CELEX: 51994PC0366
Language: de
Date: 1994-09-09
Title: Geänderter Vorschlag für eine ENTSCHEIDUNG DES RATES über den Abschluß des europäischen Übereinkommens zum Schutz der zu Versuchen oder anderen wissenschaftlichen Zwecken verwendeten Wirbeltiere im Namen der Gemeinschaft

KOVMISSION DER EUROPÄISCHEN GEMEINSCHAFTEN
                                               K0MC94) 366 endg. - CNS 198
                                               Brüssel, den 09.09.1994
                         Geänderter Vorschlag für eine
                             ENTSCHEIDUNG DES RATES
                                      ÜBER
    DEN ABSCHLUSS DES EUROPAISCHEN ÜBEREINKOMMENS ZUM SCHUTZ DER ZU VERSUCHEN
         ODER ANDEREN WISSENSCHAFTLICHEN ZWECKEN VERWENDETEN WIRBELTIERE
                             IM NAMEN DER GEMEINSCHAFT
                (gemäß Artikel 189 A, Absatz 2 des EG-Vertrages
                         von der Kommission vorgelegt)
 ---pagebreak---                                                                      2
                                BEGRÜNDUNG
1.  Im Bestreben, in Europa einen besseren Schutz der auf immer
    zahlreicheren Gebieten (Chemie, Lebensmittel, Kosmetik, Toxikologie)
    zu Versuchen oder anderen wissenschaftlichen Zwecken verwendeten
    Wirbeltiere zu gewährleisten, hat der Ministerrat des Europarates am
    31. Mai 1985 ein Europäisches Übereinkommen über den Schutz der zu
    Versuchen und anderen wissenschaftlichen Zwecken verwendeten
    Wirbeltiere (nachstehend "Übereinkommen" genannt) verabschiedet.
    In diesem Übereinkommen sind die wissenschaftlichen Ziele und
    Bedingungen festgelegt, unter denen Versuche mit Wirbeltieren
    genehmigt werden dürfen, wobei darauf geachtet wird, die Zahl der
    Versuchstiere und ihre Leiden auf ein Minimum zu beschränken und die
    von den einzel Staat liehen Behörden bei den Zuchtbetrieben,
    Lieferanten und Verwendern von Versuchstieren durchzuführenden
    Kontrollen festzulegen.
    Das Ziel des Übereinkommens besteht letztlich im Ersatz der
    Tierversuche durch Alternatiwerfahren.
2.  Das Übereinkommen, das den Mitgliedern des Europarates und der
    Europäischen Gemeinschaften seit dem 18. März 1986 zur Unterzeichnung
    offensteht, trat am 1. Januar 1991 in Kraft und wurde von der
    Gemeinschaft in Übereinstimmung mit der Entscheidung des Rates vom
    24. November 1986 ^ am 10. Februar 1987 unterzeichnet.
    Die Kommission legte dem Rat am 14. Juli 1989 ferner einen Vorschlag
    für eine Entscheidung zum Abschluß des Übereinkommens auf der
    Rechtsgrundlage von Artikel 100a des Vertrags zur Gründung der
    Europäischen Wirtschaftsgemeinschaft (KOM(89)302 endg./SYN 198) ^
    vor.
3.  Auf Gemeinschaftsebene verabschiedete die Kommission am 24. November
    1986 die Richtlinie 86/609/EWG über den Schutz der zu Versuchen oder
    anderen wissenschaftlichen Zwecken verwendeten Wirbeltiere^, in
    der die wichtigsten Bestimmungen und Grundsätze des Übereinkommens
    festgelegt sind.
    Der Rat beabsichtigte, mit dieser Richtlinie die Rechts- und
    Verwaltungsvorschriften der Mitgliedstaaten auf dem Gebiet des
    Schutzes der zu Versuchen und anderen wissenschaftlichen Zwecken
    verwendeten Wirbeltiere zu vereinheitlichen, um das einwandfreie
    Funktionieren des Binnenmarktes zu erleichtern und
    Wettbewerbsverzerrungen zwischen den Mitgliedstaaten zu vermeiden.
