CELEX: 31985L0649
Language: en
Date: 1985-12-31 00:00:00
Title: Council Directive 85/649/EEC of 31 December 1985 prohibiting the use in livestock farming of certain substances having a hormonal action

No L 382/228                           Official Journal of the European Communities                                 31 . 12 . 85
                                                   COUNCIL DIRECTIVE
                                                     of 31 December 1985
                 prohibiting the use in livestock farming of certain substances having a hormonal action
                                                        (85/649/EEC)
 THE COUNCIL OF THE EUROPEAN                                       Whereas the use of hormonal substances for fattening
 COMMUNITIES ,                                                     purposes should therefore be prohibited ; whereas the
                                                                   use of certain substances for therapeutic purposes may
                                                                   be authorized but must be strictly controlled in order
 Having regard to the Treaty establishing the European             to prevent any mistfse of them ;
 Economic Community, and in particular Article 43
thereof,
                                                                   Whereas, furthermore, since it would be difficult to be
 Having regard to the proposal from the Commission,                certain of correct operation of the scheme as a whole
                                                                   if animals so treated and the meat from such animals
 Having regard to the opinion of the European Parlia­              were to be traded, this should as a general rule be
 ment ( ! ),                                                       prohibited ; whereas, however, derogations from this
                                                                   rule may be allowed where satisfactory guarantees can
                                                                  be provided ;
 Having regard to the opinion of the Economic and
 Social Committee (2),
 Whereas the administration to farm animals of certain             Whereas as part of the adoption of harmonized rules
substances having a hormonal action is at present                 in the Community arrangements for importation from
regulated in different ways in the Member States ;                third countries that offer equivalent guarantees should
whereas while their immediate effect on animals from              be introduced ; whereas these guarantees can be
the farmer's point of view is clear, assessments of theii:        required under          Directives      72/462/ EEC (3)   and
effect on human health vary and this is reflected in              85/358/ EEC (4);
the regulations governing their use ; whereas this diver­
gence distorts the conditions of competition in pro ¬
ducts that are the subject of common market organiza ¬
tions and is a serious barrier to intra-Community                 Whereas in order to ensure that the provisions of this
trade ;
                                                                  Directive can be implemented effectively the latest
                                                                  date for introduction of the provisions of Directive
                                                                  85 /358 / EEC should be made to fall before that for
Whereas these distortions of competition and barriers
to trade, must therefore be removed by ensuring that              introduction of the provisions of this Directive ; whe­
all consumers are able to buy the products in question            reas Community control measures should ensure uni­
under largely identical conditions of supply and that             form application in all Member States of the rules
these products correspond to their anxieties and                  applicable on administration of substances having a
expectations in the best possible manner ; whereas                hormonal or thyrostatic action,
such a course of action is bound to bring about an
increase in consumption of the product in question ;
(») OJ No C 288, 11.11 . 1985, p. 158 .                           (3) OJ No L 302, 31 . 12. 1972, p. 28 .
(2) OJ No C 44, 15.2. 1985, p. 14.                                (4) OJ No L 191 , 23 . 7 . 1985, p. 46.
 ---pagebreak--- 31 . 12 . 85                            Official Journal of the European Communities                           No L 382/229
HAS ADOPTED THIS DIRECTIVE :                                             Pending the decisions referred to in the first sub­
                                                                        paragraph, products which have already received
                                                                        authorization to be placed on the market shall
                                                                        continue to be authorized .
