Key Benefits:
Publics concerned: user establishments, breeders and animal suppliers used or intended to be used for scientific purposes.
Purpose: Protection of animals used for scientific purposes.
Entry into force: the text comes into force on the day after its publication. It provides transitional provisions for projects that have benefited from an ethical opinion before that date, as well as for user establishments, breeders or animal suppliers used for scientific purposes already approved or registered.
Notice: the decree sets out the conditions for the species concerned, the origin of the animals, the conditions of accommodation and maintenance, and the experimental procedures to be completed by the user establishments, breeders and suppliers to be allowed to perform experimental procedures on animals or to raise or provide animals for this purpose. It provides for the accreditation and control of livestock establishments, suppliers and users used or intended to be used for scientific purposes.
An ethical reflection committee on animal experimentation is established with the National Committee for Animal Experimentation to issue opinions on ethical issues raised by animal experimentation.
References: the rural and maritime fishing code and the texts amended by this decree can be consulted, in their drafting, on the site Légifrance (http://www.legifrance.gouv.fr).
The Prime Minister,
On the report of the Minister of Ecology, Sustainable Development and Energy, the Minister of Higher Education and Research and the Minister of Agriculture, Agri-Food and Forestry,
Considering Council Regulation (EC) No. 338/97 of 9 December 1996 on the protection of wildlife species through the control of their trade;
Considering Directive 2005/36/EC of the European Parliament and the Council of 7 September 2005 on recognition of professional qualifications;
Having regard to Directive 2010/63/EU of the European Parliament and the Council of 22 September 2010 on the protection of animals used for scientific purposes;
Considering the environmental code, including articles L. 411-1 to L. 411-3, L. 412-2 and L. 424-11;
Vu le Criminal codearticles 131-13 and 521-2;
In view of the rural and maritime fisheries code, including chapters IV and V of title I of Book II (regulatory part);
Vu la Act No. 2000-321 of 12 April 2000 relating to the rights of citizens in their relations with administrations, including articles 21 and 24;
Vu le Decree No. 97-34 of 15 January 1997 amended on the deconcentration of individual administrative decisions;
Vu le Decree No. 97-1189 of 19 December 1997 amended to apply to the Minister of National Education, Research and Technology 1° of Article 2 of Decree No. 97-34 of 15 January 1997 the deconcentration of individual administrative decisions;
In light of Decree No. 97-1196 of 24 December 1997 adopted for application to the Minister of Defence 1° of Article 2 of Decree No. 97-34 of 15 January 1997 the deconcentration of individual administrative decisions;
Vu le Decree No. 2006-672 of 8 June 2006 modified on the establishment, composition and functioning of administrative advisory commissions;
Vu le Decree No. 2009-628 of 6 June 2009 relating to certain administrative advisory commissions under the Ministry of Higher Education and Research;
Considering the opinion of the National Commission for Animal Experimentation dated 2 February 2012;
The State Council (section of public works) heard,
Decrete:
Chapter IV of Book II title I of the Rural and Maritime Fisheries Regulatory Part is thus amended:
1° The title of section 5 is replaced by: "Other activities subject to authorization";
2° Sub-section 3 of section 5 is deleted;
3° It is created a section 6 as follows:
“Section 6
"Use of living animals for scientific purposes
"Subsection 1
" Scope of application and definitions
"Art. R. 214-87. -The provisions of this section apply where animals are used or intended to be used in experimental procedures as defined in R. 214-89, or when they are raised so that their organs or tissues may be used for scientific purposes.
"The provisions of this section apply until the animals referred to in the first paragraph have been put to death, placed in an appropriate livestock system or released into appropriate habitat.
"These provisions apply to:
“– Live vertebrate animals, including autonomous larval forms and fetal forms of mammals from the last third of their normal development;
"– autonomous larvae forms and fetal forms of mammals at a stage of development prior to the last third of their normal development, if the animal must be left alive beyond this stage of development and risk, as a result of the experimental procedures carried out, to experience pain, suffering or anxiety or to suffer lasting damage after reaching this stage of development;
“– Live cephalopods.
"The use of anaesthetic, analgesic or other methods to remove pain, suffering, anxiety or lasting damage does not place the use of an animal outside the scope of this section.
"Art. R. 214-88.-Do not enter the scope of this section the use of animals under the following conditions:
« 1° The use, whether invasive or not, for experimental purposes or for other scientific purposes, of invertebrate animals, other than cephalopods, embryonic forms of oviparous vertebrates and fetal forms of mammals before the last third of their normal development subject to the provisions of the fifth paragraph of Article R. 214-87;
« 2° Acts in farms for non-experimental purposes;
« 3° Acts for recognized livestock purposes;
« 4° The acts carried out with the primary purpose of identifying an animal;
« 5° The practice of veterinary medicine for non-experimental purposes;
« 6° Veterinary clinical trials required for the purpose of a veterinary drug marketing authorization;
« 7° Practices that are likely to cause pain, suffering, anxiety or lasting damage less than those caused by the introduction of a needle made in accordance with good veterinary practices.
"Art. R. 214-89.-For the meaning of this section and the texts taken for its application, it is understood that:
"1°" Experimental procedure”:
"any invasive or non-invasive use of an animal for experimental or other scientific purposes or for educational purposes;
"any intervention intended or of a nature to result in the birth or outbreak of an animal or the creation and conservation of a line of genetically modified animals;
"As long as this use or intervention is likely to cause this animal a pain, suffering, anxiety or lasting damage equivalent to or greater than that caused by the introduction of a needle in accordance with good veterinary practices.
