Scientific Opinion on the re-evaluation of erythorbic acid (E 315) and sodium erythorbate (E 316) as food additives

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Article
Panel on Food Additives and Nutrient Sources Added to Food
EFSA Journal
EFSA Journal 2016;14(1):4360 [51 pp.].
doi
10.2903/j.efsa.2016.4360
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.
Acknowledgements

The Panel wishes to thank the members of the Standing Working Group on the re-evaluation of food additives other than gums and colours: Polly Ester Boon, Dimitrios Chrysafidis, Birgit Dusemund, David Gott, Rainer Gürtler, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Daniel Marzin, Peter Moldeus, Pasquale Mosesso, Dominique Parent-Massin, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen and Matthew Wright for the preparatory work on this scientific opinion and EFSA staff members: Andrea Altieri and Ana Maria Rincon for the support provided to this scientific opinion. The ANS Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2011-00482
EFSA-Q-2011-00483
Adopted
9 December 2015
Approved
20 January 2016
Published
20 January 2016
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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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.

Summary

Following a request from the European Commission (EC), the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion re-evaluating the safety of erythorbic acid (E 315) and sodium erythorbate (E 316) as food additives.

Erythorbic acid (E 315) and sodium erythorbate (E 316) are authorised as food additives in the European Union (EU) in accordance with Annex II to Regulation 1333/2008 on food additives and specific purity criteria have been defined in the Commission Regulation (EU) No 231/2012.

The Joint FAO/WHO Expert Committee on Food Additives (JECFA) evaluated erythorbic acid and sodium erythorbate in 1962, 1974 and 1990, and in its latest evaluation allocated an acceptable daily intake (ADI) ‘not specified’. The Scientific Committee on Food (SCF) evaluated erythorbic acid and sodium erythorbate in 1987, 1990 and 1997, and an ADI of 6 mg/kg bw/day was confirmed in the latest evaluation.

The absorption, distribution, metabolism and excretion (ADME) of erythorbates was considered to be similar to that of ascorbic acid. The sodium ion of sodium erythorbate is expected to enter the sodium pool of the body. Although rodents seemed to have less efficient erythorbate absorption than humans, the available study in mouse indicated that gastrointestinal absorption occurs (Tsao and Salimi, 1983). Guinea pig, a species more analogous to human due to its active-carrier mediated transport, has near complete excretion within 24 h.

The Panel noted that erythorbic acid can increase iron bioavailability, which may represent a concern for individuals with iron deposition disorders.

The Panel noted that the acute toxicity of erythorbic acid or sodium erythorbate is low. The Panel also noted that in the available subchronic toxicity studies there were some limitations mainly concerning reporting, however, none of them reported any adverse effects and there was no histopathological indication of any adverse effects even after 36 weeks of exposure up to 900 mg/kg body weight (bw)/day.

The Panel considered that based on the available genotoxicity studies there was no concern with respect to genotoxicity of erythorbic acid or sodium erythorbate.

The Panel noted that there is no chronic toxicity study available, but considered from the available carcinogenicity studies that erythorbic acid or sodium erythorbate did not raise a concern with respect to carcinogenicity. The only reported adverse effect was a decrease in body weight at 1300 mg/kg bw/day in one study in male rats and the Panel identified a no observed adverse effect level (NOAEL) of 650 mg/kg bw/day from this study.

No reproductive toxicity studies with erythorbic acid or sodium erythorbate were available. However, no histopathological effects were observed on male reproductive organs in a 36-week study. In prenatal developmental studies, no maternal and developmental effects were observed when sodium erythorbate was administered during organogenesis.

The Panel recognised the limitation of the overall toxicological database (no reproductive and chronic toxicity studies). However, taking into account that erythorbic acid or sodium erythorbate gave negative results in a subchronic toxicity study up to 36 weeks, in genotoxicity studies, in carcinogenicity studies and in developmental toxicity studies, the Panel 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 based on the decreased body weight reported in one carcinogenicity study.

The combined dietary exposure to erythorbic acid (E 315) and sodium erythorbate (E 316) from their use as food additives was calculated based on (1) maximum levels set out in the EU legislation (defined as the regulatory maximum level exposure assessment scenario) and (2) usage or analytical data (defined as the refined exposure assessment scenario). In both exposure scenarios, all combined exposure estimates were below the ADI of 6 mg/kg bw/day. Therefore, 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.

Keywords
food additive, erythorbic acid, E 315, CAS No 89-65-6, sodium erythorbate, E 316, CAS No 6381-77-7
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Number of Pages
51