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.
D- or DL- calcium pantothenate; D-Pantothenyl alcohol; D- or DL- Sodium pantothenate
|GRAS Substance||ID Code||21 CFR Regulation|
|D- or DL- Calcium pantothenate||137-08-6||184.1212|
|D- or DL- Sodium pantothenate||867-81-2|
Pantothenates occur in all tissues of the body and are essential for normal metabolic function. Daily consumption of calcium pantothenate added to foods by processors in the United States appears to be less than 0.08 mg per capita (1.3 mg per kg), a value that probably also represents total per capita daily consumption of pantothenates added to foods since sodium pantothenate and pantothenyl alcohol do not appear to be used by food processors. It is estimated that the usual adult diet provides approximately 5 to 19 mg (83 to 316 mg per kg) of naturally occuring pantothenates daily. Animals of several species given 100 mg per kg or more of calcium pantothenate daily for several months showed no evidence of toxicity. Adult patients with disseminated or discoid lupus erythematosus receiving doses of 1g or more daily (16.6 mg per kg) for several months manifested no evidence of toxicity. Although the evidence is scanty, there appears to be no reason to suspect teratogenicity, fetotoxicity or carcinogenicity from intakes considerably greater than those likely to be obtained from foods. There is little information concerning the metabolism of L-pantothenic acid or its salts, although animals and human studies of administration of racemic mixtures of calcium or sodium pantothenate demonstrate no untoward effects at doses considerably higher than could be reasonably expected from pantothenates added to food. There are no specifications listed for food grade sodium pantothenate. The Select Committee believes such specifications should be developed even though there appears to be no current use of sodium pantothenate.
The Select Committee has weighed the foregoing and concludes that:
There is no evidence in the available information on D-pantothenyl alcohol, D- or DL- calcium pantothenate or D- or DL- sodium pantothenate that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when they are used 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.