CELEX: 51993PC0636
Language: en
Date: 1993-12-07
Title: Amended proposal for a COUNCIL DIRECTIVE amending Directive 70/524/EEC concerning additives in feedingstuffs

COMMISSION OF THE EUROPEAN COMMUNITIES
                                                                                     C0MC93) 636 final
                                                                                     Brussels,      7 December 1993
          Sf^'êr^W
                                                          Amended proposal for a
                                                              COUNCIL PI RECTI YE
                                                      amending Directive 70/524/EEC
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                                                 concerning additives in feedingstuffs
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                                   (presented by the Commission pursuant to Article 189A(2) of the EC-Treaty)
 ---pagebreak---                          Explanatory memorandum
At its plenary session of 15-19 November 1993, the European Parliament
gave its opinion on the proposal for a Council Directive amending
Directive 70/524/EEC on additives in feedingstuffs (C0M(93) 110 final).
The Commission has accepted amendments 1 and 2 as proposed, and the
part of amendment 3 referring to scientific documents concerning GMOs,
as well as amendments 23 and 24 (extending the composition of the
Scientific Committee on Animal Nutrition and assessment of enzymes
obtained from genetically modified micro-organisms in order to remove
risks to human and animal health and the environment).
However, the Commission has not accepted the second part of amendment 3
according to which two authorization procedures should be applied to
products obtained from GMOs, i.e. the procedure under Directive
70/524/EEC on additives and the procedure under Directive 90/220 EEC on
the deliberate release into the environment of genetically modified
organisms. (The Commission would rather opt for integrating the
substantive   provisions   of   Directive    90/220/EEC   into  Directive
70/524/EEC).
The Commission has accepted the spirit of amendments 4, 5, 6 and 7 on
the label ting of GMO additives since, in accordance with the position
it adopted during the discussion on the Roth-Behrendt report on NOVEL
FOODS, such labelling would be on a case-by-case basis to indicate the
presence of one or more significant special characteristics due to the
manufacturing process.
This proposal amends the Commission's     initial proposal  in accordance
with Article 189A(2) of the Treaty.
 ---pagebreak---                             AMENDED PROPOSAL
                                  FOR A
                           COUNCIL DIRECTIVE
amending Directive 70/524/EEC concerning additives in feedingstuffs
(presented  by the Commission   pursuant   to Article 189A(2) of  the EC
Treaty)
As a result of the opinion delivered by Parliament at its plenary
session of 15-19 November 1993 on the proposal for a Directive amending
Directive 70/524/EEC concerning additives in feedingstuffs, presented
to the Council on 24 March 1993, the Commission has decided to amend
its initial proposal as follows, in accordance with Article 189A(2) of
the Treaty:
1.  After the first recital, the following recitals are added:
    "Whereas the inclusion of enzyme and microorganism products in
    Directive 70/524/EEC means that products belonging to both of these
    new categories and their manufacturers are subject to the same
    requirements which apply to the authorization of additives and to
    manufacturers in general; whereas it is particularly necessary to
    ensure   that   the products     marketed   are   innocuous  to  the
    environment, workers, animal owners and consumers of animal
    products and furthermore that they satisfy the requirements set as
    regards effectiveness, quality and ability to be checked;
    Whereas in order to make possible the evaluation and authorization
    of enzymes produced by or derived from genetically modified
    organisms, the Commission must provide an assessment of such
    products with the aim of preventing damage to human or animal
    health or the environment;
    Whereas it appears necessary that the Scientific Committee for
    Feedingstuffs should be assisted by experts in the field of genetic
    engineering so as to ensure that the testing procedure is such as
    to rule out any damaging effects on human or animal health or the
    environment caused by the products concerned;
    Whereas in the Community authorization procedure for additives the
    requirements of Directive 90/220/EEC 3 concerning         a specific
    environmental risk evaluation must be applied in respect of all
    additives which contain genetically modified organisms: whereas
    these requirements should therefore b© inserted in Directive
    87/153/EEC fixing guidelines for the assessment of additives in
    animal nutrition 4 and that they apply concomitantly with the
    provisions of the present directive;".