"The death of animals, for the sole purpose of using their organs or tissues, according to a method defined by a joint decree of the Minister for Agriculture and the Minister for Research, is not considered to be an experimental procedure;
"2°" Project “: any program of work that meets a defined scientific objective, using one or more animal models, involving one or more experimental procedures;
"3°" Establishment”: any installation, building, group of buildings or other premises, including, where applicable, a place not completely closed or covered, as well as mobile facilities;
"4° " Breeder": any person who raises animals of the species defined by joint decree of the ministers responsible for agriculture and research, for their exclusive use in experimental procedures or for the use of their tissues or organs for scientific purposes, or raise other animals primarily for such purposes, for profit or not;
"5° "Tender": any person other than a breeder providing animals for use in experimental procedures or for the use of their tissues or organs for scientific purposes, for profit or not;
"6°" User”: any person using animals in experimental procedures or performing the death of animals within the meaning of the last paragraph of the 1st;
"7°" Invalidating affection”: in man, any decrease in the physical or psychological abilities of a person;
"8°" Colony maintained without the intake of external staff”: colony whose animals are raised only within the colony or originate from other colonies but have not been taken from nature and are held so as to be accustomed to the human being.
"Subsection 2
"Protection of animals used for scientific purposes
“Paragraph 1
« Animal species concerned and animal origin
"Art. R. 214-90.- Animals used or intended to be used in experimental procedures belonging to the species whose list is fixed by joint decree of ministers responsible for the environment, agriculture and research must have been raised for this purpose and be derived from breeders or suppliers approved in the manner provided for in sections R. 214-99 to R. 214-103.
"From a date fixed by a joint decree of ministers responsible for the environment, agriculture and research, primates come from captive farming or colonies maintained without the provision of external staff.
"Derogations to the first paragraph of this section may be granted by the Minister for Research, after the advice of the other Ministers concerned, on the basis of appropriate scientific evidence when the production of certified breeders is insufficient or not appropriate to the specific needs of the project.
"Art. R. 214-91. - Animals of wild or errant domestic species are not used in experimental procedures. On an exceptional basis, derogations may be granted by ministers responsible for agriculture and research after the favourable opinion of the National Commission for Animal Experimentation provided that the following conditions are met:
“(a) There is an essential need to carry out this experimental procedure that concerns the health and well-being of animals of the same species or a serious threat to human or animal health or the environment;
“(b) There are scientific evidence that the purpose of the experimental procedure can only be achieved by using an animal wandering or living in the wild.
"Art. R. 214-92.-Pets of non-domestic species not held in captivity are not used in experimental procedures. Derogations can only be granted by Ministers responsible for the environment and research if it is scientifically demonstrated that the objective of the experimental procedure cannot be achieved by using a high animal for use in experimental procedures.
"Where animals used or intended to be used in experimental procedures are specimens of protected species pursuant to Article L. 411-1 of the Environmental Code, this exemption may only be granted if the exemption provided for in Article L. 411-2 of the Code has been granted.
"Where animals used or intended to be used in experimental procedures are specimens of species authorized to hunt, this exemption may only be granted if the sampling authorization provided for in section L. 424-11 of the Environmental Code has been granted.
"The capture of animals in nature can only be done by a person with the skills defined by joint decree of the ministers responsible for the environment and agriculture and by using methods that do not cause animals of pain, suffering, anxiety or lasting damage that could be avoided.
"Every animal that, when caught or after it is injured or in poor health is examined by a veterinarian and measures are taken to minimize the suffering of the animal.
"Art. R. 214-93.-The use in experimental procedures of animals belonging to threatened species, other than those belonging to the order of primates, listed in Appendix A to Regulation (EC) No 338/97 of the Council of 9 December 1996 relating to the protection of wildlife species by the control of their trade, which do not fall within the scope of section 7, paragraph 1, is authorized
“(a) The procedure follows one of the purposes referred to in i of b, c or e of 1° of article R. 214-105;
“(b) There are scientific evidence that the purpose of the procedure cannot be achieved using other species than those listed in Appendix A to Council Regulation (EC) No 338/97 of 9 December 1996.
"Art. R. 214-94.-I. ― The use of primates in experimental procedures can only be authorized for experimental procedures that meet the following conditions:
“(a) The experimental procedure continues one of the purposes mentioned:
"at the i of the b or c of the 1st of Article R. 214-105 and is applied for the prevention, prophylaxis, diagnosis or treatment of invalidating or liable to be fatal;
"at or at the e of Article R. 214-105;
“(b) There are scientific evidence that the purpose of the experimental procedure cannot be achieved using other species than those belonging to the order of primates.
“II. ― The use, for experimental procedures, of primates belonging to species listed in Appendix A to Council Regulation (EC) No 338/97 of 9 December 1996 relating to the protection of wildlife species by the control of their trade, which do not fall within the scope of section 7, paragraph 1, of this Regulation, may only be authorized for experimental procedures that meet the following conditions:
“(a) The experimental procedure continues one of the purposes mentioned:
"at the i of the b or c of the 1st of Article R. 214-105 and is applied for the prevention, prophylaxis, diagnosis or treatment of invalidating or liable to be fatal;
"at the e of the 1st of Article R. 214-105;
“(b) There are scientific evidence that the purpose of the experimental procedure cannot be achieved by using other species other than those belonging to the order of primates or by using species not listed in Appendix A to Council Regulation (EC) No 338/97 of 9 December 1996.
"III. ― If, for scientifically justifiable reasons, the purpose of the experimental procedure can only be achieved by using primates for purposes other than the prevention, prophylaxis, diagnosis or treatment of invalid or potentially fatal conditions, the project manager shall file a written request with the research minister. Following the advice of the National Commission for Animal Experimentation, the Minister for Research may adopt a provisional measure co-signed by Ministers responsible for the environment, agriculture and research to authorize the project. The European Commission is informed of this interim measure and can oppose it.
