Emulsifier · EU 491
Sorbitan Monostearate
FDA status: Approved. EU: Approved. No U.S. state has enacted a specific ban yet.
According to the U.S. Food and Drug Administration, Sorbitan Monostearate is FDA-approved, and no U.S. state has moved to restrict it independently of federal policy. Its composite safety score is 2 out of 5 (Caution), and the European Union separately classifies it as approved. By tracked product count it ranks #76 of 417.
- #76 of 417 by tracked product prevalence
The verdict
Sorbitan Monostearate is FDA-approved, and no U.S. state has moved to restrict it. By Open Food Facts product count it sits #76 of 417 among additives with tracked product presence (82nd percentile).
- 2/5
- Caution
- Approved
- FDA status
- #76 of 417
- product-prevalence rank
- 0
- state regulations
Product-footprint and regulatory snapshot
Sorbitan Monostearate: 489 tracked U.S. products (common band, #76 of 417) frame how often this additive appears on shelves.
| Property | Value | Source |
|---|---|---|
| Tracked Products | 489 · #76 of 417 | Open Food Facts (US) |
| FDA Status | Approved | FDA SAFFA |
| EU Status | Approved | EC 1333/2008 |
| E-Number | 491 | EU additive register |
| CAS Number | - | CAS Registry |
| Category | Emulsifier | FDA functional class |
| Composite Safety Score | 2 / 5 (Caution) | PlainIngredients methodology |
| EFSA ADI | 26 | EFSA scientific opinion |
| U.S. State Actions | 0 states | State legislative records |
Values reflect official agency classifications as published by the U.S. Food and Drug Administration and the European Union's regulatory framework. See our methodology for scoring details.
What is Sorbitan Monostearate?
Sorbitan Monostearate is a food additive (491) classified as emulsifier.
Health Concerns
- EFSA evaluation: Re‐evaluation of sorbitan monostearate -E 491-, sorbitan tristearate -E 492-, sorbitan monolaurate -E 493-, sorbitan monooleate -E 494- and sorbitan m. EFSA overexposure risk: high. Flagged by ANSES (French food safety agency) as additive of interest
Common Uses
Shelf-footprint peer axes
Nationwide peers for a common OFF footprint
Nearest OFF product-count peers (489 tracked here); safety-score column omitted on prevalence-led pages.
Nearest OFF product count to 489
Nearest other additives by Open Food Facts product count (floored at ≥50).
Frequently Asked Questions
Is Sorbitan Monostearate safe to consume?
Sorbitan Monostearate scores 2/5 (Caution). FDA status is Approved. On the Open Food Facts U.S. sample it is a common additive (489 tracked products, #76 of 417), so product footprint, not just the score label, frames how widely a shopper will meet it.
What is Sorbitan Monostearate used for in food?
Sorbitan Monostearate shows up as Sauces, dressings, baked goods, ice cream in the Emulsifier class, and the OFF sample puts it in the common footprint band (489 products).
Where does Sorbitan Monostearate sit among food additives PlainIngredients tracks?
Among additives with at least one tracked product, it ranks #76 of 417 by Open Food Facts product count. See /methodology#corpus-placement for the ranking bases.
What health concerns are associated with Sorbitan Monostearate?
Research has identified the following health concerns for Sorbitan Monostearate: EFSA evaluation: Re‐evaluation of sorbitan monostearate -E 491-, sorbitan tristearate -E 492-, sorbitan monolaurate -E 493-, sorbitan monooleate -E 494- and sorbitan m. EFSA overexposure risk: high. Flagged by ANSES (French food safety agency) as additive of interest. These findings inform its safety score of 2/5. Consult a healthcare provider for personalized guidance, especially if you have pre-existing conditions.