2008/933/EC: Commission Decision of 4 December 2008 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON89788 (MON-89788-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document number C(2008) 7517) (Text with EEA relevance)
Date: 2008-12-04
Institutions: European Commission
Subjects: animal nutrition, food safety, foodstuff, genetically modified organism, labelling, market approval, marketing, soya bean

11.12.2008

EN

Official Journal of the European Union

L 333/7

COMMISSION DECISION

of 4 December 2008

authorising the placing on the market of products containing, consisting of, or produced from
to Regulation (EC) No
genetically modified soybean MON89788 (MON-89788-1) pursuant

1829/2003 of the European Parliament and of the Council

(notified under document number C(2008) 7517)

(Only the French and Dutch texts are authentic)

(Text with EEA relevance)

(2008/933/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

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

Whereas:

(1)

(2)

On 31 October 2006, Monsanto Europe S.A. submitted
to the competent authority of the Netherlands an appli­
cation,
in accordance with Articles 5 and 17 of Regu­
lation (EC) No 1829/2003, for the placing on the market
of
containing,
consisting of, or produced from MON89788 soybean
(the application).

ingredients,

foods,

food

feed

and

it

includes

The application also covers the placing on the market of
other products containing or consisting of MON89788
soybean for the same uses as any other soybean with the
exception of cultivation. Therefore,
in accordance with
and 17(5) of Regulation (EC) No
Articles 5(5)
and information
1829/2003,
required
IV to Directive
the
2001/18/EC of
Council of 12 March 2001 on the deliberate release
into the environment of genetically modified organisms
and repealing Council Directive 90/220/EEC (2) and
information and conclusions about the risk assessment
carried out in accordance with the principles set out in
Annex II to Directive 2001/18/EC.

and
the European Parliament and of

the data
III

by Annexes

(3)

On 11 July 2008, the European Food Safety Authority
(EFSA) gave a favourable opinion in accordance with

it

Articles 6 and 18 of Regulation (EC) No 1829/2003 and
concluded that
the placing on the
is unlikely that
market of
the products containing, consisting of, or
produced from MON89788 soybean 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 (3). In its opinion,
EFSA considered all the specific questions and concerns
raised by the Member States in the context of the consul­
tation of the national competent authorities as provided
for by Articles 6(4) and 18(4) of that Regulation.

In its opinion, EFSA also concluded that the environmen­
tal monitoring plan, consisting of a general surveillance
plan, submitted by the applicant
is in line with the
intended use of the products.

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

A unique identifier should be assigned to each GMO as
in Commission Regulation (EC) No
provided for
65/2004 of 14 January 2004 establishing a system for
the development and assignment of unique identifiers for
genetically modified organisms (4).

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 for foods, food ingredients and
consisting of, or produced from
feed containing,
MON89788 soybean. However,
in order to ensure the
use of the products within the limits of the authorisation
the labelling of
provided for by this Decision,
feed
containing or consisting of
the GMO and products
other than food and feed containing or consisting of
the GMO for which authorisation is requested should
the
be
products in question must not be used for cultivation.

complemented by a

indication that

clear

(4)

(5)

(6)

(7)

(1) OJ L 268, 18.10.2003, p. 1.
(2) OJ L 106, 17.4.2001, p. 1.

(3) http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753816_

1178620787358.htm
(4) OJ L 10, 16.1.2004, p. 5.

L 333/8

EN

Official Journal of the European Union

11.12.2008

(8)

Similarly, the EFSA opinion does not justify the impo­
sition of specific conditions or restrictions for the placing
on the market and/or specific conditions or restrictions
for the use and handling,
including post-market moni­
toring requirements, or of specific conditions for the
protection of particular ecosystems/environment and/or
geographical areas, as provided for
(e) of
Articles 6(5)
and 18(5) of Regulation (EC) No
1829/2003.

in point

(9)

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.

of

Parliament

(10) Article 4(6) of Regulation (EC) No 1830/2003 of the
of
and
European
22 September 2003 concerning the traceability and
labelling of genetically modified organisms and the trace­
ability of
food and feed products produced from
genetically modified organisms and amending Directive
2001/18/EC (1),
lays down labelling requirements for
products consisting of, or containing GMOs.

