Naegeli Hanspeter, Bresson Jean-Louis, Dalmay Tamas, Dewhurst Ian Crawford, Epstein Michelle M, Firbank Leslie George, Guerche Philippe, Hejatko Jan, Moreno Francisco Javier, Mullins Ewen, Nogué Fabien, Rostoks Nils, Sánchez Serrano Jose Juan, Savoini Giovanni, Veromann Eve, Veronesi Fabio, Álvarez Fernando, Ardizzone Michele, Raffaello Tommaso
EFSA J. 2021 Jan 29;19(1):e06375. doi: 10.2903/j.efsa.2021.6375. eCollection 2021 Jan.
Following the submission of application EFSA-GMO-RX-017 under Regulation (EC) No 1829/2003 from Bayer Agriculture BVBA 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 insect-resistant and herbicide-tolerant genetically modified maize MON 88017 × MON 810, 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, a systematic search and evaluation of literature, and updated bioinformatic analysis. 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 88017 × MON 810 considered for renewal are identical to the sequence of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-017 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 88017 × MON 810.
根据拜耳农业有限公司依据(欧盟)第1829/2003号法规提交的申请EFSA-GMO-RX-017,欧洲食品安全局转基因生物小组被要求对耐虫和耐除草剂转基因玉米MON 88017×MON 810续期授权申请中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。此次续期申请收到的数据包含上市后环境监测报告、文献的系统检索与评估以及更新的生物信息分析。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。在假设续期申请中所考虑的玉米MON 88017×MON 810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,在续期申请EFSA-GMO-RX-017中,没有证据表明存在新的危害、暴露情况的变化或科学不确定性,这些情况会改变对玉米MON 88017×MON 810的原始风险评估结论。