E491 / Thickeners, stabilisers & emulsifiers
Sorbitan monostearate
Safety in brief
Use caution
Recorded EatMatrix rating, not a new clinical review. The amount, your sensitivities and country rules still matter.
- Watch for
- No allergen or sensitivity is recorded for this ingredient here. Check the whole product label; this is not an allergen-free guarantee.
- Our advice
- Read the whole food label and consider how often you eat the product. A name or E number does not tell you the amount, and an ingredient rating cannot assess the entire food.
What it is
Sorbitan monostearate is an ester of sorbitol and stearic acid used as an emulsifier and surfactant in food and cosmetic formulations. It helps stabilize mixtures of oil and water, preventing separation in products such as baked goods, margarine, lotions, and creams. It is approved by EFSA and the FDA within regulated amounts, though the stearic acid component may be derived from animal or plant sources.
Also appears on labels as: Sorbitan monostearate, E491, E 491, E-491, INS 491, Span 60, Sorbitan stearate, Sorbitan monoester of stearic acid, Hexitol anhydride ester of stearic acid, Sorbitol anhydride monostearate, Stearic acid sorbitan ester, Sorbitan fatty acid ester.
Dietary information
- Vegan
- Depends on source
- Halal
- Depends on source
- Gluten-free
- Yes
- Allergens
- None recorded
Recorded ingredient information. Check the product label or certification: sources, other ingredients and cross-contact can vary.
Research & body effects
Selected research on E491
How to read study types- Regulator reviewEFSA opinion on sorbitan monostearate in enzyme preparations
Updated intake estimates put some high-eating toddlers and children over the group limit on paper. EFSA judged this a clear overestimate and not a safety concern.
- Regulator reviewEFSA re-evaluation of sorbitan esters
Set a group safe daily limit of 10 mg sorbitan per kg of body weight. Intake did not exceed it in any age group.
Summaries of each source's published abstract or statement, checked . This is a selection of sources, not a complete literature review. Authority assessments apply to the uses and places they cover.
Health notes from our ingredient record
- Generally recognized as safe at typical food use levels.
- May cause mild digestive discomfort in sensitive individuals if consumed in large quantities.
Other references from our ingredient record
These links come from the original ingredient record. They are separate from the source reviews above and have not all been checked for the exact ingredient, amount consumed or claim. Dates are shown newest first.
- Re‐evaluation of sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) when used as food additives — EFSA Panel on Food Additives, EFSA Journal (2017). Official EFSA scientific opinion (bibliographic reference, imported 2026-10-13). It covers the additive as a group assessment and is not an individual human study; read the opinion for its findings.
- Re‐evaluation of sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) when used as food additives — EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), EFSA Journal (2017). The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of sorbitan monostearate (E 491) and sorbitan tristearate (E 492) among other sorbitan esters when used as food additives. The Scientific Committee on Food (SCF) allocated an acceptable daily intake (ADI) of 25 mg/kg body weight per day for E 491, E 492 and E 495 singly or in combination. The Panel concluded that there is no safety concern.[safe]
Country rules
Country checks for E491
Permission depends on the market, type of food, amount and conditions. A scientific opinion or an E-number alone does not establish a legal use. These checks are separate from the stored EatMatrix rating.
Compare all eight markets and their sources
| Market | What is checked |
|---|---|
| European Union | Regulation (EC) 1333/2008, Annex II Part B, version , contains the exact code E491: Sorbitan monostearate. Listing alone does not allow every food use. Part E food categories, limits, specifications and applicable later acts still need a product-specific check. Source read: . |
| Great Britain | The FSA register record for E491 (Sorbitan monostearate) lists “Authorised” in England, Scotland and Wales. Register updated: 01 April 2025; record checked: . Food-specific conditions and specifications still need a separate legal check. |
| United States | Selected US conditions for Sorbitan monostearate Official federal text current through ; read . Food uses, limits and exceptionsNamed preparation and use conditions The section gives multiple use-specific and combined-emulsifier limits. Examples: cakes/mixes allow at most 0.61% when used alone, on a dry-weight basis; combinations with polysorbates 60/65 have individual ceilings and a combined 0.66% ceiling. Icings/fillings use a different 0.7% individual and 1% combination limit, with partner-specific ceilings. Other topping, coating, yeast and fat-emulsion conditions remain in the source; these examples are not the complete list. EatMatrix’s reading: a legal use condition answers where and how an ingredient may be used. It is not a test of your product, a personal safe intake or a claim that the ingredient benefits your body. Match the named substance, food and amount. Other federal provisions, food standards, state rules and later changes may also apply; this is a selected source review, not a complete product-compliance decision. |
| Northern Ireland | Review pending. Check the applicable EU rules and territory arrangements; the GB register alone does not establish this status. FSA guidance is a starting source, not a verified permission for this entry. |
| Canada | Named food-use records located. Health Canada lists the preparations below for specified foods and purposes. This is conditional permission for those uses, not approval of every product or a personal safety verdict. Only the named records and conditions below were located. Exact composition and specifications still need matching. Source tables captured . List publication dates are shown separately. Good Manufacturing Practice (GMP) is a condition of use, not an unlimited amount or a recommended intake. Food and Drug Regulations B.16.003 requires the listed source, purpose, amount and other conditions to match. The official consolidation read was current to 21 September 2026; product specifications and applicable later changes still need checking. Read 11 listed food-use conditionsSorbitan MonostearateHealth Canada: List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents. List published ; item S.21.
