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Polysorbate 80 is a nonionic surfactant defined as polyoxyethylene (20) sorbitan monooleate and known by the registry entries CAS No 9005-65-6 and EC No 500-019-9. It is obtained by esterifying sorbitan, a sorbitol derivative, with oleic acid and ethoxylating it with about 20 mol of ethylene oxide. It is an amber or yellow, viscous, oily liquid; in food it is listed as an emulsifier under the code E 433.
Also known as Tween 80, this substance carries water-loving polyethylene oxide chains and an oil-loving oleic acid tail in the same molecule. With an HLB value of about 15, it disperses oil stably in water and makes poorly water-soluble substances such as flavor oils and vitamins soluble. It dissolves in water and ethanol and is largely unaffected by changes in pH.
Also referred to by the code E 433, the product is used in ice cream, sauces, bakery products, flavor emulsions, cosmetics, as a pharmaceutical excipient and in laboratory buffers. In selection, the oleic acid content, acid and peroxide values, water, ethylene oxide and dioxane residues and the quality grade are decisive. This product can be supplied from ATAMAN KİMYA; for technical information and supply requests, it is recommended to contact ATAMAN KİMYA.
WHAT IS POLYSORBATE 80?
Polysorbate 80 is a polyoxyethylene sorbitan fatty acid ester produced from sorbitan of sorbitol origin, oleic acid and ethylene oxide. The average of 20 ethylene oxide units in the molecule forms the water-loving part, while the oleic acid residue forms the oil-loving part. This structure makes it an effective emulsifier that allows oil and water to mix.
Commercial polysorbate 80 is not a single pure compound. It is a mixture made up of partial esters of sorbitol and sorbitan; the length of the ethoxylate chains varies from molecule to molecule. For this reason the number 20 represents an average, and the formula and molecular weight represent typical values.
The 80 at the end of the name indicates that the fatty acid part is oleic acid. Polysorbate 20 contains lauric acid, polysorbate 40 palmitic acid and polysorbate 60 stearic acid. Because the oleic acid chain contains a double bond, polysorbate 80 is liquid at room temperature; polysorbate 60, with stearic acid, has a firmer, gel-like consistency.
The substance is a hydrophilic emulsifier, and its HLB value is given as about 15. This value is typical of products that stabilize emulsions in which oil is dispersed in water. The same property also makes it possible to dissolve water-insoluble substances inside micelles.
In pharmacopoeial grade it is defined according to the USP/NF, European Pharmacopoeia and Japanese Pharmacopoeia monographs, and in food grade according to the E 433 specification. These specifications limit parameters such as the oleic acid proportion, acid value, saponification value, hydroxyl value, water, peroxide and ethylene oxide.
The Tween brand belongs to Croda International; the same substance is sold by different manufacturers under names such as Kolliphor PS 80, Montanox 80, Alkest TW 80 and T-Maz 80K. Even though these products share the same chemical definition, the impurity profile, peroxide level and quality grade differ from one manufacturer to another.
Grades under the same name are not interchangeable. Food, pharmaceutical, super refined, cosmetic, technical and laboratory grades are produced with different limits. In sensitive uses such as parenteral drugs, super refined grades with low peroxide are preferred, while in technical applications the standard grade may be sufficient.
Polysorbate 80 must not be confused with polysorbate 20, 40, 60 and 65; these are separate substances carrying a different fatty acid or a different degree of ethoxylation. Sorbitan monooleate, that is Span 80, is a non-ethoxylated, oil-soluble emulsifier. This text covers only standard polysorbate 80, that is, the E 433 product.
COMMON PRODUCT AND CHEMICAL NAMES OF POLYSORBATE 80:
Polisorbat 80
Polysorbate 80
Tween 80
Polioksietilen (20) sorbitan monooleat
Polyoxyethylene (20) sorbitan monooleate
Polioksietilen sorbitan monooleat
Polyoxyethylene sorbitan monooleate
POE (20) sorbitan monooleat
PEG-20 sorbitan monooleat
PEG-20 Sorbitan Oleate
Sorbimacrogol oleate 300
Polisorbat 80 E 433
E 433
INS 433
Gıda kalitesi Polisorbat 80
Food grade Polysorbate 80
Polysorbate 80 NF
Polysorbatum 80
Polysorbat 80
Kolliphor PS 80
Montanox 80
Alkest TW 80
T-Maz 80K
Super Refined Polysorbate 80
The great majority of these names express the same substance in different languages, with different systematic spellings or under different manufacturer brands. Polysorbatum 80 is the Latin spelling used in the European Pharmacopoeia; Polysorbat 80 is the German spelling. E 433 and INS 433 are the codes the product receives as a food additive.
Tween is a registered trademark of Croda International. Kolliphor PS 80 is BASF’s brand for a pharmaceutical excipient, Montanox 80 is Seppic’s, and Alkest TW 80 is the product name of Oxiteno and Indorama. The super refined grade is offered by Croda after a special purification, aiming at low peroxide and low impurities.
One point to note is that some database and seller pages give the formula C₂₄H₄₄O₆ and a molecular weight of 428.6 g/mol for polysorbate 80. These values belong to non-ethoxylated sorbitan monooleate, that is Span 80, and must not be used as identification data for polysorbate 80.
The CAS number of polysorbate 80 is 9005-65-6. The number 9005-64-5 is used for polysorbate 20, 9005-66-7 for polysorbate 40 and 9005-67-8 for polysorbate 60. Sorbitan monooleate is registered under 1338-43-8. In a request, not only the name but also the CAS number should be stated.
Polysorbate 80 products offered in commercial lists with additional wording such as “Solubilizer” may be a separate item. This text describes standard polysorbate 80, not such specially named products. When placing an order, the full product name, quality grade and CAS number should be written together.
CAS NO, EC / EINECS NO AND CHEMICAL IDENTIFICATION OF POLYSORBATE 80
Product name: Polysorbate 80 / Polisorbat 80
Common abbreviation: PS 80; Tween 80
Chemical name: Polyoxyethylene (20) sorbitan monooleate
INCI name: Polysorbate 80
Food additive number: E 433; Codex INS 433
CAS No: 9005-65-6
EC / EINECS No: 500-019-9
Molecular formula: C₆₄H₁₂₄O₂₆ (typical representation)
Molecular weight: About 1309.68 g/mol; rounded to 1310 g/mol in some documents
Chemical class: Nonionic, polyethoxylated sorbitan fatty acid ester
Main functions: Emulsifier, solubilizer, dispersant, wetting agent, stabilizer, foam control, adjustment of fat globule structure
Polysorbate 80 is identified in food legislation by the code E 433, and in the JECFA and Codex system by the code INS 433. It is registered as a flavoring component under FEMA number 2917 and its UNII code is 6OZP39ZG8H. In the cosmetic ingredient database it appears under the name Polysorbate 80.
The formula C₆₄H₁₂₄O₂₆ represents an ideal molecule carrying 20 ethylene oxide units. The real product is a mixture of many molecules with different degrees of ethoxylation. For this reason, molecular weight and formula are not directly measured values in quality control, but typical values that help in identification.
The existence of an INCI name does not mean the product can be added to every cosmetic product, and the existence of a food additive number does not show that every grade can be used in food. For food, compliance with the E 433 specification must be sought, and for cosmetics and pharmaceuticals the relevant quality and regulatory conditions must be sought separately.
The CAS number is necessary to match the product with the correct substance, but it is not sufficient on its own. Food, pharmaceutical, super refined and technical grades are sold under the same number. In purchase requests, the quality grade, monograph and documents should be stated together with the CAS number.
