Safety and efficacy of a feed additive consisting of vitamin B(12) (cyanocobalamin) produced by fermentation with Ensifer adhaerens CGMCC 21299 for all animal species (NHU Europe GmbH)

一种由 Ensifer adhaerens CGMCC 21299 发酵产生的维生素 B(12)(氰钴胺素)组成的饲料添加剂对所有动物物种的安全性和有效性 (NHU Europe GmbH)

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Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of vitamin B(12) (cyanocobalamin) produced by fermentation with a non-genetically modified strain of Ensifer adhaerens (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 E. adhaerens 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 E. adhaerens 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 E. adhaerens CGMCC 21299 is effective in meeting animal's nutritional requirements when administered via feed.

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