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Assessment of genetically modified maize MON 87411 for food and feed uses import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐124)

机译:根据法规(EC)第1829/2003号对用于食品和饲料用途进口和加工的转基因玉米MON87411进行评估(申请EFSA‐GMO‐NL‐2015‐124)

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摘要

Maize MON 87411 was developed to confer resistance to corn rootworms ( spp.) by the expression of a modified version of the gene and a DvSnf7 dsRNA expression cassette, and tolerance to glyphosate‐containing herbicides by the expression of a CP4 5‐enolpyruvylshikimate‐3‐phosphate synthase ( ) gene. The molecular characterisation data and bioinformatics analyses did not identify issues requiring assessment for food and feed safety. No statistically significant differences in the agronomic and phenotypic characteristics tested between maize MON 87411 and its conventional counterpart were identified. The compositional analysis of maize MON 87411 did not identify differences that required further assessment except for palmitic acid levels in grains from not treated maize MON 87411. The GMO Panel did not identify safety concerns regarding the toxicity and allergenicity of the Cry3Bb1 and CP4 EPSPS proteins, as expressed in maize MON 87411 and found no evidence that the genetic modification might significantly change the overall allergenicity of maize MON 87411. The nutritional impact of maize MON 87411‐derived food and feed is expected to be the same as those derived from the conventional counterpart and non‐GM commercial reference varieties. The GMO Panel concludes that maize MON 87411, as described in this application, is nutritionally equivalent to and as safe as the conventional counterpart and the non‐GM maize reference varieties tested, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize MON 87411 grains into the environment, maize MON 87411 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 87411. The GMO Panel concludes that maize MON 87411, as described in this application, is as safe as its conventional counterpart and the tested non‐GM maize reference varieties with respect to potential effects on human and animal health and the environment.
机译:玉米MON87411的开发是通过表达该基因的修饰版本和DvSnf7 dsRNA表达盒来赋予对玉米根虫的抗性,并通过表达CP4 5-烯醇式丙酮酸Shikimate-3来耐受含草甘膦的除草剂。磷酸合酶()基因。分子表征数据和生物信息学分析未发现需要评估食品和饲料安全性的问题。在玉米MON87411和常规玉米之间,在农艺和表型特征方面没有发现统计学上的显着差异。玉米MON87411的成分分析没有发现需要进一步评估的差异,除了未经处理的玉米MON87411谷物中的棕榈酸含量外.GMO专家组没有发现有关Cry3Bb1和CP4 EPSPS蛋白的毒性和致敏性的安全问题,如玉米MON 87411中所述,没有发现证据表明遗传修饰可能会显着改变玉米MON 87411的总体致敏性。玉米MON 87411衍生的食品和饲料的营养影响预计与常规配比相同和非转基因商业参考品种。 GMO专家组得出结论,本申请中所述的MON 87411玉米在营养上与常规对等品和经过测试的非转基因玉米参考品种相当,并且安全性高,因此无需对食品/饲料进行上市后监控。在将活的玉米MON87411谷物意外释放到环境中的情况下,玉米MON87411不会引起环境安全问题。上市后环境监测计划和报告间隔符合MON 87411玉米的预期用途。GMO专家组得出结论,如本申请所述,MON 87411玉米与常规玉米和经过测试的非转基因玉米一样安全。玉米参考品种对人类和动物健康以及环境的潜在影响。

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