Food Safety Substance

Polysorbate 80E433

Polysorbate 80 (E433) is a food additive with PUBLISHED in the EU, GRAS in the US, and data from 8 regulatory sources.

CAS 9005-65-6 E433 emulsifier Indexable evidence set
FDA
GRAS
ADI / TDI
ADI 25 mg/kg bw/day
Codex
57 row(s)
SOURCE D1 identity resolution e number aliases | Food Additives | dsstox identifiers | 8 matched regulatory source group(s)

Substance Identity

Resolved identifiers used to render this food-safety record.

Substance name
Polysorbate 80
CAS
9005-65-6
E-number
E433
Food category
emulsifier
DTXSID
DTXSID0021175
Evidence tier
Indexable evidence set (15)
SOURCE EU Commission FDA | Health Canada | Codex Alimentarius

Multi-Jurisdiction Comparison

Side-by-side status rows for the same resolved substance across public food regulators.

JurisdictionAuthorityStatusEvidence
European UnionEU CommissionPUBLISHEDEU additive listing; Annex II entry
CanadaHealth CanadaListedEmulsifying, stabilizing or thickening agent
CodexCodex AlimentariusListedEmulsifier
SOURCE EU Commission EU Food Additives | EU Food Additives Database

EU Food Additive Status

EU Commission food-additive listing rows from eu_food_additives.

JurisdictionE-numberStatusTypeNameNote
European UnionE433PUBLISHEDsubstanceFADPolyoxyethylene sorbitan monooleate (polysorbate 80)-
SOURCE EU Commission EU Annex II Authorised | EU Food Additives Database

EU Annex II Authorised Uses

Authorised additive rows and use conditions from EU Annex II tables.

JurisdictionE-numberNameINSPolicy itemNote
European UnionE433Polyoxyethylene sorbitan monooleate (polysorbate 80)-POL-FAD-IMPORT-3153-

Conditions and restrictions

JurisdictionFood categoryRestrictionCommentSource
European Union---EU Annex II Union List
European Union---EU Food Additives Database
SOURCE Codex Alimentarius Codex GSFA

Codex GSFA Status

Codex Alimentarius GSFA permissions and maximum-use rows.