"IV. – Monkeys belonging to the Gorilla, Pan and Pongo genres are not used in experimental procedures. By derogation, if valid reasons exist, it may be adopted, by joint decree of ministers responsible for the environment, agriculture and research, after consultation with the National Commission of Animal Experimentation, an interim measure allowing the use of monkeys belonging to the three genera of which it is in experimental procedures for the preservation of the species or the fact of the unexpected appearance, in the man, of The European Commission is immediately informed of this interim measure and can oppose it.
“Paragraph 2
" Conditions of accommodation and maintenance of animals
"Art. R. 214-95.-Without prejudice to the provisions of Article R. 214-17, the officials and staff of the user, breeders and suppliers shall ensure that:
“(a) All animals benefit from housing, environment, food, water supply and care appropriate to their health and well-being;
“(b) Any restriction on the ability of an animal to meet its physiological and ethological needs is limited to the strict minimum;
"(c) The environment conditions and mood parameters in which animals are high, detained or used are subject to daily checks;
"(d) Measures shall be taken to put an end to any anomaly or pain, suffering, anxieties or sustained damage that may be avoided within the shortest time;
“e) Animals are transported in conditions appropriate to their health and well-being.
"A joint decision of Ministers responsible for the environment, agriculture and research defines standards of care and accommodation. Exemptions to these standards may be granted for scientific reasons or for reasons related to animal welfare or animal health by joint decision of the same ministers.
"Art. R. 214-96.-The dogs, cats and primates in the user establishments, breeders or suppliers are identified by an individual and permanent marking. When the animals are washed, this marking is in accordance with the terms and conditions for the application of Article L. 212-10.
"Users, breeders or suppliers are required to keep individual information relating to each dog, cat or primate, defined by decree of ministers responsible for the environment and agriculture, for at least three years after the death or placement of the animal and to make it available to the authorized agents.
"In the event of placement, pursuant to section R. 214-112, the relevant information on the medical, health and behavioural history in the individual file mentioned above shall accompany the animal.
"Art. R. 214-97.-The person responsible for a user institution or a farmer or animal supplier for experimental procedures shall keep records of the animals in which the animal monitoring elements defined by joint order of the ministers responsible for agriculture and research are recorded.
"These records are kept for five years.
“Paragraph 3
« Conditions of death
"Art. R. 214-98.-The death penalty is carried out by limiting the pain, suffering and anguish of the animal as much as possible, by a competent person of the breeder establishment, supplier or user. However, in the case of a field study, an animal may be put to death outside an establishment.
"The list and conditions for the use of methods of death are specified by joint decree of ministers responsible for the environment, agriculture and research and the Minister of Defence.
"Derogations concerning the methods of death identified in the order mentioned in the preceding paragraph may be granted by the Minister responsible for research provided that, on the basis of scientific data, the alternative method is considered equivalent or on the basis of scientific evidence demonstrating that the purpose of the experimental procedure cannot be affected by the use of a method of death specified in the order referred to in the paragraph above.
"The provisions of the first paragraph and those of the order in the second paragraph of this section do not apply when an animal is put to death in an emergency for reasons related to animal welfare, public health, animal health, public safety or the environment.
"Subsection 3
"Agreement and control of pastoral establishments,
suppliers and users
“Paragraph 1
"How to Accredit
"Art. R. 214-99.-Any farmer, supplier or user must be registered. For this purpose, subject to the provisions of section R. 214-127, an application for approval is made by the person responsible for the establishment to the prefect of the establishment's location department.
"This application is accompanied by a file whose elements are specified by a joint decision of the Ministers responsible for Agriculture and Research and the Minister of Defence.
"Art. R. 214-100.- Accreditation is granted according to the purpose of the establishment, the nature of its facilities, the animal species hosted, the type of experimental procedures implemented and the qualification of its personnel. The prefect may restrict the extent of the requested accreditation or assort it from any condition deemed useful.
"The approval is granted for a period of six years.
"Any modification of the elements taken into account in the granting of the initial accreditation and termination of activity must be notified to the prefect. If applicable, an extension of the scope of the approval may be granted by the prefect, after justification by the person in charge of the establishment.
"An amendment to the registration is required once a significant change in the structure or operation of the farmer, supplier or user is likely to adversely affect the well-being of the animals.
"Accredit becomes null and void if the establishment ceases to operate. It may be suspended or withdrawn if the conditions that allowed the grant of the licence are no longer complied with under the conditions set out in section L. 206-2.
“Paragraph 2
“Requirements for staff in institutions
"Art. R. 214-101.-Any farmer institution, supplier or user must have on-site staff whose composition, training and role are defined by joint decree of the ministers responsible for agriculture and research and the Minister of Defence.
"Art. R. 214-102.-Any breeder establishment, supplier or user shall designate a competent health veterinarian for the animals concerned or, in the event that this would be more appropriate for certain species, an expert with the required qualifications. This veterinarian or, where applicable, the expert is responsible for providing advice on the well-being and treatment of animals, including the structure referred to in R. 214-103.
"Art. R. 214-103.-Any farmer establishment, supplier or user shall have a structure responsible for the well-being of animals whose composition, role and operation are defined by joint decree of the ministers responsible for agriculture and research and the Minister of Defence.
"By derogation from the previous paragraph, the prefect may authorize a very small breeder, supplier or user to carry out the tasks entrusted to this structure by other means than those specified by the order mentioned in the preceding paragraph.
“Paragraph 3
“Inspection of institutions
"Art. R. 214-104.-The officers referred to in Article L. 214-23 are entitled to exercise control over the application of the provisions of this section in the user establishments, pastoral establishments and supplier establishments.
"The farmer establishments, suppliers and users are inspected on a regular basis according to the terms defined by the joint order of the ministers responsible for agriculture and research and the Minister of Defence.
