Report on the Verification of the Performance of MON 15985 and MON 1445 Event-specific Methods on the Cotton Event MON 15985 x MON 1445 Using Real-Time PCR

The JRC as Community Reference Laboratory for GM Food and Feed (CRL-GMFF), established by Regulation (EC) No 1829/2003, has carried out an in-house verification study to assess the performance of two quantitative event-specific methods on the cotton event MON 15985 x MON 1445 (unique identifier MON-15985-7 x MON-Ø1445-2) which combines the MON 15985 and MON 1445 transformation events. The two methods have been validated individually on single-trait events, to detect and quantify each event in cotton samples. This 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 to 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 methods and the control samples: whole cotton seeds containing the transformation event (line DP468BGII/RR) and whole conventional cotton seeds (line DP5415). The JRC prepared the in-house verification samples (calibration samples and blind samples at different GM percentages). The results of the in-house verification study were evaluated with reference to ENGL method performance requirements (http://gmo-crl.jrc.ec.europa.eu/guidancedocs.htm) and to the validation results on the individual parental events (http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm). The results of this CRL-GMFF in-house verification studies are made publicly available at http://gmo-crl.jrc.ec.europa.eu/JRC.DDG.I.4-Molecular biology and genomic