Event-specific Method for the Quantification of Maize MON87460 Using Real-time PCR: Validation Report and Validated Method
The European Union Reference Laboratory for GM 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 MON 87460 transformation event in maize DNA (unique identifier MON-8746Ø-4). The collaborative study 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 Company provided the detection method and the samples (genomic DNA extracted from homogenised seeds containing the transformation event and from conventional homogenised seeds). The EU-RL GMFF prepared the validation samples (calibration samples and blind samples at defined GM percentages [DNA/DNA], unknown to laboratories participating to the collaborative study). The collaborative trial involved twelve laboratories from ten European countries.
The results of the international collaborative study 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 Commission Regulation (EC) No 641/2004.
The results of the collaborative study are made publicly available at http://gmo-crl.jrc.ec.europa.eu/.
SAVINI Cristian;
MAZZARA Marco;
PINSKI Gregor;
VAN DEN EEDE Guy;
2012-11-20
Publications Office of the European Union
JRC74374
978-92-79-26179-4,
1831-9424,
EUR 25486 EN,
OP LB-NA-25486-EN-N,
http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm,
https://publications.jrc.ec.europa.eu/repository/handle/JRC74374,
10.2788/45380,
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