CHEMICAL STRUCTURE AND MOLECULAR PROPERTIES OF POLYSORBATE 80
The backbone of polysorbate 80 is built on sorbitan. Sorbitol turns into sorbitan by internal ring closure; one of its hydroxyl groups forms an ester bond with oleic acid, while polyoxyethylene chains containing a total of about 20 ethylene oxide units are attached to the others. In this way a four-armed structure emerges from the sorbitan ring.
The polyoxyethylene chains consist of repeating ether bonds. Because the ether oxygens form hydrogen bonds with water, this region is strongly hydrophilic. In water the chains form a hydrated, flexible and wide shell; this shell prevents oil droplets from approaching one another.
The oil-loving part is the oleic acid chain, which has 18 carbons and a cis double bond at carbon 9. The double bond creates a bend in the chain. Because this bend prevents the chains from packing in order, the product remains liquid at room temperature; polysorbate 60 and 65, with saturated fatty acids, have a firmer structure.
The molecule is not ionic. Because there is no charged group in its structure, the action of polysorbate 80 is much less affected by pH and by the salt concentration of the medium than that of soaps such as stearates. It does not form insoluble salts with hard water ions. This property makes its use easier in acidic sauces and salty systems.
The ester bond is the chemically most sensitive region. Under strongly acidic or basic conditions, at high temperature and through the action of esterase enzymes, the ester is hydrolyzed and oleic acid is released. As a result the surface activity weakens and free fatty acid may accumulate in the medium.
The double bond in oleic acid and the polyethylene oxide chains are open to oxidation. Light, heat, oxygen and trace metals can start radical reactions and form hydroperoxides, aldehydes and carboxylic acids. This is the reason why the peroxide value is limited in specifications and why super refined grades were developed.
Polysorbate 80 forms micelles in water at high concentration. The critical micelle concentration is about 0.012 mM, which corresponds to about 15 mg per liter, that is about 0.0016 percent. The aggregation number given on one seller page is about 60, and the average value of 79,000 points to the micelle mass.
Nonionic surfactants with polyethylene oxide chains become cloudy at a certain temperature because of the hydration water that the chains release as temperature rises. On one manufacturer page a cloud point of 65 °C is given for polysorbate 80; this value depends on concentration and measurement conditions and should not be regarded as a definite limit.
The structural properties related to solubility can be summarized as follows. First, the number of ether oxygens and their hydration. Second, the hydrophobicity of the oleic acid chain. Third, the disruption of chain order by the double bond. Fourth, the broad molecular distribution that results from the product being a mixture.
PHYSICAL AND CHEMICAL PROPERTIES OF POLYSORBATE 80
General technical properties:
Values may vary according to the manufacturer, the grade and the measurement method; the information below is for general information purposes and does not replace the manufacturer-specific TDS and SDS documents.
Physical appearance: Clear, amber or yellow, oily and viscous liquid; slightly characteristic odor, described as odorless in some documents
Chemical character: Nonionic, hydrophilic, polyethoxylated sorbitan fatty acid ester; O/W emulsifier and solubilizer
Molecular formula: C₆₄H₁₂₄O₂₆ (typical representation)
Molecular weight: About 1309.68 g/mol; 1310 g/mol in some documents
CAS No: 9005-65-6
EC / EINECS No: 500-019-9
Composition and purity: Defined by monograph limits rather than by a single purity percentage. In pharmacopoeial and food specifications at least 58 percent of the fatty acids is oleic acid; the oxyethylene proportion is given in the range of 65.0–69.5 percent. These are specification limits, and typical values depend on the manufacturer
HLB value: About 15
Density: About 1.06–1.10 g/cm³ at 25 °C; 1.07 g/cm³ is mostly given in safety data sheets
Viscosity: 300–500 mm²/s kinematic at 25 °C; about 425 mPa·s dynamic
Solubility in water: Soluble in water; also soluble in ethanol, methanol and ethyl acetate. Practically insoluble in fixed oils and liquid paraffin
pH (aqueous solution): 5–7 at a concentration of 50 g/L at 20 °C; given as 5–7 or 6–7 for a 5 percent solution. It should not be taken as a single value without stating the concentration
Acid value: At most about 2 mg KOH/g in pharmacopoeial and food specifications
Saponification value: 45–55 mg KOH/g
Hydroxyl value: 65–80 mg KOH/g in most specifications; different ranges are seen in some supplier documents
Water (moisture): At most 3.0 percent in pharmacopoeial and food specifications; some suppliers give at most 0.5 percent or 5 percent
Residue on ignition: At most 0.25 percent
Peroxide value: Limited to about 10 mEq/kg in pharmacopoeial texts; this value is much lower in super refined grades
Ethylene oxide and 1,4-dioxane: In the EU specification at most 0.2 mg/kg ethylene oxide and at most 5 mg/kg 1,4-dioxane; limits of 1 ppm and 10 ppm are seen in some supplier documents
Heavy metals: General limit at most 10 ppm; in the food specification at most 3 mg/kg arsenic and at most 2 mg/kg lead
Fatty acid composition: Oleic acid at least 58 percent; myristic at most 5 percent, palmitic at most 16 percent, palmitoleic at most 8 percent, stearic at most 6 percent, linoleic at most 18 percent and linolenic at most 4 percent may be given
Flash point: Above 149 °C in most safety data sheets; above 100 °C in some documents, and about 200 °C at one supplier
Decomposition: At high temperature carbon monoxide and carbon dioxide are formed. Light, oxygen and trace metals accelerate peroxide formation
Reactivity: Stable under normal conditions. Incompatible with strong oxidizers, bases and heavy metal salts; it must be protected from moisture, heat and light
Short Description of Physical Properties
Polysorbate 80 is a fluid yet viscous liquid at room temperature. Its ability to give clear or slightly opalescent solutions with water is the property most often sought in use. Its density is slightly higher than that of water; therefore, when the product is added to water it may sink to the bottom and needs stirring to mix.
Some values in data sheets look inconsistent at first sight. The water limit may vary between 0.5 percent and 5 percent, and the hydroxyl value between 42–58 and 65–80. These differences mostly come from the quality grade, the pharmacopoeia edition and the measurement method; therefore the values should always be checked against the product’s own COA.
The value of about 79,000 given as average molecular weight on some pages expresses the micelle, not a single molecule. Since the aggregation number is about 60 and the molecular mass about 1310, the product is close to this value. This value must not be used as the molecular weight in the product’s formula.
The melting or freezing point is not consistent across documents; some sources give a value below 20 °C, others above. The product is liquid at room temperature, whereas at low temperature its consistency may increase. The value above 100 °C given as boiling point does not reflect a real boiling behavior, but shows the limit before decomposition.
The pH value is given with small differences, and the 5–7 range used for the 5 percent solution depends on free fatty acid and trace basic or acidic residues. If the acid value has risen, the product may have aged or hydrolyzed. For this reason pH alone is not a quality criterion.
HOW DOES POLYSORBATE 80 WORK AT THE MOLECULAR LEVEL?
When polysorbate 80 is added to water, the polyoxyethylene chains form hydrogen bonds with water molecules through their ether oxygens and become hydrated. The oleic acid tail, on the other hand, avoids water. This two-faced structure directs the molecules to the water-oil interface; the tail faces the oil phase and the hydrated chains face the water phase.
The molecules placed at the interface lower the interfacial tension; breaking oil into small droplets becomes easier. The hydrated chain layer around the droplet physically prevents the droplets from approaching one another. This mechanism is steric stabilization, and because it does not depend on electrical charge it is more resistant to changes in salt and pH.
