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
EFSA J. 2025 May 13;23(5):e9380. doi: 10.2903/j.efsa.2025.9380. eCollection 2025 May.
Following the submission of dossier GMFF-2023-21254 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 of tissue-selective herbicide-tolerant genetically modified maize MON 87427, 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 MON 87427 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-2023-21254 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 87427.
拜耳作物科学有限责任公司依据（欧盟）第1829/2003号法规提交了GMFF-2023-21254号档案后，欧洲食品安全局转基因生物小组被要求就耐组织选择性除草剂转基因玉米MON 87427用于食品和饲料用途（不包括在欧盟境内种植）的授权申请续展所提交的数据进行科学风险评估。此次续展申请所收到的数据包括上市后环境监测报告、范围界定综述检索到的文献评估、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得到过评估。假设续展所考虑的玉米MON 87427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-2023-21254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，从而改变对玉米MON 87427的原风险评估结论。
