Report on the verification of the performance of MIR604 and GA21 maize event-specific methods on the maize event MIR604 x GA21 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 SYNBTØ11- 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://gmocrl. jrc.ec.europa.eu/StatusOfDossiers.aspx; therefore, in line with the approach defined by the ENGL (Annex 1, http://gmocrl. 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.