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根据欧盟法规(EC)No 1829/2003(申请编号EFSA-GMO-NL-2018-153)对转基因大豆GMB151进行食品和饲料用途评估。

Assessment of genetically modified soybean GMB151 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2018-153).

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, Fernandez Antonio, Gennaro Andrea, Gómez Ruiz Jose Ángel, Kagkli Dafni Maria, Lanzoni Anna, Neri Franco Maria, Papadopoulou Nikoletta, Paraskevopoulos Konstantinos, Raffaello Tommaso, Streissl Franz, De Sanctis Giacomo

出版信息

EFSA J. 2021 Apr 19;19(4):e06424. doi: 10.2903/j.efsa.2021.6424. eCollection 2021 Apr.

Abstract

Soybean GMB151 was developed to confer tolerance to 4-hydroxyphenylpyruvate dioxygenase (HPPD) inhibitor herbicides and resistance to nematodes. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between soybean GMB151 and its conventional counterpart needs further assessment, except for palmitic acid and heptadecenoic acid in seeds and carbohydrate and crude protein in forage, which does not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the HPPD-4 and Cry14Ab-1 proteins as expressed in soybean GMB151, and finds no evidence that the genetic modification would change the overall allergenicity of soybean GMB151. In the context of this application, the consumption of food and feed from soybean GMB151 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that soybean GMB151 is as safe as the conventional counterpart and non-GM soybean reference varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable soybean GMB151 seeds into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean GMB151. The GMO Panel concludes that soybean GMB151 is as safe as its conventional counterpart and the tested non-GM soybean reference varieties with respect to potential effects on human and animal health and the environment.

摘要

大豆GMB151旨在获得对4-羟基苯丙酮酸双加氧酶(HPPD)抑制剂除草剂的耐受性和对线虫的抗性。分子特征数据和生物信息学分析未发现需要进行食品/饲料安全性评估的问题。除了种子中的棕榈酸和十七碳烯酸以及饲料中的碳水化合物和粗蛋白外,大豆GMB151与其传统对照品种在农艺/表型和成分特征方面所确定的差异均无需进一步评估,这些差异不会引发营养和安全方面的担忧。转基因生物小组未发现大豆GMB151中表达的HPPD-4和Cry14Ab-1蛋白的毒性和致敏性存在安全问题,也没有证据表明基因改造会改变大豆GMB151的整体致敏性。在本申请的背景下,食用大豆GMB151的食品和饲料对人类和动物不存在营养方面的担忧。转基因生物小组得出结论,大豆GMB151与传统对照品种以及测试的非转基因大豆参考品种一样安全,无需对食品/饲料进行上市后监测。如果大豆GMB151的活种子意外释放到环境中,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大豆GMB151的预期用途。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,大豆GMB151与其传统对照品种以及测试的非转基因大豆参考品种一样安全。

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