"Subsection 4
“Experimental procedures
“Paragraph 1
“ Licenity, choice and implementation of experimental procedures
"Art. R. 214-105.-Seules are lawful experimental procedures that meet the following two conditions:
« 1° Have one or more of the following:
“(a) Basic research;
“(b) Translational or applied research conducted to:
“(i) Prevention, prophylaxis, diagnosis or treatment of diseases, poor health conditions or other anomalies or their effects in humans, animals or plants;
“ii) Assessment, detection, control or modification of physiological conditions in humans, animals or plants;
“(iii) The well-being of animals and the improvement of the conditions for the production of high animals for agronomic purposes;
"(c) One of the purposes of b when developing, producing or testing the quality, efficacy and safety of human or veterinary drugs, foodstuffs, animal feeds and other substances or products;
"(d) The protection of the natural environment in the interest of the health or well-being of man or animal;
“e) Research for the preservation of species;
“(f) Higher education or vocational or technical training leading to trades that involve the conduct of experimental procedures on animals or the care and maintenance of these animals and the continuing professional training in this field;
“(g) Medico-legal investigations;
« 2° Respect the following alternative, reduction and refinement principles:
"—experimental procedures are of a strict necessity and cannot be replaced by other experimental methods that do not imply the use of live animals and may bring the same level of information;
"– the number of animals used in a project is reduced to its minimum without compromising the objectives of the project. For this purpose, the sharing of organs or tissues of animals put to death is permitted between establishments;
"– the conditions of livestock, accommodation, care and methods used are the most appropriate to minimize any pain, suffering, anxiety or lasting damage that animals may experience.
"Art. R. 214-106.-The choice of methods used in experimental procedures must allow the least possible use of animals to achieve the objectives of the project.
"It is also guided by the desire to select the experimental procedures that:
“(a) Are most likely to provide satisfactory results;
“(b) best meets the following requirements:
"using animals of species that are less likely to experience pain, suffering, anguish or sustained damage under the conditions of the experimental procedure;
"– to cause the least possible pain, suffering, anguish or lasting damage.
"Art. R. 214-107. - To the extent possible, death must be avoided as a limit of the experimental procedure and replaced by appropriate precise stopping criteria and whose implementation is as early as possible. When death cannot be avoided as a limit, the experimental procedure must be performed on as few animals as possible, by reducing as much time as possible, the intensity of suffering and as much as possible by ensuring the conditions of death without pain.
"Art. R. 214-108.-An experimental procedure is not implemented if it involves intense pain, suffering or anxiety that may prolong without being able to relieve them.
"Derogations from the previous paragraph may be granted by the Minister for Research for exceptional scientific reasons, after the advice of the other ministers signatories to the order referred to in R. 214-122. The Minister for Research notifies this interim measure to the European Commission, which may oppose it.
"Art. R. 214-109.-Unless it is not appropriate, all experimental procedures must be performed under general or local anaesthesia and using analgesics or any other appropriate method, so that pain, suffering and anxiety are limited as much as possible.
"Experimental procedures leading to serious injuries that may cause significant pain are not conducted without anesthesia.
"The decision not to use anesthesia can only be justified if anesthesia is considered more traumatic to the animal than the experimental procedure itself or if it is incompatible with the purpose of the experimental procedure.
"Experimental procedures incompatible with the use of anaesthetics or analgesics are scientifically justified in the application for authorization of the project referred to in R. 214-122.
"The administration of substances that prevent or limit the ability of animals to express pain cannot be done without an adequate level of anaesthesia or analgesia. In this case, the application for project authorization includes scientific elements accompanied by details of the anesthetic or analgesic protocol.
"When anesthesia has ceased to produce its effect, an animal likely to experience pain receives preventive, curative or postoperative analgesic treatment, or is treated using other appropriate methods to relieve pain as long as it is compatible with the purpose of the experimental procedure.
"As soon as the end of the experimental procedure has been reached, appropriate measures are taken to minimize the pain, suffering and anguish of the animal.
"Art. R. 214-110.-An experimental procedure is deemed to be completed when no observations are made. With respect to new lines of genetically modified animals, the experimental procedure is completed when no pain, suffering, anxiety or lasting damage of a level equivalent to or greater than that caused by the introduction of a needle is no longer observed or expected on the offspring.
"At the end of an experimental procedure, the veterinarian or any other competent person designated by the project manager decides whether the animal is kept alive.
"If an animal is kept alive, it receives the appropriate care and is hosted in conditions consistent with its state of health. It is placed under the supervision of a veterinarian or other competent person designated by the project manager, from the end of the experimental procedure, to ensure its well-being.
"Art. R. 214-111.-An animal is not kept alive after an experimental procedure if it is likely to continue to experience pain, suffering or anxiety or to suffer the effect of lasting damage of the "moderate" or "severe" classes defined by the order referred to in Article R. 214-122. It is in this case put to death before the end of the anesthesia or as soon as possible when the experimental procedure was done without anesthesia.
"Art. R. 214-112.-The placement or release of animals used or intended for use in experimental procedures, in suitable habitat suitable for the species, may be authorized by the prefect of the department of the place of that placement or release, provided that:
"the condition of the animal, certified by a veterinarian, permits it;
"There is no danger to public health, animal health and the environment;
"—appropriate measures have been taken to preserve its well-being.
"The breeders, suppliers and users whose animals are intended to be placed must have a placement program ensuring the socialization of the animals to be placed. Where applicable, a rehabilitation program is established for wildlife species animals before releasing them to their natural habitat. The release in the natural environment is subject to the prior obtaining, according to the animals concerned, of the necessary exemptions pursuant to the 4th of Article L. 411-2 of the Environmental Code, of the necessary authorizations pursuant to the II of Article L. 411-3 of the Environmental Code or of the necessary authorizations pursuant to Article L. 424-11 of the Environmental Code.
