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根据(欧盟)第1829/2003号法规(申请编号EFSA-GMO-NL-2020-169)对转基因油菜籽MON 94100进行食品和饲料用途评估。

Assessment of genetically modified oilseed rape MON 94100 for food and feed uses, under regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2020-169).

作者信息

Mullins Ewen, Bresson Jean-Louis, Dalmay Tamas, Dewhurst Ian Crawford, Epstein Michelle M, Firbank Leslie George, Guerche Philippe, Hejatko Jan, Moreno Francisco Javier, Naegeli Hanspeter, Nogué Fabien, Rostoks Nils, Sánchez Serrano Jose Juan, Savoini Giovanni, Veromann Eve, Veronesi Fabio, Ardizzone Michele, De Sanctis Giacomo, Federici Silvia, Fernandez Dumont Antonio, Gennaro Andrea, Gomez Ruiz Jose Angel, Goumperis Tilemachos, Lanzoni Anna, Lenzi Paolo, Neri Franco Maria, Papadopoulou Nikoletta, Raffaello Tommaso, Streissl Franz

出版信息

EFSA J. 2022 Jul 22;20(7):e07411. doi: 10.2903/j.efsa.2022.7411. eCollection 2022 Jul.

Abstract

Oilseed rape MON 94100 was developed to confer tolerance to dicamba herbicide. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between oilseed rape MON 94100 and its conventional counterpart needs further assessment, except for the levels of carbohydrates, calcium and ADF in seeds, which do not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the dicamba mono-oxygenase (DMO) protein as expressed in oilseed rape MON 94100. The GMO Panel finds no evidence that the genetic modification impacts the overall safety of oilseed rape MON 94100. In the context of this application, the consumption of food and feed from oilseed rape MON 94100 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that oilseed rape MON 94100 is as safe as the conventional counterpart and non-GM oilseed rape reference varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable oilseed rape MON 94100 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 oilseed rape MON 94100. The GMO Panel concludes that oilseed rape MON 94100 is as safe as its conventional counterpart and the tested non-GM oilseed rape reference varieties with respect to potential effects on human and animal health and the environment.

摘要

油菜籽MON 94100经培育后具有对麦草畏除草剂的耐受性。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。除了种子中碳水化合物、钙和酸性洗涤纤维的含量外,油菜籽MON 94100与其传统对照品种在农艺学/表型和成分特征方面所确定的差异均无需进一步评估,而这些含量差异也未引发营养和安全方面的担忧。转基因生物小组未发现油菜籽MON 94100中表达的麦草畏单加氧酶(DMO)蛋白在毒性和致敏性方面存在安全问题。转基因生物小组未发现有证据表明基因改造会影响油菜籽MON 94100的整体安全性。在本申请的背景下,表示油菜籽MON 94100的食品和饲料消费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,油菜籽MON 94100与传统对照品种以及所测试的非转基因油菜籽参考品种一样安全,并且认为无需对食品/饲料进行上市后监测。万一油菜籽MON 94100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油菜籽MON 94100的预期用途相符。转基因生物小组得出结论,就对人类和动物健康以及环境的潜在影响而言,油菜籽MON 94100与其传统对照品种以及所测试的非转基因油菜籽参考品种一样安全。

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