Food Safety Substance
Polysorbate 65E436
Polysorbate 65 (E436) is a food additive with PUBLISHED in the EU, GRAS in the US, and data from 7 regulatory sources.
CAS 9005-71-4
E436
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 | 7 matched regulatory source group(s)
Substance Identity
Resolved identifiers used to render this food-safety record.
Substance name
Polysorbate 65
CAS
9005-71-4
E-number
E436
DTXSID
DTXSID30891988
Evidence tier
Indexable evidence set (15)
SOURCE
EU Commission
FDA | Health Canada | Regulatory source
Multi-Jurisdiction Comparison
Side-by-side status rows for the same resolved substance across public food regulators.
| Jurisdiction | Authority | Status | Evidence |
|---|---|---|---|
| European Union | EU Commission | PUBLISHED | EU additive listing; Annex II entry |
| Canada | Health Canada | Listed | Emulsifying, stabilizing or thickening agent |
| Codex | Codex Alimentarius | Listed | Emulsifier |
SOURCE
EU Commission
EU Food Additives | EU Food Additives Database Reg 1333 2008
EU Food Additive Status
EU Commission food-additive listing rows from eu_food_additives.
| Jurisdiction | E-number | Status | Type | Name | Note |
|---|---|---|---|---|---|
| European Union | E436 | PUBLISHED | substanceFAD | Polyoxyethylene sorbitan tristearate (polysorbate 65) | - |
SOURCE
EU Commission
EU Annex II Authorised | EU Food Additives Database Reg 1333 2008
EU Annex II Authorised Uses
Authorised additive rows and use conditions from EU Annex II tables.
| Jurisdiction | E-number | Name | INS | Policy item | Note |
|---|---|---|---|---|---|
| European Union | E436 | Polyoxyethylene sorbitan tristearate (polysorbate 65) | - | POL-FAD-IMPORT-3156 | - |
Conditions and restrictions
| Jurisdiction | Food category | Restriction | Comment | Source |
|---|---|---|---|---|
| European Union | - | - | - | Regulatory source |
| European Union | - | - | - | Regulatory source |
SOURCE
Regulatory source
Codex GSFA Status
Codex Alimentarius GSFA permissions and maximum-use rows.
| Jurisdiction | INS / E-number | Function | Food category | Max level | Notes |
|---|---|---|---|---|---|
| Codex | 436 | Emulsifier | 01.1.4 Flavoured fluid milk drinks | 3,000 mg/kg | Except 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... |
| Codex | 436 | Emulsifier | 01.3.2 Beverage whiteners | 4,000 mg/kg | Excluding 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... |
| Codex | 436 | Emulsifier | 01.4.1 Pasteurized cream (plain) | 1,000 mg/kg | Except for use in products conforming to the Standard for Cream and Prepared Creams (CXS 288-1976) as an emulsifier. [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 01.4.2 Sterilized and UHT creams, whipping and whipped creams, and reduced fat creams (plain) | 1,000 mg/kg | [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 01.4.3 Clotted cream (plain) | 1,000 mg/kg | [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 01.4.4 Cream analogues | 5,000 mg/kg | [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 01.5.2 Milk and cream powder analogues | 4,000 mg/kg | Excluding products conforming to the Standard for a Blend of Skimmed Milk and Vegetable Fat in Powdered Form (CODEX STAN 251-2006). [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 01.6.1 Unripened cheese | 80 mg/kg | Excluding products conforming to the Standard for Mozzarella (CODEX STAN 262-2006).; Excluding products conforming to the Standard for Cottage Cheese (CXS 273-1968).; Excluding... |
| Codex | 436 | Emulsifier | 01.7 Dairy-based desserts (e.g. pudding, fruit or flavoured yoghurt) | 3,000 mg/kg | Except 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... |
| Codex | 436 | Emulsifier | 02.1.2 Vegetable oils and fats | 5,000 mg/kg | Excluding 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... |
| Codex | 436 | Emulsifier | 02.1.3 Lard, tallow, fish oil, and other animal fats | 5,000 mg/kg | Excluding 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.;... |
| Codex | 436 | Emulsifier | 02.2.2 Fat spreads, dairy fat spreads and blended spreads | 10,000 mg/kg | Except 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... |
| Codex | 436 | Emulsifier | 02.3 Fat emulsions mainly of type oil-in-water, including mixed and/or flavoured products based on fat emulsions | 5,000 mg/kg | For use in fat emulsions for baking purposes only. [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 02.4 Fat-based desserts excluding dairy-based dessert products of food category 01.7 | 3,000 mg/kg | For use in fat emulsions for baking purposes only. [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 03.0 Edible ices, including sherbet and sorbet | 1,000 mg/kg | [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 04.1.2.11 Fruit fillings for pastries | 3,000 mg/kg | [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 04.1.2.8 Fruit preparations, including pulp, purees, fruit toppings and coconut milk | 1,000 mg/kg | Excluding products conforming to the Standard for Date Paste (CODEX STAN 314R-2013).; For use in coconut milk only. [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 04.1.2.9 Fruit-based desserts, including fruit-flavoured water-based desserts | 3,000 mg/kg | [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 04.2.2.6 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 04.2.2.5 | 3,000 mg/kg | Excluding 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... |
| Codex | 436 | Emulsifier | 05.1.2 Cocoa mixes (syrups) | 500 mg/kg | [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 05.1.3 Cocoa-based spreads, including fillings | 1,000 mg/kg | Excluding products conforming to the Standard for Cocoa Butter (CODEX STAN 86-1981). [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 05.1.4 Cocoa and chocolate products | 5,000 mg/kg | When used in combination as emulsifiers: ammonium salts of phosphatidic acid (INS 442), polyglycerol esters of interesterified ricinoleic acid (INS 476), sorbitan monostearate... |
