CELEX: 51984PC0295
Language: en
Date: 1984-06-12
Title: PROPOSAL FOR A COUNCIL DIRECTIVE AMENDING DIRECTIVE 81/602/EEC CONCERNING THE PROHIBITION OF CERTAIN SUBSTANCES HAVING A HORMONAL ACTION AND OF ANY SUBSTANCES HAVING A THYROSTATIC ACTION

N o C 170/4                            Official Journal of the European Communities                               29.6. 84
              Proposal for a Council Directive amending Directive 81/602/EEC concerning the
             prohibition of certain substances having a hormonal action and of any substances having a
                                                       thyrostatic action
                                                      COM(84) 295 final
                               (Submitted by the Commission to the Council on 13 June 1984)
                                                        (84/C 170/03)
THE COUNCIL OF THE EUROPEAN                                        soon as possible on the administering to farm animals
COMMUNITIES,                                                       of Oestradiol 176, Progesterone, Testosterone,
                                                                   Trenbolone and Zeranol for fattening purposes;
Having regard to the Treaty establishing the
European Economic Community, and in particular
                                                                   Whereas it is important to authorize only substances
Article 43 thereof,
                                                                   which have a favourable effect on farm animal
                                                                   production and whose administration will neither
Having regard to Council Directive 81/602/EEC of
                                                                   present harmful effects on human health nor harm the
31 July 1981 concerning the prohibition of certain
                                                                   consumer by altering the characteristics of meat;
substances having a hormonal action and of any
substances having a thyrostatic action ('), and in
particular Articles 5 and 7 thereof,                               Whereas the Scientific Veterinary Committee, the
                                                                   Scientific Committee for Animal Nutrition and the
Having regard to Council Directive 64/433/EEC of                   Scientific Committee for Food have studied this
26 June 1964 on health problems affecting intra -                  problem on the basis of a report of a Commission
Community trade in fresh meat (2), as last amended                 scientific group on anabolic agents in animal
by Directive 83/90/EEC (3), and in particular Article              production; whereas the Commission has declared its
4 (2) thereof,                                                     intention to continue to consult these Committees
                                                                   and the numerous interested parties, in particular the
Having regard to the proposal from the Commission,                 consumers, on these questions;
Having regard to the opinion of the European                       Whereas it appears that some data necessary on the
Parliament,                                                        toxicology of Trenbolone and Zeranol and their
                                                                   metabolites are still lacking; whereas, in consequence,
Having regard to the opinion of the Economic and                   their use for fattening purposes must in the present
Social Committee,                                                  circumstances be prohibited;
Whereas the adoption of Community provisions                       Whereas, on scientific grounds, it appears that the use
concerning the absorption by farm animals of sub-                  of Oestradiol 176, Testosterone and Progesterone,
stances having a hormonal action or thyrostatic action             and those derivatives which readily yield the parent
have the object, in the interest of consumers, of                  compound on hydrolysis after absorption from the
protecting human health and of removing barriers to                site of application, would not present any harmful
intra-Community trade of animals, meat and meat                    effects to the health of the consumer nor harm the
products resulting from differences between the                    consumer by altering the characteristics of meat when
health requirements of Member States;                              used under the appropriate conditions as growth
                                                                   promoters in farm animals; whereas, in consequence,
Whereas it is therefore necessary to supplement the                Member States may authorize their use for fattening
provisions already laid down on the matter by the                  purposes;
aforementioned Directive 64/433/EEC and Council
Directive 71/118/EEC of 15 February 1971
concerning health problems of trade in fresh poul-                 Whereas approval of products containing authorized
trymeat (4), as last amended by Directive . . . , and by           substances must comply with the relevant principles
the aforementioned Directive 81/602/EEC;                           and criteria set out in Council Directive 81/851/EEC
                                                                   of 28 September 1981 on the approximation of the
Whereas, in accordance with Article 5 of Directive                 laws of the Member States relating to veterinary
81/602/EEC, it is necessary to take a decision as                  medicinal products ( s ), and Council Directive
                                                                   81/852/EEC of 28 September 1981 on the approxi-
                                                                   mation of the laws of Member States relating to
(') OJ No L 222, 7. 8. 1981, p. 32.                                analytical,   pharmaco-toxicological      and    clinical
(2) OJ No 121, 29. 7. 1964, p. 2012/64.
