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Document 02010L0063-20190626
Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (Text with EEA relevance)Text with EEA relevance
Consolidated text: Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (Text with EEA relevance)Text with EEA relevance
Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (Text with EEA relevance)Text with EEA relevance
02010L0063 — EN — 26.06.2019 — 001.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
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DIRECTIVE 2010/63/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276 20.10.2010, p. 33) |
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REGULATION (EU) 2019/1010 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 June 2019 |
L 170 |
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25.6.2019 |
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DIRECTIVE 2010/63/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 22 September 2010
on the protection of animals used for scientific purposes
(Text with EEA relevance)
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter and scope
To that end, it lays down rules on the following:
the replacement and reduction of the use of animals in procedures and the refinement of the breeding, accommodation, care and use of animals in procedures;
the origin, breeding, marking, care and accommodation and killing of animals;
the operations of breeders, suppliers and users;
the evaluation and authorisation of projects involving the use of animals in procedures.
This Directive shall apply until the animals referred to in the first subparagraph have been killed, rehomed or returned to a suitable habitat or husbandry system.
The elimination of pain, suffering, distress or lasting harm by the successful use of anaesthesia, analgesia or other methods shall not exclude the use of an animal in procedures from the scope of this Directive.
This Directive shall apply to the following animals:
live non-human vertebrate animals, including:
independently feeding larval forms; and
foetal forms of mammals as from the last third of their normal development;
live cephalopods.
This Directive shall not apply to the following:
non-experimental agricultural practices;
non-experimental clinical veterinary practices;
veterinary clinical trials required for the marketing authorisation of a veterinary medicinal product;
practices undertaken for the purposes of recognised animal husbandry;
practices undertaken for the primary purpose of identification of an animal;
practices not likely to cause pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice.
Article 2
Stricter national measures
Before 1 January 2013 Member States shall inform the Commission about such national provisions. The Commission shall bring them to the attention of other Member States.
Article 3
Definitions
For the purposes of this Directive the following definitions shall apply:
‘procedure’ means any use, invasive or non-invasive, of an animal for experimental or other scientific purposes, with known or unknown outcome, or educational purposes, which may cause the animal a level of pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice.
This includes any course of action intended, or liable, to result in the birth or hatching of an animal or the creation and maintenance of a genetically modified animal line in any such condition, but excludes the killing of animals solely for the use of their organs or tissues;
‘project’ means a programme of work having a defined scientific objective and involving one or more procedures;
‘establishment’ means any installation, building, group of buildings or other premises and may include a place that is not wholly enclosed or covered and mobile facilities;
‘breeder’ means any natural or legal person breeding animals referred to in Annex I with a view to their use in procedures or for the use of their tissue or organs for scientific purposes, or breeding other animals primarily for those purposes, whether for profit or not;
‘supplier’ means any natural or legal person, other than a breeder, supplying animals with a view to their use in procedures or for the use of their tissue or organs for scientific purposes, whether for profit or not;
‘user’ means any natural or legal person using animals in procedures, whether for profit or not;
‘competent authority’ means an authority or authorities or bodies designated by a Member State to carry out the obligations arising from this Directive.
Article 4
Principle of replacement, reduction and refinement
Article 5
Purposes of procedures
Procedures may be carried out for the following purposes only:
basic research;
translational or applied research with any of the following aims:
the avoidance, prevention, diagnosis or treatment of disease, ill-health or other abnormality or their effects in human beings, animals or plants;
the assessment, detection, regulation or modification of physiological conditions in human beings, animals or plants; or
the welfare of animals and the improvement of the production conditions for animals reared for agricultural purposes;
for any of the aims in point (b) in the development, manufacture or testing of the quality, effectiveness and safety of drugs, foodstuffs and feed-stuffs and other substances or products;
protection of the natural environment in the interests of the health or welfare of human beings or animals;
research aimed at preservation of the species;
higher education, or training for the acquisition, maintenance or improvement of vocational skills;
forensic inquiries.
Article 6
Methods of killing
However, in the case of a field study an animal may be killed by a competent person outside of an establishment.
Competent authorities may grant exemptions from the requirement in paragraph 3:
to allow the use of another method provided that, on the basis of scientific evidence, the method is considered to be at least as humane; or
when, on the basis of scientific justification, the purpose of the procedure cannot be achieved by the use of a method of killing set out in Annex IV.
CHAPTER II
PROVISIONS ON THE USE OF CERTAIN ANIMALS IN PROCEDURES
Article 7
Endangered species
Specimens of those endangered species listed in Annex A to Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein ( 2 ), which do not fall within the scope of Article 7(1) of that Regulation, shall not be used in procedures, with the exception of those procedures meeting the following conditions:
the procedure has one of the purposes referred to in points (b)(i), (c) or (e) of Article 5 of this Directive; and
there is scientific justification to the effect that the purpose of the procedure cannot be achieved by the use of species other than those listed in that Annex.
Article 8
Non-human primates
Subject to paragraph 2, specimens of non-human primates shall not be used in procedures, with the exception of those procedures meeting the following conditions:
the procedure has one of the purposes referred to in
points (b)(i) or (c) of Article 5 of this Directive and is undertaken with a view to the avoidance, prevention, diagnosis or treatment of debilitating or potentially life-threatening clinical conditions in human beings; or
points (a) or (e) of Article 5;
and
there is scientific justification to the effect that the purpose of the procedure cannot be achieved by the use of species other than non-human primates.
A debilitating clinical condition for the purposes of this Directive means a reduction in a person’s normal physical or psychological ability to function.
Specimens of non-human primates listed in Annex A to Regulation (EC) No 338/97, which do not fall within the scope of Article 7(1) of that Regulation, shall not be used in procedures, with the exception of those procedures meeting the following conditions:
the procedure has one of the purposes referred to in:
points (b)(i) or (c) of Article 5 of this Directive and is undertaken with a view to the avoidance, prevention, diagnosis or treatment of debilitating or potentially life-threatening clinical conditions in human beings; or
Article 5(e);
and
there is scientific justification to the effect that the purpose of the procedure cannot be achieved by the use of species other than non-human primates and by the use of species not listed in that Annex.
Article 9
Animals taken from the wild
Any animal found, at or after capture, to be injured or in poor health shall be examined by a veterinarian or another competent person and action shall be taken to minimise the suffering of the animal. Competent authorities may grant exemptions from the requirement of taking action to minimise the suffering of the animal if there is scientific justification.
Article 10
Animals bred for use in procedures
However, from the dates set out in Annex II, Member States shall ensure that non-human primates listed therein may be used in procedures only where they are the offspring of non-human primates which have been bred in captivity or where they are sourced from self-sustaining colonies.
For the purposes of this Article a ‘self-sustaining colony’ means a colony in which animals are bred only within the colony or sourced from other colonies but not taken from the wild, and where the animals are kept in a way that ensures that they are accustomed to humans.
The Commission shall, in consultation with the Member States and stakeholders, conduct a feasibility study, which shall include an animal health and welfare assessment, of the requirement laid down in the second subparagraph. The study shall be published no later than 10 November 2017. It shall be accompanied, where appropriate, by proposals for amendments to Annex II.
The study shall be published no later than 10 November 2022.
Article 11
Stray and feral animals of domestic species
The competent authorities may only grant exemptions from paragraph 1 subject to the following conditions:
there is an essential need for studies concerning the health and welfare of the animals or serious threats to the environment or to human or animal health; and
there is scientific justification to the effect that the purpose of the procedure can be achieved only by the use of a stray or a feral animal.
CHAPTER III
PROCEDURES
Article 12
Procedures
The competent authority may grant an exemption from the first subparagraph on the basis of scientific justification.
Article 13
Choice of methods
In choosing between procedures, those which to the greatest extent meet the following requirements shall be selected:
use the minimum number of animals;
involve animals with the lowest capacity to experience pain, suffering, distress or lasting harm;
cause the least pain, suffering, distress or lasting harm;
and are most likely to provide satisfactory results.
Death as the end-point of a procedure shall be avoided as far as possible and replaced by early and humane end-points. Where death as the end-point is unavoidable, the procedure shall be designed so as to:
result in the deaths of as few animals as possible; and
reduce the duration and intensity of suffering to the animal to the minimum possible and, as far as possible, ensure a painless death.
Article 14
Anaesthesia
Procedures that involve serious injuries that may cause severe pain shall not be carried out without anaesthesia.
When deciding on the appropriateness of using anaesthesia, the following shall be taken into account:
whether anaesthesia is judged to be more traumatic to the animal than the procedure itself; and
whether anaesthesia is incompatible with the purpose of the procedure.
In these cases, a scientific justification shall be provided, accompanied by the details of the anaesthetic or analgesic regimen.
Article 15
Classification of severity of procedures
Article 16
Reuse
Member States shall ensure that an animal already used in one or more procedures, when a different animal on which no procedure has previously been carried out could also be used, may only be reused in a new procedure provided that the following conditions are met:
the actual severity of the previous procedures was ‘mild’ or ‘moderate’;
it is demonstrated that the animal’s general state of health and well-being has been fully restored;
the further procedure is classified as ‘mild’, ‘moderate’ or ‘non-recovery’; and
it is in accordance with veterinary advice, taking into account the lifetime experience of the animal.
Article 17
End of the procedure
Article 18
Sharing organs and tissues
Member States shall facilitate, where appropriate, the establishment of programmes for the sharing of organs and tissues of animals killed.
Article 19
Setting free of animals and rehoming
Member States may allow animals used or intended to be used in procedures to be rehomed, or returned to a suitable habitat or husbandry system appropriate to the species, provided that the following conditions are met:
the state of health of the animal allows it;
there is no danger to public health, animal health or the environment; and
appropriate measures have been taken to safeguard the well-being of the animal.