JurisdictionINS / E-numberFunctionFood categoryMax levelNotes
Codex433Emulsifier01.1.4 Flavoured fluid milk drinks3,000 mg/kgExcept for products conforming to the Standard for Fermented Milks (CXS 243-2003): as an emulsifier in flavoured fermented milks and flavoured drinks based on fermented milks...
Codex433Emulsifier01.3.2 Beverage whiteners4,000 mg/kgExcluding products conforming to the Standard for a Blend of Evaporated Skimmed Milk and Vegetable Fat (CODEX STAN 250-2006).; Excluding products conforming to the Standard for a...
Codex433Emulsifier01.4.1 Pasteurized cream (plain)1,000 mg/kgExcept for use in products conforming to the Standard for Cream and Prepared Creams (CXS 288-1976) as an emulsifier. [Group: POLYSORBATES]
Codex433Emulsifier01.4.2 Sterilized and UHT creams, whipping and whipped creams, and reduced fat creams (plain)1,000 mg/kg[Group: POLYSORBATES]
Codex433Emulsifier01.4.3 Clotted cream (plain)1,000 mg/kg[Group: POLYSORBATES]
Codex433Emulsifier01.4.4 Cream analogues5,000 mg/kg[Group: POLYSORBATES]
Codex433Emulsifier01.5.2 Milk and cream powder analogues4,000 mg/kgExcluding products conforming to the Standard for a Blend of Skimmed Milk and Vegetable Fat in Powdered Form (CODEX STAN 251-2006). [Group: POLYSORBATES]
Codex433Emulsifier01.6.1 Unripened cheese80 mg/kgExcluding products conforming to the Standard for Mozzarella (CODEX STAN 262-2006).; Excluding products conforming to the Standard for Cottage Cheese (CXS 273-1968).; Excluding...
Codex433Emulsifier01.7 Dairy-based desserts (e.g. pudding, fruit or flavoured yoghurt)3,000 mg/kgExcept for products conforming to the Standard for Fermented Milks (CXS 243-2003): as an emulsifier in flavoured fermented milks and flavoured drinks based on fermented milks...
Codex433Emulsifier02.1.2 Vegetable oils and fats5,000 mg/kgExcluding products conforming to the Standard for Named Vegetable Oils (CXS 210-1999).; Excluding products conforming to the Standard for Edible Fats and Oils not covered by...
Codex433Emulsifier02.1.3 Lard, tallow, fish oil, and other animal fats5,000 mg/kgExcluding products conforming to the Standard for Edible Fats and Oils not covered by Individual Standards (CXS 19-1981).; For use in fat emulsions for baking purposes only.;...
Codex433Emulsifier02.2.2 Fat spreads, dairy fat spreads and blended spreads10,000 mg/kgExcept for use in products conforming to the Standard for Dairy Fat Spreads (CXS 253-2006), as an emulsifier only.; In dairy fat spreads limited to products with < 70% fat content...
Codex433Emulsifier02.3 Fat emulsions mainly of type oil-in-water, including mixed and/or flavoured products based on fat emulsions5,000 mg/kgFor use in fat emulsions for baking purposes only. [Group: POLYSORBATES]
Codex433Emulsifier02.4 Fat-based desserts excluding dairy-based dessert products of food category 01.73,000 mg/kgFor use in fat emulsions for baking purposes only. [Group: POLYSORBATES]
Codex433Emulsifier03.0 Edible ices, including sherbet and sorbet1,000 mg/kg[Group: POLYSORBATES]
Codex433Emulsifier04.1.2.11 Fruit fillings for pastries3,000 mg/kg[Group: POLYSORBATES]
Codex433Emulsifier04.1.2.8 Fruit preparations, including pulp, purees, fruit toppings and coconut milk1,000 mg/kgExcluding products conforming to the Standard for Date Paste (CODEX STAN 314R-2013).; For use in coconut milk only. [Group: POLYSORBATES]
Codex433Emulsifier04.1.2.9 Fruit-based desserts, including fruit-flavoured water-based desserts3,000 mg/kg[Group: POLYSORBATES]
Codex433Emulsifier04.2.2.6 Vegetable (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), seaweed, and nut and seed pulps and preparations (e.g. vegetable desserts and sauces, candied vegetables) other than food category 04.2.2.53,000 mg/kgExcluding products conforming to the Regional Standard for Harissa (Red Hot Pepper Paste) (CXS 308R-2011).; Excluding products conforming to the Codex Regional Standard for Tehena...
Codex433Emulsifier05.1.2 Cocoa mixes (syrups)500 mg/kg[Group: POLYSORBATES]
Codex433Emulsifier05.1.3 Cocoa-based spreads, including fillings1,000 mg/kgExcluding products conforming to the Standard for Cocoa Butter (CODEX STAN 86-1981). [Group: POLYSORBATES]
Codex433Emulsifier05.1.4 Cocoa and chocolate products5,000 mg/kgWhen used in combination as emulsifiers: ammonium salts of phosphatidic acid (INS 442), polyglycerol esters of interesterified ricinoleic acid (INS 476), sorbitan monostearate...
Codex433Emulsifier05.1.5 Imitation chocolate, chocolate substitute products5,000 mg/kg[Group: POLYSORBATES]
Codex433Emulsifier05.2 Confectionery including hard and soft candy, nougats, etc. other than food categories 05.1, 05.3 and 05.41,000 mg/kgExcluding products conforming to the Codex Regional Standard for Halawa Tehenia (CODEX STAN 309R-211). [Group: POLYSORBATES]
