CELEX: 51998PC0099
Language: en
Date: 1998-02-25
Title: Proposal for a Council Regulation (EC) concerning the compulsory indication on the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 79/112/EEC

COMMISSION OF THE EUROPEAN COMMUNITIES
                                              Brussels, 25.02.1998
                                              COM(1998)99final
                               Proposal for a
                      COUNCIL REGULATION (EC)
 concerning the compulsory indication on the labelling of certain foodstuffs
produced from genetically modified organisms of particulars other than those
                  provided for in Directive 79/112/EEC
                      (presented by the Commission)
 ---pagebreak---  ---pagebreak---                               EXPLANATORY MEMORANDUM
1. On 19 September 1997, the Commission adopted Regulation n° 1813/97 concerning
   the compulsory indication on the labelling of certain foodstuffs produced from
   gcnetically modificd organisms of particulars other than those provided for in
   Directive79/112/EEC.
2. This Commission Regulation applics to the labelling of foods and food ingrcdients
   produced from gcnetically modificd soyabcans and gcnetically modificd maize
   which were granted consent under Dircctivc 90/220/EEC bcforc the cnlry into force
   of the Novel Foods Regulation. It was publishcd in the Official Journal on 20.09.97,
   and entered into force on 1 November 1997.
3. Regulation (CE) n° 1813/97 was adopted on the basis of article 4(2) of Directive
   79/112/EEC on the approximation of the laws of the Member States relating to the
   labelling, presentation and advertising of foodstuffs
4. In the interest of consumer proteclion, in order to ensure fair conditions of
   competition within the internal market, and in view of the need to ensure a coherent
   Community policy for foods produced from biotechnology, it was considered
   necessary to ensure that labelling rulcs for the information of the final consumer
   based on the samc principlcs apply to foods and food ingrcdients produced from
   OMOs which havc bccn placcd on the market bcforc the cnlry into force oi'
   Regulation (EC) n° 258/97 pursuant to a consent given under Dircctivc 90/220/EEC,
   and to foods and food ingrcdients which arc placcd on the market thercafter.
5. In order to achieve this goal, the first step, implcmenlcd by the aforementioned
   Regulation (CE) n° 1813/97, consisted in requiring that the same provisions as those
   laid down in Article 8 of Regulation (CE) n° 258/97 apply to foods and food
   ingredients produced from genetically modificd soyabeans covered by Decision
   96/281/EC and genetically modified maize covered by Decision 97/98/EC.
6. However, laying down general labelling rules for the aforementioned products is not
    sufficient in order to clarify which soya or maize products have to be labelled, and,
   when so, how. In order to achieve this rcsult, it is also necessary, as a second step,
    drawing on the approach taken in Article 8 of Regulation (EC) N° 258/97, to lay
    down detailed uniform Community rules.
    As a matter of fact, Article 3 of Regulation (CE) n° 1813/97 itsclf alrcady laid down
    that "Detailed uniform Community rules for the labelling of the foodstuffs refcned
    to in Article 1 shall be adopted as soon as possible."
7.  The measures proposed in the attachcd proposal for a Regulation constitutc the
    detailed uniform Community rules announccd in Article 3 of Regulation (CE)
    n° 1813/97.
                                              oi
 ---pagebreak---                                           Proposal for
                          Council Regulation (EC) N°..../ 97 of....
      concerning the compulsory indication on the labelling of ccrtain foodstuffs
   produced from genetically modified organisms of particulars other than those
                           provided for in Directive 79/112/EEC
                                   (Text with EEA relevance)
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 79/112/EEC of 18 December 1978 on the
approximation of the laws of the Member States relating to the labelling, presentation and
advertising of foodstuffs1, as last amended by Directive 97/4/EC of the European
Parliament and of the Council2, and in particular Article 4(2) thereof;
Having regard to the proposal from the Commission,
1.   Whereas, in accordance with the provisions of Part C of Council Directive
     90/220/EEC of 23 April 1990 on the deliberate release into Ihe environment of
     genetically modified organisms3, consents have been given for the placing on the
     market of certain genetically modified products by Commission Decision 96/281/EC
     of 3 April 1996 concerning the placing on the market of genetically modified soya
     beans (Glycine max L.) with increased tolerance to the herbicide glyphosate pursuant
     to Council Directive 90/220/EEC4, and by Commission Decision 97/98/EC of 23
     January 1997 concerning the placing on the market of genetically modified maize
     (Zea mays L.) with the combined modification for insecticidal properties conferred
     by the Bt-endotoxin gene and increased tolerance to the herbicide glufosinate
     ammonium pursuant to Council Directive 90/220/EEC5;
2.   Whereas in accordance with Directive 90/220/EEC there have been no safely
     grounds for mentioning on the label of genetically modified soya beans ((ilycine
