Event-specific method for the quantification of maize event GA21 using real-time PCR v. 1.01 : validation report and validated method

The JRC as European Union Reference Laboratory for GM Food and Feed (EURL-GMFF), established by Regulation (EC) No 1829/2003, in collaboration with the European Network of GMO Laboratories (ENGL), has carried out a collaborative study to assess the performance of a quantitative event-specific method to detect and quantify the GA21 transformation event in maize DNA (unique identifier MON-ØØØ21-9). The collaborative trial was conducted according to internationally accepted guidelines (1, 2). In accordance with Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed and 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 method and the samples (genomic DNA extracted from wild-type and 100% maize GA21 event). The JRC prepared the validation samples (calibration samples and blind samples at unknown GM percentage [DNA/DNA]). The international collaborative trial involved thirteen laboratories from eight countries of the European Union. The results of the international collaborative trial met the ENGL performance requirements and the scientific understanding about satisfactory method performance. Therefore, the CRL-GMFF considers the method validated as fit for the purpose of regulatory compliance. The results of the collaborative study are made publicly available at http://gmo-crl.jrc.it/.