CHAPTER IV
AUTHORISATION
Requirements for breeders, suppliers and users
Article 20
Authorisation of breeders, suppliers and users
Authorisation shall be granted only if the breeder, supplier or user and its establishment is in compliance with the requirements of this Directive.
Article 21
Suspension and withdrawal of authorisation
Article 22
Requirements for installations and equipment
Article 23
Competence of personnel
The staff shall be adequately educated and trained before they perform any of the following functions:
carrying out procedures on animals;
designing procedures and projects;
taking care of animals; or
killing animals.
Persons carrying out the functions referred to in point (b) shall have received instruction in a scientific discipline relevant to the work being undertaken and shall have species-specific knowledge.
Staff carrying out functions referred to in points (a), (c) or (d) shall be supervised in the performance of their tasks until they have demonstrated the requisite competence.
Member States shall ensure, through authorisation or by other means, that the requirements laid down in this paragraph are fulfilled.
Article 24
Specific requirements for personnel
Member States shall ensure that each breeder, supplier and user has one or several persons on site who shall:
be responsible for overseeing the welfare and care of the animals in the establishment;
ensure that the staff dealing with animals have access to information specific to the species housed in the establishment;
be responsible for ensuring that the staff are adequately educated, competent and continuously trained and that they are supervised until they have demonstrated the requisite competence.
Member States shall ensure that persons specified in Article 40(2)(b) shall:
ensure that any unnecessary pain, suffering, distress or lasting harm that is being inflicted on an animal in the course of a procedure is stopped; and
ensure that the projects are carried out in accordance with the project authorisation or, in the cases referred to in Article 42, in accordance with the application sent to the competent authority or any decision taken by the competent authority, and ensure that in the event of non-compliance, the appropriate measures to rectify it are taken and recorded.
Article 25
Designated veterinarian
Member States shall ensure that each breeder, supplier and user has a designated veterinarian with expertise in laboratory animal medicine, or a suitably qualified expert where more appropriate, charged with advisory duties in relation to the well-being and treatment of the animals.
Article 26
Animal-welfare body
Article 27
Tasks of the animal-welfare body
The animal-welfare body shall, as a minimum, carry out the following tasks:
advise the staff dealing with animals on matters related to the welfare of animals, in relation to their acquisition, accommodation, care and use;
advise the staff on the application of the requirement of replacement, reduction and refinement, and keep it informed of technical and scientific developments concerning the application of that requirement;
establish and review internal operational processes as regards monitoring, reporting and follow-up in relation to the welfare of animals housed or used in the establishment;
follow the development and outcome of projects, taking into account the effect on the animals used, and identify and advise as regards elements that further contribute to replacement, reduction and refinement; and
advise on rehoming schemes, including the appropriate socialisation of the animals to be rehomed.
The records shall be made available to the competent authority upon request.
Article 28
Breeding strategy for non-human primates
Member States shall ensure that breeders of non-human primates have a strategy in place for increasing the proportion of animals that are the offspring of non-human primates that have been bred in captivity.
Article 29
Scheme for rehoming or setting free of animals
Where Member States allow rehoming, the breeders, suppliers and users from which animals are intended to be rehomed shall have a rehoming scheme in place that ensures socialisation of the animals that are rehomed. In the case of wild animals, where appropriate, a programme of rehabilitation shall be in place before they are returned to their habitat.
Article 30
Animal records
Member States shall ensure that all breeders, suppliers and users keep records of at least the following:
the number and the species of animals bred, acquired, supplied, used in procedures, set-free or rehomed;
the origin of the animals, including whether they are bred for use in procedures;
the dates on which the animals are acquired, supplied, released or rehomed;
from whom the animals are acquired;
the name and address of the recipient of animals;
the number and species of animals which died or were killed in each establishment. For animals that have died, the cause of death shall, when known, be noted; and
in the case of users, the projects in which animals are used.
Article 31
Information on dogs, cats and non-human primates
Member States shall ensure that all breeders, suppliers and users keep the following information on each dog, cat and non-human primate:
identity;
place and date of birth, when available;
whether it is bred for use in procedures; and
in the case of a non-human primate, whether it is the offspring of non-human primates that have been bred in captivity.
The file shall be established at birth or as soon as possible thereafter and shall cover any relevant reproductive, veterinary and social information on the individual animal and the projects in which it has been used.
In the case of rehoming, relevant veterinary care and social information from the individual history file referred to in paragraph 2 shall accompany the animal.
Article 32
Marking and identification of dogs, cats and non-human primates
Article 33
Care and accommodation
Member States shall, as far as the care and accommodation of animals is concerned, ensure that:
all animals are provided with accommodation, an environment, food, water and care which are appropriate to their health and well-being;
any restrictions on the extent to which an animal can satisfy its physiological and ethological needs are kept to a minimum;
the environmental conditions in which animals are bred, kept or used are checked daily;
arrangements are made to ensure that any defect or avoidable pain, suffering, distress or lasting harm discovered is eliminated as quickly as possible; and
animals are transported under appropriate conditions.
Inspections
Article 34
Inspections by the Member States
The competent authority shall adapt the frequency of inspections on the basis of a risk analysis for each establishment, taking account of:
the number and species of animals housed;
the record of the breeder, supplier or user in complying with the requirements of this Directive;
the number and types of projects carried out by the user in question; and
any information that might indicate non-compliance.
Article 35
Controls of Member State inspections
Requirements for projects
Article 36
Project authorisation
Article 37
Application for project authorisation
Member States shall ensure that an application for project authorisation is submitted by the user or the person responsible for the project. The application shall include at least the following:
the project proposal;
a non-technical project summary; and
information on the elements set out in Annex VI.
Article 38
Project evaluation
The project evaluation shall be performed with a degree of detail appropriate for the type of project and shall verify that the project meets the following criteria:
the project is justified from a scientific or educational point of view or required by law;
the purposes of the project justify the use of animals; and
the project is designed so as to enable procedures to be carried out in the most humane and environmentally sensitive manner possible.
The project evaluation shall consist in particular of the following:
an evaluation of the objectives of the project, the predicted scientific benefits or educational value;
an assessment of the compliance of the project with the requirement of replacement, reduction and refinement;
an assessment and assignment of the classification of the severity of procedures;
a harm-benefit analysis of the project, to assess whether the harm to the animals in terms of suffering, pain and distress is justified by the expected outcome taking into account ethical considerations, and may ultimately benefit human beings, animals or the environment;
an assessment of any justification referred to in Articles 6 to 12, 14, 16 and 33; and
a determination as to whether and when the project should be assessed retrospectively.
The competent authority carrying out the project evaluation shall consider expertise in particular in the following areas:
the areas of scientific use for which animals will be used including replacement, reduction and refinement in the respective areas;
experimental design, including statistics where appropriate;
veterinary practice in laboratory animal science or wildlife veterinary practice where appropriate;
animal husbandry and care, in relation to the species that are intended to be used.
Subject to safeguarding intellectual property and confidential information, the project evaluation shall be performed in an impartial manner and may integrate the opinion of independent parties.
Article 39
Retrospective assessment
Member States shall ensure that when determined in accordance with Article 38(2)(f), the retrospective assessment shall be carried out by the competent authority which shall, on the basis of the necessary documentation submitted by the user, evaluate the following:
whether the objectives of the project were achieved;
the harm inflicted on animals, including the numbers and species of animals used, and the severity of the procedures; and
any elements that may contribute to the further implementation of the requirement of replacement, reduction and refinement.
Article 40
Granting of project authorisation
The project authorisation shall be limited to procedures which have been subject to:
a project evaluation; and
the severity classifications assigned to those procedures.
The project authorisation shall specify the following:
the user who undertakes the project;
the persons responsible for the overall implementation of the project and its compliance with the project authorisation;
the establishments in which the project will be undertaken, where applicable; and
any specific conditions following the project evaluation, including whether and when the project shall be assessed retrospectively.
Article 41
Authorisation decisions
Article 42
Simplified administrative procedure
When introducing a simplified administrative procedure, Member States shall ensure that the following provisions are met:
the application specifies elements referred to in Article 40(2)(a), (b) and (c);
a project evaluation is performed in accordance with Article 38; and
that the period referred to in Article 41(1) is not exceeded.
Article 43
Non-technical project summaries
Subject to safeguarding intellectual property and confidential information, the non-technical project summary shall provide the following:
information on the objectives of the project, including the predicted harm and benefits and the number and types of animals to be used;
a demonstration of compliance with the requirement of replacement, reduction and refinement.
The non-technical project summary shall be anonymous and shall not contain the names and addresses of the user and its personnel.
Article 44
Amendment, renewal and withdrawal of a project authorisation
Article 45
Documentation
CHAPTER V
AVOIDANCE OF DUPLICATION AND ALTERNATIVE APPROACHES
Article 46
Avoidance of duplication of procedures
Each Member State shall accept data from other Member States that are generated by procedures recognised by the legislation of the Union, unless further procedures need to be carried out regarding that data for the protection of public health, safety or the environment.
Article 47
Alternative approaches
Article 48
Union Reference Laboratory
Article 49
National committees for the protection of animals used for scientific purposes
CHAPTER VI
FINAL PROVISIONS
Article 50
Adaptation of Annexes to technical progress
In order to ensure that the provisions of Annexes I and III to VIII reflect the state of technical or scientific progress, taking into account the experience gained in the implementation of this Directive, in particular through the reporting referred to in Article 54(1), the Commission may adopt, by means of delegated acts in accordance with Article 51 and subject to the conditions laid down in Articles 52 and 53, modifications of those Annexes, with the exception of provisions of Sections I and II of Annex VIII. The dates referred to in Section B of Annex III shall not be brought forward. When adopting such delegated acts, the Commission shall act in accordance with the relevant provisions of this Directive.
