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SORBITAN MONOSTEARATE

1,4- anhydro-6-O-stearoyl-D-altritol;1,4-anhydro-D-glucitol 6-octadecanoate;1,4-anhydro-D-glucitol, 6-octadecanoate;1,4-anhydro-dextro-glucitol 6-octadecanoate; anhydrosorbitol monostearate;anhydrosorbitol stearate;arlacel 2121; arlacel 60;arlacel Lc;armotan MS; crill 3; crill K 3; (2-((2R,3S,4R)-3,4-dihydroxyoxolan-2-yl)-2-hydroxy-ethyl) octadecanoate; [2-[(2R,3S,4R)-3,4-dihydroxyoxolan-2-yl]-2-hydroxyethyl] octadecanoate; drewsorb 60; durtan 60; emasol S-10V; emsorb 2505; emultex SMS; D-glucitol, 1,4-anhydro-, 6-octadecanoate; glucitol, anhydro-, monooctadecanoate; glycomul S; glycomul S KFG;hodag SMS; sorbitan monooctadecanoate; sorbitan monostearate; sorbitan monostearate FCC; sorbitan, esters, monooctadecanoate; sorbitan, monooctadecanoate; sorbitan, monostearate; sorbon S 60; sorgen 50; span 55;span 60; stearic acid, monoester with sorbitan
Wax-like creamy white powder.Sorbitan monostearate is an ester of sorbitol and stearic acid

CAS number: 1338‐41‐6
Chemical formula :C24H46O6
Molecular weight: 430.62
synonyms: 1,4- anhydro-6-O-stearoyl-D-altritol;1,4-anhydro-D-glucitol 6-octadecanoate;1,4-anhydro-D-glucitol, 6-octadecanoate;1,4-anhydro-dextro-glucitol 6-octadecanoate; anhydrosorbitol monostearate;anhydrosorbitol stearate;arlacel 2121; arlacel 60;arlacel Lc;armotan MS; crill 3; crill K 3;
(2-((2R,3S,4R)-3,4-dihydroxyoxolan-2-yl)-2-hydroxy-ethyl) octadecanoate; [2-[(2R,3S,4R)-3,4-dihydroxyoxolan-2-yl]-2-hydroxyethyl] octadecanoate; drewsorb 60; durtan 60; emasol S-10V; emsorb 2505; emultex SMS; D-glucitol, 1,4-anhydro-, 6-octadecanoate; glucitol, anhydro-, monooctadecanoate; glycomul S; glycomul S KFG;hodag SMS
sorbitan monooctadecanoate; sorbitan monostearate; sorbitan monostearate FCC; sorbitan, esters, monooctadecanoate; sorbitan, monooctadecanoate; sorbitan, monostearate; sorbon S 60; sorgen 50; span 55;span 60; stearic acid, monoester with sorbitan
Wax-like creamy white powder.
Sorbitan monostearate is an ester of sorbitol and stearic acid.
The sorbitol end of the molecule is very soluble in water. The stearic acid end is soluble in fats. These properties make the molecule very good at making emulsions of oil and water.
It is sometimes known as a synthetic wax.
Appearance :Powder
Physical State :Solid
Solubility :Soluble in ethanol (50 mg/ml), isopropanol, mineral oil, and vegetable oil. Insoluble in water.
Storage :Store at room temperature
Melting Point :53-57° C
Boiling Point :579.01° C at 760 mmHg (Predicted)
Density :1.00 g/cm3 at 25° C
Refractive Index :n20D 1.50 (Predicted)
ıupac name : [2-[(2R,3R,4S)-3,4-dihydroxyoxolan-2-yl]-2-hydroxyethyl] octadecanoate
Uses. Sorbitan monostearate is primarily used as an emulsifier to keep water and oils mixed. Sorbitan monostearate is used in the manufacture of food and healthcare products and is a non-ionic surfactant with emulsifying, dispersing, and wetting properties.
Oil-in-water emulsifier. Can be used to control viscosity. Improves water resistance of formulations and is compatible with organic and inorganic sun filters.
Outstanding O/W emulsifier with excellent spreading properties for a smooth and light skin feel. Improves water resistance of formulations and is compatible with organic and inorganic sun filters. Stabilises emulsions of every type of oily material in water, irrespective of its required HLB. Used in creams and milks.Sorbitan stearate is a surfactant composed of sweetener sorbitol and stearic acid, a naturally occurring fatty acid.
