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Research article - Peer-reviewed, 2018

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

Younes, Maged; Aquilina, Gabriele; Castle, Laurence; Engel, Karl‐Heinz; Fowler, Paul; Frutos Fernandez, Maria Jose; Fürst, Peter; Gürtler, Rainer; Gundert‐Remy, Ursula; Husøy, Trine; Mennes, Wim; Oskarsson, Agneta; Rainieri, Sandra; Shah, Romina; Waalkens‐Berendsen, Ine; Wölfle, Detlef; Boon, Polly; Lambré, Claude; Tobback, Paul; Wright, Matthew;
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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 (E477) 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 E477 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 25mg/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 (E477) of 25mg/kg bw per day expressed as propane 1,2 diol. This corresponds to an ADI for E477 of 80mg/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 E477 because exposure estimates from the refined non-brand loyal scenario did not exceed the ADI for E477 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 E477, E1520 and E405. 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 E477. (c) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.


food additive; propane-1,2-diol esters of fatty acids; propylene glycol esters of fatty acids; E 477

Published in

EFSA Journal
2018, Volume: 16, number: 12, article number: 5497