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关于根据(欧盟)第1829/2003号法规(申请编号:EFSA-GMO-BE-2016-138)对用于食品、饲料、进口和加工的转基因油菜籽MS11进行评估的欧洲食品安全局科学意见的补充声明。

Statement complementing the EFSA Scientific Opinion on the 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

Mullins Ewen, Bresson Jean-Louis, Dalmay Tamas, Dewhurst Ian Crawford, Epstein Michelle M, Firbank Leslie George, Guerche Philippe, Hejatko Jan, Naegeli Hanspeter, Moreno Francisco Javier, Nogué Fabien, Rostoks Nils, Sánchez Serrano Jose Juan, Savoini Giovanni, Veromann Eve, Veronesi Fabio, Gennaro Andrea, Neri Franco Maria

出版信息

EFSA J. 2022 Mar 11;20(3):e07190. doi: 10.2903/j.efsa.2022.7190. eCollection 2022 Mar.

DOI:10.2903/j.efsa.2022.7190
PMID:35311007
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8914582/
Abstract

In a previous scientific opinion on application EFSA-GMO-BE-2016-138, the EFSA Panel on Genetically Modified Organisms (GMO Panel) could not conclude on the comparative analysis and on the food/feed safety assessment of genetically modified (GM) oilseed rape (OSR) MS11 because of the lack of an appropriate compositional data set. Following a request from the European Commission, the GMO Panel assessed additional information related to OSR MS11 to complement the original scientific opinion. The GMO Panel concluded that the information submitted (on the composition of the two-event stack MS11 × RF3) could not be used for the assessment of the composition of OSR MS11 and requested the applicant to perform a complementary set of field trials to generate additional data. The applicant did not perform the requested field trials and did not provide any new experimental data on the composition of OSR MS11. Hence, the GMO Panel is still not in the position to conclude on either the compositional analysis or the toxicological, allergenicity or nutritional assessment of OSR MS11. Therefore, the previous conclusions of the GMO Panel still hold.

摘要

在欧洲食品安全局转基因生物小组(GMO小组)就申请EFSA-GMO-BE-2016-138发布的前一份科学意见中,由于缺乏适当的成分数据集,GMO小组无法就转基因油菜籽(OSR)MS11的比较分析以及食品/饲料安全性评估得出结论。应欧盟委员会要求,GMO小组评估了与OSR MS11相关的补充信息,以完善原科学意见。GMO小组得出结论,提交的信息(关于双事件组合MS11×RF3的成分)不能用于评估OSR MS11的成分,并要求申请人进行一组补充田间试验以生成更多数据。申请人未进行要求的田间试验,也未提供任何关于OSR MS11成分的新实验数据。因此,GMO小组仍然无法就OSR MS11的成分分析、毒理学、致敏性或营养评估得出结论。所以,GMO小组先前的结论仍然有效。

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