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Genetically Modified Organisms

SYN-EV176-9

Products subject to Commission Decisions on withdrawal from the market

Event Bt176 maize
Addressee Syngenta Crop Protection AG, Basel Switzerland and all affiliated companies
Address of addressee Syngenta Crop Protection AG

Schwarzwaldallee 215

CH-4058 Basel - SWITZERLAND
Product Market Withdrawal The product hereunder are subject to the following provisions (see Commission Decision of 25 April 2007 on the withdrawal from the market of Bt176 (SYN-EV176-9) maize and its derived products) :

the presence of material which contains, consists of or is produced from SYN-EV176-9 maize in food or feed products notified under Article 8(1) and Article 20(1) of the Regulation shall be tolerated until 5 years after the date of notification of this Decision:

(a) provided that this presence is adventitious or technically unavoidable; and

(b) in a proportion no higher than 0,9 %.For the purpose of:



1.) Food and food ingredients containing or consisting or produced from Bt176 maize1



notified as existing food falling within the scope of Article 8(1)(a) of Regulation (EC) No 1829/2003, which consists of and/or contains a or is produced from genetically modified organism (GMO) and which has been placed on the market in accordance with Part C to the Directive 90/220/EEC before the entry into force of Regulation (EC) No 258/97, Decision to grant consent: 97/98/EC, Official Journal L 31/69, p. 69-70 - 01/02/1997, URL: http://europa.eu.int/eur-lex/lex/LexUriServ/LexUriServ.do?uri=CELEX:31997D0098:EN:HTML



2.) Food additives produced from SYN-EV176-9 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 or consisting of Bt176 maize (including feed materials and feed additives) (1)



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 or is produced from a genetically modified organism (GMO) and which has been placed on the market in accordance with Part C to the Directive 90/220/EEC, Decision to grant consent: 97/98/EC, Official Journal L 31/69, p. 69-70 - 01/02/1997, URL: http://europa.eu.int/eur-lex/lex/LexUriServ/LexUriServ.do?uri=CELEX:31997D0098:EN:HTML



4.) Feed produced from Bt176 maize (including feed materials and feed additives)

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).



(1) The scope covers any progeny derived from crosses of the product with any traditionally bred maize.



* The authorising decision under Directive 90/220/EEC covers the seeds from inbred lines and hybrids derived from maize (Zea mays L.) line (CG 00256-176). Seeds for further food and feed use are included in the notification in accordance with Article 8(1)(a) / Article 20(1)(a) of Regulation (EC) No. 1829/2003 and as referred to in Article 11 of Regulation (EC) No. 641/2004. (11 July 2005)
Designation Genetically modified maize (Zea mays L.) with the combined modification for insecticide properties conferred by the Bt-endotoxin gene and increased tolerance to the herbicide glufosinate ammonium. The product consists of inbred lines and hybrids derived from a maize (Zea mays L.) line (CG 00256-176) which has been transformed using plasmids containing:



(i) one copy of the bar gene, from Streptomyces hygroscopicus, (encoding a phosphinotricin acetyltranseferase), under the regulation of the 35S promoter and the 35S terminator from the cauliflower mosaic virus (CaMV);

(ii) two copies of a synthetic truncated gene encoding an insect control protein representing the active portion of the CryIA(b) delta-endotoxin, from Bacillus thuringiensis subsp. kurstaki strain HDI-9 and containing intron # 9 from the maize phosphoenolphyruvate carboxylase gene; the first copy is under the regulation of a promoter from the maize phosphoenolphyruvate carboxylase gene and the CaMV 35S terminator, and the second copy under the regulation of a promoter derived from a maize calcium dependent protein kinase gene and the CaMV35S terminator;

(iii) the prokaryotic gene bla (coding for a ß- lactamase conferring resistance to ampicilin) under prokaryotic promoter.
Method for detection Event-specific real-time PCR quantitative method for SYN-EV176-9 maize

This detection method is under validation by the Joint Research Centre (JRC) of the European Commission, URL: http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm
Reference material Joint Research Centre (JRC) of the European Commission, URL: http://www.irmm.jrc.be
Unique identifier SYN-EV176-9
Annex II to the Cartagena Protocol Biosafety Clearing House, Record ID 1243, URL: http://bch.biodiv.org/database/record.aspx?searchid=124270&recordid=1243
Conditions or restrictions on the placing on the market Not applicable
Post-market monitoring require-ments Not appropriate
Date of entry into the register 18/04/05
Date of placing on the market 01/02/1997 (as food and feed)



01/01/1997 (as food additives, feed additives and feed materials)
Legal base Commission Decision on the withdrawal from the market of Bt176 (SYN-EV176-9) maize and its derived products
Further information on risk assessment Opinion of the Scientific Committee on Foods from 21/02/97, URL:

http://europa.eu.int/comm/food/fs/sc/oldcomm7/out02_en.html

      Opinion of the Scientific Committee for Animal Nutrition from 13/12/1996, URL:

http://www.bmgf.gv.at/cms/site/attachments/6/2/4/CH0264/CMS1085743089437/opinion1_bt176.pdf

      Opinion of the Scientific Committee for Pesticides from 09/12/1996, URL:

http://europa.eu.int/comm/food/fs/sc/oldcomm3/out01_en.html