(1) im Amtsblatt nicht veröffentlicht
(2) ABl. Nr. C 200 vom 05.08.1989, S. 8
(3) ABl. Nr. L 358 vom 18.12.1986, S. 1
 ---pagebreak---                                                                         3
4.  Da für die Themen im Geltungsbereich des Übereinkommens teilweise die
    Gemeinschaft und teilweise die Mitgliedstaaten zuständig sind, nahm
    der Rat am 24. November 1986 eine Entschließung an, in der die
    Mitgliedstaaten, die das Übereinkommen noch nicht unterzeichnet
    hatten, aufgefordert wurden, dies möglichst rasch zu tun*4'.
    Das Übereinkommen wurde von neun Mitgliedstaaten unterzeichnet und
    von dreien ratifiziert. Die Gemeinschaft und die Mitgliedstaaten, die
    das Übereinkomen noch nicht unterzeichnet haben oder ihm noch nicht
    beigetreten sind, sollten dies somit im Rahmen ihrer Zuständigkeit
    tun. Die Annahmeurkunden sollten wenn möglich von der Gemeinschaft
    und ihren Mitgliedstaaten gleichzeitig hinterlegt werden.
5.  Es hat sich gezeigt, daß in der Richtlinie 86/609/EWG die jährliche
    Übermittlung der statistischen Daten gemäß Artikel 28 des
    Übereinkommens nicht gefordert wurde; nach dem Übereinkommen kann ein
    diesbezüglicher Vorbehalt eingelegt werden  (Artikel 34).
    Zur Einhaltung der Verpflichtung zur jährlichen Übermittlung der im
    Übereinkommen vorgesehenen Informationen sollte die Richtlinie
    86/609/EWG geändert werden. Angesichts der Schwierigkeiten einer
    jährlichen Übermittlung der Daten durch die Mitgliedstaaten und die
    Gemeinschaft muß die Gemeinschaft einen diesbezüglichen Vorbehalt
    einlegen.
6.  Infolge des Inkrafttretens des Vertrages über die Europäische Union
    wurde die Rechtsgrundlage insofern geändert, als Artikel 228 Absatz 2
    und 3, zweiter Unterabsatz, in Verbindung mit Artikel 100a des
    Vertrags zur Gründung der Europäischen Wirtschaftsgemeinschaft hierzu
    gewählt wurde; dadurch wird eine Befürwortung durch das Europäische
    Parlament erforderlich. Diese wurde für notwendig erachtet, weil der
    Abschluß des Übereinkommens durch die Gemeinschaft eine Änderung der
    Richtlinie erfordert, um die Verpflichtung zur jährlichen
    Übermittlung der Daten einzuführen. Da jedoch die Richtlinie
    86/609/CEE angesichts des obenerwähnten Vorbehalts nicht mehr
    geändert werden muß, wird Artikel 228, Absatz 2 und 3, erster
    Unterabsatz, in Verbindung mit Artikel 100a als Rechtsgrundlage des
    Vorschlags für eine geänderte Entscheidung vorgeschlagen.
