No C 351/16 Official Journal of the European Communities 31. 12. 85 
Proposal for a Council Directive on the protection of animals used for experimental and other 
scientific purposes 
COM(85) 637 final 
(Submitted by the Commission to the Council on 20 December 1985) 
(85/C 351/07) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Articles 43 
and 100 thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European Parliament, 
Having regard to the opinion of the Economic and Social 
Committee, 
Whereas a European Convention for the Protection of 
Vertebrate Animals used for Experimental and Other 
Scientific Purposes was adopted by the Committee of 
Ministers of the Council of Europe on 31 May 1985; 
Whereas certain provisions of the Convention could affect 
certain common rules laid down in particular by Council 
Directives 64/432/EEC of 26 June 1964 on animal health 
problems affecting intra-Community trade in bovine 
animals and swine ('), 75/318/EEC of 20 May 1975 on the 
approximation of the laws of Member States relating to 
analytical, pharmaco-toxicological and clinical standards 
and protocols in respect of the testing of proprietary 
medicinal products (2), 79/831/EEC of 18 September 1979 
amending for the sixth time Directive 67/548/EEC on the 
approximation of the laws, regulations and administrative 
provisions relating to the classification, packaging and 
labelling of dangerous substances (3), 81/852/EEC of 
28 September 1981 on the approximation of the la ws of the 
Member States relating to analytical, pharmaco-toxicolo­
gical and clinical standards and protocols in respect of the 
testing of veterinary medicinal products (4), and 83/228/ 
EEC of 18 April 1983 on the fixing of guidelines for the 
assessment of certain products used in animal nutrition (5) 
and Commission Directive 84/449/EEC of 25 April 1984 
adapting to technical progress for the sixth time Council 
Directive 67/548/EEC (6); 
Whereas the European Convention for the protection of 
vertebrate animals used for experimental and other 
scientific purposes is open to signature by the Member 
States; whereas the Convention is also open for signature 
by the European Communities; 
Whereas, however, Community measures on the subject 
should be adopted without delay; 
(!) OJ No 121, 29.7. 1964, p. 1977/64. 
(2) OJNoL 147, 9. 6. 1975, p. 1. 
(3) OJ No L 259, 15. 10. 1979, p. 10. 
(4) OJ No L 317, 6. 11. 1981, p. 16. 
(5) OJ No L 126, 13. 5. 1983, p. 23. 
(6) OJ No L 251, 19. 9. 1984, p. 1. Whereas there exist between the national laws at present in 
force for the protection of animals used for experimental 
purposes disparities affecting the functioning of the 
common market; 
Whereas the Community should also take action to avoid 
in general all forms of cruelty to animals; 
Whereas, in order to eliminate these disparities, the laws of 
the Member States should be harmonized; whereas that 
would accordingly enable action to be taken at Community 
level to protect animals used for experimental purposes 
from unnecessary pain and suffering, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
1. This Directive is concerned with the animals used for 
experimental and other scientific purposes. It is aimed to 
ensure that the number of animals used for experimen­
tation is reduced to a minimum, that such animals are 
properly taken care of and that no pain or suffering is 
inflicted unnecessarily. 
2. Experimentation using experimental animals shall be 
undertaken only for one or more of the following purposes 
and subject to the restrictions laid down in this Directive. 
(a) (i) the avoidance or prevention of disease, ill-health or 
other abnormality, or their effects, in humans, 
vertebrate or invertebrate animals or plants, 
including the production and the quality, effective­
ness and safety testing of drugs, substances or 
products; 
(ii) the diagnosis or treatment of disease, ill-health or 
other abnormality, or their effects, in humans, 
vertebrate or invertebrate animals or plants; 
(b) the assessment, detection, regulation or modification 
of physiological conditions in humans, vertebrate and 
invertebrate animals or plants; 
(c) the protection of the environment; 
(d) scientific research; 
(e) education and training; 
(f) forensic inquiries. 
Article 2 
For the purpose of this Directive the following definitions 
shall apply: 
31. 12. 85 Official Journal of the European Communities No C 351/17 
(a) 'animal' unless otherwise qualified, means any live 
non-human vertebrate, including foetuses and free 
living larval and/or reproducing larval forms; and 
invertebrates of the Phylum mollusca, Class cepha­
lopoda. 
