Event-specific Method for the Quantification of Soybean MON87769 Using Real-time PCR: Validation Report and Validated Method
The European Union Reference Laboratory for Genetically Modified Food and Feed (EU-RL 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 MON87769 transformation event in soybean DNA (unique identifier MON-87769-7). The collaborative trial 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 provided the detection method and the control samples (genomic DNA extracted from soybean seeds harbouring the MON87769 event and from conventional soybean seeds). The EU-RL GMFF prepared the validation samples (calibration samples and samples at unknown GM percentage [DNA/DNA]). The collaborative trial involved twelve laboratories from nine European countries.
The results of the international collaborative trial met the ENGL performance requirements. The method is therefore considered applicable to the control samples provided, in accordance with the requirements of Annex I-2.C.2 to Regulation (EC) No 641/2004.
The results of the collaborative study are made publicly available at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm.
MAZZARA Marco;
DELOBELE Chrystele;
PINSKI Gregor;
SAVINI Cristian;
VAN DEN EEDE Guy;
2012-12-12
Publications Office of the European Union
JRC74371
978-92-79-26180-0,
1831-9424,
EUR 25487 EN,
OP LB-NA-25487-EN-N,
http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm,
https://publications.jrc.ec.europa.eu/repository/handle/JRC74371,
10.2788/4544,
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