When the concentration exceeds the critical micelle concentration, polysorbate 80 forms micelles. The micelle core is made of oleic acid chains and the outer shell of hydrated polyethylene oxide chains. Flavor oils, fat-soluble vitamins and some active substances settle in the core or the intermediate layer and remain clear in the aqueous solution.
The solubilizing effect depends on concentration. If there is not enough polysorbate, the insoluble substance causes turbidity or separation; excess polysorbate, on the other hand, may be unnecessary in terms of taste, foam and cost. For this reason, the ratio between polysorbate and the substance to be solubilized is determined experimentally in practice.
The effect in ice cream is more specific. Milk proteins form a protective film on the surface of fat globules. Polysorbate 80 partially removes these proteins from the surface; the weakened shell allows partial coalescence of the globules during freezing. The resulting fat network traps air and gives the product a dry, melt-resistant texture.
The same surface effect also plays a role in managing foam. In whipped foods, polysorbate 80 may support foam formation by regulating the foam film at the air-water interface. In some carbonated beverage and fermentation applications, on the other hand, it acts as an antifoam by disrupting the stability of the foam film.
In biopharmaceutical products, polysorbate 80 settles at air-water, ice-water and silicone oil interfaces before the protein molecules do. In this way the adhesion, unfolding and aggregation of proteins at the interface are reduced. At the same time, the stability of the product under stress conditions such as freezing and thawing, shaking and vial surfaces is supported.
The weak points of the molecule are the ester bond and the oxidizable parts. In the biopharmaceutical literature degradation is followed through two routes. The first is oxidation; light, trace metals, excipients containing peroxide and metal ions leaching from glass accelerate this route. The second is hydrolysis caused by host cell esterases.
In food, polysorbate 80 is accepted to be partially hydrolyzed in the intestine and split into oleic acid and polyoxyethylene sorbitan parts. Oleic acid is a fatty acid found naturally in foods and takes part in normal fatty acid metabolism.
In the laboratory, the same surface activity is used to reduce the adhesion of antibodies to plastic surfaces in wash buffers, to solubilize membrane proteins and to reduce cell clumping in mycobacterial cultures. The same effect may, at high concentrations, disrupt cell membranes and some enveloped viruses.
IN WHICH SECTORS IS POLYSORBATE 80 USED?
Polysorbate 80 takes part in several sectors as an emulsifier, solubilizer and dispersant. The food and pharmaceutical fields are the most widespread; cosmetics, biotechnology, agriculture and some industrial applications follow them. The main sectors and functions are given below.
Ice cream and frozen desserts
It supports partial coalescence by changing the protein film on the fat globule surface. It gives ice cream a dry structure, smooth texture and resistance to melting. In FDA regulation the upper limit of use in ice cream is defined as 0.1 percent.
Sauces, salad dressings and food emulsions
It is used to reduce oil-water separation and to keep the emulsion stable. Since its effect is little affected by pH and salt, it also works in acidic and salty sauces. The amount of use is limited by regulation.
Bakery and pastry
It can be used in dough and cake systems to support the distribution of fat, aeration and product softness. In the EU assessment, its use as a whipping agent in fine bakery wares has also come up.
Chocolate, confectionery and chewing gum
It regulates dispersion in fat and sugar systems and, in some products, limits wetting of the surface and separation of fat. Its use depends on permissions that vary by country and product category.
Beverage flavors and vitamin dispersions
It is used to disperse and solubilize water-insoluble flavor oils, colorants and fat-soluble vitamins in aqueous beverages. In vitamin supplements it is limited by the FDA in terms of daily intake level.
Pickles and processed foods
In chemical sources it is mentioned as an emulsifier and dispersant, especially in pickle products. In US regulation the upper limit for pickles is given as 500 ppm. Use should be verified according to the legislation of the target country.
Antifoam applications
In some food processes, for example in systems such as yeast and cottage cheese, it is used as an antifoam at a very low level. In the EU, regulation 2020/356 defines antifoam use at a level of 10 mg/kg in some carbonated beverage categories.
Cosmetics and personal care
It is used as an emulsifier and solubilizer in lotions, creams, shampoos, shower products, sunscreens and oral care products. It keeps perfume and flavor oils clear in aqueous bases.
Pharmaceuticals and pharmaceutical excipients
It takes part as a solubilizer, emulsifier and wetting agent in liquid drugs, fat-soluble vitamins, parenteral products, vaccines and soft gelatin capsules. In biopharmaceuticals it contributes to protein stability.
Biotechnology and laboratory
It is widely used at a concentration of 0.05–0.5 percent in immunoassay wash buffers. It is added to mycobacterial media such as Middlebrook 7H9 to reduce clumping. It also takes part in the processing of membrane proteins and some enveloped viruses.
Agriculture
It is used as a wetting agent, spreader and emulsifier in pesticides and agricultural chemicals. It supports the spreading of the droplet on the leaf surface and the distribution of the active substance.
Paint, textile, lubricants and rubber
It is reported to take part as a wetting agent and emulsifier in coatings, textile processing and lubricant emulsions. In these fields food or pharmaceutical grade is not required, and technical grade is mostly sufficient.
Animal feed
Some sources point to its use as an emulsifier in feeds and veterinary products. Feed legislation is separate and use should be verified product by product.
For each field, the quality of the product, its documents and compliance with the relevant legislation must be evaluated separately.
IS POLYSORBATE 80 USED IN COSMETIC, FOOD AND PHARMACEUTICAL APPLICATIONS?
Cosmetic applications
Yes. Polysorbate 80 takes part in the cosmetic ingredient database as an emulsifier and surfactant. It is used in lotions, creams, shampoos, oral care products and perfume solutions. In secondary sources the typical use level is given as 0.5–5 percent; this level is not a definite limit.
The Cosmetic Ingredient Review panel found polysorbate 80 safe at current use concentrations. A safety assessment for each finished product and the legislation of the target country must be checked separately. Allergic contact reactions have been rarely reported in sensitive skin.
Food applications
Yes. Polysorbate 80 is the emulsifier known in food as E 433. It is used in ice cream, sauces, bakery products, confectionery, beverage flavor emulsions and food supplements. It is an additive added directly to food and its use is limited according to category.
In 2015 the European Food Safety Authority re-evaluated the polysorbates as the group E 432–436 and set the acceptable daily intake for the group at 25 mg per kilogram of body weight per day. This value is based on a no-observed-effect level of 2,500 mg/kg per day in rats and a safety factor of 100.
JECFA also uses an acceptable daily intake of 0–25 mg per kilogram per day for the polysorbate group. The Scientific Committee on Food had accepted a lower value of 10 mg/kg in 1985. It was assessed that in highest exposure scenarios intake could approach or exceed this value.
In the EU, the use of additives is regulated by category, and polysorbate 80 can be used only in defined food categories and with upper limits. EFSA has also recommended stricter limits for toxic elements. The current text of Annex II should be checked according to the product category.
In the USA it is permitted under 21 CFR 172.840. Category-specific limits are defined, such as 0.1 percent in ice cream, 0.4 percent in whipped topping products, 500 ppm in pickles and 0.082 percent in gelatin desserts. In Australia and New Zealand E 433 is among the additives permitted under good manufacturing practice.
In Turkey, food additives are regulated by the Turkish Food Codex Regulation on Food Additives and the relevant regulation on specifications. The permitted categories, quantity limits and specification for E 433 must be verified separately from the current text; in this work no definite limit is given because the Turkish legislation text has not been verified.
A mouse study published in 2015 reported that polysorbate 80 and carboxymethylcellulose could alter the gut microbiota and the mucosa. The study was done only in mice, and there are comments that the doses were far above human exposure. It should not be directly transferred to humans.
