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.
Ox bile extract, cholic acid, desoxycholic acid, glycocholic acid and taurocholic acid
|GRAS Substance||ID Code||21 CFR Section|
|Ox bile extract||8008-63-7||184.1560|
The amounts of the bile acids ingested as constituents of ox bile extract used as a food additive are relatively insignificant, compared to the amounts normally present in the bile of man. The available information indicates that orally administered cholic acid, desoxycholic acid, glycocholic acid, and taurocholic acid are readily absorbed and excreted without accumulation. They exhibit a relatively low toxicity for several animal species tested.
The Select Committee has no information to indicate that the individual bile acids or their salts are used in foods. However, the intake estimates available for ox bile extract, of which bile acids and their salts are major constituents, indicate that average daily consumption of ox bile extract added to foods is small, amounting to 0.1 mg or less. The intake of individuals bile acids or their salts would be, commensurately, very small. Such biological effects as have been reported in animal studies, have been elicited at levels of administration that are several orders of magnitude greater that the levels to which man is now exposed in his daily diet.
In the light of the information contained in this report, the Select Committee concludes that:
There is no evidence in the available information on ox bile extract, or its constituents — cholic acid, desoxycholic acid. glycocholic acid, and taurocholic acid — 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 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.