Event-specific Method for the Quantification of Cotton Line MON 531 Using Real-time PCR - Validation Report and Validated Method – v. 1.01

The JRC as European Union Reference Laboratory for the 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 MON 531 transformation event in cotton DNA (unique identifier MON-ØØ531-6). 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, Monsanto provided the detection method and the samples (cotton seeds containing the transformation event and conventional cotton 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 seven European countries. The results of the international collaborative trial mostly 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 641/2004JRC.I.3-Molecular Biology and Genomic