Emulsifier · EU 435
Polyoxyethylene 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, Polyoxyethylene Sorbitan Monostearate is FDA-approved, and no U.S. state has moved to restrict it independently of federal policy. Its composite safety score is 3 out of 5 (Mixed Evidence), and the European Union separately classifies it as approved. By tracked product count it ranks #395 of 417.
- #395 of 417 by tracked product prevalence
The verdict
Polyoxyethylene Sorbitan Monostearate is FDA-approved, and no U.S. state has moved to restrict it. By Open Food Facts product count it sits #395 of 417 among additives with tracked product presence (0th percentile).
- 3/5
- Mixed Evidence
- Approved
- FDA status
- #395 of 417
- product-prevalence rank
- 0
- state regulations
Regulatory snapshot
Polyoxyethylene Sorbitan Monostearate: composite 3/5 (Mixed Evidence) with FDA Approved and EU Approved.
| Property | Value | Source |
|---|---|---|
| FDA Status | Approved | FDA SAFFA |
| EU Status | Approved | EC 1333/2008 |
| E-Number | 435 | EU additive register |
| CAS Number | - | CAS Registry |
| Category | Emulsifier | FDA functional class |
| Composite Safety Score | 3 / 5 (Mixed Evidence) | PlainIngredients methodology |
| EFSA ADI | 25 | EFSA scientific opinion |
| U.S. State Actions | 0 states | State legislative records |
| Tracked Products | 1 | Open Food Facts (US) |
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 Polyoxyethylene Sorbitan Monostearate?
Polyoxyethylene Sorbitan Monostearate is a food additive (435) classified as emulsifier.
Health Concerns
- EFSA evaluation: Scientific Opinion on the re-evaluation of polyoxyethylene sorbitan monolaurate -E 432-, polyoxyethylene sorbitan monooleate -E 433-, polyoxyethylene . EFSA overexposure risk: moderate. Flagged by ANSES (French food safety agency) as additive of interest
Common Uses
Catalog-profile peer axes
Nationwide catalog-profile peers for Polyoxyethylene Sorbitan Monostearate
Product-count (1) and safety-score (3/5) peer columns, disjoint link sets.
Score 3/5 peers (≥50 OFF products)
Nearest other additives by PlainIngredients safety score (floored at ≥50 tracked products), distinct from the count row.
Frequently Asked Questions
Is Polyoxyethylene Sorbitan Monostearate safe to consume?
Polyoxyethylene Sorbitan Monostearate scores 3/5 (Mixed Evidence). FDA status is Approved. The mixed-evidence band means federal approval and remaining open questions coexist, read the health-concern and state-action rows before treating the score as a green light.
What is Polyoxyethylene Sorbitan Monostearate used for in food?
Polyoxyethylene Sorbitan Monostearate is commonly used as: Sauces, dressings, baked goods, ice cream. It belongs to the Emulsifier category of food additives.
Where does Polyoxyethylene Sorbitan Monostearate sit among food additives PlainIngredients tracks?
Among additives with at least one tracked product, it ranks #395 of 417 by Open Food Facts product count. See /methodology#corpus-placement for the ranking bases.
What health concerns are associated with Polyoxyethylene Sorbitan Monostearate?
Research has identified the following health concerns for Polyoxyethylene Sorbitan Monostearate: EFSA evaluation: Scientific Opinion on the re-evaluation of polyoxyethylene sorbitan monolaurate -E 432-, polyoxyethylene sorbitan monooleate -E 433-, polyoxyethylene . EFSA overexposure risk: moderate. Flagged by ANSES (French food safety agency) as additive of interest. These findings inform its safety score of 3/5. Consult a healthcare provider for personalized guidance, especially if you have pre-existing conditions.