(b) 'experimental animals' means animals used or to be 
used in required or approved experimentation; 
(c) 'bred animals' means animals specially bred in facilities 
approved by the authority; 
(d) 'experimentation or 'experiment' means all tests, 
demonstrations and procedures carried out on an 
animal which may cause it pain, suffering, distress or 
lasting harm, including any course of action intended 
to, or liable to, result in the birth of an animal in any 
such condition, but excluding the least painful methods 
accepted in modern practice (i.e. 'humane' methods) of 
killing or marking an animal; an experiment starts 
when an animal is first prepared for use and ends when 
no further observations are to be made for that 
experiment; the elimination of pain, suffering, distress 
or lasting harm by the successful use of anaesthesia or 
analgesia or other methods does not place the use of an 
animal outside the scope of this definition; 
(e) 'authority' means the authority designated by each 
Member State as being responsible for supervising the 
practice of experimentation within the meaning of this 
Directive; 
(f) 'competent person' means any person who is con­
sidered by a Member State to be competent to perform 
the relevant function described in this Directive; 
(g) 'establishment means any installation, building, group 
of buildings or other premises and may include a place 
which is not wholly enclosed or covered and mobile 
facilities; 
(h) 'breeding establishment' means an establishment 
where animals are bred with a view to their use in 
experiments; 
(i) 'supplying establishment' means an establishment, 
other than a breeding establishment, from which 
animals are supplied with a view to their use in 
experiments; 
(j) 'user establishment' means an establishment where 
animals are used for experiments. 
Article 3 
Each Member State shall ensure that experimentation using 
animals considered as endangered species by Council 
Regulation (EEC) No 3626/82 (') or under national 
legislation of the Member State shall be prohibited. 
Article 4 
Member States shall ensure that, as far as the general care 
and accommodation of animals is concerned: 
(i) OJ No L 384, 31. 12. 1982, p. 1. — all experimental animals shall be adequately housed, 
fed, and cared for; 
— any restriction on the extent to which an experimental 
animal can satisfy its physiological and ethological 
needs shall be limited only as permitted by the 
provisions set out in Annex II; 
— the environmental conditions in which experimental 
animals are bred, kept or used must be checked daily; 
— the well-being and state of health of animals shall be 
observed by a competent person to prevent pain or 
avoidable suffering, distress or lasting harm; 
— arrangements are made to ensure that any defect or 
suffering discovered is corrected as quickly as possible. 
Article 5 
1. Each Member State shall designate an authority 
responsible for supervising the practice of experimentation 
within the meaning of this Directive. 
2. The designated authority shall have responsibility for 
authorizing competent persons to undertake or to supervise 
the practice of experimentation in registered or approved 
establishments. 
3. The designated authority should, in discharging its 
functions under this Directie, have access to the advice of 
interested parties, including scientific, industrial and 
animal welfare interests. 
Article 6 
1. An experiment shall not be performed if another 
scientifically satisfactory method of obtaining the result 
sought, not entailing the use of an animal, is reasonably and 
practicably available. 
2. When an experiment has to be performed, the choice 
of species shall be carefully considered and, where required, 
shall be explained to the responsible authority. In a choice 
between experiments, those which use the minimum 
number of animals, cause the least pain, suffering, distress 
or lasting harm and which are most likely to provide 
satisfactory results shall be selected. 
3. All experiments shall be designed to avoid distress 
and unnecessary pain to the experimental animals, using 
whenever appropriate general or local anaesthesia. They 
should be subject to the 'anaesthesia condition' laid down 
in Annex III and to the 'pain condition' laid down in 
Annex IV. The measures set out in Annex V shall be taken 
in all cases. 
Article 7 
Member States shall ensure that all personnel handling 
experimental animals have received training or instruction 
in animal welfare appropriate to his/her function. 
No C 351/18 Official Journal of the European Communities 31. 12. 85 
Article 8 
1. Details of experiments must be notified 30 days in 
advance to the authority, which shall have the possibility of 
disallowing the experiment, or of requiring changes 
thereto, within the said 30 days. 
2. All decisions disallowing an experiment, requiring 
changes to an experiment or refusing authorization to 
conduct an experiment should indicate the reasons on 
which they are based and should provide for the possibility 
of an appeal. 
3. Each experiment shall be performed in all respects in 
accordance with any directions given under paragraph 1, 
and in conformity with the animal well-being aspects of 
good laboratory practice and in conformity with all 
provisions of this Directive. 
4. All experiments on non-human primates shall be 
subject to prior authorization. Such experiments shall be 
authorized only where there is a justification and where 
they are essential to solve a serious medical problem or 
where they are necessary to comply with Community 
measures for the protection of public health. 
5. Notifications made pursuant to this Article may also 
cover a programme of work involving experiments of a 
similar nature, using standard testing procedures, where 
the experiment is not expected to cause pain, distress or 
equivalent suffering of more than trivial severity. 
