CELEX: 51987PC0113
Language: en
Date: 1987-03-16
Title: Proposal for a COUNCIL DIRECTIVE amending Directive 70/524/EEC concerning additives in feedingstuffs in respect of Olaquindox#Proposal for a COUNCIL DIRECTIVE amending Directive 70/524/EEC concerning additives in feedingstuffs in respect of Carbadox#(presented by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (87) 113
Vol. 1987/0050
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1983 über die Freigabe der historischen Archive der Europäischen Wirtschaftsgemeinschaft und
der Europäischen Atomgemeinschaft (ABI. L 43 vom 15.2.1983, S. 1), zuletzt geändert durch die
Verordnung (EU) Nr. 2015/496 vom 17. März 2015 (ABI. L 79 vom 25.3.2015, S. 1), ist dieser Akt
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Verschlusssachen als herabgestuft angesehen.
 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                                    COM(87) 113 final
                                                    Brussels , 16 March 1987
                                                                             /
                                   Proposai for a
                                COUNCIL DIRECTIVE
    amending Directive 70 / 524 / EEC concerning additives in feedingstuff s
                           in respect of Olaquindox
                                   Proposai for a
                                 COUNCIL DIRECTIVE
    amending Directive 70 /524 /EEC concerning additives in feedingstuff s
                             in respect of Carbadox
                        (presented by the Commission )
C0MC87 ) 113 final
 ---pagebreak---                                                                         &Ъ      I
                               EXPLANATORY MEMORANDUM
 1 . Since 23 November 1970 the use of additives in Livestock feedingstuffs
 in the Community has been governed by Council Directive 70/ 524/ EEC . 1 Since
 that date onLy those substances authorized under the Directive may be in¬
 corporated in feedingstuffs . Two types of authorization are provided for,
depending on the extent of the guarantees offered by the additive . Annex I
to the Directive Lists those additives which meet all its requirements and
which , therefore, may be freely used throughout the Community; Annex II Lists
those in respect of which examination has not been completed, but which nonethe¬
 less offer adequate guarantees of innocuousness for the Member States to
be allowed to authorize them, provisionally and at national level , for a
period which has since 3 December 1986 been Limited to five years .
As in other fields where Community legislation is greatly affected by cons¬
tantly advancing scientific and technical knowledge , the Council has en-
rusted the Commission with the task of making the necessary amendments to
the annexes to the Directive . The procedure adopted involves the Standing
Committee for Feedingstuffs .
In order to avail itself of all the scientific guarantees required, the
Commission set up , on 2 September 1976 , the Scientific Committee on Animal
Nutrition^, which it consults on any proposals for measures which might
have repercussions on animal health and consequently upon human health .
When such proposais are being prepared, great importance is attached to
the opinions of the Scientific Committee .
2.    On 22 December 1986 a draft was put to the Standing Committee for
Feedingstuffs authorizing , throughout the Community , the use of both
Carbadox and Olaquindox .
- The two additives had been listed in Annex^_IJ- to Directive 70/524/EEC
since 1 July 1974 and 1 December 1976 respectively, and they had thus been
authorized for several years in most Member States , because of their effect
in promoting the growth of pigs .
( 1 ) 0J N * L 270, 14.12.1970, p.1
( 2 ) 0J N° L 279, 9.10.1976, p. 35
 ---pagebreak--- - Under Directive 84 / 587 / EEC , a decision on Community authorization had to
be taken , because of the five-year limit on national authorizations applying
since 3 December 1986 .
- After a thorough examination of the matter and further studies , the
Scientific Committee issued a favourable opinion on these two additives,^
subject to compliance with certain conditions .
- Voting in the Standing Committee did not allow an opinion to be issued :
53 for and 23 against ( Germany , Denmark and the United Kingdom ).
3 . These three Member States voted against because of the toxic characte-
ristics of Carbadox . The United Kingdom did not adopt any position on
Olaquindox .
4    In view of the opinion of the Scientific Committee on Animal Nutrition ,
the Commission proposes that the Council authorize Carbadox and Olaquindox
with the provisos which have been suggested .      To this end the Commission
is putting forward two proposals , so that a decision can be taken on each
of these additives on its own merits .
