2007/692/EC: Commission Decision of 24 October 2007 authorising the placing on the market of food and feed produced from genetically modified sugar beet H7-1 (KM-ØØØH71-4) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document number C(2007) 5125) (Text with EEA relevance )
Date: 2007-10-24
Institutions: European Commission
Subjects: animal nutrition, foodstuff, genetically modified organism, market approval, sugar beet

27.10.2007

EN

Official Journal of the European Union

L 283/69

COMMISSION DECISION

of 24 October 2007

authorising the placing on the market of food and feed produced from genetically modified sugar
beet H7-1 (KM-ØØØH71-4) pursuant to Regulation (EC) No 1829/2003 of the European Parliament
and of the Council

(notified under document number C(2007) 5125)

(Only the French, Dutch and German texts are authentic)

(Text with EEA relevance)

(2007/692/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Regulation (EC) No 1829/2003 of
the
the Council of 22 September
European Parliament and of
2003 on genetically modified food and feed (1), and in
particular Articles 7(3) and 19(3) thereof,

Whereas:

(1)

(2)

(3)

On 12 November 2004, KWS SAAT AG and Monsanto
Europe S.A. submitted to the competent authorities of
the United Kingdom an application, in accordance with
Articles 5 and 17 of Regulation (EC) No 1829/2003, for
the placing on the market of foods, food ingredients, and
feed produced from sugar beet H7-1 (the application).

The initial scope of the application also included beet
leaves and small pieces of roots resulting from the root
processing that may be fermented to produce silage for
animal feed. These products, which are not considered as
produced from GMOs but as containing or consisting of
GMOs, were removed from the scope of the application
by the applicants on 14 February 2006.

gave

(EFSA)

opinion

favourable

the placing on the market of

On 20 December 2006,
the European Food Safety
in
a
Authority
accordance with Articles 6 and 18 of Regulation
(EC) No 1829/2003 and concluded that it is unlikely
that
the products
produced from sugar beet H7-1, as described in the
application (the products) will have any adverse effects
on human or animal health or the environment in the
context of their intended uses (2). In its opinion, EFSA
considered all specific questions and concerns raised by
the Member States.

(1) OJ L 268, 18.10.2003, p. 1. Regulation as amended by Commission

Regulation (OJ L 368, 23.12.2006, p. 99).

(2) http://www.efsa.europa.eu/EFSA/

efsa_locale-1178620753816_1178620785055.htm

(4)

(5)

(6)

(7)

(8)

(9)

Taking into account those considerations, authorisation
should be granted for the products.

A unique identifier should be assigned to each GMO as
provided for
in Commission Regulation (EC) No
65/2004 of 14 January 2004 establishing a system for
the development and assignment of unique identifiers for
genetically modified organisms (3).

On the basis of the EFSA opinion, no specific labelling
requirements, other than those provided for in Articles
13(1) and 25(2) of Regulation (EC) No 1829/2003,
appear to be necessary.

Similarly,
justify the
the EFSA opinion does not
imposition of specific conditions or restrictions for the
placing on the market and/or specific conditions or
restrictions for the use and handling,
including post-
in
market monitoring requirements, as provided for
point (e) of Articles 6(5) and 18(5) of Regulation (EC)
No 1829/2003.

information on the authorisation of

All relevant
the
products should be entered in the Community register
of genetically modified food and feed, as provided for in
Regulation (EC) No 1829/2003.

In accordance with Articles 4(2) and 16(2) of Regulation
(EC) No 1829/2003, the conditions for authorisation of
the products are binding all persons placing them on the
market.

(10)

The Standing Committee on the Food Chain and Animal
Health has not delivered an opinion within the time limit
laid down by its chairman; the Commission has therefore
submitted a proposal to the Council on 25 June 2007 in
of Council Decision
accordance with Article
1999/468/EC (4),
the Council being required to act
within three months.

5

(3) OJ L 10, 16.1.2004, p. 5.
(4) OJ L 184, 17.7.1999, p. 23.