(») OJ No L 59, 5. 3. 1983, p. 10.
(4) OJ No L 55, 8. 3. 1971, p. 23.                                 (s) OJ No L 317, 6. 11. 1981, p. 1.
 ---pagebreak--- 29.6. 84                                 Official Journal of European Communities                             No C 170/5
standards and protocols in respect of the testing of               2.     Member States shall ensure            that   the
veterinary medicinal products (*); whereas additional              aforementioned substances are:
requirements as regards carrier substances, conditions
of use and withdrawal periods must also be complied                — only administered to farm animals by implan-
with; whereas a Community procedure within the                         tation which is located in a part of the animal
Standing Veterinary Committee, set up by Council                       which must be discarded at slaughter,
Decision 68/361/EEC of 15 October 1968 (2)> should
be used to establish a list of products which may be               — only administered to animals which are
approved and the conditions of their use, as well as to                identified at the time of implantation and that
modify the list of authorized substances in the light of               these animals are not slaughtered before the
progress in scientific and technical knowledge;                        expiry of the delay period laid down in
                                                                       application of subparagraph (3a),
Whereas Member States may choose not to allow in                   — administered by a veterinarian.
their territory the marketing and administration to
farm animals, for fattening purposes, of substances
and products which may be authorized under the                     3. (a) Before 1 April 1986, in accordance with the
present Community rules, but must not raise any                             procedure laid down in Article 16 and
obstacle for human health reasons to the importation                        following the relevant principles and criteria
of animals, meat and meat products from other                               of Directives 81/851/EEC and 81/852/
Member States where such substances and products                            EEC, there shall be established:
have been authorized in accordance with Community
rules;                                                                      — a list of products containing as active
                                                                                substances the substances referred to in
                                                                                paragraph 1 which may be approved for
Whereas it is suitable to prescribe, in accordance with                         marketing and use in the Community,
Article 7 of Directive 81/602/EEC and Article 4 (2)
of Directive 64/433/EEC, the measures necessary for                         — the conditions of use of products
the control of farm animals, of meat and meat                                   contained in the abovementioned list in
products in relation to the use of substances having a                          application of paragraph 2, in particular
hormonal action or thyrostatic action, as well as                               the delay period necessary and detailed
tolerances for these substances and the frequency of                            provisions concerning the control of
sampling; and that these measures must also facilitate                          these conditions of use,
the cooperation between Member States in the
application of these controls and, where necessary,                         -r- the means of identification of animals.
provide for the adoption, in accordance with the
procedure of the Standing Veterinary Committee, of                    (b) Member States shall ensure that the
measures necessary to ensure the coordination and                           products mentioned under subparagraph (a)
uniform application of these controls,                                      are subject to the rules of Articles 24 to 50
                                                                            of Directive 81/851/EEC except for those
                                                                            rules which relate to the national author-
HAS ADOPTED THIS DIRECTIVE:                                                 ization for marketing.
                             Article 1                             4.     In order to take account of scientific and
Directive 81/602/EEC is hereby amended as follows:                 technical progress, the list of substances referred to
                                                                   in paragraph 1 which may be administered to
                                                                   animals for fattening purposes may be completed
 1. Article 5 is replaced by the following:                        or amended in accordance with the procedure laid
                                                                   down in Article 16.
     'Article 5
                                                                   Any substance which may be authorized:
     1.    By way of derogation from Article 2,
     Member States may authorize the administering to              — must have a favourable effect on farm animal
     farm animals, for fattening purposes, of Oestradiol               production,
     176 Testosterone and Progesterone and those deri-
     vatives which readily yield the parent compound               — must not endanger human or animal health nor
     on hydrolysis after absorption from the site of                    harm the consumer by altering the charac-
     application.                                                       teristics of farm animal products,
                                                                   — must comply with the relevant principles and
 O O J N o L 3 1 7 , 6. 11. 1981, p. 16.                                criteria of Directives 81/851/EEC             and
 (2) OJ No L 255, 18. 10. 1968, p. 23.                                  81/852/EEC.
 ---pagebreak--- No C 170/6                           Official Journal of the European Communities                               29. 6. 84
   5.     However, any decision concerning the                     Article 11
   possible inclusion of Trenbolone or Zeranol on the
   list shall be made by the Council, acting by a                  1.    The samples referred to in Article 9 (2) and
   qualified majority on a proposal from the                       Article 10 shall be taken officially and examined
   Commission, and in conformity with the other                    by an authorized laboratory for the presence of
                                                                   residues.
   conditions laid down in paragraph 4.'