6. The provisions of this Article shall not preclude the 
performing of experiments required by existing Com­
munity Directives or recommendations. 
Article 9 
1. On the basis of requests for authorization and 
notifications received, and on the basis of the reports made, 
the authority in each Member State shall: 
— ensure that unnecessary duplication of experimen­
tation is avoided as far as possible, 
— collect, and as far as possible make publicly available, 
the statistical information on the use of animals in 
experiments set out in Annex VI. 
2. Member States shall take all necessary steps to ensure 
that the confidentiality of commercially sensitive inform­
ation communicated pursuant to this Directive is protected. 
Article 10 
1. Member States shall ensure that experimentation for 
teaching purposes is carried out as far as possible on bred 
animals and following authorization by the authority. 
Whenever possible audio-visual or other suitable methods 
should be used instead of carrying out experiments. 
2. Experiments shall not be permitted in secondary 
schools or other institutions of education and training of equivalent or lower level, except where the course of 
education or training concerned is specifically directed to 
preparing for a career involving the performance of 
experiments or the treatment or care of animals and the 
experiments entail no severe or enduring pain or severe or 
enduring suffering. 
Article 11 
Breeding and supplying establishments shall be registered 
with the authority and shall comply with the requirements 
of Articles 4 and 7. A supplying establishment shall not 
obtain any animal from any source other than a breeding 
establishment unless the supplier can demonstrate that the 
animal has been obtained from another supplying es­
tablishment and is not a feral or stray animal, or has been 
lawfully imported. 
Article 12 
The registration provided for in Article 11 shall specify the 
competent person in charge of the establishment who shall 
administer or arrange for suitable care of the animals of the 
species bred or kept in the establishment. 
Article 13 
1. Breeding and supplying establishments shall record 
the number and the species of animals sold or supplied, the 
dates on which they are sold or supplied, and the name and 
address of the recipient and the number and species of 
animals dying while in the breeding or supplying establish­
ment in question. 
2. Each authority shall prescribe the records which are 
to be kept and made available to it by the person in charge 
of the establishments mentioned in paragraph 1; such 
records shall be kept for a minimum of three years from the 
date of the last entry and shall be subject to periodic 
inspection by officers of the authority. 
Article 14 
1. Each dog and cat in any breeding or supplying 
establishment shall be permanently marked with a unique 
individual identification in the least painful manner before 
it is weaned, except for cases provided for under 
paragraph 3. 
2. Where an unmarked dog or cat is taken into an 
establishment as referred to in paragraph 1 for the first time 
after it has been weaned it shall be marked as soon as 
possible. 
3. Where a dog or cat is transferred from one 
establishment as referred to in paragraph 1 to another 
before it is weaned and it is not practicable to mark it 
beforehand, a full documentary record, specifying in 
particular its mother, must be maintained by the receiving 
establishment until it can be so marked. 
4. Particulars of the identity and source of each dog or 
cat shall be entered in the records of all establishments as 
referred to in paragraph 1. 
31. 12. 85 Official Journal of the European Communities No C 351/19 
5. In no case shall feral or stray cats and dogs be used for 
experiments. 
Article 15 
1. User establishments shall be registered with or 
otherwise approved by the authority. Provisions should be 
made at user establishments for installations and equip­
ment appropriate to the species of animals used and the 
performance of the experiments conducted there, the 
design, construction and functioning of which shall be such 
as to ensure that the experiments are performed as 
effectively as practicable, with the object of obtaining 
consistent results with the minimum number of animals 
and the minimum degree of pain, suffering, distress or 
lasting harm. 
2. In each user establishment: 
(a) a competent person working full-time in the establish­
ment who is responsible for the care of the animals and 
the functioning of the equipment used in the experi­
ment shall be identified and shall have the authority to 
terminate experiments, if he is reasonably convinced 
that the experiment is not being properly conducted; 
(b) sufficient trained persons shall be provided; 
(c) adequate arrangements shall be made for the provision 
of veterinary advice and treatment and the names of 
veterinarians responsible for the welfare of animals 
shall be specified; 
(d) only competent persons shall undertake experimen­
tation, or supervise the undertaking of experimen­
tation. Such persons shall have received instruction in a 
scientific discipline relevant to the experimental work 
being undertaken, and in the requisite skills of 
laboratory animal handling and care and shall have 
satisfied the responsible authority that they have 
attained a satisfactory standard in relation to those 
matters. 
3. In user establishments only animals supplied from 
breeding or supplying establishments shall be used. Bred 
animals should be used whenever possible. 
