CELEX: 51995PC0132
Language: en
Date: 1995-04-26
Title: Draft COUNCIL DIRECTIVE amending Directive 70/524/EEC concerning additives in feedingstuffs

COMMISSION OF THE EUROPEAN COMMUNITIES
                          Brussels, 26.04.1995
                          COM(95) 132 final
                    Draft
          COUNCIL DIRECTIVE
      amending Directive 70/524/EEC
    concerning additives in feedingstuffs
       (presented by the Commission)
 ---pagebreak---                    EXPLANATORY MEMORANDUM
Since 23 November 1970 the use of additives in livestock feedingdstuffs 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
incorporated 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 liste 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 nonetheless 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
constantly advancing scientific and technical knowledge, the Council has
entrusted 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 Nutrition2, which it consults on any proposals for measures which
might have repercussions on animal health and consequently upon human
health. When such proposals are being prepared, great importance is
attached to the opinions of the Scientific Committee.
        OJ N o . L 2 7 0 , 14.12.1970,    p.  1.
        OJ No. L 2 7 9 ,   09.10.1976,    p.  35
                                 t.
 ---pagebreak--- 2.    On 28 March 1995 a draft was put to the Standing Committee for
      Feedingstuffs authorizing, throughout the Community, the use of Avoparcine
      in feed for dairy cattle:
             The additive has been listed in Annex I to Directive 70/524/EEC since
             «he application of Directive S0/2Q&ÏEEC3 of 9 April 1990. It has been
             authorized for several years in most Member States arising to its
             beneficial effect on milk producëouL
             A decision must be taken on Community authorization, given that the
             five-year limit on national authorization expires on 10 April 1995.
             The Scientific Committee for &mma\ Nutrition, after a thorough
             examination of the dossier and after requesting further studies, has
             issued a favourable opinion on $KS additive4.
The vote of the Standing Committee dtd not aftow an opinion to be issued.
                                       54 for
                                     24 against
                                   7 abstentions
             OJ No. L 106, 26.04.1990, p. 30.
              Opinion of 25 March 1994, confirmed on 29 September
              1994. To be published in the 10th Series of the
             Reports of the Scientific Committee for Animal
             Nutrition.
              Supplementary opinion of the Scientific Committee of
              24 March 1995.
 ---pagebreak--- 3. In the absence of an opinion from the Standing Committee for Feedingstuffs,
   the Council must decide whether the measures proposed by the Commission
   are justified.
4. This draft has no impact on the Community budget.
                                 <#
 ---pagebreak---                         Council Directive
                               of
                  amending Directive 70/524/EEC
             concerning additives in feedingstuffs
THE COUNOI* OF THE EUROPEAN UNION,
Having regard to the Traty establishing the European Community,
Having regard to Council Directive 70/524/EEC of 23 November 1970
concerning additives in feedingstuffs1, as last amended by the
Act of Accession of Austria > Finland and Sweden, and in
particular Article 7 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 91/248/EEC2;
Whereas a new use of the antibiotic "Avoparcin" has been widely
tested in several member States; whereas, on the basis of
experience gained and studies undertaken, it appears that this
new use can be authorized throughout the Community;
Whereas the Scientific Committee for Animal Nutrition issued an
opinion on this new use of Avoparcin;
Whereas in absence of an opinion from the Standing Committee for
Feedingstuffs, the Commission has      been unable to adopt the
provisions planned in accordance with the procedure provided for
in Article 23 of the abovementioned Directive,
          OJ N* L270, 14.12.1970, p. 1,
          OJ N* L 124, 18.5.1991, p. 1
 ---pagebreak--- HAS ADOPTED THIS DIRECTIVE :
                           ArUpjle, I
Annex I to Directive 70/524/EEC is hereby amended as set out in
the Annex hereto.
                           Article 2
1.   Member States shall bring into force the laws, regulations
     or administrative provisions necessary to comply with this
     Directive by 1st July 1995 at the latest. They shall
     immediately inform the Commission thereof.
     When member States adopt these measures, they shall contain
     a reference to this Directive or shall be accompagnied by
     such reference at the time of their official publication.
     The procedure for such reference shall be adopted by Member
     States.
2.   Member states shall communicate to the Commission the text
     of the main provisions of domestic law which they adopt in
     the field governed by this Directive.
                           Article 3
This Directive shall enter into force on the third day following
its publication   in  the  Official   Journal   of  the   European
Communities,
                           Article 4
This Directive is addressed to the Member States.
Done at Brussels,                         For the Commission
                             6
 ---pagebreak---                                                  ANNEX
  In Annex I to Directive 70/524/EEC, Part A "Antibiotics", the following is added to entry n* E 715
  "Avoparcin":
     EC     Additive  Chemical    Species or  Maximum  Minimum    Maximum  other provisions 1
     N*                formula,   category of age      content    content
                     description  animal
                                                        mg/kg of complete
                                              i
                                                           feedingstuff
                                  Dairy                    4         10    Indicate in the
                                  cattle                                   instructions for
^
                                                                           use :
                                                                           "The dose of
                                                                           avoparcin in the
                                                                           daily ration i
                                                                           -must not exceed
                                                                            150 mg,
                                                                           -must not be less
                                                                           than 50 mg."
 ---pagebreak---                                                                       BSN 0254-1475
                                                                C0M(95) 132 final
                                                  DOCUMENTS
    EN                                                                           03
 i
i
-4
  1
 •4
                                         Catalogue number : CB-CO-95-141-EN-C
                                                                 ISBN92-77-87659-X
    Office for Officiai Publications of the European Communities
    L-2985 Luxembourg
                                             s