About
Sorbitan monostearate is a partial ester of sorbitol and stearic acid used as a non-ionic emulsifier and stabiliser in a wide range of foods including baked goods, confectionery, margarine, and yeast preparations. It helps blend water- and oil-based ingredients, improving texture, consistency, and shelf life.
Safety summary
EFSA's 2017 re-evaluation established a group ADI of 10 mg sorbitan/kg body weight per day (equivalent to 26 mg sorbitan monostearate/kg bw/day) for the sorbitan ester family E491–E495, derived from a NOAEL of 2,600 mg/kg bw/day. The substance does not raise concern for genotoxicity, and dietary exposure at mean and 95th-percentile levels did not exceed the ADI for the general population. A minor theoretical ADI exceedance was observed only in toddlers and children at the 95th percentile in a limited number of surveys, but EFSA concluded the conservative modelling likely overestimated actual exposure and that the finding was not of safety concern.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Approved under Annex II and III of Regulation (EC) No 1333/2008. Group ADI of 10 mg sorbitan/kg bw/day for E491–E495 singly or in combination (equivalent to 26 mg sorbitan monostearate/kg bw/day). Also authorised as a carrier in food additives (colours, anti-foaming agents, glazing agents for fruit) at quantum satis under Annex III.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Formally added to permitted food additives via Food Safety and Standards (Food Products Standards and Food Additives) Eighth Amendment Regulations, 2020 (Gazette notification No.1/Additional Additives-III/Stds/Notification/FSSAI/2017 dated 09.10.2020). Appendix A lists sorbitan monostearate/tristearate/monopalmitate at a maximum of 10 g/kg in table margarine/fat spreads; also approved for yeast and related products.source |
| FDA (Food and Drug Administration) (United States) | Approved | Regulated as a direct food additive under 21 CFR 172.842 as an emulsifier; also listed in the FDA Food Additive Status List as a permitted defoaming agent under 21 CFR 173.340 and in food-contact materials. No numerical ADI established by FDA.source |
Who should approach with care
Research citations
- 1FDA. Substances Added to Food (formerly EAFUS) – Sorbitan Monostearate. hfpappexternal.fda.gov
- 2EFSA. Scientific opinion on the safety of a proposed amendment of the conditions of use of the food additive sorbitan monostearate (E 491) in enzyme preparations, 2025. efsa.europa.eu
- 3FSSAI. Food Safety and Standards (Food Products Standards and Food Additives) Eighth Amendment Regulations, 2020 — Gazette Notification No. 1/Additional Additives-III/Stds/Notification/FSSAI/2017, 2020. fssai.gov.in
- 4EFSA. Re-evaluation of sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) when used as food additives, 2017. efsa.europa.eu
- 5PubMed. Re-evaluation of sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) when used as food additives, 2017. pubmed.ncbi.nlm.nih.gov