POLYSORBATE 80 ( POLYSORBAT 80) Polisorbat 80
IUPAC name: Polyoxyethylene (20) sorbitan monooleate; Tween 80; E number: E433;CAS-No: 9005-65-6 ; Polysorbate 80 (INCI: polyoxyethylene (20), sorbitan monooleate) is an amber/golden-colored viscous liquid used as as an emulsifier or surfactant in foods, medicines, skincare products, vaccines etc. It also acts as a surfactant in soaps and cosmetics.Tween 80; Polyoxyethylene Sorbitan Monooleate; POE (20) sorbitan monooleate; Polysorbate 80; polyethyleneglycol sorbitan monooleate 1-6.5 moles ethoxylated; Sorbitan monooleate, ethoxylated. Polysorbate 80 is used as an emulsifier in foods. Tween 80, polysorbates are a class of emulsifiers used in pharmaceuticals and food preparation. They are often used in cosmetics to solubilise essential oils and fragrance oils into water-based products.
Emulsifier, dispersant, solubilizer, lubricant, detergent, antistat, wetting agent for cosmetics & pharmaceuticals, polishes, insecticides, leather degreasing and veterinary products.
A non-ionic, hydrophilic emulsifier, co-emulsifier and solubilizer for pharmaceutical preparations like emulsions and creams, gels and foams as well as softgels.
Polysorbates are non-ionic surfactants and emulsifiers derived from polyethoxylated sorbitan and stearic or oleic acid.
Polysorbates are mainly used as a solubilizer, emulsifier or suspension stabilizer for pharmaceutical application. Depending on the HLB value of the product they can either act as solubilzer or emulsifier.
Polysorbate 80 is its high HLB value more suitable as a solubilizer of poorly water soluble drug substances in either liquid or solid dosage forms.
It is suitable for usage in physical mixing, melt granulation, spray drying and hot melt extrusion processes.
Polysorbate 80 can be used as an emulsifier in foods, medicines, cosmetics, textiles, agriculture, and occasionally in laboratory identification of bacteria.
Use: Polysorbate 80 is a common fragrance and essential oil solublizer as well as an emulsifying agent. It is soluble in water and alcohol and insoluble in oils.
It is typically a co-emulsifier that is used both as a viscosity modifier and a dispersing agent for fragrances and essential oils for room sprays and linen sprays.
When combined with liquid oils, Polysorbate 80 creates a blooming bath oil.
It can also be used in a self-emulsifying sugar or salt scrub.
In bath bombs, you can add up to 6% as a wetting agent to help prolong fizzing in the tub.
Previous name: Polysorbate 80 PH
CAS-No.: 9005-65-6
Regulatory Status: Ph. Eur, USP/NF: Polysorbate 80
General characterization: Kolliphor® PS 80 is a oily, colorless or brownish-yellow, clear or slightly opalescent liquid.
Skin Tolerance: Our Kolliphor® PS types have a good skin tolerance.
Raw material origin: All Kolliphor® PS grades are based on vegetable and synthetic raw materials.
Application
Solubilizer, suspension stabilizer, emulsifier, skin penetration enhancer.
Kolliphor® PS 20 is suitable for oral solid dosage forms, semi solid dosage forms and liquid dosage forms. It can also be used as solubilizer in softgel formulations.
Polysorbate 80
Accession Number
DB11063
Description
Polysorbate, a substance formulated by the reaction of sorbitan fatty acid ester (a nonionic surfactant) with ethylene oxide, is used in many foreign countries, including the U.S. and the EU, where it acts as an emulsifier, a solubilizer in many foods, including bread, cake mix, salad dressing, shortening oil and chocolate 18.
