Naegeli Hanspeter, Birch Andrew Nicholas, Casacuberta Josep, De Schrijver Adinda, Gralak Mikołaj Antoni, Guerche Philippe, Jones Huw, Manachini Barbara, Messéan Antoine, Nielsen Elsa Ebbesen, Nogué Fabien, Robaglia Christophe, Rostoks Nils, Sweet Jeremy, Tebbe Christoph, Visioli Francesco, Wal Jean-Michel, Álvarez Fernando, Ardizzone Michele, Mestdagh Sylvie, Ramon Matthew
EFSA J. 2017 Jan 12;15(1):e04659. doi: 10.2903/j.efsa.2017.4659. eCollection 2017 Jan.
Following the submission of application EFSA-GMO-RX-001 under Regulation (EC) No 1829/2003 from Pioneer Overseas Corporation and Dow Agrosciences LLC, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the frame of a renewal of authorisation application of the insect-resistant and herbicide-tolerant genetically modified (GM) maize 1507. The data package received in the frame of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, an updated bioinformatics analysis and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed this data package for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the frame of the original application. Under the assumption that the DNA sequence of the event in maize 1507 considered for renewal is identical to the corrected sequence of the originally assessed event, the GMO Panel concludes that no new hazards or modified exposure and no new scientific uncertainties were identified for the application for renewal that would change the conclusions of the original risk assessment on maize 1507 (EFSA, 2005b, 2009).
先锋海外公司和陶氏益农有限责任公司根据(欧盟)第1829/2003号法规提交了申请EFSA-GMO-RX-001后,欧洲食品安全局转基因生物小组(GMO小组)被要求对在抗虫和耐除草剂转基因玉米1507授权申请续展框架内提交的数据进行科学风险评估。在此次续展申请框架内收到的数据包包含上市后环境监测报告、文献的系统检索和评估、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小组评估了该数据包,以确定在授权期内发现的、在原申请框架内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。假设续展所考虑的玉米1507事件的DNA序列与最初评估事件的校正序列相同,GMO小组得出结论,对于续展申请,未发现会改变对玉米1507原风险评估结论的新危害或暴露变化,也未发现新的科学不确定性(欧洲食品安全局,2005年b版,2009年)。