Aluminium Ammonium Sulfate and Aluminium Potassium Sulfate (FoodAdditives)

摘要

Food Safety Commission of Japan (FSCJ) conducted a risk assessment of aluminium ammoniumsulfate 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 ammoniumsulfate and aluminium potassium sulfate as additives are assumed reasonably to behave as ionsafter dissociation, such as aluminium, ammonium, potassium, and sulfate ions, in digestivetract prior to their absorption. FSCJ thus evaluated the safety of aluminium ammonium sulfateand aluminium potassium sulfate used as additives, in considering the substances that arecomposed of ammonium ion, sulfate ion, potassium ion and aluminium ion. FSCJ concluded thatthere were no safety concerns of sulfate, ammonium and potassium ions as the use of aluminiumammonium sulfate and aluminium potassium sulfate for food additives. FSCJ specified the lowestno-observed-adverse-effect level (NOAEL) of 30 mg/kg bw/day for aluminium ion based on thereproductive developmental toxicity studies in rats. FSCJ also recognized no carcinogenicity ofaluminium additives. FSCJ judged no clear relationship of dietary intake of aluminium with theinfluences on the bone, mainly due to the insufficient amounts of evidence. FSCJ judged nosufficient evidence to indicate a causal relationship between dietary intake of aluminium andneurological diseases including Alzheimer’s disease. FSCJ confirmed that no human data exist toindicate 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 0.57mg/kg bw/week for the general population. A safety factor of 100 was applied to the NOAEL of 30mg/kg bw/day obtained in a developmental toxicity study in rats. Converting the value thusobtained 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.