Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Durjava Mojca, Dusemund Birgit, Kouba Maryline, López-Alonso Marta, López Puente Secundino, Marcon Francesca, Mayo Baltasar, Pechová Alena, Petkova Mariana, Ramos Fernando, Villa Roberto Edoardo, Woutersen Ruud, Cocconcelli Pier Sandro, Amaduzzi Angelica, Galobart Jaume, Holcznecht Orsolya, Manini Paola, Villa Alberto Navarro, Pettenati Elisa, Radovnikovic Anita, Rossi Barbara, Vettori Maria Vittoria, Pizzo Fabiola
EFSA J. 2024 Apr 17;22(4):e8752. doi: 10.2903/j.efsa.2024.8752. eCollection 2024 Apr.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of vitamin B (cyanocobalamin) produced by fermentation with a non-genetically modified strain of (CGMCC 21299), when used as a nutritional additive for all animal species. No viable cells or DNA of the production strain were detected in the additive. Therefore, cyanocobalamin produced by fermentation with CGMCC 21299 does not raise safety concerns as regards to the production strain. The Panel on Additives and Products or Substances used in Animal Feed concluded that cyanocobalamin produced by fermentation with CGMCC 21299 is considered safe for all animal species, for the consumers and the environment. Due to the presence of nickel, the additive is considered a skin and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. Due to the lack of data, the Panel could not conclude on the potential of the additive to be an eye irritant. Cyanocobalamin produced by fermentation with CGMCC 21299 is effective in meeting animal's nutritional requirements when administered via feed.
应欧盟委员会要求,欧洲食品安全局被要求就使用非转基因的(CGMCC 21299)菌株发酵生产的维生素B(氰钴胺)作为所有动物物种的营养添加剂时的安全性和有效性发表科学意见。在该添加剂中未检测到生产菌株的活细胞或DNA。因此,用CGMCC 21299发酵生产的氰钴胺在生产菌株方面不存在安全问题。动物饲料添加剂及产品或物质专家小组得出结论,用CGMCC 21299发酵生产的氰钴胺对所有动物物种、消费者和环境而言都是安全的。由于含有镍,该添加剂被认为是一种皮肤和呼吸道致敏剂。吸入和皮肤接触被视为有风险。由于缺乏数据,专家小组无法就该添加剂成为眼部刺激物的可能性得出结论。用CGMCC 21299发酵生产的氰钴胺通过饲料给药时能有效满足动物的营养需求。