
Article 1 
Sweet maize from genetically modified maize line Bt11 (hereinafter referred to as the product), as designated and specified in the Annex, may be placed on the Community market as a novel food or novel food ingredient.
Article 2 
The product shall be labelled as ‘genetically modified sweet maize’, in accordance with the labelling requirements laid down in Article 13 of Regulation (EC) No 1829/2003.
Article 3 
The product 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 Syngenta Seeds BV, Westeinde 62, 1600 AA Enkhuizen, The Netherlands, representing Syngenta Seeds AG, Switzerland. It shall be valid for a period of 10 years.
Done at Brussels, 19 May 2004.
For the Commission
David BYRNE
Member of the Commission
ANNEX

(a) Authorisation holderNameSyngenta Seeds BVAddressWesteinde 62, 1600 AA Enkhuizen, The NetherlandsOn behalf ofSyngenta Seeds AG, Schwarzwaldallee 215, CH-4058 Basel, Switzerland(b) Designation and specification of the productSweet maize, fresh or canned, that is progeny from traditionally crosses of traditionally bred maize with genetically modified maize line Bt11 that contains:
— a synthetic version of the cryIA (b) gene derived from Bacillus thuringiensis kurstaki strain HD1 under the control of a 35S promoter from Cauliflower Mosaic Virus, and IVS 6 intron from the maize alcohol dehydrogenase gene and the nopaline synthase terminator sequence of Agrobacterium tumefaciens, and
— a synthetic version of the pat gene derived from Streptomyces viridochromogenes under the control of a 35S promoter from Cauliflower Mosaic Virus, an IVS intron from the maize alcholdehydrogenase gene and the nopaline synthase terminator sequence of Agrobacterium tumefaciens.(c) Labellin‘Genetically modified sweet maize’(d) Method for detection
— Event specific real-time quantitative PCR based method for genetically modifiedBt11 sweet maize, published in European Food Research and Technology, Vol. 216/2003, pages 347-354.
— Validated by the Joint Research Centre (JRC) of the European Commission, in collaboration with the European Network of GMO Laboratories (ENGL), published at http://engl.jrc.it/crl/oj/bt11sm.pdf.
— Reference Material: IRMM-412R, produced by the Joint Research Centre (JRC) of the European Commission.(e) Unique identifierSYN-BT Ø11-1(f) Information required under Annex II to the Cartagena ProtocolBiosafety Clearing House, Record ID 1240
(see: http://bch.biodiv.org/Pilot/Record.aspx?RecordID=1240)(g) Conditions or restrictions on the placing on the market of the productNot applicable(h) Post-market monitoring requirementsNot appropriate