4. User establishments shall maintain records of all 
animals used and make them available as required by the 
responsible authority. In particular, these records shall 
show the number of species of all animals acquired, from 
whom they were acquired and their date of arrival. Such 
records shall be made available as required by the 
responsible authority. User establishments shall be subject 
to periodic inspection by officers of the authority. 
Article 16 
1. Animals of the species listed in Annex I which are 
used in experiments shall be acquired only from a breeding 
establishment or a supplying establishment. 
2. The list set out in the Annex may be modified in 
accordance with the procedure set out in Article 18. 
Article 17 
1. A Committee responsible for adapting the Annexes of 
this Directive to technical progress (hereinafter referred to 
as 'the Committee') is hereby set up. It shall consist of 
representatives of the Member States and be chaired by a 
representative of the Commission. 2. The Committee shall draw up its own rules of 
procedure. 
Article 18 
1. Where the procedure laid down in this Article is to be 
followed, matters shall be referred to the Committee by the 
Chairman, either on his/her own initiative or at the request 
of the representative of a Member State. 
2. The representative of the Commission shall submit to 
the Committee a draft of the measures to be adopted. The 
Committee shall deliver its opinion on the draft within a 
time limit which may be determined by the Chairman 
according to the urgency of the matter. It shall decide by a 
majority of 45 votes, the votes of the Member States being 
weighted as provided for in Article 148 (2) of the Treaty. 
The Chairman shall not vote. 
3. (a) The Commission shall adopt the measures en­
visaged where these are in accordance with the 
opinion of the Committee. 
(b) Where the measures envisaged are not in accord­
ance with the opinion of the Committee, or in the 
absence of an opinion, the Commission shall 
forthwith submit a proposal to the Council on the 
measures to be adopted. The Council shall act by a 
qualified majority. 
(c) If the Council does not act within three months of 
the proposal being submitted to it, the measures 
proposed shall be adopted by the Commission. 
Article 19 
1. In order to avoid unnecessary duplication of 
experiments for the purposes of satisfying national or 
Community legislation on health and safety, Member 
States shall recognize the results of experiments carried out 
in the territory of another Member State, unless further 
testing is necessary in order to protect public health and 
safety and the Member State concerned gives detailed 
reasons justifying its decision to require further testing to 
the person seeking to market the product concerned, and to 
the Commission. 
2. Member States shall, without prejudice to the 
requirements of existing Community Directives, furnish 
information to the Commission on their legislation and 
administrative practice relating to experimentation, includ­
ing requirements to be satisfied prior to the marketing of 
products, as well as factual information on all experiments 
carried out in their territory, and on authorization or any 
other administrative particulars pertaining to these 
experiments. 
Article 20 
This Directive shall not restrict the right of the Member 
States to apply or adopt stricter measures for the protection 
of animals used in experiments or for the control and 
restriction of the use of animals for experiments. 
No C 351/20 Official Journal of the European Communities 31. 12. 85 
Article 21 
1. Member States shall take the measures necessary to 
comply with this Directive within 12 months following 
notification. They shall inform the Commission thereof. 
2. Member States shall communicate to the Commis­
sion the provisions of national law which they adopt in the 
field covered by this Directive. 
Article 22 summary of the information collected under the provisions 
of Article 9, second indent, and the Commission shall 
prepare a report to the Council and the European 
Parliament. 
Article 23 
Member States shall inform the Commission every three 
years of the measures taken in this area provide a suitable This Directive is addressed to the Member States. 
ANNEX I 
Genus and species of experimental animals covered for the purposes of Article 16 
Mouse 
Rat 
Guinea Pig 
Golden hamster 
Rabbit 
Chicken 
Non-human primates 
Dog 
Cat 
Quail 
Frog Mus musculus 
Rattus norvegicus 
Cavia porcellus 
Mesocricetus auratus 
Oryctolagus cuniculus 
Gallus gallus 
Canis familiaris 
Felis catus 
Coturnix coturnix 
Anura 
ANNEX II 
Housing, feeding and care of experimental animals; the conduct of experiments, training of persons, etc. 
1. 
1.1. 
1.2. 
1.3. 
1.4. 
2. 
2.1. 
2.2. 
2.3. 
2.4. 
2.5. 
2.6. The physical facility 
Functions and general design 
Holding rooms 
Laboratories and special purpose rooms 
Service rooms 
The environment in the holding rooms and its control 
Ventilation 
Temperature 
Humidity 
Lighting 
Noise 
Alarm systems 
31. 12. 85 Official Journal of the European Communities No C 351/21 
3. 
3.1. 
3.2. 
3.3. 
3.4. 
3.5. 
3.6. 
3.7. 
