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

摘要

The European Union Reference Laboratory for GM Food and Feed (EURL-GMFF), established byRegulation (EC) No 1829/2003, has carried out a verification study to assess the performance ofthree quantitative event-specific methods on the maize event Bt11 x MIR604 x GA21 (uniqueidentifier SYN-BTØ11-1 x SYN-IR6Ø4-5 x MON-ØØØ21-9) which combines the Bt11, MIR604and GA21 transformation events. The three methods have been validated individually on singletraitevents, to detect and quantify each event in maize samples. This study was conductedaccording to internationally accepted guidelines (1, 2).In accordance to Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modifiedfood and feed and to Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for theimplementation of Regulation (EC) No 1829/2003, Syngenta Seeds S.A.S. provided thedetection methods and the control samples: genomic DNA extracted from homogenised seedsof Bt11 x MIR604 x GA21 maize (NP2673GA21xNP2171Bt11+MIR604), genomic DNA extractedfrom homogenised seeds of non-GM maize (NP2673/NP2171) and flour ground from seeds ofNP2673GA21xNP2171Bt11+MIR604 and from seeds of NP2673/NP2171. The EURL-GMFFprepared the in-house verification samples (calibration samples and blind samples at differentGM percentages).The results of the in-house verification study were evaluated with reference to the EuropeanNetwork of GMO Laboratories (ENGL) method performance requirements (http://gmocrl.jrc.ec.europa.eu/guidancedocs.htm) and to the validation results on the individual parentalevents (http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm).The results of this EURL-GMFF in-house verification study are made publicly available athttp://gmo-crl.jrc.ec.europa.eu/