Re-evaluation of sucrose acetate isobutyrate (E 444) as a food additive

The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of sucrose acetate isobutyrate (SAIB, E 444) as a food additive. The SCF allocated an acceptable daily intake (ADI) of 10 mg/kg body weight (bw) per day in 1994. JECFA established an ADI of 20 mg/kg bw per day in 1997. Both the JECFA and the SCF concluded that the hepatic effects observed in the dog have little relevance to the safety evaluation in humans. The Panel agreed with this conclusion. Oral absorption is approximately 70% in rats, about 50% in dogs and ≥ 88% in humans. The Panel concluded that SAIB does not raise concern for genotoxicity. No treatment-related effects have been observed on clinical signs, haematology and clinical chemistry in humans at a dose of 20 mg/kg bw per day for 14 days. The Panel identified a no observed adverse effect level (NOAEL) of 2,000 mg/kg bw per day, the highest dose tested, from chronic toxicity, carcinogenicity and reproductive and developmental studies in rats. Applying an uncertainty factor of 100, an ADI of 20 mg/kg bw per day for SAIB can be established. Overall, the Panel concluded that the present data set on absorption, distribution, metabolism and excretion, genotoxicity, subchronic, developmental and long-term toxicity, and carcinogenicity give reason to revise the ADI of 10 mg/kg bw per day allocated by the SCF in 1994 to 20 mg/kg bw per day. Considering that the ADI is not exceeded in any population group, the Panel also concluded that the use of SAIB (E 444) as a food additive at the permitted or reported use and use levels would not be of safety concern.