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根据(欧盟)第1829/2003号法规对转基因玉米MIR162进行再授权评估(申请编号EFSA-GMO-RX-025)。

Assessment of genetically modified maize MIR162 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-025).

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 Martín, Goumperis Tilemachos, Kagkli Dafni Maria, Lenzi Paolo, Lewandowska Aleksandra, Raffaello Tommaso, Streissl Franz

出版信息

EFSA J. 2022 Sep 22;20(9):e07562. doi: 10.2903/j.efsa.2022.7562. eCollection 2022 Sep.

Abstract

Following the submission of application EFSA-GMO-RX-025 under Regulation (EC) No 1829/2003 from Syngenta Crop Protection NV/SA, 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 insect-resistant genetically modified maize MIR162, for food and feed uses, excluding cultivation within the EU. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses, and additional documents or studies performed by or on behalf of the applicant. 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. The GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-025 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MIR162.

摘要

在先正达作物保护股份有限公司根据(欧盟)第1829/2003号法规提交申请EFSA-GMO-RX-025之后,欧洲食品安全局转基因生物小组被要求就抗虫转基因玉米MIR162续期授权申请中提交的数据进行科学风险评估,该评估针对食品和饲料用途,不包括在欧盟境内种植。此次续期申请收到的数据包括上市后环境监测报告、文献的系统检索与评估、更新的生物信息学分析,以及由申请人或代表申请人进行的其他文件或研究。转基因生物小组评估了这些数据,以确定在授权期内是否存在新的危害、暴露变化或新的科学不确定性,且这些在原始申请时未曾评估过。转基因生物小组得出结论,续期申请EFSA-GMO-RX-025中没有证据表明存在新的危害、暴露变化或科学不确定性,这些情况会改变对玉米MIR162原始风险评估的结论。

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1
Guidance on allergenicity assessment of genetically modified plants.
EFSA J. 2017 Jun 22;15(6):e04862. doi: 10.2903/j.efsa.2017.4862. eCollection 2017 Jun.
2
Technical Note on the quality of DNA sequencing for the molecular characterisation of genetically modified plants.
EFSA J. 2018 Jul 11;16(7):e05345. doi: 10.2903/j.efsa.2018.5345. eCollection 2018 Jul.

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