CELEX: 51985PC0832
Language: en
Date: 1985-12-18
Title: AMENDED PROPOSAL FOR A COUNCIL DIRECTIVE PROHIBITING THE USE IN LIVESTOCK FARMING OF CERTAIN SUBSTANCES HAVING A HORMONAL ACTION

31. 12. 85                                Official Journal of the European Communities                              No C 351/13
                       ORIGINAL PROPOSAL                                                   AMENDED PROPOSAL
                           Article 17                                                           Article 17
The laws of the Member State shall determine the                     Unchanged.
procedure for registration and for invalidation of trade-
marks and the effects of invalidation. They may further
provide that a trade-mark to which one of the grounds for
invalidation mentioned in this Directive applies shall not be
capable of defeating the claims of third parties.
                                                                                               Article 17a
                                                                     The symbol composed of a capital letter R contained
                                                                     within a circle, thus ® , may be used to indicate a registered
                                                                     trade-mark.
                          Article 18                                                           Article 18
1.     The Member States shall bring into force the laws,            1.    Unchanged.
regulations and administrative provisions necessary to
comply with this Directive not later than... They shall
immediately inform the Commission thereof.
2.     The Member States shall communicate to the                          Unchanged.
Commission the text of the main provisions of national law
which they adopt in the field governed by this Directive.
                          Article 19                                                           Article 19
This Directive is addressed to the Member States.                    Unchanged.
               Amended proposal for a Council Directive prohibiting the use in livestock farming of certain
                                              substances having a hormonal action (})
                                                        COM(85) 832 final
                     (Submitted by the Commission to the Council pursuant to the second paragraph of
                                      Article 149 of the EEC Treaty on 18 December 1985)
                                                           (85/C 351/06)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                             market organizations and is a serious barrier to intra-
                                                                     Community trade;
Having regard to the Treaty establishing the European
Economic Community, and in particular Article 43 thereof,
                                                                    Whereas this distortion of competition and barrier to trade
                                                                     should be removed by ensuring that all consumers should
Having regard to the proposal from the Commission,                   be able to buy the products in question under identical
                                                                     conditions of supply and these products should, to meet
Having regard to the opinion of the European Parliament,             their anxieties and expectations, be in the best possible
                                                                     state; whereas such a course of action is bound to bring
Having regard to the opinion of the Economic and Social              about an increase in consumption of the product in
Committee,                                                           question;
"Whereas the administration to farm animals of certain
                                                                    Whereas the use of hormonal substances for fattening
substances having a hormonal action is at present regulated
                                                                     purposes should therefore be prohibited; where the use of
in different ways in the Member States; whereas while their
                                                                    certain substances for therapeutic purposes may be
immediate effect on animals from the farmer's point of
                                                                    authorized but must be strictly controlled in order to
view is clear, assessments of their effect on human health
                                                                    prevent any misuse of them;
vary and this is reflected in the regulations governing their
use; whereas this divergence distorts the conditions of
competition in products that are the subject of common              Whereas, since it would be difficult to be certain of correct
                                                                    operation of the scheme as a whole if animals so treated and
(!) OJ No C 313, 4. 12. 1985, p. 4.                                 the meat from such animals were to be traded, this should
 ---pagebreak--- No C 351/14                             Official Journal of the European Communities                                31. 12. 85
as a general rule be prohibited; whereas derogations from              — the means of identification of animals.
this rule may be allowed where satisfactory guarantees can
be provided;                                                           However, any decision on inclusion of products based
                                                                       on trenbolone and zeranol may be taken only on the
Whereas, as part of the adoption of harmonized rules in the            basis of authorization by the Council acting by a
Community, arrangements for importation from third                     qualified majority in response to a proposal from the
countries that offer equivalent guarantees should be                   Commission.
introduced; whereas these guarantees can be required
under Directives 72/462/EEC (*) and 85/358/EEC (2),                    Until each of the decisions provided for above has been
                                                                       applied, pharmaceutical specialities which have al-
Whereas, in order to ensure that the provisions of this                ready received authorization to be placed on the
Directive can be implemented effectively, the latest date for          market will continue to be authorized.
introduction of the provisions of Directive 85/358/EEC
should be made to fall before that for introduction of the             Products on the list mentioned at (b) shall be subject to
provisions of this Directive; whereas Community control                the rules of Articles 24 to 50 of Directive 81/851/EEC,
measures should be involved in order to ensure uniform                 excluding those rules dealing with national author-
application in the Member States of the rules applicable on            izations on marketing.
administration of substances having a hormonal or
thyrostatic action,                                                (b) Products used for therapeutic purposes must be
                                                                       injected by a veterinarian and the animal must be
                                                                       clearly identified. The dose must be recorded and the
HAS ADOPTED THIS DIRECTIVE:
                                                                       animal may not be slaughtered before expiry of the
                                                                       waiting period fixed in implementation of the provi-
                           Article 1                                   sions set out at (a).
For the purposes of implementation of this Directive the
definitions of meats and of farm animals given in Article 1                                   Article 4
of Directive 81/602/EEC shall apply.
