98/292/EC: Commission Decision of 22 April 1998 concerning the placing on the market of genetically modified maize (Zea mays L. line Bt-11), pursuant to Council Directive 90/220/EEC (Text with EEA relevance)
Date: 1998-04-22
Institutions: European Commission
Subjects: United Kingdom, food inspection, genetically modified organism, maize, market approval

L 131/28

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 Bt-11), pursuant to Council Directive 90/220/EEC

(Text with EEA relevance)

(98/292/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,

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 the United Kingdom;

Whereas the product has been notified for handling in
the environment during import and storage consistent
with its use as an animal feed and the production of
industrial and food products but not for further grain
production;

the

the United
Whereas
Kingdom have
subsequently forwarded the dossier
thereon to the Commission with a favourable opinion;

authorities of

competent

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

Whereas, as the product will enter the market of the
Community mixed with other maize grain,
including
non-genetically modified maize grain, the notifier subse-
quently modified the proposed labelling in the original
dossier as follows:

(cid:190) exporters from countries where the product is grown,
importers into the Community as well as the food and
feed processing industry in the Community will be
provided with product documentation informing
them the possibility that the product may be present
in bulk maize consigments,

(cid:190) the product documentation to be provided will
include, among others, information that the product
has been produced by genetic modification as well as
information on the potential uses of the product,

(cid:190) the product documentation will also indicate that
specific labelling requirements may be applicable in
the Community for products derived from maize line
Bt-11;

Whereas,
original dossier with further information;

the notifier subsequently supplemented the

Whereas, 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 import of this
product with the aim of use as any other maize grain is
likely to cause any adverse effects on human health and
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 synthetic cryIA (b) gene
expressing resistance to certain lepidopteran pests and the
synthetic pat gene expressing increased tolerance to
glufosinate ammonium herbicides;

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.

5. 5. 98

EN

Official Journal of the European Communities

L 131/29

HAS ADOPTED THIS DECISION:

Article 1

1. Without prejudice to other Community legislation,
in particular Regulation (EC) No 258/97 of the European
Parliament and the Council (1), and subject to paragraphs
2 and 3 of this Article, consent shall be given by the
competent authorities of the United Kingdom to the
placing on the market of the following product, notified
by Novartis Seeds Inc.

(Ref. C/GB/96/M4/1):

(b) a synthetic version of the pat gene derived from Strep-
tomyces viridochromogenes under the control of a 35S
promoter from Cauliflower Mosaic Virus, an IVS 2
intron from the maize alcohol dehydrogenase gene
and the nopaline synthase terminator sequence of
Agrobacterium tumefaciens.

The consent

2.
from progenies
shall cover grains
derived from crosses of maize line Bt-11 with any tradi-
tionally bred maize imported into the Community.

3.
The consent shall cover the placing on the market of
the product to be used as any other maize grain but not
for cultivation.

grains
of
containing:

genetically modified maize

line Bt-11

Article 2

This Decision is addressed to the Member States.

(a) a synthetic version of the cryIA (b) gene derived from
Bacillus thuringiensis subsp. kurstaki strain HD1
under the control of a 35S promoter from Cauliflower
Mosaic Virus, and IVS 6 intron from the maize
alcohol dehydrogenase
and the nopaline
synthase
sequence of Agrobacterium
tumefaciens, and

terminator

gene

Done at Brussels, 22 April 1998.

For the Commission

Ritt BJERREGAARD

Member of the Commission

(1) OJ L 43, 14. 2. 1997, p. 1.