CELEX: 51985PC0637
Language: en
Date: 1985-12-18
Title: PROPOSAL FOR A COUNCIL DIRECTIVE ON THE PROTECTION OF ANIMALS USED FOR EXPERIMENTAL AND OTHER SCIENTIFIC PURPOSES

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