FDA Status
Approved
Polyoxyethylene Sorbitan Monooleate (433) is a emulsifier additive holding a composite safety score of 3 out of 5 (Mixed Evidence). The U.S. Food and Drug Administration currently classifies it as Approved, while the European Union lists it as Approved. It is most commonly used as Sauces, dressings, baked goods, ice cream.
No U.S. state has enacted specific legislation targeting Polyoxyethylene Sorbitan Monooleate to date, keeping federal FDA classification as the operative standard. State-level food safety legislation remains active nationally, and that picture may shift as new bills advance.
Peer-reviewed research has flagged 1 distinct area of health concern for Polyoxyethylene Sorbitan Monooleate, which factors directly into the assigned safety score. The European Food Safety Authority has published an evaluation dated 2015-07-17, with an Acceptable Daily Intake (ADI) of 25. EFSA has noted an overexposure risk classification of "moderate" for typical consumption patterns. All figures above draw on FDA SAFFA inventory records, EU food additive regulation (EC) No 1333/2008, EFSA scientific opinions where published, and legislative records from individual U.S. states.
Regulatory Snapshot
| Property | Value | Source |
|---|---|---|
| FDA Status | Approved | FDA SAFFA |
| EU Status | Approved | EC 1333/2008 |
| E-Number | 433 | 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 | Not yet tracked | 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.
3.0 / 5
Composite Safety Mixed Evidence
Safety Score: 3 out of 5
Safety Rating 60.0%
EU Status
Approved
433
U.S. State Regulations
0 states
None enacted
Safety Assessment
Polyoxyethylene Sorbitan Monooleate receives a safety score of 3/5 (Mixed Evidence) based on a composite analysis of FDA regulatory status, EU approval, scientific literature on health effects, and state-level legislative actions. The FDA has approved Polyoxyethylene Sorbitan Monooleate for use in food products under specified conditions.
Research has identified 1 area of health concern associated with Polyoxyethylene Sorbitan Monooleate. Consumers with specific health conditions should consult a healthcare provider before consuming products containing this ingredient.
What is Polyoxyethylene Sorbitan Monooleate?
Polyoxyethylene Sorbitan Monooleate is a food additive (433) 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
Sauces, dressings, baked goods, ice cream
Frequently Asked Questions
Is Polyoxyethylene Sorbitan Monooleate safe to consume?
Polyoxyethylene Sorbitan Monooleate has a safety score of 3/5 (Mixed Evidence). It is approved by the FDA for use in food. As with all food additives, moderation is advisable.
What is Polyoxyethylene Sorbitan Monooleate used for in food?
Polyoxyethylene Sorbitan Monooleate is commonly used as: Sauces, dressings, baked goods, ice cream. It belongs to the Emulsifier category of food additives.
Is Polyoxyethylene Sorbitan Monooleate banned in any US states?
Currently, no US states have enacted specific bans or regulations targeting Polyoxyethylene Sorbitan Monooleate. However, state food safety legislation is evolving rapidly.
What is the difference between FDA and EU regulation of Polyoxyethylene Sorbitan Monooleate?
The FDA classifies Polyoxyethylene Sorbitan Monooleate as "Approved", while the EU status is "Approved" (433). The FDA and EU use separate evaluation frameworks — the EU often applies the precautionary principle, sometimes banning additives that remain approved in the US. Always check both jurisdictions when evaluating food additive safety.
What health concerns are associated with Polyoxyethylene Sorbitan Monooleate?
Research has identified the following health concerns for Polyoxyethylene Sorbitan Monooleate: 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.
How is the safety score for Polyoxyethylene Sorbitan Monooleate calculated?
The safety score of 3/5 for Polyoxyethylene Sorbitan Monooleate is a composite assessment based on FDA regulatory status, EU approval status, published scientific research on health effects, and state-level legislative actions. A score of 1 means "Banned / Avoid" and 5 means "Generally Safe." The score is updated as new regulatory actions or scientific evidence emerge.
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Related Data Sources
Data Sources
- FDA Substances Added to Food (SAFFA) Inventory
- EU Food Additive Regulations (EC) No 1333/2008
- State food safety legislation and bill records
Related Resources
Read our methodology — how this data is sourced, computed, and verified.
Related
Data sourced from official EWG, FDA GRAS, and ingredient toxicology databases. See our methodology for details. Retrieved and formatted by PlainIngredients Editorial