FDA Status
Approved
Sorbitan Monooleate (494) is a emulsifier additive holding a composite safety score of 2 out of 5 (Caution). 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 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 Sorbitan Monooleate, which factors directly into the assigned safety score. The European Food Safety Authority has published an evaluation dated 2017-05-05. EFSA has noted an overexposure risk classification of "high" 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 | 494 | EU additive register |
| CAS Number | — | CAS Registry |
| Category | Emulsifier | FDA functional class |
| Composite Safety Score | 2 / 5 (Caution) | PlainIngredients methodology |
| EFSA ADI | Not established | 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.
2.0 / 5
Composite Safety Caution
Safety Score: 2 out of 5
Safety Rating 40.0%
EU Status
Approved
494
U.S. State Regulations
0 states
None enacted
Safety Assessment
Sorbitan Monooleate receives a safety score of 2/5 (Caution) 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 Sorbitan Monooleate for use in food products under specified conditions.
Research has identified 1 area of health concern associated with Sorbitan Monooleate. Consumers with specific health conditions should consult a healthcare provider before consuming products containing this ingredient.
What is Sorbitan Monooleate?
Sorbitan Monooleate is a food additive (494) 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
Sauces, dressings, baked goods, ice cream
Frequently Asked Questions
Is Sorbitan Monooleate safe to consume?
Sorbitan Monooleate has a safety score of 2/5 (Caution). Scientific studies have raised health concerns. Check with a healthcare provider for personalized advice.
What is Sorbitan Monooleate used for in food?
Sorbitan Monooleate is commonly used as: Sauces, dressings, baked goods, ice cream. It belongs to the Emulsifier category of food additives.
Is Sorbitan Monooleate banned in any US states?
Currently, no US states have enacted specific bans or regulations targeting Sorbitan Monooleate. However, state food safety legislation is evolving rapidly.
What is the difference between FDA and EU regulation of Sorbitan Monooleate?
The FDA classifies Sorbitan Monooleate as "Approved", while the EU status is "Approved" (494). 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 Sorbitan Monooleate?
Research has identified the following health concerns for Sorbitan Monooleate: 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.
How is the safety score for Sorbitan Monooleate calculated?
The safety score of 2/5 for 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