Polysorbate 80 is a hydrophilic nonionic surfactant. It is utilized as a surfactant in soaps and cosmetics and also as a lubricant in eye drops. In food or pharmaceutical products, it can act as an emulsifier. Polysorbate 80 is an excipient that is used to stabilize aqueous formulations of medications for parenteral administration or vaccinations.15
A solubilizing agent acts as a surfactant and increases the solubility of one agent in another. A substance that would not normally dissolve in a particular solution is able to dissolve with the use of a solubilizing agent.15
It is also known as an emulsifier, which helps ingredients mix together and prevent separation, and water-containing small amounts of salts, and is included in several vaccines licensed in the USA.9
Polysorbate 80
Tween 80
PHARMACOLOGY
Indication
It is used as a solubilizer, antimicrobial preservative and disinfectant 16.
Associated Conditions
Eye lubrication
Eye discomfort
Polysorbate 80 is a nonionic surfactant and emulsifier often used in foods and cosmetics.
This synthetic compound is a viscous, water-soluble yellow liquid.
General description
Polysorbate 80 is a surfactant.
Polysorbates are a combination of oleic esters of sorbitol and sorbitanes with polyethylene glycol chains.
Application
Polysorbate 80 has been used in drug (rapamycin) treatment and to study the effect of rapamycin on osteolysis and tumor growth.
It has also been used in the preparation of spray-dried emulsions and to study antibacterial efficacy
Biochem/physiol Actions
Polysorbates is used as emulsifiers, dissolving agents and stabilizer for essential oils, topical application and medical infusions including intravenous, subcutaneous or intramuscular administration.
Chemistry
Polysorbate 80 is derived from polyethoxylated sorbitan and oleic acid. The hydrophilic groups in this compound are polyethers also known as polyoxyethylene groups, which are polymers of ethylene oxide. In the nomenclature of polysorbates, the numeric designation following polysorbate refers to the lipophilic group, in this case, the oleic acid (see polysorbate for more detail).
It is an amber/golden-colored viscous liquid. It is made from polyethoxylated sorbitan (chemical compounds derived from the dehydration of sugar alcohol) and oleic acid, a fatty acid found in animal and vegetable fats.
The full chemical names for polysorbate 80 are:
Polyoxyethylene (20) sorbitan monooleate
(x)-sorbitan mono-9-octadecenoate poly(oxy-1,2-ethanediyl)
The critical micelle concentration of polysorbate 80 in pure water is reported as 0.012 mM
POE (20) sorbitan monooleate, Polyethylene glycol sorbitan monooleate, Polyoxyethylenesorbitan monooleate, Polysorbate 80, Polysorbatum 80, TWEEN 80
CAS Number 9005-65-6
IUPAC name
Polyoxyethylene (20) sorbitan monooleate
PS 80
CAS Number: 9005-65-6
E number: E433
Alkest TW 80
Scattics
Canarcel
Poegasorb 80
Montanox 80
Tween 80
Kolliphor PS 80
Tween 80; Polyoxyethylene Sorbitan Monooleate; POE (20) sorbitan monooleate; Polysorbate 80; polyethyleneglycol sorbitan monooleate 1-6.5 moles ethoxylated; Sorbitan monooleate, ethoxylated
CAS names
Sorbitan, mono-(9Z)-9-octadecenoate, poly(oxy-1,2-ethanediyl) derivs.
IUPAC names
2-[2-[3,5-bis(2-hydroxyethoxy)oxolan-2-yl]-2-(2-hydroxyethoxy)ethoxy]ethyl (E)-octadec-9-enoate
Sorbitan monooleate ethoxylated (CAS # 9005-65-6)
SORBITAN MONOOLEATE, ETHOXYLATED
Sorbitan monooleate, ethoxylated
Tween 80
Trade names
Leunapon-SMO
Other names
Polyoxyethylene-80-sorbitan monooleate
Sorbitan, mono-(9Z)-9-octadecenoate, poly(oxy-1,2-ethanediyl) derivs.
Uses
Food use
Polysorbate 80 is used as an emulsifier in foods.
What is it?
This is a well known synthetic compound, also known as Tween 80.