| Codex | 436 | Emulsifier | 05.1.5 Imitation chocolate, chocolate substitute products | 5,000 mg/kg | [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 05.2 Confectionery including hard and soft candy, nougats, etc. other than food categories 05.1, 05.3 and 05.4 | 1,000 mg/kg | Excluding products conforming to the Codex Regional Standard for Halawa Tehenia (CODEX STAN 309R-211). [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 05.3 Chewing gum | 5,000 mg/kg | [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 05.4 Decorations (e.g. for fine bakery wares), toppings (non-fruit) and sweet sauces | 3,000 mg/kg | [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 06.4.2 Dried pastas and noodles and like products | 5,000 mg/kg | [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 06.4.3 Pre-cooked pastas and noodles and like products | 5,000 mg/kg | For use in instant noodles only. [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 06.5 Cereal and starch based desserts (e.g. rice pudding, tapioca pudding) | 3,000 mg/kg | [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 06.6 Batters (e.g. for breading or batters for fish or poultry) | 5,000 mg/kg | On the dry ingredient, dry weight, dry mix or concentrate basis. [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 06.8.1 Soybean-based beverages | 2,000 mg/kg | For 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... |
| Codex | 436 | Emulsifier | 07.1.1 Breads and rolls | 3,000 mg/kg | [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 07.1.2 Crackers, excluding sweet crackers | 5,000 mg/kg | On the flour basis. [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 07.1.3 Other ordinary bakery products (e.g. bagels, pita, English muffins) | 3,000 mg/kg | On the flour basis. [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 07.1.4 Bread-type products, including bread stuffing and bread crumbs | 3,000 mg/kg | On the flour basis. [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 07.1.5 Steamed breads and buns | 3,000 mg/kg | On the flour basis. [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 07.1.6 Mixes for bread and ordinary bakery wares | 3,000 mg/kg | On the flour basis. [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 07.2 Fine bakery wares (sweet, salty, savoury) and mixes | 3,000 mg/kg | [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 08.2 Processed meat, poultry, and game products in whole pieces or cuts | 5,000 mg/kg | Excluding 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... |
| Codex | 436 | Emulsifier | 08.3 Processed comminuted meat, poultry, and game products | 5,000 mg/kg | Excluding 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... |
| Codex | 436 | Emulsifier | 08.4 Edible casings (e.g. sausage casings) | 1,500 mg/kg | [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 10.4 Egg-based desserts (e.g. custard) | 3,000 mg/kg | [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 12.1.1 Salt | 10 mg/kg | [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 12.2.1 Herbs and spices | 2,000 mg/kg | Excluding products conforming to the Standard for Dried Seeds – Nutmeg (CXS 352-2022).; Excluding products conforming to the SStandard for dried floral parts: Cloves (CXS... |
| Codex | 436 | Emulsifier | 12.2.2 Seasonings and condiments | 5,000 mg/kg | [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 12.5 Soups and broths | 1,000 mg/kg | [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 12.6.1 Emulsified sauces and dips (e.g. mayonnaise, salad dressing, onion dip) | 3,000 mg/kg | [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 12.6.2 Non-emulsified sauces (e.g. ketchup, cheese sauce, cream sauce, brown gravy) | 5,000 mg/kg | Except for use in products conforming to the Standard for Chili Sauce (CXS 306-2011): Polyoxyethylene (20) sorbitan monolaurate (INS 432), Polyoxyethylene (20) sorbitan monooleate... |
| Codex | 436 | Emulsifier | 12.6.3 Mixes for sauces and gravies | 5,000 mg/kg | On the served to the consumer basis. [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 12.6.4 Clear sauces (e.g. fish sauce) | 5,000 mg/kg | Excluding products conforming to the Standard for Fish Sauce (CODEX STAN 302-2011). [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 12.7 Salads (e.g. macaroni salad, potato salad) and sandwich spreads excluding cocoa- and nut-based spreads of food categories 04.2.2.5 and 05.1.3 | 2,000 mg/kg | [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 13.3 Dietetic foods intended for special medical purposes (excluding products of food category 13.1) | 1,000 mg/kg | Excluding products conforming to the Guidelines for Ready to Use Therapeutic Foods (CXG 95-2022). [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 13.4 Dietetic formulae for slimming purposes and weight reduction | 1,000 mg/kg | [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 13.6 Food supplements | 25,000 mg/kg | [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 14.1.4 Water-based flavoured drinks, including sport, energy, or electrolyte drinks and particulated drinks | 500 mg/kg | On the served to the consumer basis. [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 14.2.6 Distilled spirituous beverages containing more than 15% alcohol | 120 mg/kg | [Group: POLYSORBATES] |
| Codex | 436 | Emulsifier | 14.2.7 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 food additives
Health Canada Status
Health Canada food-additive permissions by functional class and food scope.
