Polysorbate 60
Polysorbate 60

Polysorbate 60

Common names: Polyoxyethylene (20) sorbitan monostearate, PEG-20 sorbitan monostearate, Tween 60 (brand name), E435 (European food additive code).
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KIDSADVISORY SAFETY RATING
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Risky
Published by Jordana Tobelem, RD, LDN — Last Updated on Apr 21, 2025
Medically reviewed by Dr. William Lin, MD
Polysorbate 60, also known as polyoxyethylene (20) sorbitan monostearate, is a synthetic emulsifier widely utilized in the food industry to blend oil and water components, ensuring product stability and texture. It is commonly found in baked goods, such as cakes and breads, where it helps retain moisture and softness, as well as in products like ice cream and whipped toppings to maintain smoothness and prevent ingredient separation.[1]
While regulatory agencies have deemed polysorbate 60 safe for consumption, some studies suggest potential health concerns. Research indicates that certain emulsifiers, including polysorbates, may disrupt gut bacteria and trigger inflammation, potentially leading to metabolic syndrome and other health issues. However, these findings are primarily based on animal studies, and further research is necessary to fully understand the implications for human health.[2]

Safety Overview

Regulatory Bodies

FDA (US)
The U.S. Food and Drug Administration (FDA) includes polysorbate 60 in its database of substances added to food, indicating its recognized use as an emulsifier.[3]
Health Canada
Health Canada permits the use of polysorbate 60 as an emulsifying agent in various food products, with specific maximum levels outlined in the List of Permitted Emulsifying, Gelling, Stabilizing, or Thickening Agents.[4]
EFSA (Europe)
In its re-evaluation, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) assessed the safety of polysorbate 60 (E 435) and other related polysorbates as food additives.[5]
WHO (World Health Organization)
The World Health Organization, through the Joint FAO/WHO Expert Committee on Food Additives (JECFA), has evaluated polysorbate 60, assigning it an Acceptable Daily Intake (ADI) of 0-25 mg/kg body weight.[6]

FDA GRAS

U.S. Food and Drug Administration – Generally Recognized as Safe (GRAS)
Current Status
Classified
Polysorbate 60 is classified as GRAS (Generally Recognized As Safe) by regulatory authorities when used in accordance with good manufacturing practices. Regulatory agencies such as the U.S. Food and Drug Administration have approved its use in food products within defined usage limits.[3]

EWG Rating

Environmental Working Group
  • EWG Rating: Polysorbate 60 is rated with a low hazard score by The Environmental Working Group (EWG), indicating minimal overall health concerns.[7]
  • Level of Caution: Despite the low hazard rating, the EWG notes that polysorbate 60 may contain impurities such as ethylene oxide and 1,4-dioxane, which are associated with potential health risks.[8]
  • Possible Health Risks: These impurities have been linked to cancer and reproductive toxicity; however, the presence of such contaminants depends on the manufacturing process, and high-purity grades of polysorbate 60 may not pose these risks.[8]
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More about Polysorbate 60

  • Baked Goods: Cakes, Muffins, Frostings
  • Dairy and Frozen Desserts: Ice Cream, Whipped Toppings, Non-Dairy Creamers
  • Processed Foods: Salad Dressings, Shortenings, Instant Puddings

Historical Use
Approved as a food additive in the early 1960s, polysorbate 60 has been employed to improve texture and shelf life in products like baked goods and frozen desserts.[9]
Current Exposure
Consumers frequently encounter polysorbate 60 in various processed foods, including baked goods, frozen desserts, and imitation dairy products, where it functions to maintain product consistency and prevent ingredient separation.[2]

Gut Microbiota Disruption
Studies have indicated that certain emulsifiers, including polysorbates like Polysorbate 60, may disrupt gut bacteria, potentially leading to inflammation and metabolic syndrome.[2]
Intestinal Barrier Function
Research has shown that polysorbates can impair the function of the intestinal mucosal barrier, potentially increasing bacterial translocation and affecting gut health.[10]
Reproductive and Developmental Toxicity
High-dose animal studies have reported that polysorbate 60 may affect reproduction and lactation, though these effects were observed at doses significantly higher than typical human exposure levels.[11]
Carcinogenicity and Genotoxicity
Extensive studies have demonstrated that polysorbates, including polysorbate 60, are neither carcinogenic nor genotoxic; however, they may enhance the activity of known chemical carcinogens without being carcinogenic themselves.[12]

Toxicological Studies
Acute and long-term studies indicate that polysorbate 60 exhibits low toxicity in animals, with high oral LD50 values and minimal adverse effects observed at typical consumption levels.[13]
Long-Term Safety
Chronic exposure studies have not demonstrated significant toxic effects, supporting the safety of polysorbate 60 when used within established guidelines.[5]

High-Risk Groups
Individuals with pre-existing gastrointestinal conditions, such as inflammatory bowel disease (IBD), may be more susceptible to adverse effects from emulsifiers like Polysorbate 60, which can disrupt the gut microbiota and exacerbate inflammation.[14]
Health Impacts
Research indicates that in pediatric patients, excessive amounts of polysorbates in biotherapeutics have been linked to hypersensitivity and other toxicity-related effects.[15]

Recommended Intake
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has set an ADI for polysorbate 60 at 0–25 mg/kg body weight, indicating the amount considered safe for daily consumption over a lifetime without appreciable health risk.[6]

General Safety Level
While polysorbate 60 is generally considered safe for use, there have been reports of immediate hypersensitivity reactions, including anaphylaxis, linked to polysorbates in some individuals.[16]
Sensitive Individuals
Patients with known allergies to polyethylene glycols (PEGs) may exhibit cross-reactivity to polysorbates, potentially leading to allergic reactions upon exposure.[17]

FAQ

What is polysorbate 60?