(4) ABl. Nr. C 331 vom 23.12.1986, S. 1
 ---pagebreak---             GEÄNDERTER VORSCHLAG FÜR EINE ENTSCHEIDUNG DES RATES
        über den Abschluß des europäischen Übereinkommens zum Schutz
                                                                        t
              der zu Versuchen oder anderen wissenschaftlichen
                       Zwecken verwendeten Wirbeltiere
                           im Namen der Gemeinschaft
DER RAT DER EUROPÄISCHEN UNION -
gestützt auf den Vertrag zur Gründung der Europäischen Gemeinschaft,
insbesondere auf Artikel 100a, in Verbindung mit Artikel 228, Ziffer 2 und
3, erster Absatz,
auf Vorschlag der Kommission(^),
nach Stellungnahme des Europäischen Parlaments^)
nach Stellungnahme des Wirtschafts- und Sozialausschusses(3)
in Erwägung nachstehender Gründe:
Mit der Richtlinie 86/609/EWG vom 24. November 1986 zur Angleichung der
Rechts- und Verwaltungsvorschriften der Mitgliedstaaten zum Schutz der zu
Versuchen oder anderen wissenschaftlichen Zwecken verwendeten Wirbeltiere
(4) hat der Rat gemeinsame Regeln festgelegt, die den Grundsätzen, Zielen
und wichtigsten Bestimmungen des Europäischen Übereinkommens zum Schutz der
zu Versuchen oder anderen wissenschaftlichen Zwecken verwendeten Wirbeltier
entsprechen, das am 31. Mai 1985 vom Ministerrät des Europarates angenommen
worden war.
Die Richtlinie 86/609/EWG beinhaltet keine Pflicht zur jährlichen
Übermittlung von statistischen Daten; infolgedessen ist die Gemeinschaft
zur Erfüllung der in Artikel 28 Absatz 1 des Übereinkommens festgelegten
Verpflichtung nicht fähig, und ein diesbezüglicher Vorbehalt ist .
einzulegen.
(1)    ABl. Nr. C 200 vom 05.08.1989,  S. 8
(2)    ABl. Nr. C 291 vom 20.11.1989,  S. 43
(3)    ABl. Nr. C 329 vom 30.12.1986,  S. 1
(4)    ABl. Nr. L 358 vom 18.12.1986,  S. 1
 ---pagebreak--- Die Bestimmungen des Übereinkommens wirken sich auf die Bedingungen der
                                                                         s
Herstellung und des Inverkehrbringens von Erzeugnissen und Stoffen aus, zu
deren Entwicklung die betreffenden Versuchsreihen beitrtagen; sie
beeinflussen somit das Funktionieren des Binnenmarktes - eines der
Hauptziele der Gemeinschaft.
Die Gemeinschaft unterzeichnete am 10 Februar 1987 das Übereinkommen, das am
1. Januar 1991 in Kraft trat.
Die Gemeinschaft sollte diese Übereinkommen unterzeichnen -
HAT FOLGERNDE ENTSCHEIDUNG ERLASSES:
                                  Artikel 1
Das Übereinkommezn zum Schutz der zu Versuchen oder anderen
wissenschaftlichen Zwecken verwendeten Wirbeltiere, das am 31. Mai 1985 in
Straßburg angenommen wurde, wird mit einem Vorbehalt zu Artikel 28, Absatz
1, angenommen.
Der Text des Übereinkommens und des Vorbehalts sind dieser Entscheidung
beigefügt.
                                 Artikel 2
Der Vorsitzende des Rates wird ermächtigt, die Person oder Personen zu
bezeichnen, die dazu ermächtigt sind, die Urkunde über den Beitritt zum
Übereinkommen gemäß Artikel 31 des Übereinkommens beim Generalsekretär des
Europarates zu hinterlegen.
Geschehen zu
                                                  Im Namen des Rates
                                                     Der Präsident
 ---pagebreak---                     Text des Vorbehalts der Gemeinschaft
                                                                        c
"Gemäß Artikel 34, Absatz 1, des europäischen Übereinkommens über den Schutz
der zu Versuchen oder anderen wissenschaftlichen Zwecken verwendeten
Wirbeltiere erklärt die Europäische Gemeinschaft, daß sie die in Artikel 28
Absatz 1 dieses Übereinkommens festgelegte Pflicht zur Übermittlung
statistischer Daten für sich nicht als bindend betrachtet."