Codex433Emulsifier05.3 Chewing gum5,000 mg/kg[Group: POLYSORBATES]
Codex433Emulsifier05.4 Decorations (e.g. for fine bakery wares), toppings (non-fruit) and sweet sauces3,000 mg/kg[Group: POLYSORBATES]
Codex433Emulsifier06.4.2 Dried pastas and noodles and like products5,000 mg/kg[Group: POLYSORBATES]
Codex433Emulsifier06.4.3 Pre-cooked pastas and noodles and like products5,000 mg/kgFor use in instant noodles only. [Group: POLYSORBATES]
Codex433Emulsifier06.5 Cereal and starch based desserts (e.g. rice pudding, tapioca pudding)3,000 mg/kg[Group: POLYSORBATES]
Codex433Emulsifier06.6 Batters (e.g. for breading or batters for fish or poultry)5,000 mg/kgOn the dry ingredient, dry weight, dry mix or concentrate basis. [Group: POLYSORBATES]
Codex433Emulsifier06.8.1 Soybean-based beverages2,000 mg/kgFor use only in composite/ flavoured soybean beverages and soybean-based beverages conforming to the Regional Standard for Non-Fermented Soybean Products (Asia) (CXS 322R-2015) as...
Codex433Emulsifier07.1.1 Breads and rolls3,000 mg/kg[Group: POLYSORBATES]
Codex433Emulsifier07.1.2 Crackers, excluding sweet crackers5,000 mg/kgOn the flour basis. [Group: POLYSORBATES]
Codex433Emulsifier07.1.3 Other ordinary bakery products (e.g. bagels, pita, English muffins)3,000 mg/kgOn the flour basis. [Group: POLYSORBATES]
Codex433Emulsifier07.1.4 Bread-type products, including bread stuffing and bread crumbs3,000 mg/kgOn the flour basis. [Group: POLYSORBATES]
Codex433Emulsifier07.1.5 Steamed breads and buns3,000 mg/kgOn the flour basis. [Group: POLYSORBATES]
Codex433Emulsifier07.1.6 Mixes for bread and ordinary bakery wares3,000 mg/kgOn the flour basis. [Group: POLYSORBATES]
Codex433Emulsifier07.2 Fine bakery wares (sweet, salty, savoury) and mixes3,000 mg/kg[Group: POLYSORBATES]
Codex433Emulsifier08.2 Processed meat, poultry, and game products in whole pieces or cuts5,000 mg/kgExcluding products conforming to the Standard for Cooked Cured Pork Shoulder (CODEX STAN 97-1981).; Excluding products conforming to the Standard for Cooked Cured Ham (CODEX STAN...
Codex433Emulsifier08.3 Processed comminuted meat, poultry, and game products5,000 mg/kgExcluding products conforming to the Standard for Corned Beef (CODEX STAN 88-1981).; Excluding products conforming to the Standard for Cooked Cured Chopped Meat (CODEX STAN...
Codex433Emulsifier08.4 Edible casings (e.g. sausage casings)1,500 mg/kg[Group: POLYSORBATES]
Codex433Emulsifier10.4 Egg-based desserts (e.g. custard)3,000 mg/kg[Group: POLYSORBATES]
Codex433Emulsifier12.1.1 Salt10 mg/kg[Group: POLYSORBATES]
Codex433Emulsifier12.2.1 Herbs and spices2,000 mg/kgExcluding products conforming to the Standard for Dried Seeds – Nutmeg (CXS 352-2022).; Excluding products conforming to the SStandard for dried floral parts: Cloves (CXS...
Codex433Emulsifier12.2.2 Seasonings and condiments5,000 mg/kg[Group: POLYSORBATES]
Codex433Emulsifier12.5 Soups and broths1,000 mg/kg[Group: POLYSORBATES]
Codex433Emulsifier12.6.1 Emulsified sauces and dips (e.g. mayonnaise, salad dressing, onion dip)3,000 mg/kg[Group: POLYSORBATES]
Codex433Emulsifier12.6.2 Non-emulsified sauces (e.g. ketchup, cheese sauce, cream sauce, brown gravy)5,000 mg/kgExcept for use in products conforming to the Standard for Chili Sauce (CXS 306-2011): Polyoxyethylene (20) sorbitan monolaurate (INS 432), Polyoxyethylene (20) sorbitan monooleate...
Codex433Emulsifier12.6.3 Mixes for sauces and gravies5,000 mg/kgOn the served to the consumer basis. [Group: POLYSORBATES]
Codex433Emulsifier12.6.4 Clear sauces (e.g. fish sauce)5,000 mg/kgExcluding products conforming to the Standard for Fish Sauce (CODEX STAN 302-2011). [Group: POLYSORBATES]
Codex433Emulsifier12.7 Salads (e.g. macaroni salad, potato salad) and sandwich spreads excluding cocoa- and nut-based spreads of food categories 04.2.2.5 and 05.1.32,000 mg/kg[Group: POLYSORBATES]
Codex433Emulsifier13.3 Dietetic foods intended for special medical purposes (excluding products of food category 13.1)1,000 mg/kgExcluding products conforming to the Guidelines for Ready to Use Therapeutic Foods (CXG 95-2022). [Group: POLYSORBATES]
Codex433Emulsifier13.4 Dietetic formulae for slimming purposes and weight reduction1,000 mg/kg[Group: POLYSORBATES]
Codex433Emulsifier13.6 Food supplements25,000 mg/kg[Group: POLYSORBATES]
Codex433Emulsifier14.1.4 Water-based flavoured drinks, including sport, energy, or electrolyte drinks and particulated drinks500 mg/kgOn the served to the consumer basis. [Group: POLYSORBATES]
Codex433Emulsifier14.2.6 Distilled spirituous beverages containing more than 15% alcohol120 mg/kg[Group: POLYSORBATES]
Codex433Emulsifier14.2.7 Aromatized alcoholic beverages (e.g. beer, wine and spirituous cooler-type beverages, low alcoholic refreshers)120 mg/kg[Group: POLYSORBATES]
SOURCE Health Canada

