E433 / Thickeners, stabilisers & emulsifiers
Polyoxyethylene sorbitan monooleate (polysorbate 80)
Safety in brief
Safe in moderation
Recorded EatMatrix rating, not a new clinical review. The amount, your sensitivities and country rules still matter.
- Watch for
- Recorded sensitivities: Rare hypersensitivity reactions reported, mostly with injectable pharmaceutical formulations rather than food use..
- 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
Polysorbate 80 (Tween 80) is a synthetic emulsifier made from sorbitol, oleic acid, and ethylene oxide, used to stabilize emulsions in foods, cosmetics, pharmaceuticals, and some vaccines. In food it appears in ice cream, dressings, and baked goods to prevent ingredients from separating and to create smooth textures. It is approved for food use by the FDA and EFSA within set limits, though it is one of the more closely studied emulsifiers due to emerging gut-health research.
Also appears on labels as: Polyoxyethylene sorbitan monooleate, Polysorbate 80, Tween 80, POE sorbitan monooleate, POE monooleate, Polyoxyethylene (20) sorbitan monooleate, Polyoxyethylene sorbitan oleate, Sorbitan monooleate, polyoxyethylene, Ethoxylated sorbitan monooleate, PEG sorbitan monooleate, PEG-20 sorbitan monooleate, Polyoxyethylene sorbitan ester of oleic acid.
Dietary information
- Vegan
- Yes
- Halal
- Yes
- Gluten-free
- Yes
- Allergens
- Caution
Recorded ingredient information. Check the product label or certification: sources, other ingredients and cross-contact can vary.
Research & body effects
What selected human studies mean for E433
A newer randomized pilot: changes are not all the same
First published online in August 2025, with its journal issue in April 2026, this exploratory study describes 60 healthy volunteers. After two weeks on an emulsifier-free diet, participants continued for four weeks with one of five added preparations or no additives. It found no significant differences from placebo in measured intestinal or systemic inflammation, or metabolic endpoints. Stool bacteria and fermentation products can change without proving clinical disease.
Polysorbate-80 was a separate study arm. The abstract does not establish that every individual microbiome result was significant for this arm.
The initial cholesterol decrease occurred during the shared diet phase. It cannot identify a benefit caused by removing this one additive. Small arms and short follow-up leave longer-term effects uncertain.
Disease-specific diets answer another question
A 2025 exploratory trial assigned 24 people with active Crohn’s disease to higher- or lower-emulsifier diets for four weeks. Outcomes improved in both groups, with no significant difference between diets. Many additives varied together. Carrageenan and polysorbate-80 exposures were low, while CMC’s amount could not be quantified. This cannot isolate this additive or overturn a trial using a different dose and population.
EatMatrix’s reading and a practical choice
A study can raise a useful question without settling whether an additive causes illness. We keep the tested form, comparison, measured outcome and unanswered questions together. Compare the whole food, including fibre, salt, free sugars and how often you eat it. An E number alone does not tell you the amount you consumed.
If you have inflammatory bowel disease or persistent symptoms, discuss food changes with your care team; a restrictive diet based on these summaries is not a proven personal treatment. WHO healthy-diet guidance
Selected sources checked 9 October 2026. Cohort and five-preparation trial: abstracts read; full methods, supplements and complete funding/conflict appraisal remain pending. CMC, insulin-sensitivity, colitis and whole-diet trials: selected main-text methods/results/limitations and declarations read, not all supplements. Some CMC, insulin and whole-diet trial authors disclose industry relationships; the colitis pilot reports foundation funding and no potential conflicts. Indexed comments were identified, but their complete texts were not all accessible; absence of an indexed correction is not proof none exists. This is not an exhaustive clinical or current-country-use review. Recorded ratings and country permissions are unchanged.
Selected research on E433
How to read study types- Randomized trialFive-additive pilot trial (online 2025; April 2026 issue)
Four-week pilot: no significant placebo difference in inflammation/metabolic endpoints. Polysorbate-80 was a separate study arm. The abstract does not establish that every individual microbiome result was significant for this arm.
