Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on the presence of 1,2-Benzisothiazolin-3-one as an impurity in saccharin used as a food additive

BIT is one of a number of trace impurities which may be present at varying concentrations depending on the synthetic route and the purification processes used to manufacture saccharin. BIT is also a biocide used as an emulsion stabiliser in the preparation of food contact materials. The SCF established a t-TDI for BIT of 0.02 mg/kg bw in 1992. The Panel has estimated the intake of BIT from consumption of saccharin at the Acceptable Daily Intake (ADI) for sodium saccharin of 0-5 mg/kg bw and assuming this saccharin contained BIT at the highest reported concentration (800 mg/kg). Using these assumptions an intake of 0.004 mg BIT/kg bw would result from consumption of saccharin at its ADI. This is around 0.05% of (2000-fold lower than) the no-observed-adverse-effect-level (NOAEL) for BIT in a 90-day oral toxicity study in rats conducted since the SCF established the t-TDI. The Panel accepted that the levels of BIT in commercially available saccharin are usually much lower than 800 mg/kg. The Panel considered that assuming consumption of saccharin at its ADI and containing the highest reported levels of BIT was conservative. The Panel concluded that even the highest levels of BIT detected in these samples do not represent a safety concern.