CELEX: 51993PC0110
Language: en
Date: 1993-03-23
Title: Proposal for a COUNCIL DIRECTIVE AMENDING DIRECTIVE 70/524/EEC CONCERNING ADDITIVES IN FEEDINGSTUFFS

[ISSION OF THE EUROPEAN COMMUNITIES
                                        COM(93) < | i o f i n a l
                                        Brussels, 23 March 1993
                      Proposal for a
                    COUNCIL DIRECTIVE
     AMENDING DIRECTIVE 70/524/EEC CONCERNING ADDITIVES
                       IN FEEDINGSTUFFS
              (presented by the Commission)
 ---pagebreak---                            Explanatory memorandum
The purpose of the proposed measures is to amplify the provisions
recommended by the Commission in the proposal for a Council Decision
permitting the Member states to allow temporarily, at national level, the
use of enzymes, microorganisms and their preparations in feedingstuffs until
those products have received Community authorization pursuant to Council
Directive 70/524/EEC concerning additives in feedingstuffs.
A number of dossiers have now been submitted to the Commission by the Member
States with a view to obtaining Community authorization and it is
consequently necessary to adapt the provisions on the labelling of additives
laid down by Directive 70/524/EEC to these new classes of products so that
they can be identified and checked at all stages of use.
 ---pagebreak---                                       - 2-
                               COUNCIL DIRECTIVE
                                       Of
              amending Directive 70/524/EEC concerning additives
                                in feedingstuffs
                                   (../../EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic community,
and in particular Article 43 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the European Parliament<2),
Having regard to the opinion of the Economic and Social Committee^),
Whereas Council Directive 70/524/EEC concerning additives in
feedingstuffs(*•), as last amended by Directive 92/113/EEc(5) f lays down
the principles relating to the authorization and the use of additives;
Whereas advances in scientific and technological knowledge permit the use
of certain enzymes, microorganisms and their preparations in animal
nutrition in order to improve the digestibility of nutrients or to
stabilize the flora of the digestive system of animals and to reduce the
quantity of certain substances dangerous to the environment;
Whereas Decision 93/.. ./EEc(6) permits the Member States to allow
temporarily and subject to certain conditions the use and marketing of
enzymes, microorganisms and their preparations at national level until
those products receive Community authorization pursuant to Directive
70/524/EEC;
(1)
(2)
(3)
(4) OJ No L 270, 14.12.1970, p. 1.
(5) OJ No L 16, 25. 1.1993, p. 2.
(6)
 ---pagebreak---                                     - 3 -
Whereas the grant of such authorization implies that special labelling
provisions be inserted in the abovementioned Directive for this new
generation of additives and for the premixtures and feedingstuffs in which
they will be incorporated,
HAS ADOPTED THIS DIRECTIVE:
                                  Article 1
Council Directive 70/524/EEC of 23 November 1970 concerning additives in
feedingstuffs is hereby amended as follows:
1. Article 14(1) is amended as follows:
   (a) The title of point A is replaced by the following:
   "A.  for all additives with the exception of enzymes and microorganisms:"
   (b)  In point B, subparagraph (d) is worded as follows:
        (d)     trace elements, colorants including pigments, preserving
                agents and other additives with the exception of those
                belonging to the groups of enzymes and microorganisms:
                active substance level.
