Sorbitan Monostearate
Sorbitan Monostearate

Sorbitan Monostearate

Common names: Span 60 (brand name)Glycomul S (brand name)E491 (European food additive code).
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KIDSADVISORY SAFETY RATING
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Safe
Published by Jordana Tobelem, RD, LDN — Last Updated on May 6, 2025
Medically reviewed by Dr. William Lin, MD
Sorbitan monostearate, commonly known as Span 60, is a non-ionic surfactant extensively utilized in the food industry for its emulsifying properties. It facilitates the stable blending of oil and water components, thereby enhancing the texture and shelf life of various products, including baked goods, desserts, and coffee whiteners.[1] Additionally, sorbitan monostearate serves as a dispersing and wetting agent, contributing to the uniform consistency of numerous food items.[1]
Regarding safety, toxicological evaluations have not indicated significant adverse effects at this intake level.[2] Nonetheless, it is advisable for consumers to adhere to recommended guidelines to ensure the safe consumption of food additives.[2]

Safety Overview

Regulatory Bodies

FDA (US)
Sorbitan monostearate is approved by the FDA as a direct food additive and is listed under 21 CFR § 172.842, where its use is permitted in specific food categories as an emulsifier or stabilizer.[3]
Health Canada
Sorbitan monostearate is included in the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents, allowing its use in foods like toppings and candy coatings at regulated maximum levels.[4]
EFSA (Europe)
EFSA has re-evaluated sorbitan monostearate (E 491) and established an Acceptable Daily Intake (ADI) of 10 mg/kg body weight/day, concluding it does not pose a safety concern at current use levels.[2]
WHO (World Health Organization)
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has assessed sorbitan monostearate and supports its safe use in food when consumed within the acceptable intake limits.[5]

FDA GRAS

U.S. Food and Drug Administration – Generally Recognized as Safe (GRAS)
Current Status
Not Classified
Sorbitan monostearate is not classified as GRAS (Generally Recognized As Safe) by the U.S. Food and Drug Administration (FDA). Instead, it is regulated as a food additive under 21 CFR § 172.842, meaning its use is permitted in specific food categories based on safety evaluations and intended technological functions. Its inclusion as a food additive requires premarket approval, distinguishing it from substances that achieve GRAS status through general scientific consensus.[3]

EWG Rating

Environmental Working Group
  • EWG Rating: Sorbitan stearate has a low hazard rating, indicating minimal safety concerns.​[6]
  • Level of Caution: The EWG's Skin Deep® database does not list sorbitan stearate on its Restricted or Unacceptable Lists, suggesting a low level of caution is necessary.[6]
  • Possible Health Risks: There are low concerns regarding cancer, allergies, immunotoxicity, and developmental or reproductive toxicity associated with sorbitan stearate.[6]
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More about Sorbitan Monostearate

  • Baked Goods: Bread, pastries, cake mixes
  • Confectionery: Chocolate coatings, chewing gum, candy
  • Dairy and Imitation Products: Coffee creamers, whipped toppings, non-dairy ice cream

Historical Use
Sorbitan monostearate, also known as Span 60, has been used for decades in the food industry as a non-ionic surfactant and emulsifier, primarily to stabilize oil-in-water emulsions in products like baked goods and dairy alternatives.[7]
Current Exposure
Today, consumers are routinely exposed to sorbitan monostearate through processed foods such as margarine, coffee creamers, confectionery coatings, and desserts, where it enhances texture and extends shelf life.[7]

Gut Microbiota Alterations
Sorbitan monostearate, along with other emulsifiers, has been shown in animal studies to alter gut microbiota composition, potentially contributing to microbial imbalance and low-grade inflammation.[8]
Intestinal Inflammation
Experimental models suggest that chronic intake of sorbitan-based emulsifiers may increase intestinal permeability and inflammation, potentially contributing to metabolic syndrome.[8]
Tumor Promotion Potential
While sorbitan monostearate has not been found carcinogenic, related sorbitan esters like sorbitan laurate demonstrated weak tumor-promoting activity in murine models under specific experimental conditions.[9]
Metabolic Safety
Long-term toxicity studies in mice found no significant adverse effects on body weight or mortality with high dietary doses of sorbitan monostearate, suggesting a low metabolic risk at tested levels.[10]

Toxicological Studies
In vitro assessments have demonstrated that sorbitan monostearate exhibits low cytotoxicity toward normal human fibroblasts, with higher LC₅₀ values compared to other surfactants, indicating minimal adverse effects at typical usage concentrations.[11]
Long-Term Safety
While specific long-term studies on sorbitan monostearate are limited, its structural similarity to other non-ionic surfactants suggests a favorable safety profile when used within recommended guidelines.[11]