3   OJ No L 117, 8.5.1990, p. 15.
4   OJ No L 64, 7.3.1987, p. 19.
 ---pagebreak--- 2. The following is inserted in Article 1:
   "1. The following Article is Inserted after Article 7:
                              "Article 7a
   If an additive contains genetically modified organisms within the
   meaning of Article 2(1) and (2) of Council Directive 90/220/EEC on
   the deliberate release into the environment of genetically modified
   organisms, a specific environmental risk assessment similar to that
   laid down in the abovementioned Directive shall be carried out; for
   this purpose, the following documents to be included in the dossier
   submitted pursuant to Article 9 in order to ensure compliance with
   Article 7(2):
        a copy of the competent     authority's written  consent to the
        deliberate release of     genetically modified    organisms for
        research and development  purposes pursuant to   Article 6(4) of
        Directive 90/220/EEC and   the results of the    release(s) with
        respect to the risk in     each case to human    health and the
        envIronment;
        the complete technical file with the information required by
        Annexes I and II to Directive 90/220/EEC and the environmental
        risk evaluation carried out on the basis of this information.
3. Point 1(c)   (now  point 2(c))   of  Article 1  is  replaced   by the
   fol lowing:
   "C. for additives belonging to the groups:
   (a) of enzymes: the specific name of the active constItuent(s)
        according to its (their) enzymatic activity(les) 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 m l ) , the name or
        business name and the adress or registred 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
 ---pagebreak---         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 and, where applicable, indication
        of any particular significant characteristics due to the
        manufacturing process, in accordance with the provisions
        concerning labelling in the column entitled "Other provisions"
        in the Annexes;
   (b) of 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 name or business name and the 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 and,
        where applicable, Indication of any particular significant
        characteristics due to the manufacturing process, in accordance
        with the provisions concerning label Sing in the column entitled
        "Other provisions" in the Annexes."
4. Point 2(a)    (now   point 3(a))   of  Article 1   Is  replaced  by  the
   fol lowing:
   "(a)     Subparagraphs (h) and (i) below are added:
   (h) enzymes: the specific name of the active constItuent(s)
        according to its (their) enzymatic activity(les) 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 m i ) , the expiry
        date of the guarantee or the storage life from the date- of
        manufacture, the name or business naina and the address or
        registered place of business of the manufacturer if he is not
        responsible for the particulars on the label and, where,
        applicable,     indication    of   any    particular    significant
        characteristics due to the manufacturing process, in accordance
        with the provisions concerning labelling In th© column entitled
        "Other provisions" in the Annexes;
 ---pagebreak---    (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 nam© and the address
       or registered place of business of the manufacturer if he is
       not responsible for the particulars on the label and, where
       applicable,      indication    of    any   particular    significant
        characteristics due to the manufacturing process, in accordance
       with the provisions concerning labelling in the column entitled
        "Other provisions" in the Annexes;"
5. Point 3 subparagraphes (h) and (i) (now point 4 subparagraphes (h)
   and (i)) of Article 1 is replaced by the following:
   "(h)     for     enzymes: the      specific    name    of    the active
            const I tuent(s)    according    to   its   (their)    enzymatic
            act ivity( les) 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 m l ) , the expiry date of the guarantee
            or the storage life from the date of manufacture and, where
            applicable,    indication of any particular         significant
            characteristics due to the manufacturing process, in
            accordance with the provisions concerning labelling in the
            column entitled "Other provisions" in the Annexes;
   (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 (CFU/g),
        the expiry date of the guarantee or the storage life from the
       date of manufacture and, where applicable, indication of any
        particular significant characteristics due to the manufacturing
        process, in accordance with the provisions concerning labelling
        in the column entitled "Other provisions" in the Annexes."
6. Point 4 of Article 4 becomes point 5.
 ---pagebreak---                                                                      ISSN 0254-1475
                                                              COM(93) 636 final
                                                     DOCUMENTS
EN                                                                              03
                                Catalogue number : CB-CO-93-676-EN-C
                                                             ISBN 92-77-62409-4
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