Exposure is narrow and well below established intake limits
E1521 is only authorised in two narrow food categories, so most people encounter it only through food supplement tablets or tabletop sweetener products, not through everyday food. EFSA's 2018 refined exposure assessment estimated the highest mean daily intake at roughly 3.5mg per kilogram of body weight in children, and the 95th percentile at about 6.1mg/kg bw/day in elderly consumers. Both figures sit within or below the group acceptable daily intake set by earlier scientific committees. EFSA noted the estimates very likely overstate real intake because actual market data showed only around 2% of food supplements on sale contained PEG at all.
Refined dietary exposure estimates for E1521 from food supplement and tabletop sweetener use fall within the range of existing group ADIs, and EFSA concluded the estimates very likely overestimate real exposure given low actual market prevalence.
2018Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), EFSA Journal
The Scientific Committee on Food (SCF) established a group ADI of 5mg/kg bw/day for PEG 300-4000; JECFA set a group ADI of 10mg/kg bw/day for PEG 200-10000.
RegulatorySCF opinion; JECFA evaluation
Toxicology: poorly absorbed, largely excreted unchanged
PEG is poorly absorbed from the gut. Higher-molecular-weight grades pass through the digestive tract largely intact and are excreted in faeces; lower-molecular-weight fractions are absorbed to a greater degree but are rapidly cleared by the kidneys. This low bioavailability is central to its use as a laxative medicine at much higher doses than food additive exposure, and is also why food-additive-level intake raises no significant absorption-related concern. No carcinogenicity, genotoxicity, or reproductive toxicity has been established at food-relevant exposure levels in the scientific literature reviewed by EFSA.
Higher-molecular-weight PEG grades (1000 and above) are poorly absorbed from the gastrointestinal tract and excreted primarily in faeces; lower grades show greater but still limited absorption with renal clearance.
2018Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), EFSA Journal