CELEX: 51980PC0614
Language: en
Date: 1980-10-31
Title: PROPOSAL FOR A COUNCIL REGULATION (EEC) CONCERNING THE USE OF SUBSTANCES WITH A HORMONAL ACTION AND THOSE HAVING A THYROSTATIC ACTION IN DOMESTIC ANIMALS (presented by the Commission to the Council)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (80) 614
Vol. 1980/0193
 ---pagebreak--- Disclaimer
Conformément au règlement (CEE, Euratom) n° 354/83 du Conseil du 1er février 1983
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p. 1), tel que modifié par le règlement (CE, Euratom) n° 1700/2003 du 22 septembre 2003
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In accordance with Council Regulation (EEC, Euratom) No 354/83 of 1 February 1983
concerning the opening to the public of the historical archives of the European Economic
Community and the European Atomic Energy Community (OJ L 43, 15.2.1983, p. 1), as
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In Übereinstimmung mit der Verordnung (EWG, Euratom) Nr. 354/83 des Rates vom 1.
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Wirtschaftsgemeinschaft und der Europäischen Atomgemeinschaft (ABI. L 43 vom 15.2.1983,
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                                COM(80)614 final
                                                Brussels , 31st October 1980
                 PROPOSAL FOR A COUNCIL REGULATION ( EEC )
     CONCERNING THE USE OF SUBSTANCES WITH A HORMONAL ACTION AND
        THOSE HAVING A THYROSTATIC ACTION IN DOMESTIC ANIMALS
                                          K'. .
                                      i v
             ( presented by the Commission to the Council )
                                                           /
C0M(80 ) 614 final
 ---pagebreak---                                     EXPLANATORY NOTE
  At its meeting of 30th September
                                       !
  the Council invited the Commission to submit urgent proposals concerning substances
  with hormonal effect in animal production following its recent favourable
  orientation :
  - envisaging the prohibition of the use of all hormonal substances for rearing
      animals and in consequence their presence in meat produced or imported into the
      Community ,                                                                     .
  - recognising the necessity to accelerate the work of harmoni sation in this
    . field , in order to provide uniform and reinforced controls not only at the
      level of the final product ( by fixing levels for residues and methods of
      analysis ) but also upstream at the level of production and distribution of
      hormones ( rules concerning distribution of veterinary medicines ) and at
      the place of livestock rearing and at the abattoirs .
  The Commission has examined the subject of the use of hormones in animal
  production , the presence of these substances in meat and meat products , their ,
  possible effects on human health and the quality of the products 0     This
                                                     '     • J
  examination has included both natural and artificial hormones­
       *
  The Commission considers that rapid action must be taken to prohibit the use of
  these substances for rearing animals „     This is necessary in particular in
  respect of the artificial substances in view of the effects of these substances
  in relation to carcinogenicity , physiological effects and meat quality ,.    The
   latter aspect is also important as regards use of natural substances" since
  physiological effects may also occur when exposure to exceptional levels
accidentally takes place .    The need for control i s . obvious *
 ---pagebreak---                                            - 2 -
   ■Although Member States already have national measures in force , .it is clear that
    no centre. I system wUl b<s fully effssetiv * unUis it 1s ei#v<elep8ri s r4              an
    a Community basis',," These rules are needed so that trade of animals and fresh
   meat can flow unimpeded within the Community ,,                                         r      . ,
    These controls need to be,' applied at the level , of distribution of the products ,,
    at the level of the place of production in respect of livestock,' and at the •
    abbatoirs producing fresh meat w - As regards the production and distribution of                    ^
    hormones existing initiatives at Community level must be completed and where
    necessary extended ,. The Commission recalls that it made" a proposal in respect of
- veterinary medicines in 1976 . As a_ result of discussion of this proposal , the Commis­
   sion considers that it should als'o include a N provision that • hormonal - 'substances
    which can be used in the preparation of " veterinary medi does' should be supplied
             \                                                                                          ,
■ only to authorised persons ;- . The Commission urges the Council to resolve this question
    and| take an early decision *
   -A related initiative which the Commission is - urgently considering" concerns a             "
    draft, proposal - on medicated . feedingstuffs B It -is already necessary ^ however r
 ' to provide for controls on the distribution and use of hormones for veterinary
    therapeutic purposes *         /                                       ,
  • To * suppoft this primary control ,, - measures must be adopted to fflon'itor live , animals ^
    on' the farm for illicit use of these substances „.- This action -wi 1 1 need
     approori ate sampling procedures . 'adopted - to . the different animal categories ,- and .
