Polysorbate 80
9005-65-6 · E 433 · Polyoxyethylene (20) sorbitan · Polyoxyethylene (20) sorbitan monooleate · Polyoxyethylene sorbitan monooleate (polysorbate 80) · Polysorbate 80 · E433 · 433 · 2-[2-[3,5-bis(2-hydroxyethoxy)oxolan-2-yl]-2-(2-hydroxyethoxy)ethoxy]ethyl (E)-octadec-9-enoate · Polyoxyethylene sorbitan monooleate · Polyoxyethylene sorbitan monooleate (polysorbate 80) · Polysorbate 80 · Mono-oleato de polioxietileno sorbitano (polissorbato 80) · MONOLEATO DI POLIOSSIETILENE SORBITANO (POLISORBATO 80) · Monooleat de polioxietilenă sorbitan (polisorbat 80) · MONOOLEAT TAL-POLIOSSIETILEN SORBITAN (POLISORBAT 80) · Monooleat tal-poliossietilensorbitan (polisorbat 80) · Monooleato de sorbitano polioxietilenado (polisorbato 80) · MONOOLEATO DE SORBITÁN POLIOXIETILENADO · Monooleato di poliossietilensorbitano (polisorbato 80) · Monooleinian polioksyetylenosorbitolu (polisorbat 80) · MONOOLÉATE DE POLYOXYÉTHYLÈNE SORBITAN (POLYSORBATE 80) · Monooléate de polyoxyéthylène de sorbitane (polysorbate 80) · Polioksietilen sorbitan monooleat (polisorbat 80) · Polioksietileno sorbitano monooleatas (polisorbatas 80) · Polioksietilēna sorbitāna monooleāts (polisorbāts 80) · Polioxi-etilén-szorbitan-monooleát (poliszorbát 80) · POLIOXIETILÉN-SZORBITAN-MONOOLEÁT (POLISZORBÁT 80) · Polyoksyetyleenisorbitaani-mono-oleaatti (polysorbaatti 80) · POLYOKSYETYLEENISORBITAANIMONO-OLEAATTI (POLYSORBAATTI 80) · Polyoxietylensorbitanmonooleat (Polysorbat 80) · Polyoxyethyleensorbitaanmonoöleaat (polysorbaat 80) · Polyoxyethylen(20)sorbitanmonooleat (polysorbat 80) · POLYOXYETHYLEN-SORBITANMONOOLEAT (POLYSORBAT 80) · Polyoxyethylene sorbitan monooleate (polysorbate 80) · Polyoxyethylensorbitanmonooleát (polysorbát 80) · Polyoxyetylénsorbitanmonooleát (polysorbát 80) · POLYOXYLÉNSORBITANMONOOLEÁT (POLYSORBÁT 80) · POLÜOKSÜETÜLEEN SORBITAANMONOOLEAAT (POLÜSORBAAT 80) · Polüoksüetüleensorbitaanmonooleaat (polüsorbaat 80) · Μονοελαϊκή πολυοξυ-αιθυλενο-σορβιτάνη (polysorbate 80) · Полиоксиетилен сорбитан моноолеат (полисорбат 80)E number E433INS 433CAS 9005-65-6
Listed as an emulsifier and a stabiliser by Canada, Codex and the US.