Article 51
Exercise of the delegation
Article 52
Revocation of the delegation
Article 53
Objections to delegated acts
At the initiative of the European Parliament or the Council this period shall be extended by 2 months.
The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections.
Article 54
Information on implementation and provision of statistical data
Member States shall submit and publish that data, by electronic transfer in a format established by the Commission in accordance with paragraph 4.
No later than six months after the submission by Member States of the data referred to in the second subparagraph, the Commission services shall publish and regularly update a Union-wide overview on the basis of that data.
Member States shall submit that statistical information to the Commission, at the latest by 10 November of the following year, by electronic transfer, in a non-summarised format established by the Commission in accordance with paragraph 4.
The Commission shall establish and maintain a searchable, open access database containing that statistical information. On an annual basis, the Commission services shall make publicly available the statistical information submitted by the Member States in accordance with this paragraph and a summary report thereof.
Article 55
Safeguard clauses
The Commission shall put the matter before the Committee referred to in Article 56(1) within 30 days of receipt of the information from the Member State and shall, in accordance with the regulatory procedure referred to in Article 56(3), either:
authorise the provisional measure for a time period defined in the decision; or
require the Member State to revoke the provisional measure.
Article 56
Committee
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 3 months.
▼M1 —————
Article 58
Review
The Commission shall review this Directive by 10 November 2017, taking into account advancements in the development of alternative methods not entailing the use of animals, in particular of non-human primates, and shall propose amendments, where appropriate.
The Commission shall, where appropriate, and in consultation with the Member States and stakeholders, conduct periodic thematic reviews of the replacement, reduction and refinement of the use of animals in procedures, paying specific attention to non-human primates, technological developments, and new scientific and animal-welfare knowledge.
Article 59
Competent authorities
Member States may designate bodies other than public authorities for the implementation of specific tasks laid down in this Directive only if there is proof that the body:
has the expertise and infrastructure required to carry out the tasks; and
is free of any conflict of interests as regards the performance of the tasks.
Bodies thus designated shall be considered competent authorities for the purposes of this Directive.
The Commission shall make publicly available the list of those contact points.
Article 60
Penalties
Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by 10 February 2013, and shall notify the Commission without delay of any subsequent amendment affecting them.
Article 61
Transposition
They shall apply those provisions from 1 January 2013.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The method of making such reference shall be laid down by Member States.
Article 62
Repeal
Article 63
Amendment of Regulation (EC) No 1069/2009
Point (a)(iv) of Article 8 of Regulation (EC) No 1069/2009 is replaced by the following:
animals used in a procedure or procedures defined in Article 3 of Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes ( *1 ), in cases where the competent authority decides that such animals or any of their body parts have the potential to pose serious health risks to humans or to other animals, as a result of that procedure or those procedures without prejudice to Article 3(2) of Regulation (EC) No 1831/2003;
Article 64
Transitional provisions
Article 65
Entry into force
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 66
Addressees
This Directive is addressed to the Member States.
ANNEX I
LIST OF ANIMALS REFERRED TO IN ARTICLE 10
Mouse (Mus musculus)
Rat (Rattus norvegicus)
Guinea pig (Cavia porcellus)
Syrian (golden) hamster (Mesocricetus auratus)
Chinese hamster (Cricetulus griseus)
Mongolian gerbil (Meriones unguiculatus)
Rabbit (Oryctolagus cuniculus)
Dog (Canis familiaris)
Cat (Felis catus)
All species of non-human primates
Frog (Xenopus (laevis, tropicalis), Rana (temporaria, pipiens))
Zebra fish (Danio rerio)
ANNEX II
LIST OF NON-HUMAN PRIMATES AND DATES REFERRED TO IN THE SECOND SUBPARAGRAPH OF ARTICLE 10(1)
|
Species |
Dates |
|
Marmoset (Callithrix jacchus) |
1 January 2013 |
|
Cynomolgus monkey (Macaca fascicularis) |
5 years after the publication of the feasibility study referred to in Article 10(1), fourth subparagraph, provided the study does not recommend an extended period |
|
Rhesus monkey (Macaca mulatta) |
5 years after the publication of the feasibility study referred to in Article 10(1), fourth subparagraph, provided the study does not recommend an extended period |
|
Other species of non-human primates |
5 years after the publication of the feasibility study referred to in Article 10(1), fourth subparagraph, provided the study does not recommend an extended period |
ANNEX III
REQUIREMENTS FOR ESTABLISHMENTS AND FOR THE CARE AND ACCOMMODATION OF ANIMALS
Section A: General section
1. The physical facilities
1.1. Functions and general design
(a) All facilities shall be constructed so as to provide an environment which takes into account the physiological and ethological needs of the species kept in them. Facilities shall also be designed and managed to prevent access by unauthorised persons and the ingress or escape of animals.
(b) Establishments shall have an active maintenance programme to prevent and remedy any defect in buildings or equipment.
1.2. Holding rooms
(a) Establishments shall have a regular and efficient cleaning schedule for the rooms and shall maintain satisfactory hygienic standards.
(b) Walls and floors shall be surfaced with a material resistant to the heavy wear and tear caused by the animals and the cleaning process. The material shall not be detrimental to the health of the animals and shall be such that the animals cannot hurt themselves. Additional protection shall be given to any equipment or fixtures so that they are not damaged by the animals nor do they cause injury to the animals themselves.
(c) Species that are incompatible, for example predator and prey, or animals requiring different environmental conditions, shall not be housed in the same room nor, in the case of predator and prey, within sight, smell or sound of each other.
1.3. General and special purpose procedure rooms
(a) Establishments shall, where appropriate, have available laboratory facilities for the carrying out of simple diagnostic tests, post-mortem examinations, and/or the collection of samples that are to be subjected to more extensive laboratory investigations elsewhere. General and special purpose procedure rooms shall be available for situations where it is undesirable to carry out the procedures or observations in the holding rooms.
(b) Facilities shall be provided to enable newly-acquired animals to be isolated until their health status can be determined and the potential health risk to established animals assessed and minimised.
(c) There shall be accommodation for the separate housing of sick or injured animals.
1.4. Service rooms
(a) Store-rooms shall be designed, used and maintained to safeguard the quality of food and bedding. These rooms shall be vermin and insect-proof, as far as possible. Other materials, which may be contaminated or present a hazard to animals or staff, shall be stored separately.
(b) The cleaning and washing areas shall be large enough to accommodate the installations necessary to decontaminate and clean used equipment. The cleaning process shall be arranged so as to separate the flow of clean and dirty equipment to prevent the contamination of newly-cleaned equipment.
(c) Establishments shall provide for the hygienic storage and safe disposal of carcasses and animal waste.
(d) Where surgical procedures under aseptic conditions are required there shall be provision for one or more than one suitably equipped room, and facilities provided for postoperative recovery.
2. The environment and control thereof
2.1. Ventilation and temperature
(a) Insulation, heating and ventilation of the holding room shall ensure that the air circulation, dust levels, and gas concentrations are kept within limits that are not harmful to the animals housed.
(b) Temperature and relative humidity in the holding rooms shall be adapted to the species and age groups housed. The temperature shall be measured and logged on a daily basis.
(c) Animals shall not be restricted to outdoor areas under climatic conditions which may cause them distress.
2.2. Lighting
(a) Where natural light does not provide an appropriate light/dark cycle, controlled lighting shall be provided to satisfy the biological requirements of the animals and to provide a satisfactory working environment.
(b) Illumination shall satisfy the needs for the performance of husbandry procedures and inspection of the animals.
(c) Regular photoperiods and intensity of light adapted to the species shall be provided.
(d) When keeping albino animals, the lighting shall be adjusted to take into account their sensitivity to light.
2.3. Noise
(a) Noise levels including ultrasound, shall not adversely affect animal welfare.
(b) Establishments shall have alarm systems that sound outside the sensitive hearing range of the animals, where this does not conflict with their audibility to human beings.
(c) Holding rooms shall where appropriate be provided with noise insulation and absorption materials.
2.4. Alarm systems
(a) Establishments relying on electrical or mechanical equipment for environmental control and protection, shall have a stand-by system to maintain essential services and emergency lighting systems as well as to ensure that alarm systems themselves do not fail to operate.
(b) Heating and ventilation systems shall be equipped with monitoring devices and alarms.
(c) Clear instructions on emergency procedures shall be prominently displayed.
3. Care of animals
3.1. Health
(a) Establishments shall have a strategy in place to ensure that a health status of the animals is maintained that safeguards animal welfare and meets scientific requirements. This strategy shall include regular health monitoring, a microbiological surveillance programme and plans for dealing with health breakdowns and shall define health parameters and procedures for the introduction of new animals.
(b) Animals shall be checked at least daily by a competent person. These checks shall ensure that all sick or injured animals are identified and appropriate action is taken.
3.2. Animals taken from the wild
(a) Transport containers and means of transport adapted to the species concerned shall be available at capture sites, in case animals need to be moved for examination or treatment.
(b) Special consideration shall be given and appropriate measures taken for the acclimatisation, quarantine, housing, husbandry, care of animals taken from the wild and, as appropriate, provisions for setting them free at the end of procedures.
