Scientific Opinion on the re-evaluation of ascorbic acid (E 300), sodium ascorbate (E 301) and calcium ascorbate (E 302) as food additives

The EFSA Panel on Food additives and Nutrient Sources added to Food (ANS Panel) provides a scientific opinion re-evaluating the safety of ascorbic acid (E 300), sodium ascorbate (E 301) and calcium ascorbate (E 302) as food additives. The use of ascorbic acid and its salts as food additives was evaluated by the Joint FAO/WHO Expert Committee on Food Additives and by the Scientific Committee on Food. Ascorbic acid is absorbed from the intestine by a sodium-dependent active transport process and, at low doses, the absorption is almost complete until a saturation point, after which increasing amounts of unabsorbed substance are excreted. Ascorbic acid and its salts have very low acute toxicities, and short-term tests in animals showed little effect, and even so only at high doses. The Panel concluded that there is no genotoxicity concern for ascorbic acid, sodium ascorbate or calcium ascorbate. Long-term carcinogenicity tests with ascorbic acid did not show any chronic toxicity, even at high doses, and also showed no signs of carcinogenicity. Prenatal developmental studies did not show adverse developmental effects. The Panel estimated the combined exposure to ascorbic acid (E 300), calcium ascorbate (E 301) and sodium ascorbate (E 302). The Panel concluded that, given the fact that adequate data on exposure and toxicity were available and no adverse effects were reported in animal studies, there is no safety concern for the use of ascorbic acid (E 300), sodium ascorbate (E 301) and calcium ascorbate (E 302) as food additives at the reported uses and use levels and there is no need for a numerical ADI for ascorbic acid and its salts.