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Safety and efficacy of a feed additive consisting of manganese(II)‐betaine complex for all animal species (Biochem Zusatzstoffe Handels‐ und Produktionsges. mbH)

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Legal notice: The scientific output published implements EFSA's decision on the confidentiality requests submitted on specific items. As certain items have been awarded confidential status by EFSA they are consequently withheld from public disclosure by redaction.

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of manganese(II)‐betaine complex as a nutritional feed additive for all animal species and categories. Based on the tolerance study performed in chickens, the FEEDAP Panel concluded that the additive is safe for chickens for fattening when used up to the maximum proposed level of manganese in feed; this conclusion was extrapolated to all animal species and categories at the corresponding maximum manganese levels in complete feed (100 mg Mn/kg feed for fish and 150 mg Mn/kg feed for all other animal species). The FEEDAP Panel concluded that the use of additive in animal nutrition does not represent a concern for consumer safety or for the environment. The additive is irritant to the eyes, but not irritant to skin. Owing to the presence of nickel the additive is considered to be a dermal and respiratory sensitiser. The Panel concluded that the additive is efficacious as a nutritional additive for all animal species under the proposed conditions of use.