Scientific Opinion on the safety and efficacy of D-(+)-biotin as a feed additive for all animal species based on a dossier submitted by EUROPE-ASIA Import Export GmbH

Abstract

D-(+)-Biotin (hereafter referred to as biotin) acts as an essential cofactor for the enzymes acetyl-CoA, propionyl-CoA, β-methylcrotonyl-CoA and pyruvate carboxylase, which are important in the synthesis of fatty acids, the catabolism of branched-chain amino acids and the gluconeogenic pathway. Biotin may also have a role in the regulation of gene expression arising from its interaction with nuclear histone proteins. Biotin is safe for the target animals with a margin of safety that is probably at least 10 times the requirements and use levels. The use of biotin in animal nutrition is not of safety concern for consumers. In the absence of reliable data on irritation and sensitisation, but considering the long history of safe use in cosmetics, it is unlikely that biotin is irritant to skin and eyes or is a skin sensitiser. Considering the high dusting potential of biotin and the absence of data on inhalation toxicity, the FEEDAP Panel concludes that there is a potential for inhalation exposure from handling biotin, which could be hazardous. The use of biotin in animal nutrition does not pose a risk to the environment. Synthetic D-(+)-biotin is regarded as an effective source of the vitamin in animal nutrition when administered via feed or water for drinking.