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 propionate; Dilauryl thiodipropionate; Propionic acid; Sodium propionate; Thiodipropionic acid
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21 CFR Section
Propionic acid occurs naturally in various foods including butter and cheese. Its absorption and metabolism are demonstrated in experimental animals and humans where it is a normal intermediary metabolite. As incorporated in foods as its sodium or calcium salt or as the free acid, propionic acid does not occur at the concentrations or under the conditions that are necessary to produce signs of mucosal damage in experimental animals.
Propionic acid, sodium propionate, and calcium propinate have demonstrated low acute toxicity after oral administration to mice or rats. The adverse effects observed in chicken embryos occurred only after injection of large amounts of calcium propionate or sodium propionate into the yolk sac, and the reversions observed in a host-mediated assay of calcium propionate were unrelated to dose. These results in chickenembryos and the host-mediated assay must be viewed in the light of other microbial assays and animal studies that demonstrate no adverse effects and the fact that propionate is a normal intermediary metabolite. Microbial assays for mutagenicity of propionic acid and calcium and sodium propionate were negative. Investigations of the teratogenicity of calcium propionate in four mammalian systems also were negative. Short-term feeding tests show the most sensitive animals tested, young and vitamin B12- deficient animals, experience adverse effects on weight gain only when propionate intakes are many orders of magnitude greater than the estimate of human dietary intake of propionate used as a food ingredient, about 1 mg per kg per day. Long-term feeding studies of propionic acid and calcium propionate have not been reported. However, a long-term feeding study of sodium propionate showed no adverse effects in rats.
The Select Committee has weighed the foregoing and concludes that:
There is no evidence in the available information on propionic acid, calcium propionate, and sodium propionate 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.