Event-specific method for the quantification of soybean event DP-356043-5 using real-time PCR : 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 DP-356043-5 transformation event in soybean DNA (unique identifier DP-356Ø43-5). 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 with Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003, Pioneer Overseas Corporation provided the detection method and the samples (genomic DNA extracted from homogenised seeds containing the transformation event and from non-GM homogenised seeds). The JRC prepared the validation samples (calibration samples and blind samples at unknown GM percentage [DNA/DNA]). The collaborative trial involved twelve laboratories from nine European countries. The results of the international collaborative trial 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/. This document replaces "Event-specific Method for the Quantification of Soybean Event DP-356043-5 Using Real-time PCR - Validation Report and Protocol" with ISBN number 978-92-79-14882-8 and PUBSY request number JRC 56605.