It is an amber/golden-colored viscous liquid. It is made from polyethoxylated sorbitan (chemical compounds derived from the dehydration of sugar alcohol) and oleic acid, a fatty acid found in animal and vegetable fats.
What does it do?
Polysorbate 80 is used as an emulsifier or defoamer in foods, vitamins, medicines, and vaccines.
Why is it used in food?
It is used as a defoamer for the fermenting process of some wines, and also to bind some ice-creams and other ‘puddings’, to keep their creamy texture without separating. It is also used to bulk foods up and keep sauces smooth.
Why is it used in cosmetics?
It can also act as a surfactant in soaps and cosmetics, as well as a solubilizer – helping to dissolve ingredients so that they can more easily blend together. It is used as a solubilizer. It makes products look creamier and more attractive.
Why is it used in medicine?
It is used as an ingredient in some vaccines, as well as in some vitamins and supplements. Polysorbate 80 is used to improve the consistency of gel capsules and to make pills disperse in the stomach.
What products is it used in?
Polysorbate 80 is a versatile and useful ingredient, so it is present in quite a few products. Here is a short, generalized list of where it is most often found:
• Food shortening
• Chewing Gum
• Ice Cream
• Gelatin
• Vitamins
• Soap
• Shampoo
• Cosmetics
• Skin Creams
• Condiments
• Medicines
• Vaccines
For example, in ice cream, polysorbate is added up to 0.5% (v/v) concentration to make the ice cream smoother and easier to handle, as well as increasing its resistance to melting.
Adding this substance prevents milk proteins from completely coating the fat droplets.
This allows them to join together in chains and nets, which hold air in the mixture, and provide a firmer texture that holds its shape as the ice cream melts.
Health and beauty use
Polysorbate 80 is also used as a surfactant in soaps and cosmetics (including eyedrops), or a solubilizer such as in a mouthwash.
The cosmetic grade of polysorbate 80 may have more impurities than the food grade.
Medical use
Polysorbate 80 is an excipient that is used to stabilize aqueous formulations of medications for parenteral administration, and used as an emulsifier in the making of the popular antiarrhythmic amiodarone.
It is also used as an excipient in some European and Canadian influenza vaccines.
Influenza vaccines contain 2.5 μg of polysorbate 80 per dose. Polysorbate 80 is found in many vaccines used in the United States.
It is also used in the culture of Mycobacterium tuberculosis in Middlebrook 7H9 broth. It is also used as an emulsifier in the estrogen-regulating drug Estrasorb.
Also used in granulation for stabilization of drug and excipients while doing IPA binding
Laboratory use
Some mycobacteria contain a type of lipase (enzyme that breaks up lipid molecules); when these species are added to a mixture of polysorbate 80 and phenol red, they cause the solution to change color, so this is used as a test to identify the phenotype of a strain or isolate.
On RODAC agar plates used in microbiological control, polysorbate 80 counteracts any disinfectants often found on sampled surfaces, thereby allowing the microbes found on these surfaces to grow.