Health Canada Status

Health Canada food-additive permissions by functional class and food scope.

JurisdictionClassPermitted foodsMaximum levelList
CanadaEmulsifying, stabilizing or thickening agent(a)Annatto formulations(a)25% of the total colour formulationList of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaEmulsifying, stabilizing or thickening agent(b)Breath fresheners(b)100 ppmList of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaEmulsifying, stabilizing or thickening agent(c)Cake icing mixes; Cake icings(c)If used singly, the amount not to exceed 5,000 ppm of the finished icing. If used in combination with polysorbate 60 or sorbitan monostearate, or both, the total combined amount not to exceed 5,000 ppm of the finished icing.List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaEmulsifying, stabilizing or thickening agent(d)Creamed cottage cheese(d)80 ppmList of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaEmulsifying agent(d.1) (Naming the flavour) flavour(d.1) Good Manufacturing PracticeList of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaStabilizing agent(e)Ice cream mix(e)If used singly, the amount not to exceed 1,000 ppm of the ice cream. If used in combination with polysorbate 65, the total combined amount not to exceed 1,000 ppm of the ice cream. If used in any combination with other stabilizing agents, the total combined amount not to exceed 5,000 ppm, provided that the amount of polysorbate 80 does not exceed 1,000 ppm of the ice cream.List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaStabilizing agent(f)Ice milk mix(f)If used singly, the amount not to exceed 1,000 ppm of the ice milk. If used in combination with polysorbate 65, the total combined amount not to exceed 1,000 ppm. If used in any combination with other stabilizing agents, the total combined amount not to exceed 5,000 ppm, provided that the amount of polysorbate 80 does not exceed 1,000 ppm. This total combined amount does not include propylene glycol mono fatty acid esters that may be added up to their maximum level of use set out in this list.List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaEmulsifying, stabilizing or thickening agent(g)Imitation dry cream mixes(g)If used singly, the amount not to exceed 1,000 ppm. If used in any combination with polysorbate 60, polysorbate 65 or sorbitan monostearate, the total combined amount not to exceed 4,000 ppm, provided that the amount of polysorbate 80 does not exceed 1,000 ppm.List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaEmulsifying, stabilizing or thickening agent(h)Liquid smoke flavour concentrates(h)Good Manufacturing Practice. Residue not to exceed 3,000 ppm in the food containing the liquid smoke flavour concentrate.List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaEmulsifying, stabilizing or thickening agent(i)Liquid smoke flavours(i)Good Manufacturing Practice. Residue not to exceed 275 ppm in the food containing the liquid smoke flavour.List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaThickening agent(j)Pickles and relishes(j)500 ppmList of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaEmulsifying agent(k)Rice-based ready-to-eat cereals(k)1,000 ppmList of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaEmulsifying, stabilizing or thickening agent(l)Salt(l)10 ppm. For use in the manufacture of coarse crystal salt.List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaEmulsifying, stabilizing or thickening agent(m)Sausage casings(m)1,500 ppm of the casingList of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaEmulsifying agent(n)Seasonings for use in boneless (naming the poultry), brawn, canned (naming the poultry), headcheese, prepared meat, prepared poultry meat or preserved meat(n)Good Manufacturing Practice. Residue not to exceed 1,500 ppm in the food containing the seasoning.List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaStabilizing agent(o)Sherbet(o)If used singly, the amount not to exceed 1,000 ppm. If used in combination with polysorbate 65, the total combined amount not to exceed 1,000 ppm. If used in any combination with other stabilizing agents, the total combined amount not to exceed 7,500 ppm, provided that the amount of polysorbate 80 does not exceed 1,000 ppm.List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaEmulsifying, stabilizing or thickening agent(p)Spice oils and spice oleoresins for use in pumping pickle used in the curing of preserved meat or preserved meat by-product(p)2,000 ppm of the pumping pickleList of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaEmulsifying, stabilizing or thickening agent(q)Turmeric formulations(q)50% of the total colour formulationList of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaEmulsifying, stabilizing or thickening agent(r)Unstandardized beverage bases; Unstandardized beverage mixes(r)If used singly, the amount not to exceed 500 ppm in the beverage as consumed. If used in combination with sorbitan monostearate, the total combined amount not to exceed 500 ppm in the beverage as consumed.List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaEmulsifying agent(r.1)Unstandardized dips(r.1)0.05%List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaEmulsifying, stabilizing or thickening agent(s)Unstandardized frozen desserts(s)1,000 ppmList of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaEmulsifying, stabilizing or thickening agent(t)Unstandardized salad dressings(t)2,500 ppmList of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaEmulsifying agent(u)Vegetable oils, except olive oil(u)1,250 ppmList of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaEmulsifying agent(v)Wheat-based ready-to-eat cereals(v)500 ppmList of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaEmulsifying, stabilizing or thickening agent(w)Whipped cream(w)1,000 ppmList of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaEmulsifying, stabilizing or thickening agent(x)Whipped vegetable oil toppings(x)If used singly, the amount not to exceed 500 ppm. If used in any combination with polysorbate 60, polysorbate 65 or sorbitan monostearate, the total combined amount not to exceed 4,000 ppm, provided that the amount of polysorbate 80 does not exceed 500 ppm.List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents
CanadaTo improve viability of spray-dried bacterial cultures-(a) Good Manufacturing Practice. Residue not to exceed 6 ppm in the dried infant cereal product.List of Permitted Food Additives with Other Purposes of Use
CanadaTo improve viability of spray-dried bacterial cultures-(b) Good Manufacturing Practice. Residue not to exceed 3 ppm in the infant formula powder and the nutritional supplement powder.List of Permitted Food Additives with Other Purposes of Use
SOURCE EU Commission EU Food Contact Materials

