Papadopoulou Nikoletta, Ramon Matthew, Waigmann Elisabeth
EFSA J. 2017 Aug 7;15(8):e04968. doi: 10.2903/j.efsa.2017.4968. eCollection 2017 Aug.
The GMO Panel has previously assessed genetically modified (GM) soybean 40-3-2 as a single event and as part of a two-event stack, 305423 × 40-3-2. These soybean events were found to be as safe as their conventional counterparts and other appropriate comparators with respect to potential effects on human and animal health and the environment. On 4 April 2017, European Commission requested EFSA to analyse new nucleic acid sequencing and updated bioinformatics data for soybean event 40-3-2 and to indicate whether the conclusions of the GMO Panel on the previously assessed GM soybeans remain valid. The new sequencing data indicated that, the sequence of soybean event 40-3-2 as present in the stacked soybean 305423 × 40-3-2 contains an additional nucleotide in the 5' flanking region of a 72 bp additional insert of CP4 EPSPS present in soybean 40-3-2. Re-examination of the original sequencing data of the single soybean event 40-3-2 by the applicant, indicated that this additional nucleotide was already present in the original plant material used for the risk assessment of soybean event 40-3-2. Thus, with the exception of bioinformatics analyses, the studies performed for the risk assessment of the single event soybean 40-3-2 and the two-event stack soybean 305423 × 40-3-2 remain valid. The updated bioinformatic analyses performed on the corrected sequence did not give rise to safety issues. Therefore, EFSA concludes, based on the information provided, that the original risk assessment of the soybean event 40-3-2 as a single and the stacked soybean 305423 × 40-3-2 remains valid.
转基因生物小组先前已将转基因大豆40-3-2作为单一事件以及双事件组合（305423×40-3-2）的一部分进行了评估。这些大豆事件在对人类和动物健康以及环境的潜在影响方面，被发现与它们的传统对应物和其他合适的对照物一样安全。2017年4月4日，欧盟委员会要求欧洲食品安全局分析大豆事件40-3-2的新核酸测序和更新的生物信息学数据，并指出转基因生物小组对先前评估的转基因大豆的结论是否仍然有效。新的测序数据表明，堆叠大豆305423×40-3-2中存在的大豆事件40-3-2的序列，在大豆40-3-2中存在的CP4 EPSPS的72 bp额外插入片段的5'侧翼区域包含一个额外的核苷酸。申请人对单一大豆事件40-3-2的原始测序数据进行重新检查后表明，这个额外的核苷酸已经存在于用于大豆事件40-3-2风险评估的原始植物材料中。因此，除了生物信息学分析外，对单一事件大豆40-3-2和双事件堆叠大豆305423×40-3-2进行风险评估所开展的研究仍然有效。对校正序列进行的更新生物信息学分析未产生安全问题。因此，欧洲食品安全局根据所提供的信息得出结论，大豆事件40-3-2作为单一事件以及堆叠大豆305423×40-3-2的原始风险评估仍然有效。
