Title: Verification of the Performance of Bt11, MIR604 and GA21 Maize Event-specific Methods on the Maize Event Bt11 x MIR604 x GA21 Using Real-time PCR. Validation Report and Protocols
Authors: CHARLES DELOBEL ChrysteleMUNARO BarbaraMAZZARA MarcoVAN DEN EEDE Guy
Publisher: Publications Office of the European Union
Publication Year: 2010
JRC Publication N°: JRC62744
ISBN: 978-92-79-19152-7
ISSN: 1018-5593
Other Identifiers: EUR 24715 EN
OPOCE LB-NA-24715-EN-C
URI: http://publications.jrc.ec.europa.eu/repository/handle/JRC62744
DOI: 10.2788/41999
Type: EUR - Scientific and Technical Research Reports
Abstract: The European Union Reference Laboratory for GM Food and Feed (EURL-GMFF), established by Regulation (EC) No 1829/2003, has carried out a verification study to assess the performance of three quantitative event-specific methods on the maize event Bt11 x MIR604 x GA21 (unique identifier SYN-BTØ11-1 x SYN-IR6Ø4-5 x MON-ØØØ21-9) which combines the Bt11, MIR604 and GA21 transformation events. The three methods have been validated individually on singletrait events, to detect and quantify each event in maize samples. This 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 S.A.S. provided the detection methods and the control samples: genomic DNA extracted from homogenised seeds of Bt11 x MIR604 x GA21 maize (NP2673GA21xNP2171Bt11+MIR604), genomic DNA extracted from homogenised seeds of non-GM maize (NP2673/NP2171) and flour ground from seeds of NP2673GA21xNP2171Bt11+MIR604 and from seeds of NP2673/NP2171. The EURL-GMFF 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 the European Network of GMO Laboratories (ENGL) method performance requirements (http://gmocrl. jrc.ec.europa.eu/guidancedocs.htm) and to the validation results on the individual parental events (http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm). The results of this EURL-GMFF in-house verification study are made publicly available at http://gmo-crl.jrc.ec.europa.eu/
JRC Institute:Institute for Health and Consumer Protection

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