 ---pagebreak---                    ENTWURF BINER ERKLÄRUNG DBR KOMMISSION
                                                                 3
                      (in das Ratsprotokoll aufzunehmen)
"Die Kommission erklärt, daß die von den Mitgliedstaaten und der
Gemeinschaft geäußerten Vorbehalte Gebiete in ihrem jeweiligen
Zuständigkeitsbereich betreffen. "
 ---pagebreak---                                                                       y
       ENTWURF EINER ERKLÄRUNG, DIE IN DAS PROTOKOLL ÜBER DIE SITZUNG
                          DES RATES AUFZUNEHMEN IST
"Die im Rat vereinigten Vertreter der Mitgliedstaaten, die das in Artikel 1
erwähnte Übereinkommen noch nicht ratifiziert haben oder ihm noch nicht
beigetreten sind, erklären, daß sie die notwendigen Maßnahmen ergreifen,
damit die Urkunden zur Annahme des Übereinkommens durch die Gemeinschaft und
ihre Mitgliedstaaten möglichst gleichzeitig und spätestens am
hinterlegt werden können."
 ---pagebreak---                                   • * •
                             •                           •
                            •
  COUNCIL
                                                            *
                                                                      CONSEIL
                                                          •
  OF EUROPE                                                       DE L'EUROPE
         EUROPEAN CONVENTION FOR THE PROTECTION
      OF VERTEBRATE ANIMALS USED FOR EXPERIMENTAL
               AND OTHER SCIENTIFIC PURPOSES
                   CONVENTION EUROPÉENNE
         SUR LA PROTECTION DES ANIMAUX VERTÉBRÉS
             UTILISÉS À DES FINS EXPÉRIMENTALES
              OU Ä D'AUTRES FINS SCIENTIFIQUES
                                  STRASBOURG
                                Provisional edition
                                 Edition proTboic*
"•"nOBMDKI           ÇESRJÇ^MVjr : •' - - ^:*•î•s^v••1.,''" • * '
 ---pagebreak---                                                                                                 4o
                                                  PREAMBLE
         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 il wishes to co-operate with other States in the protection of live animals used
tor 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
 »o use animals where there is a reasonable expectation that the result will be to extend knowledge
 or he 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 unavoid-
able they shall be kept to a minimum.
         HHVC agreed as follows :
                                                    PART I
                                               General principles
                                                    Article 1
 1.      This Convention applies to any animal used or intended for use in any experimental or
other scientific procedure where that procedure may cause pain, suffering, distress or lasting
harm. It docs not apply to any non-experimenLal agricultural or clinical veterinary practice.
2.       In this Convention :
        a. "animal", unless otherwise qualified, means any live non-human vertebrate, including
free-living and/or reproducing larval forms, bur excluding other foetal or embryonic forms ;,
         6. "intended for use" means bred or kept for the purpose of sale, disposal or use in any
experimental or other scientific procedure :
                                                                    f^fffÊmmm m >w n ' "
                 viwoww m,.wjjin—>ewwiWE*i»''nwww»r          *"  ••
 ---pagebreak---                                                  -  3 —
                                                                                                     s1
         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, bur excluding che lea« painful
 methods accepted in modem practice (that Is. "humane" methods) of killing or marking an
 animal. A procedure staris-when an animal is first prepared for use and" ends when no further
 observations are to be made for that procedure : the elimination of pain, suffering, disrres* or
 lairing harm-by the successful use of anaesthesia or analgesia or outer methods does not place
 the use of an animal outside the scope of this definition :
          d, "competent penon " means any person who is considered by a Party to be competent in
 itt territory to perform the relevant function described in this Convention :
          a. "responsible authority" means, in the territory of a given Party, any authority, body or
 person designated for the relevant purpose ;
         / . "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 arc bred with a view
 to their use in procedures ;
          h. 'supplying establishment'' means any establishment, other than a breeding establish-
 ment, from which animals are supplied with a view to their use in procedures ;
          i. 'user establishmim" 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.
                                                Article 2
          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 ;
          n. 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 ;
 e.       protection of the environment :
 d.       scientific research ;
 e.       education and training :
./•       forensic inquiries.
                                                Article 3
          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.
 ---pagebreak---                                                                                            ""U
                                                Article 4
         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.
