Re-evaluation of stearyl tartrate (E 483) as a food additive.

The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re-evaluating the safety of stearyl tartrate (E 483) as a food additive. The previously evaluated toxicological studies were not available, in addition to no genotoxicity data being available. Thus, adequate toxicity data on stearyl tartrate were not available for its re-evaluation. In addition, adequate data demonstrating the complete hydrolysis of stearyl tartrate (E 483) in the gastrointestinal tract and/or presystemically, that could allow read-across from data on its constituents, were lacking. Therefore, the safety of the use of stearyl tartrate as a food additive could not be assessed and the acceptable intake established by the Scientific Committee on Food (SCF) in 1978 could not be confirmed. Exposure to stearyl tartrate (E 483) was calculated using the maximum level exposure assessment scenario as neither use levels nor analytical data were available. Mean exposure to stearyl tartrate (E 483) as a food additive ranged from 0.1 mg/kg body weight (bw) per day in infants to 82.5 mg/kg bw per day in toddlers. The 95th percentile of exposure ranged from 0 mg/kg bw per day in adults to 192.7 mg/kg bw per day in toddlers. The Panel also noted that information from the Mintel's GNPD indicates that only two products have been labelled with stearyl tartrate (E 483) since 1996. Some recommendations were proposed by the Panel.