Chemical formula: C64H124O26
Molar mass: 1310 g/mol
Appearance: Amber colored liquid
Density: 1.102 g/mL, oily liquid
Boiling point: > 100°C
Solubility in water: 100 mL/L
Solubility in other solvents: soluble in ethanol, cottonseed oil, corn oil, ethyl acetate, methanol, toluene
Viscosity: 300–500 centistokes (@25°C
Polysorbate 80 (glycol)
Polyoxyethylene 20 sorbitan monooleate
Inhibited ethylene glycol, antifreeze
2-hydroxyethyl 2-deoxy-3,5-bis-O-(2-hydroxyethyl)-6-O-{2-[(9E)-octadec-9-enoyloxy]ethyl}hexofuranoside
PEG-3 Sorbitan oleate
sorbate80
glycosperse 0-20
Tween&trade 80
glycosperse 0-20x
liposorb 0-20
glycospers e 0-20
Polyoxyethylene (20)
glycosperse 0-20 veg
Tween(R) 80
polysorb ate 80 b.p.c
Polysorbate 80 B.P.C
Polysorbate 80, U.S.P
POE(6) Sorbitan Monooleate
POE (5) sorbitan monooleate
Sorethytan (20) mono-oleate
POE (20) sorbitan monooleate
Sorbitan mono-oleate polyoxyethylene
Polyethylene oxi de sorbitan mono-oleate
Polysorbate 80 [USAN:BAN:INN:JAN]
2-[2-[3,5-bis(2-hydroxyethoxy)oxolan-2-yl]-2-(2-hydroxyethoxy)ethoxy]ethyl (E)-octadec-9-enoate
Sorbitan, monooleate polyoxyethylene deriv
CAS-9005-65-6
POLYOXYETHYLENESORBITAN MONOOLEATE (TWEEN 80)
(x)-sorbitan mono-9-octadecenoate poly(oxy-1,2-ethanediyl) derivs
Sorbitan, mono-9-octadecenoate, poly(oxy-1,2-ethanediyl) derivs
Sorbitan, mono-(9Z)-9-octadecenoate, poly(oxy-1,2-ethanediyl) derivs
Sorbitan, mono-9-octadecanoate, poly(oxy-1,2-ethanediyl) derivs., (Z)-
2-hydroxyethyl 2-deoxy-3,5-bis-O-(2-hydroxyethyl)-6-O-[2-(oleoyloxy)ethyl]hexofuranoside
See also
Polysorbate 20, used as a wetting agent in mouth drops
Polysorbate 40
Polysorbate 60, used as an emulsifier in powdered drink preparations such as hot cocoa mix
Polysorbate 65
polisorbato Español
polysorbate Français
polysorbate
Polysorbate 80
polysorbatum LINGUA LATINA
Synonyms
Glycol (polysorbate 80)
Polyethylene oxide sorbitan mono-oleate
Polyoxyethylene (20) sorbitan monooleate
Polyoxyethylene sorbitan monooleate
Polyoxyethylene sorbitan oleate
Tween 80
Sorbitan Fatty Acid Esters
Polyoxyethylene sorbitan esters are synthesized by the addition, via polymerization, of ethylene oxide to sorbitan fatty acid esters.
These nonionic hydrophilic emulsifiers are very effective antistaling agents and, thus, are used in a wide variety of bakery products.
These emulsifiers are much more widely known as the polysorbates, e.g., polysorbate 20, 60, and 80.
Polysorbate 20, 60, and 80 utilize lauric, stearate, and oleate, respectively, for the fatty acid portion of the molecule.
Polysorbate 60 is a monostearate, whereas polysorbate 65 is a tristearate.
Use: Our Polysorbate 80 (polyoxyethylene sorbitan monooleate) is derived from olive oil.
It is a non-toxic, nonionic surfactant/emulsifier and a water-soluble yellowish liquid used as a dispersing agent which allows oil and water to mix without the use of alcohol.
It is a fragrance solubilizer and stabilizer; it lubricates and has a soothing effect on the skin.
This skin- safe ingredient is used extensively in oil-in-water emulsions (lotions, conditioners, cream rinses, shampoos, liquid soaps, body polishes or scrubs, etc.) and also for body mists and linen sprays.
Will be found as an ingredient in many body toiletries, cosmetics and wipes now in the market.
Emulsifier, dispersant, solubilizer, lubricant, detergent, antistat, wetting agent for cosmetics & pharmaceuticals, polishes, insecticides, leather degreasing and veterinary products.
