Application (Reference EFSA-GMO-NL-2007-37) for the placing on the market of the insect-resistant genetically modified maize MON89034, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto
Application (Reference EFSA-GMO-NL-2007-37) for the placing on the market of the insect-resistant genetically modified maize MON89034, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto
复制标题
DOI：
10.2903/j.efsa.2008.909
复制
发表时间：
2008-12-01
期刊：
影响因子：
3.3
通讯作者：
Wal, Jean-Michel
中科院分区：
文献类型：
--
作者：
Andersson, Hans Christer;Arpaia, Salvatore;Wal, Jean-Michel
本文件提供了欧洲食品安全局(EFSA)转基因生物科学小组(GMO小组)对转基因玉米MON89034(唯一识别符MON-89O34-3)的意见。在发表其科学意见时，GMO小组考虑了新的申请EFSAGMO-NL-2007-37、申请者(孟山都)提供的补充信息和成员国提交的科学意见。适用范围EFSA-GMONL-2007-37适用于食品和饲料、玉米MON89034及其所有衍生产品的进口和加工，但不包括欧盟的种植。转基因专家小组参照转基因生物科学小组指导文件中关于转基因植物、衍生食品和饲料的风险评估的预期用途和适当原则对玉米MON89034进行了评估。科学评估包括插入的DNA的分子特征和新蛋白质的表达。对其农艺性状和组成进行了比较分析，并从潜在毒性、过敏性和营养品质等方面对新表达的蛋白质和整个食品/饲料的安全性进行了评价。利用农杆菌介导法转化玉米MON89034，进行环境影响评价和上市后环境监测。玉米MON89034含有Cry1A。105和Cry2Ab2表达盒(T-DNA I)，但不包含nptII表达盒(T-DNA II)。Cry1a。105和Cry2Ab2表达框对某些害虫具有抗性。分子鉴定数据表明，单个插入片段和一个完整的T-DNA I表达框拷贝已整合到玉米基因组DNA中。对整合位点进行了适当的分析，包括插入DNA和侧翼区的序列测定和生物信息学分析。连接区的生物信息学分析表明，没有任何潜在的编码已知毒素或过敏原的新ORF。通过遗传修饰引入的基因的表达已经得到了充分的分析，并且经过几代人的遗传修饰已经证明了其稳定性。转基因专家小组认为，玉米MON89034的DNA插入和侧翼区域的分子特征不会引起任何安全问题，并为转基因的稳定性提供了充分的证据。根据对具有代表性的环境范围样本的成分分析结果，转基因小组得出结论，玉米MON89034的饲料和籽粒在成分上与非转基因对照和其他常规玉米相同，只是存在Cry1A。105和Cry2Ab2蛋白。此外，田间试验没有显示表型特征和农艺性能的变化，除了引入的诱变株系。没有迹象表明与接触Cry1a有关的不利影响。105蛋白或Cry2Ab2蛋白在小鼠急性经口毒性研究中被发现。在一项为期90天的喂养研究中，喂食包括玉米MON89034籽粒在内的饲料的大鼠没有不良反应。对肉鸡的饲喂研究为玉米MON89034与常规玉米的营养等效性提供了证据。此外，整个植物的整体过敏性没有改变。转基因专家小组认为，玉米MON89034与常规玉米一样安全。玉米MON89034及其衍生产品在预期用途方面不太可能对人类和动物健康产生任何不利影响。玉米MON89034的申请涉及食品和饲料用途、玉米MON89034及其所有衍生产品的进口和加工，但不包括欧盟的种植。因此，没有要求对种植玉米MON89034可能产生的环境影响进行科学评估。考虑到应用范围，而不是为了种植，转基因专家小组认为，玉米MON89034传播和建立的可能性非常低，这种玉米造成的意外环境影响与传统玉米品种没有什么不同。申请人提供的上市后环境监测计划范围符合玉米MON89034的预期用途。申请人提供的监测计划符合欧空局的指导文件和转基因专家小组关于上市后环境监测的意见。总之，转基因专家小组认为，有关玉米MON89034的现有信息回应了成员国提出的科学意见，而且就对人类和动物健康或环境的潜在影响而言，转基因玉米MON89034与非转基因玉米MON89034一样安全。因此，转基因专家小组得出结论，玉米MON89034不太可能对人类或动物健康或其预期用途的环境产生任何不利影响。
This document provides an opinion of the Scientific Panel on Genetically Modified Organisms (GMO Panel) of the European Food Safety Authority (EFSA) on genetically modified maize MON89034 (Unique Identifier MON-89O34-3) developed to provide resistance to certain insect pests.In delivering its scientific opinion, the GMO Panel considered the new application EFSAGMO-NL-2007-37, additional information provided by the applicant (Monsanto) and the scientific comments submitted by the Member States. The scope of application EFSA-GMONL-2007-37 is for food and feed uses, import and processing of maize MON89034 and all derived products, but excluding cultivation in the EU.The GMO Panel assessed maize MON89034 with reference to the intended uses and the appropriate principles described in the Guidance Document of the Scientific Panel on Genetically Modified Organisms for the risk assessment of genetically modified plants and derived food and feed. The scientific assessment included molecular characterisation of the inserted DNA and expression of the new proteins. A comparative analysis of agronomic traits and composition was undertaken and the safety of the newly expressed proteins and the whole food/feed was evaluated with respect to potential toxicity, allergenicity and nutritional quality. An assessment of environmental impacts and the post-market environmental monitoring plan was undertaken.Maize MON89034 was transformed by Agrobacterium tumefaciens-mediated gene transfer technology. Maize MON89034 contains the Cry1A. 105 and the Cry2Ab2 expression cassettes (T-DNA