Naegeli Hanspeter, Bresson Jean-Louis, Dalmay Tamas, Dewhurst Ian Crawford, Epstein Michelle M, Firbank Leslie George, Guerche Philippe, Hejatko Jan, Moreno Francisco Javier, Mullins Ewen, Nogué Fabien, Rostoks Nils, Sánchez Serrano Jose Juan, Savoini Giovanni, Veromann Eve, Veronesi Fabio, Ardizzone Michele, Devos Yann, Federici Silvia, Dumont Antonio Fernandez, Gennaro Andrea, Gómez Ruiz Jose Ángel, Neri Franco Maria, Papadopoulou Nikoletta, Paraskevopoulos Konstantinos, Lanzoni Anna
EFSA J. 2021 Jun 17;19(6):e06610. doi: 10.2903/j.efsa.2021.6610. eCollection 2021 Jun.
Oilseed rape 73496 was developed to confer tolerance to the herbicidal active substance glyphosate through the expression of the glyphosate acetyltransferase protein GAT4621. The molecular characterisation data and bioinformatic analyses identify no issues requiring food/feed safety assessment. None of the identified differences between oilseed rape 73496 and its conventional counterpart in the agronomic/phenotypic endpoints tested needs further assessment. Differences identified in seed composition of oilseed rape 73496 as compared to its conventional counterpart raise no safety and nutritional concerns in the context of the scope of this application. No safety concerns are identified regarding toxicity and allergenicity of the GAT4621 protein as expressed in oilseed rape 73496. No evidence is found that the genetic modification would change the overall allergenicity of oilseed rape 73496. Based on the outcome of the comparative and nutritional assessments, the consumption of oilseed rape 73496 does not represent any nutritional concern, in the context of the scope of this application. The implementation of a post-market monitoring plan is recommended to confirm the predicted consumption data and to verify that the conditions of use are those considered during the pre-market risk assessment. In the case of accidental release of viable oilseed rape 73496 seeds into the environment, oilseed rape 73496 would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of oilseed rape 73496. The GMO Panel concludes that oilseed rape 73496, as described in this application, is as safe as its conventional counterpart and the non-genetically modified oilseed rape reference varieties tested with respect to potential effects on human and animal health and the environment.
油菜73496通过表达草甘膦乙酰转移酶蛋白GAT4621而获得了对除草活性物质草甘膦的耐受性。分子特征数据和生物信息学分析未发现需要进行食品/饲料安全性评估的问题。在测试的农艺/表型终点方面，油菜73496与其传统对应品种之间所确定的差异均无需进一步评估。与传统对应品种相比，油菜73496种子成分中所确定的差异在本申请范围内不会引发安全性和营养方面的担忧。对于油菜73496中表达的GAT4621蛋白的毒性和致敏性，未发现安全性问题。没有证据表明基因改造会改变油菜73496的整体致敏性。基于比较评估和营养评估的结果，在本申请范围内，食用油菜73496不存在任何营养方面的担忧。建议实施上市后监测计划，以确认预测的消费数据，并核实使用条件是否与上市前风险评估期间所考虑的条件一致。如果油菜73496有活力的种子意外释放到环境中，油菜73496不会引发环境安全方面的担忧。上市后环境监测计划和报告间隔与油菜73496的预期用途相符。转基因生物小组得出结论，本申请中所述的油菜73496在对人类和动物健康以及环境的潜在影响方面与其传统对应品种以及所测试的非转基因油菜参考品种一样安全。