                                                                   2.    The examination for residues referred to in
2. Article 7 is replaced by the following Articles:                paragraph 1 must be carried out in accordance
                                                                  with proven methods which are scientifically
                                                                   recognized, in particular those laid down by
    'Article 7                                                     Community provisions.
   Without prejudice to the provisions of Directive
   64/433/EEC, Member States shall ensure that                     It must be possible to assess the examination for
   checks on compliance with the prohibitions as laid             residues using the reference methods established in
   down in Articles 2 and 3, checks on farm animals,               accordance with Article 4 (1) (b) of Directive
   the meat of such animals, the meat products                    64/433/EEC.
   obtained therefrom for the presence of residues of
   hormonal substances referred to in Article 2 (a)                3.    All positive findings shall be confirmed by an
   and checks on compliance with the conditions of                official laboratory using the reference method
   use of products provided for in Article 5 are                  referred to above in paragraph 2.
   carried out in their territory in accordance with
   the provisions of this Directive.
                                                                  Article 12
                                                                   1.    Where examination as referred to in Article
   Article 8                                                       11 (3) has confirmed the presence of prohibited
                                                                  substances or of residues exceeding the maximum
   Member States shall ensure that on-the-spot                    natural physiological levels of authorized sub-
   random checks for the presence of prohibited sub-              stances, the competent authorities shall be
   stances as referred to in Articles 2 and 3 are made            informed without delay of:
   officially at the levels of manufacturing, handling,
   storage, transport, distribution and sale.                     (a) all information needed to identify the origin of
                                                                       the animals;
                                                                  (b) the result of the examination.
   Article 9
                                                                  2.     The competent authorities shall thereupon
   1.     Member States shall ensure that on-the-spot
                                                                  ensure that:
   random checks are made officially for the presence
   of prohibited substances as referred to in Articles 2          (a) an investigation is made at the farm of origin
   and 3 at agricultural holdings where animals are                    to determine the reason for the presence of
   reared, held or fattened for slaughter.                             residues;
                                                                  (b) an investigation of the source or sources of the
                                                                       substance concerned is made as necessary at
   2.     The checks shall include taking random                       the levels of distribution, sale, transport,
   samples from animals for examination for the                        handling, storage and manufacture.
   presence of residues.
                                                                   3.    The competent authorities shall also ensure
                                                                  that:
   Article 10
                                                                   (a) the herd or animals at the farm of origin and
   1.     Member States shall ensure that random                       herds which, as a result of the investigations
   checks are taken officially from animals and meat,                  referred to in paragraph 2 may be assumed to
   including meat destined for the production of meat                  contain the residue in question, are provided
   products, at the slaughterhouse of production for                   with official marking and subject to appro-
   examination for the presence of residues of sub-                    priate examinations;
   stances mentioned in Article 2 (a).                             (b) if the examination reveals the presence of
                                                                       prohibited substances, the animals shall be
   2.     In particular, random samples shall be taken                 confiscated or destroyed;
   of animals and meat from holdings submitting                    (c) if the examination reveals the presence of
   regularly calves and fattened bovine animals for                    residues of authorized substances above the
   slaughter.                                                          limits mentioned in paragraph 1, the slaughter
 ---pagebreak--- 29.6.84                            Official Journal of the European Communities                           N o C 170/7
       of the animals concerned for              human           2.     On the basis of this information, the
       consumption shall be prohibited until it can be           Commission shall report to the Member States
       ensured that the amount of residue no longer              meeting in the Standing Veterinary Committee set
       exceeds the permitted levels. This period may             up by the Council Decision of 15 October 1968
       in no case be shorter than the delay period               (hereinafter called 'the Committee'); if necessary,
       fixed for the substance in application of Article         in accordance with the procedure laid down in
       5 (3) (a). However, where it is ascertained that          Article 16, measures may be taken to ensure the
       the conditions of use laid down have not been             uniform application of the controls laid down by
       complied with, the animals concerned shall be             this Directive.
       confiscated or destroyed;
   (d) during the period of examination, the animals             Article 16
       must not be disposed of to other parties:
                                                                 1.    Where the procedure laid down in this
                                                                 Article is to be used, matters shall, without delay,
  4.     By way of derogation from paragraph 3 (c),              be referred by the chairman, either on his initiative
  animals whose slaughter is prohibited may be                   or at the request of a Member State, to the
  slaughtered before the end of the prohibition                  Committee.
