2008/280/EC: Commission Decision of 28 March 2008 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize GA21 (MON-ØØØ21-9) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document number C(2008) 1112)
Date: 2006-03-28
Institutions: European Commission
Subjects: United Kingdom, food safety, foodstuff, foodstuffs legislation, genetically modified organism, labelling, maize, market approval

29.3.2008

EN

Official Journal of the European Union

L 87/19

COMMISSION DECISION

of 28 March 2008

authorising the placing on the market of products containing, consisting of, or produced from
genetically modified maize GA21 (MON-ØØØ21-9) pursuant to Regulation (EC) No 1829/2003 of
the European Parliament and of the Council

(notified under document number C(2008) 1112)

(Only the French text is authentic)

(2008/280/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

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 Article 7(3) and Article 19(3) thereof,

Whereas:

is unlikely that

the placing on the market of

On 2 October 2007, the European Food Safety Authority
(EFSA) gave a single comprehensive favourable opinion
for both applications in accordance with Articles 6 and
18 of Regulation (EC) No 1829/2003 and concluded that
it
the
products containing, consisting of, or produced from
(the
GA21 maize as described in the applications
products) will have adverse effects on human or animal
In its opinion, EFSA
health or
considered all specific questions and concerns raised by
the Member States in the context of the consultation of
the national competent authorities provided for by
Articles 6(4) and 18(4) of that Regulation.

the environment (3).

(1)

(2)

(3)

On 29 July 2005, Syngenta Seeds S.A.S., on behalf of
Syngenta Crop Protection AG,
to the
competent authorities of the United Kingdom an appli-
in accordance with Articles 5 and 17 of Regu-
cation,
lation (EC) No 1829/2003, for the placing on the market
of
containing,
consisting of, or produced from GA21 maize.

ingredients,

submitted

foods,

food

feed

and

cultivation. Therefore,

it
by Annexes

That application also covers the placing on the market of
other products containing or consisting of GA21 maize
for the same uses as any other maize with the exception
in accordance with the
of
provision of Articles 5(5) and 17(5) of Regulation (EC)
includes the data and information
No 1829/2003,
IV to Directive
required
2001/18/EC of
the
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

III

On 17 April 2007, Syngenta Seeds S.A.S., on behalf of
to the
Syngenta Crop Protection AG,
Commission an application, in accordance with Articles
8(4) and 20(4) of Regulation (EC) No 1829/2003, for the
authorisation of existing products produced from GA21
maize (food additives, feed materials and feed additives
produced from GA21 maize).

submitted

(5)

(6)

(7)

(8)

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 the foods, food ingredients,
and feed containing, consisting of, or produced from
GA21 maize. However,
in order to ensure the use of
the products within the limits of authorisation provided
by this Decision,
feed containing or
the labelling of
consisting of the GMO and other products than food
the GMO for
and feed containing or consisting of
which authorisation is
comp-
the products in
lemented by a clear indication that
question must not be used for cultivation.

requested should be

(1) OJ L 268, 18.10.2003, p. 1. Regulation as amended by Commission
Regulation (EC) No 1981/2006 (OJ L 368, 23.12.2006, p. 99).
(2) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation

(EC) No 1830/2003 (OJ L 268, 18.10.2003, p. 24).

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

1178620785956.htm
(4) OJ L 10, 16.1.2004, p. 5.

L 87/20

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Official Journal of the European Union

29.3.2008

(9)

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

(10) All relevant

information on the authorisation of

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

(11) 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

(12)

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 Article 9(1) and Article 15(2)(c), of Regu-
lation (EC) No 1946/2003 of the European Parliament
and of the Council of 15 July 2003 on transboundary
movements of genetically modified organisms (2).

(13)

The Standing Committee on the Food Chain and Animal
Health did not deliver an opinion within the time limit
laid down by its Chairman. The Commission therefore
submitted to the Council a proposal relating to these
measures.

(14) At its meeting on 18 February 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 and that the
Commission could finalise the decision-making process.
It
the
measures,

the Commission to adopt

is accordingly for

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

HAS ADOPTED THIS DECISION:

Article 1

Genetically modified organism and unique identifier
Genetically modified maize (Zea mays L.) GA21, as specified in
point (b) of the Annex to this Decision, is assigned the unique
identifier MON-ØØØ21-9, 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-ØØØ21-9 maize;

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

ØØØ21-9 maize;

(c) products, other than food and feed, containing or consisting
of MON-ØØØ21-9 maize for the same uses as any other
maize 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 ‘maize’.

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

2.
and in documents accompanying products
consisting
Article 2(b) and (c).

of MON-ØØØ21-9 maize

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 the point (h) of the
Annex, is put in place and implemented.

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Official Journal of the European Union

L 87/21

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

Article 7

Validity

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.

Article 6

Authorisation holder

The authorisation holder shall be Syngenta Seeds S.A.S., France,
representing Syngenta Crop Protection AG, Switzerland.

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

Article 8

Addressee

This Decision is addressed to Syngenta Seeds S.A.S., Chemin de
l’Hobit 12, BP 27, F-31790 Saint-Sauveur, France.

Done in Brussels, 28 March 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

L 87/22

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29.3.2008

ANNEX

(a) Applicant and Authorisation holder:

Name:

Syngenta Seeds S.A.S.

Address:

Chemin de l’Hobit 12, BP 27, F-31790 Saint-Sauveur, France

On behalf of Syngenta Crop Protection AG, Schwarzwaldallee 215, CH 4058 Basle, Switzerland

(b) Designation and specification of the products:

(1) Foods and food ingredients containing, consisting of, or produced from MON-ØØØ21-9 maize;

(2) Feed containing, consisting of, or produced from MON-ØØØ21-9 maize;

(3) Products other than food and feed containing or consisting of MON-ØØØ21-9 maize for the same uses as any

other maize with the exception of cultivation.

The genetically modified maize MON-ØØØ21-9, as described in the application, expresses the mEPSPS protein which
confers tolerance to herbicide glyphosate

(c) 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 ‘maize’.

(2) The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing

or consisting of MON-ØØØ21-9 maize referred to in Article 2(b) and (c).

(d) Method for detection:

— Event specific real-time quantitative PCR based methods for genetically modified maize MON-ØØØ21-9,

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

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

— Reference Material: AOCS 0407-A and AOCS 0407-B accessible via the American Oil Chemists Society (AOCS) at

http://www.aocs.org

(e) Unique identifier:

MON-ØØØ21-9

(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.

Note:

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