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根据(欧盟)第1829/2003号法规(申请编号EFSA-GMO-BE-2016-138)对用于食品和饲料用途、进口及加工的转基因油籽油菜MS11进行评估。

Assessment of genetically modified oilseed rape MS11 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA-GMO-BE-2016-138).

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, De Sanctis Giacomo, Devos Yann, Fernandez-Dumont Antonio, Gennaro Andrea, Gómez Ruiz Jose Ángel, Lanzoni Anna, Neri Franco Maria, Papadopoulou Nikoletta, Paraskevopoulos Konstantinos

出版信息

EFSA J. 2020 May 14;18(5):e06112. doi: 10.2903/j.efsa.2020.6112. eCollection 2020 May.

Abstract

Oilseed rape MS11 has been developed to confer male sterility and tolerance to glufosinate-ammonium-containing herbicides. Based on the information provided in the application and in line with the scope of application EFSA-GMO-BE-2016-138, the genetically modified organism (GMO) Panel concludes that 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 characteristics tested between oilseed rape MS11 and its conventional counterpart needs further assessment. No conclusions can be drawn for the compositional analysis due to the lack of an appropriate compositional data set. No toxicological or allergenicity concerns are identified for the Barnase, Barstar and PAT/bar proteins expressed in oilseed rape MS11. Owing to the incompleteness of the compositional analysis, the toxicological, allergenicity and nutritional assessment of oilseed rape MS11 cannot be completed. In the case of accidental release of viable oilseed rape MS11 seeds into the environment, oilseed rape MS11 would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the scope of the application. Since oilseed rape MS11 is designed to be used only for the production of hybrid seed, it is not expected to be commercialised as a stand-alone product for food/feed uses. Thus, seeds harvested from oilseed rape MS11 are not expected to enter the food/feed chain, except accidentally. In this context, the GMO Panel notes that, oilseed rape MS11 would not pose risk to humans and animals, while the scale of environmental exposure will be substantially reduced compared to a stand-alone product.

摘要

油菜MS11已被培育成具有雄性不育特性,并对含草铵膦的除草剂具有耐受性。根据申请中提供的信息,并符合应用范围EFSA-GMO-BE-2016-138,转基因生物(GMO)小组得出结论,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。在油菜MS11与其常规对照之间测试的农艺/表型特征中,所确定的差异均无需进一步评估。由于缺乏合适的成分数据集,无法得出成分分析的结论。未发现油菜MS11中表达的Barnase、Barstar和PAT/bar蛋白存在毒理学或致敏性问题。由于成分分析不完整,油菜MS11的毒理学、致敏性和营养评估无法完成。如果油菜MS11的活种子意外释放到环境中,油菜MS11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应用范围。由于油菜MS11仅设计用于杂交种子生产,预计不会作为食品/饲料用途的单一产品商业化。因此,除意外情况外,预计从油菜MS11收获的种子不会进入食品/饲料链。在此背景下,转基因生物小组指出,油菜MS11不会对人类和动物构成风险,同时与单一产品相比,环境暴露规模将大幅降低。

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