FDA Status
Approved
Emulsifier · EU 491
Sorbitan Monostearate
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 Monostearate: 2/5 (Caution)
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. It is more widely-used than most tracked additives.
- 82th percentile by tracked product prevalence
The verdict
Sorbitan Monostearate is FDA-approved, and no U.S. state has moved to restrict it. It is more widely-used than most tracked additives (82th percentile by tracked product count).
- 2/5
- Caution
- Approved
- FDA status
- 82th pctile
- by product prevalence
- 0
- state regulations
Sorbitan Monostearate (491) 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. This ingredient appears in approximately 489 tracked food products across our database. It is most commonly used as Sauces, dressings, baked goods, ice cream.
No U.S. state has enacted specific legislation targeting Sorbitan Monostearate 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 Monostearate, which factors directly into the assigned safety score. The European Food Safety Authority has published an evaluation dated 2017-05-05, with an Acceptable Daily Intake (ADI) of 26. 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 | 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 |
| Tracked Products | 489 | 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
491
U.S. State Regulations
0 states
None enacted
Safety Assessment
Sorbitan Monostearate's 2/5 (Caution) score reflects where this specific ingredient lands on that scale. The FDA has approved Sorbitan Monostearate for use in food products under specified conditions.
Research has identified 1 area of health concern associated with Sorbitan Monostearate. Consumers with specific health conditions should consult a healthcare provider before consuming products containing this ingredient.
How Sorbitan Monostearate compares
Where a safety score of 2/5 falls among all 4,509 scored ingredients tracked on PlainIngredients.
Ingredients by safety score (Sorbitan Monostearate highlighted)
43 of 4,509 scored ingredients (1%) share a safety score of 2/5.
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
Sauces, dressings, baked goods, ice cream
Frequently Asked Questions
Is Sorbitan Monostearate safe to consume?
Sorbitan Monostearate 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 Monostearate used for in food?
Sorbitan Monostearate is commonly used as: Sauces, dressings, baked goods, ice cream. It belongs to the Emulsifier category of food additives.
Is Sorbitan Monostearate banned in any US states?
Currently, no US states have enacted specific bans or regulations targeting Sorbitan Monostearate. However, state food safety legislation is evolving rapidly.
What is the difference between FDA and EU regulation of Sorbitan Monostearate?
The FDA classifies Sorbitan Monostearate as "Approved", while the EU status is "Approved" (491). 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 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.
How is the safety score for Sorbitan Monostearate calculated?
The safety score of 2/5 for Sorbitan Monostearate 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 Monostearate
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.