FDA Status
Approved
Emulsifier · EU 494
Sorbitan Monooleate
FDA status: Approved. EU: Approved. No U.S. state has enacted a specific ban yet.
2.0 / 5
Composite safety Caution
Score 2 of 5
Sorbitan Monooleate: 2/5 (Caution)
According to the U.S. Food and Drug Administration, Sorbitan Monooleate 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.
The verdict
Sorbitan Monooleate is FDA-approved, and no U.S. state has moved to restrict it.
- 2/5
- Caution
- Approved
- FDA status
- Approved
- EU status
- 0
- state regulations
Sorbitan Monooleate (494) is a emulsifier additive holding a composite safety score of 2 out of 5 (Caution). According to the U.S. Food and Drug Administration's Substances Added to Food inventory, it is currently classified 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.
EU Status
Approved
494
U.S. State Regulations
0 states
None enacted
Safety Assessment
Sorbitan Monooleate's 2/5 (Caution) score reflects where this specific ingredient lands on that scale. 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.
How Sorbitan Monooleate compares
Where a safety score of 2/5 falls among all 4,509 scored ingredients tracked on PlainIngredients.
Ingredients by safety score (Sorbitan Monooleate highlighted)
43 of 4,509 scored ingredients (1%) share a safety score of 2/5.
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.
Data Sources
- FDA Substances Added to Food (SAFFA) Inventory
- EU Food Additive Regulations (EC) No 1333/2008
- State food safety legislation and bill records
What to do about Sorbitan Monooleate
This additive is flagged, worth checking labels for.
- Check the FDA status (Approved) and EU status (Approved) before assuming it is risk-free. How we score
- Compare it against the most-restricted additives in the U.S. supply. View rankings
- Scan a whole ingredient label at once to flag the concerning entries. Label checker
Safety scores summarise regulatory status and published concerns; they are not medical or dietary advice.
Every figure on PlainIngredients is rendered directly from FDA, EU, EFSA and U.S. state regulatory records, no number is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.