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. 2019 Nov 7;17(11):e05845. doi: 10.2903/j.efsa.2019.5845. eCollection 2019 Nov.
Following the submission of application EFSA-GMO-RX-015 under Regulation (EC) No 1829/2003 from Bayer Agriculture BVBA, the EFSA Panel on Genetically Modified Organisms (GMO Panel) 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 genetically modified maize MON 89034, for food and feed uses, excluding cultivation within the EU. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses and additional documents or studies performed by or on behalf of the applicant. 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 89034 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-015 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 89034.
根据拜耳农业有限公司依据(EC) No 1829/2003号法规提交的申请EFSA-GMO-RX-015，欧洲食品安全局转基因生物小组（GMO小组）被要求对提交的关于抗虫转基因玉米MON 89034续期授权申请的数据进行科学风险评估，该申请用于食品和饲料用途，不包括在欧盟境内种植。此次续期申请收到的数据包括上市后环境监测报告、文献的系统检索与评估、更新的生物信息学分析以及申请人或代表申请人进行的其他文件或研究。GMO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，而这些在原申请时并未进行评估。假设续期申请中所考虑的玉米MON 89034事件的DNA序列与最初评估的事件序列相同，GMO小组得出结论，在续期申请EFSA-GMO-RX-015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，从而改变对玉米MON 89034最初风险评估的结论。