Listed as emulsifiers (CA, US, Codex) · stabilisers (CA, US, Codex) · thickeners (CA, US) · colours (US) · flavour enhancers (US) · flavouring agents and adjuvants (US) · surface-active agents (US) · solvents and vehicles (US)
- Canada: Emulsifying agent — Health Canada, List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents (List 4)
- Canada: Emulsifying, stabilizing or thickening agent — Health Canada, List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents (List 4)
- United States: Emulsifier or emulsifier salt — FDA, Substances Added to Food: POLYSORBATE 80
- Codex Alimentarius: Emulsifier — CXS 192-1995 Table One, INS 433
- Canada: Emulsifying, stabilizing or thickening agent — Health Canada, List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents (List 4)
- Canada: Stabilizing agent — Health Canada, List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents (List 4)
- United States: Stabilizer or thickener — FDA, Substances Added to Food: POLYSORBATE 80
- Codex Alimentarius: Stabilizer — CXS 192-1995 Table One, INS 433
- Canada: Emulsifying, stabilizing or thickening agent — Health Canada, List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents (List 4)
- Canada: Thickening agent — Health Canada, List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents (List 4)
- United States: Stabilizer or thickener — FDA, Substances Added to Food: POLYSORBATE 80
- United States: Color or coloring adjunct — FDA, Substances Added to Food: POLYSORBATE 80
- United States: Flavor enhancer — FDA, Substances Added to Food: POLYSORBATE 80
- United States: Flavoring agent or adjuvant — FDA, Substances Added to Food: POLYSORBATE 80
- United States: Surface-active agent — FDA, Substances Added to Food: POLYSORBATE 80
- United States: Solvent or vehicle — FDA, Substances Added to Food: POLYSORBATE 80
Polysorbate 80 is one of the most widely used emulsifiers in food, found in ice cream, dressings, sauces and drinks. It keeps oil and water mixed where a fat-soluble emulsifier alone cannot.
Where it is and isn’t permitted
| Jurisdiction | Status | Scope and limits | Citation |
|---|---|---|---|
| Australia and New Zealand | Permitted, with conditions | 54 food categories no numerical limit (good manufacturing practice) Show every food category
| Food Standards Code, Schedule 15, S15—5and 53 further provisionsretrieved 2026-10-17 |
| Canada | Permitted, with conditions | highest permitted level 2,500 mg/kg 28 permitted uses Show every permitted use
| Health Canadaand 27 further provisionsretrieved 2026-10-17 |
| European Union | Permitted, with conditions | 21 food categories highest permitted level 10,000 mg/l Show every food category
| Regulation (EC) No 1333/2008, Annex IIand 20 further provisionsretrieved 2026-10-18 |
| Great Britain | Permitted, with conditions | 20 food categories highest permitted level 10,000 mg/kg or mg/l Show every food category
| Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024)and 19 further provisionsretrieved 2026-10-18 |
| Japan | Permitted, with conditions | Designated additive: Appended Table 1, item 399, ポリソルベート八〇 (“Polysorbate 80” in the unofficial English translation). …Designated additive: Appended Table 1, item 399, ポリソルベート八〇 (“Polysorbate 80” in the unofficial English translation). Standards for use — Specifications and Standards for Foods, Food Additives, etc. (MHW Notification No. 370 of 1959), Part II (Food Additives), F (Standards for use), entry ポリソルベート80: (1) [sets maximum levels of use for the foods stated; sets a combined limit where it is used together with the additives stated] “ポリソルベート80の使用量は、カプセル・錠剤等通常の食品形態でない食品にあってはその1kgにつき25g以下、ココア及びチョコレート製品、ショートニング、即席麺の添付調味料、ソース類、チューインガム並びに乳脂肪代替食品にあってはその1kgにつき5.0g以下、アイスクリーム類、菓子の製造に用いる装飾品(糖を主成分とするものに限る。)、加糖ヨーグルト、ドレッシング、マヨネーズ、ミックスパウダー(焼菓子及び洋生菓子の製造に用いるものに限る。)、焼菓子(洋菓子に限る。)及び洋生菓子にあってはその1kgにつき3.0g以下、あめ類、スープ、フラワーペースト(ココア及びチョコレートを主要原料とし、これに砂糖、油脂、粉乳、卵、小麦粉等を加え、加熱殺菌してペースト状とし、パン又は菓子に充填又は塗布して食用に供するものに限る。)及び氷菓にあってはその1kgにつき1.0g以下、海藻の漬物、チョコレートドリンク及び野菜の漬物にあってはその1kgにつき0.50g以下、非熟成チーズにあってはその1kgにつき0.080g以下、海藻の缶詰及び瓶詰並びに野菜の缶詰及び瓶詰にあってはその1kgにつき0.030g以下、その他の食品にあってはその1kgにつき0.020g以下でなければならない。また、ポリソルベート20、ポリソルベート60又はポリソルベート65のうち1種以上と併用する場合にあっては、それぞれの使用量の和がポリソルベート80としての基準値以下でなければならない。” The Japanese is the standard as published. There is no official English translation of the Notification; the English in square brackets is this site’s description of what each sentence does, not a translation of the foods or the levels. Compositional specifications for this additive, in the same Notification, are not imported and are not shown here; nor are the general rules in F 添加物一般, which apply to every additive. | Regulations for Enforcement of the Food Sanitation Act (MHW Ordinance No. 23 of 1948), Appended Table 1retrieved 2026-10-18 |