Pharmaceutical applications
Yes, but as an excipient, not as an active substance. Polysorbate 80 is included in the USP/NF, European Pharmacopoeia and Japanese Pharmacopoeia monographs. It is used as a solubilizer, emulsifier and wetting agent in liquid drugs, fat-soluble vitamin preparations and parenteral products.
It is added to vaccines and biopharmaceutical products for protein stability. In this field the peroxide level and oxidation products are critical; therefore super refined grades with low peroxide are preferred. Every amount and grade to be used requires a product-specific pharmaceutical evaluation.
Hypersensitivity to polysorbate 80 is reported very rarely and the evidence is weak. One proposed mechanism is a non-immune route developing through oxidized impurities. A possible cross-reaction with polyethylene glycol is also being discussed. In case of doubt, an allergy specialist should be consulted.
The fact that a chemical is used in one sector does not mean it can be used in other sectors as well.
INDUSTRIAL APPLICATIONS OF POLYSORBATE 80
The industrial use of polysorbate 80 rests on the water-loving polyethylene oxide chains and the oil-loving oleic acid tail. The headings below describe, application by application, the function of the product, the reasons for its preference and its limits. Food and pharmaceutical applications are placed first.
Ice cream and frozen desserts
In the ice cream mix, polysorbate 80 partially removes the milk proteins on the surface of the fat globules and allows the globules to cluster in a controlled way during freezing. The resulting fat network traps air and gives the product a dry, smooth texture that holds its shape.
In supplier sources, levels of about 0.02–0.06 percent alone and about 0.015–0.04 percent together with mono- and diglycerides are mentioned. The upper limit in the USA is 0.1 percent. Excessive use may cause too much clustering of fat; alternatives are mono- and diglycerides, lecithin and polysorbate 65.
Sauces, salad dressings and food emulsions
In sauces and salad dressings it surrounds oil droplets, delays separation of the emulsion and lowers surface tension. Because it is nonionic, it also works in acidic and salty environments, which is a clear advantage over fatty acid soaps.
It is used at a very low level, because at a high level the taste of the product and its tendency to foam may be affected. Alternatives are lecithin, mono- and diglycerides, sucrose esters and modified starch. Label declaration and permitted levels should be checked according to the target country.
Beverage flavors and vitamin dispersions
It is used to disperse or solubilize water-insoluble flavor oils, colorants and fat-soluble vitamins in aqueous beverage bases. The ratio between the oil phase and polysorbate 80 determines whether a cloudy emulsion or a clear solution is obtained.
The limitations are the effect on taste and the upper limits in legislation. Trials are needed in systems with low pH and high ethanol. Alternatives are gum arabic, modified starch, Quillaja extract and lecithin; each gives a different droplet size and turbidity.
Bakery, chocolate and confectionery
In bakery products it can be used to support the distribution of fat and product softness, and in whipped systems to regulate the distribution of air cells. In chocolate and confectionery it is evaluated as a dispersant in fat-sugar systems.
In these fields mono- and diglycerides and polyglycerol esters are more common. Polysorbate 80 is permitted only in certain categories and at certain levels. The additive list of the target country should be checked before use.
Cosmetic and personal care emulsions
In lotions and creams it is used as the main emulsifier that disperses the oil phase in water, or as the partner of a lipophilic emulsifier such as sorbitan oleate. The ratio of the two emulsifiers is adjusted to bring the HLB value of the mixture close to the value required by the oil phase.
In shampoos, shower gels and oral care products it keeps perfume and flavor oils clear. Alternatives are polysorbate 20, hydrogenated castor oil ethoxylates, alkyl glycosides and polyglycerol esters.
Pharmaceutical and biopharmaceutical formulations
It is used as a solubilizer in liquid drugs and fat-soluble vitamin preparations, and as a wetting agent and emulsifier in soft gelatin capsules. In parenteral and biopharmaceutical products it contributes to stability by reducing the degradation of proteins at the interface.
In this field the peroxide level, oxidation products and free fatty acid accumulation are critical. Degraded polysorbate may lead to particle formation from free fatty acids. Alternatives are polysorbate 20, poloxamer 188 and alkyl saccharides; each should be evaluated specifically for the product.
Laboratory and biotechnology
In immunoassay and blot wash buffers, at concentrations of 0.05–0.5 percent, it reduces the adhesion of antibodies and proteins to plastic surfaces. It is added to mycobacterial media to prevent cell clumping.
It can also be used for solubilizing membrane proteins, but other detergents may be needed for work requiring stronger solubilization. Alternatives are Triton X-100, polysorbate 20 and milder nonionic detergents.
Agriculture and industrial applications
In pesticides and agricultural chemicals, it acts as a wetting agent, spreader and emulsifier that helps the droplet spread on the leaf surface. In paint, textile processing and lubricant emulsions it acts as a wetting agent and emulsifier.
In these fields food or pharmaceutical quality is not required. The choice is mostly made on cost and emulsion stability. Alternatives are other polysorbates, alcohol ethoxylates and other nonionic surfactants.
POINTS TO NOTE WHEN USING POLYSORBATE 80
Polysorbate 80 is an excipient of low acute toxicity that is widely used in many sectors. Even so, the quality grade must be chosen correctly, it must be protected from oxidation and it must be used at the right dosage. The main points to keep in mind during use are as follows:
• The quality grade must be chosen correctly. The E 433 specification is needed for food, the relevant pharmacopoeia monograph for drugs, and a super refined grade may be needed for sensitive biopharmaceutical applications. Technical grade must not be used in these fields
• The peroxide value must be checked. Aged product or product exposed to light may contain peroxides and aldehydes; these substances have a negative effect on odor, taste and the stability of sensitive components
• It must be protected from light and oxygen. The container must be closed tightly after each use; in sensitive applications an inert gas atmosphere such as nitrogen or small packages may be preferred
• Metal and equipment compatibility must be observed. Stainless steel or carbon steel is recommended in safety data sheets. Trace iron and copper can accelerate oxidation
• It must be kept away from incompatible substances. Strong oxidizers, bases and heavy metal salts spoil or decompose the product
• Preservative interaction must be considered. Some phenolic preservatives such as parabens may bind to polysorbate micelles and lose antimicrobial effectiveness; a preservative efficacy test must be done
• The dose must be kept low. The lowest effective level should be tried; excess may cause problems in terms of taste, foam, consistency or biological effect
• Viscosity must be taken into account. A product whose consistency increases in the cold can make weighing and transfer difficult; gentle heating can be done, but long-term high temperature must be avoided
• The dissolving order must be tried. Dispersion is easier if polysorbate 80 is first diluted with a small amount of water. Premixing with the oil phase is often applied for clear solubilization
• Legislation must be verified. Food categories, upper limits and labeling rules may differ in the EU, the USA and Turkey. Current texts must be checked before use
• The fatty acid source must be asked about. Oleic acid may be of vegetable or animal origin. In products requiring halal, kosher, vegetarian or allergen declarations, a source document must be requested
• The environment must be considered. Biodegradation is given between 32 percent and 100 percent in different safety data sheets. Large amounts must not be released into waterways and the sewer
• Protective equipment must be used. The product is not classified as hazardous in most documents, but protective glasses and gloves are recommended in case of contact with eyes and skin
This information is for general information purposes and does not replace the product-specific SDS and TDS documents.
STARTING FORMULATION APPROACHES FOR POLYSORBATE 80
The examples below are starting approaches prepared to show how polysorbate 80 can be evaluated in food, oral care and cosmetic formulations. They are not verified commercial recipes, production instructions or final formulas compliant with legislation.
