Accessibility navigation

Refined exposure assessment of polyethylene glycol (E 1521) from its use as a food additive

Younes, M., Aggett, P., Aguilar, F., Crebelli, R., Dusemund, B., Filipič, M., Frutos, M. J., Galtier, P., Gott, D., Gundert‐Remy, U., Kuhnle, G. G. ORCID:, Lambré, C., Lillegaard, I. T., Moldeus, P., Mortensen, A., Oskarsson, A., Stankovic, I., Waalkens‐Berendsen, I., Woutersen, R. A., Wright, M. , Boon, P., Lindtner, O., Tlustos, C., Tard, A. and Leblanc, J.‐C. , (2018) Refined exposure assessment of polyethylene glycol (E 1521) from its use as a food additive. Technical Report. EFSA ISSN 18314732

Text (Open Access) - Published Version
· Available under License Creative Commons Attribution No Derivatives.
· Please see our End User Agreement before downloading.


It is advisable to refer to the publisher's version if you intend to cite from this work. See Guidance on citing.

To link to this item DOI: 10.2903/j.efsa.2018.5293


The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on the refined exposure assessment of polyethylene glycol (E 1521) when used as a food additive. Polyethylene glycols were evaluated by several international bodies and the AFC Panel previously adopted scientific opinions on the safety polyethylene glycol (E 1521). In 2006, the Panel concluded that based on all the data, consumption of PEG through use as plasticisers in film‐coating formulations for food supplement tablets and/or capsules at the intended use level are not of safety concern. In 2007, in another opinion of the AFC Panel related to d‐alpha‐tocopheryl polyethylene glycol 1000 succinate (TPGS) in use for food for particular nutritional purposes, the Panel noted that TPGS intakes would correspond to intake to PEG 1000 at levels equivalent to 3.3–8.5 mg/kg body wieght (bw) per day which are within the range of group acceptable daily intakes (ADIs) of the SCF (1997) and JECFA (1980). This assessment could only take into account the use of polyethylene glycol (E 1521) in food supplements and thus the food supplements consumers only scenario was performed. It resulted in exposure estimates of polyethylene glycol (E 1521) up to 3.5 mg/kg bw per day at the mean and up to 6.1 mg/kg bw per day at the high level. The current exposure assessment is based on the methodology used in the re‐evaluation of food additives together with reported use levels received following a call for data in 2017. Considering the uncertainties of the exposure assessment, these estimates very likely overestimated the real exposure to polyethylene glycol (E 1521). The Panel also noted that the highest calculated exposure estimate falls within the range of the group ADI previously established by SCF (5 mg/kg bw per day for PEG 300–4000) and of the one set by JECFA (10 mg/kg bw per day for PEG 200–10000).

Item Type:Report (Technical Report)
Divisions:Life Sciences > School of Chemistry, Food and Pharmacy > Department of Food and Nutritional Sciences > Human Nutrition Research Group
ID Code:79968


Downloads per month over past year

University Staff: Request a correction | Centaur Editors: Update this record

Page navigation