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)

• CELEX: Regulation (EC) No 1829/2003
• Articles: 9

Article 1 Genetically modified organism and unique identifier

Genetically modified maize ( Zea mays L.) NK603xMON810 produced by crosses between maize containing MON-ØØ6Ø3-6 and MON-ØØ81Ø-6 events, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-ØØ6Ø3-6xMON-ØØ81Ø-6, 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 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;

(b)

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

(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.

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’.

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).

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.

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.

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., Scheldelaan 460, Haven 627 — B 2040 Antwerp — Belgium.

Schedules & Appendices

ANNEX

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.

(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.