Event-specific method for the quantification of sugar beet line H7-1 using real-time PCR v. 1.01 : validation report and validated method

The JRC as European Union Reference Laboratory (EURL) for the GM Food and Feed (see Regulation EC 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 H7-1 transformation event in sugarbeet DNA (unique identifier KM-ØØØH71-4). The collaborative trial was conducted according to internationally accepted guidelines. Monsanto provided the method-specific samples (seeds of sugarbeet line H7-1, 100% event H7-1 and seeds of non-GM conventional sugarbeet line, 0% event H7-1) whereas the JRC, upon extraction of the respective DNA, prepared the validation samples (calibration samples and blind samples at unknown GM percentage). The trial involved thirteen laboratories from ten European countries. The results of the collaborative trial fully met ENGL's performance requirements and the scientific understanding about satisfactory method performance. Therefore, the JRC as Community Reference Laboratory considers the method validated as fit for the purpose of regulatory compliance. The results of the collaborative study are publicly available under http://gmo-crl.jrc.it/. The method will also be submitted to CEN, the European Standardisation body, to be considered as international standard. This document replaces "Event-specific Method for the Quantification of Sugar beet line H7-1 Using Real-time PCRValidation Report and Protocol" with ISBN number 92-79-01536-2 and PUBSY request number JRC32190