  period if the competent authority is informed at
  least one week before the proposed slaughter date,             2.    Within the Committee, the votes of Member
  stating the place of slaughter. The officially                 States shall be weighted as provided in Article 148
  marked animals must be accompanied to the place                of the Treaty. The chairman shall not vote.
  of slaughter by an official veterinary certificate
  containing the information          required     under         3.    The representative of the Commission shall
  paragraph 1 (a).                                               submit a draft of the measures to be adopted. The
                                                                 Committee shall deliver its opinion on such
  The carcase of each animal whose slaughter is
                                                                 measures within a period to be determined by the
  notified pursuant to the above subparagraph shall
                                                                 chairman in keeping with the urgency of the
  be officially examined for the residue concerned
                                                                 question submitted for examination. Opinions shall
  and shall be detained until the result of the exami-
                                                                 be delivered by a majority of 45 votes.
  nation is known.
                                                                 4.    The Commission shall adopt the measures
                                                                 and implement them immediately where they are
  Article 13                                                     in accordance with the opinion of the Committee.
  Where the checks and investigations referred to in            Where they are not in accordance with the opinion
  Articles 8 to 12 disclose the presence of prohibited           of the Committee or if no opinion is delivered, the
  substances referred to in Articles 2 and 3, Member             Commission shall, without delay, propose to the
  States shall ensure that the substances concerned              Council the measures to be adopted. The Council
  are placed under official control until the                    shall adopt the measures by a qualified majority.
  necessary sanctions are taken.                                 If, within three months from the date on which a
                                                                 matter was referred to it the Council has not
                                                                 adopted any measures, the Commission shall adopt
  Article 14                                                     the proposed measures and implement them
                                                                 immediately, save where the Council has decided
   1.    Where the findings in one       Member State
                                                                 against these measures by a simple majority.
  indicate the need for investigation   in one or more
  other Member States, the Member      State concerned
  shall inform the other Member         States and the           Article 17
   Commission thereof.                                            1.    Where the procedure laid down in this
                                                                 Article is to be followed, the chairman shall,
   2.    In accordance with the procedure of Article             without delay, refer the matter, either on his own
   17, measures may be taken to ensure the coordi-               initiative or at the request of a Member State, to
   nation of the investigations necessary in relation to         the Committee.
   the presence of prohibited substances.
                                                                 2.     Within the Committee, the votes of Member
                                                                 States shall be weighted as provided in Article 148
                                                                 of the Treaty. The chairman shall not vote.
  Article 15
   1.    Member States shall inform the Commission               3.     The Commission representative shall submit a
   annually of the details of the result of sampling,            draft of the measures to be adopted. The
   examinations and investigations made for the                  Committee shall deliver its opinion on such
   presence of residues of substances referred to in             measures within a period of two days. Opinions
  Article 2 (a).                                                 shall be delivered by a majority of 45 votes.
 ---pagebreak--- No C 170/8                        Official Journal of the European Communities                            29.6. 84
   4. The Commission shall adopt the measures                                         Article 2
   and shall apply them immediately where they are
   in accordance with the opinion of the Committee.          Member States shall bring into force the laws, regu-
   Where they are not in accordance with the opinion         lations and administrative provisions necessary to
   of the Committee or if no opinion is delivered, the       comply with this Directive:
   Commission shall, without delay, propose to the           — not later than 1 July 1985 as regards the
   Council the measures to be adopted. The Council               prohibition of the administration of Trenbolone
   shall adopt the measures by a qualified majority.             and Zeranol to farm animals for fattening
                                                                 purposes, in application of Articles 2 and 5 of
   If, within 15 working days from the date on which             Directive 81/602/EEC, as amended by Article 1
   the proposal was submitted to it, the Council has             (1) of this Directive,
   not adopted any measures, the Commission shall
   adopt the proposed measures and apply them                — not later than 1 July 1986 for the remaining
   immediately, save where the Council has decided               provisions. They shall forthwith inform the
   against these measures by a simple majority.'                 Commission thereof.
                                                                                        Article 3
3. Articles 8, 9 and 10 shall become Articles 18, 19
   and 20.                                                       This Directive is addressed to the Member States.