Verification of the Performance of MIR604 and GA21 Maize Event-specific Methods on the Maize Event MIR604 x GA21 Using Real-time PCR. Validation Report and Protocols

Abstract

The European Union Reference Laboratory for GM Food and Feed (EURL-GMFF), established by Regulation (EC) No 1829/2003, has carried out an in-house verification study to assess the performance of two quantitative event-specific methods on maize event MIR604 x GA21 (unique identifier SYN-IR6Ø4-5 x MON-ØØØ21-9) which combines the MIR604 and GA21 transformation events. The two methods have been validated individually on single-trait 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 MIR604 x GA21 maize (NP2171MIR604/NP2673GA21), genomic DNA extracted from homogenised seeds of non-GM maize (NP2171/NP2673) and flour ground from seed of NP2171MIR604/NP2673GA21 and from seed of NP2171/NP2673. 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 studt are made publicly available at http://gmo-crl.jrc.ec.europa.eu/.