Event-specific method for the quantification of cotton GHB119 using real-time PCR : validation report and validated method

In line with its mandate the European Union Reference Laboratory for GM Food and Feed (EU-RL GMFF), in collaboration with the European Network of GMO Laboratories (ENGL), has validated an event-specific polymerase chain reaction (PCR) method for detecting and quantifying cotton event GHB119 (unique identifier BCS-GHØØ5-8). The validation study was conducted according to the EU-RL GMFF validation procedure [http://gmo-crl.jrc.ec.europa.eu/guidancedocs.htm] and internationally accepted guidelines. In accordance with current EU legislation1, Bayer CropScience has provided the detection method and the samples (genomic DNA from cotton seeds harbouring the GHB119 event as positive control DNA, genomic DNA from conventional cotton seeds as negative control DNA). The EU-RL GMFF prepared the validation samples (calibration samples and blind samples at test GM percentage [DNA/DNA]), organised an international collaborative study, and analysed the results. The study confirms that the method meets the method performance requirements as established by the EU-RL GMFF and the ENGL detailing the provisions of Annex I-2.C.2 to Regulation (EC) No 641/20041 and it fulfils the analytical requirements of Regulation (EU) No 619/2011.