     suitable sanctions in case of infringements *          ,                                       • ,
     A further strategic point where control must be considered is at the slaughterhouse
     in the form of' screening fresh meat for residues as part of the post-mortem
   'examination *                    • The extension of this examination- to - ante-mortem
     inspection of the live animal either at the slaughterhouse or farm of origin wilt,
     probably . provide' a more-effective 'control * In ail cases it is essential to
 • provide a; common regulation for laboratory methods which must be used for these
     examinations ,,      In addition ,, to enable tracing of the origin of animals when
     positive results are found , the establishment of a system to permit the                       ..
     i dent i f i cat ion of animals irv the Community is important *.
                             t
 ---pagebreak---                                   - 3 -
The work already dene lay the Commission in respect of the preBlfms of eontrol
has concentrated particularly on methods of analysis . Good methods which are
suitable both qualitatively and quantitatively are not easi ly ^developed but
recent progress should enable the Commission to take appropriate action shortly
                                                                  \
in this respect particularly as regards artificial substances which are of
special , concern . This question is more difficult in respect of nature 1 hormones
as there is always a certain level of these hormones naturally present in meat
animals .   In consequence the development of checks on the use of these substances
is more difficult .
In order to avoid distortion of competition it is necessary to provide for
the harmonisation of the means of financing these controls .   To this effec "
provision is included so that these costs must be borne    by the product its ; Lf .
                                                                χ
The proposal of the Commission lays doNn the basis for these controls .
The introduction of a ban at the Community level , and of the necessary control
measures , will involve additional costs cf production whi ch m~.y eventually be
reflected in the long term on the price of meat .   But at the ^     time consumers
will be assured of better protection and a 'better quality prod .,
 ---pagebreak---                                        PROPOSAL
                                 for a
                              COUNCIL REGULATION
                concerning the use of substances with a hormonal
                action and those having a thyrostatic action in
                                 domestic animals
. THE COUNCIL OF THE EUROPEAN COMMUNITIES :                                .
  Having regard to the Treaty establishing the European Economi ^ Community and in
  particular Article 43 thereof ;                 ' '-.
  Having regard to the proposal from the Commission/             5      '
  Having regard to the Opinion of the European Parliament /
  Having regard to the Opinion of the Economic and Social Committee /
  Whereas due to the residues that they leave in meat , substances with a    hormonal
  action or thyrostatic action may be dangerous to human health ; whereas these
  substances may also affect the quality of the meat ;
  Whereas for these reasons, their use for fattening purposes must be banned , in the '
  interest of the consumer ;
  Whereas , moreover , if the use of natural substances may be authorised for therapeutic
  purposes , this must be at the same time strictly controlled , both by the
  establishment of a list of authorised products and by the establishment of the
  conditions under which they may be used ; whereas the particular danger of artificial
  substances does not permit their inclusion under this autorisation ;
  Whereas the present Regulation calls for means of application in particular
  concerning the fixing of tolerances , frequency of sampling and methods used to
  detect the presence of residues ;
 ---pagebreak--- Whereas means permitting the assurance of an effective control of Community
provisions and of the application of the necessary sanctions must be established ;
Whereas it is suitable , in order to avoid distortion of competition , to provide
that the costs resulting from this control must be borne     by the product itself      V
in conformity with the current practi.ee generally followed in the Community ,
HAS ADOPTED THIS REGULATION :
                                   Arti cle 1
This Regulation shall apply to the use of substances with a hormonal action and
those having a thyrostatic action in domestic animals' and to the presence of
residues of these substances in domestic animals , fresh meat and fresh poultry
meat -                                         -
                                   Article 2
For the purposes of this Regulation the following definitions shall apply :
( a ) Domestic animals : animals of the following species : bovine , swine , sheep ,
       goats , domestic solipeds and poultry *
(b )   Fresh meat : fresh meat as defined in Article 1 of Directive 64 / 433 / EEC and in
       Article 2 of Directive 72 / 462 / EEC ,
( c ) Fresh poultrymeat : fresh poultrymeat as defined in Article 1 of Directive
       71 / 118 / EEC *  ,                       - ' " ■              ...
