Re‐evaluation of aluminium sulphates (E 520–523) and sodium aluminium phosphate (E 541) as food additives

aluminium, E 520, E 521, E 522, E 523, E 541, sulphates
First published in the EFSA Journal
27 July 2018
Adopted
27 June 2018
Type
Scientific Opinion

Abstract

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provided a scientific opinion re‐evaluating the safety of aluminium sulphates (E 520–523) and sodium aluminium phosphate, acidic (E 541) as food additives. The Panel considered that adequate exposure and toxicity data were available. Aluminium sulphates (E 520–523) and sodium aluminium phosphate, acidic (E 541) are permitted as food additives in only a few specific products and the exposure is probably near zero. Aluminium compounds have low bioavailability and low acute toxicity. There is no concern with respect to genotoxicity and carcinogenicity. The no observed adverse effect level (NOAEL) for aluminium compounds in subchronic studies was 52 mg Al/kg body weight (bw) per day in rats and 90 mg Al/kg bw per day in dogs and the lowest NOAEL for neurotoxicity in rats was 30 mg Al/kg bw per day and for developing nervous system was 10–42 mg Al/kg bw per day in studies in mice and rats. The Panel concluded that aluminium sulphates (E 520–523) and sodium aluminium phosphate, acidic (E 541) are of no safety concern in the current authorised uses and use levels.

Panel members at the time of adoption

Peter Aggett, Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Metka Filipič, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert‐Remy, Gunter Georg Kuhnle, Claude Lambré, Jean‐Charles Leblanc, Inger Therese Lillegaard, Peter Moldeus, Alicja Mortensen, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens‐Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes.
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
Contact
fip [at] efsa.europa.eu
doi
10.2903/j.efsa.2018.5372
EFSA Journal 2018;16(7):5372
Question Number
On request from
European Commission