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

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.

• Authors: EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), Maged Younes, 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, Matthew Wright, Alessandro Di Domenico, Henk van Loveren, Alessandra Giarola, Zsuzsanna Horvath, Federica Lodi, Alexandra Tard, Rudolf Antonius Woutersen
• Journal: EFSA journal. European Food Safety Authority (EFSA J) Vol. 16 Issue 7 Pg. e05372 (Jul 2018) ISSN: 1831-4732 [Electronic] United States
• PMID: 32625999 (Publication Type: Journal Article)
• Copyright: © 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.