CELEX: 51992PC0207
Language: en
Date: 1992-05-20
Title: Amendment to the proposal for a COUNCIL DIRECTIVE amending Directive 81/602/EEC and 88/146/EEC as regards the prohibition of certain substances having a hormonal action and of any substances having a thyrostatic action

COMMISSION OF THE EUROPEAN COMMUNITIES
                                                C0M(92) 207 final
                                                Brussels, 20 May 1992
                      Amendment to the proposal for a
                              COUNCIL DIRECTIVE
               amending Directive 81/602/EEC and 88/146/EEC
         as regards the prohibition of certain substances having
                  a hormonal action and of any substances
                     having a thyrostatic action
         (presented by the Commission pursuant to Article 149(3)
                             of the EEC-Treaty)
I-
 ---pagebreak---                             EXPLANATORY MEMORANDUM
                                                                       -   y\ -
On 14th September  1990 the Commission submitted a modified proposal      to the
Council  for  a Directive  amending   Directives 81/602/EEC  and  88/146/EEC as
regards the prohibition of certain substances having a hormonal action and of
any substance having a thyrostatic act ion* 1 ).
Following the opinion given by the European Parliament at its session of 9th -
13th December 1991, the Commission agreed to modify its proposal.
The  modification  establishes   more   precise  details  in  relation   to  the
authorization  for use of testosterone    for the prevention and   treatment of
ovine balonoposthitis and in relation to the controls to be carried out.
(1)   O.J. C 245, 29.09.1990
 ---pagebreak---                  AMENDMENT TO THE PROPOSAL FOR A COUNCIL DIRECTIVE
                    amending Directive 81/602/EEC and 88/146/EEC
             as regards the prohibition of certain substances having
                       a hormonal action and of any substances
                            having a thyrostatic action * 1 ) .
The Commission presented the above mentioned Proposal to the Council on 14th
September 1990.      As a result of the opinion given by the European Parliament
during   its session     of   9th -    13th December      1991    the   initial   Proposal   is
amended as follows :
1. The following recitals are added :
       'whereas, in certain regions of the Community and under certain climatic
       conditions,    sheep,     in  particular     extensively     reared    castrated    male
       sheep, are susceptible to the disease known as 'ovine balanoposthitis',
       which   causes   the animals considerable         stress, suffering       and   loss of
       condition;    whereas     the   least   painful    and   most   effective    method   of
       prevention    and    control    of    this   disease    known    at   present    is  the
       administration of       testosterone; whereas        it  is therefore desirable to
       authorize    the   administration      of   this  substance     for   therapeutic    and
       preventive purposes to animals affected by the disease; whereas such
       authorization must, however, be subject              to strict    controls to ensure
       that   this   substance      is   not   used   for    fattening     purposes;    whereas
       Directives 81/602/EEC and 88/146/EEC must be amended accordingly;'
       'whereas    the   very     existence,     let   alone    the   treatment,     of   ovine
       balanoposthi t is on a farm may result          in heavy losses for the producer;
       whereas this factor must always be taken into account;'
(1)    O.J. C 245, 29.09.1990
 ---pagebreak---                                          - 2 -
2. In Article 1, paragraph 4a is replaced by the following :
      'the veterinary medicinal       products used     for  treatment    and  prevention
      must   be administered    only by a veterinarian        to castrated male      sheep
      which are clearly identified;'
3. In Article 1, paragraph 4b is replaced by the following :
      'the disease must have been diagnosed on the basis of examination of the
      animal by a veterinarian; preventive treatment must be authorized by the
      competent    authorities.    In the   latter   case,   the competent      veterinary
      authorities must establish the meteorological and environmental              factors
      necessitate      preventive    treatment     against     ovine    balanoposthitis,
      providing that some proved cases have occurred previous to the decision
      to   authorize    preventive   treatment.     The   competent    authorities    must
      specify    the   particular   characteristics      and   location   of   the   farms
      concerned, and the period and frequency of treatment;'
4. In Article 1, paragraph 4c is replaced by the following :
      'both   in the case of therapeutic treatment and preventive action, the
      veterinarian must keep a record of the following :
         -  the nature of the treatment
            the nature of the medicinal product authorized
            the date of treatment
            the identity of the animals treated
            the date when slaughter is authorized
      This information must be made available at the request of the competent
      authorities who must ensure that the information accompanies the animals
      until    the   time  of  slaughter   and   in    particular    that   the   official
      veterinarian responsible for ante and post mortem inspection is informed
      prior   to making a decision concerning the fitness of the carcass for
      consumpt ion;'
 ---pagebreak---                                         - 3 -
5. Article 2 is replaced by the following :
      'The Council, acting by a qualified majority on a proposal                 from   the
      Commission, may adopt derogations from Articles 5 and 6 in respect of
      trade  in animals intended for reproduction and reproductive animals at
      the end of their career, and sheep which have been treated for ovine
      balanoposthitis, which,     in the course of      their   existence,     have    been
      treated  under   the  provisions    of  Article   4  (1)   (2)   (3) and     (4) of
      Directive 81/602/EEC and in respect of meat from these various animals,
      taking into account the guarantees given and provided that the waiting
      period has expired.'
      'Notwithstanding    Article   6(1)   for   the  purpose   of    Article     7(2)   of
      Directive 86/469/EEC, guarantees at       least equivalent     to those required
      under paragraph 1 shall be established in accordance with the procedure
      laid down in Article 8, and must be provided in respect of imports from
      third countries of sheep as referred to         in Article 4(3) of Directive
      81/602/EEC   and  meat   derived   therefrom.   Guarantees     that    the   waiting
      period has expired must also be given.'
6. Article 3 is replaced by the following :
      'Before   1 January   1993   the Commission    will   submit    a   report    to  the
      Council and the European Parliament on the experience gained, together
      with proposals for possible amendments to the provisions in force.'
7. Article 4 is replaced by
      'Member   States   shall   bring   into   force   the   laws,     regulations     and
      administrative provisions necessary to comply with this Directive before
      'When Member   States adopt    these measures, the      latter shall      contain a
      reference to this Directive or shall be accompanied by such reference on
      the occasion of their official publication.         The methods of making such
      a reference shall be laid down by the Member States.'
      'Member  States shall    communicate   to the Commission       the provisions of
      national law which they adopt in the field governed by this Directive.'
 ---pagebreak---  ---pagebreak---                                             U                        ISSN 0254-1475
                                                              COM (92) 207 final
                                                      DOCUMENTS
EN                                                                              03
                                Catalogue number: CB-CO-92-220-EN-C
                                                             ISBN 92-77-44285-9
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