The ratios given are example starting levels for laboratory preliminary trials, and the total of each formula is 100%. Every component must be of a quality suitable for the relevant application, and the use of polysorbate 80 must be verified in the legislation of the target country.
The peroxide value of the product used, the quality grade, the structure of the oil phase, the pH and the temperature change the result. In every application, technical evaluation, product safety and relevant regulatory checks must be made; the ratios should be reviewed by experts.
EXAMPLE 1: EVALUATION OF FAT GLOBULE DESTABILIZATION WITH POLYSORBATE 80 IN AN ICE CREAM MIX
Purpose: To examine the effect of polysorbate 80 in a milk-based ice cream mix on partial coalescence of fat globules, air retention, shape retention and melting behavior.
Starting approach:
Milk fat: about 10%
Milk solids-not-fat: about 10%
Sucrose: about 13%
Glucose syrup solids: about 4%
Stabilizer blend: about 0.3%
Polysorbate 80: about 0.04%
Water and other aqueous content: about 62.66%
Application approach:
• The dry ingredients are dispersed in hot water and milk; polysorbate 80 is first diluted with a small amount of warm water and added to the mix.
• The mix is pasteurized, homogenized and cooled; the conditions are determined according to product type and legislation.
• The mix is aged at low temperature for several hours; the exchange of polysorbate with the proteins on the fat globule surface takes place during this time.
• The mix is frozen in an ice cream machine; overrun and draw temperature are recorded.
• Trials are made by gradually changing the polysorbate 80 level between 0.02% and 0.06%; it is taken into account that the upper limit in the USA is 0.1%.
• Dryness, shape retention, melting rate, degree of fat globule clustering and mouthfeel are compared by sensory and instrumental means.
• At an excessive level, too much clustering of fat and a greasy structure may occur, so the lowest effective level is sought.
• All components must be of food grade, and the use of E 433 must be verified for the ice cream category in the target country.
EXAMPLE 2: EVALUATION OF SOLUBILIZING A FLAVOR OIL WITH POLYSORBATE 80 IN A MOUTHWASH
Purpose: To examine the effect of the polysorbate 80 level and of the polysorbate:flavor ratio in clear solubilization of peppermint flavor oil in an aqueous-alcoholic oral care base.
Starting approach:
Purified water: about 80.65%
Ethanol: about 10%
Glycerin: about 8%
Polysorbate 80: about 1%
Peppermint flavor: about 0.3%
Sodium saccharin: about 0.05%
Application approach:
• Polysorbate 80 and the flavor oil are first mixed together to prepare a homogeneous premix.
• Water, ethanol and glycerin are mixed in a separate vessel; the premix is added slowly under stirring.
• Saccharin is added in the last step; stirring continues until the solution becomes clear.
• Clarity is monitored by gradually increasing the polysorbate:flavor ratio, for example between 3:1 and 5:1.
• Turbidity, color, odor and taste are compared after storage at room temperature and at low temperature.
• Excess polysorbate may cause a soapy taste and foaming; if a preservative system is added, its interaction with polysorbate must be evaluated separately.
• The product is evaluated as a cosmetic or oral care product; cosmetic legislation and a safety assessment are required.
• Ethanol is flammable; during work, ignition sources are kept away and the area is ventilated.
EXAMPLE 3: EVALUATION OF THE POLYSORBATE 80 AND SORBITAN OLEATE EMULSIFIER PAIR IN AN O/W LOTION
Purpose: To examine the effect of the ratio of polysorbate 80 to sorbitan oleate in an oil-in-water lotion on HLB balance, droplet size, viscosity and physical stability.
Starting approach:
Purified water: about 76.2%
Glycerin: about 3%
Caprylic/capric triglyceride: about 14%
Cetyl alcohol: about 2%
Polysorbate 80: about 2.4%
Sorbitan oleate: about 1.6%
Xanthan gum: about 0.3%
Preservative system: about 0.5%
Application approach:
• The HLB value required by the oil phase is determined; the ratio of polysorbate 80 to sorbitan oleate is changed gradually so that the average HLB of the mixture approaches this value. In this example the HLB of the mixture is about 10.7.
• The water phase is prepared with polysorbate 80, glycerin and xanthan gum; the oil phase with triglyceride, cetyl alcohol and sorbitan oleate. The two phases are heated to about 70–75 °C.
• The oil phase is added to the water phase under stirring and the emulsion is formed with a homogenizer; the product is cooled under stirring.
• The preservative system is added at a suitable temperature; the manufacturer’s recommendations are followed.
• Droplet size, viscosity, pH, centrifuge resistance and phase separation after temperature cycling are monitored.
• Because of the polysorbate–preservative interaction, a preservative efficacy test must be done.
• Cosmetic grade, low-peroxide polysorbate 80 and a final product safety assessment are required.
• When working with hot phases, heat-resistant gloves and protective glasses are used.
SIMILAR PRODUCTS AND ALTERNATIVES TO POLYSORBATE 80
An alternative to polysorbate 80 does not simply mean choosing another emulsifier. When an alternative is determined, function, HLB value, pH and salt tolerance, taste effect, regulatory permission, label declaration and cost must be evaluated together.
POLYSORBATE 80 AND POLYSORBATE 20
Polysorbate 20 is the lauric acid ester coded E 432 and its HLB value is about 16.7. It dissolves more easily in water than polysorbate 80 and is milder in structure. It is often preferred in perfume solubilization, in biopharmaceuticals and in laboratory buffers.
The oleic acid chain of polysorbate 80 is longer and fits better with oil phases. In ice cream and emulsion applications polysorbate 80 is more common. Solubilization and stability trials are needed to replace one with polysorbate 20.
POLYSORBATE 80 AND POLYSORBATE 60
Polysorbate 60 is the stearic acid ester coded E 435 and its HLB value is about 14.9. It has a firmer, gel-like consistency. It is used in bakery products, in whipped topping products and in cosmetics.
Because it carries a saturated fatty acid, it is more resistant to oxidation than oleic acid polysorbate 80. However, it is less fluid in the cold and its solubilizing power is different. The choice is made according to the physical form of the product and the processing temperature.
POLYSORBATE 80 AND POLYSORBATE 65
Polysorbate 65 is the triester of stearic acid coded E 436 and its HLB value is about 10.5. Since it is more lipophilic, it is used in oil-in-water systems, especially in ice cream and whipped products.
Although it shares some of the same fields of use as polysorbate 80, its solubilizing effect is weaker. In ice cream, polysorbate 65 and 80 are sometimes tried together. Both can be considered subject to the same group acceptable daily intake.
POLYSORBATE 80 AND SORBITAN MONOOLEATE
Sorbitan monooleate, known as Span 80, is the non-ethoxylated ester coded E 494, and its HLB value is about 4.3. It is oil-soluble and is suitable for water-in-oil emulsions rather than oil-in-water ones.
When used together with polysorbate 80, the HLB value of the mixture is adjusted by the ratio of the two emulsifiers. This pair is common in cosmetic and food emulsions. Span 80 alone cannot fulfill the solubilizing function of polysorbate 80.
POLYSORBATE 80 AND MONO- AND DIGLYCERIDES
Mono- and diglycerides of fatty acids, E 471, are the most common emulsifier group in food. They are used in ice cream, margarine, bread and cake systems and are often applied together with polysorbate 80.
In ice cream, mono- and diglycerides regulate the structure of the fat globule, while polysorbate 80 increases controlled clustering. The two are not exact substitutes for each other. In systems requiring aqueous solubilization, mono- and diglycerides may not be sufficient.
POLYSORBATE 80 AND LECITHIN
Lecithin, E 322, is a natural emulsifier with a phospholipid structure. It is obtained from soy or sunflower and provides the advantage of natural origin on the label. It is used in margarine, chocolate, sauces and powder products.
