EFSA re-evaluation and ADI
In 2016, the EFSA Panel on Food Additives and Nutrient Sources (ANS) completed a full re-evaluation of E444. The panel reviewed animal feeding studies and metabolic data and concluded that the ADI set by the EU's Scientific Committee on Food (SCF) of 10 mg/kg body weight per day could be raised to 20 mg/kg body weight per day, bringing it into line with the earlier JECFA (1997) figure. No evidence of carcinogenicity, genotoxicity or reproductive toxicity was identified in the studies reviewed.
EFSA's ANS panel re-evaluated E444 and set an ADI of 20 mg/kg body weight per day, concluding that no genotoxic, carcinogenic or reproductive toxicity signal was present in the available data.
2016Regulatory reviewEFSA ANS Panel, EFSA Journal
JECFA had previously established an ADI of 20 mg/kg body weight per day for SAIB based on a series of rat and dog feeding studies, with no adverse effects attributable to the compound at the doses used.
1997RegulatoryJECFA (Joint FAO/WHO Expert Committee on Food Additives)
Metabolism and breakdown
Once ingested, SAIB is hydrolysed in the gut into sucrose, acetic acid and isobutyric acid, all of which are normal components of food and are metabolised by routine biochemical pathways. The body does not accumulate it. This metabolic profile is one reason no special exposure restriction was considered necessary beyond the ADI.
Animal and in vitro studies show SAIB is hydrolysed to sucrose, acetate and isobutyrate, all normal metabolites, with no unusual metabolic products detected.
2016Regulatory reviewEFSA ANS Panel, EFSA Journal