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

Maged Younes, Gabriele Aquilina, Laurence Castle, Karl-Heinz Engel, Paul Fowler, Maria Jose Frutos Fernandez, Peter Fürst, Rainer Gürtler, Ursula Gundert-Remy, Trine Husøy, Wim Mennes, Agneta Oskarsson, Sandra Rainieri, Romina Shah, Ine Waalkens-Berendsen, Detlef Wölfle, Polly Boon, Claude Lambré, Paul Tobback, Matthew WrightDimitrios Chrysafidis, Ana Maria Rincon, Alexandra Tard, Peter Moldeus, EFSA Panel on Food Additives and Flavourings (FAF)

Research output: Contribution to specialist publicationArticle

1 Citation (Scopus)

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 31concluded 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.
Original languageEnglish
Pagese05497
Number of pages30
Volume16
No.12
Specialist publicationEFSA Journal
DOIs
Publication statusPublished - Dec 2018

Keywords

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

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