Sorbitol is a white, sweetish, hygroscopic, crystalline sugar alcohol of six-carbon. It is found naturally in various berries and fruits. Or it is prepared synthetically by high-pressure catalytic hydrogenation of glucose sugar derived from cornstarch. It melts at 93 to 98 C depending on the form. It is used as a a sweetening agent, food additive, toothpaste, tobacco, toiletries and in cosmetics. It is used for vitamin-C fermentation. It is used as a excipient and intravenous osmotic diuretic in pharmaceutical fields. It is also used in the manufacture of polyethers for polyurethanes and surfactants. The term sorbitan describes the anhydride form of sorbitol, whose fatty acids are lipophilic whereas sorbitol body is hydrophilic. This bifunctionality in one molecule provides the basic properties useful in cleaners, detergents, polymer additives, and textile industry as emulsifiers, wetting agents, and viscosity modifiers. Sorbitan esters are rather lipophilic (or hydrophobic) surfactants exhibiting low HLB (Hydrophilic-Lipophilic Balance) values; having an affinity for, tending to combine with, or capable of dissolving in lipids (or water-insoluble). While, the ethoxylated sorbitan esters are hydrophilics exhibiting high HLB values; having an affinity for water; readily absorbing or dissolving in water. The type of fatty acid and the mole number of ethylene oxide provides diverse HLB values for proper applications.
HLB numbers describe following characterestics:
<10 : Lipid soluble (or water-insoluble)
>10 : Water Soluble
4-8 : Antifoaming
7-11 : Water-in-oil emulsion
12-16 : Oil-in-water emulsion
11-14 : Good Wetting
12-15 : Good detergency
16-20 : Stabilizing
HLB values of sorbitan compounds are:
Surfactants
HLB Value
CAS RN
Sorbitan hexastearate ethoxylate EO 6 mole
3.0
Sorbitan isostearate
4.3
Sorbitan laurate
8.6
1338-39-2
Sorbitan monoisostearate ethoxylate EO 20 mole
15.0
66794-58-9
Sorbitan monolaurate ethoxylate EO 20 mole
16.9
9005-64-5
Sorbitan monooleate ethoxylate EO 20 mole
15.0
9005-65-6
Sorbitan monopalmitate ethoxylate EO 20 mole
15.6
9005-66-7
Sorbitan monostearate ethoxylate EO 20 mole
14.9
9005-67-8
Sorbitan monstearate ethoxylate EO 6 mole
9.5
Sorbitan oleate
4.3
1338-43-8
Sorbitan palmitate
6.7
26266-57-9
Sorbitan sesquioleate
4.5
8007-43-0
Sorbitan stearate
4.7
1338-41-6
Sorbitan tetraoleate ethoxylate EO 30 mole
11.5
Sorbitan tetraoleate ethoxylate EO 40 mole
12.5
Sorbitan tetraoleate ethoxylate EO 6 mole
8.5
63089-86-1
Sorbitan tetrastearate ethoxylate EO 60 mole
13.0
66828-20-4
Sorbitan trioleate ethoxylate EO 20 mole
11.0
9005-70-3
Sorbitan trioleate
1.8
26266-58-0
Sorbitan tristearate ethoxylate EO 20 mole
10.5
9005-71-4
Sorbitan tristearate
2.1
26658-19-5
This is a safety assessment of polysorbates as used in cosmetics. These ingredients mostly function as surfactants in
cosmetics. The safety assessment combined the polysorbates reviewed in 3 former safety assessments with polysorbates that
had not been assessed for safety into 1 report. The Panel reviewed relevant data related to these ingredients. The Cosmetic
Ingredient Review (CIR) Expert Panel (Panel) concluded that polysorbates were safe as cosmetic ingredients in the practices
of use and concentration of this safety assessment when formulated to be nonirritating. This conclusion supersedes the
conclusion reached in the 3 former safety assessments.
INTRODUCTION
This is a re-review of the available scientific literature and unpublished data relevant to assessing the safety of
polysorbates as used in cosmetics (Table 1). This safety assessment combines polysorbates reviewed previously in 3 safety
assessments with other polysorbates that have not been reviewed by the CIR Panel into a group of 82 polyethoxylated
sorbitan or sorbitol esters of fatty acids (Table 2). These ingredients have a common core structure of sorbitan or sorbitol,
etherified with polyethyoxy (PEG) chains, and esterified with fatty acids. These ingredients mostly function as surfactants in
cosmetics.
