Commission Decision of 13 January 2006 authorising the placing on the market of foods and food ingredients derived from genetically modified maize line MON 863 as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2005) 5939) (Only the French and Dutch texts are authentic) (2006/68/EC)

ANNEX INFORMATION TO BE ENTERED IN THE COMMUNITY REGISTER OF GENETICALLY MODIFIED FOOD AND FEED

1. Applicant and authorisation holder

:

Name

:

Monsanto Europe SA

Address

:

Avenue de Tervuren 270-272, B-1150 Brussels, Belgium

On behalf of Monsanto Company, 800 N. Lindbergh Boulevard St. Louis, Missouri 63167, USA.

2. Designation and specification of the products

:

Foods and food ingredients derived from genetically modified maize (Zea maize L.) line MON 863 with increased protection to insects and from all its crosses with traditionally bred maize lines. MON 863 maize contains two cassettes:

(a)

cassette 1:

A modified cry3Bb1 gene derived from Bacillus thuringiensis subsp. kumamotoensis, which confers resistance to the corn rootworm Diabrotica spp., under the regulation of the 4AS1 promoter derived from Cauliflower Mosaic Virus, the wtCAB translation enhancer from wheat (Triticum aestivum), the transcription enhancer ract1 intron from the actin 1 gene of rice (Oryza sativa) and terminator sequences tahsp 17 3’ from wheat;

(b)

cassette 2:

The nptII gene from E. coli, which confers resistance to aminoglycosides comprising kanamycin and neomycin, under the regulation of the 35S Cauliflower Mosaic Virus promoter, and the NOS 3’ terminator sequences from Agrobacterium tumefaciens as well as the non-functional, truncated ble gene from E. coli.

3. Labelling

:

‘Genetically modified maize’ or ‘produced from genetically modified maize’.

4. Method for detection

:

• Event-specific real-time quantitative PCR based method for genetically modified maize line MON 863.

• Validated by the Joint Research Centre (JRC) of the European Commission, in collaboration with the European Network of GMO Laboratories (ENGL), published at http://gmo-crl.jrc.it/statusofdoss.htm

• Reference material: IRMM-416 produced by the Joint Research Centre (JRC) of the European Commission.

5. Unique identifier

:

MON-ØØ863-5

6. Information required under Annex II to the Cartagena Protocol

:

Not applicable.

7. Conditions or restrictions for the placing on the market of the product

:

Not applicable.

8. Post market monitoring requirements

:

Not applicable.