Rychen Guido, Aquilina Gabriele, Azimonti Giovanna, Bampidis Vasileios, Bastos Maria de Lourdes, Bories Georges, Chesson Andrew, Cocconcelli Pier Sandro, Flachowsky Gerhard, Gropp Jürgen, Kolar Boris, Kouba Maryline, López-Alonso Marta, López Puente Secundino, Mantovani Alberto, Mayo Baltasar, Ramos Fernando, Saarela Maria, Villa Roberto Edoardo, Wester Pieter, Costa Lucio, Dierick Noël, Glandorf Boet, Herman Lieve, Kärenlampi Sirpa, Leng Lubomir, Tebbe Christoph, Aguilera Jaime, Manini Paola, Tarrés-Call Jordi, Wallace Robert John
EFSA J. 2018 Jul 18;16(7):e05336. doi: 10.2903/j.efsa.2018.5336. eCollection 2018 Jul.
Cyanocobalamin is a synthetic form of vitamin B used in pharmaceuticals, supplements and as a food additive. It is intended to be used in feed for all animal species and categories. The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of cyanocobalamin produced by fermentation with strains SCM 2034 or CICC 11008s or strain CMCC (B) 70000. Since relevant data were not provided by the applicant that would allow a proper identification and characterisation of the production strains, the Additives and Products or Substances used in Animal Feed (FEEDAP) Panel cannot conclude on the safety of the use of vitamin B produced using CICC 11008s and CMCC (B) 70000 in animal nutrition for the target animals, the consumer, the user and the environment. Due to significant uncertainties on the identity and safety of the production strain SCM 2034, including the presence of antibiotic resistance genes, the absence of viable cells of the production strain or their DNA in the product, the FEEDAP Panel cannot conclude on the safety of the use of vitamin B, produced by SCM 2034 in animal nutrition for the target species, consumers and the environment. Due to high endotoxin content, potential inhalation exposure when handling premixtures and reported irritancy for skin and eyes, vitamin B produced by SCM2034 is considered to pose a risk to user safety. Vitamin B additives produced by spp. are regarded as effective in meeting animals' requirements.
氰钴胺素是维生素B的一种合成形式，用于制药、补充剂及作为食品添加剂。它拟用于所有动物种类和类别的饲料。欧盟委员会要求欧洲食品安全局就其对目标动物、消费者、使用者和环境的安全性以及用菌株SCM 2034或中国工业微生物菌种保藏管理中心（CICC）11008s或中国医学微生物菌种保藏管理中心（CMCC）（B）70000发酵生产的氰钴胺素的功效发表意见。由于申请人未提供能对生产菌株进行适当鉴定和特性描述的相关数据，动物饲料添加剂及产品或物质（FEEDAP）小组无法就使用中国工业微生物菌种保藏管理中心11008s和中国医学微生物菌种保藏管理中心（B）70000生产的维生素B在动物营养中用于目标动物、消费者、使用者和环境的安全性得出结论。由于生产菌株SCM 2034的身份和安全性存在重大不确定性，包括存在抗生素抗性基因、产品中不存在生产菌株的活细胞或其DNA，FEEDAP小组无法就SCM 2034生产的维生素B在动物营养中用于目标物种、消费者和环境的安全性得出结论。由于内毒素含量高、处理预混料时可能存在吸入暴露以及报告的对皮肤和眼睛的刺激性，SCM2034生产的维生素B被认为对使用者安全构成风险。由[未提及具体菌种名称]生产的维生素B添加剂被认为能有效满足动物需求。
