Biological safety - use of animals by humans - T-AP former website.
The member States of the Council of Europe, signatory hereto,
Recalling that the aim of the Council of Europe is to achieve a greater unity between its members and that it wishes to co-operate with other States in the protection of live animals used for experimental and other scientific purposes;
Recognising that man has a moral obligation to respect all animals and to have due consideration for their capacity for suffering and memory;
Accepting nevertheless that man in his quest for knowledge, health and safety has a need to use animals where there is a reasonable expectation that the result will be to extend knowledge or be to the overall benefit of man or animal, just as he uses them for food, clothing and as beasts of burden;
Resolved to limit the use of animals for experimental and other scientific purposes, with the aim of replacing such use wherever practical, in particular by seeking alternative measures and encouraging the use of these alternative measures;
Desirous to adopt common provisions in order to protect animals used in those procedures which may possibly cause pain, suffering, distress or lasting harm and to ensure that where unavoidable they shall be kept to a minimum,
Have agreed as follows:
Part I General principles
a "animal", unless otherwise qualified, means any live non-human vertebrate, including free-living and/or reproducing larval forms, but excluding other foetal or embryonic forms;
b "intended for use" means bred or kept for the purpose of sale, disposal or use in any experimental or other scientific procedure;
c "procedure" means any experimental or other scientific use of 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 conditions, but excluding the least painful methods accepted in modern practice (that is "humane" methods) of killing or marking an animal.
A procedure starts when an animal is first prepared for use and ends when no further observations are made for that procedure; 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;
d "competent person" means any person who is considered by a Party to be competent in its territory to perform the relevant function described in this Convention;
e "responsible authority" means, in the territory of a given Party, any authority, body or person designated for the relevant purpose;
f "establishment" means any stable or mobile facility, any building, group of buildings or other premises, including a place which is not wholly enclosed or covered;
g "breeding establishment" means any establishment where animals are bred with a view to their use in procedures;
h "supplying establishment" means any establishment, other than a breeding establishment, from which animals are supplied with a view to their use in procedures;
i "user establishment" means any establishment where animals are used in procedures;
j "humane method of killing" means the killing of an animal with a minimum of physical and mental suffering appropriate to the species.
A procedure may be performed for one or more of the following purposes only and subject to the restrictions laid down in this Convention:
i avoidance or prevention of disease, ill-health or other abnormality, or their effects, in man, vertebrate or invertebrate animals or plants, including the production and the quality, efficacy and safety testing of drugs, substances or products;
ii diagnosis or treatment of disease, ill-health or other abnormality, or their effects, in man, vertebrate or invertebrate animals or plants;
b detection, assessment, regulation or modification of physiological conditions in man, vertebrate and invertebrate animals or plants;
c protection of the environment;
d scientific research;
e education and training;
f forensic inquiries.
Each Party undertakes to take all the necessary steps to give effect to the provisions of this Convention and to ensure an effective system of control and supervision as soon as possible and in any case within a period of five years from the date of entry into force of the present Convention in respect of that Party.
No provision in this Convention shall affect the liberty of the Parties to adopt stricter measures for the protection of animals used in procedures or for the control and restriction of the use of animals in procedures.
Part II General care and accommodation
Part III Conduct of procedure
When a procedure has to be performed, the choice of species shall be carefully considered and, where required, be explained to the responsible authority; in a choice between procedures, those should be selected 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.
A procedure shall be performed under general or local anaesthesia or analgesia or by other methods designed to eliminate as far as practicable pain, suffering, distress or lasting harm applied throughout the procedure unless:
a the pain caused by the procedure is less than the impairment of the animal's well-being caused by the use of anaesthesia or analgesia, or
b the use of anaesthesia or analgesia is incompatible with the aim of the procedure. In such cases, appropriate legislative and/or administrative measures shall be taken to ensure that no such procedure is carried out unnecessarily.
either specific authorisation by the responsible authority;
or specific declaration of such procedure to the responsible authority and judicial or administrative action by that authority if it is not satisfied that the procedure is of sufficient importance for meeting the essential needs of man or animal, including the solution of scientific problems.
During a procedure, an animal used shall remain subject to the provisions of Article 5 except where those provisions are incompatible with the objective of the procedure.
a an animal is to be kept alive, it shall receive the care appropriate to its state of health, be placed under the supervision of a veterinarian or other competent person and kept under conditions conforming to the requirements of Article 5. The conditions laid down in this sub-paragraph 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 5 for its well-being, it shall be killed by a humane method as soon as possible.
a the further procedure is one in which the animal is subject throughout to general anaesthesia which is to be maintained until the animal is killed; or
b the further procedure will involve minor interventions only.
Notwithstanding the other provisions of this Convention, where it is necessary for the legitimate purposes of the procedure, the responsible authority may allow the animal concerned to be set free provided that it is satisfied that the maximum practicable care has been taken to safeguard the animal's well-being. Procedures that involve setting the animal free shall not be permitted solely for educational or training purposes.
