Polysorbate 60 (E435) & Polysorbate 80 (E433): What They Are Used For, Safety, Gut Microbiota Research & Japan vs. EU/US Rules

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Look at the ingredient list on imported chocolate, salad dressings, ice cream, softgel dietary supplements, or cosmetics, and you will often see Polysorbate 60 (E435) or Polysorbate 80 (E433).

At the same time, searches for polysorbates are full of questions and concerns: “What is Polysorbate 60 used for?”, “Are polysorbates toxic synthetic detergents?”, “Does Polysorbate 80 destroy gut mucus and microbiota?”, “Do they contain carcinogenic 1,4-dioxane?”, and “How are they regulated in Japan compared with the US and EU?”

In this article, based on the risk assessment by the Food Safety Commission of Japan (FSCJ), Japan’s Ministry of Health, Labour and Welfare (MHLW) standards for use, EFSA (European Food Safety Authority) and US FDA regulations, and peer-reviewed gut microbiome studies, we examine what Polysorbates 20, 60, 65, and 80 are, why they are used, how Japan’s rules and ADI compare with the EU and US, and how experimental mouse doses compare with actual human intake. For the broader history of emulsifiers and Japan’s group labeling rules, see our article on emulsifiers and our article on surfactants.

Conclusion

• Polysorbates (also known by the trade name Tween) are non-ionic surfactants (emulsifiers) made by linking ethylene oxide to sorbitan fatty acid esters to make them water-soluble. Japan approved four types—Polysorbate 20, Polysorbate 60, Polysorbate 65, and Polysorbate 80—as designated food additives in 2008.
• Polysorbate 60 (polyoxyethylene sorbitan monostearate, E435) carries a saturated stearic acid chain and is used to prevent oil-water separation in dressings, stabilize foam in whipped toppings and cake mixes, and retard fat bloom in chocolate. Polysorbate 80 (polyoxyethylene sorbitan monooleate, E433) carries an unsaturated oleic acid chain and is used to improve meltdown resistance and dryness in ice cream, solubilize oil-based flavorings in beverages and pickles, and emulsify or solubilize the contents of supplement softgels and pharmaceuticals.
• Contrary to the belief that Japan is lenient on additives, Japan regulates polysorbates more strictly than the EU and international bodies. While EFSA and JECFA set a group ADI (Acceptable Daily Intake) of 25 mg/kg body weight/day, Japan’s Food Safety Commission set the group ADI 2.5 times lower at 10 mg/kg body weight/day. (The EU itself used the SCF’s 10 mg/kg until EFSA’s 2015 re-evaluation.) Japan also sets maximum levels food by food—from 25 g/kg in capsules and tablets down to 0.020 g/kg (0.002%) for “other foods”—and bread was not included among the listed foods, so only the 0.020 g/kg “other foods” limit applies.
• On Japanese food labels, however, polysorbates used as emulsifiers can be hidden under the group name “乳化剤” (Emulsifier), whereas the EU requires Emulsifier: Polysorbate 60 (or E435) and the US requires Polysorbate 60 to be named individually.
• Regarding manufacturing impurities (ethylene oxide and 1,4-dioxane), Japan’s specifications and EU Regulation No 231/2012 both set purity limits: Japan allows up to 1.0 µg/g ethylene oxide and 10 µg/g dioxane, while the EU allows up to 0.2 mg/kg ethylene oxide and 5 mg/kg 1,4-dioxane.
• Concerns that “Polysorbate 80 erodes intestinal mucus and causes colitis” originate from a 2015 mouse study (Nature) that added 1% Polysorbate 80 to drinking water (0.1% also caused low-grade inflammation). Scaled by mouse water intake to a 70 kg human, 1% equals roughly 100 g per day—more than 100 times Japan’s ADI. A short human trial found gut microbiota changes with another emulsifier (CMC), but no published human feeding trial of Polysorbate 80 at dietary levels was found, so effects in people remain unknown.

What are Polysorbates 20, 60, 65, and 80? Chemical structure and HLB values

Sorbitan fatty acid esters (Span) linked with ethylene oxide

When sorbitol (a sugar alcohol derived from corn or other starches) is dehydrated into “sorbitan” and esterified with edible fatty acids, the result is a sorbitan fatty acid ester (known commercially as the Span series).

Sorbitan esters are oil-loving (lipophilic). By reacting them with approximately 20 moles of ethylene oxide, chemists attach long water-loving (hydrophilic) polyoxyethylene chains, creating polysorbates (the Tween series). Polysorbates were commercialized in the 1940s by the Atlas Powder Company in the United States, where William C. Griffin published the HLB (Hydrophile-Lipophile Balance) scale in 1949.

