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.
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