Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

food additive, propane-1,2-diol esters of fatty acids, propylene glycol esters of fatty acids, E 477
First published in the EFSA Journal
6 dicembre 2018
Adopted
7 novembre 2018
Type
Scientific Opinion

Abstract

The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane‐1,2‐diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short‐term studies in rats and dogs at the highest doses tested. The Panel considered that E 477 did not raise a concern for genotoxicity. No chronic toxicity, carcinogenicity, reproductive and developmental toxicity studies with propane‐1,2‐diol esters of fatty acids were available to the Panel. The Panel considered that any potential adverse effect of propane‐1,2‐diol ester of fatty acids would be due to propane‐1,2‐diol, previously re‐evaluated as a food additive and for which an ADI of 25 mg/kg bw per day was established. Considering the overall metabolic and toxicity database, the Panel confirmed the previously established ADI for propane‐1,2‐diol esters of fatty acids (E 477) of 25 mg/kg bw per day expressed as propane 1,2 diol. This corresponds to an ADI for E 477 of 80 mg/kg bw per day, based on the concentration of free and bound propane‐1,2‐diol amounting to a maximum of 31% as laid down in the EU specification. The Panel concluded that there would not be a safety concern at the reported use levels for E 477 because exposure estimates from the refined non‐brand loyal scenario did not exceed the ADI for E 477 in any of the population groups. However, the Panel aims to explore the feasibility of establishing a group ADI for those food additives that result in an exposure to propane‐1,2‐diol, such as E 477, E 1520 and E 405. Additionally, the Panel will also consider performing a combined exposure assessment to propane‐1,2‐diol resulting from the use of these food additives. The Panel also recommended some modifications of the EU specifications for E 477.

Panel members at the time of adoption

Gabriele Aquilina, Laurence Castle, Karl‐Heinz Engel, Paul Fowler, Maria Jose Frutos Fernandez, Peter Fürst, Rainer Gürtler, Ursula Gundert‐Remy, Trine Husøy, Wim Mennes, Peter Moldeus, Agneta Oskarsson, Sandra Rainieri, Romina Shah, Ine Waalkens‐Berendsen, Detlef Wölfle and Maged Younes.
Panel on Food Additives and Flavourings
Contact
fip [at] efsa.europa.eu
doi
10.2903/j.efsa.2018.5497
EFSA Journal 2018;16(12):5497
Question Number
On request from
European Commission