| South Korea | Permitted, with conditions | Designated food additive: Standards and Specifications for Food Additives, Part III, 1. …Designated food additive: Standards and Specifications for Food Additives, Part III, 1. 일반식품첨가물 (general food additives), 폴리소르베이트80 (“Polysorbate 80”, the English the Code prints beside it). Main use (주용도) of 폴리소르베이트80: 유화제. Standard for use (사용기준) of 폴리소르베이트80: (1) [to be used under the general standard for use in II. 2. 1), the minimum amount that achieves the technical effect, with no limit set for this additive in particular] “II. 2. 1)의 규정에 따라 사용하여야 한다.” The Korean is the standard as published. There is no official English translation of the current Code (the English version on MFDS’s website is the 2020 edition and has no legal effect); the English in square brackets is this site’s description of what each sentence does, not a translation of the foods or the levels. Compositional specifications (Part IV) are not imported, nor are the general standards in Part II, which apply to every additive. | Standards and Specifications for Food Additives (식품첨가물의 기준 및 규격), MFDS Notification, Part III (Standards for use, by item)retrieved 2026-10-18 |
| United States | Permitted, with conditions | 21 CFR 172.840retrieved 2026-10-17 | |
| Codex Alimentarius | Permitted, with conditions | 57 food categories highest permitted level 25,000 mg/kg Show every food category and its notes
| CXS 192-1995 Table One, INS 433and 56 further provisionsretrieved 2026-09-07 |
How much is permitted
A listing usually limits the quantity as well as the food. Only one of the forms that takes is a figure: quantum satis and good manufacturing practice permit the amount the technological effect requires and no more, which is a limit rather than the absence of one. Figures below are the range across every food category this page is listed in, and categories differ between regulators — see how much is permitted.
| Australia and New Zealand | — | 54 GMP |
|---|---|---|
| Canada | 80 mg/kg – 2,500 mg/kg | 10 numeric limit, 6 GMP, 12 no quantity stated |
| European Union | 10 mg/kg – 10,000 mg/kg | 19 numeric limit, 2 quantum satis |
| Great Britain | 10 mg/kg – 10,000 mg/kg | 18 numeric limit, 2 quantum satis |
| Japan | — | 1 no quantity stated |
| South Korea | — | 1 no quantity stated |
| United States | — | 1 no quantity stated |
| Codex Alimentarius | 10 mg/kg – 25,000 mg/kg | 57 numeric limit |
What it is made from
Made by attaching about twenty ethylene oxide units to sorbitan monooleate. The ethylene oxide is petroleum-derived; the oleic acid may be plant or animal in origin.
- Vegan status depends on the source
- Vegetarian status depends on the source
- May raise a halal question
- May raise a kosher question
This is not an omission. What this additive is made from is not fixed — depending on the manufacturer it may be plant, animal or microbial in origin, nobody is required to say which, and the same product can change source between production runs. Ask the manufacturer if it matters to you; a label cannot answer it.
Compare other additives on the dietary indexes.
- CAS registry number
- 9005-65-6
The two specifications, compared
The European Union sets identity and purity by regulation; JECFA publishes its own through FAO, advisory until a country adopts it. Both documents are below in full. These are the parameters each puts a number on.
| Parameter | European Union | JECFA |
|---|---|---|
| Assay | no less than 65 % | no more than 69.5 % |
| Sulphated ash | — | no more than 0.25 % |
| Lead | no more than 2 mg/kg | no more than 2 mg/kg |
| Arsenic | no more than 3 mg/kg | — |
| Mercury | no more than 1 mg/kg | — |
| Cadmium | no more than 1 mg/kg | — |
The two documents state the same figures for every parameter compared here.