| Jurisdiction | Class | Permitted foods | Maximum level | List |
|---|---|---|---|---|
| Canada | Emulsifying, stabilizing or thickening agent | (a)Breath fresheners | (a)200 ppm | List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents |
| Canada | Emulsifying, stabilizing or thickening agent | (b)Cakes | (b)If used singly, the amount not to exceed 3,000 ppm on a dry basis. If used in combination with polysorbate 60, the total combined amount not to exceed 5,000 ppm on a dry basis, provided that the amount of polysorbate 65 does not exceed 3,000 ppm on a dry basis. | List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents |
| Canada | Stabilizing agent | (c)Ice cream mix | (c)If used singly, the amount not to exceed 1,000 ppm of the ice cream. If used in combination with polysorbate 80, 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 65 does not exceed 1,000 ppm of the ice cream. | List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents |
| Canada | Stabilizing agent | (d)Ice milk mix | (d)If used singly, the amount not to exceed 1,000 ppm of the ice milk. If used in combination with polysorbate 80, the total combined amount not to exceed 1,000 ppm of the ice milk. 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 65 does not exceed 1,000 ppm of the ice milk. 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 |
| Canada | Emulsifying, stabilizing or thickening agent | (e)Imitation dry cream mixes | (e)If used singly, the amount not to exceed 4,000 ppm. If used in any combination with polysorbate 60, polysorbate 80 or sorbitan monostearate, the total combined amount not to exceed 4,000 ppm. | List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents |
| Canada | Stabilizing agent | (f)(Naming the flavour) milk; (Naming the flavour) partly skimmed milk; (Naming the flavour) partly skimmed milk with added milk solids; (Naming the flavour) skim milk; (Naming the flavour) skim milk with added milk... | (f)5,000 ppm | List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents |
| Canada | Stabilizing agent | (g)Sherbet | (g)If used singly, the amount not to exceed 1,000 ppm. If used in combination with polysorbate 80, 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 65 does not exceed 1,000 ppm. | List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents |
| Canada | Emulsifying, stabilizing or thickening agent | (h)Unstandardized beverage bases; Unstandardized beverage mixes | (h)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 |
| Canada | Emulsifying, stabilizing or thickening agent | (i)Unstandardized confectionery coatings | (i)If used singly, the amount not to exceed 0.5%. If used in any combination with polysorbate 60, sorbitan monostearate or sorbitan tristearate, the total combined amount not to exceed 1.0%, provided that the amount of polysorbate 65 does not exceed 0.5%. | List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents |
| Canada | Emulsifying, stabilizing or thickening agent | (j)Unstandardized frozen desserts | (j)1,000 ppm | List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents |
| Canada | Emulsifying, stabilizing or thickening agent | (k)Vegetable oil creaming agents; Vegetable oil topping mixes | (k)If used singly, the amount not to exceed 4,000 ppm. If used in combination with polysorbate 60 or sorbitan monostearate, or both, the total combined amount not to exceed 4,000 ppm. | List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents |
| Canada | Emulsifying, stabilizing or thickening agent | (l)Whipped vegetable oil toppings | (l)If used singly, the amount not to exceed 4,000 ppm. If used in any combination with polysorbate 60, polysorbate 80 or sorbitan monostearate, the total combined amount not to exceed 4,000 ppm. | List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents |
SOURCE
EU Commission
EU Food Contact Materials
EU FCM Substances
EU food-contact material rows and migration-limit fields.
| Jurisdiction | FCM no. | Ref no. | Substance | Use | SML | Regulation |
|---|---|---|---|---|---|---|
| European Union | 573 | 79440 | polyethyleneglycol sorbitan tristearate | additive/PPA | - | Regulation (EU) No 10/2011, Annex I |
SOURCE
WHO/JECFA
JECFA ADI Values
JECFA ADI records and evaluation years.
| Jurisdiction | Chemical name | JECFA no. | CAS | ADI | ADI upper | Function | Evaluation year |
|---|---|---|---|---|---|---|---|
| JECFA | POLYSORBATE 65 | - | - | no_data | - | - | 1973 |
| JECFA | POLYOXYETHYLENE (20) SORBITAN TRISTEARATE | - | 9005-71-4 | 0-25 mg/kg bw | 25 | EMULSIFIER | 1973 |
SOURCE
Ingredient record
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 65 used for in food?
Polysorbate 65 appears in food-use rows as: emulsifier; Emulsifier; Emulsifying, stabilizing or thickening agent.
Is Polysorbate 65 / E436 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 65?
Polysorbate 65 has this ADI/reference value in the food-safety tables: ADI 25 mg/kg bw/day. Source: food substances.
Is Polysorbate 65 also used in cosmetics?
Polysorbate 65 has a same-CAS cosmetics cross-reference: Polysorbate 65, EU status permitted.