Carbadox
- Opinion of 6 July 1978 - Reports of the Scientific Committee on Animal
   Nutrition - 2nd sériés - Doc . EUR 6918 ( 1980 ) p. 7
- Opinion of 7 July 1982 - Reports of the Scientific Committee on Animal
   Nutrition - 4th sériés - Doc . EUR 8769 ( 1984 ), p. 82
Olaquindox
- Opinion of 8 July 1981 - Reports of the Scientific Committee on Animal
   Nutrition - Doc . EUR 8769 ( 1984 ) p. 1
- Opinion of 3 May 1984 - Reports of the Scientific Committee on Animal
   Nutrition - 5th sériés - Doc . EUR 10410 ( 1986 ), p.1
 ---pagebreak---                                          4
                                 Proposai for a
                                COUNCIL DIRECTIVE
   amending Directive 70 /524 / EEC concerning additives in feedingstuf f s
                          in respect of Olaquindox
THE COUNCIL OF THE EUROPEAN 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 feedingstuff s , as last amended by Commission Directive 86/ 525 / EEC ,
and in particular Articles 7 and 24 thereof ,
Having regard to the proposal from the Commission ,
Whereas Directive 70 / 524 / EEC provides for regular amendment of the content of
its Annexes to take account of advances in scientific and technical knowledge ;
whereas the Annexes were consolidated by Commission Directive 85/429/EEC3;
Whereas the use of Olaquindox as growth promoter was hitherto authorized at
national level ; whereas the studies carried out and the experience gained
indicate that this additive can be authorized throughout the Community for the
use specified , provided that certain provisions aimed at ensuring its safe use
are complied with ;
Whereas , since the Standing Committee for Feedingstuff s has not delivered an
opinion , the Commission is unable to adopt the measures it envisaged , in
accordance with the procedure laid down in Article 24 of the said Directive
70 / 524 / EEC ,
HAS ADOPTED THIS DIRECTIVE :
10J No L 270, 14.12.1970, p. 1 .
20J No L 310, 5.11.1986, p. 19 .
30J No L 245, 12.9.1985, p. 1 .
 ---pagebreak---                                       “3 “
                                    ArticLe 1
Annex I  to Directive 70 / 524 / EEC is hereby amended as set out in the Annex
hereto .
                                    Article 2
Member States shall , by 30 November 1987 at the latest , bring into force
the laws , regulations or administrative provisions necessary to comply with
Article 1 . They shall immediately inform the Commission thereof .
                                    Article 3
This Directive is addressed to the Member States .
 ---pagebreak---      In Annex I , under part J 'Growth Promoters' , the foLlowing item is inserted :                                                          ANNEX
                                     Chemical formula                Species or                 Mininun     Maxinun
                                                                                    Maxinun
EEC N*         Additive                                               category                  content     content         Other provisions
                                        Description                  of animal
                                                                                      age
                                                                                                mg/ kg of conplete
                                                                                                     feedings tuff
                                                                                                                      Ί
  E 851       Olaquindox     2- (N-2 1 - (hydroxyethy l )
                              ca rtiamoY l ) -3-methy Iqui nox-
                             aline N1 , N^-dioxide
                              Mininun purity: 98%
                                                                                                                         use prohibited at least 4 weeks
                              Particular features of the              Piglets      4 months        15            50      before s laughter
                              authorized preparation:                                               50( 2)     ioo(2)
                                                                                   4 months
                              - maxinun Olaquindox
                                 content : 10%
                                                                                                                       l maxinun amount of dust emitted
                              - mininun stability :                                                                    f during handling as determined
                                  24 months                                                                              by the method of Stauber
                                                                                                                         Heubach ( 1 ): 0. 1 /ig olaquindox
                               - median :      Calcium
                                   carbonate containing                                                                  indication on the label of the
                                   1.5% of Glyceryl                                                                      additives and the premixtures of
                                  polyethyleneglycol                                                                     safety instructions aimed at pre¬
                                   ricinoleate                                                                           venting the inhalation of dust
                                                                                                                         during handling
( 1 ) Lite rature référencés : Fresenius Z Anal Chem          ( 1984) 318:522-524 Springer Verlag 1984
 (2) Milk replacers only .