"Art. R. 214-113.-An animal already used in an experimental procedure cannot be reused in a new experimental procedure, where another animal with no experimental procedure previously applied could also be used, if the following four conditions are met:
“(a) The actual gravity of the previous experimental procedures was "light" or "moderate" as defined by the order referred to in R. 214-122;
“(b) It is demonstrated that the animal has fully recovered its state of health and general well-being;
"(c) The gravity of the new experimental procedure is "light", "moderate" or "without waking" as defined by the order mentioned in article R. 214-122;
"(d) A favourable opinion was given by a veterinarian taking into account the fate of the animal concerned over its lifetime.
"In exceptional circumstances, by derogation from this section, and after a veterinary examination of the animal, the research minister may authorize the reuse of an animal, after taking the advice of the Animal Experimental Ethics Committee, as defined in section R. 214-117, of which the establishment reports, provided that the animal has not been used more than once in an experimental procedure of suffering,
“Paragraph 2
“Competences required to design or realize
experimental procedures on animals
"Art. R. 214-114.-Any user establishment, breeder or animal supplier used or intended to be used in experimental procedures has a sufficient number of staff with appropriate qualification.
"A joint decision of Ministers responsible for the environment, industry, health, national education, agriculture and research and the Minister of Defence defines the level of education and training required to perform the following functions:
« 1° The design or realization of experimental procedures;
« 2° The application of experimental procedures to animals;
« 3° Care for animals;
« 4° Killing animals.
"Art. R. 214-115.-A level of study and training necessary to design or carry out experimental procedures is also recognized, in accordance with the terms set out by joint decree of ministers responsible for agriculture and research and of the Minister of Defence, to professionals, other than those mentioned in Article R. 214-114, nationals of a Member State of the European Union or of another State Party to the agreement on the certificate
"If the access or exercise of these activities is not regulated in the Member State of origin, professionals must also justify two years of full-time professional experience over the last ten years. This justification is not required when the training leading to this profession is regulated in the Member State or party to the agreement on the European Economic Area in which it has been validated.
"In the event of substantial differences between, on the one hand, the training required in France to carry out the activities referred to in Article R. 214-114 and, on the other hand, the training received by the applicant and the knowledge acquired during his or her professional experience, the applicant, at his or her choice, submits to a suitability test or performs an adaptation course of up to three years. A joint decision of the Ministers responsible for agriculture and research and the Minister of Defence sets out the content of this test and the procedure for organizing this test and training.
"Art. R. 214-116.-Service services relating to the design or implementation of experimental procedures carried out in France on a temporary and occasional basis by professionals national of a Member State of the European Union or a State Party to the European Economic Area, established in the territory of one of these States, are governed by Article L. 204-1.
"When an audit of the professional qualifications of the service provider reveals a substantial difference between these qualifications and the required training that would adversely affect the safety or health of the service recipient, the employee is able to demonstrate that he has acquired the missing knowledge and skills, by a suitability test, the terms and conditions of which are specified by joint order of the agriculture and research ministers and the Minister of Defence.
"Subsection 5
“Authorization of projects
“Paragraph 1
"Ethics committees in animal experimentation
and Ethical Evaluation of Projects
"Art. R. 214-117.-I. ― Subject to the provisions of section R. 214-127, any project is subject to an ethical assessment by an animal testing ethics committee approved by the Minister responsible for research.
"To this end, animal experimentation ethics committees are created at the initiative of user institutions. Any user institution must report to a single committee. Several user establishments may depend on the same committee.
“II. ― Subject to the provisions of section R. 214-127, Animal Experimental Ethics Committees are approved by the Minister for Research. To be approved, a committee must:
« 1° Justify the multidisciplinary competence of its members;
« 2° Guarantee respect for the national charter on the ethics of animal experimentation referred to in article R. 214-134;
« 3° Ensure respect for ethical assessment principles;
« 4° To present guarantees of independence and impartiality;
« 5° Provide operational means to carry out the ethical evaluation of projects within the time constraints of this Response.
"III. ― Subject to the provisions of section R. 214-127, the Minister for Research shall be informed, as soon as possible, of any amendment affecting compliance with any of the conditions for the granting of the approval listed in the II of this section.
"When the conditions of accreditation are no longer met, the Minister shall put the ethics committee in place to comply, within a time limit that he or she may not exceed six months.
"In the absence of compliance with the expiry of this period, and after the Ethics Committee has been put in a position to make its submissions, the Minister may decide to suspend the licence for a period not exceeding three months or to withdraw it.
"IV. ― A joint decision of Ministers responsible for agriculture and research and the Minister of Defence specifies the terms and conditions for the application of this section, including the content of the application for approval.
"Art. R. 214-118.-Ethics committees in animal experimentation are composed, at a minimum, of five people, including:
« 1° A person justifying competence in the field of the design of experimental procedures on animals;
« 2° A person justifying competence in the field of experimental procedures on animals;
« 3° A person justifying competence in at least one of the following areas:
“–care of animals;
“ ― putting animals to death;
« 4° A veterinary;
« 5° A non-specialized person in matters relating to the use of animals for scientific purposes.
"A member of an Animal Experimental Ethics Committee cannot participate in a deliberation to which he is interested either in his personal name or as a proxy, or in a matter of nullity of deliberation.
"Art. R. 214-119.-The ethical evaluation of the projects referred to in section R. 214-123 is carried out by the Animal Experimental Ethics Committee under the User Institution.
"It ensures that the project meets the following criteria:
« 1° The project is scientifically or educationally justified, or required by law;
« 2° The objectives justify the use of animals;
« 3° The project is designed to allow the conduct of experimental procedures in the most respectful conditions of the animal and the environment.
"The terms and conditions of the ethical assessment are set by a joint decision of the Ministers responsible for agriculture and research and the Minister of Defence.
"In the ethical evaluation of projects, the Animal Experimental Ethics Committee takes into account the principles set out in the charter referred to in R. 214-134.
