Aluminium and the nervous system
Aluminium is not an essential nutrient and accumulates in the body over time, particularly in bone and brain tissue. Animal studies and some human epidemiological work have raised concerns about neurological effects at higher exposures. EFSA set a tolerable weekly intake (TWI) for aluminium of 1mg per kilogram of body weight per week, based on effects seen in animal studies on the nervous system and reproductive function.
EFSA set a tolerable weekly intake for aluminium of 1mg per kg of body weight per week, derived from animal data showing effects on the nervous system and reproductive function.
2008Regulatory reviewEFSA Panel on Food Additives, Flavourings, Processing Aids and Food Contact Materials (AFC) - Safety of aluminium from dietary intake
EFSA found that dietary aluminium exposure from all sources, including food additives, already exceeded the TWI in high consumers before any contribution from aluminium silicate additives was added.
2020Regulatory reviewEFSA Journal - Re-evaluation of sodium aluminium silicate (E554) and potassium aluminium silicate (E555)
Why the EU removed this additive from the permitted list
The European Commission deleted E556 from the list of permitted food additives in 2012, with the deletion taking effect in 2014. The stated reason was that calcium aluminium silicate could be replaced by other anti-caking agents that do not contribute aluminium to the diet. Because overall aluminium exposure from food was already of concern, removing sources of aluminium from additives was a precautionary measure.
Commission Regulation (EU) No 380/2012 deleted E556 from Annex II of Regulation (EC) No 1333/2008, on the basis that it could be replaced by alternative anti-caking agents not containing aluminium.
2012RegulatoryCommission Regulation (EU) No 380/2012 - Official Journal of the European Union
Safety data gap for the aluminium silicate group
EFSA's 2020 re-evaluation of the closely related E554 and E555 found that the safety of those additives could not be properly assessed because the required toxicological and physicochemical data had not been submitted. The panel noted that estimated aluminium exposure from E554 alone reached 2.13mg/kg body weight per week in children, more than double the TWI. E556 was not covered by this re-evaluation but shares the same core aluminium-exposure concern.
EFSA concluded that the safety of sodium aluminium silicate (E554) and potassium aluminium silicate (E555) could not be assessed due to insufficient toxicological data, and noted that aluminium exposure from E554 reached up to 2.13mg/kg body weight per week in children, exceeding the TWI of 1mg/kg body weight per week.
2020Regulatory reviewEFSA Journal - Re-evaluation of sodium aluminium silicate (E554) and potassium aluminium silicate (E555)