Aluminium accumulates in the body and affects the nervous system at higher exposures
Aluminium from all food and drink sources is absorbed in small amounts but accumulates slowly in bones, the brain and other tissues because the body clears it slowly. Animal studies show neurological effects and effects on the developing brain at doses well above typical dietary exposure. On this basis, regulators set a tolerable weekly intake covering all dietary aluminium combined, not just food additives.
EFSA set a tolerable weekly intake (TWI) of 1 mg aluminium per kilogram of body weight per week, based on neurotoxicity and neurodevelopmental effects seen in animal studies.
2008Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources (ANS), EFSA Journal
Animal studies identified a NOAEL of 10-42 mg aluminium per kilogram body weight per day for developmental nervous system effects in mice and rats.
2018AnimalEFSA Panel on Food Additives and Nutrient Sources (ANS), re-evaluation of aluminium sulphates E520-523 and E541, EFSA Journal
JECFA set a provisional tolerable weekly intake of 2 mg aluminium per kilogram of body weight per week, also based on neurodevelopmental studies.
2011Regulatory reviewJoint FAO/WHO Expert Committee on Food Additives (JECFA)
Exposure from E521 in permitted foods is near zero
The two food categories where E521 is permitted (candied fruits and liquid egg white) are consumed in very small amounts. EFSA's 2018 re-evaluation estimated that exposure from these uses is most probably near the lower end of their calculated range, and concluded the additives pose no safety concern at authorised use levels. The wider concern about aluminium comes from background dietary exposure across all sources, not from E521 specifically.
EFSA concluded that aluminium sulphates E520-523 are of no safety concern in their current authorised uses and use levels, estimating that actual dietary exposure from these specific additives is probably negligible.
2018Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources (ANS), re-evaluation of aluminium sulphates E520-523 and E541, EFSA Journal
No concerns regarding genotoxicity, carcinogenicity or reproductive/developmental toxicity were identified at the exposure levels resulting from the authorised food uses of E520-523.
2018Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources (ANS), EFSA Journal
Some population groups exceed the aluminium TWI from diet overall
Dietary aluminium comes from many sources including drinking water, cookware, antacid medicines, and naturally occurring levels in cereals, vegetables and tea. EFSA has noted that some consumers, particularly high-end consumers, may exceed the 1 mg/kg body weight per week TWI when all sources are combined. Children are a particular concern because of their lower body weight and developing nervous systems.
A 2011 EFSA dietary exposure assessment found that mean dietary exposure to aluminium from food sources ranged from 0.2 to 1.5 mg/kg body weight per week across European countries, with some high-end consumers exceeding the TWI.
2011ObservationalEFSA Panel on Contaminants in the Food Chain (CONTAM), EFSA Journal