"Art. R. 214-120.-In the light of the file provided for the ethical evaluation of a project, the Animal Experimental Ethics Committee under review may require that a retrospective evaluation of the project be conducted following the completion of the project. This retrospective assessment is carried out by the committee in accordance with the terms set out by a joint decision of the Ministers responsible for agriculture and research and the Minister of Defence.
"Projects using primates as well as projects involving "severe" experimental procedures, including those that, implemented by derogation from the first paragraph of article R. 214-108, involve intense pain, suffering or anxiety that may prolong without being able to relieve them, must be subject to retrospective evaluation.
"Projects that include only "light" and "without revival" experimental procedures are exempt from the retrospective evaluation requirement.
"Art. R. 214-121. -All relevant documents, including project authorization and the result of the ethical evaluation of the project, are retained by the user institution for at least five years from the expiry date of the project authorization and made available to authorized agents.
"Without prejudice to the previous paragraph, documents relating to projects that must be subject to retrospective evaluation are retained until the outcome of the latter.
"The statistical information on the use of animals in experimental procedures, including information on the actual severity of experimental procedures and on the origin and species of primates used in experimental procedures, must be collected and transmitted annually by the user institution to the research minister.
“Paragraph 2
" Application for authorization
"Art. R. 214-122.-Without prejudice to the application of the provisions of section R. 214-127, the completion of a project involving the execution of one or more experimental procedures shall be subject to an authorization granted by the Minister responsible for research under the conditions set out in section R. 214-123.
"The application is filed by the project manager. It specifies the class of severity ("without waking", "light", "moderate" or "severe") of the experimental procedures used for the realization of the project.
"The terms and conditions for filing the application and the composition of the application file as well as the criteria for classification of procedures are specified by a joint decision of Ministers responsible for the environment, agriculture and research and the Minister of Defence.
"Art. R. 214-123.- Authorization can only be granted to a project if it has been subject to a favourable ethical assessment.
"The authorization is granted for a maximum of five years, in accordance with the terms defined by a joint Agriculture and Research Ministers Order and the Minister of Defence.
"An authorization may be granted to multiple generic projects executed by the same user if these projects are intended to meet regulatory requirements or if they use animals for production or diagnostic purposes through recognized methods.
"Art. R. 214-124.-The Minister for Research shall acknowledge receipt of the application for authorization as soon as possible and shall indicate to the applicant the time limit referred to in section R. 214-125 during which the decision will be made.
"In the event of an incomplete or erroneous request, the Minister for Research shall inform the applicant, as soon as possible, of the need to provide additional documents and possible consequences for the calculation of the applicable time limit.
"The file is made available electronically to the Animal Experimental Ethics Committee.
"For institutions under its authority or guardianship, an order of the Minister of Defence defines the procedure for processing applications for project authorization.
"Art. R. 214-125. -The decision regarding a project authorization is notified no later than eight weeks after the full and correct application is received. This deadline includes the ethical evaluation of the project that cannot exceed seven weeks.
"When the complexity or multidisciplinary nature of the project justifies it, the Animal Experimental Ethics Committee requests the Minister responsible for research to extend the time limit for the ethical assessment referred to in the preceding paragraph for an additional period not exceeding three weeks. The extension and its duration shall be duly substantiated and notified to the applicant before the expiry of the eight-week period referred to in the preceding paragraph.
"Art. R. 214-126.-I. ― Any modification of the project that may have a negative impact on the well-being of animals is subject to a new application for authorization.
"The granting of a new project authorization is based on a new positive outcome of the ethical evaluation of the project.
"The decision on a new application for approval for an amendment to the project is notified no later than four weeks after the application is received.
"This period includes that of ethical evaluation, which cannot exceed three weeks.
“II. ― The research minister may withdraw the project authorization when the project is not carried out in accordance with the authorization.
"The removal of a project authorization shall not affect the well-being of animals used or intended for use in the project.
"The procedure to be followed for the renewal, modification or withdrawal of project authorizations is set by a joint decision of the Ministers responsible for agriculture and research and the Minister of Defence.
"Subsection 6
“National Defence Establishments
"Art. R. 214-127.-For the purposes of the provisions of this section, the Minister of Defence is solely responsible for receiving and instructing applications for authorization, approval and derogation, and for granting or denying such authorizations, approvals and derogations where the experimental procedures relate to institutions under its authority or guardianship. For the placement or release provided for in article R. 214-112, the authorization of the prefect of the department of the place of that placement or release is also requested.
"The Minister of Defence shall be the sole recipient of statements and information relating to institutions under his authority or guardianship.
"Art. R. 214-128.-When the Minister of Defence adopts by order one of the interim measures provided for in sections R. 214-94 and R. 214-108, he shall immediately inform the Ministers responsible for the environment, agriculture and research. It informs the European Commission of this interim measure.
"Art. R. 214-129.-The inspections under section R. 214-104 shall be carried out by veterinarians specially authorized for this purpose by the Minister of Defence, for establishments under his authority or guardianship.
"Subsection 7
“National bodies
“Paragraph 1
"National Animal Experimentation Commission
"Art. R. 214-130.-It is established with the Minister for Agriculture and the Minister for Research a National Commission for Animal Experimentation.
"The Commission shall give its opinion on any proposed amendments to legislation or regulations relating to animal experimentation and the exemptions provided for in sections R. 214-91 and R. 214-94.
"The National Commission for Animal Experimentation renders a notice to the Minister responsible for agriculture for the approval of the trainings of persons called to design experimental procedures and projects as defined in R. 214-89, to use animals for scientific purposes and to ensure the maintenance and care of animals. These training courses are approved for a period of five years. Their renewal is subject to a new notice from the commission.
