CELEX: 51998PC0339
Language: en
Date: 1998-06-02
Title: Proposal for a Council Decision concerning the provisional prohibition of the sale in Austria 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

COMMISSION OF THE EUROPEAN COMMUNITIES
                                                   Brussels, 02.06.1998
                                                   COM(1998) 339 final
                                      Proposal for a
                                 COUNCIL DECISION
                  concerning the provisional prohibition of the sale in
                  Austria of genetically modified maize (ZeamaysL.)         '
with the combined modification for insecticidal properties conferred by the Bt-endotoxin
          gene and increased tolerance to the herbicide glufosinate ammonium
                           (presented by the Commission)
 ---pagebreak---  ---pagebreak--- EXPLANATORY MEMORANDUM
     In accordance with Article 21 of Directive 90/220/EEC, the Commission
     adopted a Decision on the placing on the market of genetically modified maize
     notified by Ciba-Geigy on 23 January 1997. The Decision was taken following
     the opinions of the Scientific Committee for Pesticides (SCP), the Scientific
     Committee for Animal Nutrition (SCAN) and the Scientific Committee for
     Food (SCF).
     In accordance with Article 13 of the Directive, the Competent Authorities of
     France granted the necessary consent on 5 February 1997.
     On 17 February 1997 Austria informed the Commission that it had banned the
     sale of the Bt-maize in its territory with a Decree signed on 14 February.
     On 28 February 1997 the arguments of the Austrian Authorities which
     concerned potential adverse effects for human health and the environment from
     transfer of the antibiotic resistance gene as well as the possible development of
     insect resistance to Bt-toxin were submitted to the three relevant Scientific
     Committees which had originally examined the dossier with the following
     questions:
     a)       Does the information submitted by Austria constitute new relevant
             scientific evidence which was not taken into account by the
             Committees at the time their Opinions were delivered?
    b)       Would this information thus cause the Committees to consider that this
             product constitutes a risk to human health or the environment?
    The three Scientific Committees gave their Opinions on the information
    submitted on 21 March 1997 (SCF), 10 April 1997 (SCAN) and 12 May 1997
    (SCP). According to these Opinions, the information submitted by Austria
    does not constitute new evidence which would occasion a review of the
    Opinions of the Scientific Committees.
                                             e_
 ---pagebreak--- 6.  As a consequence, on 10 September 1997 the Commission adopted a draft
    Decision requesting Austria to repeal its national provision prohibiting the sale
    of the Bt-maize in its territory. This draft measure was then submitted to the
    Regulatory Committee under Article 21 of the Directive.
7.  On 13 April 1998 the Regulatory Committee, which was consulted by written
    procedure, failed to deliver an opinion on the Draft Commission Decision.
    According to Article 21 of the Directive, the Commission must therefore,
    without delay, submit to the Council a proposal relating to the measures to be
    taken. The Council shall act by qualified majority.
8.  The same Article stipulates that if, on the expiry of a period of three months
    from the date of the referral to the Council, the latter has not acted, the
    proposed measures shall be adopted by the Commission.
9^  In the framework of the adoption of its Decision on the placing on the market,
    the Commission decided on 18 December 1996 to launch a programme for
    monitoring insect resistance to Bt-maize. The Expert Group on monitoring
    insect resistance to Bt, established by the Competent Authorities under
    Directive 90/220/EEC, has developed a draft monitoring protocol intended to
    be applied when cultivation of Bt plants commences in the EC. The relevant
    Scientific Committees are fully involved in the preparation of this monitoring
    programme.
10. At the same time a subgroup of the Competent Authorities under Directive
    90/220/EEC has been set up to assess the general issue of any potential adverse
    effects for human health and the environment on the transfer of antibiotic
    resistance genes from plants to micro organisms. The relevant Scientific
    Committees are fully involved in this work.
                                                3
 ---pagebreak---                                       Proposal for a
                                 COUNCIL DECISION
                  concerning the provisional prohibition of the sale in
                  Austria 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
                             (Presented by the Commission)
                                         Is Vj^o
 ---pagebreak--- THE COUNCIL OF THE E U R O » * * UNION,
Having regardto the Treaty eitablishmg the Europtan Coow»mity,
Having regard to Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into
the environment of genetically modified organisms(1), as last amended by Commission Directive
97/35/EC^, and in particular Article 16 (2) thereof;
Having regard to the Proposal from the Commission,
Whereas 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/EEC^ it has been
decided that consent shall be given for the placing on the market of the product; *
Whereas on 5 February 1997 the French authorities granted such consent;
Whereas pursuant to Article 13 (5) of Directive 90/220/EEC, the product may be used
throughout the Community;
Whereas Austria provisionally prohibited the sale of genetically modified maize in question by
a measure which entered into force on 14 February 1997;
Whereas, on 17 February 1997 Austria informed the Commission and the other Member States
of such action and gave reasons for its decision relying on Article 16 (1) of Directive
90/220/EEC ;
Whereas the Commission must take a decision on the matter pursuant to Article 16 (2) of that
Directive;
 Whereas the Commission sought the opinions of the Scientific Committee for Animal Nutrition
 established by Commission Decision 76/791/EEC(4), of the Scientific Committee for Food
 established by Commission Decision 95/273/EEC(5), and of the Scientific Committee for
 Pesticides established by Commission Decision 78/436/EEC(6) on the information submitted by
 Austria;
 Whereas the Scientific Committees did not consider that the information submitted by Austria
 constituted new relevant scientific evidence which was not taken into account during the
 (,)
         OJN° LI 17, 8.5.1990, p.15.
 (2)
         OJ N° L169,27.6.1997, p.72.
 < 3)     OJN°L31,1.2.1997,p.69.
 (4)
         OJN° L279, 9.10.1976, p.35.
 (5)
          OJN°L167,18.7.1995, p.22.
 (6)
          OJN°L124,12.5.1978, p.16
 ---pagebreak--- original evaluation of the dossier and which would occasion a review of their original opinions
on this product;
Whereas the Austrian authorities submitted on 9 May 1997 additional information concerning
the likely rate of development of insect-resistance to the Bt-toxin;
Whereas the aspect of the environmental effects of the development of insect resistance to the
Bt-maize had already been fully considered by the Scientific Committee for Pesticides;
Whereas under the circumstances there is no reason to consider that the product constitutes a
risk to human health or the environment;
Whereas-the Austrian measures must therefore be repealed;
Whereas the Committee set up by Article 21 of Directive 90/220/EEC and consulted by written
procedure on 16 March 1998 has not delivered an opinion on the measures laid down in a draft
Commission decision,
 ---pagebreak--- HAS ADOPTED THIS DECISION:
                                               Article 1
Austria shall repeal at the latest 20 days after notification of this Decision its national provisions
which prohibit the placing on the market of the genetically modified maize covered by
Commission Decision 97/98/EC, to which the French authorities gave their consent on 5
February 1997.
                                               Article 2
This Decision is addressed to Austria.
Done at Brussels,
                                                                                  For the Council
 ---pagebreak---  ---pagebreak---                                                                   ISSN 0254-1475
                                                           COM(98) 339 final
                                             DOCUMENTS
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                                    Catalogue number : CB-C0-98-347-EN-C
                                                             ISBN 92-78-36553-X
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