Mullins Ewen, Bresson Jean-Louis, Dalmay Tamas, Dewhurst Ian Crawford, Epstein Michelle M, Firbank Leslie George, Guerche Philippe, Hejatko Jan, Naegeli Hanspeter, Moreno Francisco Javier, Nogué Fabien, Rostoks Nils, Sánchez Serrano Jose Juan, Savoini Giovanni, Veromann Eve, Veronesi Fabio, Ardizzone Michele, De Sanctis Giacomo, Dumont Antonio Fernandez, Federici Silvia, Gennaro Andrea, Gomez Ruiz Jose Angel, Goumperis Tilemachos, Kagkli Dafni Maria, Lanzoni Anna, Lenzi Paolo, Lewandowska Aleksandra, Neri Franco Maria, Paraskevopoulos Konstantinos, Raffaello Tommaso, Streissl Franz
EFSA J. 2022 Aug 12;20(8):e07451. doi: 10.2903/j.efsa.2022.7451. eCollection 2022 Aug.
Genetically modified maize MON 89034 × 1507 × MIR162 × NK603 × DAS-40278-9 was developed by crossing to combine five single events: MON 89034, 1507, MIR162, NK603 and DAS-40278-9. The GMO Panel previously assessed the five single maize events and 16 of the subcombinations and did not identify safety concerns. No new data on the single maize events or the assessed subcombinations were identified that could lead to the 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 five-event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that five-event stack maize, as described in this application, is as safe as the non-GM comparator and non-GM maize varieties tested. In the case of accidental release of viable five-event stack maize grains into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in nine of the maize subcombinations not previously assessed and concludes that these are expected to be as safe as the single events, the previously assessed subcombinations and the five-event stack maize. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 89034 × 1507 × MIR162 × NK603 × DAS-40278-9. Post-market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the five-event stack maize and its subcombinations are as safe as its non-GM comparator and the tested non-GM maize varieties with respect to potential effects on human and animal health and the environment.
转基因玉米MON 89034×1507×MIR162×NK603×DAS - 40278 - 9是通过杂交将五个单一事件组合而成：MON 89034、1507、MIR162、NK603和DAS - 40278 - 9。转基因生物小组先前对这五个单一玉米事件及其中16个亚组合进行了评估，未发现安全问题。未发现有关单一玉米事件或已评估亚组合的新数据会导致修改其安全性的原始结论。分子特征分析、比较分析（农艺、表型和成分特征）以及毒理学、致敏性和营养评估结果表明，单一玉米事件与五事件叠加玉米中新表达蛋白质的组合不会引发食品和饲料安全及营养问题。转基因生物小组得出结论，本申请所述的五事件叠加玉米与非转基因对照物及测试的非转基因玉米品种一样安全。如果有活力的五事件叠加玉米籽粒意外释放到环境中，这不会引发环境安全问题。转基因生物小组评估了九个先前未评估的玉米亚组合中单一事件之间相互作用的可能性，并得出结论，预计这些亚组合与单一事件、先前评估的亚组合以及五事件叠加玉米一样安全。上市后环境监测计划和报告间隔符合转基因玉米MON 89034×1507×MIR162×NK603×DAS - 40278 - 9的预期用途。不认为有必要对食品/饲料进行上市后监测。转基因生物小组得出结论，五事件叠加玉米及其亚组合在对人类和动物健康以及环境的潜在影响方面与非转基因对照物和测试的非转基因玉米品种一样安全。