"It may also be consulted by the ministers to whom it is placed, as well as by the Minister of Defence or the Minister of Health, to advise and make any proposals that it considers useful on:
« 1° Animal husbandry used for scientific purposes;
« 2° Methods to improve conditions for the transport, accommodation and use of animals used for scientific purposes;
« 3° Training of persons called to use animals for scientific or educational purposes or to provide them with care;
« 4° The development, validation and promotion of alternative approaches that could provide the same level or higher level of information than experimental procedures using animals, but without involving the use of animals or reducing the number of animals used or using less painful experimental procedures;
« 5° The National Annual Review of the Activities of Ethics Committees, prepared by the National Committee for Ethical Reflection on Animal Experimentation.
"Art. R. 214-131.-The National Commission for Animal Experimentation is also responsible for:
"to advise the competent authorities and structures responsible for animal welfare on matters related to the acquisition, livestock, accommodation, care and use of animals in experimental procedures and to ensure the sharing of best practices;
"to exchange information on the functioning of animal welfare structures and on project evaluations with the national committees of other Member States to share best practices within the European Union.
"Art. R. 214-132.-In addition to its president appointed for five years renewable by joint decision of the ministers responsible for agriculture and research, the commission includes:
« 1° Eight representatives of the State:
“(a) The Director of Research at the Ministry of Research or his representative;
“(b) The Director of Animal Health and Protection at the Ministry of Agriculture or his representative;
"(c) The Director in charge of higher education to the Ministry in charge of higher education or his representative;
"(d) The Director of School Education at the Ministry of National Education or his representative;
“e) The Director General of Health at the Ministry of Health or his representative;
“(f) The Director of Industry at the Department of Industry or its representative;
“(g) The Director of Nature Protection at the Ministry of the Environment or his representative;
“(h) The Central Director of the Armed Health Service at the Ministry of Defence or his representative;
« 2° Twelve qualified personalities appointed for five years renewable by joint decision of the Ministers responsible for agriculture and research and distributing as follows:
“(a) Three personalities representing the public research sector;
“(b) Three personalities proposed by representative organizations of the private industrial sector;
"(c) Three personalities proposed by recognized organizations of public utility in animal protection and wildlife protection;
"(d) Three personalities offered by animal experimentation professionals.
"For each member referred to in 2° above, an alternate is appointed under the same conditions.
"The commission shall vote by a majority of the votes of the members present or supple. In case of equal sharing of votes, the President's voice is preponderant.
"Art. R. 214-133.-The National Commission for Animal Experimentation meets at least twice a year. It may also be exceptionally united either at the request of one of the ministers among those responsible for the environment, agriculture, research and health or the Minister of Defence, or at the request of half of its members.
"The Chairperson of the Commission may call to participate in the sessions, in a consultative capacity and on a specific and specific item on the agenda, any person whose opinion it considers appropriate to collect the notice.
"The commission secretariat is provided by the research minister's services.
"The commission has rules of procedure.
“Paragraph 2
« National Committee for Ethical Reflection
on animal experimentation
"Art. R. 214-134.-A National Committee for Ethical Reflection on Animal Experimentation is placed with the National Commission for Animal Experimentation.
"The purpose of this committee is to provide advice on ethical issues raised by animal experimentation.
"He is responsible, inter alia:
« 1° Develop, publish and update, if necessary, a national charter on the ethics of animal experimentation and make any proposals on its implementation;
« 2° To lead the development and updating of a guide to good practices of the ethics committees;
« 3° To prepare the national annual report of ethics committees and make recommendations to improve their practices;
« 4° To address to the National Commission for Animal Experimentation any recommendation of a method that could improve the well-being of animals used for experimental purposes or for other scientific purposes.
"Art. R. 214-135.-In addition to its president, the National Committee for Ethical Reflection on Animal Experimentation includes fourteen members, including:
« 1° Two state representatives:
“(a) The Director of Research at the Ministry of Research or his representative;
“(b) The Director of Animal Health and Protection at the Ministry of Agriculture or his representative;
« 2° Two qualified personalities, professionals in animal experimentation, selected in the public sector of research and higher education;
« 3° Two qualified personalities, professionals of animal experimentation, proposed by representative organizations of the private industrial sector, including a pharmacist;
« 4° A personality of the medical sector exercising all or part of its activity in hospitals;
« 5° A personality of the veterinary sector;
« 6° Three qualified personalities in the fields of philosophy, legal sciences and sociology;
« 7° Three designated personalities on the proposal of recognized organizations of public utility for the protection of animals and the protection of wildlife.
"The chair and members of the committee, referred to in 2° to 7°, are appointed for five years renewable by joint order of the Minister for Agriculture and the Minister for Research.
"For each member mentioned in 2° to 7° above, an alternate is appointed under the same conditions.
"The members of the committee shall be replaced in the event of resignation, death or termination of their duties under which they were appointed. The term of office of the new members expires on the date that their predecessor would normally have ended.
"Art. R. 214-136.-The committee shall meet on the convocation of its chair and at least twice a year. It may also meet either at the request of one of the Ministers among those responsible for the environment, agriculture, research, and health or the Minister of Defence, or at the request of half of its members.
"The committee secretariat is provided by the secretariat of the National Commission for Animal Experimentation.
"The committee prepares an annual activity report to the president of the National Animal Experimentation Commission.
"The committee sets out its rules of procedure.
