Event-specific Method for the Quantification of Soybean Line 40-3-2 Using Real-time PCR - Validation Report and Protocol - Report on the Validation of a DNA Extraction Method for Soybean Seeds
The JRC as Community Reference Laboratory for GM Food and Feed (CRL-GMFF), established by Regulation (EC) No 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 40-3-2 transformation event in soybean DNA (unique identifier MON-¿4¿32-6). The collaborative trial was conducted according to internationally accepted guidelines (1, 2).
In accordance with Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed and with 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 method and the samples (soybean seeds containing the transformation event and conventional soybean seeds). The JRC prepared the validation samples (calibration samples and blind samples at unknown GM percentage [DNA/DNA]). The collaborative trial involved fourteen laboratories from nine European countries.
The results of the international collaborative trial met the ENGL performance requirements and the scientific understanding about satisfactory method performance. Therefore, the CRL-GMFF considers the method validated as fit for the purpose of regulatory compliance.
The results of the collaborative study are made publicly available at http://gmo-crl.jrc.it/.
MAZZARA Marco;
MUNARO Barbara;
LARCHER Sara;
GRAZIOLI Emanuele;
CHARLES DELOBEL Chrystele;
SAVINI Cristian;
VAN DEN EEDE Guy;
2008-02-07
Publications Office of the European Union
JRC42837
978-92-79-70912-8,
1831-9424,
EUR 23086 EN,
OP KJ-1A-23086-EN-N,
https://publications.jrc.ec.europa.eu/repository/handle/JRC42837,
10.2760/720444,
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