similar to the animals of commercial farms, the accommodation of the animals must meet at least the standards referred to in the Royal Decree 348/200, March 10, which is incorporated into the legal system Directive 98/58/EC concerning the protection of animals kept for farming, in the Real Decree 1047 / 1994, 20 of may, concerning minimum standards for the protection of calves, and in Royal Decree 1135 / 31 October 2002, on minimum standards for the protection of pigs.

Table 7.1 cattle body weight (kg) minimum size of the enclosure (m²) minimum surface of soil/animal (m²/animal) length of feeder for ad libitum feeding of descornados cattle (m/animal) length of feeder for restricted feeding of descornados cattle (m/animal) date referred to in article 6, paragraph 2 up to 100.





2.50 2.30-0.10 0.30 1 January 2017 more than 100 to 200.





4.25 3.40 0.15 0.50 over 200 to 400.





6.00 4.80 0.18 0.60 more than 400 to 600.





9.00 7.50 0.21 0.70 of more than 600 to 800.





11,00





8,75





0,24





0,80






Más de 800.





16.00 10.00 0.30 1.00 picture 7.2 ovine and caprine animals body weight (kg) minimum size of the enclosure (m²) minimum surface of soil/animal (m²/animal) minimum height of gaps between enclosures (m) length of feeder for feeding ad libitum (m/animal)






Length of feeder for restricted feeding (m/animal) date referred to in article 6, paragraph 2 less of 20.





1.0 0.7 1.0 0.10 0.25 1 January 2017 more than 20 to 35.





1,5





1,0





1,2





0,10





0,30






De más de 35 a 60.





2,0





1,5





1,2





0,12





0,40






Más de 60.





3.0 1.8 1.5 0.12 0.50 7.3 box pigs and dwarf pigs (kg) live weight minimum size of the enclosure * (m²) minimum ground surface per animal (m²/animal) minimum rest area per animal (in thermally neutral conditions) (m²/animal) date referred to in article 6, paragraph 2 up to 5.





2.0 0.20 0.10 1 January 2017 more than 5 to 10.





2.0 0.25 0.11 over 10 to 20.





2.0 0.35 0.18 from more than 20 to 30.





2.0 0.50 0.24 more than 30 to 50.





2.0 0.70 0.33 over 50 to 70.





3.0 0.80 0.41 over 70 to 100.





3.0 1.00 0.53 from more than 100 to 150.





4,0





1,35





0,70






Más de 150.





5.0 2.50 0.95 adult (conventional) boars.





7.5 1.30 can confine pigs in smaller enclosures for a brief period of time, for example by dividing separations the main campus, when it is justified by reasons veterinary or experimental, as for example when an individual feed intake is required.

Table 7.4 equidae the shortest side must measure at least 1.5 times the height at the withers of the animal. The height of indoor enclosures must be such that the animals can stand up on their hind legs.




Height at the Withers (m) minimum surface of soil/animal (animal/m²) minimum enclosure height (m) date referred to in article 6, paragraph 2 for each animal housed individually or in groups of 3 animals maximum per every animal housed in groups of 4 animals or more stable of breeding/Mare with foal up to 1.40.





9.0 6.0 16 3.00 1 January 2017 over 1.40 to 1.60.





12,0





9,0





20





3,00






Más de 1,60.





16.0 (2 x AC) ² * 20 3.00 * in order to ensure one sufficient space, the minimum requirements of space for each individual animal should calculate according to the height at the Withers (AC).

8. birds. In the framework of an investigation of agricultural nature, when the objective of the project set to keep animals in conditions similar to the animals of commercial farms, the accommodation of the animals must meet at least the standards referred to in Royal Decree 348/2000, of March 10, which is incorporated into the legal system Directive 98/58/EC concerning the protection of animals kept for farming, the Royal Decree 2/2002, of 1 January, establishing minimum standards for the protection of laying hens, and the Royal Decree 692/2010 may 20, by which establish minimum standards for the protection of chickens for meat production and amending Royal Decree 1047/21994 , May 20, concerning minimum standards for the protection of calves.

Table 8.1 hens if scientific reasons these minimum dimensions, could not provide the experimenter should justify the duration of the closure, in consultation with the staff veterinarian. In such circumstances, birds can stay in smaller enclosures, suitably enriched, and with a minimum area of 0.75 m2 floor.




Body mass (g) minimum size of the enclosure (m²) minimum area per bird (m²) minimum height (cm) minimum length of trough per bird (cm) date referred to in article 6, paragraph 2 up to 200.





