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U.S. Department of Health and Human Services

Food

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Select Committee on GRAS Substances (SCOGS) Opinion: Biotin

The GRAS Substances (SCOGS) Database allows access to opinions and conclusions from 115 SCOGS reports published between 1972-1980 on the safety of over 370 Generally Recognized As Safe (GRAS) food substances. The GRAS ingredient reviews were conducted by the Select Committee in response to a 1969 White House directive by President Richard M. Nixon.

Biotin

  • SCOGS-Report Number: 92*
  • Type Of Conclusion: 1
  • ID Code: 58-85-5
  • Year: 1978
  • 21 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 40 μg 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 μg of biotin per day for a 4–month–old (about 20 μg 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 μg biotin per day (about 5 μg per kg body weight). Considerably larger doses (up to 2 mg 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 experiments in rats, the effective doses have been extremely large (about 50 mg 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.

*Complete reports containing details of the safety studies that formed the basis of the opinions and conclusions and are available from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161 (703) 605-6000.