What Is Propyl Gallate?
The FDA's regulation, 21 CFR 184.1660, says natural occurrence of propyl gallate has not been reported and that it is made commercially by esterifying gallic acid with propyl alcohol. It is used as an antioxidant at levels not exceeding good manufacturing practice, which the rule says results in a maximum total antioxidant content of 0.02 percent of a food's fat or oil content.
The National Toxicology Program says propyl gallate has been used since 1948 to stabilize cosmetics, food packaging materials and foods containing fats, and may be found in edible fats, oils, mayonnaise, shortening, baked goods, candy, dried meat, fresh pork sausage and dried milk.
In a December 1982 study that fed rats and mice diets with 6,000 or 12,000 ppm propyl gallate for 103 weeks, the NTP did not consider propyl gallate carcinogenic for either species, though it noted more preputial gland, pancreatic islet-cell and adrenal tumors in low-dose male rats and said increased malignant lymphoma in male mice may have been related to the diet. The Joint FAO/WHO Expert Committee on Food Additives set an acceptable daily intake of 0 to 1.4 mg per kilogram of body weight in 1993 and maintained it in 1996.
Sources checked September 15, 2026. Every point below links the page it came from.
The sources behind this answer
- Regulatory filingUnder 21 CFR 184.1660, natural occurrence of propyl gallate has not been reported, and it is commercially prepared by esterifying gallic acid with propyl alcohol. US FDA, 21 CFR 184.1660 (eCFR) ↗
- Regulatory filingThe FDA regulation says good manufacturing practice for propyl gallate results in a maximum total antioxidant content of 0.02 percent of the food's fat or oil content. US FDA, 21 CFR 184.1660 (eCFR) ↗
- Government sourceThe NTP says propyl gallate has been used since 1948 as an antioxidant in cosmetics, food packaging and fatty foods, and may be found in fats, oils, mayonnaise, baked goods, candy, dried meat and dried milk. National Toxicology Program, Technical Report TR-240 ↗
- StudyIn its 1982 feeding study, the NTP did not consider propyl gallate carcinogenic for rats or mice, while noting more of some tumors in low-dose male rats and a possible link to malignant lymphoma in male mice. National Toxicology Program, Technical Report TR-240 ↗
- StudyThe NTP study fed groups of 50 rats and 50 mice of each sex diets containing 6,000 or 12,000 ppm propyl gallate for 103 weeks. National Toxicology Program, Technical Report TR-240 ↗
- Government sourceJECFA's acceptable daily intake for propyl gallate is 0 to 1.4 mg per kg of body weight, set in 1993 and maintained in 1996. JECFA, World Health Organization ↗
Sources checked September 15, 2026. A brand statement is the company’s own claim, which we report but have not verified. Our grades are model-based estimates, not lab tests.