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, Anguita Montserrat, Bozzi Cionci Nicole, Innocenti Matteo L, Kolona Maria, Tarrés Call Jordi
EFSA J. 2025 Aug 6;23(8):e9609. doi: 10.2903/j.efsa.2025.9609. eCollection 2025 Aug.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of L-arginine produced with a genetically modified strain of (CCTCC M 20231961) as a nutritional feed additive for all animal species and categories. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the production strain CCTCC M 20231961 does not raise safety concerns. No viable cells or DNA of the production strain are detected in the final product. Therefore, the FEEDAP Panel concludes that the additive does not pose any safety concern regarding the production strain. The use of L-arginine produced by fermentation with CCTCC M 20231961 in feed 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 L-arginine in water for drinking. The use of L-arginine produced by fermentation with CCTCC M 20231961 in animal nutrition is considered safe for the consumers and for the environment. The FEEDAP Panel cannot conclude on the potential of the additive to be irritant to skin and/or eyes and to be a potential dermal sensitiser. The feed additive consisting of L-arginine produced by fermentation with CCTCC M 20231961 is regarded as an efficacious source of the amino acid L-arginine for all non-ruminant species. For the 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）被要求就使用基因改造的 （CCTCC M 20231961） 菌株生产的L-精氨酸作为所有动物种类和类别的营养饲料添加剂的安全性和有效性发表科学意见。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，生产菌株CCTCC M 20231961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。因此，FEEDAP小组得出结论，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，以适当数量添加到日粮中时，使用CCTCC M 20231961发酵生产的L-精氨酸对目标物种在饲料中是安全的。FEEDAP小组对L-精氨酸用于饮用水存在担忧。使用CCTCC M 20231961发酵生产的L-精氨酸在动物营养中对消费者和环境被认为是安全的。FEEDAP小组无法就该添加剂对皮肤和/或眼睛的刺激性以及成为潜在皮肤致敏剂的可能性得出结论。由CCTCC M 20231961发酵生产的L-精氨酸组成的饲料添加剂被视为所有非反刍动物物种的有效L-精氨酸氨基酸来源。为使补充的L-精氨酸在反刍动物中与在非反刍动物物种中一样有效，需要防止其在瘤胃中降解。