EU FCM Substances

EU food-contact material rows and migration-limit fields.

JurisdictionFCM no.Ref no.SubstanceUseSMLRegulation
European Union56979120polyethyleneglycol sorbitan monooleateadditive/PPA-Regulation (EU) No 10/2011, Annex I
SOURCE JECFA JECFA ADI

JECFA ADI Values

JECFA ADI records and evaluation years.

JurisdictionChemical nameJECFA no.CASADIADI upperFunctionEvaluation year
JECFAPOLYOXYETHYLENE (20) SORBITAN MONOOLEATE-9005-65-60-25 mg/kg bw25EMULSIFIER1973
JECFAPOLYSORBATE 80--no_data--1973
SOURCE ingredients ghs classifications

Cross-Reference to Cosmetics / Chemicals / Pharma

Same-CAS public rows from adjacent Roots verticals where available.

SOURCE FAQPage JSON-LD public food renderer rows

Frequently Asked Questions

Food-use, safety, ADI, and cross-vertical answers mirrored into FAQPage JSON-LD.

What is Polysorbate 80 used for in food?

Polysorbate 80 appears in food-use rows as: emulsifier; Emulsifier; Emulsifying, stabilizing or thickening agent.

Is Polysorbate 80 / E433 safe?

This page does not assign a standalone safety verdict; it renders public regulatory evidence. ADI/reference value: ADI 25 mg/kg bw/day. EU status evidence: PUBLISHED. US/FDA evidence: GRAS.

What is the ADI for Polysorbate 80?

Polysorbate 80 has this ADI/reference value in the food-safety tables: ADI 25 mg/kg bw/day. Source: food_substances.

Is Polysorbate 80 also used in cosmetics?

Polysorbate 80 has a same-CAS cosmetics cross-reference: Polysorbate 80, EU status permitted.