Sorbitan monostearate is an emulsifier. This material coats yeast cells and protects the cells from damage by oxygen and assists in the rehydration of the yeast. Sorbitan monostearate is a mixture of partial stearic and palmitic acid esters of sorbitol and its mono- and dianhydrides.
Sorbitan esters (also known as Spans) are nonionic surfactants that are used as emulsifying agents in the preparation of emulsions, creams, and ointments for pharmaceutical and cosmetic use.
Sorbitan monostearate is an ester of sorbitol, also called sorbitan. The substance made from sorbitol and animal or vegetable fats serves as an emulsifier.
Sorbitan Monostearate, FCC is used as an emulsifier to keep oils and water mixed. The FCC grade meets the requirements of the Food Chemical Codex indicates and is suitable for all food, beverage and nutritional supplement applications. Spectrum Chemical offers over 300 Food grade chemical ingredients packaged in laboratory size bottles to production drum quantities and are manufactured, packaged and stored under current Good Manufacturing Practices (cGMP) per 21CFR part 211 in FDA registered and inspected facilities.
Sorbitan Monostearate, NF is used as an emulsifier and nonionic surfactant in pharmaceutical formulations. All Spectrum Chemical NF products are manufactured, packaged and stored under current Good Manufacturing Practices (cGMP) per 21CFR part 211 in FDA registered and inspected facilities.
Sorbitan Monostearate, an ester of sorbitan and stearic acid, is referred to as a synthetic wax that is used as an emulsifier to keep oils and water mixed. Ungraded products supplied by Spectrum are indicative of a grade suitable for general industrial use or research purposes and typically are not suitable for human consumption or therapeutic use.
Sorbitan esters have widely application areas.  Within food industry, they have various functions such as emulsification, aerating, wetting, texture control, gloss control, crystallization control and so on. Moreover, they are used as dough strengthener, defoamer, dispersant in foodstuffs. By using appropriate sorbitan esters, the quality of food products can be improved and the shelf life can be increased.
Shelf Life: 12 months in unopened original packaging under the storage conditions (from date of production).
Storage: Avoid sunlight, rain. Store in unbroken packaging at the cool, dry and well-ventilated place. The storage temperature should below 28 ℃ to minimise the agglomeration (the natural tendency).
Transportation: Keep safety of the packaging in the transportation.
Sorbitol
Sorbitol is a sugar alcohol with a sweet taste and can be used as a sugar replacement and humectant in chewing gum, mints, cookies, bread, and cakes. It is commonly made from starches of corn and potato and follow the hydrogenation process.
Stearic Acid
It is a common saturated fatty acid found in nature both in animal fats/oils and vegetable oils. It can also be used in the production of soaps, cosmetics, and detergents.
The commercial food grade stearic acid may contain 48.7–50.0% palmitic acid.
As sorbitol has six hydroxyl groups and that’s why sorbitan monostearate may also contain palmitic acid esters of sorbitol, sorbitan and isosorbide besides sorbitol, sorbitan, and isosorbide esters of stearic acid.
Appearance, A white to yellow waxy bead or flake with a slight characteristic smell.
Hydrophilic-Lipophilic Balance (HLB): With the HLB value 4.7, meaning it is lipophilic and soluble in oil instead of water. It will form W/O (water-in-oil) type emulsion, and it is a strong emulsifying dispersion and has a wetting effect.
Solubility:Not soluble in cold water, but can be dispersed in hot water.
Soluble in ethanol, mineral oil, and vegetable oil.
Other name: Sorbitan esters of fatty acids; Sorbitan ester; Monostearate sorbitan; Span 60
Sorbitan monostearate is used as an emulsifier, commonly together with polysorbates to keep water and oil mixed in many food products.
It is commonly used in instant dry yeast, fat and oil emulsions, desserts, food supplements, cake, spread, margarine, coffee whiteners, and so on.
The following are its main uses and functions in food:
Dry yeast: maintain the moisture, increase the shelf life of dry yeast, and help the rehydration of yeast cells before blended with other dough ingredients.
Ice cream: promote emulsifying of dairy fat, prevent the formation of ice crystals, and improve the mouthfeel.
Margarine: improve emulsion stability and reduce sandiness.
Whipping cream: improve foam volume and contribute to a nice and stiff foam.
Bread & Cake: increase the loaf volume and improve the texture of bread and cake.
Confections and chocolate: stabilize the emulsion of oils and fats.
Meanwhile, it can be condensed with ethylene oxide to synthesize polyoxyethylene (20) sorbitan monostearate (polysorbate 60), which is also a food emulsifier.
Is Sorbitan monostearate Safe to Eat?