1.00 0.025 30 3 1 2017 January more than 200 to 300.





1.00 0.03 30 3 of more than 300 to 600.





1.00 0.05 40 7 more than 600 to 1 200.





2.00 0.09 15 50 of 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






Más de 2 400.





2.00 0.21 75 15 table 8.2 domestic turkeys all sides of the enclosure must be measured, at least 1.5 m long. If these minimum dimensions not could provide for scientific reasons, the experimenter must justify the duration of the closure, in consultation with veterinary staff. In such circumstances, birds can stay in smaller enclosures, suitably enriched, and with a minimum surface of soil of 0.75 m2 and a minimum height of 50 cm for birds less than 0.6 kg, 75 cm for birds below 4 kg, and 100 cm for birds over 4 kg. These enclosures can be used to accommodate small groups of birds in accordance with the minimum space indicated in table 8.2.




Body mass (kg) minimum size of the enclosure (m²) minimum area per bird (m²) minimum height (cm) minimum length of trough per bird (cm) date referred to in article 6, paragraph 2 up to 0.3.





2.00 0.13 50 3 1 2017 January more than 0.3 to 0.6.





2,00





0,17





50





7






De más de 0,6 a 1.





2,00





0,30





100





15






De más de 1 a 4.





2,00





0,35





100





15






De más de 4 a 8.





2.00 0.40 100 15 of more than 8 to 12.





2.00 0.50 20 150 of more than 12 to 16.





2.00 0.55 20 150 of more than 16 to 20.





2,00





0,60





150





20






Más de 20.





3.00 1.00 150 20 table 8.3 quail body mass (g) minimum size of the enclosure surface (m²) per bird hosted partner surface (m²) per additional bird Group (SQM) minimum height-hosted (cm) minimum length of trough per bird (cm) date referred to in article 6, paragraph 2 up to 150.





1.00. 0.5 0.10 20 4 1 January 2017 more than 150.





1.00. 0.6 0.15 30 4 box 8.4 ducks and geese if scientific reasons these minimum dimensions, could not provide the experimenter should justify the duration of the closure, in consultation with veterinary staff. In such circumstances, birds can stay in smaller enclosures, suitably enriched, and with a minimum area of 0.75 m2 floor. These enclosures can be used to accommodate small groups of birds in accordance with the minimum space indicated in table 8.4.




Body mass


(g) minimum size of the enclosure surface (m²) per bird (m²) * minimum height (cm) minimum length of trough per bird (cm) date referred to in article 6, paragraph 2 ducks 1 January 2017 up to 300.





2.00 0.10 10-50 more than 300 to 1 200 *.





2.00 0.20 200 10 of more than 1 200 to 3 500.





2,00





0,25





200





15






Más de 3 500.





2,00





0,50





200





15








Ocas








Hasta 500.





2.00 0.20 10 200 from more than 500 to 2 000.





2,00





0,33





200





15






Más de 2 000.





2.00 0.50 15 200 * in this area should include a pond having a minimum 0.5 square meters for each 2 m² of grounds and a minimum depth of 30 cm. Pond can take up to a 50 per cent the minimum area of the enclosure.

* Birds that do not yet have feathers can stay in venues with a minimum height of 75 cm.

Table 8.5 ducks and geese: minimum size of ponds * area (m²) depth (cm) ducks.





0,5





30






Ocas.





0.5 between 10 and 30 * these dimensions correspond to 2 m² of grounds. Pond can take up to a 50 per cent the minimum area of the enclosure.

Table 8.6 pigeon compounds must be long and narrow (for example, 2 m by 1 m), rather than squares, so that birds can perform short flights.




Size of the minimum size of the enclosure (m²) minimum height (cm) minimum length of trough per bird (cm) minimum length of perch per bird (cm) date referred to in article 6, paragraph 2 up to 6.





2 200 5 30 1 2017 January between 7 and 12.





3 200 5 30 per additional bird more than 12.





0.15 5 30 table 8.7 diamonds mandarin enclosures must be long and narrow (for example, 2 m by 1 m) so the birds to perform short flights. For the realization of studies of reproduction, they can stay couples in precincts smaller, properly fortified, with a minimum area of land of 0.5 m2 and a minimum height of 40 cm. The experimenter must justify the duration of the closure, in consultation with veterinary staff.




Size of the minimum size of the enclosure (m²) minimum height (cm) minimum number of feeders date referred to in article 6, paragraph 2 up to 6.





1.0 100 2 1 2017 January between 7 and 12.





1,5





200





2






Entre 13 y 20.





