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Genetically Modified Organisms

SYN-BT Ø11-1

Products subject to Commission Decisions on withdrawal from the market

Event Bt11
Authorisation holder Name Syngenta Crop Protection AG, Basel Switzerland and all affiliated companies
Authorisation holder Address Syngenta Crop Protection AG

Schwarzwaldallee 215

CH-4058 Basel - SWITZERLAND
Products 1.) Foods and food ingredients containing, consisting of or produced from Bt11 maize

sweet maize, fresh or canned, that is progeny from traditionally crosses of traditionally bred maize with genetically modified maize line Bt11. Commission Decision 2004/657/EC O.J. L 300 of 25 September 2004.

Food produced from maize Bt11 notified as existing food falling within the scope of Article 8(1)(a) of Regulation (EC) No 1829/2003, which is produced from a genetically modified organism (GMO) and which has been placed on the market in accordance with Art. 5 of Regulation (EC) No 258/97, notification forwarded to Member States on 06/02/1998, opinion on substantial equivalence by the UK Advisory Committee on Novel Foods and Processes from 14/02/1997.

2.) Food additives produced from Bt11 maize

Notified as existing food additives within the meaning of Article 8 (1)(b) of Regulation (EC) 1829/2003, authorised under Directive 89/107/EEC and complying with the relevant specifications laid down under this legislation.

3.) Feed containing, consisting of or produced from Bt11 maize1 (feed materials and feed additives) to be used as any other maize grain but not for cultivation

notified as existing feed falling within the scope of Article 20(1)(a) of Regulation (EC) No 1829/2003, which consists of and/or contains a genetically modified organism (GMO) and which has been placed on the market in accordance with Part C to the Directives 90/220/EEC, Decision to grant consent: 98/292/EEC, Official Journal L 131, p. 28 - 29 - 05/05/1998. Notified as existing feed falling within the scope of Article 20(1) (b) of Regulation (EC) No 1829/2003, namely as feed materials and feed additives (subject to Directive 70/524/EEC) which are produced from a genetically modified organism (GMO).

4.) Other products containing or consisting of Bt11 maize1 with the exception of cultivation notified as falling within the scope of Article 20(1)(a) of Regulation (EC) No 1829/2003, products which consists of and/or contains a genetically modified organism (GMO) and which has been placed on the market in accordance with Part C to the Directives 90/220/EEC, Decision to grant consent: 98/292/EEC, Official Journal L 131, p. 28 - 29 - 05/05/1998.

(1) The scope covers any progeny derived from crosses of the product with any traditionally bred maize imported into the European Community.
Designation Genetically modified maize line Bt11 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.
Labelling Article 13(1) and 25(1) of Regulation (EC) No 1829/2003
Method for detection Event specific real-time quantitative PCR based method for genetically modified SYN-BT Ø11-1 sweet maize, published in European Food Research and Techonolgy, 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).

URL: http://gmo-crl.jrc.it/detectionmethods/Bt11-protocol.pdf
Reference material IRMM-412R, produced by the Joint Research Centre (JRC) of the European Commission.
Unique identifier SYN-BT Ø11-1
Annex II to the Cartagena Protocol Biosafety Clearing House, URL:
https://bch.biodiv.org/database/record.shtml?id=12199
https://bch.biodiv.org/database/record.shtml?id=7842
https://bch.biodiv.org/database/record.shtml?id=7852
Scientific Opinion http://europa.eu.int/comm/food/fs/sc/scf/out129_en.pdf
Conditions or restrictions on the placing on the market Not applicable
Post-market monitoring requirements Not appropriate
Date of authorisation 19/05/2004: foods and food ingredients containing, consisting of or produced from Bt11 maize (sweet maize, fresh or canned).

Application for renewal submitted: food additives produced from Bt11 maize; feed containing, consisting of or produced from Bt11 maize (feed materials and feed additives) to be used as any other maize grain but not for cultivation; other products containing or consisting of Bt11 maize with the exception of cultivation.
Legal base Article 7 of the Regulation (EC) No 258/97
Article 19(3) of Directive 2001/18/EC
Articles 8 and 20 of the Regulation (EC) No 1829/2003
Authorisation expiration date 18/05/2014: foods and food ingredients containing, consisting of or produced from Bt11 maize.

Procedure for renewal ongoing: foods produced from Bt11 maize (including food additives); feed containing, consisting of or produced from Bt11 maize (feed materials and feed additives) to be used as any other maize grain but not for cultivation; other products containing or consisting of Bt11 maize with the exception of cultivation.