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, Paraskevopoulos Konstantinos, Lanzoni Anna
EFSA J. 2018 Apr 11;16(4):e05233. doi: 10.2903/j.efsa.2018.5233. eCollection 2018 Apr.
The GMO Panel was previously not in the position to complete the food/feed safety assessment of maize 5307 due to an inadequate 28-day toxicity study necessary for an appropriate assessment of eCry3.1Ab protein. Following a mandate from the European Commission, the GMO Panel assessed a supplementary 28-day toxicity study in mice on the eCry3.1Ab protein (1,000 mg/kg body weight (bw) per day) to complement its scientific opinion on application EFSA-GMO-DE-2011-95 for the placing on the market of the maize 5307 for food and feed uses, import and processing. The supplementary 28-day toxicity study did not show adverse effects. Taking into account the previous assessment and the new information, the GMO Panel concludes that maize 5307, as assessed in the scientific opinion on application EFSA-GMO-DE-2011-95 (EFSA GMO Panel, 2015) and in the supplementary toxicity study, is as safe and nutritious as its conventional counterpart in the scope of this application.
由于缺乏对eCry3.1Ab蛋白进行适当评估所需的充分的28天毒性研究，转基因生物小组此前无法完成对玉米5307的食品/饲料安全性评估。应欧盟委员会的要求，转基因生物小组评估了一项关于eCry3.1Ab蛋白（每天1000毫克/千克体重）的补充28天小鼠毒性研究，以补充其关于EFSA-GMO-DE-2011-95申请的科学意见，该申请涉及玉米5307用于食品和饲料用途、进口及加工的上市许可。补充28天毒性研究未显示出不良影响。考虑到之前的评估和新信息，转基因生物小组得出结论，在EFSA-GMO-DE-2011-95申请的科学意见（EFSA转基因生物小组，2015年）及补充毒性研究中所评估的玉米5307，在本申请范围内与其传统对应物一样安全且营养。
