Aluminium exposure from supplement use
Aluminium is a cumulative metal that the body absorbs slowly from food, water, and food additives. Regulators set a tolerable weekly intake (TWI) of 1 mg of aluminium per kilogram of body weight per week to protect against long-term accumulation. EFSA calculated that at the maximum permitted levels of E1452 in supplements, mean exposure to aluminium from this additive alone reaches up to 26% of that TWI, and at the 95th percentile (highest consumers) can reach 47%. At the lower levels that manufacturers actually report using, the contribution is much smaller, below 3% at the 95th percentile. The gap between what is legally allowed and what is actually used is large, and EFSA specifically asked the European Commission to verify real-world usage.
At the regulatory maximum permitted level, aluminium exposure from E1452 reached up to 26% of the tolerable weekly intake at the mean and up to 47% at the 95th percentile of consumers.
2017Regulatory reviewEFSA ANS Panel, re-evaluation of modified starches including E1452 as food additives, EFSA Journal
At industry-reported use levels, aluminium exposure from E1452 was below 3% of the TWI at the 95th percentile, substantially lower than the regulatory maximum scenario.
2017Regulatory reviewEFSA ANS Panel, re-evaluation of modified starches including E1452 as food additives, EFSA Journal
EFSA recommended the European Commission seek confirmation on the actual use of E1452, given the discrepancy between permitted maximum levels and industry-reported use levels.
2017RegulatoryEFSA ANS Panel, re-evaluation of modified starches including E1452 as food additives, EFSA Journal
Long-term aluminium accumulation
Aluminium is not a nutrient. The body has limited mechanisms to excrete it efficiently, so long-term elevated exposure leads to accumulation, primarily in bone and the nervous system. EFSA's TWI is based on animal studies showing neurological and reproductive harm at sustained higher doses. Human epidemiological data on dietary aluminium are observational and do not establish firm causation, but the accumulation principle is the basis for regulators setting a precautionary limit.
EFSA established a tolerable weekly intake of 1 mg aluminium per kilogram of body weight per week based on animal studies showing neurological and reproductive effects at sustained exposure.
2008RegulatoryEFSA Panel on Contaminants in the Food Chain (CONTAM), dietary exposure to aluminium, EFSA Journal
Aluminium accumulates primarily in bone and the central nervous system. At high chronic exposure in animal studies, neurological and reproductive harm was observed.
2008AnimalEFSA Panel on Contaminants in the Food Chain (CONTAM), dietary exposure to aluminium, EFSA Journal
The starch component itself
The starch backbone of E1452 is not absorbed intact. It is hydrolysed by digestive enzymes in the small intestine and fermented by gut bacteria in the large intestine, producing short-chain fatty acids in the same way as other dietary starches. EFSA found no genotoxic concern from the starch portion and concluded that modified starches as a class do not raise a concern at reported use levels. The aluminium component, not the starch, is the specific flag for this additive.
Modified starches including E1452 are extensively hydrolysed in the gut; the starch component is not absorbed intact and shows no genotoxic signal in in-silico analyses.
2017Regulatory reviewEFSA ANS Panel, re-evaluation of modified starches including E1452 as food additives, EFSA Journal