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根据欧盟法规(EC)No 1829/2003(文件编号GMFF-2023-21234)对转基因棉花MON 88913续期授权的评估。

Assessment of genetically modified cotton MON 88913 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2023-21234).

作者信息

Casacuberta Josep, Barro Francisco, Braeuning Albert, de Maagd Ruud, Epstein Michelle M, Frenzel Thomas, Gallois Jean-Luc, Koning Frits, Messéan Antoine, Moreno F Javier, Nogué Fabien, Savoini Giovanni, Schulman Alan H, Tebbe Christoph, Veromann Eve, Camargo Ana M, Lenzi Paolo, Piffanelli Pietro, Raffaello Tommaso

出版信息

EFSA J. 2025 May 13;23(5):e9377. doi: 10.2903/j.efsa.2025.9377. eCollection 2025 May.

Abstract

Following the submission of dossier GMFF-2023-21234 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, 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 genetically modified cotton MON 88913, 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 sequence of the event in cotton MON 88913 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal dossier GMFF-2023-21234 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on cotton MON 88913.

摘要

拜耳作物科学有限责任公司依据欧盟法规(EC)No 1829/2003提交了GMFF-2023-21234号档案后,欧洲食品安全局转基因生物小组被要求就耐除草剂转基因棉花MON 88913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、对范围界定审查检索到的文献的评估、申请人或代表申请人进行的额外研究搜索以及更新的生物信息学分析。转基因生物小组评估了这些数据,以确定在授权期内是否存在新的危害、暴露情况变化或新的科学不确定性,且这些情况在原申请中未曾评估过。假设续期考虑的棉花MON 88913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,在续期档案GMFF-2023-21234中,没有证据表明存在新的危害、暴露情况变化或科学不确定性会改变对棉花MON 88913的原风险评估结论。

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