Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2011‐103)
Résumé
Maize Bt119MIR1629MIR60491507953079GA21 (six-event stack maize) was produced byconventional crossing to combine six single events: Bt11, MIR162, MIR604, 1507, 5307 and GA21. TheGMO Panel previously assessed the six single events and 22 of their combinations and did not identifysafety concerns. No new data on the maize single events or their 22 combinations that could lead tomodification of the original conclusions on their safety have been identified. The molecularcharacterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) andthe outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination ofthe single maize events and of the newly expressed proteins in the six–event stack maize does not giverise to food and feed safety and nutritional concerns. The GMO Panel concludes that the six-event stackmaize, as described in this application, is as safe as and nutritionally equivalent to its non-GM comparatorand the non-GM reference varieties tested. In the case of accidental release of viable grains of the six-event stack maize into the environment, this would not raise environmental safety concerns. The GMOPanel assessed the likelihood of interactions among the single events in the 34 maize subcombinationsnot previously assessed and concludes that these are expected to be as safe as and nutritionallyequivalent to the single events, the previously assessed subcombinations and the six-event stack maize.The post-market environmental monitoring plan and reporting intervals are in line with the intended usesof the six-event stack maize. Post-market monitoring of food/feed is not considered necessary. The GMOPanel concludes that the six-event stack maize and its subcombinations are as safe as its non-GMcomparator and the tested non-GM reference varieties with respect to potential effects on human andanimal health and the environment.