3.3. Housing and enrichment
(a) Housing
Animals, except those which are naturally solitary, shall be socially housed in stable groups of compatible individuals. In cases where single housing is allowed in accordance with article 33(3) the duration shall be limited to the minimum period necessary and visual, auditory, olfactory and/or tactile contact shall be maintained. The introduction or re-introduction of animals to established groups shall be carefully monitored to avoid problems of incompatibility and disrupted social relationships.
(b) Enrichment
All animals shall be provided with space of sufficient complexity to allow expression of a wide range of normal behaviour. They shall be given a degree of control and choice over their environment to reduce stress-induced behaviour. Establishments shall have appropriate enrichment techniques in place, to extend the range of activities available to the animals and increase their coping activities including physical exercise, foraging, manipulative and cognitive activities, as appropriate to the species. Environmental enrichment in animal enclosures shall be adapted to the species and individual needs of the animals concerned. The enrichment strategies in establishments shall be regularly reviewed and updated.
(c) Animal enclosures
Animal enclosures shall not be made out of materials detrimental to the health of the animals. Their design and construction shall be such that no injury to the animals is caused. Unless they are disposable, they shall be made from materials that will withstand cleaning and decontamination techniques. The design of animal enclosure floors shall be adapted to the species and age of the animals and be designed to facilitate the removal of excreta.
3.4. Feeding
(a) The form, content and presentation of the diet shall meet the nutritional and behavioural needs of the animal.
(b) The animals’ diet shall be palatable and non-contaminated. In the selection of raw materials, production, preparation and presentation of feed, establishments shall take measures to minimise chemical, physical and microbiological contamination.
(c) Packing, transport and storage shall be such as to avoid contamination, deterioration or destruction. All feed hoppers, troughs or other utensils used for feeding shall be regularly cleaned and, if necessary, sterilised.
(d) Each animal shall be able to access the food, with sufficient feeding space provided to limit competition.
3.5. Watering
(a) Uncontaminated drinking water shall always be available to all animals.
(b) When automatic watering systems are used, they shall be regularly checked, serviced and flushed to avoid accidents. If solid-bottomed cages are used, care shall be taken to minimise the risk of flooding.
(c) Provision shall be made to adapt the water supply for aquaria and tanks to the needs and tolerance limits of the individual fish, amphibian and reptile species.
3.6. Resting and sleeping areas
(a) Bedding materials or sleeping structures adapted to the species shall always be provided, including nesting materials or structures for breeding animals.
(b) Within the animal enclosure, as appropriate to the species, a solid, comfortable resting area for all animals shall be provided. All sleeping areas shall be kept clean and dry.
3.7. Handling
Establishments shall set up habituation and training programmes suitable for the animals, the procedures and length of the project.
Section B: Species-specific section
1. Mice, rats, gerbils, hamsters and guinea pigs
In this and subsequent tables for mice, rats, gerbils, hamsters and guinea pigs, ‘enclosure height’ means the vertical distance between the enclosure floor and the top of the enclosure and this height applies over more than 50 % of the minimum enclosure floor area prior to the addition of enrichment devices.
When designing procedures, consideration shall be given to the potential growth of the animals to ensure adequate space is provided (as detailed in Tables 1.1 to 1.5) for the duration of the study.
Table 1.1.
Mice
|
|
Body weight (g) |
Minimum enclosure size (cm2) |
Floor area per animal (cm2) |
Minimum enclosure height (cm) |
Date referred to in Article 33(2) |
|
In stock and during procedures |
up to 20 |
330 |
60 |
12 |
1 January 2017 |
|
over 20 to 25 |
330 |
70 |
12 |
||
|
over 25 to 30 |
330 |
80 |
12 |
||
|
over 30 |
330 |
100 |
12 |
||
|
Breeding |
|
330 For a monogamous pair (outbred/inbred) or a trio (inbred). For each additional female plus litter 180 cm2 shall be added. |
|
12 |
|
|
Stock at breeders (*1) Enclosure size 950 cm2 |
less than 20 |
950 |
40 |
12 |
|
|
Enclosure size 1 500 cm2 |
less than 20 |
1 500 |
30 |
12 |
|
|
(*1)
Post-weaned mice may be kept at these higher stocking densities for the short period after weaning until issue, provided that the animals are housed in larger enclosures with adequate enrichment, and these housing conditions do not cause any welfare deficit such as increased levels of aggression, morbidity or mortality, stereotypes and other behavioural deficits, weight loss, or other physiological or behavioural stress responses. |
|||||
Table 1.2.
Rats
|
|
Body weight (g) |
Minimum enclosure size (cm2) |
Floor area per animal (cm2) |
Minimum enclosure height (cm) |
Date referred to in Article 33(2) |
|
In stock and during procedures (*1) |
up to 200 |
800 |
200 |
18 |
1 January 2017 |
|
over 200 to 300 |
800 |
250 |
18 |
||
|
over 300 to 400 |
800 |
350 |
18 |
||
|
over 400 to 600 |
800 |
450 |
18 |
||
|
over 600 |
1 500 |
600 |
18 |
||
|
Breeding |
|
800 Mother and litter. For each additional adult animal permanently added to the enclosure add 400 cm2 |
|
18 |
|
|
Stock at breeders (*2) Enclosure size 1 500 cm2 |
up to 50 |
1 500 |
100 |
18 |
|
|
over 50 to 100 |
1 500 |
125 |
18 |
||
|
over 100 to 150 |
1 500 |
150 |
18 |
||
|
over 150 to 200 |
1 500 |
175 |
18 |
||
|
Stock at breeders (*2) Enclosure size 2 500 cm2 |
up to 100 |
2 500 |
100 |
18 |
|
|
over 100 to 150 |
2 500 |
125 |
18 |
||
|
over 150 to 200 |
2 500 |
150 |
18 |
||
|
(*1)
In long-term studies, if space allowances per individual animal fall below those indicated above towards the end of such studies, priority shall be given to maintaining stable social structures.
(*2)
Post-weaned rats may be kept at these higher stocking densities for the short period after weaning until issue, provided that the animals are housed in larger enclosures with adequate enrichment, and these housing conditions do not cause any welfare deficit such as increased levels of aggression, morbidity or mortality, stereotypes and other behavioural deficits, weight loss, or other physiological or behavioural stress responses. |
|||||
Table 1.3.
Gerbils
|
|
Body weight (g) |
Minimum enclosure size (cm2) |
Floor area per animal (cm2) |
Minimum enclosure height (cm) |
Date referred to in Article 33(2) |
|
In stock and during procedures |
up to 40 |
1 200 |
150 |
18 |
1 January 2017 |
|
over 40 |
1 200 |
250 |
18 |
||
|
Breeding |
|
1 200 Monogamous pair or trio with offspring |
|
18 |
Table 1.4.
Hamsters
|
|
Body weight (g) |
Minimum enclosure size (cm2) |
Floor area per animal (cm2) |
Minimum enclosure height (cm) |
Date referred to in Article 33(2) |
|
In stock and during procedures |
up to 60 |
800 |
150 |
14 |
1 January 2017 |
|
over 60 to 100 |
800 |
200 |
14 |
||
|
over 100 |
800 |
250 |
14 |
||
|
Breeding |
|
800 Mother or monogamous pair with litter |
|
14 |
|
|
Stock at breeders (*1) |
less than 60 |
1 500 |
100 |
14 |
|
|
(*1)
Post-weaned hamsters may be kept at these higher stocking densities, for the short period after weaning until issue provided that the animals are housed in larger enclosures with adequate enrichment, and these housing conditions do not cause any welfare deficit such as increased levels of aggression, morbidity or mortality, stereotypes and other behavioural deficits, weight loss, or other physiological or behavioural stress responses. |
|||||
Table 1.5.
Guinea pigs
|
|
Body weight (g) |
Minimum enclosure size (cm2) |
Floor area per animal (cm2) |
Minimumenclosure height (cm) |
Date referred to in Article 33(2) |
|
In stock and during procedures |
up to 200 |
1 800 |
200 |
23 |
1 January 2017 |
|
over 200 to 300 |
1 800 |
350 |
23 |
||
|
over 300 to 450 |
1 800 |
500 |
23 |
||
|
over 450 to 700 |
2 500 |
700 |
23 |
||
|
over 700 |
2 500 |
900 |
23 |
||
|
Breeding |
|
2 500 Pair with litter. For each additional breeding female add 1 000 cm2 |
|
23 |
2. Rabbits
During agricultural research, when the aim of the project requires that the animals are kept under similar conditions to those under which commercial farm animals are kept, the keeping of the animals shall at least follow the standards laid down in Directive 98/58/EC ( 3 ).
A raised area shall be provided within the enclosure. This raised area must allow the animal to lie and sit and easily move underneath, and shall not cover more than 40 % of the floor space. When for scientific or veterinary reasons a raised area cannot be used, the enclosure shall be 33 % larger for a single rabbit and 60 % larger for two rabbits. Where a raised area is provided for rabbits of less than 10 weeks of age, the size of the raised area shall be at least of 55 cm by 25 cm and the height above the floor shall be such that the animals can make use of it.
Table 2.1.
Rabbits over 10 weeks of age
Table 2.1 is to be used for both cages and pens. The additional floor area is as a minimum 3 000 cm2 per rabbit for the third, the fourth, the fifth and the sixth rabbit, while 2 500 cm2 as a minimum shall be added for each additional rabbit above a number of six.
|
Final body weight (kg) |
Minimum floor area for one or two socially harmonious animals (cm2) |
Minimum height (cm) |
Date referred to in Article 33(2) |
|
less than 3 |
3 500 |
45 |
1 January 2017 |
|
from 3 to 5 |
4 200 |
45 |
|
|
over 5 |
5 400 |
60 |
Table 2.2.
