Scientific Opinion on the re-evaluation of propionic acid (E 280), sodium propionate (E 281), calcium propionate (E 282) and potassium propionate (E 283) as food additives

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Article
Panel on Food Additives and Nutrient Sources Added to Food
Acknowledgements

The Panel wishes to thank the members of the Working Group “A” Food Additives and Nutrient Sources (2011-2014): Pierre Galtier, Rainer Gürtler, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Pasquale Mosesso, Dominique Parent-Massin, Ivan Stankovic, Christina Tlustos and Matthew Wright for the preparatory work on this scientific opinion and EFSA staff: Ana Rincon and Stavroula Tasiopoulou for the support provided to this scientific opinion.

EFSA Journal
EFSA Journal 2014;12(7):3779 [45 pp.].
doi
10.2903/j.efsa.2014.3779
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.
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2011-00464
EFSA-Q-2011-00465
EFSA-Q-2011-00466
EFSA-Q-2011-00467
Adopted
3 July 2014
Published
22 July 2014
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

The EFSA ANS Panel provides a scientific opinion re-evaluating the safety of propionic acid (E 280), sodium propionate (E 281), calcium propionate (E 282) and potassium propionate (E 283) which are authorised as food additives in the EU and have been previously evaluated by the SCF and JECFA. JECFA allocated an ADI “not limited”. The SCF concluded that potassium propionate could be added to the list of preservatives and established an ADI ”not specified”. Propionates are naturally occurring substances in the normal diet. The Panel considered that forestomach hyperplasia reported in long-term studies in rodents is not a relevant endpoint for humans because humans lack this organ. Based on the reported presence of reversible diffuse epithelial hyperplasia in the oesophagus the LOAEL for a 90-day study in dogs was considered by the Panel to be 1 % propionic acid in the diet and the NOAEL to be 0.3 % propionic acid in the diet. The Panel considered that there is no concern with respect to genotoxicity and carcinogenicity. The Panel concluded that the present database did not allow allocation of an ADI for propionic acid - propionates. The overall mean and 95th percentile exposures to propionic acid - propionates resulting from their use as food additives (major contributor to exposure) ranged from 0.7-21.1 and 3.6-40.8 mg/kg bw/day, respectively. The Panel noted that the concentration provoking site of contact effect in the 90-day study in dogs (1 % propionic acid in the diet) is a factor of three higher than the concentration of propionic acid - propionates in food at the highest permitted level and concluded that for food as consumed, there would not be a safety concern from the maximum concentrations of propionic acid and its salts at their currently authorised uses and use levels as food additives.

Keywords
Propionic acid, CAS 70-09-4, E 280, sodium propionate, CAS 137-40-6, E 281, calcium propionate, CAS 4075-81-4, E 282, potassium propionate, CAS 327-62-8, E 283
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Number of Pages
45