Mullins Ewen, Bresson Jean-Louis, Dalmay Tamas, Dewhurst Ian Crawford, Epstein Michelle M, Firbank Leslie George, Guerche Philippe, Hejatko Jan, Moreno Francisco Javier, Naegeli Hanspeter, Nogué Fabien, Rostoks Nils, Sánchez Serrano Jose Juan, Savoini Giovanni, Veromann Eve, Veronesi Fabio, Camargo Ana M, Goumperis Tilemachos, Lenzi Paolo, Piffanelli Pietro, Raffaello Tommaso
EFSA J. 2024 Apr 29;22(4):e8715. doi: 10.2903/j.efsa.2024.8715. eCollection 2024 Apr.
Following the joint submission of dossier GMFF-2022-9170 under Regulation (EC) No 1829/2003 from Bayer Agriculture B.V. and Corteva Agriscience Belgium B.V., 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 and insect resistant genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations, 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 maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations 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-2022-9170 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations.
根据拜耳农业荷兰有限公司和科迪华农业科学比利时有限公司依据(欧盟)第1829/2003号法规联合提交的档案GMFF-2022-9170,欧洲食品安全局转基因生物小组被要求对耐除草剂和抗虫转基因玉米MON 89034×1507×MON 88017×59122及其10个子组合中的8个在续展授权申请时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。此次续展申请收到的数据包括上市后环境监测报告、范围界定综述检索文献的评估、申请人自行开展或代表申请人开展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,以确定在授权期间是否存在新的危害、暴露变化或新的科学不确定性,而这些在原始申请时并未进行评估。假设玉米MON 89034×1507×MON 88017×59122及其续展考虑的10个子组合中的8个事件的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-2022-9170中没有证据表明存在新的危害、暴露变化或科学不确定性,从而改变对玉米MON 89034×1507×MON 88017×59122及其10个子组合中的8个的原始风险评估结论。