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, Gennaro Andrea, Neri Franco Maria, Paraskevopoulos Konstantinos
EFSA J. 2017 Aug 1;15(8):e04922. doi: 10.2903/j.efsa.2017.4922. eCollection 2017 Aug.
In this opinion, the EFSA Panel on Genetically Modified Organisms (GMO Panel) assessed the three-event stack maize MON 87427 × MON 89034 × NK603 and its three subcombinations, independently of their origin. The GMO Panel has previously assessed the three single events combined to produce this three-event stack maize and did not identify safety concerns. No new data on the single events, leading to modification of the original conclusions on their safety, were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single maize events and of the newly expressed proteins in the three-event stack maize did not give rise to issues regarding food and feed safety or nutrition. In the case of accidental release of viable grains of maize MON 87427 × MON 89034 × NK603 into the environment, the three-event stack maize would not raise environmental safety concerns. The GMO Panel concludes that the three-event stack maize is as safe and as nutritious as the non-GM comparator and the tested non-GM reference varieties in the context of its scope. The GMO Panel considered that its previous conclusions on the two-event stack maize MON 89034 × NK603 remain valid. For the two maize subcombinations for which no experimental data were provided the GMO Panel assessed the likelihood of interactions among the single events, and concluded that their combination would not raise safety concerns. These two subcombinations are therefore expected to be as safe as the single events, the previously assessed maize MON 89034 × NK603 and maize MON 87427 × MON 89034 × NK603. Since the post-market environmental monitoring plan for the three-event stack maize does not include any provisions for the two subcombinations not previously assessed, the GMO Panel recommended the applicant to revise the plan accordingly.
在本意见中，欧洲食品安全局转基因生物小组（GMO小组）对三事件叠加玉米MON 87427×MON 89034×NK603及其三个子组合进行了评估，不考虑其来源。GMO小组此前已对用于培育该三事件叠加玉米的三个单事件进行过评估，未发现安全问题。未发现导致改变其安全性原始结论的单事件新数据。基于分子、农艺、表型和成分特征，三事件叠加玉米中单个玉米事件与新表达蛋白质的组合未引发食品、饲料安全或营养方面的问题。如果玉米MON 87427×MON 89034×NK603的活种子意外释放到环境中，该三事件叠加玉米不会引发环境安全问题。GMO小组得出结论，在其评估范围内，三事件叠加玉米与非转基因对照物及经测试的非转基因参考品种一样安全且营养。GMO小组认为其先前关于双事件叠加玉米MON 89034×NK603的结论仍然有效。对于未提供实验数据的两个玉米子组合，GMO小组评估了单事件之间相互作用的可能性，并得出结论，它们的组合不会引发安全问题。因此，预计这两个子组合与单事件、先前评估的玉米MON 89034×NK603以及玉米MON 87427×MON 89034×NK603一样安全。由于三事件叠加玉米的上市后环境监测计划未包括对先前未评估的两个子组合的任何规定，GMO小组建议申请人相应地修订该计划。
