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Verification of Performance of a Bt11 Event-Specific Method on Bt11 "Field Maize" Using Real-Time PCR- Validation Report - Maize Seeds Sampling and DNA Extraction

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The JRC as Community Reference Laboratory for GM Food and Feed (CRL-GMFF), established by Regulation (EC) No 1829/2003, has carried out an in-house verification study to assess the performance of the Bt11 event-specific method to detect and quantify the Bt11 transformation event in "field maize" DNA (unique identifier SYN-BTØ11-1). The method has been previously validated to detect and quantify the Bt11 event in "sweet maize" DNA. The study was conducted according to internationally accepted guidelines (1, 2). In accordance to Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed and to Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003, Syngenta Seeds provided the detection method and the control samples (genomic DNA extracted from Bt11 field maize leaf tissue and genomic DNA from non-GM field maize leaf tissue). The JRC prepared the in-house verification samples (calibration samples and blind samples at different GM percentages). The results of the in-house verification study were evaluated with reference to ENGL method performance requirements (http://gmo-crl.jrc.it/doc/Method 20requirements.pdf) and to the validation results obtained for Bt11 sweet maize (http://gmo-crl.jrc.it/statusofdoss.htm). The results of CRL-GMFF in-house verification studies are made publicly available at http://gmo-crl.jrc.it/.
2007-11-20
OPOCE
JRC37487
978-92-79-06929-1,   
1018-5593,   
EUR 22911 EN,    OP LB-NA-22911-EN-C,   
https://publications.jrc.ec.europa.eu/repository/handle/JRC37487,   
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