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):e05846. doi: 10.2903/j.efsa.2019.5846. eCollection 2019 Nov.
Following the submission of application EFSA-GMO-RX-013 under Regulation (EC) No 1829/2003 from Syngenta Crop Protection NV/SA, the EFSA Panel on Genetically Modified Organisms (GMO) 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 MIR604, 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 MIR604 considered for renewal is identical to the corrected sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-013 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MIR604.
在先正达作物保护股份有限公司依据（EC）No 1829/2003 法规提交申请 EFSA - GMO - RX - 013 之后，欧洲食品安全局转基因生物小组被要求对在抗虫转基因玉米 MIR604 授权申请续展背景下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。此次续展申请所收到的数据包含上市后环境监测报告、对文献的系统检索与评估、更新的生物信息学分析，以及由申请人或代表申请人进行的其他文件或研究。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、改变的暴露情况或新的科学不确定性，而这些在原申请中未曾评估过。假设续展所考虑的玉米 MIR604 事件的 DNA 序列与最初评估事件的校正序列相同，转基因生物小组得出结论，在续展申请 EFSA - GMO - RX - 013 中，没有证据表明存在会改变对玉米 MIR604 原风险评估结论的新危害、改变的暴露情况或科学不确定性。
