Scientific Opinion on the re-evaluation of ascorbyl palmitate (E 304(i)) and ascorbyl stearate (E 304(ii)) as food additives

The EFSA Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of ascorbyl palmitate (E 304(i)) and ascorbyl stearate (E 304(ii)) as food additives. The use of these food additives was evaluated by the Joint FAO/WHO Expert Committee on Food Additives and by the Scientific Committee on Food. Biological data on ascorbyl palmitate and stearate are sparse and the safety assessment of them for use as food additives is mainly based on the assumption that ascorbyl palmitate and ascorbyl stearate fully hydrolyse pre-systemically to ascorbic acid and their respective fatty acids. This was supported by an in vitro study reporting near-complete hydrolysis of ascorbyl palmitate in simulated intestinal fluid and by human data. The Panel considered that the toxicity of ascorbyl palmitate can be extrapolated from data describing the toxicity of ascorbic acid and palmitic acid and further considered that this assumption is also valid for ascorbyl stearate. The Panel concluded that the available toxicological data were too limited to establish an ADI for ascorbyl palmitate (E 304(i)) or ascorbyl stearate (E 304(ii)). Exposure estimates based on the high percentile for the maximum level exposure scenario range from 0.4 to 10.8 mg/kg bw/day across all population groups and from 0.3 to 9.9 mg/kg bw/day for the refined brand-loyal scenario. Considering the available data, the Panel concluded that there is no safety concern for the use of ascorbyl palmitate (E 304(i)) and ascorbyl stearate (E 304(ii)) as food additives at the reported uses and use levels.