                                                PARTIT
                                    General care and accommodation
                                                Article 5
  1.     Any animal used or intended for use in a procedure shall be provided with accommodation,
 an environment, at least a minimum degree of freedom of movement, food, water and care,
 appropriate lu its health and well-being. Any restriction on the extent to which an animal can
 satisfy its physiological and etiological needs shall be limited as far as practicable. In the im-
 plementation of this provision, regard should be paid to the guidelines foe accommodation and
 care of animals set out in Appendix A to this Convention.
 2.      The environmental conditions in which animals are bred, kept or used shall be checked
 daily.
 si.     The well-being and state of health of animals shall be observed sufficiently closely and
 frequently to prevent pain or avoidable suffering, distress or lasting harm.
 4.      Each Party shall determine arrangements to ensure that any defect or suffering discovered
 is corrected as quickly as possible.:
                                               PART III
                                         Conduct of procedure
                                               Article 6
 1.      A procedure shall not be performed for any of the purposes referred to in Article 2, if
 another scientifically satisfactory method, not entailing the use of an animal, is reasonably and
practicably available.                                                         ,..
2. . Each Party should encourage scientific research into the development of methods which
could provide the same information as that obtained in procedures.
                                               Article 7
         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.
                                               Article 8
        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
 ---pagebreak---                                                 - 5—
                                                                                                        ^J
        ö. the use of anaesthesia or analgesia is compatible wiLh 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.
                                               Article 9
1.      Where il is planned to subject an animal to a procedure in which it will or may experience
severe pain which is likely to endure, that procedure must be specifically declared and justified to,
or specifically authorised by, the responsible authority.
2.      Appropriate legislative and/or administrative measures shall be taken to ensure that no
such procedure is carried out unnecessarily.
        Such measures shall include :
         — 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         f) $
importance for meeting the essential needs of man or animal, including the solution of scientific
problems.
                                               Article 10
         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.
                                               Article 11
 1.      At the end of a procedure It shall be decided whether the animal shall be kept alive or
killed by a humane method. An animal 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 this article shall be taken by a competent
 person, in particular a veterinarian, or the person who, in accordance with, Article 13. is
 responsible for, or has performed, the procedure.                                                         £V
3.       Where, at the end of a 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 con-
ditions 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.       No animal which has been used in a procedure entailing severe or enduring pain or
 suffering, irrespective of whether anaesthesia or analgesia was employed, shall be used in a
further procedure unless it has returned to good health and well-being, and either :
         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.
 ---pagebreak---                                                                                                   n
                                                    - ft - .
                                                                                                       i
                                                 Article 12
         Notwithstanding the other provisions of this Convention, where It is necessary- for i l -
legitimate purposes of the procedure, the responsible authority may allow the animal concerned
to he set free provided rhat it is satisfied that the maximum practicable care has been taken to safe-
guard the animal's well-being. Procedures that involve setting the animal free shall nor he permitted
solely for educational or training purposes.
                                                   PART IV
                                                Authorisation
                                                   Article 13
           A procedure for the purposes referred to in Article 2 may be carried out only 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.
                                                   PARTV
                                   Breeding or supplying establishments
                                                  Article 14
           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.
                                                  Article 15
          The registration provided for in Article 14 shall specify 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.
                                                  Article 16
  1.     . Arrangements shall be made at registered breeding establishments to record, in respect of
  the animais bred there, the number and species of such animals leaving, the dates they leave and
  the name and address of the recipient.
  2.       Arrangements shall be made at registered supplying establishments to record the number
  and species of such animals entering and leaving, the dates of these movements, from whom the
  animals concerned were acquired and the name and address of the recipient.
  3.       The responsible 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 and 2 of
  this article ; such records shall be kept for a minimum of three years from the date of the last
  entry.
 ---pagebreak---                                                 — 7
                                                                                                ir
                                               Article 17
 1. ' Each dog and cat in an establishment shall be individually and permanently marked in
the least painful manner possible before it is weaned.