2.0 200 3 per additional bird more than 20.





0.05 1 per 6 birds 9. Amphibians.

Box 9.1 Urodelos water body length * (cm) minimum water surface (cm²) minimum water surface by additional animal housed in Group (cm²) minimum depth of water (cm) date referred to in article 6, paragraph 2 up to 10.





262,5 50 13 1 2017 January more than 10 to 15.





525 110 13 of more than 15 to 20.





875 200 15 of more than 20 to 30.





1.837,5 440 15 more than 30.





3,150 800 20 * measurement of the anterior end of the head to the cloaca.

Table 9.2 aquatic Anurans * body length * (cm) minimum water surface (cm²) minimum water surface by additional animal housed in Group (cm²) minimum depth of water (cm) date referred to in article 6, paragraph 2 less of 6.





160 40 6 1 2017 January between 6 and 9.





300 75 8 of more than 9 to 12.





600





150





10






Más de 12.





920 230 12.5 * these conditions apply to the Aquarium for maintenance, but for reasons of efficiency do not apply to the tanks used for natural mating and Superovulation, since these latter procedures require smaller aquariums. Minimum clearances of the table correspond to the indicated sizes adult; young animals and tadpoles must keep apart or modify the dimensions of the Aquarium proportionally to the size scale.

* Measurement of the anterior end of the head to the cloaca.

Table 9.3 semi-aquatic Anurans body length * (cm) minimum size of the enclosure * (cm²) minimum area per additional animal housed in the enclosure Group (cm²) minimum height * (cm) minimum water depth (cm) date referred to in article 6, paragraph 2 to 5.0.





1,500 200 20 10 1 2017 January more than 5.0 to 7.5.





3.500





500





30





10






Más de 7,5.





4,000 700 30 15 * measurement of the anterior end of the head to the cloaca.

 * One third of land and two-thirds of water where the animals can dive.

Measured from the surface of the land area to the inside of the top of the terrarium; In addition, the height of the enclosures must be adapted to the Interior.

Table 9.4 semi-terrestrial Anurans body length * (cm) minimum size of the enclosure * (cm²) minimum area per additional animal housed in the enclosure Group (cm²) minimum height * (cm) minimum water depth (cm) date referred to in article 6, paragraph 2 to 5.0.





1,500 200 20 10 1 2017 January more than 5.0 to 7.5.





3.500





500





30





10






Más de 7,5.





4,000 700 30 15 * measurement of the anterior end of the head to the cloaca.

 * Two-thirds of land and one-third of water where the animals can dive.

Measured from the surface of the land area to the inside of the top of the terrarium; In addition, the height of the enclosures must be adapted to the Interior.

Table 9.5 arboreal Anurans body length * (cm) minimum size of the enclosure * (cm²) minimum area per additional animal housed in the enclosure Group (cm²) minimum height * (cm) date referred to in article 6, paragraph 2 to 3.0.





 900 100 30 1 January 2017 more than 3.0.





1,500 200 30 * measurement of the anterior end of the head to the cloaca.

 * Two-thirds of land and one-third of water where the animals can dive.

Measured from the surface of the land area to the inside of the top of the terrarium; In addition, the height of the enclosures must be adapted to the Interior.

10. reptiles.

Table 10.1 aquatic turtles body length * (cm) (cm²) minimum water surface






Surface of water minimum per additional animal housed in Group (cm²) minimum depth of water (cm) date referred to in article 6, paragraph 2 up to 5.





600 100 10 1 2017 January more than 5 to 10.





1,600 300 15 of more than 10 to 15.





3,500 600 20 of more than 15 to 20.





6,000 1,200 30 from more than 20 to 30.





10,000 2,000 35 more than 30.





20,000 5,000 40 * measured in a straight line from the front to the back of the shell.

Table 10.2 terrestrial snakes body length * (cm) minimum floor surface (cm²) minimum area per additional animal housed in the enclosure Group (cm²) minimum height * (cm) date referred to in article 6, paragraph 2 up to 30.





300 150 10 1 2017 January more than 30 to 40.





400 200 12 from more than 40 to 50.





600 300 15 of more than 50 to 75.





1,200 600 20 more than 75.





2,500 1,200 28 * measurement of the anterior end of the head to the tail.

Measured from the surface of the land area to the inside of the top of the terrarium; In addition, the height of the enclosure must be adapted to the Interior.

11. fish.

11.1 supply and water quality.