EatMatrix reading: match the exact preparation and food first. A manufacturing limit is not an acceptable daily intake (ADI). A label without the amount cannot establish exposure, and an unlisted name here does not establish a ban. |
| Australia | Review pending. Food Standards Code permissions and conditions need an additive-specific check. FSANZ food-additive rules is a starting source, not a verified permission for this entry. |
| New Zealand | Review pending. Food Standards Code permissions and conditions need an additive-specific check. FSANZ food-additive rules is a starting source, not a verified permission for this entry. |
| Japan | Review pending. The relevant list, identity and use standards need an additive-specific check. CAA food-additive lists is a starting source, not a verified permission for this entry. |
Sources & review status
Check what each source covers: an authority’s conclusion, a research finding and a country’s legal permission answer different questions.
What this guide covers
- Selected research
- 2 source summaries, with publication dates and study types. Several publications may describe the same study population.
- Official assessment sources
- Commission-listed EFSA references for E491. Bibliographic identity checked; latest findings and current use rules need separate review.
- Original ingredient record
- 2 research links; newest recorded date: . Sources added separately to this guide are not included in this count.
This guide brings together our ingredient record and the dated sources shown here. Missing information describes a gap in this guide; it does not mean an ingredient is untested, safe or harmful. This is not a complete review of every study, preparation or current country rule. The amount in a product and how it is used still matter.
How to read the ratings, research and country checksAgency labels recorded by EatMatrix
These are imported database classifications, not verified current statements from each authority. Use the dated official sources below for their actual scope and conclusions.
| Authority | Database label |
|---|---|
| FDA | Safe |
| WHO | Use caution |
| EFSA | Safe |
| FSANZ | Safe |
| Japan | Safe |
| UK FSA | Safe |
Official assessment sources for E491
The European Commission’s re-evaluation table lists official EFSA documents for this additive. Their identifiers and subjects were checked against publisher bibliographic records. A missing research link in the EatMatrix database does not mean the additive has never been assessed.
Name in the Commission table: Sorbitan monostearate.
- Re‐evaluation of sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) when used as food additives
EFSA scientific opinion. Published: .
These are assessment references, including historical or group assessments. They do not establish the latest scientific conclusion, a human health benefit or risk, or current permission to use the additive in a particular food. Later assessments, corrections and food-use conditions need separate review. The recorded EatMatrix rating above is unchanged.
European Commission re-evaluation table, status as of . EatMatrix checked this bibliography on .
Database updated: . What does an E number mean on a food label?
Common questions
Frequently asked questions
What is EatMatrix's recorded rating for E491?
The recorded EatMatrix rating for E491 (Sorbitan monostearate) is “Use caution”. It is calculated from labels stored in our ingredient database. These labels are not verified current regulator decisions or country permissions. A database update date is not a scientific review date.
Is E491 vegan, halal or gluten-free?
According to our ingredient data for Sorbitan monostearate — vegan: depends on the source, vegetarian: depends on the source, halal: depends on the source, kosher: depends on the source, gluten-free: yes, dairy-free: yes. Manufacturing sources can vary between products; check the label if it matters to you.
What is E491 and why is it used?
Sorbitan monostearate is an ester of sorbitol and stearic acid used as an emulsifier and surfactant in food and cosmetic formulations. It helps stabilize mixtures of oil and water, preventing separation in products such as baked goods, margarine, lotions, and creams. It is approved by EFSA and the FDA within regulated amounts, though the stearic acid component may be derived from animal or plant sources.
Does E491 contain allergens?
No known allergens are recorded for Sorbitan monostearate.
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This page shows information and classifications recorded in our ingredient database. Current scientific and market-specific verification remains pending as described above. It is general information, not medical advice.