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, De Sanctis Giacomo, Fernandez Dumont Antonio, Ruiz Gómez José Ángel, Lanzoni Anna, Papadopoulou Nikoletta, Paraskevopoulos Konstantinos
EFSA J. 2018 Jul 25;16(7):e05347. doi: 10.2903/j.efsa.2018.5347. eCollection 2018 Jul.
Following the submission of application EFSA-GMO-RX-008 under Regulation (EC) No 1829/2003 from Pioneer Hi-Bred International, Inc. and Dow AgroSciences LLC, 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, herbicide-tolerant genetically modified maize 1507 × NK603, for food and feed uses, import and processing, excluding cultivation within the EU. The data received in the context of this renewal application contained 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. In conclusion, under the assumption that the DNA sequence of the events in maize 1507 × NK603 considered for renewal are identical to the newly reported 1507 sequence and the NK603 sequence of the originally assessed two-event stack maize, the GMO Panel concludes that there is no evidence in the renewal application EFSA-GMO-RX-008 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize 1507 × NK603 (EFSA, 2006).
先锋国际良种公司(Pioneer Hi-Bred International, Inc.)和陶氏益农公司(Dow AgroSciences LLC)根据(EC)No 1829/2003号法规提交了EFSA-GMO-RX-008申请后,欧洲食品安全局转基因生物小组被要求就抗虫、耐除草剂转基因玉米1507×NK603用于食品和饲料、进口及加工(不包括在欧盟境内种植)的授权申请续期所提交的数据进行科学风险评估。本次续期申请所收到的数据包括对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开展的其他文件或研究。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、暴露情况的变化或新的科学不确定性,且这些在原申请时未进行评估。总之,在假设续期所考虑的玉米1507×NK603事件的DNA序列与最初评估的双事件叠加玉米的新报告1507序列和NK603序列相同的情况下,转基因生物小组得出结论,续期申请EFSA-GMO-RX-008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,这些会改变对玉米1507×NK603的原风险评估结论(欧洲食品安全局,2006年)。