98/291/EC: Commission Decision of 22 April 1998 concerning the placing on the market of genetically modified spring swede rape (Brassica napus L. ssp. oleifera), 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, market approval, oil seed rape, seed

L 131/26

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 spring swede rape
(Brassica napus L. ssp. oleifera), pursuant to Council Directive 90/220/EEC

(Text with EEA relevance)

(98/291/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,

GmbH, may be present in bulk swede rape consign-
ments,

(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 genetically
modified swede rape;

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 organims;

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

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 raised objections to the said dossier;

Whereas subsequently the notifier formally requested that
the scope of the notification be limited to ‘handling of
the product during import and before and during storage
and processing';

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

(cid:190) those companies which are known to import

for
processing the product into the Community will be
provided with product documentation informing
them of the possibility that the product covered by
the notification and produced outside the Community
by or under licence from Hoechst Schering AgrEvo

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
the
there is no reason to believe that
product with the aim of processing would have any effects
on human health or the environment;

the import of

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 en-
vironment from the handling of the product in the en-
vironment during import and before and during storage
and processing;

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 131/27

(b) an npt II gene coding for neomycin phosphotrans-
ferase II under the regulation of the nopaline synthase
promoter
terminator
sequence.

and on actopine

synthase

The consent shall cover the placing on the market of
2.
the product or handling in the environment during
import and before and during storage and processing.

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

HAS ADOPTED THIS REGULATION:

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 paragraph 2
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 AgrEvo UK
Crop Protection (Ref. C/UK/95/M5/1):

seeds of spring swede rape (Brassica napus L. spp. olei-
fera) derived from traditional breeding crosses between
non-genetically modified swede rape and a line resulting
from transformation event Topas 19/2 which has been
transformed using plasmid pOCA/AC containing:

(a) a synthetic pat gene coding for phosphinothricin
acetyltransferase under the regulation of 35S promoter
and terminator sequences from cauliflower mosaic
virus, and

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