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根据欧盟法规(EC)No 1829/2003对转基因棉花GHB614 × LLCotton25进行再授权评估(档案编号GMFF-2024-21890)。

Assessment of genetically modified cotton GHB614 × LLCotton25 for renewal authorisation under regulation (EC) No 1829/2003 (dossier GMFF-2024-21890).

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 Aug 7;23(8):e9572. doi: 10.2903/j.efsa.2025.9572. eCollection 2025 Aug.

Abstract

Following the submission of dossier GMFF-2024-21890 under Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seeds US LLC, 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 GHB614 × LLCotton25, 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 cotton GHB614 × LLCotton25 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-2024-21890 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on cotton GHB614 x LLCotton25.

摘要

在巴斯夫农业解决方案种子美国有限责任公司根据(欧盟)第1829/2003号法规提交档案GMFF - 2024 - 21890之后,欧洲食品安全局转基因生物小组被要求对耐除草剂转基因棉花GHB614×LLCotton25的授权申请续期所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。在此续期申请中收到的数据包括上市后环境监测报告、对范围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、暴露情况的改变或新的科学不确定性,且这些情况在原申请中未被评估过。在假设续期所考虑的棉花GHB614×LLCotton25事件的DNA序列与最初评估的事件序列相同的情况下,转基因生物小组得出结论,续期档案GMFF - 2024 - 21890中没有证据表明存在新的危害、暴露情况的改变或科学不确定性,这些会改变对棉花GHB614×LLCotton25的原风险评估结论。

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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.

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