Potassium alum and ammonium alum cause negative health effects
the verdict
REFUTED
the evidence says no
refutedsupported
the weight of evidence
0 sources for · 2 against
A formal safety evaluation by the Food Safety Commission of Japan concluded that ammonium and potassium ions from ammonium alum and potassium alum present no safety concerns as food additives.
Abstract Food Safety Commission of Japan (FSCJ) conducted a risk assessment of aluminium ammonium sulfate and aluminium potassium sulfate. This evaluation was requested from Ministry of Health, Labour and Welfare (MHLW) to revise the standards for use of additives. Aluminium ammonium sulfate and aluminium potassium sulfate as additives are assumed reasonably to behave as ions after dissociation, such as aluminium, ammonium, potassium, and sulfate ions, in digestive tract prior to their absorption. FSCJ thus evaluated the safety of aluminium ammonium sulfate and aluminium potassium sulfate used as additives, in considering the substances that are composed of ammonium ion, sulfate ion, potassium ion and aluminium ion. FSCJ concluded that there were no safety concerns of sulfate, ammonium and potassium ions as the use of aluminium ammonium sulfate and aluminium potassium sulfate for food additives. FSCJ specified the lowest no-observed-adverse-effect level (NOAEL) of 30 mg/kg bw/day for aluminium ion based on the reproductive developmental toxicity studies in rats. FSCJ also recognized no carcinogenicity of aluminium additives. FSCJ judged no clear relationship of dietary intake of aluminium with the influences on the bone, mainly due to the insufficient amounts of evidence. FSCJ judged no sufficient evidence to indicate a causal relationship between dietary intake of aluminium and neurological diseases including Alzheimer’s disease. FSCJ confirmed that no human data exist to indicate the clear association of the dietary intake with human health effects of aluminium. FSCJ specified this metal (Al) to be 1.0 mg/kg bw/week for the children (1 to 6 years) and 0.57 mg/kg bw/week for the general population. A safety factor of 100 was applied to the NOAEL of 30 mg/kg bw/day obtained in a developmental toxicity study in rats. Converting the value thus obtained to the aluminium intake per a week, FSCJ established a tolerable weekly intake (TWI) of 2.1 mg/kg bw/week (as Al) for aluminium.
(1 to 6 years) and 0.57
mg/kg bw/week for the general population. A safety factor of 100 was applied to the NOAEL of 30
mg/kg bw/day obtained in a developmental toxicity study in rats. Converting the value thus
obtained to the aluminium intake per a week, FSCJ established a tolerable weekly intake (TWI)
of 2.1 mg/kg bw/week (as Al) for aluminium. Conclusion in Brief
Food Safety Commission of Japan (FSCJ) conducted a risk assessment of aluminium ammonium
sulfate and aluminium potassium sulfate. This evaluation was requested from Ministry of Health,
Labour and Welfare (MHLW) to revise the standards for use of additives. These include the
substances in Table 1 . Both aluminium ammonium
sulfate and aluminium potassium sulfate are additives used in baking powder and also in agents
for food producing and processing.
Table 1. Aluminium ammonium sulfate and aluminium potassium sulfate.
Aluminium ammonium sulfate
CAS No. 7784-26-1 as aluminium ammonium sulfate
dodecahydrate
CAS No. 7784-25-0 as aluminium ammonium sulfate
(anhydride)
Aluminium potassium sulfate
CAS No. 7784-24-9 as aluminium potassium sulfate
dodecahydrate
CAS No. 10043-67-1 as aluminium potassium sulfate
(anhydride)
Open in a new tab The data used in the assessment include pharmacokinetics (Absorption, Distribution,
Metabolism, Excretion (ADME)), genotoxicity, repeated dose toxicity, carcinogenicity, and
reproductive and developmental toxicity. Epidemiological studies and case reports of aluminium
are also included.
Aluminium ammonium sulfate and aluminium potassium sulfate as additives are assumed reasonably
to behave as ions after dissociation, such as aluminium, ammonium, potassium, and sulfate ions,
in digestive tract prior to their absorption. Therefore, the data on the related substances
including these specific ions as well as aluminium ammonium sulfate and aluminium potassium
sulfate are added for the evaluation. FSCJ thus evaluated the safety of aluminium ammonium
sulfate and aluminium potassium sul
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