 ---pagebreak---                                         Ί-
                                 Proposal for a
                               COUNCIL DIRECTIVE
 amending Directive 70 / 524 / EEC concerning additives in feedingstuff s
                          in respect of Carbadox
THE COUNCIL OF THE EUROPEAN COMMUNITIES ,
Having regard to the Treaty establishing the European Economic Community ,
Having regard to Council Directive 70 / 524 / EEC of 23 November 1970 concerning
                              1                                                     2
additives in feedingstuf fs , as last amended by Commission Directive 86 / 525 / EEC ,
and in particular Articles 7 and 24 thereof ,
Having regard to the proposal from the Commission ,
Whereas Directive 70 / 524 / EEC provides for regular amendment of the content of
its Annexes to take account of advances in scientific and technical knowledge ;
whereas the Annexes were consolidated by Commission Directive 85/429/EEC3;
Whereas the use of Carbadox as growth promoter was hitherto authorized at national
level ; whereas the studies carried out and the experience gained indicate that
this additive can be authorized throughout the Community for the use specified ,
provided that certain provisions aimed at ensuring its safe use are complied with ;
Whereas , since the Standing Committee for Feedingstuff s has not delivered an
opinion , the Commission is unable to adopt the measures it envisaged , in accordance
with the procedure laid down in Article 24 of the said Directive 70/ 524 / EEC ,
HAS ADOPTED THIS DIRECTIVE :
10J No L 270,  14.12.1970 , p. 1 .
20J No L 310,  5.11.1986 , p. 19 .
30J No L 245 , 12.9.1985 , p. 1 .
 ---pagebreak---                                     - s -
                                   Artide 1
Annex I to Directive 70 / 524 / EEC is hereby amended as set out in the Annex
hereto .
                                   Article 2
Member States shall , by 30 November 1987 at the latest , bring into force the
laws , regulations or administrative provisions necessary to comply with Article
1.   They shall immediately inform the Commission thereof .
                                   Article 3
This Directive is addressed to the Member States .
 ---pagebreak---                                                                                AW€X
In Amex I, under part J 'Growth Promoters' , the following item is inserted :
                                                                                              Mininun     Maxinun
                                      Chemical formula             Species or    Maxirrun
                                                                                              content      content    Other provisions
 EEC N*          Additive
                                         Description              category of      age
                                                                                              mg/ kg of conplete
                                                                     animal                       feedings tuff
    E 850       Carbacbx       methyl 3- (2–qui noxa l i (jiyl–
                                methylene ) carbazate-N ,
                                N^-dioxide
                               Mininun purity: 96 %
                                Particular features of            Piglets       4 months         20          50      Use prohibited at least 4 weeks
                                the authorized prepar¬                                                               before s lauster
                                ation:
                                                                                                                     Maxi nun anoint of cbst emitted
                                - ttaxinun Carbacbx
                                  content : 101
                                                                                                                     during handling, as determined
                                                                                                                     by the method of Staiber
                                - Mininun stabi lity :                                                             r Hecbach ( 1 )
                                  24 months                                                                          0.1 pg carbacbx
                                - Calciun Propionate :                                                               Indication on the label of the
                                  0.11 - 0.5%
                                                                                                                     additives and the premixtures
                                - Calciun Silicate :                                                                 of safety instructions aimed
                                  5%                                                                                 at preventing the inhalation
                                                                                                                     of dust during handling .
                                - Preparation mediun :
                                   soya meal containing
                                   7% of soya oi l
( 1 ) Literature référencés : Fresenius Z Anal Chem ( 1984 ) 318:522-524 Springer Verlag 1984
 ---pagebreak---                                                 le
                                                                                           1)
    FICHE D' IMPACT DE CERTAINS ACTES LEGISLATIFS SUR LES PME ET L' EMPLOI
          1-     OBLIGATIONS ADMINISTRATIVES DECOULANT DE L' APPLICATION DE
                 LA LEGISLATION POUR LES ENTREPRISES
                 Néant
          2.     AVANTAGES POUR L' ENTREPRISE
                 - OUI /JWQNXX
                 - LESQUELS
                    Valeur ajoutée aux aliments contenant ces produits
          3.     INCONVENIENTS POUR L' ENTREPRISE
                 ( coûts supplémentaires )
                 - OUI / NON
                 - CONSEQUENCES
          4.     EFFETS SUR L' EMPLOI
                 Bénéfique
          5.     Y A- T- IL EU CONCERTATION PREALABLE AVEC LES PARTENAIRES
                 SOCIAUX ?
                 - oUI /WÛNxx Organisations Européennes ( Industrie, ccxmerce et consonma-
                                                                                   teurs )
                 - AVIS DES PARTENAIRES SOCIAUX
                    Ftositif
          6.     Y A- T- IL UNE APPROCHE ALTERNATIVE MOINS CONTRAIGNANTE ?
                  Ncn
1) Les pnopositions en cause visent à autoriser l' errploi de deux additifs destinés è
   l' alimentation animale et fabriqués respectivement par Pfizer et Bayer et utilisés
   par les fabricants d' aliments composés pour animaux .