( d ) Resi due : detectable quantities of a substance with a hormonal or thyrostatic
       action and their metabolites *                                                   ,
( e ) Examination for residues : the examination for detection of residues *
( f ) Tolerance : the maximum permitted quantity of residue in domestic animals or
       in fresh meat *
 ( g ) Holding : an officially supervised agricultural , industrial or commercial
       undertaking in which domestic animals are regularly kept*'
 ---pagebreak---                                     - 3 -
                                Article 3
Notwithstanding Article 4 ,
( a ) The use on domestic animals of substances with oestrogenic ,
       androgenic and gestagenic effect and of substances having a thyrostatic
       effect is prohibited ,               <
( b ) The putting into trade in the territory of the Community of domestic animals
       and of fresh meat containing residues in excess of the tolerance is prohibited .
                                 Article 4
1 , The use of natural hormonal substances with actions or effects referred to •
     in Article 3(a ) is authorised to treat domestic animals therapeutically
     including synchronisation of oestrus provided that ;
     - the competent authority has approved the product for therapeutic use and its
        conditions of manufacture in accordance with Council Directive             on
        the approximation of the laws of Member States on medicinal veterinary
      . products , and has specified the conditions of use including a withdrawal period
        during which the domestic animal cannot be delivered for slaughter .
     - the product is administered by a veterinarian , who shall keep a record of the
        use of the product , including quantity date and identifi cation of the treated
        domestic animal ,        ,
     - manufacturers and all handlers of these substances shall keep a record of
        production and sales .
                                                                         /
2 , Additional provisions concerning the application of paragraph . 1 , in particular -
     the establishment of a Community list of natural hormonal substances , shall be
     adopted by the Council acting by a qualified majority on a Proposa I f rom the
      Commission ,  This list may be amended in accordance with the procedure of
     Article 9 ,
 ---pagebreak---                                         -4-                                   ¥
                                     Article 5
1 .. Fresh meat put into trade, in the Community must be subject to examination
      for residues of the substances referred to in Article 3 .
2 . However , the examination of the fresh meat may
      be replaced or supplemented by an examination of the domestic animal either
      at the place of slaughter or at the holding of origin or transit .
3 , The Council , acting by a qualified majority on Proposal from the Commission ,
                                                                      \
      shall decide the general rules for the application of paragraphs 1 and 2 in
     parti cular :
     •- the frequency of sampling .
      - the tolerances for residues .
4 „ The methods and procedures required for detecting the presence of residues
     of the substances shall be decided in accordance with the procedure laid down
      in Article 9 .                 -
                                     Article 6
Domestic animals covered by this Regulation must be registered or identified
to permit investigation where necessary at the holding of origin or transit ,. '
      *
                                     Article 7
All costs for the controls and examinations provided for in Article 5 shall be
 borne     by a tax   on    the . .product at the slaughterhouse without reimbursement
 from public funds *
                                     Article 8                   -
 Member States shall ensure that , in case of contravention of the present Regulation :
 ~ domestic animals and fresh meat concerned are confiscated and destroyed ;
 - sanctions are Applied to all persons contravening the present Regulation .
 ---pagebreak---                                                                        V 1
                                      Article 9
                                                                                  ,    \
  This Regulation shall not apply to the use of substances for the purposes of
  Pfestahshi
                                      Article 10
1 *. Where the procedure laid down in this Article is to be used , the matter shall
     be referred without delay to the Standing Veterinary Committee ( hereinafter
     referred to as 'the Committee 1 ), set up by the Council Decision of 15 October
     1968 , by the chairman , either oh his own initiative or at the request of a
     Member State *
2 * Within the Committee , the votes of the Member States shall be weighted as
     provided in Article 148(2 ) of the Treaty *   The chairman shall not vote *
3 * The Commission representative shall submit a draft of the measures to be
   • adopted *  The Committee shall deliver its opinion on the measures within a
     period to be determined by the chairman in keeping with the urgency of the
     question submitted for examination *   Opinions shall be delivered by a majority
     of 41 votes *
4 * The Commission shall adopt the measures and shall implement them immediately,'
     where they are in accordance with the opinion of the Committee ,,   Where they
     are not in accordance with the opinion of the Committee or if no opinion is
     delivered , the Commission shall without delay submit to the Council a proposal
     on the measures to be adopted *   The Council shall adopt the measures by a
     qualified majority *
If the Council has not adopted any measures within three months from the date
on which the proposal was submitted to it , the Commission shall adopt the
proposed measures and apply them immediately *                                       .
                                    \   Article 11
   This Regulation shall enter into force on 1 January 1981 .
   This Regulation shall be binding in its entirety and directly applicable in
   all Member States .
                               \