How the 4 types differ: fatty acid chains and HLB values

The four polysorbates approved in Japan (and E432–E436 in the EU) differ by the type and number of fatty acid chains attached to the sorbitan ring. Comparing their HLB values (where higher numbers indicate greater water solubility) clarifies why each is chosen for specific foods:

(Note: The EU also authorizes Polysorbate 40 [polyoxyethylene sorbitan monopalmitate, E434], which is not designated in Japan.)

What is Polysorbate 60 and 80 used for in food, supplements, and cosmetics?

Because “what is polysorbate 60 used for” and “polysorbate 80 uses” are among the most frequent search queries, let us look at their exact technological functions.

Polysorbate 60 (E435): Dressings, whipped toppings, and cake mixes

Polysorbate 60 (polyoxyethylene (20) sorbitan monostearate) is primarily used for three purposes:

1. Preventing oil-water separation in emulsified dressings and sauces: It forms a resilient hydrophilic film around dispersed oil droplets so emulsified salad dressings do not separate on the shelf. (Note: Japan’s standards for use allow up to 3.0 g/kg in both dressings and mayonnaise, but the ingredients defined for “mayonnaise” in Japan’s JAS standard do not include emulsifiers.)
2. Foam stabilization and aeration in whipped toppings, cake mixes, and shortenings: Combined with mono- and diglycerides, Polysorbate 60 improves air incorporation (overrun), yielding cakes with fine, uniform crumb volume and non-dairy whipped toppings that hold their peaks.
3. Retarding fat bloom in chocolate and compound coatings: It stabilizes cocoa butter crystal polymorphic transitions so chocolate does not develop a whitish surface film (“bloom”) during temperature fluctuations.

Polysorbate 80 (E433): Ice cream meltdown control, flavor solubilization, and softgels

Polysorbate 80 (polyoxyethylene (20) sorbitan monooleate) leverages the fluidity of its oleic acid tail:

1. Controlling fat destabilization and meltdown in ice cream: During freezing and whipping, Polysorbate 80 partially displaces milk proteins from the surface of fat globules. This controlled partial coalescence allows fat globules to form a three-dimensional scaffolding around air cells, giving ice cream a smooth, dry appearance when scooped and slowing meltdown at room temperature.
2. Solubilizing essential oils and oil-soluble flavors in beverages and pickles: It disperses citrus oils, mint oils, and spice oleoresins into clear aqueous beverages or pickling brines without cloudiness or oil rings.
3. Dietary supplement softgels, pharmaceuticals, and cosmetics: It is widely used to emulsify fat-soluble nutrients (vitamin D, vitamin E, CoQ10, omega-3s) inside softgel capsules, stabilize aqueous eye drops and injectable biologics, and emulsify facial cleansers and lotions.

Regulation and ADI comparison: Japan vs. EU (EFSA) vs. US (FDA)

Japan’s ADI (10 mg/kg/day) is stricter than EFSA and JECFA (25 mg/kg/day)

Safety evaluations by Japan, the EU, and the WHO/FAO Joint Expert Committee on Food Additives (JECFA) differ in the Acceptable Daily Intake (ADI) they assign:

In its 2007 assessment, Japan’s Food Safety Commission judged that genotoxicity was not a particular concern and used diarrhea in repeated-dose studies as the critical endpoint. Diarrhea from large doses of poorly absorbed substances is normally not treated as toxicity, but because polysorbates were also suspected of locally irritating the gut lining, the FSCJ took the cautious view and set a group ADI of 10 mg/kg bw/day—40% of the EU and JECFA figure (MHLW Food Additives Subcommittee document, 2007, Japanese). EFSA noted in 2015 that the highest exposure estimate for toddlers (24.5 mg/kg/day) was very close to its ADI.

Japan’s standards for use: food-by-food maximum levels

Polysorbates were designated in Japan in 2008. Their use is limited by food category under the Food Sanitation Act (expressed as Polysorbate 80; the sum applies when several are combined):

• Up to 25 g/kg: Capsules, tablets and other foods not in ordinary food form
• Up to 5.0 g/kg (0.5%): Cocoa and chocolate products, shortening, seasonings supplied with instant noodles, sauces, chewing gum, milk-fat substitutes
• Up to 3.0 g/kg (0.3%): Ice cream, sugar-based confectionery decorations, sweetened yogurt, dressings, mayonnaise, mix powders for baked and Western confectionery, Western baked and fresh confectionery
• Up to 1.0 g/kg: Candies, soups, chocolate-based flour paste, frozen desserts
• Up to 0.50 g/kg: Pickled seaweed and vegetables, chocolate drinks
• Up to 0.080 g/kg: Unripened cheese; up to 0.030 g/kg: canned/bottled seaweed and vegetables
• Up to 0.020 g/kg (0.002%): All other foods
• Bread: The US FDA (21 CFR 172.836) allows Polysorbate 60 in yeast-leavened bakery products, but Japan left bread off the list because estimated intake from bread would be large, so bread falls under the 0.020 g/kg “other foods” limit

(Source: MHLW Food Additives Subcommittee report, August 2007, Japanese. Foods approved for special-use labeling as low-calorie foods are exempt.)

