Report on the verification of the performance of Bt11, 59122, MIR604, TC1507 and GA21 eventspecific PCR-based methods applied to DNA extracted from GM Stack Bt11 x 59122 x MIR604 xTC1507 x GA21 maize

An application was submitted by Syngenta Crop Protection AG to request the authorisation of genetically modified stack (GM stack) Bt11 x 59122 x MIR604 x TC1507 x GA21 maize (tolerant to herbicide products containing glufosinate ammonium/glyphosate and resistant to certain lepidopteran/coleopteran pests) and all sub-combinations of the individual events as present in the segregating progeny (except for 1507 x 59122), for food and feed uses, and import and processing, in accordance with articles 5 and 17 of Regulation (EC) No 1829/2003 on GM Food and Feed. The unique identifier assigned to GM stack Bt11 x 59122 x MIR604 x TC1507 x GA21 maize is SYN-BTØ11-1 × DAS-59122-7 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × MON-ØØØ21-9. The GM stack Bt11 x 59122 x MIR604 x TC1507 x GA21 maize has been obtained by conventional crossing of genetically modified maize events: Bt11, 59122, MIR604, TC1507 and GA21, without any new genetic modification. The European Union Reference Laboratory for GM Food and Feed (EU-RL GMFF) has previously validated individually, and declared fit for purpose, the detection methods for the single events Bt11, 59122, MIR604, TC1507 and GA21 (see http://gmocrl. jrc.ec.europa.eu/StatusOfDossiers.aspx). In line with the approach defined by the European Network of GMO Laboratories (ENGL) (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 genomic DNA extracted from GM stack Bt11 x 59122 x MIR604 x TC1507 x GA21 maize. The results of the in-house verification led to the conclusion that the individual methods meet the ENGL performance criteria also when applied to genomic DNA extracted from the GM stack Bt11 x 59122 x MIR604 x TC1507 x GA21 maize. Noteworthy the 59122 event-specific method applied to GM stack DNA differs from the validated method for the pH value of PCR buffer (pH 8.0 instead of pH 8.3). However, this deviation does not significantly affect the performance of the method and hence the pH 8.0-method is considered equivalent to the originally validated pH 8.3 method protocol.