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, Paraskevopoulos Kostas
EFSA J. 2017 Jun 29;15(6):e04861. doi: 10.2903/j.efsa.2017.4861. eCollection 2017 Jun.
Following the submission of application EFSA-GMO-RX-003 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 context of the renewal of authorisation application of the insect-resistant genetically modified maize 59122. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search 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 maize 59122 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 that would change the conclusions of the original risk assessment on maize 59122.
在先锋海外公司和陶氏益农有限责任公司根据（欧盟）第1829/2003号法规提交申请EFSA-GMO-RX-003之后，欧洲食品安全局转基因生物小组（GMO小组）被要求对在抗虫转基因玉米59122授权申请续展过程中提交的数据进行科学风险评估。在此续展申请过程中收到的数据包括上市后环境监测报告、对文献的系统检索和评估、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。GMO小组评估了这些数据，以查找授权期内发现的可能的新危害、暴露变化或新的科学不确定性，而这些在原始申请中并未得到评估。假设续展所考虑的玉米59122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，未发现会改变对玉米59122原始风险评估结论的新危害、暴露变化或新的科学不确定性。
