Report on the Verification of the Performance of Bt11, MIR162, MIR604 and GA21 Event-specific PCR-based Methods Applied to DNA Extracted from Stack Maize Bt11 x MIR162 x MIR604 x GA21

An application was submitted by Syngenta Crop Protection AG to request the authorisation of genetically modified Bt11 x MIR162 x MIR604 x GA21 maize (resistant to lepidopteran and coleopteran pests, able to utilise mannose as the only primary carbon source and tolerant to glufosinate ammonium and glyphosate) 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. The unique identifier assigned to Bt11 x MIR162 x MIR604 x GA21 maize is SYN-BTØ11-1x YN-IR162-4xSYN-IR6Ø4-5xMON-ØØØ21-9. The genetically modified maize line Bt11 x MIR162 x MIR604 x GA21 maize has been obtained by conventional crossing of four genetically modified maize events: Bt11, MIR162, MIR604, and GA21 without any new genetic modification. The EU-RL GMFF has previously validated individually, and declared fit for purpose, the detection methods for the single events Bt11, MIR162, MIR604 and GA21 (see http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx). In line with the approach defined by the ENGL (http://gmo-crl.jrc.ec.europa.eu/doc/Min_Perf_Requirements_Analytical_methods.pdf) the EU-RL GMFF therefore 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 MIR604 x GA21. The hereby reported the in-house verification study lead to the conclusion that the individual methods meet the ENGL criteria also when applied to DNA extracted from the GM maize stack Bt11 x MIR162 x MIR604 x GA21JRC.I.3-Molecular Biology and Genomic