Council

the

(11)

This Decision is to be notified through the Biosafety
Clearing-House to the Parties to the Cartagena Protocol
on Biosafety to the Convention on Biological Diversity,
pursuant to Articles 9(1) and 15(2)(c) of Regulation (EC)
No 1946/2003 of the European Parliament and of the
Council of 15 July 2003 on transboundary movements
of genetically modified organisms (2).

(12)

The applicant has been consulted on the measures
provided for in this Decision.

(13)

The Standing Committee on the Food Chain and Animal
Health has not delivered an opinion within the time limit
laid down by its Chairman.

(14) At its meeting on 19 November 2008, the Council was
unable to reach a decision by qualified majority either for
or against the proposal. The Council
indicated that its
proceedings on this file were concluded. It is accordingly
for the Commission to adopt the measures,

HAS ADOPTED THIS DECISION:

Article 1

Genetically modified organism and unique identifier
Genetically modified soybean (Glycine max) MON89788, as
is
specified in point

the Annex to this Decision,

(b) of

(1) OJ L 268, 18.10.2003, p. 24.
(2) OJ L 287, 5.11.2003, p. 1.

assigned the unique identifier MON-89788-1, 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 containing, consisting of, or
produced from MON-89788-1 soybean;

(b) feed containing, consisting of, or produced from MON-

89788-1 soybean;

(c) products other than food and feed containing or consisting
of MON-89788-1 soybean for the same uses as any other
soybean with the exception of cultivation.

Article 3

Labelling

1.
For the purposes of the labelling requirements laid down
in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003
and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name
of the organism’ shall be ‘soybean’.

The words ‘not for cultivation’ shall appear on the label of
containing or
in

2.
and in documents accompanying products
consisting
of MON-89788-1
Article 2(b) and (c).

soybean

referred

to

Article 4

Monitoring for environmental effects

1.
The authorisation holder shall ensure that the monitoring
plan for environmental effects, as set out in point (h) of the
Annex, is put in place and implemented.

2.
The authorisation holder shall submit to the Commission
annual reports on the implementation and the results of the
activities set out in the monitoring plan.

Article 5

Community register

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.

11.12.2008

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Official Journal of the European Union

L 333/9

Article 6

Authorisation holder

Article 8

Addressee

The authorisation holder
shall be Monsanto Europe S.A.,
Belgium, representing Monsanto Company, United States of
America.

This Decision is addressed to Monsanto Europe S.A., Avenue de
Tervuren 270-272, B-1150 Brussels.

Article 7

Validity

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

Done at Brussels, 4 December 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

L 333/10

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Official Journal of the European Union

11.12.2008

ANNEX

(a) Applicant and authorisation holder:

Name:

Monsanto Europe S.A.

Address:

Avenue de Tervuren 270-272, B-1150 Brussels

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 containing, consisting of, or produced from MON-89788-1 soybean;

2. feed containing, consisting of, or produced from MON-89788-1 soybean;

3. products other than food and feed containing or consisting of MON-89788-1 soybean for the same uses as any

other soybean with the exception of cultivation.

The genetically modified MON-89788-1 soybean, as described in the application, expresses the CP4 EPSPS protein
which confers tolerance to the glyphosate herbicide.

(c) Labelling:

1. for the purposes of the specific labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No
1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’;

2. the words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or

consisting of MON-89788-1 soybean referred to in Article 2(b) and (c) of this Decision.

(d) Method for detection:

— event specific real-time PCR based method for the quantification of MON-89788-1 soybean,

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

published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm

— reference material: AOCS 0906-A and AOCS 0906-B accessible via the American Oil Chemists Society at

http://www.aocs.org/tech/crm/soybean.cfm

(e) Unique identifier:

MON-89788-1

(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological

Diversity:
Biosafety Clearing-House, Record ID: see (to be completed when notified).

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

Not required.

(h) Monitoring plan:

Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

(Link: plan published on the Internet)

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

Not required.

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