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根据(欧盟)第1829/2003号法规(申请编号EFSA-GMO-NL-2015-124)对转基因玉米MON 87411进行食品和饲料用途、进口及加工的评估。

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).

作者信息

Naegeli Hanspeter, Birch Andrew Nicholas, Casacuberta Josep, De Schrijver Adinda, Gralak Mikołaj Antoni, Guerche Philippe, Jones Huw, Manachini Barbara, Messéan Antoine, Nielsen Elsa Ebbesen, Nogué Fabien, Robaglia Christophe, Rostoks Nils, Sweet Jeremy, Tebbe Christoph, Visioli Francesco, Wal Jean-Michel, Ardizzone Michele, De Sanctis Giacomo, Fernandez Dumont Antonio, Gennaro Andrea, Gómez Ruiz José Angel, Lanzoni Anna, Neri Franco Maria, Papadopoulou Nikoletta, Paraskevopoulos Konstantinos, Ramon Matthew

出版信息

EFSA J. 2018 Jun 28;16(6):e05310. doi: 10.2903/j.efsa.2018.5310. eCollection 2018 Jun.

Abstract

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.

摘要

玉米MON 87411通过表达修饰版的基因和DvSnf7双链RNA表达盒来获得对玉米根虫(多种)的抗性,并通过表达CP4 5-烯醇丙酮酸莽草酸-3-磷酸合酶()基因来耐受含草甘膦除草剂。分子特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。未发现玉米MON 87411与其传统对照品种在测试的农艺和表型特征上有统计学显著差异。玉米MON 87411的成分分析未发现需要进一步评估的差异,但未处理的玉米MON 87411籽粒中的棕榈酸水平除外。转基因生物小组未发现玉米MON 87411中表达的Cry3Bb1和CP4 EPSPS蛋白的毒性和致敏性存在安全问题,也未发现有证据表明基因改造可能会显著改变玉米MON 87411的总体致敏性。预计源自玉米MON 87411的食品和饲料的营养影响与源自传统对照品种和非转基因商业参考品种的食品和饲料相同。转基因生物小组得出结论,本申请所述的玉米MON 87411在营养上等同于测试的传统对照品种和非转基因玉米参考品种,并且同样安全,无需对食品/饲料进行上市后监测。如果有活力的玉米MON 87411籽粒意外释放到环境中,玉米MON 87411不会引发环境安全问题。上市后环境监测计划和报告间隔符合玉米MON 87411的预期用途。转基因生物小组得出结论,本申请所述的玉米MON 87411在对人类和动物健康及环境的潜在影响方面与其传统对照品种和测试的非转基因玉米参考品种一样安全。

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