At designation, MHLW’s deliberately exaggerated estimate—assuming every listed food used the maximum level—was 289 mg/person/day for adults (about 58% of the ADI) and 157 mg/person/day for children (about 99%). The MHLW list of market-basket intake surveys contains no year covering polysorbates, so no measured intake data for Japan could be found.

Labeling differences: Group name “Emulsifier” in Japan vs. E-numbers and specific names in the EU and US

While Japan’s permitted food list and ADI are stricter, label transparency for shoppers is higher in the EU and the US:

• Japan (Food Labeling Standards): When used for emulsification, dispersion, foaming, or defoaming in food, Polysorbate 60 or 80 can be declared simply under the collective group name “乳化剤” (Emulsifier). Some products list the substance name instead, and cosmetics list it by name in the ingredient list.
• EU (Regulation 1169/2011): Must state the functional class Emulsifier followed by the specific name (Polysorbate 60) or E-number (E435).
• United States (21 CFR 101.4): Must declare the specific common name (Polysorbate 60 or Polysorbate 80) in the ingredient list.

Purity specifications for manufacturing impurities (1,4-dioxane and ethylene oxide)

Because polysorbates are synthesized using ethylene oxide, trace unreacted ethylene oxide or its dimerization byproduct 1,4-dioxane can remain if purification (vacuum stripping) is inadequate. Both Japan and the EU enforce strict legal purity specifications for food-grade polysorbates:

• Ethylene oxide: Maximum 1.0 µg/g (1 ppm) in Japan’s specifications and 0.2 mg/kg (0.2 ppm) in EU Regulation (EU) No 231/2012.
• 1,4-Dioxane: Maximum 10 µg/g (10 ppm) in Japan and 5 mg/kg (5 ppm) in the EU.

Even if a person consumed 100 mg of polysorbate daily containing Japan’s maximum of 10 µg/g 1,4-dioxane, daily exposure would be about 1 µg. Japan’s FSCJ estimated the lifetime cancer risk from these impurities to be below the one-in-a-million level generally regarded as negligible, while asking that levels be reduced as far as technically possible.

How to read the research on Polysorbate 80, gut microbiota, and intestinal mucus

The 2015 mouse study (Nature): experimental dose vs. actual human dietary intake

The claim that “Polysorbate 80 strips the gut mucus layer and triggers colitis and metabolic syndrome” stems primarily from a landmark mouse study by Chassaing et al. (2015, Nature).

When evaluating how this applies to everyday food, the critical factor is dose comparison:

1. The mouse dose: Mice were given drinking water containing 1.0% Polysorbate 80 or carboxymethylcellulose (CMC) for 12 weeks. In follow-up dose tests, 0.1% Polysorbate 80 still produced low-grade inflammation and increased adiposity (Chassaing 2015, PMC4910713).
2. Human equivalent dose: Based on mouse water intake (about 5 mL/day for a 30 g mouse), 1% delivers roughly 1,500 mg/kg bw/day—equivalent to about 100 g per day for a 70 kg human (more than 100 times Japan’s ADI); even 0.1% equals about 10 g. Mouse and human guts and microbiota differ, however, so this conversion alone cannot settle the risk to people.
3. Actual dietary intake: No public survey measuring actual polysorbate intake in Japan was found. Japan’s designation document cites industry-based per-capita consumption of 12–21 mg/day in the EU and 60–111 mg/day in the US.

