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.

Peer review of the pesticide risk assessment of the active substance aluminium ammonium sulfate

“…The oral bioavailability of different aluminium compounds in humans and experimental animals may vary in food and drink matrices. An overall oral absorption of 0.3% was agreed for aluminium ammonium sulfate on the basis of the evaluation of data from aluminium ammonium sulfate and other aluminium compounds and supported by EFSA ANS Panel ( 2018 ). Aluminium distributes in most organs within the body with accumulation mainly in bone, lung, muscle, liver and brain.…”

“…The only available genotoxicity studies for aluminium ammonium sulfate were two in vitro gene mutation assays in bacteria performed with the products ‘Curb Liquid Formulation’ and ‘Curb Powder Formulation’, respectively: They were both considered acceptable and negative. Other information available from literature, from EFSA AFC Panel ( 2008 ) and EFSA ANS Panel ( 2018 ) on different aluminium compounds confirmed the absence of mutagenicity in procaryotic or eucaryotic cells but indicated in vitro and in vivo clastogenic activity likely related to indirect mechanisms. The experts considered that this is not compromising the possibility of setting reference values as the effects were seen at relatively high exposure levels and they were considered unlikely to be relevant to human exposure to aluminium via the diet and all other possible sources of exposure to aluminium.…”

“…No convincing evidence for a carcinogenicity potential of aluminium ammonium sulfate was concluded 8 on the basis of limited data from available carcinogenicity studies on other aluminium salts. According to EFSA AFC Panel ( 2008 ), some evidence of carcinogenicity related to physical properties of particles/fibres was observed but not considered relevant to dietary exposure of humans; no carcinogenic risk was concluded in EFSA ANS Panel ( 2018 ). It was also noted that US EPA considered that carcinogenicity was not demonstrated (US EPA, 2006 ) and IARC concluded (IARC, 1984 ) that there is limited evidence that certain exposure in the aluminium production industry is carcinogenic to humans giving rise to cancer of the lung and bladder (IARC did not implicate aluminium itself as a human carcinogen).…”

“…In early reviews, both EFSA AFC Panel ( 2008 ) and JECFA ( 2007 ) concluded that a potential for effects on reproduction (more specifically spermatogenesis) was identified with soluble aluminium compounds. Two guideline multigeneration studies were subsequently conducted with aluminium sulfate and aluminium ammonium sulfate administered in rats via drinking water, and have been reviewed by JEFCA ( 2012 ) and by EFSA ANS Panel ( 2018 ) who concluded that the studies did not provide any evidence of reproductive toxicity . In the multigeneration study performed with aluminium ammonium sulfate, the experts agreed to set the parental NOAEL at 33.5 mg Al/kg bw per day (based on effects on food consumption and body weight/body weight gains and on changes in pituitary and kidney weights).…”

Postharvest Treatments with Sulfur-Containing Food Additives to Control Major Fungal Pathogens of Stone Fruits

“…Although sulfites (SO 3 2− ), bisul-fites (HSO 3 − ), and metabisulfites (S 2 O 5 2− ) have been sometimes linked to adverse allergies [21,22], the compounds in the sulfites group (E-numbers E 220-228) are currently approved as food additives for different uses on whole fresh fruits and vegetables [23]. Likewise, nowadays, the aluminum sulfates (E-numbers E 520-523) are considered of minimal human health concern in the regulated uses, after re-evaluation by the EFSA in 2018 [24]. Regarding agricultural uses, the control of gray mold caused by B. cinerea by postharvest sulfur dioxide (SO 2 ) fumigations or in-package sodium metabisulfite pads is widely extended in the table grape industry [25,26].…”