L 283/70

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Official Journal of the European Union

27.10.2007

(11) However, the Council has not acted within the required
time limit; a decision should now be adopted by the
Commission,

Article 5

Authorisation holders

HAS ADOPTED THIS DECISION:

1.

The authorisation holders shall be:

(a) KWS SAAT AG, Germany;

Article 1

and

Genetically modified organism and unique identifier

Genetically modified sugar beet (Beta vulgaris subsp. vulgaris)
H7-1, as specified in point (b) of the Annex to this Decision,
is assigned the unique identifier KM-ØØØH71-4, as provided
for in Regulation (EC) No 65/2004.

Article 2

Authorisation

The following products are authorised for the purposes of
Articles 4(2) and 16(2) of Regulation (EC) No 1829/2003, in
accordance with the conditions set out in this Decision:

(a)

foods and food ingredients produced from KM-ØØØH71-4
sugar beet;

(b) Monsanto Europe S.A., Belgium,

representing Monsanto

Company, United States of America.

Both authorisation holders

2.
for
fulfilling the duties imposed on authorisation holders by this
Decision and Regulation (EC) No 1829/2003.

responsible

shall be

Article 6

Validity

This Decision shall apply for a period of 10 years from the date
of its notification.

Article 7

Addressees

(b) feed produced from KM-ØØØH71-4 sugar beet.

This Decision is addressed to:

(a) KWS SAAT AG, Grimsehlstrasse 31, D-37574 Einbeck,

Article 3

Labelling

Germany;

and

For the purposes of
the specific labelling requirements laid
and 25(2) of Regulation (EC)
down in Articles 13(1)
No 1829/2003, the ‘name of the organism’ shall be ‘sugar beet’.

(b) Monsanto Europe S.A., Scheldelaan 460, Haven 627,

B-2040 Antwerp, Belgium.

Article 4

Community register

Done at Brussels, 24 October 2007.

The information set out in the Annex to this Decision shall be
entered in the Community register of genetically modified food
and feed, as provided for in Article 28 of Regulation (EC)
No 1829/2003.

For the Commission

Markos KYPRIANOU
Member of the Commission

27.10.2007

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Official Journal of the European Union

L 283/71

ANNEX

(a) Applicants and Authorisation holders:

Name:

KWS SAAT AG

Address: Grimsehlstrasse 31, D-37574 Einbeck, Germany

and

Name: Monsanto Europe S.A.

Address: Scheldelaan 460, Haven 627, B-2040 Antwerp, Belgium

On behalf of Monsanto Company — 800 N. Lindbergh Boulevard — St. Louis, Missouri 63167 — United States of
America.

(b) Designation and specification of the products:

(1) Foods and food ingredients produced from KM-ØØØH71-4 sugar beet;

(2) Feed produced from KM-ØØØH71-4 sugar beet.

The genetically modified KM-ØØØH71-4 sugar beet, as described in the application, expresses the CP4 EPSPS protein
after insertion of the cp4 epsps gene from Agrobacterium sp. strain CP4 into sugar beet (Beta vulgaris subsp. vulgaris).

The CP4 EPSPS protein confers tolerance to glyphosate containing herbicides.

(c) Labelling:

For the purposes of the specific labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No
1829/2003, the ‘name of the organism’ shall be ‘sugar beet’.

(d) Method for detection:

— Event specific realtime PCR-based method for the quantification of KM-ØØØH71-4 sugar beet.

— Validated on seeds by the Community reference laboratory established under Regulation (EC) No 1829/2003,

published at http://gmo-crl.jrc.it/statusofdoss.htm

— Reference Material: ERM®-BF419 accessible via the Joint Research Centre (JRC) of the European Commission, the

Institute of Reference Materials and Measurements (IRMM) at
http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm

(e) Unique identifier:

KM-ØØØH71-4

(f)

Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological
Diversity:

Not applicable.

(g) Conditions or restrictions on the placing on the market, use or handling of the products:

Not required.

(h) Monitoring plan

Not applicable.

(i) Post-market monitoring requirements for the use of the food for human consumption

Not required.

Note:

links to relevant documents may need to be modified over the time. Those modifications will be made available to
the public via the updating of the Community register of genetically modified food and feed.