Yes, it almost has no side effects and the safety has been approved by the U.S. Food and Drug Administration (FDA) and European Food Safety Authority (EFSA), as well as the Joint FAO/WHO Expert Committee on Food Additives (JECFA). 
FDA
Sorbitan monostearate may be safely used as an emulsifier in the following food, sometimes together with polysorbate (60, 65, 80) (1):
Whipped edible oil topping
Cakes and cake mixes, icings and fillings
Nonstandardized confectionery coatings and standardized cacao products
Edible vegetable fat-water emulsions in beverage coffee
It can also be used as a rehydration aid in the production of active dry yeast with the maximum usage 1%. It may also be safely used in mineral premixes and dietary supplements for animal feeds. (2)
EFSA
Sorbitan monostearate (E491) is listed in Commission Regulation (EU) No 231/2012 as an authorised food additive and categorized in “ additives other than colours and sweeteners” (3).
Safety re-evaluation in 2017
EFSA changed the ADI of 25 mg/kg bw per day set by The Scientific Committee on Food (SCF) in 1974 and established a group ADI of 10 mg/kg bw per day for sorbitan esters (expressed as sorbitan) , and the ADI of sorbitan monostearate is 26 mg/kg bw per day. (4)
Approved uses
Its application is listed together with other sorbitan esters: sorbitan tristearate (E492), sorbitan monolaurate (E493), sorbitan monooleate (E494) and sorbitan monopalmitate (E495) and with the maximum use levels “5000-10000 mg/kg” while the use level in dry yeast and yeast for baking is “quantum satis”.
The following food may contain it (5):
Flavoured fermented milk products  
Beverage whiteners
Fat and oil emulsions
sugar confectionery
Chewing gum 
Decorations, coatings and fillings   
Fine bakery wares
Emulsified sauces
Desserts
UK Food Standards Agency
Categorized in “Emulsifiers, stabilisers, thickeners and gelling agents” (6)Food Standards Australia New Zealand
It is an approved ingredient in Australia and New Zealand with the code number 491. (7)
JECFA
Function Class: food additives, emulsifier. (8)
Acceptable daily intake: ADI “0-25 mg/kg bw” set in 1973. (9)
Frequently asked questions
Is SMS Halal?
Yes, it is is a synthetic ester that would be halal complying with the Muslim policy if the fatty acid stearic acid derived from vegetable oils instead of animal origins.
Is SMS Vegan?
Yes, it is corn derivative and vegan if the raw material stearic acid from vegetable oils as the manufacturing process without the use of animal matter or products derived from animal origin.
However, some manufacturers may use stearic acid from animal sources. Therefore, vegetarians should avoid it.
Conclusion
Now you may have a knowledge of the emulsifier – Sorbitan monostearate (E491), from the following aspects:
What kinds of food labels have you found this ingredient in? Or if you have any questions or remarks about this additive, feel free to let me know in the comments.
Sorbitan monostearate (Span 60) is a non-ionic surfactant with emulsifying, dispersing, and wetting properties used as a food additive, additive in mixtures for drug use and in skin care products. It is approved for use by FDA in quantities not exceeding the amount reasonably required to accomplish the intended effect. 0.5-5% of Liposorb® S (sorbitan monostearate) is used for oil-in-water emulsions in combination with a high hydrophilic-lipophilic balance emulsifier to produce smooth lotions and creams in skin and hair care, make-up bases, and mild cleaning products. Sorbitan monostearate based organogels and vesicles (niosomes) formulated to enhance the oral bioavailability were characterized for use as a drug delivery vehicle. In combination with other non-ionic surfactants sorbitan monostearate is patented for use in vaccine formulations as a saponin-containing adjuvant for oil-in-water injectable emulsions. It is fatty acid ester of sorbitan (a sorbitol derivative) and stearic acid sometimes called synthetic wax. Has low hydrophilic-lipophilic balance. Non-toxic.
