Verification of the Performance of Bt11 and MIR604 Maize Event-specific Methods on the Maize Event Bt11 x MIR604 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
two quantitative event-specific methods on the maize event Bt11 x MIR604 (unique identifier
SYN-BTØ11-1 x SYN-IR6Ø4-5) which combines the Bt11 and MIR604 transformation events.
The two methods have been validated individually on single-trait 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 maize (NP2276Bt11/NP2391MIR604), genomic DNA extracted from
homogenised seeds of non-GM maize (NP2276/NP2391) and flour ground from seeds of
NP2276Bt11/NP2391MIR604 and from seed of NP2276/NP2391. The EURL-GMFF prepared the
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 verification study are made publicly available at http://gmocrl.
jrc.ec.europa.eu/.
CHARLES DELOBEL Chrystele;
FOTI Nicoletta;
MAZZARA Marco;
VAN DEN EEDE Guy;
2011-01-26
Publications Office of the European Union
JRC62742
978-92-79-19077-3,
1018-5593,
EUR 24702 EN,
OP LB-NA-24702-EN-C,
https://publications.jrc.ec.europa.eu/repository/handle/JRC62742,
10.2788/28470,
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