Event-specific method for the quantification of soybean line MON 87701 using real-time PCR : validation report

The European Union Reference Laboratory for Genetically Modified 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 MIR162 transformation event (unique identifier SYN-IR162-4) in maize DNA. 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 control samples (genomic DNA extracted from homogenised seeds containing the transformation event and from conventional homogenised seeds). The EURL-GMFF prepared the validation samples (calibration samples and blind samples at unknown GM percentage [DNA/DNA]). The collaborative study involved twelve laboratories from nine European countries. The results of the international collaborative study met the ENGL performance requirements. The method is therefore considered applicable to the control samples provided, in accordance with the requirements of Annex I-2.C.2 to Commission Regulation (EC) No 641/2004. The results of the collaborative study are made publicly available at http://gmo crl.jrc.ec.europa.eu/.