How the EU defines it
The legal specification an additive must meet to be sold as this E number in the EU — what it is, how it may be made, and the purity it must reach. From Commission Regulation (EU) No 231/2012.
E 433 Polyoxyethylene sorbitan monooleate (polysorbate 80)
A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial oleic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Synonyms: Polysorbate 80; Polyoxyethylene (20) sorbitan monooleate
Assay, identification and purity criteria
Description and assay
- Assay
- Content not less than 65 % of oxyethylene groups, equivalent to not less than 96,5 % of polyoxyethylene (20) sorbitan monooleate on the anhydrous basis
- Description
- A lemon to amber-coloured oily liquid at 25 °C with a faint characteristic odour
Identification
- Solubility
- Soluble in water, ethanol, methanol, ethyl acetate and toluene. Insoluble in mineral oil and petroleum ether
- Infrared absorption spectrum
- Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity criteria
- Water content
- Not more than 3 % (Karl Fischer method)
- Acid value
- Not more than 2
- Saponification value
- Not less than 45 and not more than 55
- Hydroxyl value
- Not less than 65 and not more than 80
- 1,4-dioxane
- Not more than 5 mg/kg
- Ethylene glycols (mono- and di-)
- Not more than 0,25 %
- Arsenic
- Not more than 3 mg/kg
- Lead
- Not more than 2 mg/kg
- Mercury
- Not more than 1 mg/kg
- Cadmium
- Not more than 1 mg/kg
How JECFA defines it
The international specification for identity and purity, prepared by the Joint FAO/WHO Expert Committee on Food Additives and published by FAO. It is a different document from any above, written by a different body and revised on its own cycle; it is advisory, and a country adopts it or does not.
INS 433 Polyoxyethylene (20) Sorbitan Monooleate
Consists of a mixture of the partial esters of sorbitol and its mono- and dianhydrides (which have an acid value below 7.5 and a water content below 0.2%) with edible commercial oleic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides.
Synonyms: Polysorbate 80; INS No. 433
Assay, identification and purity criteria
Description and assay
- Specification history
- Prepared at the 17th JECFA (1973), published in FNP 4 (1978) and in FNP 52 (1992). Metals and arsenic specifications revised at the 55 th JECFA (2000). An ADI of 0-25 mg/kg bw was established at the 17 th JECFA (1973)
- C.A.S. number
- 9005-65-6
- Structural formula
- Nominal formula and approximate composition: where w + x + y + z = approx. 20 and RCO- is the fatty acid moiety
- Assay
- Not less than 65.0 and not more than 69.5% of oxyethylene groups, equivalent to not less than 96.5 and not more than 103.5% of polyoxyethylene (20) sorbitan monooleate, calculated on the anhydrous basis. Lemon to amber coloured oily liquid at 25 o , with a faint characteristic odour
- FUNCTIONAL USES
- Emulsifier, dispersing agent
- METHOD OF ASSAY
- Determine the content of Oxyethylene groups .
Identification
- Solubility (Vol. 4)
- Soluble in water, ethanol, methanol, ethyl acetate and toluene; insoluble in mineral oil and petroleum ether
- Infrared absorption
- The infrared spectrum of the sample is characteristic of a partial fatty acid ester of a polyoxyethylated polyol
- Colour reaction
- To 5 ml of a 5% (w/v) aqueous solution of the sample add 10 ml of ammonium cobaltothiocyanate solution and 5 ml of chloroform, shake well and allow to separate; a blue colour is produced in the chloroform layer. (Ammonium cobaltothiocyanate solution: 37.5 g of cobalt nitrate and 150 g of ammonium thiocyanate made up to 100 ml with water - freshly prepared).
- Test for fatty acids
- To 5 ml of a 5% (w/v) aqueous solution of the sample add 5 ml sodium hydroxide TS. Boil for a few min, cool, and acidify with dilute hydrochloric acid. The solution is strongly opalescent, owing to the fatty acids liberated.
