Scientific Opinion on application (Reference EFSA-GMO-UK-2008-56) for the placing on the market of insect resistant and herbicide tolerant genetically modified maize Bt11 x MIR604 x GA21, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta Seeds
Scientific Opinion on application (Reference EFSA-GMO-UK-2008-56) for the placing on the market of insect resistant and herbicide tolerant genetically modified maize Bt11 x MIR604 x GA21, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta Seeds
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DOI：
10.2903/j.efsa.2010.1616
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发表时间：
2010-05-01
期刊：
影响因子：
3.3
通讯作者：
Wal, Jean-Michel
中科院分区：
文献类型：
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作者：
Andersson, Hans Christer;Arpaia, Salvatore;Wal, Jean-Michel
本科学意见报告了对转基因抗虫和耐除草剂玉米Bt 11 x MIR 604 x GA 21投放市场的风险评估，用于食品和饲料用途、进口和加工。常规杂交方法用于从相应的单一玉米事件的品系产生玉米Bt 11 x MIR 604 x GA 21。单个玉米事件中插入物的结构以及表型都保留在堆叠的玉米事件中。玉米Bt 11 x MIR 604 x GA 21中Cry 1Ab、PAT、mCry 3A、PMI和mEPSPS蛋白的表达水平被证明与相应的单一玉米事件的表达水平相当。组成、表型和农艺学特征的比较分析表明玉米Bt 11 x MIR 604 x GA 21与其常规对应物等同，除了新表达的蛋白质提供对某些鳞翅目和鞘翅目目标害虫的抗性以及对草铵膦和/或草甘膦基除草剂的耐受性。安全性评估未发现玉米Bt 11 x MIR 604 x GA 21的潜在毒性和过敏性问题。一项对肉鸡的饲养研究证实，这种转基因玉米与其传统玉米和一种商业化的非转基因玉米品种在营养上是等效的。考虑到玉米Bt 11 x MIR 604 x GA 21的预期用途（不包括在欧洲联盟内的种植），不需要对玉米Bt 11 x MIR 604 x GA 21种植的潜在环境影响进行科学评估。如果在运输和加工过程中有活力的玉米Bt 11 x MIR 604 x GA 21谷粒意外释放到环境中，除了存在草铵膦基和/或草甘膦基除草剂外，没有迹象表明野生玉米植物的建立或存活的可能性增加。重组DNA极不可能转移并建立在环境或人类和动物消化道中的细菌基因组中。总之，欧洲食品安全局转基因生物专家组认为，关于玉米Bt 11 x MIR 604 x GA 21的可用信息解决了成员国提出的科学评论，并且在本申请中评估的玉米Bt 11 x MIR 604 x GA 21在对人类和动物健康以及环境的潜在影响方面与其常规对应物和其他适当的比较物一样安全。在其预期用途的范围内。欧洲食品安全局转基因生物专家小组得出结论，在其预期用途的背景下，玉米Bt 11 x MIR 604 x GA 21不太可能对人类和动物健康以及环境产生不利影响。
This scientific opinion reports on an evaluation of a risk assessment for placing on the market the genetically modified insect resistant and herbicide tolerant maize Bt11 x MIR604 x GA21 for food and feed uses, import and processing. Conventional crossing methods were used in the production of maize Bt11 x MIR604 x GA21 from lines of the respective single maize events. The structure of the inserts in the single maize events as well as the phenotypes were both retained in the stacked maize events. The expression levels of the Cry1Ab, PAT, mCry3A, PMI and mEPSPS proteins in maize Bt11 x MIR604 x GA21 were demonstrated to be comparable with those of the respective single maize events. The comparative analysis of compositional, phenotypic and agronomic characteristics indicated equivalence of maize Bt11 x MIR604 x GA21 with its conventional counterpart except for the newly expressed proteins which provided resistance to certain lepidopteran and coleopteran target pests and tolerance to glufosinate-ammonium-and/or glyphosate-based herbicides. The safety assessment identified no concerns regarding potential toxicity and allergenicity of maize Bt11 x MIR604 x GA21. A feeding study on broiler chickens confirmed the nutritional equivalence of this GM maize to its conventional counterpart and a commercial non-GM maize variety. Considering the intended uses of maize Bt11 x MIR604 x GA21, which excludes cultivation within the European Union, no scientific assessment of potential environmental effects associated with cultivation of maize Bt11 x MIR604 x GA21 was required. In case of accidental release of viable maize Bt11 x MIR604 x GA21 grains into the environment during transportation and processing, there are no indications of increased likelihood of establishment or survival of feral maize plants except in the presence of the glufosinate-ammonium-and/or glyphosate-based herbicides. It is highly unlikely that the recombinant DNA will transfer and establish in the genome of bacteria in the environment or human and animal digestive tracts. In conclusion, the EFSA GMO Panel considers that the information available for maize Bt11 x MIR604 x GA21 addresses the scientific comments raised by Member States and that the maize Bt11 x MIR604 x GA21, as assessed in this application, is as safe as its conventional counterpart and other appropriate comparators with respect to potential effects on human and animal health and the environment, in the context of its intended uses. The EFSA GMO Panel concludes that maize Bt11 x MIR604 x GA21 is unlikely to have an adverse effect on human and animal health and the environment, in the context of its intended uses.