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POLYSORBATE 80

POLYSORBATE 80; N° CAS : 9005-65-6; Origine(s) : Synthétique. Nom INCI : POLYSORBATE 80; Noms français : ETHOXYLATED ANHYDROSORBITOL MONO-OLEATE; ETHOXYLATED SORBITAN MONOOLEATE; Mono-oléate de polyoxyéthylènesorbitanne; POLYETHYLENE GLYCOL SORBITAN MONOOLEATE; POLYOXYETHYLENE SORBITANNE MONOOLEATE; SORBITAN, MONO-9-OCTADECENOATE, POLY(OXY-1,2-ETHANEDIYL) DERIVS., (Z)-; SORBITAN, MONO-9-OCTADECENOATE, POLY-1,2-ETHANEDIYL, DERIVS.; SORBITAN, MONOOLEATE POLYOXYETHYLENE DERIV.; SORBITAN, MONOOLEATE, POLYOXYETHYLENE DERIVS. Utilisation et sources d'émission: Fabrication de produits pharmaceutiques, fabrication de cosmétiquesClassification : Composé éthoxylé, Tensioactif non ionique. Le polysorbate 80 est utilisé dans les cosmétiques en tant que tensioactif non ionique (HLB 15) et émulsifiant : il aide l'huile à se mélanger à l'eau pour former des émulsions, il permet aussi aux autres ingrédients de mieux se dissoudre dans les solvants (solubilisant). Il est utilisé dans de multiples produits cosmétiques. Le Polysorbate 80 est produit par éthoxylation, il est interdit en Bio.
Ses fonctions (INCI): Dénaturant : Rend les cosmétiques désagréables. Principalement ajouté aux cosmétiques contenant de l'alcool éthylique
Agent émulsifiant : Favorise la formation de mélanges intimes entre des liquides non miscibles en modifiant la tension interfaciale (eau et huile)
Tensioactif : Réduit la tension superficielle des cosmétiques et contribue à la répartition uniforme du produit lors de son utilisation.                                                                                                         E432: Monolaurate de polyoxyéthylène sorbitane (polysorbate 20) 

E433 :Monooléate de polyoxyéthylène sorbitane (polysorbate 80) 

E434 :Monopalmitate de polyoxyéthylène sorbitane (polysorbate 40) 

E435:  Monostéarate de polyoxyéthylène sorbitane (polysorbate 60) 

E436 Tristéarate de polyoxyéthylène sorbitane (polysorbate 65) ; TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)
PART 172 -- FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION

Subpart I--Multipurpose Additives

Sec. 172.838 Polysorbate 65.
The food additive polysorbate 65 (polyoxyethylene (20) sorbitan tristearate), which is a mixture of polyoxyethylene ethers of mixed stearic 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 stearic acid (usually containing associated fatty acids, chiefly palmitic) with sorbitol to yield a product with a maximum acid number of 15 and a maximum water content of 0.2 percent, which is then reacted with ethylene oxide.

(b) The food additive meets the following specifications:

Saponification number 88-98.

Acid number 0-2.

Hydroxyl number 44-60.

Oxyethylene content 46 percent-50 percent.

(c) The additive is used, or intended for use, as follows:

(1) As an emulsifier in ice cream, frozen custard, ice milk, fruit sherbet and nonstandardized frozen desserts when used alone or in combination with polysorbate 80, whereby the maximum amount of the additives, alone or in combination, does not exceed 0.1 percent of the finished frozen dessert.

(2) As an emulsifier in cakes and cake mixes, with or without one or a combination of the following:

(i) Sorbitan monostearate.

(ii) Polysorbate 60.

When used alone, the maximum amount of polysorbate 65 shall not exceed 0.32 percent of the cake or cake mix, on a dry-weight basis. When used with sorbitan monostearate and/or polysorbate 60, it shall not exceed 0.32 percent, nor shall the sorbitan monostearate exceed 0.61 percent or the polysorbate 60 exceed 0.46 percent, and no combination of these emulsifiers shall exceed 0.66 percent of the cake or cake mix, all calculated on a dry-weight basis.

(3) 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 80;

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.

(4) As an emulsifier in solid-state, edible vegetable fat-water emulsions intended for use as substitutes for milk or cream in beverage coffee, with or without one or a combination of the following:

(i) Sorbitan monostearate.

(ii) Polysorbate 60.

The maximum amount of the additive or additives shall not exceed 0.4 percent by weight of the finished edible vegetable fat-water emulsion.

(5) As an emulsifier in cake icings and cake fillings, with or without one or a combination of the following:

(i) Sorbitan monostearate.

(ii) Polysorbate 60.

