首页> 美国卫生研究院文献>EFSA Journal >Assessment of genetically modified maize MON 87427 × MON 87460 × MON 89034 × MIR162 × NK603 and subcombinations for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2016‐134)
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Assessment of genetically modified maize MON 87427 × MON 87460 × MON 89034 × MIR162 × NK603 and subcombinations for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2016‐134)

机译:根据法规(EC)1829/2003(应用EFSA‐GMO‐NL‐2016‐134)评估用于食品和饲料用途的转基因玉米MON 87427×MON 87460×MON 89034×MIR162×NK603及其亚组合

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摘要

Maize  87427 ×  87460 ×   89034 ×  162 ×  603 (five‐event stack maize) was produced by conventional crossing to combine five single events:  87427,  87460,  89034, 162 and 603. The Panel previously assessed the five single maize events and eleven of the subcombinations and did not identify safety concerns. No new data on the single maize events or the 11 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 in the five‐event stack maize does not give rise to food and feed safety and nutritional concerns. The Panel concludes that the five‐event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non‐ comparator and the non‐ reference varieties tested. In the case of accidental release of viable grains of the five‐event stack maize into the environment, this would not raise environmental safety concerns. The Panel assessed the likelihood of interactions among the single events in the 14 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 five‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the five‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The Panel concludes that the five‐event stack maize and its subcombinations are as safe as its non‐ comparator and the tested non‐ reference varieties with respect to potential effects on human and animal health and the environment.
机译:玉米87427×87460×89034×162×603(五事件叠层玉米)是通过常规杂交生产的,将五个单一事件合并在一起:87427、87460、89034、162和603.专家组先前评估了五个单一玉米事件和11个玉米事件这些子组合并没有发现安全隐患。没有发现有关单一玉米事件或11种亚组合的新数据,这些新数据可能导致修改有关其安全性的原始结论。分子表征,比较分析(农学,表型和组成特征)以及毒理学,变应原性和营养评估的结果表明,单一事件和五事件堆栈玉米中新表达的蛋白质的结合并不能给出引起食品和饲料安全以及营养问题。专家组认为,如本申请所述,五叠式玉米与其非对照品和非参考品种一样安全且营养等同。万一五事件玉米中有生命的谷物意外释放到环境中,这不会引起环境安全问题。专家小组评估了先前未评估的14个玉米亚组合中单个事件之间相互作用的可能性,并得出结论认为,这些事件与单一事件,先前评估的亚组合和五事件叠层玉米一样安全且在营养上等同于玉米。售后环境监测计划和报告间隔符合五事件叠层玉米的预期用途。不需要对食品/饲料进行售后监测。专家组得出结论,在对人类和动物健康及环境的潜在影响方面,五事件叠层玉米及其亚组合与非比较品种和经过测试的非参考品种一样安全。

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