CELEX: 51980PC0464
Language: en
Date: 1980-07-25
Title: Proposal for a COUNCIL DIRECTIVE amending the annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs (submitted to the Council by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (80) 464
Vol. 1980/0160
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                           COM(80)464 final
                                           Brussels - 25 July 1980
                           Proposal for a
                         COUNCIL DIRECTIVE
          amending the annexes to Council Directive 70 / 524 / EEC
          concerning additives in feedingstuff s
             ( submitted to the Council by the Commission )
 C0M(80 ) 464 final
 ---pagebreak---                          EXPLANATORY MEMORANDUM
1 . Jhe use of additives in animal feedingstuf fs has been regulated in the
    Community since 23 November 1970 by Council Directive 70 /524 / EEC ( 1 ).
    Stfhce then/ only substances authorised by the above directive may be
    • »
    incorporated in animal feedingstuf fs . Two types of authorisations are
    provided for, depending on the level of the guarantees offered by the
    additive . Annex I sets out the list of additives which have satisfied all
        i                                                       ,           .
    the requirements contained in the Directive and which , therefore , may be
               4                                                       -       '  ' , ' "
    freely used throughout the Community; annex II lists the additives which
    have not yet been studied completely but which , as regard harmlessness ,
    nevertheless offer sufficient guarantees for Member States to be allowed
    to authorise them nationally for a limited period .
    As in other areas where Community legislation is closely linked to the
    constant advance of scientific and technical knowledge , the Council entrusted
                     • f                                           ■
    the Commission with the task of making the necessary amendments to the
    Annexes to the Directive . The procedure followed for this purpose provides,
    for the intervention of the Standing Committee for Feedingstuffs and the
    adoption by the Commission of any amendment to the Annexes to the Directive
    is therefore subject to a favourable opinion by the Committee . In the event
    of a contrary opinion or in the absence of an    opinion the Commission can
                                                                                 *
    request the Council to act on the measures which it considers it must take .
    The Council then decides by a qualified majofiry . However, if at the expiry
    of a period 6f 3 months , the Council has not taken a decision , the Commission
    may adopt the measures proposed if the Council has not taken a decision by
    a simple majority against those measures ,             -
CD 0J No L 270 , 14.12.1970 , p. 1
 ---pagebreak---     As it was anxious to provide itself with all the necessary scientific
    guarantees , the Commission , on 2 December 1976 , set up the Scientific
    fpmmittee for Animal Nutrition (1 ) which it consults on all draft measures
    Winch may have repercussions on animal health and, in consequence, on human
    health . In drafting such measures , great importance is attached to the
    opinions of the Scientific Committee .
    On 27 June 1980 the Standing Committee for Feedingstuffs did not deliver ,
    an opinion on a draft Directive prolonging by 1 year the temporary authori­
    sation concerning three additives which may be used nationally in animal
    feed until 30 dune 1981 .
    The same situvtion arose in the case of a previous prolongation and, in the
    absence of an opinion by the Standing Committee and of a Council Decision ,
    the Commission finally decided to pcolong the authorisation for the use of
    the additive in question .                                '         > ■. '
    At the vote on 27 June 1980- the representatives of the Federal Republic of
    Germany and of Italy pronounced themselves against the draft measures submitted
    by the Commission departments , considering , Ss they have done in the past , that
    the additives in question were medic-ines and that , as such , their use as
    animal feed had Little effect on animal growth but involved , on the other hand ,
    certain risks .                                                             .
    In the absence of an opinion by the Committee , the Council must decide whether
    the Commission proposals , with regard to which the Member States have expressed
    a favourable opinion are justified . For its part , the Commission considers that
    the prolongations envisaged are in accordance with the rules and principles
    which have always been observed for the examination and authorisation of
    additives allowed at national level .