     max L) or of genetically modified maize (Zea mays L.) that they have been obtained
     by genetic modification techniques;
3.   Whereas Directive 90/220/EEC does not cover non-viable products derived from
     genetically modified organisms (hereinafter referred to as "GMOs");
        OJn°L33, 8.2.1979, p. I.. ^
        OJn°L43, 14.2.1997, p. 21
        OJn°L 117, 8.5.1990, p. 15
        OJn"L 107, 30.4.1996, p. 10
        OJn r L3I, 1.2.1997, p. 69
                                             3
 ---pagebreak--- 4.   Whereas certain Member States have taken measures in respect of the labelling of
     foods and food ingredients produced from the products concerned; whereas
     differences between those measures are liable to impede the free movement of those
     foods and food ingredients and thereby adversely affect the functioning of the
     internal market; whereas it is therefore necessary to adopt uniform Community
     labelling rules for the products concerned;
5.   Whereas European Parliament and Council Regulation (EC) N° 258/97 of 27
     January 1997 concerning novel foods and novel food ingredients6, lays down, in
     Article 8, additional specific labelling requirements in order to ensure proper
      information for the final consumer; whereas these additional specific labelling
     requirements do not apply to foods and food ihgredients which have been used for
      human consumption to a significant degree within the Community before the entry
      into force of Regulation (EC) N° 258/97 and are not for this reason considered to be
      novel;
6.    Whereas, in order to prevent distortions of competition, labelling rules for the
      inlbrmation of the final consumer based on the same principles should apply to foods
      and food ingredients consisting of or derived from GMOs which have been placed on
      the market before the entry into force of Regulation (EC) N° 258/97 pursuant to a
      consent given under Directive 90/220/EEC, and to foods and food ingredients which
      are placed on the market thereafter;
7.    Whereas, therefore, Commission Regulation (EC) N° 1813/97                concerning the
      compulsory indication on the labelling of certain foodstuffs             produced from
      genetically modified organisms of particulars other than those          provided for in
      Directive 79/112/EEC7 has laid down general labelling rules              for the above-
      mentioned products;
 8.    Whereas it is now urgent to lay down detailed uniform Community rules for the
       labelling of the foodstuffs covered by Regulation (EC) N° 1813/97;
 9.    Whereas, in particular, drawing on the approach taken in Article 8 of Regulation
       (EC) N° 258/97, it is necessary to ensure that the final consumer is informed of any
       characteristic or food property, such as composition, nutritional value or nutritional
       effects or the intended use of the food, which renders a food or food ingredient no
       longer equivalent to an existing food or food ingredient; whereas, for this purpose,
       foods and food ingredients produced from genetically modified soya beans or from
       genetically modified maize which are not equivalent to conventional counterparts
       should be subject to labelling requirements;
 10. Whereas, drawing on the approach taken in Article 8 of Regulation (EC) N° 258/97,
       it is necessary that labelling requirements are based on scientific evaluation;
  11. Whereas it is necessary to establish clear labelling rules for the above-mentioned
        products, allowing official contrql on a reliable, readily repeatable and practicable
        basis; whereas common scientifically validated testing methods should be developed.
            O J n ° L 4 3 , 14.2.1997, p. 1
            OJ n° L 257, 20.9.97 p.7
                                                  4
 ---pagebreak--- 12. Whereas it is also necessary to ensure that the labelling requirements are no more
    burdensome than necessary but sufficiently detailed to supply consumers with the
    information they require.
13. Whereas at this stage the presence in foods and food ingredients of DNA resulting
    from genetic modification constitutes the criterion best complying with the above-
    mentioned requirements ; whereas such an approach could be reconsidered in the
    light of future developments in scientific knowledge;
14. Whereas foods and food ingredients produced from genetically modified soya beans
    (Glycine max L) or from genetically modified maize (Zea mays L.), in which DNA
    resulting from genetic modification is present, are not equivalent and therefore are
    subject to labelling requirements ;
15. Whereas it is possible that DNA resulting from genetic modification has been
    destroyed by successive stages of processing ; whereas, in that case, foods and food
    ingredients should be considered equivalent for labelling purposes; whereas they are
    therefore not subject to labelling requirements;
16. Whereas nevertheless some processing methods may eliminate DNA but not
    proteins; whereas it cannot be excluded that such methods can be applied to food
    uses ; whereas foods and food ingredients in which DNA resulting from genetic
    modification is not present but in which there are proteins resulting from genetic
    modification present, cannot be considered to be equivalent; whereas therefore, they
    are subject to labelling requirements.