   (c) Point C below is added:
        "C. for additives belonging to the groups:
   "(a) of enzymes: the specific name of the active constituent(s) according
        to its (their) enzymatic activity(ies) in accordance with Annexes I
        or II, the identification number according to the International
        Union of Biochemistry, the activity units (activity units per g or
        activity units per ml), the name or business name and the address or
        registered place of business of the person responsible for the
        particulars referred to in this paragraph, and the name or business
        name and the address or registered place of business of the
        manufacturer if he is not responsible for the particulars on the
        label, the expiry date of the guarantee or the storage life from the
        date of manufacture, the batch reference number and the date of
        manufacture, the words "to be used exclusively for the manufacture
        of feedingstuffs", the directions for use and, where appropriate, a
        safety recommendation where the column entitled "Other provisions"
        in the Annexes contains special provisions concerning the additives,
        the net weight and for liquid additives either the net volume or the
        net weight;
 ---pagebreak---                                     - 4 -
   (b) of microorganisms: the identification of the strain(s) in accordance
        with Annexes I or II, the file number of the strain(s), the Dumber
        of units forming the colonies (CFU/g), the name or business name and
        address or registered place of business of the person responsible
        for the particulars referred to in this paragraph, the name or
        business name and address or registered place of business of the
        manufacturer if he is not responsible for the particulars on the
        label, the expiry date of the guarantee or the storage life from the
        date of manufacture, the batch reference number and the date of
        manufacture, the words "to be used exclusively for the manufacture
        of feedingstuffs", the directions for use and, where appropriate, a
        safety recommendation where the column entitled "Other provisions"
        in the Annexes contains special provisions concerning the additives,
        the net weight and for liquid additives either the net volume or the
        net weight;
2. In Article 15(1) B
   (a)  subparagraphs (h) and (i) below are added:
   "(h) enzymes: the specific name of the active constituent(s) according
        to its (their) enzymatic activity(ies) in accordance with Annexes I
        or II, the identification number according to the International
        Union of Biochemistry, the activity units (activity units per g or
        activity units per ml), the expiry date of the guarantee or the
        storage life from the date of manufacture, the name or business name
        and the address or registered place of business of the manufacturer
        if he is not responsible for the particulars on the label;
   (i) microorganisms: the identification of the strain(s) in accordance
        with Annexes I or II, the file number of the strain(s), the number
        of units forming the colonies (CFU/g), the expiry date of the
        guarantee or the storage life from the date of manufacture, the name
        or business name and the address or registered place of business of
        the manufacturer if he is not responsible for the particulars on the
        label;"
 (b) subparagraph (h) becomes subparagraph (j) and is worded as follows:
   "(j) other additives belonging to the groups referred to in (b) to (i)
        for which no maximum level is laid down and additives belonging to
        other groups provided for in Annexes I or II: specific name of the
        additive in accordance with Annexes I or II and active substance
        level, provided that these additives fulfil a function in the
        feedingstuff as such and the amounts present can be determined by
        official methods of analysis or, failing this, by valid scientific
        methods".
 ---pagebreak---  3.. The following subparagraphs (h) and Ci) are added to Article 16(1):
     (h)   for enzymes: the pacific name of the actives const i tuent (s)
          according to its (their) enzymatic activity(ies) in accordance with
          Annexes I or il, the identification number according to the
           international Union of Biochemistry, the activity units (activity
          units per g or activity units per m l ) , the expiry date of the
          guarantee or the storage life from the date of manufacture;
     (i)  for microorganisms: the identification of the strain(s) in
          accordance with Annexes I or II, the file number of the strain(s),
          the number of units forming the colonies CCFU/g), the expiry date of
          the guarantee or the storage life from the date of manufacture.
 4. In Articles 23 paragraph 4, second line and 24 paragraph 4, second line
     the part of the sentence "except where the council has voted by a simple
    majority against such measures" is deleted in each case.
                                    Article 2
1. Member States shall bring into force the laws, regulations and
    administrative provisions necessary to comply with this Directive by 30
    June 1994. They shall notify the Commission thereof forthwith.
    Where Member States adopt such provisions they shall contain a reference
    to this Directive or shall be accompanied by such reference when they are
    officially published. Details of this reference shall be laid down by
    the Member States.
2. Member States shall communicate to the commission the text of the
    provisions of national law which they adopt in the area covered by this
    Directive. The Commission shall inform the other Member States thereof.
                                    Article 3
This Directive is addressed to the Member states.
Done at Brussels,
                                  For the Council
                                  The President
 ---pagebreak---                                                                     ISSN 0254-1475
                                                                      1
UN                                                                            «3
                               Catalogue number : CB-CO-93-132-EN-C
                                                            ISBN 92-77-53815-5
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