2.      Where an unmarked dog or cat is taken into an establishment 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 to another before it is weaned
 and it Is not practical to mark it beforehand, a full documentary record, specifying in particular
 its mother, shall be kept until it can be marked.
4.      Particulars of the identity and origin of each dog or cat shall be entered in the records of
 the establishment.
                                               PART VI
                                          User establishments
                                               Article 18
         User establishments shall be registered with or otherwise approved by the responsible
                                                                                                     o
 authority and shall comply with the conditions laid down in Article 5.
                                               Article 19
        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
                                               Article 20-
        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 treat-     A,
ment :                                                                                               ™
        d. a veterinarian or other competent person should be charged with advisory duties in
relation to the well-being of the animals.
                                               Article 21
1.      Animals of the species listed below which are for use in procedures shall be acquired
directly from or originate from registered breeding establishments, unless a genera! or special
exemption has been obtained under arrangements to be determined by the Parry :
        Mouse                Mus musculus
        Rat                  Rattus norvégiens
        Guinea pig           Cavia porcelius
        Golden hamster       Mesocricetus auratus
        Rabbit               Oryctolagus cuniculus
        Dog                  Can is familiaris
        Cat                  Felis catus
        Quail                Cotumix coturnix
 ---pagebreak---                                                                                                 ^
2.       Each Party undertakes to extend the provisions of paragraph 1 of this article to other
species, in particular of the order of primates, as soon as there is a reasonable prospect of a
sufficient supply of purpose-bred animals of the species concerned.
 3.      Straying animals of a domesticated species shall not be used in procedures. A general
 exemption made under the conditions of paragraph 1 of this article may not extend to stray dogs
 and cats.
                                               Article 22
         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.
                                               Article 23
         Procedures may. where authorised by the responsible authority, be conducted outside user
 establishments.
                                                                                                       i
                                               Article 24                                              ^
         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.
                                               PARTVn
                                       Education and training
                                               Article 25
 1.      Procedures carried out for the purpose of education, training or further training for
 professions or other occupations, including the care of animals being used or blended for use in
 procedures, must be notified to the responsible authority and shall be carried out by or under the
 supervision of a competent person, who will be responsible for ensuring that the procedures
 comply with national legislation under the terms of this Convention.
2.       Procedures within the scope of education, training, or further training for purposes other
 than those referred to in paragraph 1 above shall not be permitted.                                   Qr
3.       Procedures referred to in paragraph 1 of this article shall be restricted to those absolutely
necessary for the purpose of the education or training concerned and be permitted only if their
 objective cannot be achieved by comparably effective audio-visual or any other suitable methods.
                                               Article 26
         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
                                               Article 27
1.      Each Party shall collect statistical information on the use of animals in procedures and
this information shall where lawful be made available to the public.
 ---pagebreak---                                                    9—
                                                                                                     I  " l1 "
2.      Information shall be collected in respect of :
        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.
                                               Article 28
 1.      Subject to requitements of national legislation relating to secrecy and confidentiality,- each
Party shall communicate every year to the Secretary General of the Council of Europe infor-
mation in respect of the Items mentioned in paragraph 2 of Article 27. presented in the form
 set out in Appendix B to this Convention.
2.      The Secretary General of the Council of Europe shall publish the statistical information
received from the Parties In respect of The items mentioned in paragraph 2 of Article 27.
3.       Each Party is invited to communicate to the Secretary General of the Council of Europe
the address of its national authority from which information about more comprehensive national
statistics may be obtained on request. Such addresses will be contained in the publications of
statistics made by the Secretary General of the Council of Europe.
                                               PART IX
               Recognition of procedures carried out in the territory of another Party
                                               Article 29
 1.     In order to avoid unnecessary repetition of procedures required by law on health and
safety, each Party shall, where practicable, recognise the results of procedures carried out in the
territory of another Party.
2.      To that end the Parties undertake, where practicable and lawful, to render each other
mutual assistance, in particular by furnishing' information on their legislation and administrative
practice relating to the requirements for procedures to be carried out in support of submissions
for registration of products, as well as factual information on procedures carried out in their
territory and on authorisation or any other administrative particulars pertaining to these
procedures.