                            Article 1
                                                                         Products authorized pursuant to the above provi­
                                                                        sions shall be subject to the rules of Articles 24 to
For the purposes of implementation of this Directive                     50 of Directive 8 1 /851 /EEC, with the exception of
the definitions ot meats and of farm animals given in                   those which relate to national marketing authori­
Article 1 of Directive 81 /602/EEC (*) shall apply .                    zations ;
For the purposes of implementation of this Directive
and of Directive 81 /602/EEC 'therapeutic treatment'               (b) products used for therapeutic treatment may be
shall mean the administering to an individual farm                      administered only by a veterinarian, in the form
animal of any of the substances authorized in                           of an injection — to the exclusion of implantation
Article 3 of this Directive to treat a fertility problem                — to farm animals which have been clearly identi­
diagnosed, on examination, by a veterinarian . Such                     fied .
therapeutic treatment shall be prohibited for animals
intended for fattening.                                                 Treatment of identified animals must be registered
                                                                        by the veterinarian . An animal which has been
                                                                        treated may not be slaughtered before expiry of
                                                                        the period fixed pursuant to the provisions set out
                            Article 2                                   in (a);
                                                                   (c) any decision on the possible inclusion in the
Without prejudice to Article 4 of Directive 81 /602/                    group of substances referred to in Article 2 of any
EEC, Member States may not authorize any deroga­                        new substance having a direct or indirect oestro­
tion from Article 2 of the said Directive. However, the                 genic, androgenic or gestagenic action shall be
administering to farm animals for therapeutic pur­                      taken by the Council acting on a proposal from
poses of oestradiol - 17-P, testosterone and progeste­                  the Commission in accordance with the voting
rone and those derivatives which readily yield the                      procedure laid down in Article 43(2) of the Treaty.
parent compound on hydrolysis after absorption at                       Any new substance must, in order to be able to be
the site of application may be authorized .                             subject to such a decision, satisfy the relevant
                                                                        principles and criteria of Directives 8 1 /851 /EEC
                                                                        and 81 /852/ EEC .
                            Article 3
For the purposes of implementation of this Directive:
                                                                                              Article 4
(a) there shall be established, after the Committee for
     Veterinary Medicinal Products has given its opin­
     ion on the measures provided for in the first two             The Member States shall prescribe that undertakings
     indents, and in accordance with the procedure laid            producing substances having a thyrostatic, ©estro­
     down in Article 8 :                                           genic, androgenic or gestagenic action and those auth­
    — a list of the products containing as active                  orized for whatever purpose to market those substan­
         substances     the    substances   referred  to  in       ces, and undertakings producing pharmaceutical and
         Article 2 and satisfying the relevant principles          veterinary products based on those substances, must
         and criteria of Directive 8 1 /851 /EEC (2) and         _ keep a register detailing, in chronological order, quan­
         81 /852/ EEC (3) that may be authorized by the            tities produced or acquired and those sold or used for
         Member States,                                            the production of pharmaceutical and veterinary pro­
                                                                   ducts .
    — the conditions of use of these products, in
         particular the waiting period necessary and
         detailed provisions concerning the control of
         these conditions of use,
    — the means of identification of animals .                                                Article 5
                                                                   Member States must ensure, that no animals are
(0 OJ No L 222, 7 . 8 . 1981 , p. 32.                              dispatched from their territory to that of another
(2) OJ No L 317, 6. 11 . 1981 , p. 1 .                             Member State which have had administered to them
(3) OJ No L 317, 6. 11 . 1981 , p. 16.                             in any way whatsoever substances with a thyro­
 ---pagebreak---   No L 382 / 230                      Official Journal of the European Communities                               31 . 12 . 85
 static, oestrogenic, androgenic or gestagenic action ,          7.    In accordance with the procedure laid down in
 and that no meat from such animals is dispatched .              Article 8 , a control programme shall be drawn up
 They shall reserve the Community stamp for meat                 regarding imports from third countries, to ensure that
 from untreated animals .                                        imports do not receive more favourable treatment
                                                                 than Community products .
 With effect from the date of notification of this
 Directive and until the measures adopted pursuant to            With regard to routine inspections, this programme:
 Articles 2 and 6 are applicable:                                — will establish the frequency of controls on imports
 — national provisions governing produce intended                    from each third country,
     for Member States ' domestic markets shall not be           — will take account of the guarantees offered by the
     affected,                                                       inspection regulations of third countries .
 — Member States which prohibit the use of the sub­
     stances   referred to    in Article  5   of Directive       In the event of positive results, imports from third
     81 /602/ EEC for fattening may restrict entry into          countries will be subject to systematic inspections until
                                                                 the situation is re-established .
     their territory to untreated fattening animals and
     meat from untreated fattening animals .