- Randomized trialRelated whole-diet trial in active Crohn’s disease
Related whole-diet context: 24 patients with active Crohn’s disease had no significant between-diet outcome differences over four weeks. Many additives varied together; selected exposures were low or unquantified. This does not isolate the effect of this one additive.
Earlier source summaries checked ; latest additions checked . See the detailed research section for what was read and the remaining limits. 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
- Animal and some human studies suggest polysorbate 80 may alter gut bacteria and increase intestinal permeability ('leaky gut') with regular high intake, a topic of active research regarding ultra-processed foods.
- Rare hypersensitivity reactions have been reported, mainly linked to injectable/pharmaceutical use rather than dietary intake.
- Generally recognized as safe at typical food-use levels by regulators, though EFSA has lowered its acceptable daily intake in past reassessments.
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.
- Scientific Opinion on the re‐evaluation of polyoxyethylene sorbitan monolaurate (E 432), polyoxyethylene sorbitan monooleate (E 433), polyoxyethylene sorbitan monopalmitate (E 434), polyoxyethylene sorbitan monostearate (E 435) and polyoxyethylene sorbitan tristearate (E 436) as food additives — EFSA Panel on Food Additives, EFSA Journal (2015). 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.
Country rules
Country checks for E433
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 E433: Polyoxyethylene sorbitan monooleate (polysorbate 80). 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 E433 (Polyoxyethylene sorbitan monooleate (polysorbate 80)) 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 Polysorbate 80 Official federal text current through ; read . Food uses, limits and exceptionsExamples with different food-specific limits The regulation has multiple defined uses. Examples include at most 0.1% in specified frozen desserts, alone or combined with polysorbate 65; 500 ppm in pickles/pickle products; and at most 1% in specified shortenings/edible oils, alone or combined with polysorbate 60, subject to standards of identity. These are examples, not the complete list. Mixtures and preparation still matter Manufacturing and compositional specifications, the food category, function, combined-emulsifier limits and use directions must all match. The source includes other narrowly defined uses and conditions; a limit for one food cannot be copied to another. 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 28 listed food-use conditionsPolysorbate 80Health Canada: List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents. List published ; item P.6.
Polysorbate 80Health Canada: List of Permitted Food Additives with Other Purposes of Use. List published ; item P.6.
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 E433. Bibliographic identity checked; latest findings and current use rules need separate review.
- Original ingredient record
- 1 research link; 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 | Safe |
| EFSA | Safe in moderation |
| FSANZ | Safe |
| Japan | Safe |
| UK FSA | Safe in moderation |
Official assessment sources for E433
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: Polyoxyethylene sorbitan monooleate (polysorbate 80).
- Scientific Opinion on the re‐evaluation of polyoxyethylene sorbitan monolaurate (E 432), polyoxyethylene sorbitan monooleate (E 433), polyoxyethylene sorbitan monopalmitate (E 434), polyoxyethylene sorbitan monostearate (E 435) and polyoxyethylene sorbitan tristearate (E 436) 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 E433?
The recorded EatMatrix rating for E433 (Polyoxyethylene sorbitan monooleate (polysorbate 80)) is “Safe in moderation”. 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 E433 vegan, halal or gluten-free?
According to our ingredient data for Polyoxyethylene sorbitan monooleate (polysorbate 80) — vegan: yes, vegetarian: yes, halal: yes, kosher: yes, gluten-free: yes, dairy-free: yes. Manufacturing sources can vary between products; check the label if it matters to you.
What is E433 and why is it used?
Polysorbate 80 (Tween 80) is a synthetic emulsifier made from sorbitol, oleic acid, and ethylene oxide, used to stabilize emulsions in foods, cosmetics, pharmaceuticals, and some vaccines. In food it appears in ice cream, dressings, and baked goods to prevent ingredients from separating and to create smooth textures. It is approved for food use by the FDA and EFSA within set limits, though it is one of the more closely studied emulsifiers due to emerging gut-health research.
Does E433 contain allergens?
No known allergens are recorded for Polyoxyethylene sorbitan monooleate (polysorbate 80), with a caution: Rare hypersensitivity reactions reported, mostly with injectable pharmaceutical formulations rather than food use..
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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.