Part IV Authorisation
A procedure for the purposes referred to in Article 2 may be carried out by persons authorised, or under the direct responsibility of a person authorised, or if the experimental or other scientific project concerned is authorised in accordance with the provisions of national legislation. Authorisation shall be granted only to persons deemed to be competent by the responsible authority.
Part V Breeding or supplying establishments
Breeding and supplying establishments shall be registered with the responsible authority subject to the grant of an exemption under Article 21 or Article 22. Such registered establishments shall comply with the requirements of Article 5.
The registration provided for in Article 14 shall specifiy the person in charge of the establishment, who shall be competent to administer or arrange for suitable care for animals of the species bred or kept in the establishment.
Part VI User establishments
User establishments shall be registered with or otherwise approved by the responsible authority and shall comply with the conditions laid down in Article 5.
Provisions shall be made at user establishments for installations and equipment appropriate for the species of animals used and the performance of the procedures conducted there. The design, construction and functioning of such installations and equipment shall be such as to ensure that the procedures are performed as effectively as possible, with the object of obtaining consistent results with the minimum number of animals and the minimum degree of pain, suffering, distress or lasting harm.
In user establishments:
a the person or persons who are administratively responsible for the care of the animals and the functioning of the equipment shall be identified;
b sufficient trained staff shall be provided;
c adequate arrangements shall be made for the provision of veterinary advice and treatment;
d a veterinarian or other competent person should be charged with advisory duties in relation to the well-being of the animals.
|Guinea Pig||Cavia porcellus|
|Golden hamster||Mesocricetus auratus|
In user establishments, only animals supplied from registered breeding or supplying establishments shall be used, unless a general or special exemption has been obtained under arrangements to be determined by the Party.
Procedures may, where authorised by the responsible authority, be conducted outside user establishments.
Arrangements shall be made at user establishments to maintain records and make them available as required by the responsible authority. In particular, these records shall be sufficient to meet the requirements of Article 27 and, in addition, show the number and species of all animals acquired, from whom they were acquired and their date of arrival.
Part VII Education and training
Persons who carry out procedures, or take part in procedures, or take care of animals used in procedures, including supervision, shall have had appropriate education and training.
Part VIII Statistical information
a the numbers and kinds of animals used in procedures;
b the numbers of animals in selected categories used in procedures directly concerned with medicine and in education and training;
c the numbers of animals in selected categories used in procedures for the protection of man and the environment;
d the numbers of animals in selected categories used in procedures required by law.
Part IX Recognition of procedures carried out in the territory of another Party
Part X Multilateral consultations
Article 30 (1)
1 The Parties shall, within five years from the entry into force of this Convention and every five years thereafter, or more frequently if a majority of the Parties should so request, hold multilateral consultations within the Council of Europe to examine the application of this Convention, and the advisability of revising it or extending any of its provisions
2 These consultations shall take place at meetings convened by the Secretary General of the Council of Europe. The Parties shall communicate the name of their representative to the Secretary General of the Council of Europe at least two months before each meeting.
3 Subject to the provisions of this Convention, the Parties shall draw up the rules of procedure for the consultations.
Part XI Amendments (2)
Article 31 (3)
1 Any amendment to Appendices A and B, proposed by a Party or by the Committee of Ministers of the Council of Europe shall be communicated to the Secretary General of the Council of Europe and forwarded by him to the member States of the Council of Europe, to the European Community and to any non-member State which has acceded to, or has been invited to accede to the Convention in accordance with the provisions of Article 34.
2 Any amendments proposed in accordance with the provisions of the preceding paragraph shall be examined, not less than six months after the date of forwarding by the Secretary General, at a multilateral consultation where it may be adopted by a two-thirds majority of the Parties. The text adopted shall be forwarded to the Parties.
3 Twelve months after its adoption at a multilateral consultation, any amendment shall enter into force unless one third of the Parties have notified objections.
Part XII Final clauses (4)
Article 32 (5)
This Convention shall be open for signature by the member States of the Council of Europe and by the European Communities. It is subject to ratification, acceptance or approval. Instruments of ratification, acceptance or approval shall be deposited with the Secretary General of the Council of Europe.
Article 33 (5)
Article 34 (5)
Article 35 (5)
Article 36 (5)
Article 37 (5)
Article 38 (5)
The Secretary General of the Council of Europe shall notify the member States of the Council of Europe, the European Communities and any State which has acceded to this Convention of:
a any signature;
b the deposit of any instrument of ratification, acceptance, approval or accession;
c any date of entry into force of this Convention in accordance with Articles 33, 34 and 36; (1)
d any other act, notification or communication relating to this Convention;
In witness whereof the undersigned, being duly authorised thereto, have signed this Convention.
Done at Strasbourg, this 18th day of March 1986, in English and French, both texts being equally authentic, in a single copy which shall be deposited in the archives of the Council of Europe. The Secretary General of the Council of Europe shall transmit certified copies to each member State of the Council of Europe, to the European Communities and to any State invited to accede to this Convention.