Bampidis Vasileios, Azimonti Giovanna, de Lourdes Bastos Maria, Christensen Henrik, Dusemund Birgit, Durjava Mojca Fašmon, Kouba Maryline, López-Alonso Marta, López Puente Secundino, Marcon Francesca, Mayo Baltasar, Pechová Alena, Petkova Mariana, Ramos Fernando, Sanz Yolanda, Villa Roberto Edoardo, Woutersen Ruud, Cocconcelli Pier Sandro, Glandorf Boet, Herman Lieve, Prieto Maradona Miguel, Saarela Maria, Anguita Montserrat, Galobart Jaume, Holczknecht Orsolya, Manini Paola, Pizzo Fabiola, Tarrés-Call Jordi, Pettenati Elisa
EFSA J. 2020 Dec 14;18(12):e06335. doi: 10.2903/j.efsa.2020.6335. eCollection 2020 Dec.
The vitamin B (in the form of cyanocobalamin) under assessment is produced by fermentation with a genetically modified strain of and it is intended to be used as a nutritional additive for all animal species. In 2018, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of EFSA issued an opinion on the safety and efficacy of the product. In that assessment, the Panel could not conclude on the safety of the additive for the target species, consumers and the environment due to uncertainties on the safety of the production strain and the resulting product. Due to high endotoxin content, potential inhalation exposure when handling premixtures and reported irritancy for skin and eyes, the additive was considered to pose a risk to user safety. The applicant provided supplementary data on the identity of the production strain, its susceptibility to antibiotics and toxigenic potential, as well as on the absence of cells and recombinant DNA of the production strain in the final product. The production strain is not expected to produce any toxic compound during fermentation but harbours antimicrobial resistance genes. However, viable cells and recombinant DNA of the strain were not detected in the most concentrated form of the additive. With this new information, the FEEDAP Panel concluded that vitamin B produced by CNCM I-5541 (identified as SCM 2034 in the previous opinion) is safe for all animal species, the consumers and the environment. The applicant did not provide new evidence that would lead the FEEDAP Panel to reconsider previous conclusions regarding the safety for the user.
所评估的维生素B（氰钴胺形式）由一种转基因菌株发酵生产，拟用作所有动物物种的营养添加剂。2018年，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）就该产品的安全性和有效性发布了一份意见。在该评估中，由于生产菌株和最终产品安全性存在不确定性，专家小组无法就该添加剂对目标物种、消费者和环境的安全性得出结论。由于内毒素含量高、处理预混料时存在潜在吸入暴露以及有皮肤和眼睛刺激性的报告，该添加剂被认为对使用者安全构成风险。申请人提供了关于生产菌株的身份、其对抗生素的敏感性和产毒潜力的补充数据，以及关于最终产品中不存在生产菌株的细胞和重组DNA的补充数据。预计生产菌株在发酵过程中不会产生任何有毒化合物，但含有抗微生物抗性基因。然而，在添加剂最浓缩形式中未检测到该菌株的活细胞和重组DNA。有了这些新信息，FEEDAP专家小组得出结论，由CNCM I - 5541（在先前意见中被鉴定为SCM 2034）生产的维生素B对所有动物物种、消费者和环境都是安全的。申请人没有提供新的证据使FEEDAP专家小组重新考虑先前关于对使用者安全性的结论。
