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根据(欧盟)第1829/2003号法规(申请编号EFSA-GMO-NL-2017-139)对转基因玉米MON 87427×MON 87460×MON 89034×1507×MON 87411×59122及其子组合进行食品和饲料用途评估。

Assessment of genetically modified maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2017-139).

作者信息

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 Antonio, Gennaro Andrea, Gómez Ruiz Jose Ángel, Kagkli Dafni Maria, Lanzoni Anna, Neri Franco Maria, Papadopoulou Nikoletta, Paraskevopoulos Konstantinos, Raffaello Tommaso

出版信息

EFSA J. 2021 Jan 19;19(1):e06351. doi: 10.2903/j.efsa.2021.6351. eCollection 2021 Jan.

Abstract

Maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 (six-event stack maize) was produced by conventional crossing to combine six single events: MON 87427, MON 87460, MON 89034, 1507, MON 87411 and 59122. The GMO Panel previously assessed the six single maize events and 17 of the subcombinations and did not identify safety concerns. No new data on the single maize events or the 17 subcombinations 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 and dsRNA in the six-event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the six-event stack maize, as described in this application, is as safe as its non-GM comparator and the selected non-GM reference varieties. 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 GMO Panel assessed the likelihood of interactions among the single events in the 39 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 six-event stack maize. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of the six-event stack maize. Post-market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the six-event stack maize and its subcombinations are as safe as the non-GM comparator and the selected non-GM reference varieties with respect to potential effects on human and animal health and the environment.

摘要

玉米MON 87427×MON 87460×MON 89034×1507×MON 87411×59122(六性状叠加玉米)是通过常规杂交培育而成,将六个单性状事件组合在一起:MON 87427、MON 87460、MON 89034、1507、MON 87411和59122。转基因生物小组此前已对这六个单性状玉米事件及17个亚组合进行了评估,未发现安全问题。未发现有关单性状玉米事件或17个亚组合的新数据会导致改变其安全性的原始结论。分子特征分析、比较分析(农艺学、表型和成分特征)以及毒理学、致敏性和营养评估结果表明,六性状叠加玉米中各单性状玉米事件以及新表达的蛋白质和双链RNA的组合不会引发食品和饲料安全及营养方面问题。转基因生物小组得出结论,本申请中所述的六性状叠加玉米与其非转基因对照品种和选定的非转基因参考品种一样安全。如果六性状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此前未评估的39个玉米亚组合中各单性状事件之间相互作用的可能性,得出结论认为,预计这些亚组合与单性状事件、此前评估的亚组合以及六性状叠加玉米一样安全。上市后环境监测计划和报告间隔与六性状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,六性状叠加玉米及其亚组合与非转基因对照品种和选定的非转基因参考品种一样安全。

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