Doe plus litter
|
Doe weight (kg) |
Minimum enclosure size (cm2) |
Addition for nest boxes (cm2) |
Minimum height (cm) |
Date referred to in Article 33(2) |
|
less than 3 |
3 500 |
1 000 |
45 |
1 January 2017 |
|
from 3 to 5 |
4 200 |
1 200 |
45 |
|
|
over 5 |
5 400 |
1 400 |
60 |
Table 2.3.
Rabbits less than 10 weeks of age
Table 2.3 is to be used for both cages and pens.
|
Age |
Minimum enclosure size (cm2) |
Minimum floor area per animal (cm2) |
Minimum height (cm) |
Date referred to in Article 33(2) |
|
Weaning to 7 weeks |
4 000 |
800 |
40 |
1 January 2017 |
|
From 7 to 10 weeks |
4 000 |
1 200 |
40 |
Table 2.4.
Rabbits: Optimal dimensions for raised areas for enclosures having the dimensions indicated in Table 2.1.
|
Age in weeks |
Final body weight (kg) |
Optimum size (cm x cm) |
Optimum height from the enclosure floor (cm) |
Date referred to in Article 33(2) |
|
over 10 |
less than 3 |
55 × 25 |
25 |
1 January 2017 |
|
from 3 to 5 |
55 × 30 |
25 |
||
|
over 5 |
60 × 35 |
30 |
3. Cats
Cats shall not be single-housed for more than 24 hours at a time. Cats that are repeatedly aggressive towards other cats shall be housed singly only if a compatible companion cannot be found. Social stress in all pair- or group-housed individuals shall be monitored at least weekly. Females with kittens under four weeks of age or in the last two weeks of pregnancy may be housed singly.
Table 3.
Cats
The minimum space in which a queen and litter may be held is the space for a single cat, which shall be gradually increased so that by 4 months of age litters have been rehoused following the space requirements for adults.
Areas for feeding and for litter trays shall not be less than 0,5 metres apart and shall not be interchanged.
|
|
Floor (*1) (m2) |
Shelves (m2) |
Height (m) |
Date referred to in Article 33(2) |
|
Minimum for one adult animal |
1,5 |
0,5 |
2 |
1 January 2017 |
|
For each additional animal add |
0,75 |
0,25 |
— |
|
|
(*1)
Floor area excluding shelves. |
||||
4. Dogs
Dogs shall where possible be provided with outside runs. Dogs shall not be single-housed for more than 4 hours at a time.
The internal enclosure shall represent at least 50 % of the minimum space to be made available to the dogs, as detailed in Table 4.1.
The space allowances detailed below are based on the requirements of beagles, but giant breeds such as St Bernards or Irish wolfhounds shall be provided with allowances significantly in excess of those detailed in Table 4.1. For breeds other than the laboratory beagle, space allowances shall be determined in consultation with veterinary staff.
Table 4.1.
Dogs
Dogs that are pair or group housed may each be constrained to half the total space provided (2 m2 for a dog under 20 kg, 4 m2 for a dog over 20 kg) while they are undergoing procedures as defined in this Directive, if this separation is essential for scientific purposes. The period for which a dog is so constrained shall not exceed 4 hours at a time.
A nursing bitch and litter shall have the same space allowance as a single bitch of equivalent weight. The whelping pen shall be designed so that the bitch can move to an additional compartment or raised area away from the puppies.
|
Weight (kg) |
Minimum enclosure size (m2) |
Minimum floor area for one or two animals (m2) |
For each additional animal add a minimum of (m2) |
Minimum height (m) |
Date referred to in Article 33(2) |
|
up to 20 |
4 |
4 |
2 |
2 |
1 January 2017 |
|
over 20 |
8 |
8 |
4 |
2 |
Table 4.2.
Dogs — post-weaned stock
|
Weight of dog (kg) |
Minimum enclosure size (m2) |
Minimum floor area/animal (m2) |
Minimum height (m) |
Date referred to in Article 33(2) |
|
up to 5 |
4 |
0,5 |
2 |
1 January 2017 |
|
over 5 to 10 |
4 |
1,0 |
2 |
|
|
over 10 to 15 |
4 |
1,5 |
2 |
|
|
over 15 to 20 |
4 |
2 |
2 |
|
|
over 20 |
8 |
4 |
2 |
5. Ferrets
Table 5.
Ferrets
|
|
Minimum enclosure size (cm2) |
Minimum floor area per animal (cm2) |
Minimum height (cm) |
Date referred to in Article 33(2) |
|
Animals up to 600 g |
4 500 |
1 500 |
50 |
1 January 2017 |
|
Animals over 600 g |
4 500 |
3 000 |
50 |
|
|
Adult males |
6 000 |
6 000 |
50 |
|
|
Jill and litter |
5 400 |
5 400 |
50 |
6. Non-human primates
Young non-human primates shall not be separated from their mothers until they are, depending on the species, 6 to 12 months old.
The environment shall enable non-human primates to carry out a complex daily programme of activity. The enclosure shall allow non-human primates to adopt as wide a behavioural repertoire as possible, provide it with a sense of security, and a suitably complex environment to allow the animal to run, walk, climb and jump.
Table 6.1.
Marmosets and tamarins
|
|
Minimum floor area of enclosures for 1 (*1) or 2 animals plus offspring up to 5 months old (m2) |
Minimum volume per additional animal over 5 months (m3) |
Minimum enclosure height (m) (*2) |
Date referred to in Article 33(2) |
|
Marmosets |
0,5 |
0,2 |
1,5 |
1 January 2017 |
|
Tamarins |
1,5 |
0,2 |
1,5 |
|
|
(*1)
Animals shall be kept singly only in exceptional circumstances.
(*2)
The top of the enclosure shall be at least 1,8 m from the floor. |
||||
For marmosets and tamarins, separation from the mother shall not take place before 8 months of age.
Table 6.2.
Squirrel monkeys
|
Minimum floor area for 1 (*1) or 2 animals (m2) |
Minimum volume per additional animal over 6 months of age (m3) |
Minimum enclosure height (m) |
Date referred to in Article 33(2) |
|
2,0 |
0,5 |
1,8 |
1 January 2017 |
|
(*1)
Animals shall be kept singly only in exceptional circumstances. |
|||
For squirrel monkeys, separation from the mother shall not take place before 6 months of age.
Table 6.3.
Macaques and vervets (*1)
|
|
Minimum enclosure size (m2) |
Minimum enclosure volume (m3) |
Minimum volume per animal (m3) |
Minimum enclosure height (m) |
Date referred to in Article 33(2) |
|
Animals less than 3 yrs of age (*2) |
2,0 |
3,6 |
1,0 |
1,8 |
1 January 2017 |
|
Animals from 3 yrs of age (*3) |
2,0 |
3,6 |
1,8 |
1,8 |
|
|
Animals held for breeding purposes (*4) |
|
|
3,5 |
2,0 |
|
|
(*1)
Animals shall be kept singly only in exceptional circumstances.
(*2)
An enclosure of minimum dimensions may hold up to three animals.
(*3)
An enclosure of minimum dimensions may hold up to two animals.
(*4)
In breeding colonies no additional space/volume allowance is required for young animals up to 2 years of age housed with their mother. |
|||||
For macaques and vervets, separation from the mother shall not take place before 8 months of age.
Table 6.4.
Baboons (*1)
|
|
Minimum enclosure size (m2) |
Minimum enclosure volume (m3) |
Minimum volume per animal (m3) |
Minimum enclosure height (m) |
Date referred to in Article 33(2) |
|
Animals less than 4 yrs of age (*2) |
4,0 |
7,2 |
3,0 |
1,8 |
1 January 2017 |
|
Animals from 4 yrs of age (*2) |
7,0 |
12,6 |
6,0 |
1,8 |
|
|
Animals held for breeding purposes (*3) |
|
|
12,0 |
2,0 |
|
|
(*1)
Animals shall be kept singly only in exceptional circumstances.
(*2)
An enclosure of minimum dimensions may hold up to 2 animals.
(*3)
In breeding colonies no additional space/volume allowance is required for young animals up to 2 years of age housed with their mothers. |
|||||
For baboons, separation from the mother shall not take place before 8 months of age.
7. Farm animals
During agricultural research, when the aim of the project requires that the animals are kept under similar conditions to those under which commercial farm animals are kept, the keeping of the animals shall comply at least with the standards laid down in Directives 98/58/EC, 91/629/EEC ( 4 ) and 91/630/EEC ( 5 ).
Table 7.1.
Cattle
|
Body weight (kg) |
Minimum enclosure size (m2) |
Minimum floor area/animal (m2/animal) |
Trough space for ad-libitum feeding of polled cattle (m/animal) |
Trough space for restricted feeding of polled cattle (m/animal) |
Date referred to in Article 33(2) |
|
up to 100 |
2,50 |
2,30 |
0,10 |
0,30 |
1 January 2017 |
|
over 100 to 200 |
4,25 |
3,40 |
0,15 |
0,50 |
|
|
over 200 to 400 |
6,00 |
4,80 |
0,18 |
0,60 |
|
|
over 400 to 600 |
9,00 |
7,50 |
0,21 |
0,70 |
|
|
over 600 to 800 |
11,00 |
8,75 |
0,24 |
0,80 |
|
|
over 800 |
16,00 |
10,00 |
0,30 |
1,00 |
Table 7.2.