In soy-derived lecithin an allergen declaration is required. The color and odor of lecithin may carry over to the product. Its solubilizing power is more limited than that of polysorbate 80; performance may differ in acidic and salty systems.
POLYSORBATE 80 AND SUCROSE ESTERS
Sucrose esters, E 473, are hydrophilic emulsifiers obtained from sugar and fatty acids. Their HLB values vary over a wide range. They are used in beverages, bakery products and dairy products.
Taste effect, label perception, cost and heat resistance may differ from those of the polysorbates. Solubilizing power and permitted use levels should be evaluated separately according to the product.
POLYSORBATE 80 AND POLYGLYCEROL ESTERS
Polyglycerol esters of fatty acids, E 475, are successful in air retention and foam stability. They are used in cakes, biscuits and whippable creams. They offer a different label and perception compared with polysorbates.
Unlike polysorbate 80, they are nonionic but do not contain polyethylene oxide. Their solubilizing power is limited, so they cannot always replace polysorbate in flavor and vitamin dispersions.
POLYSORBATE 80 AND STEAROYL LACTYLATES
Sodium and calcium stearoyl lactylate, E 481 and E 482, are used as dough strengtheners and softeners in bread and dough products. They interact with starch and gluten and help the bread crumb stay soft.
Polysorbate 80, on the other hand, takes part mostly in emulsion and ice cream systems. In most applications the two do not replace each other. They can also be used together in bakery products.
POLYSORBATE 80 AND CASTOR OIL ETHOXYLATES
Ethoxylated castor oil and hydrogenated castor oil derivatives are used in cosmetics for perfume and oil solubilization and in pharmaceutical applications. Unlike polysorbates, they carry a castor oil backbone rather than sorbitan.
They can be a good alternative to polysorbate 80 in some applications, but their permissions for use in food are different. Their sensitization profile and regulatory status should be checked separately according to the relevant product.
POLYSORBATE 80 AND POLOXAMER 188
Poloxamer 188 is a nonionic surfactant made of polyethylene oxide and polypropylene oxide blocks. It is used in biopharmaceutical products as an alternative to polysorbate in protecting proteins against interfacial stress.
Because it does not carry an ester bond, it is less sensitive to hydrolysis and esterase degradation. However, its surface activity and protective effect differ depending on the application. A switch in the pharmaceutical field requires comprehensive stability studies.
POLYSORBATE 80 AND ALKYL SACCHARIDES
Alkyl saccharides are mild nonionic surfactants made up of sugar and fatty alcohol esters or ethers. They are examined as polysorbate alternatives in biopharmaceutical and cosmetic applications.
The production volume of these products is more limited and their costs may differ. Their permissions for food use are separate. They should not be expected to replace polysorbate 80 in every application.
QUALITY CONTROL AND PURCHASING CRITERIA FOR POLYSORBATE 80
Even though polysorbate 80 is sold under the same name, the fatty acid composition, peroxide level, water and impurity profile differ according to the manufacturer and the grade. Compliance with E 433 for food and with the relevant pharmacopoeia monograph for drugs must be confirmed with documents.
The main parameters that can be evaluated in quality control and the purchasing process:
• Appearance and color: It should be a clear, amber or yellow, oily liquid. Excessively dark color, turbidity, sediment or a rancid odor points to aging and degradation
• Identity: CAS 9005-65-6, the quality grade name and the monograph should be stated. It must not be confused with polysorbate 20, 40, 60 and 65
• Fatty acid composition: Oleic acid is at least 58 percent. There are upper limits for myristic, palmitic, stearic, linoleic and linolenic acid; the composition determines the physical behavior of the product
• Acid value: In general at most about 2 mg KOH/g. A high value is a sign of free fatty acid and hydrolysis
• Saponification value: It is in the range of 45–55 mg KOH/g. It shows the degree of esterification
• Hydroxyl value: 65–80 mg KOH/g in most specifications. Different ranges may be seen in supplier documents
• Water: At most 3.0 percent in pharmacopoeial and food specifications. Some suppliers give lower or higher limits. Moisture accelerates hydrolysis
• Residue on ignition: At most 0.25 percent. It shows the inorganic additive and catalyst residue
• Peroxide value: Limited to 10 mEq/kg in pharmacopoeial texts. In sensitive and parenteral uses much lower values and a super refined grade are sought
• Ethylene oxide and 1,4-dioxane: In the EU food specification at most 0.2 mg/kg ethylene oxide and at most 5 mg/kg 1,4-dioxane; some suppliers give limits of 1 ppm and 10 ppm
• Oxyethylene content: The range of 65.0–69.5 percent is used. It reflects the degree of ethoxylation and the HLB behavior
• Heavy metals and toxic elements: General limit at most 10 ppm; at most 3 mg/kg arsenic and at most 2 mg/kg lead. EFSA has recommended stricter limits
• Viscosity and density: 300–500 mm²/s at 25 °C and about 1.06–1.10 g/cm³. They can be monitored for batch consistency
• pH and solution clarity: A pH in the range of 5–7 is expected in aqueous solution. The clarity of a solution prepared at a certain concentration is a simple quality test
• Fatty acid source: Vegetable or animal origin, halal and kosher status and the allergen declaration must be documented
• Documents: A batch-based certificate of analysis, current SDS, TDS, a statement of compliance with the monograph, a food safety certificate and regulatory compliance information should be requested
• Packaging and batch: One supplier shows 220 kg HDPE drums and 1,100 kg IBCs, another 1 L, 2.5 L, 25 kg and 50 kg packages. The batch number and expiry date must be checked
• Test standards: USP/NF, the European Pharmacopoeia, the Japanese Pharmacopoeia, FCC and the EU E 433 specification are taken as reference according to the product type
The manufacturer’s typical values must be distinguished from binding product specifications. Typical values are generally for information purposes; the specification included in the purchase contract and the batch results in the certificate of analysis should be taken as the basis.
STORAGE AND TRANSPORT OF POLYSORBATE 80
Polysorbate 80 is stable for a long time under suitable conditions. However, because of the oleic acid double bond and the polyethylene oxide chains, it is sensitive to light, oxygen, a moist environment and high temperature. For this reason storage conditions are important for preserving quality.
• Temperature: A range of +15 to +25 °C is recommended on one product label and below 30 °C by another manufacturer. High temperature accelerates peroxide formation. In the cold the consistency of the product increases, but it is generally made fluid again by heating
• Light: The product must be protected from light. Opaque or dark packaging and dark storage are preferred
• Moisture: The container must be kept tightly closed. Moisture increases hydrolysis; also, water may cause the product to exceed its water limit
• Packaging: It must be stored in its original, tightly closed packaging. Suitable packaging such as HDPE drums and IBCs is used. The product in an opened container should be used as soon as possible
• Storage environment: A cool, dry and well-ventilated area is preferred. Food and pharmaceutical grade products should be kept in a separate and clean area away from other chemicals
• Tanks and equipment: Stainless steel or carbon steel is recommended. Long-term contact with equipment containing trace iron and copper can accelerate oxidation
• Incompatible substances: It must be kept separate from strong oxidizers, bases and heavy metal salts
• Fire: In most safety data sheets the product is not classified as a flammable liquid; the flash point is above 149 °C. Even so, it can burn at high temperature; it must be kept away from sparks and open flame
• Shelf life: 24 months is given by one supplier and 48 months by another. Retesting after one year is recommended for one product. At retesting, acid value, peroxide value and water are checked
• Transport: In safety data sheets the product is not classified as dangerous goods under ADR, IMDG and IATA. No UN number is assigned
• Transport classification: This may depend on the product form, composition and document date. Before shipment, the supplier’s current SDS and the applicable transport legislation should be taken as the basis
• During transport: Packaging integrity must be maintained, the product must be protected from excessive heat and direct sunlight, and it must not be loaded in a way that risks contact with non-food chemicals
SAFETY INFORMATION ON POLYSORBATE 80
Polysorbate 80 is a substance of low acute toxicity. It has been evaluated as a food additive and as a pharmaceutical excipient. In the great majority of safety data sheets it is not classified as hazardous; in some documents mild skin and eye irritation is reported.
