Naegeli Hanspeter, Bresson Jean-Louis, Dalmay Tamas, Dewhurst Ian Crawford, Epstein Michelle M, Firbank Leslie George, Guerche Philippe, Hejatko Jan, Moreno Francisco Javier, Mullins Ewen, Nogué Fabien, Rostoks Nils, Sánchez Serrano Jose Juan, Savoini Giovanni, Veromann Eve, Veronesi Fabio, Álvarez Fernando, Ardizzone Michele, De Sanctis Giacomo, Fernandez Dumont Antonio, Gennaro Andrea, Gómez Ruiz Jose Ángel, Lanzoni Anna, Neri Franco Maria, Papadopoulou Nikoletta, Paraskevopoulos Konstantinos
EFSA J. 2019 Nov 7;17(11):e05848. doi: 10.2903/j.efsa.2019.5848. eCollection 2019 Nov.
Maize MON 87427 × MON 89034 × MIR162 × MON 87411 (four-event stack maize) was produced by conventional crossing to combine four single events: MON 87427, MON 89034, MIR162 and MON 87411. The genetically modified organism (GMO) Panel previously assessed the four single maize events and four of the subcombinations and did not identify safety concerns. No new data on the single maize events or the four subcombinations that could lead to modification of the original conclusions on their safety were identified. 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 and dsRNA in the four-event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the four-event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non-GM comparator and the non-GM reference varieties tested. In the case of accidental release of viable grains of the four-event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the six maize subcombinations not previously assessed and concludes that these are expected to be as safe as and nutritionally equivalent to the single events, the previously assessed subcombinations and the four-event stack maize. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of the four-event stack maize. Post-market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the four-event stack maize and its subcombinations are as safe as its non-GM comparator and tested non-GM reference varieties with respect to potential effects on human and animal health and the environment.
玉米MON 87427×MON 89034×MIR162×MON 87411（四事件叠加玉米）是通过常规杂交培育而成，将四个单事件MON 87427、MON 89034、MIR162和MON 87411进行了组合。转基因生物小组先前已对这四个单玉米事件及其中四个亚组合进行了评估，未发现安全问题。未发现可能导致改变其安全性原始结论的关于单玉米事件或四个亚组合的新数据。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，四事件叠加玉米中各单玉米事件与新表达的蛋白质和dsRNA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，本申请所述的四事件叠加玉米与其非转基因对照物以及所测试的非转基因参考品种一样安全且营养等效。如果四事件叠加玉米的活种子意外释放到环境中，不会引发环境安全问题。转基因生物小组评估了先前未评估的六个玉米亚组合中各单事件之间相互作用的可能性，得出结论认为，这些组合预计与各单事件、先前评估的亚组合以及四事件叠加玉米一样安全且营养等效。上市后环境监测计划和报告间隔与四事件叠加玉米的预期用途相符。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，就对人类和动物健康以及环境的潜在影响而言，四事件叠加玉米及其亚组合与其非转基因对照物以及所测试的非转基因参考品种一样安全。