I) but does not contain the nptII expression cassette (T-DNA II). The Cry1A. 105 and the Cry2Ab2 expression cassettes confer resistance to certain insect pests.The molecular characterisation data established that a single insert with one copy of the intact T-DNA I expression cassette is integrated in the maize genomic DNA. Appropriate analyses of the integration site including sequence determination of the inserted DNA and flanking regions and bioinformatic analysis have been performed. Bioinformatic analysis of junction regions demonstrated the absence of any potential new ORFs coding for known toxins or allergens. The expression of the genes introduced by genetic modification has been sufficiently analysed and the stability of the genetic modification has been demonstrated over several generations. The GMO Panel is of the opinion that the molecular characterisation of the DNA insert and flanking regions of maize MON89034 does not raise any safety concern, and that sufficient evidence for the stability of the genetic modification was provided.Based on the results of compositional analysis of samples from a representative range of environments, the GMO Panel concludes that forage and kernels of maize MON89034 are compositionally equivalent to those of the non-GM control and other conventional maize, except for the presence of the Cry1A. 105 and Cry2Ab2 proteins. In addition, field trials did not show changes in phenotypic characteristics and agronomic performance except for the introduced traits.No indications of adverse effects related to the exposure to the Cry1A. 105 protein or the Cry2Ab2 protein were found in studies on acute oral toxicity in mice. There were no adverse effects in a 90-day feeding study with rats fed diets including kernels from maize MON89034. A feeding study on broiler chickens provided evidence of nutritional equivalence of maize MON89034 to conventional maize. In addition, the overall allergenicity of the whole plant is not changed. The GMO Panel is of the opinion that maize MON89034 is as safe as conventional maize. Maize MON89034 and derived products are unlikely to have any adverse effect on human and animal health in the context of the intended uses.The application for maize MON89034 concerns food and feed uses, import and processing of maize MON89034 and all derived products, but excluding cultivation in the EU. There is therefore no requirement for scientific assessment of possible environmental effects associated with the cultivation of maize MON89034. Considering the scope of the application, not for cultivation, the GMO Panel is of the opinion that the likelihood of the spread and establishment of maize MON89034 is very low and that unintended environmental effects due to this maize will be no different from that of conventional maize varieties. The scope of the post-market environmental monitoring plan provided by the applicant is in line with the intended uses of maize MON89034. The monitoring plan provided by the applicant is in line with the EFSA Guidance Document and the Opinion of the GMO Panel on post-market environmental monitoring.In conclusion, the GMO Panel considers that the information available for maize MON89034 addresses the scientific comments raised by the Member States and that the GM maize MON89034 is as safe as its non genetically modified counterpart with respect to potential effects on human and animal health or the environment. Therefore the GMO Panel concludes that maize MON89034 is unlikely to have any adverse effect on human or animal health or on the environment in the context of its intended uses.