Report on the Verification of the Performance of Bt11, MIR162, 1507 and GA21 Event-specific Methods on the Bt11 x MIR162 x 1507 x GA21 Maize Using Real-time PCR
An application was submitted by Syngenta Crop Protection AG to request the authorisation of genetically modified Bt11 x MIR162 x 1507 x GA21 maize (tolerant to herbicides containing glufosinate ammonium and glyphosate and resistant to important lepidoptera maize pests) and all sub-combinations of the individual events as present in the segregating progeny, for food and feed uses, and import and processing, in accordance with articles 5 and 17 of Regulation (EC) N° 1829/2003 GM Food and GM Feed (1). The unique identifier assigned to Bt11 x MIR162 x 1507 x GA21 maize is SYN-BTØ11-1 x SYN-IR162-4 x DAS-Ø15Ø7-1 x MON-ØØØ21-9.
Bt11 x MIR162 x 1507 x GA21 maize has been obtained by conventional crossing between four genetically modified maize events: Bt11, MIR162, 1507 and GA21. No new genetic modification was used for the development of Bt11 x MIR162 x 1507 x GA21 maize.
The EU-RL GMFF has previously validated individually, and declared fit for purpose, the detection methods for the single events Bt11, MIR162, 1507, GA21 and has published the corresponding reports http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx; therefore, in line with the approach defined by the ENGL (Annex 1, http://gmo-crl.jrc.ec.europa.eu/doc/Min_Perf_Requirements_Analytical_methods.pdf) the EU-RL GMFF has carried out only an in-house verification of the performance of each validated method when applied to DNA extracted from Bt11 x MIR162 x 1507 x GA21.
The results of the in-house verification study were evaluated with reference to ENGL requirements and to the validation results on the individual events; as a result, the EU-RL GMFF concludes that the individual methods meet the ENGL criteria and can also be applied to Bt11 x MIR162 x 1507 x GA21 maize.
This report is published at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx.
NARDINI Elena;
SACCO Maria-Grazia;
MAZZARA Marco;
KREYSA Joachim;
2013-11-12
Publications Office of the European Union
JRC84758
978-92-79-33236-4,
1831-9424,
EUR 26178,
OP LB-NA-26178-EN-N,
https://publications.jrc.ec.europa.eu/repository/handle/JRC84758,
10.2788/2732,
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