Event-specific method for the quantification of soybean FG72 using real-time PCR : validation report and validated method

In line with its mandate1 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 PCR method for detecting and quantifying soybean event FG72 (unique identifier MST-FGØ72-2). 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 guidelines2, involving 12 laboratories. In accordance with current EU legislation1, Bayer CropScience has provided the detection method and the samples (genomic DNA from soybean seeds harbouring the FG72 event as positive control DNA, genomic DNA from conventional soybean 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 and the ENGL detailing the provisions of Annex I-2.C.2 to Regulation (EC) No 641/2004 and it fulfils the analytical requirements of Regulation (EU) No 619/2011. T his report is published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.html.