Villa Roberto Edoardo, Azimonti Giovanna, Bonos Eleftherios, Christensen Henrik, Durjava Mojca, Dusemund Birgit, Gehring Ronette, Glandorf Boet, Kouba Maryline, López-Alonso Marta, Marcon Francesca, Nebbia Carlo, Pechová Alena, Prieto-Maradona Miguel, Röhe Ilen, Theodoridou Katerina, Bozzi Cionci Nicole, Pettenati Elisa, Tarrés-Call Jordi
EFSA J. 2024 Oct 10;22(10):e9028. doi: 10.2903/j.efsa.2024.9028. eCollection 2024 Oct.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of l-arginine produced by fermentation with a genetically modified strain of (CGMCC 7.401). The additive is intended to be used in feed and water for drinking for all animal species and categories. The genetic modifications introduced do not raise safety concerns. No viable cells or DNA of the production strain were detected in the final product. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive does not pose any safety concern with regard to the production strain. l-Arginine produced with CGMCC 7.401 is safe for the target species when supplemented in appropriate amounts to the diet according to the nutritional needs of the target species. The FEEDAP Panel has concerns on the use of amino acids in water for drinking for hygienic reasons, and due to the risk of imbalances when administered simultaneously via feed and water. The use of l-arginine produced with CGMCC 7.401 in animal nutrition is considered safe for the consumers and for the environment. The endotoxin activity of the additive does not represent a hazard for persons handling the additive. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be irritant to skin and/or eyes, or to be a dermal or respiratory sensitiser. The additive l-arginine produced with CGMCC 7.401 is regarded as an efficacious source of the essential amino acid l-arginine for non-ruminant species. For supplemental l-arginine to be as efficacious in ruminants as in non-ruminant species, it requires protection against degradation in the rumen.
应欧盟委员会的要求，欧洲食品安全局（EFSA）被要求就一种由转基因菌株（CGMCC 7.401）发酵生产的L-精氨酸饲料添加剂的安全性和有效性发表科学意见。该添加剂拟用于所有动物种类和类别的饲料及饮用水中。引入的基因改造不存在安全问题。在最终产品中未检测到生产菌株的活细胞或DNA。欧洲食品安全局动物饲料添加剂和产品或物质专家小组（FEEDAP）得出结论，该添加剂在生产菌株方面不存在任何安全问题。根据目标物种的营养需求，以适当剂量添加到日粮中的由CGMCC 7.401生产的L-精氨酸对目标物种是安全的。出于卫生原因，以及同时通过饲料和水给药时存在失衡风险，FEEDAP专家小组对在饮用水中使用氨基酸表示担忧。在动物营养中使用由CGMCC 7.401生产的L-精氨酸被认为对消费者和环境是安全的。该添加剂的内毒素活性对处理该添加剂的人员不构成危害。由于缺乏数据，FEEDAP专家小组无法就该添加剂对皮肤和/或眼睛产生刺激、或成为皮肤或呼吸道致敏剂的可能性得出结论。由CGMCC 7.401生产的L-精氨酸添加剂被视为非反刍动物必需氨基酸L-精氨酸的有效来源。对于反刍动物而言，要使补充的L-精氨酸与非反刍动物一样有效，需要对其进行保护以防在瘤胃中降解。
