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Food and Drug Administration, HHS § 172.836

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Food and Drug Administration, HHS § 172.836 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 sorbitol to yield a prod- water, which is then reacted with uct with a maximum acid number of 10 ethylene oxide. 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) Sorbitan monostearate; lease agents for and as a to produce the intended ef- (ii) Polysorbate 65; dough conditioner in yeast- fects, total not to exceed (iii) Polysorbate 80; 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 sorbitan monostearate 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 fat-water emul- weight of the finished vege- (2) As an emulsifier in cakes and cake sions intended for use as table fat-water emulsions. substitutes for milk 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 91 VerDate Nov<24>2008 14:38 May 05, 2009 Jkt 217067 PO 00000 Frm 00101 Fmt 8010 Sfmt 8010 Y:\SGML\217067.XXX 217067 cprice-sewell on PRODPC61 with CFR § 172.836 21 CFR Ch. I (4–1–09 Edition) 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 emulsion. (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 surfactant 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. 92 VerDate Nov<24>2008 14:38 May 05, 2009 Jkt 217067 PO 00000 Frm 00102 Fmt 8010 Sfmt 8010 Y:\SGML\217067.XXX 217067 cprice-sewell on PRODPC61 with CFR Food and Drug Administration, HHS § 172.838 (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.
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