Human clinical trials and large cohort studies (NutriNet-Santé)

Later studies using human gut bacteria, human volunteers, and large cohorts give a mixed picture:

• Ex vivo human microbiota model (Naimi et al., 2021, Microbiome, PMID 33752754): Human fecal microbiota maintained in a MiniBioReactor Array was exposed to 20 dietary emulsifiers. Polysorbate 80 and CMC caused lasting changes in microbiota composition and function, and many of the other emulsifiers had effects of similar extent; carrageenans and gums had especially strong effects, while some, such as lecithin, had no significant effect.
• Human feeding trial (FRESH study, Chassaing et al., 2022, Gastroenterology, PMID 34774538): In a double-blind trial, 16 healthy adults ate an emulsifier-free diet with or without 15 g/day of CMC for 11 days. The CMC group had slightly more abdominal discomfort, reduced microbiota diversity, and lower fecal short-chain fatty acids. This trial tested CMC, not Polysorbate 80, and was small and short.
• French NutriNet-Santé cohort (about 95,000–104,000 adults): Higher intakes of celluloses and mono-/diglycerides (E471/E472) were associated with cardiovascular disease (Sellem 2023, BMJ, PMID 37673430), and carrageenans, gums and others with type 2 diabetes (Salame 2024, Lancet Diabetes Endocrinol, PMID 38663950). These are associations from an observational study and do not show that emulsifiers are the cause.

In short, animal and lab experiments show that high concentrations of Polysorbate 80 can affect the gut mucus and microbiota, but whether dietary amounts do the same in people has not yet been tested. Shoppers who still prefer to avoid polysorbates can choose traditional ice cream made with only cream, milk, egg yolk, and sugar, or oil-and-vinegar dressings without emulsifiers.

Some home-delivery services narrow down what they sell under their own standards, beyond what the label tells you.

Frequently asked questions (FAQ)

What is the difference between Polysorbate 60 and Polysorbate 80?

Both are polyoxyethylene (20) sorbitan esters, but Polysorbate 60 (E435) is made with stearic acid (a solid saturated fatty acid) and is best at stabilizing emulsions in dressings, cake mixes, and whipped toppings. Polysorbate 80 (E433) is made with oleic acid (a liquid unsaturated fatty acid) and is preferred for ice cream meltdown control, beverage flavor solubilization, and softgel capsules.

How are Polysorbate 60 and 80 shown on Japanese food labels?

When used as a food emulsifier in Japan, manufacturers are allowed to list them under the collective group name “乳化剤” (Emulsifier) without naming the specific substance. Some products list the substance name instead, and cosmetics list them by name (ポリソルベート60 / ポリソルベート80).

Are Polysorbate 60 and 80 banned in Japan?

No. Japan approved Polysorbates 20, 60, 65, and 80 as designated food additives in 2008. Japan sets a stricter group ADI (10 mg/kg bw/day vs. 25 mg/kg bw/day in the EU and JECFA) and food-by-food maximum levels, from 25 g/kg in capsules and tablets down to 0.020 g/kg for other foods. Bread is not among the listed foods, so only the 0.020 g/kg “other foods” limit applies.

Sources and references

• Food Safety Commission of Japan (FSCJ) (2007). Risk Assessment Report: Polysorbates (Polysorbate 20, Polysorbate 60, Polysorbate 65 and Polysorbate 80).
• MHLW Pharmaceutical Affairs and Food Sanitation Council, Food Additives Subcommittee documents (July and August 2007, Japanese): https://www.mhlw.go.jp/shingi/2007/07/dl/s0704-7h.pdf / https://www.mhlw.go.jp/shingi/2007/08/dl/s0809-5c.pdf
• Ministry of Health, Labour and Welfare (MHLW) & Japan Food Chemical Research Foundation. Standards for Use of Food Additives & Japan’s Specifications and Standards for Food Additives.
• EFSA ANS Panel (2015). Scientific Opinion on the re-evaluation of polyoxyethylene sorbitan monolaurate (E 432), monooleate (E 433), monopalmitate (E 434), monostearate (E 435) and tristearate (E 436) as food additives. EFSA Journal, 13(7), 4152.
• Chassaing, B. et al. (2015). Dietary emulsifiers impact the mouse gut microbiota promoting colitis and metabolic syndrome. Nature, 519(7541), 92–96. (PMID 25731162)
• Naimi, S. et al. (2021). Direct impact of commonly used dietary emulsifiers on human gut microbiota. Microbiome, 9, 66. (PMID 33752754)
• Chassaing, B. et al. (2022). Randomized Controlled-Feeding Study of Dietary Emulsifier Carboxymethylcellulose Reveals Detrimental Impacts on the Gut Microbiota and Metabolome. Gastroenterology, 162(3), 743–756. (PMID 34774538)
• Sellem, L. et al. (2023). Food additive emulsifiers and risk of cardiovascular disease in the NutriNet-Santé cohort. BMJ, 382, e076058. (PMID 37673430) / Salame, C. et al. (2024). Lancet Diabetes Endocrinol, 12(5), 339–349. (PMID 38663950)