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Home , Polysorbate 80, Sorbitan

Food and Drug Administration, HHS § 172.836

(2) Direct esterification of glycerol accordance with the following pre- with a mixture of primarily stearic, scribed conditions: palmitic, and myristic acids; (a) The food additive is manufactured by reacting stearic acid (usually con- to yield a product with less than 0.3 taining associated fatty acids, chiefly acid number and less than 0.2 percent palmitic) with to yield a prod- water, which is then reacted with uct with a maximum acid number of 10 . and a maximum water content of 0.2 (b) The additive meets the following percent, which is then reacted with specifications: ethylene oxide. Saponification number, 65–75. (b) The food additive meets the fol- Acid number, 0–2. lowing specifications: Hydroxyl number, 65–80. Saponification number 45–55. Oxyethylene content, 60.5–65.0 percent. Acid number 0–2. (c) The additive is used or intended Hydroxyl number 81–96. for use in the following foods when Oxyethylene content 65 percent–69.5 percent. standards of identity established under (c) It is used or intended for use as section 401 of the Act do not preclude follows: such use: (1) As an emulsifier in whipped edible oil topping with or without one or a Use Limitations combination of the following: 1. As an emulsifier in pan-re- Not to exceed levels required (i) monostearate; lease agents for and as a to produce the intended ef- (ii) 65; dough conditioner in yeast- fects, total not to exceed (iii) ; leavened bakery products. 0.5 percent by weight of the flour used. whereby the maximum amount of the 2. As an emulsifier in cakes Not to exceed 0.5 percent by additive or additives used does not ex- and cake mixes. weight of the dry ingredi- ents. ceed 0.4 percent of the weight of the 3. As an emulsifier in Not to exceed 0.45 percent finished whipped edible oil topping; ex- whipped vegetable oil top- by weight of the finished cept that a combination of the additive pings and topping mixes. whipped vegetable oil top- pings. with may be 4. As an emulsifier in icings Not to exceed 0.5 percent by used in excess of 0.4 percent, provided and icing mixes. weight of the finished that the amount of the additive does icings. not exceed 0.77 percent and the amount 5. As an emulsifier in frozen Not to exceed 0.2 percent by desserts. weight of the finished fro- of sorbitan monostearate does not ex- zen desserts. ceed 0.27 percent of the weight of the 6. As an emulsifier in edible Not to exceed 0.4 percent by finished whipped edible oil topping. vegetable -water emul- weight of the finished vege- (2) As an emulsifier in cakes and cake sions intended for use as table fat-water . substitutes for or mixes, with or without one or a com- cream in beverage coffee. bination of the following: (i) Polysorbate 65. (d) When the name ‘‘polyglycerate (ii) Sorbitan monostearate. 60’’ is used in labeling it shall be fol- When used alone, the maximum lowed by either ‘‘polyoxyethylene (20) amount of polysorbate 60 shall not ex- mono-and diglycerides of fatty acids’’ ceed 0.46 percent of the cake or cake or ‘‘ethoxylated mono- and mix, on a dry-weight basis. When used diglycerides’’ in parentheses. with polysorbate 65 and/or sorbitan [42 FR 14491, Mar. 15, 1977, as amended at 42 monostearate, it shall not exceed 0.46 FR 37973, July 26, 1977; 50 FR 49536, Dec. 3, percent, nor shall the polysorbate 65 1985] exceed 0.32 percent or the sorbitan monostearate exceed 0.61 percent, and § 172.836 Polysorbate 60. no combination of these emulsifiers The food additive polysorbate 60 shall exceed 0.66 percent of the cake or (polyoxyethylene (20) sorbitan mono- cake mix, all calculated on a dry- stearate) which is a mixture of weight basis. polyoxyethylene ethers of mixed par- (3) As an emulsifier, alone or in com- tial stearic and palmitic acid esters of bination with sorbitan monostearate, sorbitol anhydrides and related com- in nonstandardized confectionery coat- pounds, may be safely used in food in ings and standardized cacao products

