Scientific Opinion on the safety of stigmasterol-rich plant sterols as food additive

The Panel on Food Additives and Nutrient Sources added to Food (ANS) delivers a scientific opinion evaluating the safety of use of stigmasterol-rich plant sterols in ready-to-freeze alcoholic cocktails as a stabiliser. Biological and toxicological data on stigmasterol-rich plant sterols were not provided, but the available data on phytosterols and their esters can be used to evaluate the safety of stigmasterol-rich plant sterols provided that the studies are performed with phytosterol preparations containing also a well-defined percentage of stigmasterol. Less than 5% of dietary phytosterols, phytostanols, and their esters are absorbed by the gastrointestinal tract of rats and human. The metabolic fate of phytosterols and their esters is similar between rats and humans. No evidence of mutagenicity or genotoxicity of phytosterols or phytosterol esters was observed. The Panel concluded that stigmasterol-rich plant sterols are not of concern with respect to genotoxicity. Toxicity studies on phytosterols and phytosterol esters were limited to 90-day subchronic toxicity studies and a 2-generation reproductive toxicity study in rats. No chronic toxicity, carcinogenicity or developmental toxicity studies conducted with phytosterols, phytostanols, and their esters were identified. For adults, mean and 95^th percentile exposures to stigmasterol-rich plant sterols from the proposed uses and use levels were 0.01-0.2 mg/kg bw/day and 0.4-7.4 mg/kg bw/day, respectively. Using the lowest NOAEL values of 1.54 g phytosterols/kg bw/day (335 mg stigmasterol/kg bw/day) the calculated Margin of Safety (MOS) values amount to 7700-154 000 at the mean and 208-3850 at the 95^th percentile for the phytosterols and to 1675-33 500 at the mean and 45-838 at the 95^th percentile for stigmasterol. The Panel considered these MOS values adequate and concluded that the proposed use and use levels of stigmasterol-rich plant sterols in ready-to-freeze alcoholic cocktails as a stabiliser would not be of safety concern.