Sorbitan monostearate is an ester of sorbitan -a sorbitol derivative- and stearic acid and is sometimes referred to as a synthetic wax. It is primarily used as an emulsifier to keep water and oils mixed. Sorbitan monostearate is used in the manufacture of food and healthcare products and is a non-ionic surfactant with emulsifying, dispersing, and wetting properties. It is also employed to create synthetic fibers, metal machining fluid, and brighteners in the leather industry, and as an emulsifier in coatings, pesticides, and various applications in the plastics, food and cosmetics industries. Sorbitans are also known as "Spans". Sorbitan monostearate has been approved by the European Union for use as a food additive -emulsifier- -E number: E 491
The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety 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. The Scientific Committee on Food (SCF) allocated an acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day for E 491, E 492 and E 495 singly or in combination; and a separate group ADI for E 493 and E 494 singly or in combination of 5 mg/kg bw per day calculated as sorbitan monolaurate in 1974. The Panel noted that after oral administration sorbitan monostearate can be either hydrolysed to its fatty acid moiety and the corresponding anhydrides of sorbitol and excreted via urine or exhaled as CO2 or excreted intact in the faeces. The Panel considered that sorbitan esters did not raise concern for genotoxicity. Based on the no observed adverse effect level (NOAEL) of 2,600 mg sorbitan monostearate/kg bw per day, taking into account the ratio between the molecular weight of sorbitan monostearate (430.62 g/mol) and sorbitan (164.16 g/mol), and applying an uncertainty factor of 100, the Panel derived a group ADI of 10 mg/kg bw per day expressed as sorbitan for sorbitan esters (E 491–495) singly or in combination. This group ADI of 10 mg sorbitan/kg bw per day is equivalent to 26 mg sorbitan monostearate/kg bw per day. The Panel concluded that the exposure at the mean and the 95th percentile level, using non‐brand‐loyal scenario, did not exceed the ADI in any of the population groups. The Panel on the request for an amendment of specifications regarding the removal of ‘congealing range’ concluded that it could be eventually replaced by another identification parameter such as melting point.
Following a request from the European Commission, the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to re‐evaluate the safety 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 a food additive.
The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations and reviews, additional literature that has become available since then and the data available following a public call for data. The Panel noted that not all original studies on which previous evaluations were based were available for re‐evaluation by the Panel.
Sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) are authorised as food additives in the European Union (EU) in accordance with Annex II and Annex III to Regulation (EC) No 1333/2008 on food additives and specific purity criteria have been defined in the Commission Regulation (EU) No 231/2012.
Toxicological data for sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) were evaluated by the Scientific Committee on Food (SCF) in 1978. The Committee established an acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day for sorbitan monostearate (E 491), sorbitan tristearate (E 492) and sorbitan monopalmitate (E 495) singly or in combination. The SCF also established a separate group ADI for sorbitan monolaurate (E 493) and sorbitan monooleate (E 494) singly or in combination of 5 mg/kg bw per day calculated as sorbitan monolaurate. The latest evaluation of sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) by Joint FAO/WHO Expert Committee on Food Additives (JECFA) was done in 1982 where an ADI of 0–25 mg/kg bw per day were confirmed.
There were indications from toxicokinetic studies in rats with radiolabelled sorbitan monostearate that this sorbitan ester could be either hydrolysed to its fatty acid moiety and the corresponding anhydrides of sorbitol or excreted intact in the faeces. After absorption, sorbitan and isosorbide moieties, sorbitol or metabolites thereof are excreted via urine or exhaled as carbon dioxide. The fatty acid moiety enters the endogenous metabolism of fatty acids. The Panel considered that in case intact sorbitan monostearate be absorbed it would be hydrolysed presystemically. No absorption, distribution, metabolism and excretion (ADME) data were available for E 492, E 493, E 494 and E 495. However, the Panel considered that these sorbitan esters will follow the same metabolic and excretion pathways as sorbitan monostearate (E 491).
The Panel considered the acute toxicity of sorbitan esters (E 491, E 492, E 493, E 494 and E 495) very low.
The Panel considered that in the subchronic toxicity studies on sorbitan monolaurate the effects on the weight of the kidneys, which in female rats were associated with histopathological tubular changes, could be attributed to the excretion of large quantities of the sorbitan moiety in the urine. Subchronic toxicity studies were not available or too limited for sorbitan oleate, sorbitan monostearate, sorbitan tristearate or sorbitan monopalmitate.
The Panel noted that no experimental in vitro and in vivo genotoxicity data were available for sorbitan tristearate, sorbitan monooleate, sorbitan monopalmitate and limited studies with different shortcomings were available for sodium monostearate. However, the available data for sorbitan monolaurate and the in silico evaluation were sufficient to consider that sorbitan esters – E 491, E 492, E 493, E 494 and E 495 – did not raise concern with respect to genotoxicity.
The Panel considered the validity of the long‐term studies performed in rats insufficient to be used for hazard characterisation. In an adequate long‐term study in mice, the no observed adverse effect level (NOAEL) was 2% in the diet (equal to 2,600 mg sorbitan monostearate/kg bw per day). Furthermore, there was no indication of carcinogenicity in long‐term studies both in mice and rats.