In the original safety assessment published in 1984, the CIR Panel concluded that 9 polysorbates were safe as used
These ingredients are:
1
Polysorbate 20
Polysorbate 21
Polysorbate 40
Polysorbate 60
Polysorbate 61
Polysorbate 65
Polysorbate 80
Polysorbate 81
Polysorbate 85
Other polysorbates, which are also polyethoxylated sorbitan or sorbitol esters of fatty acids and contain a PEG
moiety, have been reviewed by the CIR Panel. In 20002
, a safety assessment was published with a safe-as-used conclusion
for the following 33 PEG sorbitan/sorbitol fatty acid esters:
PEG-20 sorbitan cocoate
PEG-40 sorbitan diisostearate
PEG-2 sorbitan isostearate
PEG-5 sorbitan isostearate
PEG-20 sorbitan isostearate
PEG-40 sorbitan lanolate
PEG-75 sorbitan lanolate
PEG-10 sorbitan laurate
PEG-40 sorbitan laurate
PEG-44 sorbitan laurate
PEG-75 sorbitan laurate
PEG-80 sorbitan laurate
PEG-3 sorbitan oleate
PEG-6 sorbitan oleate
PEG-80 sorbitan palmitate
PEG-40 sorbitan perisostearate
PEG-40 sorbitan peroleate
PEG-3 sorbitan stearate
PEG-6 sorbitan stearate
PEG-40 sorbitan stearate
PEG-60 sorbitan stearate
PEG-20 sorbitan tetraoleate
PEG-30 sorbitan tetraoleate
PEG-40 sorbitan tetraoleate
PEG-60 sorbitan tetraoleate
PEG-60 sorbitan tetrastearate
PEG-20 sorbitan triisostearate
PEG-160 sorbitan triisostearate
PEG-18 sorbitan trioleate
Sorbeth-40 hexaoleate (previously PEG-40 sorbitol
hexaoleate)
Sorbeth-50 hexaoleate (previously PEG-50 sorbitol
hexaoleate)
Sorbeth-30 tetraoleate laurate (previously PEG-30
sorbitol tetraoleate laurate)
Sorbeth-60 tetrastearate (previously PEG-60 sorbitol
tetrastearate)
There were 2 ingredients that were included in the 2000 report, but were not listed in the International Cosmetic Ingredient
Dictionary and Handbook3 (Dictionary) at the time of the original review, and are not listed as cosmetic ingredients in the
current Dictionary.
One is PEG-18 sorbitan trioleate, which has 1 use listed in the Food and Drug Administration’s (FDA)
Voluntary Cosmetic Registration Program (VCRP)5 and is therefore included in this safety assessment. However, PEG-20
sorbitan tetraoleate has no uses listed in the VCRP, so is not included in this safety assessment.
In 20016, a safety assessment was published with a safe-as-used conclusion for the following sorbitan beeswaxes:
Sorbeth-6 beeswax (formerly PEG-6 sorbitan beeswax)
Sorbeth-8 beeswax (formerly PEG-8 sorbitan beeswax)
Sorbeth-20 beeswax (formerly PEG-20 sorbitan beeswax)
At the time of this safety assessment, the Panel had recommended that cosmetic formulations containing PEGs (specifically
PEG-6, PEG-20, and PEG-75) not be used on damaged skin. Since then, PEGs have been re-reviewed and the Panel has
removed the caveat that PEGs should not be used on damaged skin.
7
A brief summary of pertinent data from each report is provided below. The original polysorbate reports can be found
on the CIR website, http://www.cir-safety.org/ingredients. Please refer to the original reports for detailed information.
