Mullins Ewen, Bresson Jean-Louis, Dalmay Tamas, Dewhurst Ian Crawford, Epstein Michelle M, Firbank Leslie George, Guerche Philippe, Hejatko Jan, Naegeli Hanspeter, Moreno Francisco Javier, Nogué Fabien, Rostoks Nils, Sánchez Serrano Jose Juan, Savoini Giovanni, Veromann Eve, Veronesi Fabio, Ardizzone Michele, De Sanctis Giacomo, Fernández Antonio, Gennaro Andrea, Gómez Ruiz José Ángel, Goumperis Tilemachos, Kagli Dafni Maria, Lenzi Paolo, Lewandowska Aleksandra, Camargo Ana M, Neri Franco Maria, Papadopoulou Nikoletta, Raffaello Tommaso
EFSA J. 2023 Jun 26;21(6):e08031. doi: 10.2903/j.efsa.2023.8031. eCollection 2023 Jun.
Genetically modified cotton COT102 was developed to confer resistance against several lepidopteran species. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the differences in the agronomic-phenotypic and compositional characteristics between cotton COT102 and its non-GM comparator needs further assessment, except for levels of acid detergent fibre, which do not raise safety or nutritional concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the Vip3Aa19 and APH4 proteins as expressed in cotton COT102 and finds no evidence that the genetic modification would change the overall allergenicity of cotton COT102. In the context of this application, the consumption of food and feed from cotton COT102 does not represent a nutritional concern for humans and animals. The GMO Panel concludes that cotton COT102 is as safe as the non-GM comparator and non-GM cotton varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable cotton COT102 seeds into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of cotton COT102. The GMO Panel concludes that cotton COT102 is as safe as its non-GM comparator and the tested non-GM cotton varieties with respect to potential effects on human and animal health and the environment.
转基因棉花COT102的培育旨在使其对多种鳞翅目物种具有抗性。分子特征数据和生物信息学分析未发现需要进行食品/饲料安全评估的问题。除酸性洗涤纤维含量外，棉花COT102与其非转基因对照品系在农艺表型和成分特征上的差异均无需进一步评估，而酸性洗涤纤维含量也未引发安全或营养方面的担忧。转基因生物小组未发现棉花COT102中表达的Vip3Aa19和APH4蛋白的毒性和致敏性存在安全问题，且没有证据表明基因改造会改变棉花COT102的总体致敏性。在此申请的背景下，食用棉花COT102的食品和饲料对人类和动物不构成营养方面的担忧。转基因生物小组得出结论，棉花COT102与非转基因对照品系以及所测试的非转基因棉花品种一样安全，无需对食品/饲料进行上市后监测。如果棉花COT102的活种子意外释放到环境中，这不会引发环境安全问题。上市后环境监测计划和报告间隔与棉花COT102的预期用途相符。转基因生物小组得出结论，就对人类、动物健康和环境的潜在影响而言，棉花COT102与其非转基因对照品系以及所测试的非转基因棉花品种一样安全。