The information below is for general information purposes and does not replace the manufacturer-specific safety data sheet. The SDS of each supplier must be taken into account.
Main safety topics:
• Hazard classes: In most SDS the product is not classified. One document reports skin irritation H316 and eye irritation H320, and another reports H412 for the aquatic environment. Classification may vary according to supplier and product composition
• Acute toxicity: The oral LD50 in rats is given in safety data sheets as about 20,000 to 42,200 mg/kg. This points to very low acute toxicity
• Food safety: The European Food Safety Authority and JECFA use an acceptable daily intake of 25 mg per kilogram per day for the group. These assessments are based on food grade product and permitted use
• Skin and eye contact: The product may cause mild irritation in the eyes and on the skin. In case of contact, rinse with plenty of water, rinse the eyes for between a few minutes and 15 minutes, and seek medical help if irritation persists
• Inhalation: Mist or vapor may irritate the respiratory tract. The person should be moved to fresh air, and medical help should be sought if symptoms persist
• Ingestion: If a large amount is swallowed, the mouth should be rinsed and, if discomfort persists, a health facility or a poison information center, 114 in Turkey, should be contacted
• Sensitization: Allergic contact reaction and hypersensitivity to polysorbate 80 have been rarely reported. The role of oxidized impurities is under discussion. For persons known to be sensitive, medical opinion should be obtained
• Fire and reactivity: The product does not ignite easily; the flash point is high. Carbon monoxide and carbon dioxide are formed in a fire. A violent reaction may occur with strong oxidizers
• Ethylene oxide and dioxane: These by-products of production are controlled in specifications with very low limits. The limits vary according to quality grade and must be verified through the COA
• Personal protective equipment: Protective glasses, gloves and suitable work clothing must be used. Ventilation should be provided in operations that produce mist
• Spills: The product should be collected with an absorbent material and placed in a closed container. Since the floor will become slippery, the remainder should be cleaned with water and detergent
• Environment: The 96-hour LC50 is reported as 471 mg/L in fish and 165 mg/L for Mysidopsis bahia. Biodegradation is given between 32 percent and 100 percent in different documents. It must not be released into waterways and the sewer
• Waste: Residual product and contaminated packaging must be disposed of according to local legislation. Product left over in food or pharmaceutical production must not be returned to the production chain
• Occupational exposure: In this work, no binding occupational exposure limit for polysorbate 80 has been verified. Current limits in Turkey and the supplier’s SDS must be checked separately
WHAT SHOULD BE CONSIDERED WHEN BUYING POLYSORBATE 80?
To choose the right product, the identity of the product must first be determined clearly. Since polysorbate 80 can be confused with polysorbate 20, 60 and 65, sorbitan monooleate and branded grades, a request that only says “polysorbate” is insufficient.
In the request, the product name Polysorbate 80 or Polisorbat 80, CAS number 9005-65-6, EC number 500-019-9 and, for food, E 433 should be stated together. Since products offered with additional wording such as “Solubilizer” may be a separate item, the full product name should be written.
The main points to consider when buying:
• Quality grade: The requirement for food, pharmaceutical, super refined, cosmetic or technical grade must be stated clearly. Technical grade must not be used in food and drugs
• Monograph and specification: Compliance with E 433 for food, and with USP/NF, the European Pharmacopoeia or the Japanese Pharmacopoeia for drugs, must be confirmed in writing
• Peroxide and impurity profile: The peroxide value, free fatty acid, water, ethylene oxide and 1,4-dioxane limits should be requested. In sensitive applications a super refined grade should be considered
• Purpose of use and legislation: In which sector, in which product category and in which country the product will be used should be clarified, and permissions and quantity limits should be verified
• Fatty acid source: The vegetable or animal origin of the oleic acid, halal and kosher status and the allergen declaration should be asked about
• Packaging and logistics: The net quantity, drum, IBC or small package option, packaging that protects from light and moisture and the storage temperature should be determined
• Batch consistency: The certificates of analysis, color and viscosity values of consecutive batches should be compared
• Shelf life: The production date and remaining shelf life of the delivered product should be asked about
• Documents: SDS, TDS, COA, a statement of compliance with the monograph, a food safety certificate and the REACH and KKDİK status should be requested
• Technical support of the supplier: Support on dosage and dissolving method in applications such as ice cream, flavor solubilization or emulsions should be evaluated
• Total cost of supply: Besides the unit price, the required dose, packaging, storage, retesting and quality control costs should be calculated together
When comparing prices, one should look not only at the price per kilogram but also at the quality grade, the peroxide level, the level of documentation and the security of supply.
SUPPLY OF POLYSORBATE 80 FROM ATAMAN KİMYA
Polysorbate 80 is a multi-purpose product evaluated as a food emulsifier, cosmetic and pharmaceutical excipient, laboratory surfactant and industrial wetting agent. On the ATAMAN KİMYA website the product appears under the names Polysorbate 80, Polysorbate 80 E433, Tween 80 and Polyoxyethylene sorbitan monooleate.
The current product pages are of the nature of general product introduction. Product-specific details such as quality grade, pharmacopoeial compliance, peroxide level, packaging, stock or documents are not included on the pages. There is also a page under the name Kolliphor PS 80; this name is a BASF brand name, and a branded product request must be confirmed separately.
For this reason it is important that companies looking for polysorbate 80 for food, drug or sensitive biopharmaceutical applications clearly confirm with ATAMAN KİMYA, before ordering, which quality grade the product is and with which documents it is supplied.
Companies wishing to get information about the supply of polysorbate 80 from ATAMAN KİMYA can request information on product suitability, current supply status, packaging options and a price quotation by sharing their areas of use and technical needs.
The current stock status of the product, its origin, quality grade, E 433 or pharmacopoeial compliance statement, peroxide and other analysis values, packaging and the regulatory conditions related to the purpose of use must be confirmed with ATAMAN KİMYA before ordering.
Sharing the following information in a quotation request makes it easier to evaluate the right polysorbate 80 product:
• Sector of use and final application
• Food, cosmetic, pharmaceutical, laboratory or technical grade requirement; E 433 for food, the target monograph for drugs
• Target product category and the country of use
• Required limits for peroxide value, acid value, water, and ethylene oxide and dioxane
• Super refined or standard grade preference
• Fatty acid source, special requirements such as halal or kosher
• Estimated order quantity
• Desired packaging type and size
• Requested technical documents: SDS, TDS, COA, monograph compliance and food safety documents
• If available, the TDS or COA information of the product currently in use
FREQUENTLY ASKED QUESTIONS ABOUT POLYSORBATE 80
What is polysorbate 80?
Polysorbate 80 is a nonionic emulsifier and solubilizer made up of sorbitan, oleic acid and about 20 ethylene oxide units. It is used in food under the code E 433, and also in cosmetics, pharmaceuticals and laboratories.
What does polysorbate 80 mean?
The name polysorbate refers to polyoxyethylene sorbitan esters, and the 80 at the end shows that the fatty acid is oleic acid. Tween 80 is Croda’s brand name. The substance is also called polyoxyethylene (20) sorbitan monooleate.
