Event-specific method for the quantification of maize 98140 by real-time PCR : validation report and validated method

The 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 98140 transformation event in maize DNA (unique identifier DP- Ø9814Ø-6). 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, Pioneer Overseas Corporation provided the detection method and the 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 seven 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.