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本文引用的文献

1
Assessment of genetically modified maize MON 87427 × MON 87460 × MON 89034 × 1507 × MON 87411 × 59122 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2017-139).根据(欧盟)第1829/2003号法规(申请编号EFSA-GMO-NL-2017-139)对转基因玉米MON 87427×MON 87460×MON 89034×1507×MON 87411×59122及其子组合进行食品和饲料用途评估。
EFSA J. 2021 Jan 19;19(1):e06351. doi: 10.2903/j.efsa.2021.6351. eCollection 2021 Jan.
2
Guidance on allergenicity assessment of genetically modified plants.转基因植物致敏性评估指南。
EFSA J. 2017 Jun 22;15(6):e04862. doi: 10.2903/j.efsa.2017.4862. eCollection 2017 Jun.

根据(欧盟)第1829/2003号法规(GMFF-2022-9170号档案)对转基因玉米MON 89034×1507×MON 88017×59122及其10个亚组合中的8个进行更新授权评估。

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2022-9170).

作者信息

Mullins Ewen, Bresson Jean-Louis, Dalmay Tamas, Dewhurst Ian Crawford, Epstein Michelle M, Firbank Leslie George, Guerche Philippe, Hejatko Jan, Moreno Francisco Javier, Naegeli Hanspeter, Nogué Fabien, Rostoks Nils, Sánchez Serrano Jose Juan, Savoini Giovanni, Veromann Eve, Veronesi Fabio, Camargo Ana M, Goumperis Tilemachos, Lenzi Paolo, Piffanelli Pietro, Raffaello Tommaso

出版信息

EFSA J. 2024 Apr 29;22(4):e8715. doi: 10.2903/j.efsa.2024.8715. eCollection 2024 Apr.

DOI:10.2903/j.efsa.2024.8715
PMID:38686342
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11056846/
Abstract

Following the joint submission of dossier GMFF-2022-9170 under Regulation (EC) No 1829/2003 from Bayer Agriculture B.V. and Corteva Agriscience Belgium B.V., the Panel on genetically modified organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide tolerant and insect resistant genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the events in maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal dossier GMFF-2022-9170 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations.

摘要

根据拜耳农业荷兰有限公司和科迪华农业科学比利时有限公司依据(欧盟)第1829/2003号法规联合提交的档案GMFF-2022-9170,欧洲食品安全局转基因生物小组被要求对耐除草剂和抗虫转基因玉米MON 89034×1507×MON 88017×59122及其10个子组合中的8个在续展授权申请时提交的数据进行科学风险评估,用于食品和饲料用途,但不包括在欧盟境内种植。此次续展申请收到的数据包括上市后环境监测报告、范围界定综述检索文献的评估、申请人自行开展或代表申请人开展的额外研究搜索以及更新后的生物信息学分析。转基因生物小组评估了这些数据,以确定在授权期间是否存在新的危害、暴露变化或新的科学不确定性,而这些在原始申请时并未进行评估。假设玉米MON 89034×1507×MON 88017×59122及其续展考虑的10个子组合中的8个事件的DNA序列与最初评估的事件序列相同,转基因生物小组得出结论,续展档案GMFF-2022-9170中没有证据表明存在新的危害、暴露变化或科学不确定性,从而改变对玉米MON 89034×1507×MON 88017×59122及其10个子组合中的8个的原始风险评估结论。