17. Whereas the necessary information should be provided in the list of ingredients
    except in the case of products for which no such list exists, in which case it should
    appear clearly on the labelling of the product;
18. Whereas, with regard to foods and food ingredients which are intended to be placed
    on the market to be supplied to the final consumer, and which may contain both
    genetically modified and conventional produce, and without prejudice to the other
     labelling requirements of this Regulation, information for the consumer on the
    possibility that genetically modified produce may be present in the foods and food
    ingredients concerned is deemed -by way of exception, in particular as regards bulk
    consignments- to fulfil the requirements of this Regulation.
19. Whereas this Regulation is without prejudice to the operators' right to include
    voluntary claims in the labels of their products as to particulars other than those laid
    down in this Regulation (such as the absence of foods and food ingredients produced
     from genetically modified soyabeans and maize, or the presence of such foods and
     food ingredients in cases where it is not scientifically verifiable but evidence of it is
     available through other means), provided such claims are made in compliance with
     the provisions of Directive 79/112/EEC.
20. Whereas, having regard to the scope and effects of the proposed action, the
     Community measures introduced by this Regulation are not only necessary but
     essential if the objectives set are to be attained; whereas those objectives cannot be
     attained by the Member States acting individually;
 ---pagebreak--- 21. Whereas this Regulation replaces Regulation (EC) N° 1813/97 which should
    therefore be repealed;
22. Whereas in pursuance of the procedure laid down in Article 17 of directive
    79/112/EEC, this text was submitted to the Standing Committee for Foodstuffs,
    which was unable to deliver an opinion, and whereas in accordance with that same
    procedure the Commission is required to address a proposal to the Council,
HAS ADOPTED THIS REGULATION
                                           Arlicle l
1. This Regulation shall apply to foods and food ingredients which are to be delivered
     as such to the final consumer (hereinafter referred to as "the specified foodstuffs")
    produced, in whole or in part, from:
          genetically modified soya beans covered by Decision 96/281/EC;
          genetically modified maize covered by Decision 97/98/EC.
2.   This Regulation shall not apply to food additives, flavourings for use in foodstuffs or
     extraction solvents used in the production of foodstuffs as referred to in Article 2(1)
     of Regulation (EC) N° 258/97.
                                           Article 2
1. The specified foodstuffs shall be subject to the additional specific labelling
     requirements laid down in paragraph 3 of this article.
2.   However, foods and food ingredients referred to in the first paragraph in which DNA
     resulting from genetic modification is not present shall not be subject to the specific
     Iabelling requirements, unless there are proteins resulting from genetic modification
     present.
3.   The specific labelling requirements referred to in paragraph 1 are the following:
     (a) Where the food consists of more than one ingredient, the words "produced from
          genetically modified soya" or "produced from genetically modified maize", as
          appropriate, shall appear in the list of ingredients provided for by Article 6 of
          Directive 79/112/EEC in parentheses immediately after the name of the
          ingredient concerned. Alternatively, these words may appear in a prominently
          displayed footnote to the list of ingredients which has a typeface of at least the
          same size as the list of ingredients itself.
     (b) In the case of products for which no list of ingredients exists, the words
          "produced from genetically modified soya" or "produced from genetically
          modified maize", as appropriate, shall appear clearly on the labelling of the
          food.
                                                 £
 ---pagebreak---      (c) Where in accordancc with the provisions of the first indent of sub paragraph (b)
         of paragraph 5 of Article 6 of Directive 79/112/EEC an ingredient is designated
         by the name of a category, that designation shall be completed by the words
         "contains" or " may contain [ingredients] produced from genetically modified
         soya/genetically modified maize", as appropriate.
     (d) Where an ingredient of a compound ingredient is derived from the specified
         foodstuffs, it shall be mentioned on the labelling of the final product, with the
         addition of the wording shown in point (b).
     (e) By way of exception, where the presence in foods and food ingredients, of
         genetically modified produce subject to the labelling provisions of points (a) to
         (d), cannot be excluded but where no evidence of it is available, the use of the
         terms "may contain" or "may have been produced from" shall be considered to
         fulfil the requirements of those points.
4.   The first, second and third paragraphs shall be without prejudice to the other
     requirements of Community law concerning the labelling of foodstuffs.
                                          Article 3
Regulation (EC) 1813/97 is hereby repealed.
                                          Article 4
The labelling requirements of this Regulation shall not apply to products which have
been lawfully manufactured and labelled in the Community, or which have been lawfully
imported into the Community and put into free circulation, before the entry into force of
this Regulation.
                                          Article 5
This Regulation shall enter into force 20 days after its publication in the Official Journal
of the European Community.
This Regulation shall be binding in its entirety and directly applicable in all Member
States.
Done at,
        For the Council
                                           ^
 ---pagebreak---  ---pagebreak---                                                                    ISSN 0254-1475
                                                             COM(98) 99 final
                                             DOCUMENTS
EN                                                                03   10    15
                                    Catalogue number : CB-CO-98-104-EN-C
                                                              ISBN 92-78-31295-9
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