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

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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

Bibliographical note

Acknowledgements: The Panel wishes to thank the Working Group on the re-evaluation of food additives other than gums and colours of the former EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) for the preparatory work on this scientific output, in particular Pasquale Mosesso and Rudolf Antonius Woutersen. The FAF Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.

Keywords

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

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