Sheep and goats
|
Body weight (kg) |
Minimum enclosure size (m2) |
Minimum floor area/animal (m2/animal) |
Minimum partition height (m) |
Trough space for ad-libitum feeding (m/animal) |
Trough space for restricted feeding (m/animal) |
Date referred to in Article 33(2) |
|
less than 20 |
1,0 |
0,7 |
1,0 |
0,10 |
0,25 |
1 January 2017 |
|
over 20 to 35 |
1,5 |
1,0 |
1,2 |
0,10 |
0,30 |
|
|
over 35 to 60 |
2,0 |
1,5 |
1,2 |
0,12 |
0,40 |
|
|
over 60 |
3,0 |
1,8 |
1,5 |
0,12 |
0,50 |
Table 7.3.
Pigs and minipigs
|
Live weight (kg) |
Minimum enclosure size (*1) (m2) |
Minimum floor area per animal (m2/animal) |
Minimum lying space per animal (in, thermoneutral conditions) (m2/animal) |
Date referred to in Article 33(2) |
|
Up to 5 |
2,0 |
0,20 |
0,10 |
1 January 2017 |
|
over 5 to 10 |
2,0 |
0,25 |
0,11 |
|
|
over 10 to 20 |
2,0 |
0,35 |
0,18 |
|
|
over 20 to 30 |
2,0 |
0,50 |
0,24 |
|
|
over 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 |
|
|
over 100 to 150 |
4,0 |
1,35 |
0,70 |
|
|
over 150 |
5,0 |
2,50 |
0,95 |
|
|
Adult (conventional) boars |
7,5 |
|
1,30 |
|
|
(*1)
Pigs may be confined in smaller enclosures for short periods of time, for example by partitioning the main enclosure using dividers, when justified on veterinary or experimental grounds, for example where individual food consumption is required. |
||||
Table 7.4.
Equines
The shortest side shall be a minimum of 1,5 times the wither height of the animal. The height of indoor enclosures shall allow animals to rear to their full height.
|
Wither height (m) |
Minimum floor area/animal (m2/animal) |
Minimum enclosure height (m) |
Date referred to in Article 33(2) |
||
|
For each animal held singly or in groups of up to 3 animals |
For each animal held in groups of 4 or more animals |
Foaling box/mare with foal |
|||
|
1,00 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 |
|
|
over 1,60 |
16,0 |
(2 × WH)2 (*1) |
20 |
3,00 |
|
|
(*1)
To ensure adequate space is provided, space allowances for each individual animal shall be based on height to withers (WH). |
|||||
8. Birds
During agricultural research, when the aim of the project requires that the animals are kept under similar conditions to those under which commercial farm animals are kept, the keeping of the animals shall comply at least with the standards laid down in Directives 98/58/EC, 1999/74/EC ( 6 ) and 2007/43/EC ( 7 ).
Table 8.1.
Domestic fowl
Where these minimum enclosure sizes cannot be provided for scientific reasons, the duration of the confinement shall be justified by the experimenter in consultation with veterinary staff. In such circumstances, birds can be housed in smaller enclosures containing appropriate enrichment and with a minimum floor area of 0,75 m2.
|
Body mass (g) |
Minimum enclosure size (m2) |
Minimum area per bird (m2) |
Minimum height (cm) |
Minimum length of feed trough per bird (cm) |
Date referred to in Article 33(2) |
|
Up to 200 |
1,00 |
0,025 |
30 |
3 |
1 January 2017 |
|
over 200 to 300 |
1,00 |
0,03 |
30 |
3 |
|
|
over 300 to 600 |
1,00 |
0,05 |
40 |
7 |
|
|
over 600 to 1 200 |
2,00 |
0,09 |
50 |
15 |
|
|
over 1 200 to 1 800 |
2,00 |
0,11 |
75 |
15 |
|
|
over 1 800 to 2 400 |
2,00 |
0,13 |
75 |
15 |
|
|
over 2 400 |
2,00 |
0,21 |
75 |
15 |
Table 8.2.
Domestic turkeys
All enclosure sides shall be at least 1,5 m long. Where these minimum enclosures sizes cannot be provided for scientific reasons, the duration of the confinement shall be justified by the experimenter in consultation with veterinary staff. In such circumstances, birds can be housed in smaller enclosures containing appropriate enrichment and with a minimum floor area of 0,75 m2 and a minimum height of 50 cm for birds below 0,6 kg, 75 cm for birds below 4 kg, and 100 cm for birds over 4 kg. These can be used to house small groups of birds in accordance with the space allowances given in table 8.2.
|
Body mass (kg) |
Minimum enclosure size (m2) |
Minimum area per bird (m2) |
Minimum height (cm) |
Minimum length of feed trough per bird (cm) |
Date referred to in Article 33(2) |
|
Up to 0,3 |
2,00 |
0,13 |
50 |
3 |
1 January 2017 |
|
over 0,3 to 0,6 |
2,00 |
0,17 |
50 |
7 |
|
|
over 0,6 to 1 |
2,00 |
0,30 |
100 |
15 |
|
|
over 1 to 4 |
2,00 |
0,35 |
100 |
15 |
|
|
over 4 to 8 |
2,00 |
0,40 |
100 |
15 |
|
|
over 8 to 12 |
2,00 |
0,50 |
150 |
20 |
|
|
over 12 to 16 |
2,00 |
0,55 |
150 |
20 |
|
|
over 16 to 20 |
2,00 |
0,60 |
150 |
20 |
|
|
over 20 |
3,00 |
1,00 |
150 |
20 |
Table 8.3.
Quails
|
Body mass (g) |
Minimum enclosure size (m2) |
Area per bird pair-housed (m2) |
Area per additional bird group-housed (m2) |
Minimum height (cm) |
Minimum length of trough per bird (cm) |
Date referred to in Article 33(2) |
|
Up to 150 |
1,00 |
0,5 |
0,10 |
20 |
4 |
1 January 2017 |
|
Over 150 |
1,00 |
0,6 |
0,15 |
30 |
4 |
Table 8.4.
Ducks and geese
Where these minimum enclosures sizes cannot be provided for scientific reasons, the duration of the confinement shall be justified by the experimenter in consultation with veterinary staff. In such circumstances, birds can be housed in smaller enclosures containing appropriate enrichment and with a minimum floor area of 0,75 m2. These can be used to house small groups of birds in accordance with the space allowances given in table 8.4.
|
Body mass (g) |
Minimum enclosure size (m2) |
Area per bird (m2) (*1) |
Minimum height (cm) |
Minimum length of feed trough per bird (cm) |
Date referred to in Article 33(2) |
|
Ducks |
|
1 January 2017 |
|||
|
Up to 300 |
2,00 |
0,10 |
50 |
10 |
|
|
Over 300 to 1 200 (*2) |
2,00 |
0,20 |
200 |
10 |
|
|
Over 1 200 to 3 500 |
2,00 |
0,25 |
200 |
15 |
|
|
Over 3 500 |
2,00 |
0,50 |
200 |
15 |
|
|
Geese |
|
||||
|
Up to 500 |
2,00 |
0,20 |
200 |
10 |
|
|
Over 500 to 2 000 |
2,00 |
0,33 |
200 |
15 |
|
|
Over 2 000 |
2,00 |
0,50 |
200 |
15 |
|
|
(*1)
This shall include a pond of minimum area 0,5 m2 per 2 m2 enclosure with a minimum depth of 30 cm. The pond may contribute up to 50 % of the minimum enclosure size.
(*2)
Pre-fledged birds may be held in enclosures with a minimum height of 75 cm. |
|||||
Table 8.5.
Ducks and geese: Minimum pond sizes (*1)
|
|
Area (m2) |
Depth (cm) |
|
Ducks |
0,5 |
30 |
|
Geese |
0,5 |
from 10 to 30 |
|
(*1)
Pond sizes are per 2 m2 enclosure. The pond may contribute up to 50 % of the minimum enclosure size. |
||
Table 8.6.
Pigeons
Enclosures shall be long and narrow (for example 2 m by 1 m) rather than square to allow birds to perform short flights.
|
Group size |
Minimum enclosure size (m2) |
Minimum height (cm) |
Minimum length of food trough per bird (cm) |
Minimum length of perch per bird (cm) |
Date referred to in Article 33(2) |
|
Up to 6 |
2 |
200 |
5 |
30 |
1 January 2017 |
|
from 7 to 12 |
3 |
200 |
5 |
30 |
|
|
for each additional bird above 12 |
0,15 |
|
5 |
30 |
Table 8.7.
Zebra finches
Enclosures shall be long and narrow (for example 2 m by 1 m) to enable birds to perform short flights. For breeding studies, pairs may be housed in smaller enclosures containing appropriate enrichment with a minimum floor area of 0,5 m2 and a minimum height of 40 cm. The duration of the confinement shall be justified by the experimenter in consultation with veterinary staff.
|
Group size |
Minimum enclosure size (m2) |
Minimum height (cm) |
Minimum number of feeders |
Date referred to in Article 33(2) |
|
Up to 6 |
1,0 |
100 |
2 |
1 January 2017 |
|
7 to 12 |
1,5 |
200 |
2 |
|
|
13 to 20 |
2,0 |
200 |
3 |
|
|
for each additional bird above 20 |
0,05 |
|
1 per 6 birds |
9. Amphibians
Table 9.1.
Aquatic urodeles
|
Body length (*1) (cm) |
Minimum water surface area (cm2) |
Minimum water surface area for each additional animal in group-holding (cm2) |
Minimum water depth (cm) |
Date referred to in Article 33(2) |
|
Up to 10 |
262,5 |
50 |
13 |
1 January 2017 |
|
over 10 to 15 |
525 |
110 |
13 |
|
|
over 15 to 20 |
875 |
200 |
15 |
|
|
over 20 to 30 |
1 837,5 |
440 |
15 |
|
|
Over 30 |
3 150 |
800 |
20 |
|
|
(*1)
Measured from snout to vent. |
||||
Table 9.2.
