The ADI has been increased from 10 mg/kg per day to 20 mg/kg per day.
Sucrose acetate isobutyrate (known as SAIB or E 444), is a clear liquid food additive that is works as an emulsifier, and is often used to help suspend flavouring agents and other oils-based ingredients in beverages.
The current ADI was set at 10 mg/kg of body weight per day by the the former European Commission Scientific Committee on Food (SCF) in 1994. However, a Joint FAO/WHO Expert Committee on Food Additives (JECFA) evaluated and established an ADI of 0–20 mg/kg per day in 1997.
The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) has now provided a scientific opinion based on the re-evaluation of this safety data – concluding that the SCF-set limit of 10 mg/kg per day can be safely raised to the 20 mg/kg per day limit outlined by JECFA in 1997.
After re-assessing the safety data, the EFSA Panel confirmed that it “identified a no observed adverse effect level (NOAEL) of 2,000 mg per kilogram of body weight (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,” said EFSA. “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.”
The EFSA panel noted that it was not provided with a newly submitted dossier, and as such based its evaluation on previous evaluations and reviews, plus literature that has become available since these reviews and data submitted following a public call for data. However, not all original studies on which previous evaluations were based were available for re-evaluation, said EFSA.
The SCF concluded that the NOAEL in a chronic toxicity and carcinogenicity feeding study in rats was 1,000 mg/kg bw per day and allocated an ADI of 10 mg/kg body weight applying an uncertainty factor of 100.
An additional evaluation on SAIB as a food additive performed in 2002 by TemaNord resulted in the conclusion that when excluding the dog, which is considered an inappropriate species for evaluating the risks to humans for this substance, the available studies did not show any treatment-related effects.
The team noted that available studies using carbon 14 labelling (14C-SAIB labelled) showed oral absorption of approximately 70% in rats, about 50% in dogs and of more than 88% in humans.
“In humans receiving 14C-SAIB at doses of 0.1–2 mg/kg bw, the absorbed radioactivity, after further metabolism, was mainly excreted as carbon dioxide in exhaled air (44–66% of the dose),” noted the team. “Urinary and faecal excretions accounted respectively for 15–21% and 10%.”
On the basis of available genotoxicity studies in vitro and in vivo, the Panel considered that SAIB did not raise concern for genotoxicity.
“Rats and mice as well as monkeys tolerate large doses of SAIB over prolonged periods without evidence of significant toxicity,” said the EFSA Panel – noting that the no observed adverse effect level (NOAEL) for rats was 2,000 mg/kg bw per day, for mouse 2,500 mg/kg bw per day and for monkeys 2,400 mg/kg bw per day.
“The Panel concluded that the present data set on the absorption, distribution, metabolism and excretion, genotoxicity, subchronic, reproductive, developmental and long-term toxicity, and carcinogenicity give reason to revise the ADI of 10 mg/kg bw per day allocated by SCF in 1994 to 20 mg/kg bw per day,” concluded the report.
Source: EFSA Journal
Volume 14, Issue 5, May 2016, doi: 10.2903/j.efsa.2016.4489
“Re-evaluation of sucrose acetate isobutyrate (E 444) as a food additive”