- Test for unsaturation
- To a solution of the sample (1 in 20) add bromine TS dropwise. The bromine is decolourized
- Gelatinization
- A mixture of 60 parts by volume of the sample and 40 parts of water yields a gelatinous mass at or below room temperature
- Saponification (Vol. 4)
- 100 g of the sample yields approximately 23 g of fatty acids and 75 g of polyols
Purity criteria
- Water (Vol. 4)
- Not more than 3% (Karl Fischer Method)
- Sulfated ash (Vol. 4)
- Not more than 0.25% Test 5 g of the sample
- Acid value (Vol. 4)
- Not more than 2
- Saponification value (Vol. 4)
- Not less than 45 and not more than 55
- Hydroxyl value (Vol. 4)
- Not less than 65 and not more than 80
- Lead (Vol. 4)
- Not more than 2 mg/kg Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the method described in Volume 4, “Instrumental Methods.”
Authorised in other additives, enzymes, flavourings and nutrients
These authorisations are not for use in food. They let this substance be used inside another additive, a food enzyme, a flavouring or a nutrient preparation — often as a carrier — and it reaches food only as part of that product. Annex III to Regulation (EC) No 1333/2008.
| Part | May be used in | Maximum level | Citation |
|---|---|---|---|
| Annex III, Part 1: Carriers in food additives | Antifoaming agentsAuthorised as a member of Table 4 of Part 6 (Polysorbates), listed as "E 432 – E 436 Polysorbates (Table 4 of Part 6)" | quantum satis | Regulation (EC) No 1333/2008, Annex III, Part 1, via Table 4 of Part 6 |
| Annex III, Part 1: Carriers in food additives | Colours and fat-soluble antioxidantsAuthorised as a member of Table 4 of Part 6 (Polysorbates), listed as "E 432 – E 436 Polysorbates (Table 4 of Part 6)" | quantum satis | Regulation (EC) No 1333/2008, Annex III, Part 1, via Table 4 of Part 6 |
| Annex III, Part 1: Carriers in food additives | Glazing agents for fruitAuthorised as a member of Table 4 of Part 6 (Polysorbates), listed as "E 432 – E 436 Polysorbates" | quantum satis | Regulation (EC) No 1333/2008, Annex III, Part 1, via Table 4 of Part 6 |
| Annex III, Part 2: Food additives other than carriers in food additives | Preparations of colours, contrast enhancers, fat soluble antioxidants and glazing agents for fruitAuthorised as a member of Table 4 of Part 6 (Polysorbates), listed as "E 432 – E 436 Polysorbates" Note (1): Except enzymes authorised as food additives. | quantum satis | Regulation (EC) No 1333/2008, Annex III, Part 2, via Table 4 of Part 6 |
| Annex III, Part 4: Food additives including carriers in food flavourings | All flavourings, except liquid smoke flavourings and flavourings based on spice oleoresinsAuthorised as a member of Table 4 of Part 6 (Polysorbates), listed as "E 432 – E 436 Polysorbates (Table 4 of Part 6)" Note (2): Spice oleoresins are defined as extracts of spices from which the extraction solvent has been evaporated leaving a mixture of the volatile oil and resinous material from the spice. | 10 000 mg/kg in flavourings | Regulation (EC) No 1333/2008, Annex III, Part 4, via Table 4 of Part 6 |
| Annex III, Part 4: Food additives including carriers in food flavourings | Foodstuffs containing liquid smoke flavourings and flavourings based on spice oleoresinsAuthorised as a member of Table 4 of Part 6 (Polysorbates), listed as "E 432 – E 436 Polysorbates (Table 4 of Part 6)" | 1 000 mg/kg in final food | Regulation (EC) No 1333/2008, Annex III, Part 4, via Table 4 of Part 6 |
| Annex III, Part 5, Section A: Food additives added in nutrients except in nutrients intended to be used in foodstuffs listed in Part E, point 01.10, of Annex II and foodstuffs for infants and young children listed in Part E, point 13.1, of Annex II | In beta carotene, lutein, lycopene and vitamins A, D and E preparationsAuthorised as a member of Table 4 of Part 6 (Polysorbates), listed as "E 432 – E 436 Polysorbates (Table 4 of Part 6)" Can be used as a carrier: Yes | quantum satis only in beta carotene, lutein, lycopene and vitamin E preparations. In vitamin A and D preparations maximum level in final food 2 mg/kg | Regulation (EC) No 1333/2008, Annex III, Part 5, Section A, via Table 4 of Part 6 |
Every name it appears under
42 recorded names. A label may use any of them.
