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):e9379. doi: 10.2903/j.efsa.2025.9379. eCollection 2025 May.
Following the submission of dossier GMFF-2023-21237 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 soybean MON 87708, 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 soybean MON 87708 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-2023-21237 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 87708.
在拜耳作物科学有限责任公司根据（EC）No 1829/2003号法规提交GMFF-2023-21237号档案后，欧洲食品安全局转基因生物小组被要求对在耐除草剂转基因大豆MON 87708的授权申请续期过程中提交的数据进行科学风险评估，该数据涉及食品和饲料用途，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其他研究的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，以查找在授权期内确定的、且在原始申请中未进行过评估的可能的新危害、暴露变化或新的科学不确定性。假设续期考虑的大豆MON 87708事件的DNA序列与最初评估事件的序列相同，转基因生物小组得出结论，在GMFF-2023-21237号续期档案中，没有证据表明存在新危害、暴露变化或科学不确定性，这些会改变对大豆MON 87708原始风险评估的结论。