3.8. 
3.9. 
3.10. 
3.11. 
3.12. 
4. 
5. 
6. Care 
Health 
Trapping 
Packing and transport 
Reception and unpacking 
Quarantine, isolation and acclimatization 
Caging 
Feeding 
Water 
Bedding 
Exercising and handling 
Cleaning 
Humane killing of animals 
Conduct of experiments 
Training of persons 
Other 
ANNEX III 
The anaesthesia condition 
1. Where the performance of an experiment may be expected to cause an animal pain or suffering unless the 
animal is properly anaesthetized, the person of persons authorized to conduct the experiment shall ensure 
that: 
(i) the animal is properly anaesthetized before the experiment begins and remains so until it is concluded; 
(ii) the animal is relieved from any post-operative pain or suffering by the administration of analgesics or 
other appropriate treatment; and 
(iii) if it is not practicable to provide that relief, the animal is immediately and humanely killed. 
2. This condition shall be dispensed with in cases where application of anaesthesia is considered, by a 
veterinarian, to be more distressing for the animal than the experiment. 
3. In cases where the animal is to be subjected to pain, suffering, distress or lasting harm which cannot 
practicably be relieved by the use of anaesthetics, analgesia or other pain-relieving techniques shall be 
applied to alleviate all suffering, in compliance with the provisions of Annex II. 
4. The animal shall be properly anaesthetized throughout the whole experiment, except in the case of trivial 
surgical experiments of less severity than superficial venesection, as set out in Annex II. 
5. Special authorization may be given for dispensation with the anaesthesia condition where the application 
of anaesthesia would frustrate the object of the experiment. No such dispensation shall be given in the case 
of a surgical experiment. Where dispensation is granted, the experiment shall remain subject to the pain 
condition (Article 5). 
6. 'Properly anaesthetized' means deprived of sensation by methods of anaesthesia (whether local or general) 
at least as effective as those used in good veterinary practice. 
7. 'Humanely killed' means the killing of an animal with a minimum of physical and mental suffering 
appropriate to the species. 
No C 351/22 Official Journal of the European Communities 31. 12. 85 
ANNEX IV 
The pain condition 
1. Where in accordance with the provisions of this Directive an animal is not properly anaesthetized, it shall 
not be subjected to pain, distress or equivalent suffering which is of more than momentary duration. 
2. Exemptions from the pain condition may be granted by the responsible authority in the case of: 
(i) any emergency presenting an imminent threat to public health; 
(ii) tests and investigations necessary for compliance with requirements of regulatory bodies; and 
(iii) specific research projects where the responsible authority, having taken advice in accordance with 
Article 5 (3), deems the research to be of sufficient value and importance to justify the exemption. 
3. Where such an exemption has been granted, an experiment shall be conducted only under constant 
veterinary surveillance, and if the veterinarian exercising constant surveillance considers that an animal is 
suffering severely (whether or not in consequence of the experiment) he and the person or persons 
authorized to conduct the experiment shall ensure that: 
(i) the animal is given immediate relief by the administration of analgesics or other appropriate and 
effective treatment; or 
(ii) it is immediately killed by a humane method. 
ANNEX V 
Measures to be taken at the end of an experiment 
1. At the end of any experiment, it shall be decided whether the animal shall be kept alive or killed by a 
humane method, subject to the condition that it shall not be kept alive if, even though it has been restored to 
normal health in all other respects, it is likely to remain in lasting pain or distress. 
2. The decisions referred to in paragraph 1 of Annex III shall be taken by a veterinarian. 
3. Where at the end of an experiment: 
(a) an animal is to be kept alive, it shall receive the care appropriate to its state of health and be placed 
under the supervision of a veterinarian or other competent person and shall be kept under conditions 
conforming to the requirements of Article 4. The conditions laid down in this subparagraph may, 
however, be waived where, in the opinion of a veterinarian, the animal would not suffer as a 
consequence of such exemption; 
(b) an animal is not to be kept alive or cannot benefit from the provisions of Article 4 for its well-being, it 
shall be killed by a humane method as soon as possible. 
4. No animal which has been used in an experiment entailing severe or enduring pain or suffering, irrespective 
of whether an anaesthetic or an analgesic was employed, shall be used in a further experiment. 
ANNEX VI 
Information (Article 9) 
Information shall be collected in respect of: 
(a) the number and kinds of animals used in experiments; 
(b) the number of animals, by category, used in experiments directly concerned with medicine and in teaching 
and learning; 
(c) the number of animals, by category, used in experiments for the protection of man and his environment; 
(d) the number of animals, by category, used in experiments required by legislation.