An adequate supply of the proper quality water should be facilitated at all times. The flow of water in recirculation systems or filtering in tanks must be sufficient to keep the parameters of water quality at acceptable levels. Supplied water must be filtered or treated to eliminate substances harmful to fish, when necessary. Water quality parameters must be always within the acceptable range for the physiology and the normal activity of the species in question and its stage of development. The water flow must be adequate to allow fish to swim properly and maintain their normal behavior. A time suitable for their acclimatization and adaptation to changes in the conditions of the quality of the water you must grant to the fish.

11.2 oxygen, nitrogen compounds, pH, and salinity.

The oxygen concentration must be suitable for the species and the environment in which fish are kept. If necessary, the aeration of the water in the tank should be supplemented. Low concentrations of nitrogen compounds should be maintained.

PH level must adapt to the needs of the species and kept as stable as possible. Salinity must adapt to the needs of the species concerned and the phase of the life of the fish. Any change in salinity should be gradually.

11.3 temperature, lighting, noise.

The temperature must be maintained within the optimal range for the species concerned and more stably. Any changes must occur gradually. Must provide appropriate photoperiod to fish. The noise level should be reduced to a minimum, and to the extent possible, devices that cause noise or vibration, such as electrical generators or filtration systems, should be separated from the tanks where the animals are housed.

11.4 density and complexity of the environment.

Occupation density must be based on all of the needs of the fish in what refers to the conditions of the environment, the health and welfare. The fish must have a sufficient volume of water so that they can swim normally, taking into account its size, age, State of health and the power system used. A suitable, as places to hide environmental enrichment should be facilitated to fish or substrate in the background, unless their behaviour patterns suggest that it is not necessary.

11.5 feeding and management.

The fish will feed with a proper diet and adequate quantity and frequency. It should pay special attention to larvae feeding when moving food live to artificial diets. The handling of fish should be reduced to the minimum possible.

Annex III methods of euthanasia of animals 1. For euthanasia of animals, use the methods listed in the table of point 3.

Still, other methods other than those listed may be used in the table of point 3: a) if animals are unconscious, on the condition that they not regain the knowledge before he died.

(b) if animals are used in the context of an investigation of agricultural nature, where the objective of the project available to keep animals in conditions similar to the animals of commercial farms, in which case may be slaughtered in accordance with the requirements laid down in annex I of Regulation (EC) No. 1099 / 2009 of the Council , 24 September 2009 on the protection of animals at the time of the killing.

2 the euthanasia of the animals must be completed by one of the following methods: to) confirmation of permanent cessation of the circulation.

(b) destruction of the brain.

(c) cervical dislocation.

(d) bleeding.

(e) confirmation of the onset of rigor mortis.

3. picture.




Animals, observations/methods fish amphibians Reptiles birds rodents rabbits dogs, cats, ferrets and foxes large mammalian Primates overdose of anesthetic.





(1)





(1)





(1)





(1)





(1)





(1)





(1)





(1)





(1)






Pistola de clavija perforadora.





 





 





(2)





 





 





 





 





 





 






Dióxido de carbono.





 





 





 





 





(3)





 





 





 





 






Dislocación cervical.





 





 





 





(4) (5) (6) concussion / blunt blow to the head.





 





 





 





(7)





(8)





(9)





(10)





 





 






Decapitación.





 





 





 





(11)





(12)





 





 





 





 






Aturdimiento eléctrico.





(13)





(13)





 





(13)





 





(13)





(13)





(13)





 






Gases inertes (Ar, N2).





 





 





 





 





 





 





 





(14) shot with appropriate rifles, guns and ammunition.





 





 





((15) (16) (15) requirements: 1) should be used, where appropriate, prior sedation of the animal.

(2) only in large reptiles.

(3) only with the gradual release of the gas. Do not use in rodent fetuses and newborn rodents.

(4) only for birds of less than 1 kg. Birds of more than 250 g must sedate.

(5) only for rodents under 1 kg. Rodents of more than 150 g must sedate.

(6) only for rabbits of less than 1 kg. Rabbits over 150 g must sedate.

(7) only for birds of less than 5 kg.

(8) only rodents under 1 kg.

(9) only for rabbits of less than 5 kg.

(10) only in infants.

(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 terms of field by sharpshooters.

(16) only in field conditions by Sharpshooters, if other methods cannot be used.

Annex IV data minimum to enter in the movement document that is referenced in the article 9.3 to) sender: identification of the Centre of origin.

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


(c) species: number and identification of the animals.

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

(e) carrier: number of authorization for the transport of live animals.

(f) type and identification of the means of transport.

