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

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Article
Food additives, ascorbic acid (E 300), sodium ascorbate (E 301), calcium ascorbate (E 302), vitamin C
First published in the EFSA Journal
6 May 2015
Adopted
14 April 2015
Type
Opinion of the Scientific Committee/Scientific Panel
Abstract

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.

Panel members at the time of adoption
Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Dominique Parent-Massin, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes.
Panel on Food Additives and Nutrient Sources Added to Food
Contact
fip [at] efsa.europa.eu
doi
10.2903/j.efsa.2015.4087
EFSA Journal 2015;13(5):4087 [124 pp.].
On request from
European Commission
Print on demand
Number of Pages
124