Polysorbate 60 is a synthetic emulsifier used in processed foods and cosmetics to help mix oil and water.

Is polysorbate 60 safe to eat?

Yes, polysorbate 60 is generally recognized as safe (GRAS) by the FDA when used within approved limits in food products.

Is polysorbate 60 toxic?

Polysorbate 60 is considered non-toxic in small amounts used in food and cosmetics, though excessive intake may cause mild side effects.

Is polysorbate 60 bad for you?

Polysorbate 60 is safe for most people in normal amounts, but some prefer to avoid it due to concerns over synthetic additives.

Is polysorbate 60 safe for skin?

Yes, polysorbate 60 is commonly used in skincare products and is generally considered safe for topical use.

References

  1. Matangi Industries (n.d.). An Introduction to Polysorbate 60: Properties, Functionality, and Applications. Available at: https://www.matangiindustries.com/blog/introduction-polysorbate-60-properties-functionality-applications ↩︎
  2. Center for Science in the Public Interest. (2022). 'Polysorbate 60, 65, and 80'. Available at: https://www.cspinet.org/article/polysorbate-60-65-and-80 ↩︎
  3. Food and Drug Administration. (n.d.). Code of Federal Regulations Title 21 - Polysorbate 60. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-172/subpart-I/section-172.836 ↩︎
  4. Health Canada. (2023). List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents (Lists of Permitted Food Additives). Available at: https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/4-emulsifying-gelling-stabilizing-thickening-agents.html ↩︎
  5. European Food Safety Authority (EFSA) (2015) 'Scientific Opinion on the re-evaluation of polyoxyethylene sorbitan monoesters (polysorbates) (E 432-436) as food additives', EFSA Journal, 13(12):4152. Available at: https://www.efsa.europa.eu/en/efsajournal/pub/4152 ↩︎
  6. World Health Organization. (2014). Polysorbate 60. Available at: https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/397 ↩︎
  7. Environmental Working Group (EWG) (n.d.) 'Polysorbate 60', EWG's Skin Deep Cosmetics Database. Available at: https://www.ewg.org/skindeep/ingredients/705139-POLYSORBATE60/ ↩︎
  8. Environmental Working Group (EWG) (n.d.) 'Ingredient: Polysorbate 60', EWG's Food Scores. Available at: https://www.ewg.org/foodscores/ingredients/7511-PolyoxyethyleneSorbitanMonostearate/ ↩︎
  9. Kaur G., Mehta S.K. (2017). Developments of Polysorbate (Tween) based microemulsions: Preclinical drug delivery, toxicity and antimicrobial applications. International Journal of Pharmaceutics, 529(1-2):134-160. Available at: https://www.sciencedirect.com/science/article/pii/S0378517317305677 ↩︎
  10. Roberts, C.L., Keita, A.V., Duncan, S.H., O'Kennedy, N., Soderholm, J.D., Rhodes, J.M., and Campbell, B.J. (2010). 'Translocation of Crohn's disease Escherichia coli across M-cells: contrasting effects of soluble plant fibres and emulsifiers', Gut, 59(10), pp. 1331-1339. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2943940/ ↩︎
  11. Oser, B.L. and Oser, M. (1956). 'Nutritional studies on rats of diets containing high levels of partial ester emulsifiers. II. Reproduction and lactation', The Journal of Nutrition, 60(4), pp. 489-505. Available at: https://academic.oup.com/jn/article-abstract/60/4/489/4728953 ↩︎
  12. Cosmetic Ingredient Review. (2015). Safety Assessment of Polysorbates as Used in Cosmetics. Available at: https://www.cir-safety.org/sites/default/files/PSorba_062015_FR_0.pdf ↩︎
  13. Final Report on the Safety Assessment of Polysorbates 20, 21, 40, 60, 61, 65, 80, 81, 85, and Related Compounds. (1984). Journal of the American College of Toxicology, 3(5), pp. 1-82. Available at: https://journals.sagepub.com/doi/10.3109/10915818409021272 ↩︎
  14. Partridge D., et al. (2019). 'Food additives: Assessing the impact of exposure to permitted emulsifiers on intestinal and metabolic healthu2014introducing the FADiets study', Nutrition Bulletin, 44(4):329-349. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6899614/ ↩︎
  15. Kriegel C., et al. (2019). 'Pediatric Safety of Polysorbates in Drug Formulations'. Children, 7(1):1. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7022221/ ↩︎
  16. Stone, C.A. Jr., Liu, Y., Relling, M.V., Krantz, M.S., Pratt, A.L., Abreo, A., Hemler, J.A., Phillips, E.J. (2018) 'Immediate Hypersensitivity to Polyethylene Glycols and Polysorbates: More Common Than We Have Recognized', Journal of Allergy and Clinical Immunology: In Practice, 7(5), pp. 1533-1540. Available at: https://pubmed.ncbi.nlm.nih.gov/30557713/ ↩︎
  17. Mortz C.G., et al. (2021). 'Allergy to polyethylene glycol and polysorbates in a patient cohort: Diagnostic work-up and decision-making in the COVID-19 vaccination era', Clinical and Translational Allergy, 12(1), e12111. Available at: https://pubmed.ncbi.nlm.nih.gov/35028130/ ↩︎

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