Report on the verification of the performance of MON 531 and MON1445 event-specific methods on the cotton event MON 531 x MON 1445 using real-time PCR : validation report and protocols

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 531 x MON 1445 (unique identifier MON ØØ531-6 x MONØ1445- 2) which combines the MON 531 and MON 1445 transformation events. The two methods have been previously validated individually on single-trait events, to detect and quantify each event in cotton samples; a validation report for each method is available at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm. 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 Europe S.A. provided the detection methods and the control samples: whole seeds of MON 531 x MON 1445 cotton (ST5599BR) and whole conventional cotton seeds of ST474. 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://gmocrl.jrc.ec.europa.eu/.