The following 35 ingredients, which are also polyethoxylated sorbitan or sorbitol esters of fatty acids, are proposed
as additions to this group:
PEG-20 sorbitan oleate
PEG-40 sorbitan oleate
PEG-4 sorbitan stearate
PEG-4 sorbitan triisostearate
PEG-2 sorbitan trioleate
PEG-3 sorbitan tristearate
Sorbeth-2 beeswax
Sorbeth-2 cocoate
Sorbeth-2 hexacaprylate/caprate
Sorbeth-12 hexacocoate
Sorbeth-2 hexaisostearate
Sorbeth-2 hexalaurate
Sorbeth-2 hexaoleate
Sorbeth-6 hexastearate
Sorbeth-150 hexastearate
Sorbeth-3 isostearate
Sorbeth-6 laurate
Sorbeth-2/oleate/dimer dilinoleate crosspolymer
Sorbeth-20 pentaisostearate
Sorbeth-30 pentaisostearate
Sorbeth-40 pentaisostearate
Sorbeth-50 pentaisostearate
Sorbeth-40 pentaoleate
Sorbeth-20 tetraisostearate
Sorbeth-30 tetraisostearate
Sorbeth-40 tetraisostearate
Sorbeth-50 tetraisostearate
Sorbeth-4 tetraoleate
Sorbeth-6 tetraoleate
Sorbeth-30 tetraoleate
Sorbeth-40 tetraoleate
Sorbeth-60 tetraoleate
Sorbeth-3 tristearate
Sorbeth-160 tristearate
Sorbeth-450 tristearate
The VCRP reported single uses for 3 other ingredients that are not listed in the Dictionary.8
Since there are reported
uses for these 3 ingredients, they are also included in this safety assessment:
PEG-30 sorbitan beeswax
PEG-20 sorbitan laurate
PEG-20 sorbitan stearate
CIR has conducted safety assessments of the acids and related chemical structure moieties of these ingredients
(Table 2). The Panel concluded that beeswax, coconut acid, isostearic acid, lanolin acid, oleic acid, lauric acid, myristic acid,
stearic acid, and multiple stearates were safe-as-used.9-17 An array of alkyl esters and numerous PEGs were also assessed to
be safe as used.7,18,19 Sorbitan esters have been reviewed with safe-as-used conclusions.20-22
Much of the new data included in this safety assessment were found on the European Chemicals Agency (ECHA)
website.
23-25 The ECHA website provides robust summaries of information generated by industry, and it is those summary
data that are reported in this safety assessment when ECHA is cited. Some of this data are for generic sorbitan monolaurate,
ethoxylated and sorbitan monostearate, ethoxylate; these chemicals fit the general definition of several of these ingredients
with the same CAS No. (ie, polysorbate 21, PEG-10 sorbitan laurate, PEG-40 sorbitan laurate, polysorbate 20, PEG-44
sorbitan laurate, PEG-75 sorbitan laurate, and PEG-80 sorbitan laurate all have the CAS No. 9005-64-5). It is expected that
data under these chemicals names are for one or some mixture of the ingredients with that CAS No and are useful for read
across information.
Polysorbate 80.
The food additive polysorbate 80 (polyoxyethylene (20) sorbitan monooleate), which is a mixture of polyoxyethylene ethers of mixed partial oleic acid esters of sorbitol anhydrides and related compounds, may be safely used in food in accordance with the following prescribed conditions:
(a) The food additive is manufactured by reacting oleic acid (usually containing associated fatty acids) with sorbitol to yield a product with a maximum acid number of 7.5 and a maximum water content of 0.5 percent, which is then reacted with ethylene oxide.
(b) The food additive meets the following specifications:
Saponification number 45-55.
Acid number 0-2.
Hydroxyl number 65-80.
Oxyethylene content 65 percent-69.5 percent.
(c) The additive is used or intended for use as follows:
(1) An emulsifier in ice cream, frozen custard, ice milk, fruit sherbet, and nonstandardized frozen desserts, when used alone or in combination with polysorbate 65 whereby the maximum amount of the additives, alone or in combination, does not exceed 0.1 percent of the finished frozen dessert.
