Event-specific method for the quantification of maize line LY038 using real-time PCR : validation report and protocol

The JRC as Community Reference Laboratory for Genetically Modified Food and Feed (CRL-GMFF), established by Commission 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 LY038 transformation event in maize DNA (unique identifier REN-00038-3). The collaborative trial was conducted according to internationally accepted guidelines. In accordance with Commission Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed and with Commission Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003, Renessen provided the detection method and the samples (maize seeds containing the transformation event and conventional maize 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 ten 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.