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首页> 外文期刊>EFSA Journal >Scientific Opinion on applications (EFSA‐GMO‐UK‐2008‐57 and EFSA‐GMO‐RX‐MON15985) for the placing on the market of insect‐resistant genetically modified cotton MON 15985 for food and feed uses, import and processing, and for the renewal of authorisation of existing products produced from cotton MON 15985, both under Regulation (EC) No 1829/2003 from Monsanto
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Scientific Opinion on applications (EFSA‐GMO‐UK‐2008‐57 and EFSA‐GMO‐RX‐MON15985) for the placing on the market of insect‐resistant genetically modified cotton MON 15985 for food and feed uses, import and processing, and for the renewal of authorisation of existing products produced from cotton MON 15985, both under Regulation (EC) No 1829/2003 from Monsanto

机译:关于将抗虫转基因棉花MON 15985投放市场用于食品和饲料,进口和加工以及将其用于食品和饲料的应用的科学意见(EFSA-GMO-UK-2008-57和EFSA-GMO-RX-MON15985)孟山都根据(EC)第1829/2003号条例对MON 15985棉花生产的现有产品的授权续期

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Cotton MON 15985 was developed by biolistic transformation of cotton MON 531 to express Cry2Ab2 and GUS in addition to the Cry1Ac and NPTII proteins. Cry proteins in MON 15985 confer resistance to major lepidopteran cotton pests, whereas the GUS and NPTII proteins were used as markers during product development. Molecular characterisation of MON 15985 did not give rise to safety issues. The EFSA GMO Panel could not conclude on the potential occurrence of unintended effects for agronomic and phenotypic characteristics owing to data limitations. Compositional data gave no indication of unintended effects for which further assessment was needed. The Panel concludes that cotton MON 15985, as described in these applications, is as safe and nutritious as its conventional counterpart and other non‐genetically modified varieties, and considers it unlikely that the overall allergenicity of the whole plant is changed. Environmental risk assessment was restricted to the exposure through faecal material from animals fed with cotton products of MON 15985 and its accidental spillage. Following a weight of evidence approach and considering the poor ability of cotton to survive outside cultivated land, despite the agronomic and phenotypic data limitations, the Panel concludes that there is very low likelihood of any adverse environmental impacts. The aadA and oriV sequences in MON 15985 may facilitate the stabilisation of nptII through double homologous recombination. However, considering the limited presence of intact DNA from MON 15985 in feed and the limited occurrence of horizontal transfer of DNA from plant material to bacteria, the Panel concludes that it is highly unlikely that nptII from MON 15985 will be transferred to bacteria.
机译:棉花MON 15985是通过对棉花MON 531进行生物射弹转化而开发的,除了表达Cry1Ac和NPTII蛋白外,它还表达Cry2Ab2和GUS。 MON 15985中的Cry蛋白赋予对主要鳞翅目棉虫的抗性,而GUS和NPTII蛋白则在产品开发过程中用作标记。 MON 15985的分子表征没有引起安全性问题。由于数据有限,EFSA GMO小组无法就农艺和表型特征的意外影响可能发生的结论得出结论。成分数据没有表明需要进一步评估的意外影响。专家组得出结论,这些申请中所述的MON 15985棉花与传统的同等品种和其他非转基因改良品种一样安全且营养丰富,并认为整个植物的总体变应原性不太可能改变。环境风险评估仅限于饲喂MON 15985棉花产品的动物的粪便中粪便的暴露及其意外溢出。专家小组得出结论认为,尽管有农艺和表型数据方面的限制,但采用大量证据方法并考虑到棉花在耕地外生存的能力较弱,小组得出结论认为,对环境造成任何不利影响的可能性很小。 MON 15985中的aadA和oriV序列可通过双重同源重组促进nptII的稳定。但是,考虑到饲料中来自MON 15985的完整DNA的存在有限以及DNA从植物材料向细菌的水平转移的发生有限,小组得出结论,来自MON 15985的nptII不太可能被转移到细菌中。

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    《EFSA Journal》 |2014年第7期|共42页
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