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.
Calcium carbonate, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate, sodium sesquicarbonate
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21 CFR Section
The Select committee is not aware of any long-term experimental studies on chronic administration of any of the carbonate salts. The results of acute toxicity and short-term feeding experiments are not readily extrapolated in determining toxic levels for carbonate salts consumed by humans. Treatment of gastric or peptic ulcers in patients with large amounts of carbonate salts in various forms has been utilized for many years and only rarely have deleterious results of changes of acid-base balance been reported. When the human respiratory and renal functions are normal, the mechanisms for disposing of bicarbonate intake in large amounts through excretion appear to be highly efficient.
Studies of mice suggest that large intakes of calcium carbonate may interfere with reproductive performance. Such effects could be indirectly attributable to certain trace nutrient deficiencies. Comparable intake levels of calcium may occur when calcium carbonate is used for therapeutic purposes but the amounts added to foods in normal manufacturing processes are not high enough to be harmful. While the Select Committee is not aware of any studies on sodium sesquicarbonate per se, reasoned judgment suggests its biochemical conversion and metabolism would be similar to that of sodium carbonate and bicarbonate.
On the consideration of the foregoing, the Select Committee concludes that:
There is no evidence in the available information on calcium carbonate, potassium carbonate, potassium bicarbonate, sodium carbonate, sodium bicarbonate, or sodium sesquicarbonate that demonstrates or suggests reasonable grounds to suspect a hazard to the public when 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.