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, Goumperis Tilemachos, Lenzi Paolo, Camargo Ana M, Piffanelli Pietro, Raffaello Tommaso
EFSA J. 2025 Aug 8;23(8):e9570. doi: 10.2903/j.efsa.2025.9570. eCollection 2025 Aug.
Following the submission of dossier GMFF-2024-22651 under Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seed 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 maize T25, 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 maize T25 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-2024-22651 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize T25.
巴斯夫农业解决方案种子美国有限责任公司根据欧盟法规(EC)No 1829/2003提交了文件GMFF-2024-22651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玉米T25的授权申请续期所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。本次续期申请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,以确定在授权期内发现的可能的新危害、变化的暴露情况或新的科学不确定性,这些在原申请时未曾评估过。在假设续期所考虑的玉米T25事件的DNA序列与最初评估事件的序列相同的情况下,转基因生物小组得出结论,续期文件GMFF-2024-22651中没有证据表明存在新危害、变化的暴露情况或科学不确定性,这些会改变对玉米T25的原风险评估结论。