For the purposes of implementation of this Directive and of        The Member States will prescribe that undertakings
Directive 81/602/EEC 'therapeutic treatment' shall mean            producing substances having a thyrostatic action, oes-
the administering to an individual farm animal of any of the       trogen, androgen and gestagen and those authorized for
substances referred to in Article 3 to treat a fertility           whatever purpose to market those substances, and
problem diagnosed, on examination, by a veterinarian.              undertakings producing pharmaceutical and veterinary
Such treatment shall remain prohibited for animals                 products based on those substances, must keep a register
intended for fattening.                                            detailing, in chronological order, quantities produced or
                                                                   acquired and those sold or used for the production of
                                                                   pharmaceutical and veterinary products.
                            Article 2
Without prejudice to the provisions of Article 4 of                                           Article 5
Directive 81/602/EEC, Member States may not authorize
any derogation from the provisions of the abovementioned
                                                                   Member States must ensure that no animals are dispatched
Directive.
                                                                   from their territory to that of another Member State that
                                                                   have had administered to them in any way whatsoever
                            Article 3                              substances with a thyrostatic or with an oestrogenic,
                                                                   androgenic or gestagenic action, and that no meat from
For the purposes of implementation of Article 4 of                 such animals is dispatched. They shall reserve the
Directive 81/602/EEC                                               Community stamp for meat from untreated animals.
 (a) there shall be established, after the Committee on            Until 31 December 1987 Member States prohibiting use of
     Veterinary Medicines has given its opinion on the             the substances mentioned in Article 5 of Directive 81/602/
     measures provided for in the first two indents, and in        EEC for fattening may restrict entry into their territory to
     accordance with the procedure laid down in Article 8,         untreated animals and meat from untreated animals.
     — a list of the products satisfying the relevant
          principles and criteria of Directives 81/851/EEC
          and 81/852 EEC that may be authorized by the                                        Article 6
          Member States for the treatments mentioned in
          Article 4 of Directive 81/602/EEC,                        1.   Member States shall prohibit importation from third
                                                                   countries of animals and of meat from animals to which
     — the conditions of use of these products, in                 have been administered in any way whatsoever substances
          particular, the delay period necessary and detailed      with a thyrostatic or with an oestrogenic, androgenic or
          provisions concerning the control of these con-          gestagenic action.
          ditions of use,
                                                                   2.    To this end, the decisions to be taken for implemen-
 (!) OJ No L 302, 31. 12. 1972, p. 28.                             tation of Directive 72/462/EEC, taking account of
 (2) OJ No L 191, 23. 7. 1985, p. 46.                              Article 13 of Directive 85/358/EEC in the case of meat, and
 ---pagebreak--- 31. 12. 85                              Official Journal of the European Communities                             No C 351/15
of the equivalent guarantee in the case of live animals, must      Committee shall deliver its opinion on the draft within a
be adopted before 1 January 1988.                                  time limit which the Chairman may lay down according to
                                                                   the urgency of the matter. The opinion shall be delivered by
3.    Member States shall ensure that imported fresh meat          a majority of 45 votes, the votes of the Member States being
coming from approved slaughterhouses in third countries            weighted as provided for in Article 148 (2) of the Treaty.
in respect of which a decision within the meaning of               The Chairman shall not vote.
paragraph 2 has been taken is, without prejudice to animal
health measures, circulated in the Community in accord-            3.     The Commission shall adopt the measures and
ance with Article 25 of Directive 72/462/EEC.                      implement them immediately where they are in accordance
                                                                   with the opinion of the Committee. Where they are not in
4.    National rules on substances with a hormonal action          accordance with the opinion of the Committee or if no
dealing with imports from third countries shall remain             opinion is delivered, the Commission shall immediately
applicable, subject to respect for the general provisions of       submit to the Council a proposal on the measures to be
the Treaty, until each of these decisions comes into               taken. The Council shall act by a qualified majority.
application.
                                                                   If within three months of the date on which a matter was
5.    As from 1 January 1988, Member States will suspend
                                                                   referred to it the Council has not adopted any measures, the
imports coming from third countries in respect of which no
                                                                   Commission shall adopt the proposed measures and
decision within the meaning of paragraph 2 has been taken.
                                                                   implement them immediately, save where the Council has
6.    For the purposes of application of the above                 decided against the measures by a simple majority.
provisions, the Commission shall draw up a list of the
products authorized by third countries for the treatments
mentioned in Article 4 of Decision 81/602/EEC.                                                Article 9
                                                                   Measures necessary to ensure a smooth transition to the
                          Article 7                                arrangements laid down in this Directive may be adopted in
                                                                   accordance with the procedure laid down in Article 8.
The Council, acting by a qualified majority in response to a       Their maximum duration shall be one year.
proposal from the Commission, may adopt derogations
from Articles 5 and 6 in respect of trade in treated animals
and meat of such animals in the framework of the                                              Article 10
provisions of Article 4 of Directive 81/602/EEC, where
satisfactory guarantees are given.                                 Member States shall bring into force the laws, regulations
                                                                   and administrative provisions necessary to comply:
                          Article 8                                — with Directive 85/358/EEC, by 1 January 1987 at the
                                                                        latest,
1.    Where the procedure laid down in this Article is to be
used, matters shall without delay be referred by the               — with this Directive, by 1 January 1988 at the latest.
chairman, either on his own initiative or at the request of a
                                                                   They shall immediately inform the Commission thereof.
Member State, to the Standing Veterinary Committee
(hereinafter called 'the Committee') set up by the Council
Decision of 15 October 1968.
                                                                                              Article 11
2.    The representative of the Commission shall submit to
the Committee a draft of the measures to be adopted. The           This Directive is addressed to the Member States.