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U.S. Department of Health and Human Services

Database of Select Committee on GRAS Substances (SCOGS) Reviews

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Biotin

 
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Report No.:  92
 
Type of Conclusion:  1
 
ID Code:  58-85-5
 
Year:  1978
 
CFR Section:  182.8159
 
SCOGS Opinion: 

Biotin, one of the B complex vitamins, is an essential nutrient functioning as a part of the enzyme systems of the human body that are involved in carboxylation and decarboxylation reactions. It is present in many foods and usual diets of adults probably supply an average of 30 to 40mg daily, with large variation. The difficulty of producing biotin deficiency in mammals without the use of avidin indicates that the usual intakes are in excess of those required for normal maintenance and growth.

Currently the only food use of biotin is in milk-free infant formulas and certain special formulas used in the management of older subjects. Infant formulas are likely to provide approximately 95 mg of biotin per day for a 4 month old (about 20 mg per kg body weight) and an adult receiving 2000 kcal in the form of foods for special dietary use under medical supervision could receive up to 300 mg biotin per day (about 5mg per kg body weight). Considerably larger doses (up to 2mg per kg body weight) have been administered without untoward effects in attempts at treating several disease conditions.

Although adverse effects of biotin administration on reproductive performance have been reported in limited experimenys in rats, the effective doses have been extremely large (about 50mg of biotin per kg of body weight). Such doses are orders of magnitude greater than those to which humans could conceivably be exposed by consumption of processed foods containing added biotin.

The Select Committee concludes that:

There is no evidence in the available information on biotin that demonstrates, or suggests reasonable grounds to suspect a hazard to the public when it is added to foods at levels that are now current or that might reasonably be expected in the future.

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