Re-evaluation of ascorbyl palmitate (E 304(i)) and ascorbyl stearate (E 304(ii))

Tabs

Article
ascorbyl palmitate, E 304(i), CAS No 137-66-6, ascorbyl stearate, E 304(ii), CAS No 2340231-5, ascorbyl esters, E 304
First published in the EFSA Journal
18 November 2015
Adopted
27 October 2015
Type
Scientific Opinion
Abstract
The EFSA Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of ascorbyl palmitate (E 304(i)) and ascorbyl stearate (E 304(ii)) as food additives. The use of these food additives was evaluated by the Joint FAO/WHO Expert Committee on Food Additives and by the Scientific Committee on Food. Biological data on ascorbyl palmitate and stearate are sparse and the safety assessment of them for use as food additives is mainly based on the assumption that ascorbyl palmitate and ascorbyl stearate fully hydrolyse pre-systemically to ascorbic acid and their respective fatty acids. This was supported by an in vitro study reporting near-complete hydrolysis of ascorbyl palmitate in simulated intestinal fluid and by human data. The Panel considered that the toxicity of ascorbyl palmitate can be extrapolated from data describing the toxicity of ascorbic acid and palmitic acid and further considered that this assumption is also valid for ascorbyl stearate. The Panel concluded that the available toxicological data were too limited to establish an ADI for ascorbyl palmitate (E 304(i)) or ascorbyl stearate (E 304(ii)). Exposure estimates based on the high percentile for the maximum level exposure scenario range from 0.4 to 10.8 mg/kg bw/day across all population groups and from 0.3 to 9.9 mg/kg bw/day for the refined brand-loyal scenario. Considering the available data, the Panel concluded that there is no safety concern for the use of ascorbyl palmitate (E 304(i)) and ascorbyl stearate (E 304(ii)) as food additives at the reported uses and use levels.
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.2015.4289
EFSA Journal 2015;13(11):4289 [57 pp.].
On request from
European Commission
Print on demand
Number of Pages
57