November 16, 2012

Panel on Additives to give opinion on the safety, efficacy of D-(+)-biotin

Press release

The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of d-(+)-biotin as an additive to feed and water for drinking for all animal species and categories, following a request from the European Commission.

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. It has a low toxicity and shows a limited retention in edible tissues and products. Current levels of intake of biotin, which includes intake arising from the consumption of animal tissues and products from biotin-treated animals, do not represent a health risk for the general population. The FEEDAP Panel considers that the use of biotin in animal nutrition is not of safety concern for consumers.

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. Biotin occurs in nature in both bound and free forms. Its use in animal nutrition is not expected to substantially increase the concentration in the environment. Therefore, the use of biotin in animal nutrition is not expected to pose a risk to the environment.

Synthetic biotin is regarded as an effective source of the vitamin in animal nutrition when administered via feed or water for drinking. The FEEDAP Panel made recommendations on the specifications of biotin; on the restricted distribution of the pure substance on the market; and on the use of biotin in water for drinking.