• Open Access

Scientific Opinion on the re-evaluation of ascorbyl palmitate (E 304(i)) and ascorbyl stearate (E 304(ii)) as food additives

Authors

  • EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)


  • Panel members: 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.
  • Correspondence: fip@efsa.europa.eu
  • Acknowledgement: The Panel wishes to thank the members of the former Working Group “A” Food Additives and Nutrient Sources (2011–2014) and 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: Ana Rincon and Alesandra Tard 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.
  • Adoption date: 27 October 2015
  • Published date: 18 November 2015
  • Question number: EFSA-Q-2011-00473, EFSA-Q-2011-00474
  • On request from: European Commission

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.

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