                                                                                          Article 7
                         Article 6
                                                                 The Council, acting by a qualified majority on a
 1.    Member States shall prohibit importation from
 third countries of animals and of meat from animals             proposal from the Commission, may adopt deroga­
                                                                 tions from Articles 5 and 6 in respect of trade in
to which have been administered in any way whatsoe­
                                                                 animals intended for reproduction and reproductive
 ver substances with a thyrostatic, oestrogenic, andro­
                                                                 animals at the end of their career which, in the course
 genic or gestagenic action .
                                                                 of their existence, have been treated under the provi­
                                                                 sions of Article 4 of Directive 81 /602/ EEC and in
2.     To this end the decisions to be taken for imple­          respect of meat from these various animals, taking
mentation of Directive 72/462/ EEC, taking account               into account the guarantees given .
of Article 13 of Directive 85 /358/ EEC in the case of
meat, and of the equivalent guarantee in the case of
live animals, must be adopted before 1 January 1988 .
                                                                                          Article 8
3.     Member States shall ensure that imported fresh
meat coming from approved slaughterhouses in third
countries in respect of which a decision within the              1.    Where the procedure laid down in this Article is
meaning of paragraph 2 has been taken is, without               to be used, matters shall without delay be referred by
prejudice to animal health measures, circulated in the          the Chairman, either on his own initiative or at the
Community in accordance with Article 25 of Directive            request of a Member State, to the Standing Veterinary
72/462/ EEC .
                                                                Committee (hereinafter called 'the Commitee') set up
                                                                by the Council Decision of 15 October 1968 .
4.     National rules on substances with a hormonal
action dealing with imports from third countries shall          2.     The representative of the Commission shall sub­
remain applicable, with due regard for the general              mit to the Committee a draft of the measures to be
provisions of the Treaty, until each of the decisions           adopted . The Committee shall deliver its opinion on
referred to in paragraph 2 comes into force.                    the draft within a time limit which the Chairman may
                                                                lay down according to the urgency of the matter. The
                                                                opinion shall be delivered by a majority of 54 votes,
5.     As from 1 January 1988, Member States shall              the votes of the Member States being weighted as
suspend imports coming from third countries in res­             provided for in Article 148(2) of the Treaty . The
pect of which no decision within the meaning of                 Chairman shall not vote .
paragraph 2 has been taken .
                                                                3 . The Commission shall adopt the measures and
6.     For the purposes of application of paragraphs 1          implement them immediately where they are in accor­
to 5 , the Commission shall draw up a list of the               dance with the opinion of the Committee. Where they
products authorized by third countries for the thera­           are not in accordance with the opinion of the Com­
peutic treatments referred to in Article 4 of Directive         mittee or if no opinion is delivered, the Commission
81 /602/ EEC .                                                  shall immediately submit to the Council a
 ---pagebreak--- 31 . 12 . 85                       Official Journal of the European Communities                      No L 382/231
proposal on the measures to be taken . The Council                                   Article 10
shall act by a qualified majority.
                                                              Member States shall bring into force the laws, regula­
If within three months of the date on which a matter          tions and administrative provisions necessary to com­
was referred to it the Council has not adopted any            ply ;
measures, the Commission shall adopt the proposed            — with Directive 85/358/EEC, by 1 January 1987 at
measures and implement them immediately, save                     the latest ;
where the Council has decided against the measures            — with this Directive, by 1 January 1988 at the latest.
by a simple majority.
                                                              They shall immediately inform the Commission the­
                                                              reof.
                                                                                     Article 11
                         Article 9
                                                              This Directive is addressed to the Member States .
The measures necessary to ensure the transition to the        Done at Brussels, 31 December 1985 .
final arrangements extending the ban laid down in                                                    For the Council
Article 2 to domestic production may be adopted in
accordance with the procedure laid down in Article . 8                                                The President
during a maximum period af one year.                                                                  R. STEICHEN