(g) place, date and time of departure provided.

(h) the estimated duration of the journey.

(i) signature and date of issue.

(j) where appropriate, authorization from the competent authority of the place of destination.

Annex V data minimum for identification in cages or confinement systems to) species.

(b) race (in your case).

(c) strain (in your case).

(d) sex.

(e) date of birth.

(f) date of crossing (if couples).

(g) number of animals.

(h) in the centers users, code project or other means that allows the identification of the procedure and is responsible for the same.

(i) observations.

Annex VI data minimum on animals should keep the breeders, suppliers and users to) name and registration number of the Centre.

(b) number of animals present in the Centre at the time to open this log, indicating the species or species to which they belong.

(c) the entries of the animal, the date in which they are produced, indicating the species, births and purchases, stating its origin (with mention of the name and address of the breeder or supplier).

(d) outputs of the animals date as they occur, the species, stating their destination and addressee (with mention of the name and address of the recipient).

(e) animals which have applied to the anesthesia or dead not used in procedures, the causes of death, when they know, 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 health examinations carried out the animals.

(i) the results of the necropsies performed.

(j) cases of disease.

(k) administered treatments.

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

(m) the data that correspond, in the case of the species of production to which the regulations required by the existence and maintenance of a book of registration or other requirements for reasons of public or animal health.

Annex VII elements to establish the minimum requirements relating to the education and training of the staff 1. National rules in force relating to the acquisition, husbandry, 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 biology fundamental and adjusted to each of the species in relation to Anatomy, physiological aspects, reproduction, genetics and genetic modifications.

4 ethology, animal husbandry and environmental enrichment.

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

6. management of the health and safety of the animals.

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

8 anesthesia, methods to relieve the pain and euthanasia 9. Use of humanitarian end points.

10. requirements for replacement, reduction and refinement.

11. design of procedures and projects, where appropriate.

Annex VIII species and dates to which refers article 21.5 species date common marmoset (Callithrix jacchus).





1 January 2013 Macaque crab-eating (Macaca fascicularis).





5 years from the publication of the feasibility study referred to in article 10, paragraph 1, fourth subparagraph of the directive 2010/63, of 22 September, provided that the study recommended an extended deadline.






Rhesus Macaque (Macaca mulatta).





5 years from the publication of the feasibility study referred to in article 10, paragraph 1, fourth subparagraph of the directive 2010/63, of 22 September, provided that the study recommended an extended deadline.






Other species of non-human primates.





5 years from the publication of the feasibility study referred to in article 10, paragraph 1, fourth subparagraph of the directive 2010/63, of 22 September, provided that the study recommended an extended deadline.





Annex IX classification of severity of procedures the severity of a procedure shall be determined by the degree of pain, suffering, distress or lasting harm expected that you can experience an animal individually during the procedure.

Section I: categories of severity without recovery: the procedures that are performed entirely under general anesthesia from which the animal does not regain consciousness, be classified as 'non-recovery'.

Mild: Procedures as a result of which animals is likely to experience mild short-term, pain, suffering or distress as well as procedures without significant alteration of wellbeing or general condition of the animals, be classified as "minor".

Moderate: Procedures as a result of which it is probable the animals to experience pain, suffering or distress short-term, moderate or mild but lasting, as well as procedures that could cause a moderate alteration of wellbeing or general condition of the animals, be classified as "moderate".

Severe: Procedures as a result of which it is likely that animals will undergo intense or moderate but long-lasting pain, suffering or distress, as well as procedures that could cause a serious alteration of the well-being or general condition of the animals, be classified as "severe".

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

Allocation to a procedure in a particular category will have take into account the type of procedure and many other factors which must be considered case by case.

The factors relating to the procedure should include:-types of manipulation and handling.

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

-Cumulative suffering in the procedure.

-Impediment of expressing natural behavior, including restrictions on the standards of accommodation, zootechnical and animal care.

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

However, for purposes of the final classification of severity of procedures, have been taken into account the following factors valued, additional case-by-case basis:-type of species and genotype.

-Maturity, age and sex of the animal.

-Degree of learning of the animal for the procedure.

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

-Methods used to reduce or eliminate pain, suffering and distress, including refinement of the accommodation conditions, animal husbandry and animal care.

-Use of humanitarian end points.

Section III: Types of procedure attributed to each category of severity on the basis of factors related to the type of procedure 1. Mild: a) anesthesia administration, except for the sole purpose of euthanasia.

(b) pharmacokinetic study where is administered a single dose and a limited number of blood samples collected (totaling

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