(2 ) 0J K'o L 279 , 9 . 10 . '9   35
 ---pagebreak---                                - 3 -
The three additives concerned have been allowed for specific uses in
annex II to the Directive on account of their favourable effects on animal
growth or on the prevention of diseases in certain animal species and of
t^e absence of observed effects likely to entail, in the recommended condi­
tions of use, risks for animal or human health . However, subsequent examina­
tion of these uses has revealed the 'need to have available further information
  *
in 'order to be able to take a decision as to their possible authorisation at
Community level . On the other hand, since'the Italian authorities have informed
the relevant Commission departments that they have to hand the resuls of a
recent study on two of the additives in question, the government experts arid
the Scientific Committee should be enabled to take cognisance of this new
information and to see whether there is a need to revise their judgement .
However, in terms of principles , the non renewal of authorisations , prior to
completion of the studies and in the absence of clearly unfavourable1 information ,
would be at variance with the rules followed hitherto for the formulation of
opinions on the authorisation or banning of an additive . Such an attitude would
be arbitrary and wobld constitute an undesirable precedent for the future .
Moreover, the fact that certain Member States' feel it necessary to restrict ;
the use of these additives to veterinary medicine threatens to have opposite
effects to the goal pursued by the Community in the area of the protection
of animal or human health . Given that , where they are not totally lacking,
national rules show great disparities with regard to the issue of medicated
feedingstuf f s , it appears to be far preferable to maintain for the moment the
substances in question under the control of the legislation governing additives
for animal feed . In addition, several Member States emphasized that this
tendency to consider as medicines substances constantly used by the breeder
to prevent ?ood deficiencies or illnesses existirtg endemically , will lead the
breeder to obtain those substances by devious means which are difficult to
control , "j                                         ■■■.•
 ---pagebreak---                                   - 4 -
3 ..- For the above reasons the Commission considers that it is imperative that
      the Council should act on its proposal to prolong the authorisation of use
      J            .           .
      |or lincomycin, dimetr^dazole and ronidazole pending the completion of the
      current studies .
      "it ■    ■             V
                 i
 ---pagebreak---           HE  COUNCIL    Of THE fcUftO^SAN COMMUNITIES ,
       Having regard to the Treaty establishing the European Economic Community ,
       Having regard to Council Directive 70 / 524 / EEC of 23 November 1970 concerning
       additives in feedingstuf fs ( 1 ), as last amended by the thirty fourth Commission
       Directive                  and in particular Article 6 and Article 16 b(4 ) thereof ,-
       Having regard to the proposal from the Commission ,
       Whereas Directive 70 / 524 / EEC provides that the Annexes must
       be constantly adapted in line with the progress of scientific and technical
       know ledge ;
       Whereas conditions of use of the antibiotic " Lincomycin " and the cocc idiostats
       " Dimetridazole and Ronidazole " at present in Annex II require additional
       examination ; whereas their authorization should therefore be extended for a limited
period whilst awaiting the outcome of these studies ;
       Whereas in the absence of an opinion of the Standing Committee for Feedingstuf fs
       the Commission has not been able to adopt the envisaged measures in accordance
       with the provisions of the - procedure laid cbwn in Article 16 b of the abovementioned
       Di rective ;
       HAS ADOPTED THIS DIRECTIVE :
       ( 1 ) 0J No L 270 , 14.12.1970 , p. 1
       ( 2 ) 0J No L     not published
 ---pagebreak---                                    Article 1
 In Annex II of Directive 7 0 /524 / EEC
 1 . in Part A "Antibiotics ",           "30 June 1980' in the "Period of authorisation"
     column is replaced by " 30 June 1981 " for item No 17 " Lincomycin " ,
2 . in Part B "Coccidiostats and other medicinal substances ",              "30 June 1980'
     in the 'Period of authorisation" column is replaced by " 30 June 1981 " for the
     following items :
     No   2 Dimetridazole
     No 12 Ronidazole
                                  Artic le 2
This Directive is addressed to the Member States .