Assessment of genetically modified maize Bt11 × MIR162 × MON 89034 × NK603 (application GMFF-2025-33624)

Genetically modified maize Bt11 × MIR162 × MON 89034 × NK603 was developed by crossing to combine four single events: Bt11, MIR162, MON 89034 and NK603. The maize Bt11 × MIR162 × MON 89034 × NK603 expresses the Cry1Ab, PAT, Vip3Aa20, PMI, Cry1A.105, Cry2Ab2, CP4 EPSPS and CP4 EPSPS L214P proteins to confer protection against certain lepidopteran pests, tolerance to glufosinate- and glyphosate-containing herbicides and to be used as a selectable marker. The GMO Panel previously assessed the four single maize events and seven of the sub-combinations and did not identify safety concerns. No new data on the single maize events or the assessed sub-combinations were identified that could lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in the four-event stack does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the four-event stack, as described in this application, is as safe as the non-GM comparator and non-GM reference varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of release of processed four-event stack or accidental spillage of viable GM maize seeds into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in three of the maize sub-combinations not previously assessed and concludes that these are expected to be as safe as the single events, the previously assessed sub-combinations and the four-event stack. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of the four-event stack and of its sub-combinations. The GMO Panel concludes that maize Bt11 × MIR162 × MON 89034 × NK603 and its sub-combinations are as safe as its non-GM comparator and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment.