Polysorbate 65 — Food Additive Index

Where it is and isn’t permitted

Status of Polysorbate 65 by jurisdiction. Every jurisdiction this site covers is listed, including those where the substance does not appear.
Jurisdiction	Status	Scope and limits	Citation
United StatesFood and Drug Administration	Permitted, with conditions		21 CFR 172.838retrieved 2026-09-07
Codex AlimentariusCodex Alimentarius Commission / JECFA	Permitted, with conditions	57 food categories highest permitted level 25,000 mg/kg Show every food category 01.1.4 Flavoured Fluid Milk Drinks — 3,000 mg/kg 01.3.2 Beverage whiteners — 4,000 mg/kg 01.4.1 Pasteurized cream (plain) — 1,000 mg/kg 01.4.2 Sterilized and UHT creams, whipping and whipped creams, and reduced fat creams (plain) — 1,000 mg/kg 01.4.3 Clotted cream (plain) — 1,000 mg/kg 01.4.4 Cream analogues — 5,000 mg/kg 01.5.2 Milk and cream powder analogues — 4,000 mg/kg 01.6.1 Unripened cheese — 80 mg/kg 01.7 Dairy-based desserts (e.g. pudding, fruit or flavoured yoghurt) — 3,000 mg/kg 02.1.2 Vegetable oils and fats — 5,000 mg/kg 02.1.3 Lard, tallow, fish oil, and other animal fats — 5,000 mg/kg 02.2.2 Fat spreads, dairy fat spreads and blended spreads — 10,000 mg/kg 02.3 Fat emulsions mainly of type oil-in-water, including mixed and/or flavoured products based on fat emulsions — 5,000 mg/kg 02.4 Fat-based desserts excluding dairy-based dessert products of food category 01.7 — 3,000 mg/kg 03.0 Edible ices, including sherbet and sorbet — 1,000 mg/kg 04.1.2.11 Fruit fillings for pastries — 3,000 mg/kg 04.1.2.8 Fruit preparations, including pulp, purees, fruit toppings and coconut milk — 1,000 mg/kg 04.1.2.9 Fruit-based desserts, incl. fruit-flavoured water-based desserts — 3,000 mg/kg 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 05.1.2 Cocoa mixes (syrups) — 500 mg/kg 05.1.3 Cocoa-based spreads, incl. fillings — 1,000 mg/kg 05.1.4 Cocoa and chocolate products — 5,000 mg/kg 05.1.5 Imitation chocolate, chocolate substitute products — 5,000 mg/kg 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 05.3 Chewing gum — 5,000 mg/kg 05.4 Decorations (e.g. for fine bakery wares), toppings (non-fruit), and sweet sauces — 3,000 mg/kg 06.4.2 Dried pastas and noodles and like products — 5,000 mg/kg 06.4.3 Pre-cooked pastas and noodles and like products — 5,000 mg/kg 06.5 Cereal and starch based desserts (e.g. rice pudding, tapioca pudding) — 3,000 mg/kg 06.6 Batters (e.g. for breading or batters for fish or poultry) — 5,000 mg/kg 06.8.1 Soybean-based beverages — 2,000 mg/kg 07.1.1 Breads and rolls — 3,000 mg/kg 07.1.2 Crackers, excluding sweet crackers — 5,000 mg/kg 07.1.3 Other ordinary bakery products (e.g. bagels, pita, English muffins) — 3,000 mg/kg 07.1.4 Bread-type products, including bread stuffing and bread crumbs — 3,000 mg/kg 07.1.5 Steamed breads and buns — 3,000 mg/kg 07.1.6 Mixes for bread and ordinary bakery wares — 3,000 mg/kg 07.2 Fine bakery wares (sweet, salty, savoury) and mixes — 3,000 mg/kg 08.2 Processed meat, poultry, and game products in whole pieces or cuts — 5,000 mg/kg 08.3 Processed comminuted meat, poultry, and game products — 5,000 mg/kg 08.4 Edible casings (e.g. sausage casings) — 1,500 mg/kg 10.4 Egg-based desserts (e.g. custard) — 3,000 mg/kg 12.1.1 Salt — 10 mg/kg 12.2.1 Herbs and spices — 2,000 mg/kg 12.2.2 Seasonings and condiments — 5,000 mg/kg 12.5 Soups and broths — 1,000 mg/kg 12.6.1 Emulsified sauces and dips (e.g. mayonnaise, salad dressing, onion dips) — 3,000 mg/kg 12.6.2 Non-emulsified sauces (e.g. ketchup, cheese sauce, cream sauce, brown gravy) — 5,000 mg/kg 12.6.3 Mixes for sauces and gravies — 5,000 mg/kg 12.6.4 Clear sauces (e.g. fish sauce) — 5,000 mg/kg 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 13.3 Dietetic foods intended for special medical purposes (excluding products of food category 13.1) — 1,000 mg/kg 13.4 Dietetic formulae for slimming purposes and weight reduction — 1,000 mg/kg 13.6 Food supplements — 25,000 mg/kg 14.1.4 Water-based flavoured drinks, including "sport," “energy,” or "electrolyte" drinks and particulated drinks — 500 mg/kg 14.2.6 Distilled spirituous beverages containing more than 15% alcohol — 120 mg/kg 14.2.7 Aromatized alcoholic beverages (e.g. beer, wine and spirituous cooler-type beverages, low-alcoholic refreshers) — 120 mg/kg	CXS 192-1995 Table One, INS 436and 56 further provisionsretrieved 2026-09-07

What it is made from

Made by attaching ethylene oxide units to sorbitan tristearate. The stearic 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.

CAS registry number: 9005-71-4

Every name it appears under

9 recorded names. A label may use any of them.

E number

E436

INS number

CAS registry number

9005-71-4

As it appears in regulation

Polysorbate 65

Other names

E 436
Polyoxyethylene (20) sorbitan
Polyoxyethylene (20) sorbitan tristearate
Polyoxyethylene sorbitan tristearate (polysorbate 65)
Polysorbate 65

Hazard reference values

No reference value for this substance in the sources we hold.

Evidence and how bodies read it

Studies, and the differing conclusions regulators drew from them, are curated by hand rather than machine-read, and none has been written for this substance yet.

Sources for this page

ecfr retrieved 2026-09-07
gsfa retrieved 2026-09-07

Full licence terms and publisher details on Sources. How this page is built and updated: Method.

Machine-readable:/api/v1/additives/polysorbate-65.json