FDA Status
Approved
Emulsifier · EU 492
Sorbitan Tristearate
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 Tristearate: 2/5 (Caution)
According to the U.S. Food and Drug Administration, Sorbitan Tristearate 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 used in a moderate number of tracked products.
- 67th percentile by tracked product prevalence
The verdict
Sorbitan Tristearate is FDA-approved, and no U.S. state has moved to restrict it. It is used in a moderate number of tracked products (67th percentile by tracked product count).
- 2/5
- Caution
- Approved
- FDA status
- 67th pctile
- by product prevalence
- 0
- state regulations
Sorbitan Tristearate (492) 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 98 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 Tristearate 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 Tristearate, 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 | 492 | 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 | 98 | 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
492
U.S. State Regulations
0 states
None enacted
Safety Assessment
Sorbitan Tristearate's 2/5 (Caution) score reflects where this specific ingredient lands on that scale. The FDA has approved Sorbitan Tristearate for use in food products under specified conditions.
Research has identified 1 area of health concern associated with Sorbitan Tristearate. Consumers with specific health conditions should consult a healthcare provider before consuming products containing this ingredient.
How Sorbitan Tristearate compares
Where a safety score of 2/5 falls among all 4,509 scored ingredients tracked on PlainIngredients.
Ingredients by safety score (Sorbitan Tristearate highlighted)
43 of 4,509 scored ingredients (1%) share a safety score of 2/5.
What is Sorbitan Tristearate?
Sorbitan Tristearate is a food additive (492) 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 Tristearate safe to consume?
Sorbitan Tristearate 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 Tristearate used for in food?
Sorbitan Tristearate is commonly used as: Sauces, dressings, baked goods, ice cream. It belongs to the Emulsifier category of food additives.
Is Sorbitan Tristearate banned in any US states?
Currently, no US states have enacted specific bans or regulations targeting Sorbitan Tristearate. However, state food safety legislation is evolving rapidly.
What is the difference between FDA and EU regulation of Sorbitan Tristearate?
The FDA classifies Sorbitan Tristearate as "Approved", while the EU status is "Approved" (492). 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 Tristearate?
Research has identified the following health concerns for Sorbitan Tristearate: 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 Tristearate calculated?
The safety score of 2/5 for Sorbitan Tristearate 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 Tristearate
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.