Event-specific method for the quantification of oilseed rape line Ms8 using real-time PCR : validation report

The JRC as Community Reference Laboratory for GM Food and Feed (CRL-GMFF) (see Regulation EC 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 Ms8 transformation event in oilseed rape DNA (unique identifier ACS-BN 5-8). 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, Bayer CropScience provided the detection method and the samples (genomic DNA extracted from wild-type and 100% oilseed rape Ms8 event). The JRC prepared the validation samples (calibration samples and blind samples at unknown GM percentage [DNA/DNA]). The collaborative trial involved thirteen laboratories from eleven European Countries. The results of the collaborative trial met the ENGL performance requirements and the scientific understanding about satisfactory method performance. Therefore, the CRL-GMFF considers the method validated as fit for the purpose of regulatory compliance. The results of the collaborative study are made publicly available under http://gmo-crl.jrc.it/. The method will also be submitted to ISO 21570 for consideration as an international standard..