High-Risk Groups
Individuals with pre-existing gastrointestinal conditions such as inflammatory bowel disease (IBD) may be more susceptible to the adverse effects of emulsifiers like sorbitan monostearate, which have been shown to impact gut barrier function and microbiota composition.[12]
Health Impacts
Research suggests that dietary emulsifiers can promote low-grade inflammation and metabolic syndrome in vulnerable populations, although direct causal links with sorbitan monostearate specifically are still under investigation.[12]

Recommended Intake
The European Food Safety Authority (EFSA) has established an Acceptable Daily Intake (ADI) for sorbitan monostearate of 10 mg/kg body weight per day, expressed as sorbitan, based on toxicological evaluations indicating no observed adverse effects at this level.[2]

Recommended Intake
The European Food Safety Authority (EFSA) has established an Acceptable Daily Intake (ADI) for sorbitan monostearate of 10 mg/kg body weight per day, expressed as sorbitan, based on toxicological evaluations indicating no observed adverse effects at this level.[2]

FAQ

What is sorbitan monostearate?

Sorbitan monostearate is an emulsifier used to blend ingredients in food and cosmetics.

Is sorbitan monostearate safe?

Yes, sorbitan monostearate is generally recognized as safe when used in approved amounts.

Sorbitan monostearate bad for you?

Sorbitan monostearate is not considered harmful when consumed in typical amounts.

Is sorbitan monostearate vegan?

Sorbitan monostearate can be vegan if sourced from plant-based ingredients.

What is sorbitan monostearate made from?

Sorbitan monostearate is made from sorbitol and stearic acid, which can be plant- or animal-derived.

References

  1. Stauffer, C.E. 2007. 'Applications of Emulsifiers in Baked Foods' in Emulsifiers in Food Technology. Blackwell Publishing Ltd pp. 117-138. ↩︎
  2. EFSA Panel on Food Additives and Nutrient Sources added to Food ANS. 2017. 'Re-evaluation of sorbitan monostearate E 491 sorbitan tristearate E 492 sorbitan monolaurate E 493 sorbitan monooleate E 494 and sorbitan monopalmitate E 495 when used as food additives' EFSA Journal 15(5) p. e04788. Available at: https://www.efsa.europa.eu/en/efsajournal/pub/4788 ↩︎
  3. U.S. Food and Drug Administration. n.d. Code of Federal Regulations Title 21 - Sorbitan Monostearate. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-172/subpart-I/section-172.842 ↩︎
  4. Health Canada. 2024. 'List of Permitted Emulsifying Gelling Stabilizing or Thickening Agents List of Permitted Emulsifying Agents'. 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. World Health Organization. 2020. Sorbitan Monostearate. Available at: https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/2271 ↩︎
  6. Environmental Working Group n.d. 'Sorbitan Stearate' EWG's Skin Deep. Available at: https://www.ewg.org/skindeep/ingredients/706235-SORBITAN_STEARATE/ ↩︎
  7. National Center for Biotechnology Information, 2024. 'Sorbitan Monostearate', PubChem, U.S. National Library of Medicine. Available at: https://pubchem.ncbi.nlm.nih.gov/compound/Sorbitan-Monostearate ↩︎
  8. Naimi S., et al., 2021. 'Direct impact of commonly used dietary emulsifiers on human gut microbiota', Microbiome, 9(1), p. 66. Available at: https://microbiomejournal.biomedcentral.com/articles/10.1186/s40168-020-00996-6 ↩︎
  9. Cosmetic Ingredient Review, 1985. 'Final Report on the Safety Assessment of Sorbitan Stearate, Sorbitan Laurate, Sorbitan Sesquioleate, Sorbitan Oleate, Sorbitan Tristearate, Sorbitan Palmitate, and Sorbitan Trioleate', International Journal of Toxicology, 4(3), pp. 45-53. Available at: https://journals.sagepub.com/doi/10.3109/10915818509078670 ↩︎
  10. Hendy R.J., et al., 1978. 'Long-term toxicity study of sorbitan monostearate (Span 60) in mice', Food and Cosmetics Toxicology, 16(6), pp. 527-534. Available at: https://www.sciencedirect.com/science/article/abs/pii/S0015626478802193 ↩︎
  11. Arechabala B., Coiffard C., Rivalland P., Coiffard L.J., and de Roeck-Holtzhauer Y., 1999. Comparison of cytotoxicity of various surfactants tested on normal human fibroblast cultures using the neutral red test, MTT assay and LDH release. Journal of Applied Toxicology, 19(3), pp. 163-165. Available at: https://pubmed.ncbi.nlm.nih.gov/10362266/ ↩︎
  12. Besedin D., et al., 2024. 'Food additives and their implication in inflammatory bowel disease and metabolic syndrome', Clinical Nutrition ESPEN, 64, pp. 483-495. Available at: https://www.sciencedirect.com/science/article/pii/S2405457724015122 ↩︎

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