Aquatic anurans (*1)
|
Body length (*2) (cm) |
Minimum water surface area (cm2) |
Minimum water surface area for each additional animal in group-holding (cm2) |
Minimum water depth (cm) |
Date referred to in Article 33(2) |
|
Less than 6 |
160 |
40 |
6 |
1 January 2017 |
|
from 6 to 9 |
300 |
75 |
8 |
|
|
over 9 to 12 |
600 |
150 |
10 |
|
|
over 12 |
920 |
230 |
12,5 |
|
|
(*1)
These conditions apply to holding (i.e. husbandry) tanks but not to those tanks used for natural mating and super-ovulation for reasons of efficiency, as the latter procedures require smaller individual tanks. Space requirements determined for adults in the indicated size categories; juveniles and tadpoles shall either be excluded, or dimensions altered according to the scaling principle.
(*2)
Measured from snout to vent. |
||||
Table 9.3.
Semi-aquatic anurans
|
Body length (*1) (cm) |
Minimum enclosure size (*2) (cm2) |
Minimum area for each additional animal in group holding (cm2) |
Minimum enclosure height (*3) (cm) |
Minimum water depth (cm) |
Date referred to in Article 33(2) |
|
up to 5,0 |
1 500 |
200 |
20 |
10 |
1 January 2017 |
|
over 5,0 to 7,5 |
3 500 |
500 |
30 |
10 |
|
|
Over 7,5 |
4 000 |
700 |
30 |
15 |
|
|
(*1)
Measured from snout to vent.
(*2)
One-third land division, two-thirds water division sufficient for animals to submerge.
(*3)
Measured from the surface of the land division up to the inner part of the top of the terrarium; furthermore, the height of the enclosures shall be adapted to the interior design. |
|||||
Table 9.4.
Semi-terrestrial anurans
|
Body length (*1) (cm) |
Minimum enclosure size (*2) (cm2) |
Minimum area for each additional animal in group-holding (cm2) |
Minimum enclosure height (*3) (cm) |
Minimum water depth (cm) |
Date referred to in Article 33(2) |
|
Up to 5,0 |
1 500 |
200 |
20 |
10 |
1 January 2017 |
|
over 5,0 to 7,5 |
3 500 |
500 |
30 |
10 |
|
|
over 7,5 |
4 000 |
700 |
30 |
15 |
|
|
(*1)
Measured from snout to vent.
(*2)
Two-thirds land division, one-third water division sufficient for animals to submerge.
(*3)
Measured from the surface of the land division up to the inner part of the top of the terrarium; furthermore, the height of the enclosures shall be adapted to the interior design. |
|||||
Table 9.5.
Arboreal anurans
|
Body length (*1) (cm) |
Minimum enclosure size (*2) (cm2) |
Minimum area for each additional animal in group-holding (cm2) |
Minimum enclosure height (*3) (cm) |
Date referred to in Article 33(2) |
|
up to 3,0 |
900 |
100 |
30 |
1 January 2017 |
|
Over 3,0 |
1 500 |
200 |
30 |
|
|
(*1)
Measured from snout to vent.
(*2)
Two-thirds land division, one-third pool division sufficient for animals to submerge.
(*3)
Measured from the surface of the land division up to the inner part of the top of the terrarium; furthermore, the height of the enclosures shall be adapted to the interior design. |
||||
10. Reptiles
Table 10.1.
Aquatic chelonians
|
Body length (*1) (cm) |
Minimum water surface area (cm2) |
Minimum water surface area for each additional animal in group holding (cm2) |
Minimum water depth (cm) |
Date referred to in Article 33(2) |
|
up to 5 |
600 |
100 |
10 |
1 January 2017 |
|
Over 5 to 10 |
1 600 |
300 |
15 |
|
|
Over 10 to 15 |
3 500 |
600 |
20 |
|
|
Over 15 to 20 |
6 000 |
1 200 |
30 |
|
|
Over 20 to 30 |
10 000 |
2 000 |
35 |
|
|
Over 30 |
20 000 |
5 000 |
40 |
|
|
(*1)
Measured in a straight line from the front edge to the back edge of the shell. |
||||
Table 10.2.
Terrestrial snakes
|
Body length (*1) (cm) |
Minimum floor area (cm2) |
Minimum area for each additional animal in group-holding (cm2) |
Minimum enclosure height (*2) (cm) |
Date referred to in Article 33(2) |
|
up to 30 |
300 |
150 |
10 |
1 January 2017 |
|
Over 30 to 40 |
400 |
200 |
12 |
|
|
Over 40 to 50 |
600 |
300 |
15 |
|
|
Over 50 to 75 |
1 200 |
600 |
20 |
|
|
Over 75 |
2 500 |
1 200 |
28 |
|
|
(*1)
Measured from snout to tail.
(*2)
Measured from the surface of the land division up to the inner part of the top of the terrarium; furthermore, the height of the enclosure shall be adapted to the interior design. |
||||
11. Fish
11.1. Water supply and quality
Adequate water supply of suitable quality shall be provided at all times. Water flow in re-circulatory systems or filtration within tanks shall be sufficient to ensure that water quality parameters are maintained within acceptable levels. Water supply shall be filtered or treated to remove substances harmful to fish, where necessary. Water-quality parameters shall at all times be within the acceptable range that sustains normal activity and physiology for a given species and stage of development. The water flow shall be appropriate to enable fish to swim correctly and to maintain normal behaviour. Fish shall be given an appropriate time for acclimatisation and adaptation to changes in water-quality conditions.
11.2. Oxygen, nitrogen compounds, pH, and salinity
Oxygen concentration shall be appropriate to the species and to the context in which the fish are held. Where necessary, supplementary aeration of tank water shall be provided. The concentrations of nitrogen compounds shall be kept low.
The pH level shall be adapted to the species and kept as stable as possible. The salinity shall be adapted to the requirements of the fish species and to the life stage of the fish. Changes in salinity shall take place gradually.
11.3. Temperature, lighting, noise
Temperature shall be maintained within the optimal range for the fish species concerned and kept as stable as possible. Changes in temperature shall take place gradually. Fish shall be maintained on an appropriate photoperiod. Noise levels shall be kept to a minimum and, where possible, equipment causing noise or vibration, such as power generators or filtration systems, shall be separate from the fish-holding tanks.
11.4. Stocking density and environmental complexity
The stocking density of fish shall be based on the total needs of the fish in respect of environmental conditions, health and welfare. Fish shall have sufficient water volume for normal swimming, taking account of their size, age, health and feeding method. Fish shall be provided with an appropriate environmental enrichment, such as hiding places or bottom substrate, unless behavioural traits suggest none is required.
11.5. Feeding and handling
Fish shall be fed a diet suitable for the fish at an appropriate feeding rate and frequency. Particular attention shall be given to feeding of larval fish during any transition from live to artificial diets. Handling of fish shall be kept to a minimum.
ANNEX IV
METHODS OF KILLING ANIMALS
|
1. |
In the process of killing animals, methods listed in the table below shall be used. Methods other than those listed in the table may be used:
(a)
on unconscious animals, providing the animal does not regain consciousness before death;
(b)
on animals used in agricultural research, when the aim of the project requires that the animals are kept under similar conditions to those under which commercial farm animals are kept; these animals may be killed in accordance with the requirements laid down in Annex I to Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing ( 8 ). |
|
2. |
The killing of animals shall be completed by one of the following methods:
(a)
confirmation of permanent cessation of the circulation;
(b)
destruction of the brain;
(c)
dislocation of the neck;
(d)
exsanguination; or
(e)
confirmation of the onset of rigor mortis. |
|
3. |
Table
Requirements 1. Shall, where appropriate, be used with prior sedation. 2. Only to be used on large reptiles. 3. Only to be used in gradual fill. Not to be used for foetal and neonate rodents. 4. Only to be used for birds under 1 kg. Birds over 250 g shall be sedated. 5. Only to be used for rodents under 1 kg. Rodents over 150 g shall be sedated. 6. Only to be used for rabbits under 1 kg. Rabbits over 150 g shall be sedated. 7. Only to be used for birds under 5 kg. 8. Only to be used for rodents under 1 kg. 9. Only to be used for rabbits under 5 kg. 10. Only to be used on neonates. 11. Only to be used for birds under 250 g. 12. Only to be used if other methods are not possible. 13. Specialised equipment required. 14. Only to be used on pigs. 15. Only to be used in field conditions by experienced marksmen. 16. Only to be used in field conditions by experienced marksmen when other methods are not possible. |
ANNEX V
LIST OF ELEMENTS REFERRED TO IN ARTICLE 23(3)
National legislation in force relevant to the acquisition, husbandry, care and use of animals for scientific purposes.
Ethics in relation to human-animal relationship, intrinsic value of life and arguments for and against the use of animals for scientific purposes.
Basic and appropriate species-specific biology in relation to anatomy, physiological features, breeding, genetics and genetic alteration.
Animal behaviour, husbandry and enrichment.
Species-specific methods of handling and procedures, where appropriate.
Animal health management and hygiene.
Recognition of species-specific distress, pain and suffering of most common laboratory species.
Anaesthesia, pain relieving methods and killing.
Use of humane end-points.
Requirement of replacement, reduction and refinement.
Design of procedures and projects, where appropriate.
ANNEX VI
LIST OF ELEMENTS REFERRED TO IN ARTICLE 37(1)(c)
Relevance and justification of the following:
use of animals including their origin, estimated numbers, species and life stages;
procedures.
