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Research article2018Peer reviewedOpen access

Re-evaluation of propane-1,2-diol (E1520) as a food additive

Younes, Maged; Aggett, Peter; Aguilar, Fernando; Crebelli, Riccardo; Dusemund, Birgit; Filipic, Metka; Frutos, Maria Jose; Galtier, Pierre; Gott, David; Gundert-Remy, Ursula; Kuhnle, Gunter Georg; Leblanc, Jean-Charles; Lillegaard, Inger Therese; Moldeus, Peter; Mortensen, Alicja; Oskarsson, Agneta; Stankovic, Ivan; Waalkens-Berendsen, Ine; Woutersen, Rudolf Antonius; Wright, Matthew;
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The EFSA Panelon Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of propane-1,2-diol (E1520) when used as a food additive. In 1996, the Scientific Committee on Food (SCF) established an acceptable daily intake (ADI) of 25mg/kg body weight (bw) per day for propane-1,2-diol. Propane-1,2-diol is readily absorbed from the gastrointestinal and is expected to be widely distributed to organs and tissues. The major route of metabolism is oxidation to lactic acid and pyruvic acid. At high concentrations, free propane-1,2-diol is excreted in the urine. No treatment-related effects were observed in subchronic toxicity studies. The available data did not raise concern with respect to genotoxicity. Haematological changes suggestive of an increased red blood cell destruction with a compensatory increased rate of haematopoiesis were observed at the highest dose level (5,000mg/kg bw per day) in a 2-year study in dogs. No adverse effects were reported in a 2-year chronic study in rats with propane-1,2-diol (up to 2,500mg/kg bw per day). The SCF used this study to derive the ADI. No adverse effects were observed in the available reproductive and developmental toxicity studies. Propane-1,2-diol (E1520) is authorised according to Annex III in some food additives, food flavourings, enzymes and nutrients and it is then carried over to the final food. Dietary exposure to E1520 was assessed based on the use levels and analytical data. The Panelconsidered that for the food categories for which information was available, the exposure was likely to be overestimated. Considering the toxicity database, the Panelconcluded that there was no reason to revise the current ADI of 25mg/kg bw per day. The Panelalso concluded that the mean and the high exposure levels (P95) of the brand-loyal refined exposure scenario did not exceed the ADI in any of the population groups from the use of propane-1,2-diol (E1520) at the reported use levels and analytical results. (C) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.


propane-1,2-diol; propylene glycol; E1520; CAS No57-55-6; food additive

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EFSA Journal
2018, Volume: 16, number: 4, article number: 5235

    UKÄ Subject classification

    Public Health, Global Health, Social Medicine and Epidemiology

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