The Panel considered that the available reproductive and developmental toxicity studies with sorbitan monostearate have limitations but no adverse effects were reported.
The Panel considered that the available database on sorbitan monostearate (E 491) was sufficient to allocate an ADI based on the NOAEL of 2,600 mg sorbitan monostearate/kg bw per day in male mice identified in a long‐term toxicity study.
The Panel noted that the available biological and toxicological data for sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) were limited but considered that a read across with data on sorbitan monostearate can be performed. Overall, the Panel considered that there was no need for a separate ADI for sorbitan monolaurate (E 493) and sorbitan monooleate (E 494).
Based on the NOAEL of 2,600 mg sorbitan monostearate/kg bw per day identified in a long‐term toxicity study in mice, taking into account the ratio between the molecular weight of sorbitan monostearate (430.62 g/mol) and sorbitan (164.16 g/mol), and applying an uncertainty factor of 100, the Panel derived a group ADI of 10 mg/kg bw per day, expressed as sorbitan, for sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) singly or in combination. This group ADI of 10 mg sorbitan/kg bw per day is, for example, equivalent to 26 mg sorbitan monostearate/kg bw per day.
In the absence of any information on the identity(ies) of the sorbitan ester(s) on which the maximum permitted levels (MPLs) and the reported use levels were expressed, the Panel calculated the exposure to sorbitan esters (E 491–495) by assuming that they were expressed as sorbitan monostearate.
The refined exposure estimates were based on 10 out of 19 food categories in which sorbitan esters (E 491–495) are authorised. Based on the assumption that the food additives are not used in the food categories for which no usage data were provided by food industry, the refined scenario would in general result in an overestimation of exposure according to Annex II of Regulation (EC) No 1333/2008. The Panel noted that no use levels were reported for eight food categories, while information from the Mintel's Global New Products Database (GNPD) showed that, for five out of these eight food categories sorbitan esters (E 491–495) were labelled, representing at most 0.6% of the total food items within the food categories. Overall, the Panel considered that exposure to sorbitan esters (E 491–495) from the food categories for which no usage data were reported was likely to have negligible impact on the refined exposure assessment. The Panel also noted that other potential sources of dietary exposure (in particular according to Annex III Part 1, 2 and 5) to sorbitan esters (E 491–495) were not considered in the exposure assessment scenarios because no data were available. Analytical data on the actual presence of sorbitan esters (E 491–495) in food are needed to reduce the sources of uncertainty.
The Panel selected the non‐brand‐loyal refined scenario as the most relevant exposure scenario for these food additives and performed the risk characterisation by comparing the non‐brand‐loyal scenario exposure estimates of sorbitan esters (E 491–495) with the group ADI of 10 mg sorbitan/kg bw per day, equivalent to 26 mg sorbitan monostearate/kg bw per day. The Panel concluded that the mean and the 95th percentile level did not exceed the ADI in any of the population groups and that there is no safety concern for the use of sorbitan esters (E 491, E 492, E 493, E 494 and E 495) as food additives at the reported uses and use levels.
An additional request to remove the congealing range from the EU specifications for sorbitan monostearate (E 491), sorbitan tristearate (E 492) and sorbitan monopalmitate (E 495) was submitted to EFSA.
The applicant provided information on the composition of commercial stearic acid used for manufacturing of sorbitan monostearate (E 491) and sorbitan tristearate (E 492). As there is a lack of definition and/or specifications of ‘commercial stearic acid’, this appeared to contain stearic acid varying from 48.6–50.0% and palmitic acid 48.7–50.0% of the fatty acid moiety. The applicant has also demonstrated that the same samples of the food additives sorbitan monostearate (E 491) and sorbitan tristearate (E 492), when analysed by two of the few internationally available laboratories performing congealing point analysis (one internal and one external), ended up to significantly different values due to a lack of a clear and common methodology.
The Panel noted that congealing point correlates with the content of the fatty acid included in the name of the food additive, especially the content of stearic acid in sorbitan monostearate (E 491) and sorbitan tristearate (E 492). Despite the statement from the industry that nothing has changed in production process for decades, the composition of the raw materials may have changed (i.e. the content of minor constituents, i.e. the content of stearic acid in edible palmitic acid, a raw material for manufacturing of sorbitan monopalmitate (E 495)).
Overall, the Panel concluded that, this removal of the congealing range from the EU specifications would result in less characterisation of the various sorbitan esters of saturated fatty acids, but this identification parameter could be replaced by another one such as melting point.
 

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