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, Ardizzone Michele, Devos Yann, Paraskevopoulos Konstantinos
EFSA J. 2017 Nov 28;15(11):e05067. doi: 10.2903/j.efsa.2017.5067. eCollection 2017 Nov.
Following the submission of application EFSA-GMO-RX-004 under Regulation (EC) No 1829/2003 from Bayer CropScience, 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 context of the renewal of authorisation application of the genetically modified (GM) herbicide-tolerant oilseed rape MS8, RF3 and MS8×RF3. The data received in the context of this renewal application contain post-market environmental monitoring reports, systematic searches and evaluation of literature, updated bioinformatics 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 oilseed rape MS8, RF3 and MS8×RF3 considered for renewed authorisation is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in the context of this renewal application for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape MS8, RF3 and MS8×RF3.
在拜耳作物科学公司根据（欧盟）第1829/2003号法规提交申请EFSA-GMO-RX-004后，欧洲食品安全局转基因生物小组（GMO小组）被要求对转基因耐除草剂油菜MS8、RF3和MS8×RF3授权申请续期时提交的数据进行科学风险评估。在此次续期申请中收到的数据包括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小组评估了这些数据，以确定在授权期内是否存在新的危害、接触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。假设续期授权所考虑的油菜MS8、RF3和MS8×RF3事件的DNA序列与最初评估事件的序列相同，GMO小组得出结论，在此次续期申请中，没有证据表明存在新的危害、接触情况的变化或科学不确定性，这些会改变对油菜MS8、RF3和MS8×RF3的原始风险评估结论。