When used alone, the maximum amount of polysorbate 65 shall not exceed 0.32 percent of the weight of the cake icing or cake filling. When used with sorbitan monostearate and/or polysorbate 60, it shall not exceed 0.32 percent, nor shall the sorbitan monostearate exceed 0.7 percent or the polysorbate 60 exceed 0.46 percent, and no combination of these emulsifiers shall exceed 1 percent of the weight of the cake icing or cake filling.

(d) To assure safe use of the additive, in addition to the  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.

[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 20, 1978]. polyethyleneglycol sorbitan monooleate; Polysorbate 80;Sorbitan monooleate, ethoxylated; EC Inventory, ; CAS names : Sorbitan, mono-(9Z)-9-octadecenoate, poly(oxy-1,2-ethanediyl) derivs.; : 2-[2-[3,5-bis(2-hydroxyethoxy)oxolan-2-yl]-2-(2-hydroxyethoxy)ethoxy]ethyl (E)-octadec-9-enoate; Sorbitan monooleate ethoxylated. Polysorbates  are  hydrophilic  emulsifying  agents,  of  which  polysorbate  20  is  more  hydrophilic than polysorbate 60 and polysorbate 80, and polysorbate 65 is more lipophilic than the s. Fig. 1 Polysorbates 20, 60, and 80 (w + x + y + z =  about  20)                (1) Polysorbate 20 English name: Polyoxyethylene (20) Sorbitan Monolaurate or Polysorbate 20   Code name: Polyoxyethylene sorbitan monolaurate (Tween 20) CAS number: 9005-64-5     Chemical formula: w + x + y + z = 20; Fatty acid is C58H114O26 as lauric acid. Molecular weight: 1,227.72 Some  hydroxyl  groups  of  sorbitol  and  anhydrous  sorbitol  are  esterified,  mainly  with  lauric  acid,  followed  by condensation of about 20 ethylene oxide molecules (fatty acids are mainly lauric acid bound to sorbitan at 1:1 molar ratio). Oxyethylene (OCH2CH2) is included at 70.0-74.0%. (2) Polysorbate 60 English name: Polyoxyethylene (20) Sorbitan Monostearate or Polysorbate 60   Code name: Polyoxyethylene sorbitan monostearate (Tween 60) CAS number: 9005-67-8     Chemical formula: w + x + y + z = 20; Fatty acid is C64H126O26 as stearic acid. Molecular weight: 1311.90 Some  hydroxyl  groups  of  sorbitol  and  anhydrous  sorbitol  are  esterified,  mainly  with  stearic acid, followed by condensation of about 20 ethylene oxide molecules (fatty acids are mainly stearic acid bound to sorbitan at 1:1 molar ratio). Oxyethylene (OCH2CH2) is included at 65.0-69.5%. (3)  Polysorbate  80      English name: Polyoxyethylene (20) Sorbitan Monooleate or Polysorbate 80   Code name: Polyoxyethylene sorbitan monooleate (Tween 80)   CAS number: 9005-65-6     In polysorbate 20, RCO- is mainly lauric acid, CH3(CH2)10CO-, and   fatty  acids  are  included.      In  polysorbate  60,  RCO-  is  mainly  stearic acid, CH3(CH2)16CO-, and  fatty acids, such as palmitic acid  are  included.      In  polysorbate  80,  RCO-  is  mainly  oleic  acid,  CH3(CH2)7CH=CH(CH2)7CO-, and  fatty acids are included. 
5Chemical formula: w + x + y + z = 20; Fatty acid is C64H124O26 as oleic acid. Molecular weight: 1,309.68 Some hydroxyl groups of sorbitol and anhydrous sorbitol are esterified, mainly with oleic acid,  followed  by  condensation  of  about  20  ethylene  oxide  molecules  (fatty  acids  are  mainly oleic acid bound to sorbitan at 1:1 molar ratio). Oxyethylene (OCH2CH2) is included at 65.0-69.5%. Fig. 2 Polysorbate 65     (w + x + y + z = about 20)       (4) Polysorbate 65   English name: Polyoxyethylene (20) Sorbitan Tristearate or Polysorbate 65   Code name: Polyoxyethylene sorbitan tristearate (Tween 65)   CAS number: 9005-71-4   Chemical formula: w + x + y + z = 20; Fatty acid is C100H194O26 as stearic acid. Molecular weight: 1,842 Some  hydroxyl  groups  of  sorbitol  and  anhydrous  sorbitol  are  esterified,  mainly  with  stearic acid, followed by condensation of about 20 ethylene oxide molecules (fatty acids are mainly stearic acid bound to sorbitan at 3:1 molar ratio). Oxyethylene (OCH2CH2) is included at 46.0-50.0%.                                                                                                                                                                                                    

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