(2) In yeast-defoamer formulations whereby the maximum amount of the additive does not exceed 4 percent of the finished yeast defoamer and the maximum amount of the additive in the yeast from such use does not exceed 4 parts per million.
(3) As a solubilizing and dispersing agent in pickles and pickle products, whereby the maximum amount of the additive does not exceed 500 parts per million.
(4) As a solubilizing and dispersing agent in:
(i) Vitamin-mineral preparations containing calcium caseinate in the absence of fat-soluble vitamins, whereby the maximum intake of polysorbate 80 shall not exceed 175 milligrams from the recommended daily dose of the preparations.
(ii) Fat-soluble vitamins in vitamin and vitamin-mineral preparations containing no calcium caseinate, whereby the maximum intake of polysorbate 80 shall not exceed 300 milligrams from the recommended daily dose of the preparations.
(iii) In vitamin-mineral preparations containing both calcium caseinate and fat-soluble vitamins, whereby the maximum intake of polysorbate 80 shall not exceed 475 milligrams from the recommended daily dose of the preparations.
(5) As a surfactant in the production of coarse crystal sodium chloride whereby the maximum amount of the additive in the finished sodium chloride does not exceed 10 parts per million.
(6) In special dietary foods, as an emulsifier for edible fats and oils, with directions for use which provide for the ingestion of not more than 360 milligrams of polysorbate 80 per day.
(7) As a solubilizing and dispersing agent for dill oil in canned spiced green beans, not to exceed 30 parts per million.
(8) As an emulsifier, alone or in combination with polysorbate 60, in shortenings and edible oils intended for use in foods as follows, when standards of identity established under section 401 of the act do not preclude such use:
(i) It is used alone in an amount not to exceed 1 percent of the weight of the finished shortening or oil.
(ii) It is used with polysorbate 60 in any combination providing no more than 1 percent of polysorbate 80 and no more than 1 percent of polysorbate 60, provided that the total combination does not exceed 1 percent of the finished shortening or oil.
(iii) The 1-percent limitation specified in paragraph (c)(8) (i) and (ii) of this section may be exceeded in premix concentrates of shortening or edible oil if the labeling complies with the requirements of paragraph (d) of this section.
(9) As an emulsifier in whipped edible oil topping with or without one or a combination of the following:
(i) Sorbitan monostearate;
(ii) Polysorbate 60;
(iii) Polysorbate 65;
whereby the maximum amount of the additive or additives used does not exceed 0.4 percent of the weight of the finished whipped edible oil topping.
(10) It is used as a wetting agent in scald water for poultry defeathering, followed by potable water rinse. The concentration of the additive in the scald water does not exceed 0.0175 percent.
(11) As a dispersing agent in gelatin desserts and in gelatin dessert mixes, whereby the amount of the additive does not exceed 0.082 percent on a dry-weight basis.
(12) As an adjuvant added to herbicide use and plant-growth regulator use dilutions by a grower or applicator prior to application of such dilutions to the growing crop. Residues resulting from such use are exempt from the requirement of a tolerance. When so used or intended for use, the additive shall be exempt from the requirements of paragraph (d)(1) of this section.
(13) As a defoaming agent in the preparation of the creaming mixture for cottage cheese and lowfat cottage cheese, as identified in §§ 133.128 and 133.131 of this chapter, respectively, whereby the amount of the additive does not exceed .008 percent by weight of the finished products.
(14) As a surfactant and wetting agent for natural and artificial colors for use in barbecue sauce where the level of the additive does not exceed 0.005 percent by weight of the barbecue sauce.
(d) To assure safe use of the additive, in addition to the other information required by the Act:
(1) The label of the additive and any intermediate premixes shall bear:
(i) The name of the additive.
(ii) A statement of the concentration or strength of the additive in any intermediate premixes.
(2) The label or labeling shall bear adequate directions to provide a final product that complies with the limitations prescribed in paragraph (c) of this section.