98/293/EC: Commission Decision of 22 April 1998 concerning the placing on the market of genetically modified maize (Zea mays L. T25), pursuant to Council Directive 90/220/EEC (Text with EEA relevance)
Date: 1998-04-22
Institutions: European Commission
Subjects: France, food inspection, genetically modified organism, maize, market approval

L 131/30

EN

Official Journal of the European Communities

5. 5. 98

COMMISSION DECISION

of 22 April 1998

concerning the placing on the market of genetically modified maize (Zea mays L.
T25), pursuant to Council Directive 90/220/EEC

(Text with EEA relevance)

(98/293/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Whereas,
original dossier with further information;

the notifier subsequently supplemented the

Having regard to the Treaty establishing the European
Community,

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 (2), and in particular
Article 13 thereof,

Whereas Articles 10 to 18 of Directive 90/220/EEC lay
down a Community procedure enabling the competent
authorities of a Member State to give consent to the
placing on the market of products containing, or
consisting of, genetically modified organisms;

Whereas a notification concerning the placing on the
market of such a product has been submitted to the
competent authorities of France;

Whereas the competent authorities of France have subse-
quently forwarded the dossier thereon to the Commission
with a favourable opinion;

Whereas the competent authorities of other Member
States have raised objections to the said dossier;

Whereas the notifier subsequently modified the proposed
labelling in the original dossier as follows:

(cid:190) to mention on the seed bags to be sold to farmers that
the product has been genetically modified to make it
tolerant to the herbicide glufosinate ammonium,

(cid:190) to indicate either on the label of seed bags to be sold
to farmers or in the accompanying documentation
that because of
the original genetic modification
specific labelling requirements may be applicable for
the harvested material, and

(cid:190) to provide information relating to the genetically
modified crops subject to this notification produced
by or under licence from Hoechst Schering AgrEvo
GmbH outside the Community, to those companies
which are known to import the crops concerned into
the Community for processing;

Whereas, therefore, in accordance with Article 13(3) of
Directive 90/220/EEC, the Commission is required to
take a decision in accordance with the procedure laid
down in Article 21 of that Directive;

Whereas the Commission sought the opinion of the rel-
evant Scientific Committees established by Commission
Decision 97/579/EC (3) on this dossier; whereas
the
opinion was delivered on 10 February 1998 by the Sci-
entific Committee on Plants which concluded that there
is no reason to believe that the placing on the market of
the product would have any adverse effects on human
health or the environment;

Whereas the Commission, having examined each of the
objections raised in the light of Directive 90/220/EEC,
the information submitted in the dossier and the opinion
of the Scientific Committee on Plants, has reached the
conclusion that there is no reason to believe that there
will be any adverse effects on human health or the envir-
onment from the introduction into maize of the gene
coding for phosphinotricine-acetyl-transferase and the
truncated gene coding for beta-lactamase;

Whereas the authorisation of chemical herbicides applied
to plants and the assessment of the impact of their use on
human health and the environment falls within the scope
of Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection products on
the market (4), as last amended by Commission Directive
97/73/EC (5), and not within the scope of Directive 90/
220/EEC;

Whereas Article 11(6) and Article 16(1) of Directive 90/
220/EEC provide additional safeguards if new informa-
tion on risks of the product becomes available;

Whereas the measures provided for in this Decision are in
accordance with the opinion of the committee established
under Article 21 of Directive 90/220/EEC,

(1) OJ L 117, 8. 5. 1990, p. 15.
(2) OJ L 169, 27. 6. 1997, p. 72.

(3) OJ L 237, 28. 8. 1997, p. 18.
(4) OJ L 230, 19. 8. 1991, p. 1.
(5) OJ L 353, 24. 12. 1997, p. 26.

5. 5. 98

EN

Official Journal of the European Communities

L 131/31

HAS ADOPTED THIS DECISION:

Article 1

1. Without prejudice to other Community legislation,
in particular Council Directives 66/402/EEC (1) and 70/
457/EEC (2) and Regulation (EC) No 258/97 of the Euro-
pean Parliament and the Council (3), and subject to para-
graph 2 of this Article, consent shall be given by the
competent authorities of France to the placing on the
market of
the following product, notified by AgrEvo
France (Ref. C/F/95/12/07):

seeds and grains of genetically modified maize (Zea mays
L.) with increased glufosinate ammonium tolerance
derived from the maize line HE/89 transformation event
T25 which has been transformed using plasmid pUC/Ac
containing:

(a) a synthetic pat gene coding for phosphinothricine
the regulation of a 35S
acetyl
promoter and terminator sequences from Cauliflower
Mosaic Virus, and

transferase under

(b) a truncated beta-lactamase gene missing about 25 %
of the gene from the 5Y end, which when complete,
codes for betalactam antibiotic resistance and the Col
E1 origin of replication of pUC.

2.
The consent shall cover any progeny derived from
crosses of the product with any traditionally bred maize.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 22 April 1998.

For the Commission

Ritt BJERREGAARD

Member of the Commission

(1) OJ 125, 11. 7. 1966, p. 2309/66.
(2) OJ L 225, 12. 10. 1970, p. 1.
(3) OJ L 43, 14. 2. 1997, p. 1.