“Paragraph 3
"Common provisions for both organizations
"Art. R. 214-137.-The functions of a member of the National Commission for Animal Experimentation and a member of the National Committee for Ethical Reflection on Animal Experimentation are exercised free of charge. They are entitled to travel and residence allowances provided by the regulations applicable to state officials. »
In chapter V of Book II title I of the Rural and Maritime Fisheries Regulatory Part, section R. 215-10 is replaced by the following provisions:
"Art. R. 215-10.-I. ― Are punished by the fine provided for the 4th class contraventions:
« 1° The fact, for any person in charge of a user institution in which experimental procedures are performed on animals, is not to ensure:
“(a) That animals that are used or intended to be used in experimental procedures come from farms or suppliers, approved in accordance with the provisions set out in R. 214-99 to R. 214-103 and R. 214-127;
“(b) That inmate animals receive the necessary care for their proper maintenance under the provisions of Article R. 214-17;
"(c) That detained dogs, cats and primates be identified by an individual and permanent marking;
"(d) That the establishment has a valid approval, the field of which is compatible with the experimental procedures that are carried out in its premises;
“e) That all projects implemented in the establishment be covered by a valid project authorization in accordance with the provisions set out in R. 214-122 to R. 214-126;
“(f) That the standards to which the facilities referred to in R. 214-95 and the texts taken for its application must be complied with;
“(g) That the persons referred to in articles R. 214-101 to R. 214-103 be in sufficient number and have the required qualification;
“(h) That the methods defined in articles R. 214-98 and R. 214-106 to R. 214-113 and the texts taken for their application, when the euthanasia of animals is carried out, be respected;
« 2° The fact, for any person in charge of a breeding establishment or supply of animals intended for use in experimental procedures:
“(a) Not to ensure that the establishment has a valid approval;
“(b) Failure to provide inmate animals with the necessary care for their proper maintenance provided for in the provisions of Article R. 214-17;
"(c) Not comply with the specific rules applicable to the facilities and operation of the premises referred to in R. 214-95;
"(d) Not to ensure that detained dogs, cats and primates are identified by an individual and permanent marking;
“e) Not to use the methods defined in section R. 214-98 when animal euthanasia is performed.
“II. ― Are punished with the penalty of fines provided for third class contraventions:
« 1° The fact, for any person in charge of a user institution in which experimental procedures on animals are practised, that they are not able to present to the control officers the evidence to justify that the agents under its responsibility have acquired competence and that they maintain their scientific and specific competence in the field of the experimental procedures concerned and the animal species concerned;
« 2° The fact, for any person in charge of a user institution, breeder or supplier, that they are not in a position to submit to the control officers the duly informed register to establish the origin and destination of the animals held during the control or who were previously detained. »
Chapter II of Book IV title I of the Environmental Code Regulatory Part is added a section 3 as follows:
“Section 3
"Use for scientific purposes
animals of non-domestic species
"Art. R. 412-11. - The conduct of biological, medical or scientific experiments on animals of non-domestic non-captivity species must meet the conditions set out in chapter IV, section 6, title I, of Book II of the Rural and Maritime Fisheries Regulatory Part. »
The members of the National Commission for Animal Experimentation referred to in 2° of the current article R. 214-117 of the Rural and Maritime Fisheries Code continue their mandate under the functions listed in 2° of the new article R. 214-132 of this code until 28 November 2013.
The members of the National Committee for Ethical Reflection on Animal Experimentation referred to in 2° to 7° of the current article R. 214-125 of the Rural and Maritime Fisheries Code continue their mandate under the functions listed in 2° to 7° of the new article R. 214-135 of the Code until 30 March 2013.
I. - Projects that have benefited from a favourable ethical opinion of the committee to which the user institution reports before the date of entry into force of this decree and whose duration does not extend beyond January 1, 2018 are considered to be authorized within the meaning of this decree.
II. - User establishments of animals used for scientific purposes approved prior to the date of entry into force of this decree, in accordance with the provisions of the Decree of 19 April 1988 establishing the conditions for the accreditation, development and operation of animal testing establishments, are considered to be approved within the meaning of this decree until the date of expiry of their approval.
Experimental institutions under the authority or guardianship of the Minister of Defence approved before the date of entry into force of this Order shall be deemed to be approved within the meaning of this Order in Council until the date of expiry of their approval.
III. - Farmers or animal suppliers used for scientific purposes registered prior to the date of entry into force of this Order in Council in accordance with the provisions of the Order of 19 April 1988 establishing the conditions for the provision of animals used for scientific or experimental research to the approved laboratories shall be considered to be approved within the meaning of this Order until it is decided on an application for approval under section R. 214-99 of this Order.
I.-In the title of Decree No. 97-1189 of 19 December 1997, the words: "to the Minister of National Education, Research and Technology of the 1°" are replaced by the words: "to the ministers responsible for the education, higher education and research of the first paragraph".
The paragraph: "Recovery" of Title II of the Schedule to this Order is supplemented by the following table:
« Rural Code and Maritime Fishing
| 1 | Authorization of projects using living animals for scientific purposes | Article R. 214-122 |
| 1 | Authorization for the execution of projects using living animals for scientific purposes where the experimental procedures concern institutions under its authority or guardianship | Article R. 214-127 |
| 2 | Accreditation of breeding establishments, suppliers or users of animals used for scientific purposes when these establishments are under its authority or guardianship | Article R. 214-127 |
The Minister of National Education, the Guard of Seals, Minister of Justice, Minister of Social Affairs and Health, Minister of Productive Recovery, Minister of Ecology, Sustainable Development and Energy, Minister of Defence, Minister of Higher Education and Research, and Minister of Agriculture, Agri-Food and Forestry, are responsible, each with respect to the decree issued, for the execution of the Official Journal
Done on 1 February 2013.
Jean-Marc Ayrault
By the Prime Minister:
Minister of Agriculture,
agri-food and forest,
Stéphane Le Foll
Minister of National Education,
Vincent Peillon
The guard of the seals,
Minister of Justice,
Christiane Taubira
Minister of Social Affairs
and Health,
Marisol Touraine
Minister of Productive Recovery
Arnaud Montebourg
The Minister of Ecology,
Sustainable Development
and energy,
Delphine Batho
Minister of Defence,
Jean-Yves Le Drian
Minister of Higher Education
and research,
Geneviève Fioraso
