2007/701/EC: Commission Decision of 24 October 2007 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize NK603xMON810 (MON-ØØ6Ø3-6xMON-ØØ81Ø-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document number C(2007) 5140) (Text with EEA relevance)
Date: 2007-10-24
Institutions: European Commission
Subjects: animal nutrition, food inspection, foodstuff, genetically modified organism, labelling, maize, market approval

31.10.2007

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Official Journal of the European Union

L 285/37

(Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory)

II

DECISIONS

COMMISSION

COMMISSION DECISION

of 24 October 2007

authorising the placing on the market of products containing, consisting of, or produced from
to
genetically modified maize NK603xMON810 (MON-ØØ6Ø3-6xMON-ØØ81Ø-6) pursuant

Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under document number C(2007) 5140)

(Only the French and Dutch texts are authentic)

(Text with EEA relevance)

(2007/701/EC)

THE COMMISSION OF THE EUROPEAN UNION,

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:

(3)

(1)

(2)

On 1 June 2004, 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 containing,
consisting of, or produced from NK603xMON810 maize
(‘the application’).

The application also covers the placing on the market
of
containing
of

consisting

products

other

or

NK603xMON810 maize for the same uses as any other
in
maize with the exception of cultivation. Therefore,
accordance with the provision of Articles 5(5) and
17(5) of Regulation (EC) No 1829/2003, it includes the
data and information required by Annexes III and IV to
Directive 2001/18/EC of the European Parliament and of
the Council of 12 March 2001 on the deliberate release
into
genetically modified
organisms (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.

environment

the

of

On 31 March 2006, the European Food Safety Authority
(‘EFSA’) gave favourable opinions in accordance with
Articles 6 and 18 of Regulation (EC) No 1829/2003
and concluded that it is unlikely that the placing on
the market of the products containing, consisting of, or
produced from NK603xMON810 maize as described in
the application (‘the products’) will have adverse effects
on human or animal health or the environment (3). In its
opinion, EFSA concluded that it was acceptable to use
the data for the single events in support of the safety of
the products and 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 Regu-
lation.

(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).

(3) http://www.efsa.europa.eu/EFSA/efsa_locale-
1178620753812_1178620784153.htm

(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).

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Official Journal of the European Union

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(4)

(5)

(6)

(7)

(8)

(9)

In October 2006, upon request of the Commission, EFSA
published detailed clarifications on how the comments of
the competent authorities of the Member States had been
taken into account
It also published
in its opinion.
further information on the different elements considered
by
on Genetically Modified
Organisms of EFSA and the reason why some specific
additional studies such as a 90-day toxicology study in
rats were not considered as necessary.

Scientific

Panel

the

In its opinion, EFSA also concluded that the environ-
mental monitoring plans,
a general
surveillance plan, submitted by the applicant is in line
with the intended use of the products.

consisting of

(11) Article 4(6) of Regulation (EC) No 1830/2003 of the
the Council of 22
European Parliament
and of
September 2003 concerning
and
traceability
the
labelling of genetically modified organisms and the trace-
food and feed products produced from
ability of
genetically modified organisms and amending Directive
2001/18/EC (2),
lays down labelling requirements for
products consisting or containing GMOs.

(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 (3).

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

(13)

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 (1).

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 12
July 2007 in accordance with Article 5 of the Council
Decision 1999/468/EC (4), the Council being required to
act within three months.

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,
consisting, or produced from
and feed containing,
in order to ensure
NK603xMON810 maize. However,
the use of the products within the limits of authorisation
the
provided by
feed
labelling of
containing or
the GMO and other
products than food and feed containing or consisting
requested
of
should be complemented by a clear indication that the
products in question must not be used for cultivation.

the GMO for which authorisation is

this Decision,
consisting of

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
including post-market moni-
for the use and handling,
toring requirements, or of specific conditions for the
protection of particular ecosystems/environment and/or
(e) of
geographical areas, as provided for
Articles
(EC)
and
6(5)
No 1829/2003.

in point
Regulation

18(5)

of

(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.

(1) OJ L 10, 16.1.2004, p. 5.

(14) However, the Council has not acted within the required
adopted by the
a Decision should be

time-limit;
Commission,

HAS ADOPTED THIS DECISION:

Article 1

Genetically modified organism and unique identifier

crosses between maize

Genetically modified maize (Zea mays L.) NK603xMON810
produced by
containing MON-
ØØ6Ø3-6 and MON-ØØ81Ø-6 events, as specified in point
(b) of the Annex to this Decision, is assigned the unique iden-
in
tifier MON-ØØ6Ø3-6xMON-ØØ81Ø-6, as provided for
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 1829/2003, in accordance
with the conditions set out in this Decision:

(a)

foods and food ingredients containing, consisting of, or
produced from MON-ØØ6Ø3-6xMON-ØØ81Ø-6 maize;

(2) OJ L 268, 18.10.2003, p. 24.
(3) OJ L 287, 5.11.2003, p. 1.
(4) OJ L 184, 17.7.1999, p. 23. Decision as last amended by Decision

2006/512/EC (OJ L 200, 22.7.2006, p. 11).

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

ØØ6Ø3-6xMON-ØØ81Ø-6 maize;

Article 5

Community register

(c) products, other than food and feed, containing or consisting
of MON-ØØ6Ø3-6xMON-ØØ81Ø-6 maize for the same
uses as any other maize with the exception of cultivation.

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 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
2.
and in documents accompanying products
containing or
consisting of MON-ØØ6Ø3-6xMON-ØØ81Ø-6 maize referred
to in Article 2(b) and (c).

Article 4

Monitoring for environmental effects

Article 6

Authorisation holder

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

Article 7

Validity

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

Article 8

Addressee

This Decision is addressed to Monsanto Europe S.A., Schel-
delaan 460, Haven 627 — B 2040 Antwerp — Belgium.

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.

Done at Brussels, 24 October 2007.

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.

For the Commission

Markos KYPRIANOU
Member of the Commission

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ANNEX

(a) Applicant and Authorisation holder:

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 containing, consisting of, or produced from MON-ØØ6Ø3-6xMON-ØØ81Ø-6 maize;

(2) Feed containing, consisting of, or produced from MON-ØØ6Ø3-6xMON-ØØ81Ø-6 maize;

(3) Products other than food and feed containing or consisting of MON-ØØ6Ø3-6xMON-ØØ81Ø-6 maize for the

same uses as any other maize with the exception of cultivation.

The genetically modified maize MON-ØØ6Ø3-6xMON-ØØ81Ø-6, as described in the application, is produced by
crosses between maize containing MON-ØØ6Ø3-6 and MON-ØØ81Ø-6 events and expresses the CP4 EPSPS protein
which confers tolerance to glyphosate herbicides and the Cry1Ab protein which confers protection against certain
lepidopteran insect pests (Ostrinia nubilalis, Sesamia spp.).

(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-ØØ6Ø3-6xMON-ØØ81Ø-6 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-ØØ6Ø3-6 and

MON-ØØ81Ø-6 maize validated on MON-ØØ6Ø3-6xMON-ØØ81Ø-6 maize.

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

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

— Reference Material: ERM®-BF413 (for MON-ØØ81Ø-6) and ERM®-BF415 (for MON-ØØ6Ø3-6) 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:

MON-ØØ6Ø3-6xMON-ØØ81Ø-6

(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.

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(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 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.