98/294/EC: Commission Decision of 22 April 1998 concerning the placing on the market of genetically modified maize (Zea mays L. line MON 810), pursuant to Council Directive 90/220/EEC (Text with EEA relevance)
Date: 1998-04-22
Institutions: European Commission
Subjects: France, food inspection, food safety, genetically modified organism, health risk, maize, market approval, product safety

L 131/32

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.
line MON 810), pursuant to Council Directive 90/220/EEC

(Text with EEA relevance)

(98/294/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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,

Wheras Articles 10 to 18 of Directive 90/220/EEC lay
down a Community procedure enabling the competent
authority 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 state on all the seed bags that they contain seeds of
maize obtained by genetic modification in order to
render the maize resistant through the expression of a
toxin from bacillus thuringiensis,

(cid:190) to provide all purchasers of such seeds with a tech-
nical guide containing comprehensive information on
the development, mode of action and use of the seeds,
including the use of biotechnology in their develop-
ment and the necessity for prescribed insect-resis-
tance-management practices,

(cid:190) to inform European grain traders of the authorisation
of maize line MON 810 and to provide them with full
product information,

(cid:190) to inform international maize traders in those coun-
tries where maize line MON 810 is authorised for
production, that this maize has been authorised for
production, that it has been developed using genetic
modification techniques and that shipments of grains
may contain genetically modified grains,

(cid:190) to inform international

trades and the appropriate
authorities of countries exporting maize that any state-
ments accompanying international shipments must be
in compliance with the requirements of Directive 90/
220/EEC,

(cid:190) to recommend that statements accompanying inter-
national shipments include the wording ‘may contain
genetically modified grains';

Whereas, the notifier has defined a management strategy
in order to minimise the development of insect resistance
and has offered to inform the Commission and/or the
Competent Authorities of Member States of the results of
monitoring of this aspect;

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
Scientific 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 concluded that
there is no reason to believe that there will be any adverse
effects on human health or the environment from the
introduction into maize of the gene cryIA (b) coding for
insect protection;

(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.

5. 5. 98

EN

Official Journal of the European Communities

L 131/33

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,

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 Monsanto
Europe SA (Ref. C/F/95/12-02):

inbred lines and hybrids derived from maize line MON
810 containing the cryIA (b) gene from Bacillus thurin-
giensis subsp. kurstaki under the control of the enhanced
35S promoter from cauliflower mosaic virus and an intron
from the gene coding for the heat shock protein 70 from
maize.

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.