E number
- E433
INS number
- 433
CAS registry number
- 9005-65-6
As it appears in regulation
- Polyoxyethylene sorbitan monooleate
- Polyoxyethylene sorbitan monooleate (polysorbate 80)
- Polysorbate 80
Other names
- E 433
- Polyoxyethylene (20) sorbitan
- Polyoxyethylene (20) sorbitan monooleate
- Polyoxyethylene sorbitan monooleate (polysorbate 80)
- Polysorbate 80
Systematic names
- 2-[2-[3,5-bis(2-hydroxyethoxy)oxolan-2-yl]-2-(2-hydroxyethoxy)ethoxy]ethyl (E)-octadec-9-enoate
Hazard reference values
EFSA and JECFA have both assessed Polysorbate 80 and their conclusions are not two comparable figures — EFSA records 25 mg/kg bw/day, JECFA 25 mg/kg bw/day (as total polyoxyethylene (20) sorbitan esters). An acceptable daily intake is a reference value set by a committee, not a threshold above which harm begins. “Not specified”, “not limited” and “not allocated” are conclusions, not missing data, and they are shown in the words each body used rather than reduced to a number. See where the two committees differ.
| Type | Value | Population | Assessed by | Opinion |
|---|---|---|---|---|
| ADI | 25 mg/kg bw/day | consumers | EFSA | not identified in the dataset |
| group ADI | 25 mg/kg bw/day (as total polyoxyethylene (20) sorbitan esters) | — | JECFA | 2026 |
Evidence and how bodies read it
What assessing bodies concluded
Each conclusion is paraphrased in the body's own framing, from the published opinion linked beneath it. Where bodies differ, both stand; this site does not adjudicate between them or add a view of its own.
EFSA 2015
The ANS Panel found no concern regarding genotoxicity, carcinogenicity or developmental toxicity for polysorbates 20, 80, 40, 60 and 65 (E 432–E 436), and allocated a group ADI of 25 mg/kg bw/day (the SCF value had been 10). It noted that high-level toddler exposure was very close to the ADI and that more usage and analytical data were needed to reduce uncertainty.
Common questions
Assembled from what is above, in the words the questions are usually asked in. Each answer is the same statement the relevant section makes, with the same citations behind it.
- What is E 433?
- E 433 is Polysorbate 80. Polysorbate 80 is one of the most widely used emulsifiers in food, found in ice cream, dressings, sauces and drinks. It keeps oil and water mixed where a fat-soluble emulsifier alone cannot.
- What is Polysorbate 80 used for in food?
- It is listed as an emulsifier and a stabiliser — the role Canada, Codex and the US assign it. This page shows every function each regulator records, with the citation for each.
- Where is Polysorbate 80 permitted?
- Of the seven regulators this site reads, Australia and New Zealand, Canada, the EU, Great Britain, Japan, South Korea, the US and the Codex standard permit it. Each permission is for named foods at named levels, not a blanket one; the table on this page gives them with citations.
- Is Polysorbate 80 vegan?
- It depends on the source, and a label will not tell you. Polysorbate 80 can be made from plant or animal material, manufacturers are not obliged to say which, and the same product can change between production runs. Anyone who needs to know has to ask the manufacturer.
Sources for this page
- anz retrieved 2026-10-17
- ca retrieved 2026-10-17
- eu retrieved 2026-10-18
- gb retrieved 2026-10-18
- jp retrieved 2026-10-18
- kr retrieved 2026-10-18
- ecfr retrieved 2026-10-17
- gsfa retrieved 2026-09-07
- euspecs retrieved 2026-10-18
- jecfaspecs retrieved 2026-09-23
Full licence terms and publisher details on Sources. How this page is built and updated: Method.
Machine-readable: a JSON record of this additive is given on request —how to ask for access.
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