Scientific Opinion on the safety of allyl isothiocyanate for the proposed uses as a food additive

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on the safety of allyl isothiocyanate (AITC) when used as a food preservative. Rats appear to resemble humans in AITC metabolism, but have a much slower clearance than humans. AITC has been investigated in acute, short-term, subchronic toxicity studies and in carcinogenicity studies in rodents. AITC did not cause any developmental toxicity in rats, hamsters and rabbits. AITC may be fetotoxic to mice at doses higher than 6.0 mg/kg bw/day. AITC is not carcinogenic in mice but transitional cell papillomas of the urinary bladder of males were observed in a long-term rat study, however, AITC is not genotoxic in vivo in mice and rats. Hence it could be assumed that there is a threshold mechanism underlying these effects on urinary bladder. The Panel considered this long-term rat study as the pivotal study. The Panel derived an ADI of 0.018 mg/kg bw/day which was rounded up to 0.02 mg/kg bw/day based on a LOAEL of 9 mg/kg bw/day and applying an uncertainty factor of 500 in order to cover uncertainties resulting from extrapolation from the LOAEL to the NOAEL and from the absence of reproductive toxicity studies. The Panel noted that AITC intakes resulting only from application as an antispoilage agent could be estimated for children and adults at 0.3 up to 2.8 and 0.2 up to 1.6 times the ADI depending on the exposure scenario. Furthermore, the Panel noted that the mean daily total exposure to AITC from all sources including natural occurrence in food, use as a flavouring and application as an antispoilage agent, based on the more refined model, results in a two to four-fold exceedance of the ADI in children and up to eight-fold exceedance in 95th percentile adult consumers.