Verification of the Performance of Bt11, MIR604 and GA21 Maize Event-specific Methods on the Maize Event Bt11 x MIR604 x GA21 Using Real-time PCR. Validation Report and Protocols
The European Union Reference Laboratory for GM Food and Feed (EURL-GMFF), established by
Regulation (EC) No 1829/2003, has carried out a verification study to assess the performance of
three quantitative event-specific methods on the maize event Bt11 x MIR604 x GA21 (unique
identifier SYN-BTØ11-1 x SYN-IR6Ø4-5 x MON-ØØØ21-9) which combines the Bt11, MIR604
and GA21 transformation events. The three methods have been validated individually on singletrait
events, to detect and quantify each event in maize samples. This study 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, Syngenta Seeds S.A.S. provided the
detection methods and the control samples: genomic DNA extracted from homogenised seeds
of Bt11 x MIR604 x GA21 maize (NP2673GA21xNP2171Bt11+MIR604), genomic DNA extracted
from homogenised seeds of non-GM maize (NP2673/NP2171) and flour ground from seeds of
NP2673GA21xNP2171Bt11+MIR604 and from seeds of NP2673/NP2171. The EURL-GMFF
prepared the in-house verification samples (calibration samples and blind samples at different
GM percentages).
The results of the in-house verification study were evaluated with reference to the European
Network of GMO Laboratories (ENGL) method performance requirements (http://gmocrl.
jrc.ec.europa.eu/guidancedocs.htm) and to the validation results on the individual parental
events (http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm).
The results of this EURL-GMFF in-house verification study are made publicly available at
http://gmo-crl.jrc.ec.europa.eu/
CHARLES DELOBEL Chrystele;
MUNARO Barbara;
MAZZARA Marco;
VAN DEN EEDE Guy;
2011-01-28
Publications Office of the European Union
JRC62744
978-92-79-19152-7,
1018-5593,
EUR 24715 EN,
OP LB-NA-24715-EN-C,
https://publications.jrc.ec.europa.eu/repository/handle/JRC62744,
10.2788/41999,
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