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specified in §§ 163.123, 163.130, 163.135, does not exceed 1 percent of the fin- 163.140, 163.145, and 163.150 of this chap- ished shortening or oil. ter, as follows: (iii) The 1–percent limitation speci- (i) It is used alone in an amount not fied in paragraph (c)(8) (i) and (ii) of to exceed 0.5 percent of the weight of this section may be exceeded in premix the finished nonstandardized confec- concentrates of shortening or edible oil tionery coating or standardized cacao if the labeling complies with the re- product. quirements of paragraph (d) of this sec- (ii) It is used with sorbitan mono- tion. stearate in any combination of up to (9) As an emulsifier in solid-state, ed- 0.5 percent of polysorbate 60 and up to ible vegetable fat-water emulsions in- 1 percent of sorbitan monostearate: tended for use as substitutes for milk Provided, That the total combination or cream in beverage coffee, with or does not exceed 1 percent of the weight without one or a combination of the of the finished nonstandardized confec- following: tionery coating or standardized cacao (i) Polysorbate 65. product. (ii) Sorbitan monostearate. (4) [Reserved] The maximum amount of the additive (5) As an emulsifier in cake icings or additives shall not exceed 0.4 per- and cake fillings, with or without one cent by weight of the finished edible or a combination of the following: vegetable fat-water . (i) Polysorbate 65. (10) As a foaming agent in non- (ii) Sorbitan monostearate. alcoholic mixes, to be added to alco- When used alone, the maximum holic beverages in the preparation of amount of polysorbate 60 shall not ex- mixed alcoholic drinks, at a level not ceed 0.46 percent of the weight of the to exceed 4.5 percent by weight of the cake icings and cake fillings. When nonalcoholic mix. used with polysorbate 65 and/or sorbi- (11) As a dough conditioner in yeast- tan monostearate, it shall not exceed leavened bakery products in an amount 0.46 percent, nor shall the polysorbate not to exceed 0.5 percent by weight of 65 exceed 0.32 percent or the sorbitan the flour used. monostearate exceed 0.7 percent, and (12) As an emulsifier, alone or in no combination of these emulsifiers combination with sorbitan monostea- shall exceed 1 percent of the weight of rate, in the minimum quantity re- the cake icing or cake filling. quired to accomplish the intended ef- (6) To impart greater opacity to fect, in formulations of white mineral sugar-type confection coatings where- oil conforming with § 172.878 and/or pe- by the maximum amount of the addi- troleum wax conforming with § 172.886 tive does not exceed 0.2 percent of the for use as protective coatings on raw weight of the finished sugar coating. fruits and vegetables. (7) As an emulsifier in nonstandard- (13) As a dispersing agent in artifi- ized dressings whereby the maximum cially sweetened gelatin desserts and in amount of the additive does not exceed artificially sweetened gelatin dessert 0.3 percent of the weight of the finished mixes, whereby the amount of the addi- dressings. tive does not exceed 0.5 percent on a (8) As an emulsifier, alone or in com- dry-weight basis. bination with polysorbate 80, in (14) As an emulsifier in chocolate fla- shortenings and edible oils intended for vored syrups, whereby the maximum use in foods as follows, when standards amount of the additive does not exceed of identity established under section 0.05 percent in the finished product. 401 of the act do not preclude such use: (15) As a and wetting (i) It is used alone in an amount not agent for natural and artificial colors to exceed 1 percent of the weight of the in food as follows: finished shortening or oil. (i) In powdered soft drink mixes in an (ii) It is used with polysorbate 80 in amount not to exceed 4.5 percent by any combination providing no more weight of the mix. than 1 percent of polysorbate 60 and no (ii) In sugar-based gelatin dessert more than 1 percent of polysorbate 80, mixes in an amount not to exceed 0.5 provided that the total combination percent by weight of the mix.

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(iii) In artificially sweetened gelatin Oxyethylene content 46 percent–50 percent. dessert mixes in an amount not to ex- (c) The additive is used, or intended ceed 3.6 percent by weight of the mix. for use, as follows: (iv) In sugar-based pudding mixes in (1) As an emulsifier in ice cream, fro- an amount not to exceed 0.5 percent by weight of the mix. zen custard, ice milk, fruit sherbet and (v) In artificially sweetened pudding nonstandardized frozen desserts when mixes in an amount not to exceed 0.5 used alone or in combination with percent by weight of the mix. polysorbate 80, whereby the maximum (16) As an emulsifier in ice cream, amount of the additives, alone or in frozen custard, fruit sherbet, and non- combination, does not exceed 0.1 per- standardized frozen desserts when used cent of the finished frozen dessert. alone or in combination with poly- (2) As an emulsifier in cakes and cake sorbate 65 and/or polysorbate 80, where- mixes, with or without one or a com- by the maximum amount of the addi- bination of the following: tives, alone or in combination, does not (i) Sorbitan monostearate. exceed 0.1 percent of the finished frozen (ii) Polysorbate 60. dessert. When used alone, the maximum (d) To assure safe use of the additive, amount of polysorbate 65 shall not ex- in addition to the other information re- ceed 0.32 percent of the cake or cake quired by the Act: mix, on a dry-weight basis. When used (1) The label of the additive and any with sorbitan monostearate and/or intermediate premixes shall bear: polysorbate 60, it shall not exceed 0.32 (i) The name of the additive. percent, nor shall the sorbitan mono- (ii) A statement of the concentration stearate exceed 0.61 percent or the or strength of the additive in any in- polysorbate 60 exceed 0.46 percent, and termediate premixes. no combination of these emulsifiers (2) The label or labeling shall bear shall exceed 0.66 percent of the cake or adequate directions to provide a final cake mix, all calculated on a dry- product that complies with the limita- weight basis. tions prescribed in paragraph (c) of this section. (3) As an emulsifier in whipped edible oil topping with or without one or a [42 FR 14491, Mar. 15, 1977, as amended at 43 combination of the following: FR 2871, Jan. 25, 1978; 45 FR 58836, Sept. 5, (i) Sorbitan monostearate; 1980; 46 FR 8466, Jan. 27, 1981; 64 FR 57976, Oct. 28, 1999] (ii) Polysorbate 60; (iii) Polysorbate 80; § 172.838 Polysorbate 65. whereby the maximum amount of the The food additive polysorbate 65 additive or additives used does not ex- (polyoxyethylene (20) sorbitan ceed 0.4 percent of the weight of the tristearate), which is a mixture of finished whipped edible oil topping. polyoxyethylene ethers of mixed ste- (4) As an emulsifier in solid-state, ed- aric acid esters of sorbitol anhydrides ible vegetable fat-water emulsions in- and related compounds, may be safely tended for use as substitutes for milk used in food in accordance with the fol- or cream in beverage coffee, with or lowing prescribed conditions: without one or a combination of the (a) The food additive is manufactured following: by reacting stearic acid (usually con- (i) Sorbitan monostearate. taining associated fatty acids, chiefly (ii) Polysorbate 60. palmitic) with sorbitol to yield a prod- uct with a maximum acid number of 15 The maximum amount of the additive and a maximum water content of 0.2 or additives shall not exceed 0.4 per- percent, which is then reacted with cent by weight of the finished edible ethylene oxide. vegetable fat-water emulsion. (b) The food additive meets the fol- (5) As an emulsifier in cake icings lowing specifications: and cake fillings, with or without one Saponification number 88–98. or a combination of the following: Acid number 0–2. (i) Sorbitan monostearate. Hydroxyl number 44–60. (ii) Polysorbate 60.

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