What is the CAS number of polysorbate 80?
The CAS number is 9005-65-6. Different numbers are used for other polysorbates, such as 9005-64-5 for polysorbate 20 and 9005-67-8 for polysorbate 60; therefore the number should be checked in the request.
What is the EC / EINECS number of polysorbate 80?
The EC number is 500-019-9. In safety data sheets this number is commonly given for polysorbate 80.
What is the chemical formula of polysorbate 80?
Its typical representation is C₆₄H₁₂₄O₂₆ and its molecular weight is about 1310 g/mol. Since the commercial product is a mixture, these values are averages. The formula C₂₄H₄₄O₆ belongs to non-ethoxylated sorbitan monooleate.
What is the HLB value of polysorbate 80 and what does it mean?
The HLB value is about 15. This shows that the water-loving side of the molecule dominates and that it is suitable for emulsions in which oil is dispersed in water, and for solubilization.
What is the INCI name of polysorbate 80?
The INCI name is Polysorbate 80. The existence of an INCI name does not mean the product can be used without limit in every cosmetic product.
Is polysorbate 80 used in cosmetics?
Yes. It takes part as an emulsifier and solubilizer in lotions, creams, shampoos and oral care products. The Cosmetic Ingredient Review panel found it safe at current use concentrations.
Does polysorbate 80 have an E code?
Yes. In food it is known as E 433 and in the Codex system as INS 433. The other polysorbates carry the codes E 432, E 434, E 435 and E 436.
What is the difference between polysorbate 80 and polysorbate 20?
Polysorbate 80 contains oleic acid and polysorbate 20 contains lauric acid. Polysorbate 20 is more hydrophilic and milder; polysorbate 80 is more compatible with oil phases. Their fields of use partly overlap, and one must not be replaced by the other without trials.
What is polysorbate 80 used for?
It is used to disperse oil in water, to solubilize water-insoluble substances, to regulate fat structure in ice cream, to wet surfaces and to support the stability of proteins.
In which sectors is polysorbate 80 used?
It is used in the food, ice cream, beverage, cosmetic, pharmaceutical and biotechnology, laboratory, agriculture and paint, textile and lubricant sectors.
How does polysorbate 80 perform its solubilizing function?
Above a certain concentration it forms micelles in water. Since the micelle core is oil-loving, it takes flavor oils and fat-soluble substances inside, while the hydrated outer shell keeps them clear in water.
What does polysorbate 80 do?
It prevents the separation of oil and water, disperses water-insoluble substances, gives texture to ice cream, lowers surface tension and protects proteins from interfacial stress in biological products.
How does polysorbate 80 work in ice cream?
It partially removes the milk proteins on the surface of fat globules. The globules cluster in a controlled way during freezing, a fat network that traps air is formed, and the product becomes dry, smooth and resistant to melting.
Is polysorbate 80 soluble in water?
Yes. It is soluble in water, ethanol and methanol. It is practically insoluble in fixed oils and liquid paraffin. Its aqueous solution is clear or slightly opalescent.
How much polysorbate 80 is used in ice cream?
In supplier sources a level of about 0.02–0.06 percent alone is mentioned. The upper limit for ice cream in the USA is 0.1 percent. Current legislation for Turkey and the EU should be checked.
Is polysorbate 80 a hazardous substance?
In most safety data sheets it is not classified as hazardous. Its acute toxicity is very low. Some documents contain statements of mild irritation or of the aquatic environment. Even so, it should be used with protective glasses and gloves.
Why can polysorbate 80 degrade or form peroxides?
The double bond of oleic acid and the polyethylene oxide chains can be oxidized by light, oxygen, heat and trace metals. The ester bond is hydrolyzed in moisture or by enzyme action. For this reason the peroxide and acid values are monitored.
Is polysorbate 80 registered under REACH?
The registration status may vary according to the product, the manufacturer and the importer. In this work the ECHA registration has not been verified first-hand. The REACH registration number or exemption statement and the KKDİK status for Turkey should be requested from the supplier.
What is the physical appearance of polysorbate 80?
It is a clear, amber or yellow, oily and viscous liquid. It may have a slightly characteristic odor. Its density is about 1.06–1.10 g/cm³.
What is the UN number of polysorbate 80?
In safety data sheets the product is not classified as dangerous goods in road, sea and air transport, so no UN number is assigned. The supplier’s current SDS should be checked before shipment.
Why are peroxide, ethylene oxide and dioxane important in polysorbate 80?
Peroxides spoil the stability of the product and of sensitive components. Ethylene oxide and 1,4-dioxane are residues from production and are controlled in specifications with very low limits. The values should be verified through the COA.
What does the price of polysorbate 80 depend on?
The price varies according to quality grade, peroxide level, whether it is super refined, fatty acid source, packaging, order quantity, origin, certification and logistics conditions. Pharmaceutical and super refined grades increase the cost.
Does polysorbate 80 have an alternative?
Yes. Polysorbate 20, 60 and 65, mono- and diglycerides, lecithin, sucrose esters, polyglycerol esters, castor oil ethoxylates and poloxamer 188 can be alternatives depending on the application. None is a direct substitute in every system.
How should polysorbate 80 be stored?
It should be stored in a cool, dry and ventilated place, in its closed original packaging, away from light, moisture, heat, strong oxidizers and bases. In sensitive uses small packages and inert gas may be preferred.
Which documents should be requested when buying polysorbate 80?
SDS, TDS and batch-based COA are the basic documents. In addition, an E 433 or pharmacopoeial compliance statement, a food safety certificate, the fatty acid source and allergen declaration, and a halal or kosher certificate may be requested.
Which technical properties are important when buying polysorbate 80?
Quality grade, oleic acid content, acid value, peroxide value, water, ethylene oxide, 1,4-dioxane, heavy metals, viscosity, color, shelf life and packaging are important.
POLYSORBATE 80 – TECHNICAL SUMMARY
Chemical name: Polyoxyethylene (20) sorbitan monooleate; polysorbate 80
Common name: Polysorbate 80, Polisorbat 80, Tween 80, E 433
CAS No: 9005-65-6
EC / EINECS No: 500-019-9
Molecular formula: C₆₄H₁₂₄O₂₆ (typical representation)
Molecular weight: About 1309.68 g/mol
Chemical class: Nonionic, polyethoxylated sorbitan fatty acid ester; hydrophilic emulsifier
Physical appearance: Clear, amber or yellow, oily viscous liquid
Key properties: HLB about 15, density about 1.06–1.10 g/cm³, viscosity 300–500 mm²/s at 25 °C, soluble in water and ethanol, pH 5–7, flash point mostly above 149 °C
Main functions: Emulsifier, solubilizer, dispersant, wetting agent, stabilizer
Important application areas: Ice cream and food emulsions, beverage flavors and vitamin dispersions, cosmetics, pharmaceuticals and biopharmaceuticals, laboratory buffers, agriculture and industrial emulsions
Parameters critical for quality control: Quality grade, oleic acid content, acid value, saponification and hydroxyl value, water, peroxide value, ethylene oxide, 1,4-dioxane, heavy metals, appearance and viscosity
Storage: In a cool, dry and ventilated area, in closed packaging; separate from light, moisture, heat, strong oxidizers and bases
Regulation: In the EU, E 433 food additive and acceptable daily intake of 25 mg/kg body weight/day for the group E 432–436; in the USA under 21 CFR 172.840; not covered by dangerous goods transport in most SDS; REACH and KKDİK status, Turkish legislation and permissions for use must be confirmed with the supplier and current legislation.
