Event-specific method for the quantification of maize line MIR604 using real-time PCR v. 1.01 : validation report, validated method and maize seeds sampling and DNA extraction

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 MIR604 transformation event in maize DNA (unique identifier SYN-IR6ø4-5). The collaborative 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 with 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 MIR604 event). The JRC prepared the validation samples (calibration samples and blind samples at unknown GM percentage [DNA/DNA]). The international collaborative study involved fourteen laboratories from ten European Countries. The results of the international collaborative study met the ENGL performance requirements and the scientific understanding about satisfactory method performance. Therefore, the EURL-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/. This document replaces "Event-Specific Method for the Quantification of Maize Line MIR604 Using Real-Time PCR - Validation Report and Protocol - Maize Seeds Sampling and DNA Extraction " with ISBN number 978-92-79-06930-7 and PUBSY request number JRC37490.