SUMMARYThe Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food has been asked to evaluate the safety in use of polyethylene glycol as a film coating agent for use in food supplement products.Polyethylene glycols are addition polymers of ethylene oxide and water identified by a number approximating to their corresponding molecular weight. The present application is being submitted for six grades of polyethylene glycol (i.e. PEG 400, PEG 3000, PEG 3350, PEG 4000, PEG 6000, and PEG 8000).The extent of polyethylene glycol absorption appears to be dependent on the molecular weight of the specific polymer, such that more complete absorption has been reported for the lower weight polyethylene glycols, while absorption is much more limited in the case of the higher molecular weight polyethylene glycols.Several pre-GLP oral and non-oral, short and long-term animal toxicity studies, as well as a more recent 90-day GLP-compliant animal toxicity study, and a number of mutagenicity tests and human clinical trials have been reported for polyethylene glycols. Together the outcomes of these studies give no reason for concern. The Panel noted that PEG 6000 and PEG 8000 were not included in the carcinogencity studies but given their lower level of absorption than the lower molecular weight PEGs this is not considered a matter of concern.Intake estimates based on the applicant's proposed use levels of polyethylene glycol as a food additive and on conservative assumptions lead to a calculated intake estimate up to 120 mg/day, amounting to 2 mg/kg bw/day assuming 60 kg bw.Additional exposure to polyethylene glycol may also occur from use of pharmaceutical products both tablets and capsules, for which coating with polyethylene glycol-containing films has been approved. Assuming similar levels of use and intake of pharmaceutical products and food supplements per day the combined intake from food supplements and pharmaceutical products would be about 4 mg/kg bw/day.Limited additional exposure in the EU could occur from the approved use of polyethylene glycol 6000 as a carrier for sweeteners, as well as from the use of the PEG in food contact materials.
Polyethylene glycol (PEG)The EFSA Journal (2006) 414, 2 of 22The estimated daily intakes of the polyethylene glycols from the use as a coating agent for food supplements are below the ADI of 0-10 mg/kg body weight allocated by JECFA and the group TDI of 5 mg/kg body weight established by the SCF for the polyethylene glycols.