Re-evaluation of E 315 and E 316 as food additives

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Article
food additive, erythorbic acid, E 315, CAS No 89-65-6, sodium erythorbate, E 316, CAS No 6381-77-7
First published in the EFSA Journal
20 January 2016
Adopted
9 December 2015
Type
Scientific Opinion
Abstract
The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of erythorbic acid (E 315) and sodium erythorbate (E 316) as food additives. The use of these food additives was evaluated by the Scientific Committee on Food (SCF) that established an acceptable daily intake (ADI) of 6 mg/kg body weight (bw)/day. Intestinal absorption of erythorbate was reported from a mice study and near complete excretion within 24 h from a guinea pig study. The Panel noted that the acute toxicity of erythorbic acid or sodium erythorbate is low, there was no indication of adverse effects from the available subchronic toxicity studies, there is no concern with respect to their genotoxicity neither to respect to carcinogenicity. The Panel identified a no observed adverse effect level (NOAEL) of 650 mg/kg bw/day based on a decrease in body weight from a carcinogenicity study. No maternal and developmental effects were observed from a prenatal developmental toxicity study with sodium erythorbate. The Panel recognised the limitation of the overall toxicological database (no reproductive and chronic toxicity studies), but did not consider necessary to increase the usual uncertainty factor of 100 in deriving an ADI. Therefore, the Panel concluded that there is no reason to revise the current ADI of 6 mg/kg bw/day. Combined dietary exposure to erythorbic acid and sodium erythorbate from their use as food additives was calculated. Considering that the ADI is not exceeded by any population group, the Panel also concluded that the use of erythorbic acid (E 315) and sodium erythorbate (E 316) as food additives at the permitted or reported use and use levels would not be of safety concern.
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.2016.4360
EFSA Journal 2016;14(1):4360 [51 pp.].
On request from
European Commission
Print on demand
Number of Pages
51