                                               PARTX
                                      Multilateral consultations
                                               Article 30
        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. 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 meetings.
 ---pagebreak---                                                 ~ 10 ~-
                                                                                                    A <
                                                                                                      iY
                                               PART XI
                                           final provisions
                                               Anicle 31
        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 32
1.      This Convention shall enter into force on the first day of the month following the expiration
of a period of $ix months after rhe date on which four member States of the Council of Europe
have expressed their consent to be bound by the Convention in accordance with the provisions of
Article 31.
2.      In respect of a Signatory' which subsequently expresses its consent to be bound by it, the
Convention shall enter into force on the first day of the month following the expiration of a
period of six months after the date of the deposit of the instrument of ratification, acceptance or
approval.
                                               Article 33
 1.     After the entry inlo force of this Convention, the Committee of Ministers of the Council of
Europe may invite any State not a member of the Council to accede to this Convention, by a
decision taken by the majority provided for in Article 20.d of the Statute of the Council of
Europe and by the unanimous vote of the représentatives of the Contracting States entitled to sit
on the Committee.
2.      In respect of any acceding State, the Convention shall enter into force on the first day of
the month following the expiration of a period of six months after the date of deposit of the
instrument of accession with the Secretary General of the Council of Europe.
                                               Article 34
 1.     Any Signatory may, at the time of signature or when depositing its instrument of ratifi-
cation, acceptance, approval or accession, make one or more reservations. No reservations may,
however, be made in respect of Articles 1 to 14 or Articles 18 to 20.
2.      Any Party which has made a reservation under the preceding paragraph may wholly or
partly withdraw it by means of a notification addressed to the Secretary General of the Council of
 Europe. The withdrawal shall take effect on the date of receipt of such notification by the
Secretary General.
3. • A Party which has made a reservation in respect of a provision of this Convention may not
claim the application of that provision by any other Party; it may, however, if its reservation is
 partial or conditional, claim the application of that provision insofar as it has itself accepted it.
                                               Article 35
 1.     Any Signatory may, at the time of signature or when depositing its instrument of ratifi-
cation, acceptance, approval or accession, specify the territory or territories to which this Con-
vention shall apply.
 ---pagebreak---                                                     Il
                                                                                             13
2.      Any Party may at any later date, by a declaration addressed to the Secretary General of
the Council of Europe, extend the application of this Convention to any other territory specified
in the declaration. In respect of such territory, the Convention shall enter into force on the first
day of the month following the expiration of a period of six months after the date of receipt of
such declaration by the Secretary General.
3.      Any declaration made under the two preceding paragraphs may, in respect of any territory
specified in such declaration, be withdrawn by a notification addressed to the Secretary General.
The withdrawal shall become effective on the first day of the month following the expiration of a
period of six months after the date of receipt of such notification by the Secretary General.
                                                Article 36
1.      Any Party may at any time denounce this Convention by means of a notification addressed
to the Secretary General of the Council of Europe.
2.      Such denunciation shall become effective on the first day of the month following the
expiration of a period of six months after the date of receipt of the notification by the Secretary
General.                                                                                               ft
                                                Article 37
        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 32, 33 and 35 ;
        d. any other act, notification or communication relating to this Convention.
                                                                                                        #
               llllilMllliimWiiWlMIHlBli
 ---pagebreak---                                                                           2o
       In witness whereof the undersigned, being duly authorised thereto,
have signed this Convention.
   ... Qpneat Strasbourg, this 18th day of March. 1986, in English and
French/bl^Tex!^                                       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.
 ---pagebreak---                                                                           2^7
                                                                    ISSN 0254-1467
                                                          KOM(94) 366 endg.
                                                     DOKUMENTE
DE                                                                             14
                                 Katalognummer : CB-CO-94-382-DE-C
                                                          ISBN 92-77-80002-X
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