Application of methods to replace, reduce and refine the use of animals in procedures.
The planned use of anaesthesia, analgesia and other pain relieving methods.
Reduction, avoidance and alleviation of any form of animal suffering, from birth to death where appropriate.
Use of humane end-points.
Experimental or observational strategy and statistical design to minimise animal numbers, pain, suffering, distress and environmental impact where appropriate.
Reuse of animals and the accumulative effect thereof on the animals.
The proposed severity classification of procedures.
Avoidance of unjustified duplication of procedures where appropriate.
Housing, husbandry and care conditions for the animals.
Methods of killing.
Competence of persons involved in the project.
ANNEX VII
DUTIES AND TASKS OF THE UNION REFERENCE LABORATORY
1. The Union Reference Laboratory referred to in Article 48 is the Commission’s Joint Research Centre.
2. The Union Reference Laboratory shall be responsible, in particular, for:
coordinating and promoting the development and use of alternatives to procedures including in the areas of basic and applied research and regulatory testing;
coordinating the validation of alternative approaches at Union level;
acting as a focal point for the exchange of information on the development of alternative approaches;
setting up, maintaining and managing public databases and information systems on alternative approaches and their state of development;
promoting dialogue between legislators, regulators, and all relevant stakeholders, in particular, industry, biomedical scientists, consumer organisations and animal-welfare groups, with a view to the development, validation, regulatory acceptance, international recognition, and application of alternative approaches.
3. The Union Reference Laboratory shall participate in the validation of alternative approaches.
ANNEX VIII
SEVERITY CLASSIFICATION OF PROCEDURES
The severity of a procedure shall be determined by the degree of pain, suffering, distress or lasting harm expected to be experienced by an individual animal during the course of the procedure.
Section I: Severity categories
Non-recovery:
Procedures which are performed entirely under general anaesthesia from which the animal shall not recover consciousness shall be classified as ‘non-recovery’.
Mild:
Procedures on animals as a result of which the animals are likely to experience short-term mild pain, suffering or distress, as well as procedures with no significant impairment of the well-being or general condition of the animals shall be classified as ‘mild’.
Moderate:
Procedures on animals as a result of which the animals are likely to experience short-term moderate pain, suffering or distress, or long-lasting mild pain, suffering or distress as well as procedures that are likely to cause moderate impairment of the well-being or general condition of the animals shall be classified as ‘moderate’.
Severe:
Procedures on animals as a result of which the animals are likely to experience severe pain, suffering or distress, or long-lasting moderate pain, suffering or distress as well as procedures, that are likely to cause severe impairment of the well-being or general condition of the animals shall be classified as ‘severe’.
Section II: Assignment criteria
The assignment of the severity category shall take into account any intervention or manipulation of an animal within a defined procedure. It shall be based on the most severe effects likely to be experienced by an individual animal after applying all appropriate refinement techniques.
When assigning a procedure to a particular category, the type of procedure and a number of other factors shall be taken into account. All these factors shall be considered on a case-by-case basis.
The factors related to the procedure shall include:
Examples are given in Section III of procedures assigned to each of the severity categories on the basis of factors related to the type of the procedure alone. They shall provide the first indication as to what classification would be the most appropriate for a certain type of procedure.
However, for the purposes of the final severity classification of the procedure, the following additional factors, assessed on a case-by-case basis, shall also be taken into account:
Section III:
Examples of different types of procedure assigned to each of the severity categories on the basis of factors related to the type of the procedure
1. Mild:
administration of anaesthesia except for the sole purpose of killing;
pharmacokinetic study where a single dose is administered and a limited number of blood samples are taken (totalling < 10 % of circulating volume) and the substance is not expected to cause any detectable adverse effect;
non-invasive imaging of animals (e.g. MRI) with appropriate sedation or anaesthesia;
superficial procedures, e.g. ear and tail biopsies, non-surgical subcutaneous implantation of mini-pumps and transponders;
application of external telemetry devices that cause only minor impairment to the animals or minor interference with normal activity and behaviour;
administration of substances by subcutaneous, intramuscular, intraperitoneal routes, gavage and intravenously via superficial blood vessels, where the substance has no more than mild impact on the animal, and the volumes are within appropriate limits for the size and species of the animal;
induction of tumours, or spontaneous tumours, that cause no detectable clinical adverse effects (e.g. small, subcutaneous, non-invasive nodules);
breeding of genetically altered animals, which is expected to result in a phenotype with mild effects;
feeding of modified diets, that do not meet all of the animals’ nutritional needs and are expected to cause mild clinical abnormality within the time-scale of the study;
short-term (< 24h) restraint in metabolic cages;
studies involving short-term deprivation of social partners, short-term solitary caging of adult rats or mice of sociable strains;
models which expose animals to noxious stimuli which are briefly associated with mild pain, suffering or distress, and which the animals can successfully avoid;
a combination or accumulation of the following examples may result in classification as ‘mild’:
assessing body composition by non-invasive measures and with minimal restraint;
monitoring ECG with non-invasive techniques with minimal or no restraint of habituated animals;
application of external telemetry devices that are expected to cause no impairment to socially adapted animals and do not interfere with normal activity and behaviour;
breeding genetically altered animals which are expected to have no clinically detectable adverse phenotype;
adding inert markers in the diet to follow passage of digesta;
withdrawal of food for < 24h in adult rats;
open field testing.
2. Moderate:
frequent application of test substances which produce moderate clinical effects, and withdrawal of blood samples (> 10 % of circulating volume) in a conscious animal within a few days without volume replacement;
acute dose-range finding studies, chronic toxicity/carcinogenicity tests, with non-lethal end-points;
surgery under general anaesthesia and appropriate analgesia, associated with post surgical pain, suffering or impairment of general condition. Examples include: thoracotomy, craniotomy, laparotomy, orchidectomy, lymphadenectomy, thyroidectomy, orthopaedic surgery with effective stabilisation and wound management, organ transplantation with effective management of rejection, surgical implantation of catheters, or biomedical devices (e.g. telemetry transmitters, minipumps etc.);
models of induction of tumours, or spontaneous tumours, that are expected to cause moderate pain or distress or moderate interference with normal behaviour;
irradiation or chemotherapy with a sublethal dose, or with an otherwise lethal dose but with reconstitution of the immune system. Adverse effects would be expected to be mild or moderate and would be short-lived (< 5 days);
breeding of genetically altered animals which are expected to result in a phenotype with moderate effects;
creation of genetically altered animals through surgical procedures;
use of metabolic cages involving moderate restriction of movement over a prolonged period (up to 5 days);
studies with modified diets that do not meet all of the animals’ nutritional needs and are expected to cause moderate clinical abnormality within the time-scale of the study;
withdrawal of food for 48 hours in adult rats;
evoking escape and avoidance reactions where the animal is unable to escape or avoid the stimulus, and are expected to result in moderate distress.
3. Severe:
toxicity testing where death is the end-point, or fatalities are to be expected and severe pathophysiological states are induced. For example, single dose acute toxicity testing (see OECD testing guidelines);
testing of device where failure may cause severe pain, distress or death of the animal (e.g. cardiac assist devices);
vaccine potency testing characterised by persistent impairment of the animal’s condition, progressive disease leading to death, associated with long-lasting moderate pain, distress or suffering;
irradiation or chemotherapy with a lethal dose without reconstitution of the immune system, or reconstitution with production of graft versus host disease;
models with induction of tumours, or with spontaneous tumours, that are expected to cause progressive lethal disease associated with long-lasting moderate pain, distress or suffering. For example tumours causing cachexia, invasive bone tumours, tumours resulting in metastatic spread, and tumours that are allowed to ulcerate;
surgical and other interventions in animals under general anaesthesia which are expected to result in severe or persistent moderate postoperative pain, suffering or distress or severe and persistent impairment of the general condition of the animals. Production of unstable fractures, thoracotomy without adequate analgesia, or trauma to produce multiple organ failure;
organ transplantation where organ rejection is likely to lead to severe distress or impairment of the general condition of the animals (e.g. xenotransplantation);
breeding animals with genetic disorders that are expected to experience severe and persistent impairment of general condition, for example Huntington’s disease, Muscular dystrophy, chronic relapsing neuritis models;
use of metabolic cages involving severe restriction of movement over a prolonged period;
inescapable electric shock (e.g. to produce learned helplessness);
complete isolation for prolonged periods of social species e.g. dogs and non-human primates;
immobilisation stress to induce gastric ulcers or cardiac failure in rats;
forced swim or exercise tests with exhaustion as the end-point.
( 1 ) OJ L 262, 27.9.1976, p. 169. Directive recast by Regulation (EC) No 1223/2009 of the European Parliament and the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59), which applies as from 11 July 2013.
( 2 ) OJ L 61, 3.3.1997, p. 1.
( *1 ) OJ L 276, 20.10.2010, p. 33 ’.
( 3 ) Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes (OJ L 221, 8.8.1998, p. 23).
( 4 ) Council Directive 91/629/EEC of 19 November 1991 laying down minimum standards for the protection of calves (OJ L 340, 11.12.1991, p. 28).
( 5 ) Council Directive 91/630/EEC of 19 November 1991 laying down minimum standards for the protection of pigs (OJ L 340, 11.12.1991, p. 33).
( 6 ) Council Directive 1999/74/EC of 19 July 1999 laying down minimum standards for the protection of laying hens (OJ L 203, 3.8.1999, p. 53).
( 7 ) Council Directive 2007/43/EC of 28 June 2007 laying down minimum rules for the protection of chickens kept for meat production (OJ L 182, 12.7.2007, p. 19).
( 8 ) OJ L 303, 18.11.2009, p. 1.