
Article 1 
Foods and food ingredients derived from genetically modified maize line MON 863 (hereinafter referred to as the products), as designated and specified in the Annex, may be placed on the Community market as novel foods or novel food ingredients.
Article 2 
The products shall be labelled as ‘genetically modified maize’ or ‘produced from genetically modified maize’ in accordance with the labelling requirements laid down in Article 13 of Regulation (EC) No 1829/2003.
Article 3 
The products and the information included in the Annex shall be entered in the Community Register of genetically modified food and feed.
Article 4 
This Decision is addressed to Monsanto Europe SA, Belgium, representing Monsanto Company, USA. It shall be valid for a period of 10 years.
Done at Brussels, 13 January 2006.
For the Commission
Markos KYPRIANOU
Member of the Commission
ANNEX

1. Applicant and authorisation holderNameMonsanto Europe SAAddressAvenue de Tervuren 270-272, B-1150 Brussels, BelgiumOn behalf of Monsanto Company, 800 N. Lindbergh Boulevard St. Louis, Missouri 63167, USA.2. Designation and specification of the productsFoods 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 identifierMON-ØØ863-56. Information required under Annex II to the Cartagena ProtocolNot applicable.7. Conditions or restrictions for the placing on the market of the productNot applicable.8. Post market monitoring requirementsNot applicable.
