Food and Drug Administration, HHS § 172.842

(b) The additive meets the specifica- (a) The food additive is manufactured tions of the Food Chemicals Codex, 7th by reacting stearic acid (usually con- ed. (2010), pp. 811–814, which is incor- taining associated fatty acids, chiefly porated by reference. The Director of palmitic) with to yield essen- the Office of the Federal Register ap- tially a mixture of esters. proves this incorporation by reference (b) The food additive meets the fol- in accordance with 5 U.S.C. 552(a) and 1 lowing specifications: CFR part 51. You may obtain copies Saponification number, 147–157 from the United States Pharmacopeial Acid number, 5–10 Convention, 12601 Twinbrook Pkwy., Hydroxyl number, 235–260 Rockville, MD 20852 (Internet address (c) It is used or intended for use, http://www.usp.org). Copies may be ex- alone or in combination with poly- amined at the Food and Drug Adminis- sorbate 60 as follows: tration’s Main Library, 10903 New (1) As an emulsifier in whipped edible Hampshire Ave., Bldg. 2, Third Floor, oil topping with or without one or a Silver Spring, MD 20993, 301–796–2039, or combination of the following: at the National Archives and Records (i) 60; Administration (NARA). For informa- (ii) Polysorbate 65; tion on the availability of this mate- (iii) ; rial at NARA, call 202–741–6030 or go to: whereby the maximum amount of the http://www.archives.gov/federal-register/ additive or additives used does not ex- cfr/ibr-locations.html. ceed 0.4 percent of the weight of the (c) When standards of identity estab- finished whipped edible oil topping; ex- lished under section 401 of the act do cept that a combination of the additive not preclude such use, polydextrose with polysorbate 60 may be used in ex- may be used in accordance with cur- cess of 0.4 percent: Provided, That the rent good manufacturing practices as a amount of the additive does not exceed bulking agent, formulation aid, humec- 0.27 percent and the amount of poly- tant, and texturizer in all foods, except sorbate 60 does not exceed 0.77 percent meat and poultry, baby food, and in- of the weight of the finished whipped fant formula. edible oil topping. (d) If the food containing the additive (2) As an emulsifier in cakes and cake purports to be or is represented for spe- mixes, with or without one or a com- cial dietary uses, it shall be labeled in bination of the following: compliance with part 105 of this chap- (i) Polysorbate 65. ter. (ii) Polysorbate 60. (e) The label and labeling of food a When used alone, the maximum single serving of which would be ex- amount of shall pected to exceed 15 grams of the addi- not exceed 0.61 percent of the cake or tive shall bear the statement: ‘‘Sen- cake mix, on a dry-weight basis. When sitive individuals may experience a used with polysorbate 65 and/or poly- laxative effect from excessive con- sorbate 60, it shall not exceed 0.61 per- sumption of this product’’. cent, nor shall the polysorbate 65 ex- [46 FR 30081, June 5, 1981, as amended at 59 ceed 0.32 percent or the polysorbate 60 FR 37421, July 22, 1994; 60 FR 54425, Oct. 24, exceed 0.46 percent, and no combina- 1995; 61 FR 14480, Apr. 2, 1996; 62 FR 30985, tion of the emulsifiers shall exceed 0.66 June 6, 1997; 63 FR 57597, Oct. 28, 1998; 65 FR percent of the weight of the cake or 64605, Oct. 30, 2000; 65 FR 79719, Dec. 20, 2000; cake mix, calculated on a dry-weight 72 FR 46564, Aug. 21, 2007; 78 FR 71464, Nov. 29, basis. 2013] (3) As an emulsifier, alone or in com- bination with polysorbate 60 in non- § 172.842 Sorbitan monostearate. standardized confectionery coatings The food additive sorbitan monostea- and standardized cacao products speci- rate, which is a mixture of partial ste- fied in §§ 163.123, 163.130, 163.135, 163.140, aric and palmitic acid esters of sorbitol 163.145, and 163.150 of this chapter, as anhydrides, may be safely used in or on follows: food in accordance with the following (i) It is used alone in an amount not prescribed conditions: to exceed 1 percent of the weight of the

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finished nonstandardized confectionery (ii) A statement of the concentration coating or standardized cacao product. or strength of the additive in any in- (ii) It is used with polysorbate 60 in termediate premixes. any combination of up to 1 percent sor- (2) The label or labeling shall bear bitan monostearate and up to 0.5 per- adequate directions to provide a final cent polysorbate 60 provided that the product that complies with the limita- total combination does not exceed 1 tions prescribed in paragraph (c) of this percent of the weight of the finished section. nonstandardized confectionery coating or standardized cacao product. [42 FR 14491, Mar. 15, 1977, as amended at 43 (4) As an emulsifier in cake icings FR 2871, Jan. 20, 1978] and cake fillings, with or without one § 172.844 Calcium stearoyl-2-lactylate. or a combination of the following: (i) Polysorbate 65. The food additive calcium stearoyl-2- (ii) Polysorbate 60. lactylate may be safely used in or on food in accordance with the following When used alone, the maximum prescribed conditions: amount of sorbitan monostearate shall (a) The additive, which is a mixture not exceed 0.7 percent of the weight of of calcium salts of stearoyl lactylic the cake icing or cake filling. When acids and minor proportions of other used with polysorbate 65 and/or poly- calcium salts of related acids, is manu- sorbate 60, it shall not exceed 0.7 per- factured by the reaction of stearic acid cent, nor shall the polysorbate 65 ex- ceed 0.32 percent or the polysorbate 60 and lactic acid and conversion to the exceed 0.46 percent, and no combina- calcium salts. tion of these emulsifiers shall exceed 1 (b) The additive meets the following percent of the weight of the cake icing specifications: or cake filling. Acid number, 50–86. (5) As an emulsifier in solid-state, ed- Calcium content, 4.2–5.2 percent. ible vegetable fat-water emulsions in- Lactic acid content, 32–38 percent. tended for use as substitutes for milk Ester number, 125–164. or cream in beverage coffee, with or without one or a combination of the (c) It is used or intended for use as following: follows: (i) Polysorbate 60. (1) As a dough conditioner in yeast- (ii) Polysorbate 65. leavened bakery products and prepared mixes for yeast-leavened bakery prod- The maximum amount of the additive ucts in an amount not to exceed 0.5 or additives shall not exceed 0.4 per- part for each 100 parts by weight of cent by weight of the finished edible flour used. vegetable fat-water emulsion. (2) As a whipping agent in: (6) It is used alone as a rehydration (i) Liquid and frozen egg white at a aid in the production of active dry level not to exceed 0.05 percent. yeast in an amount not to exceed 1 per- (ii) Dried egg white at a level not to cent by weight of the dry yeast. exceed 0.5 percent. (7) As an emulsifier, alone or in com- bination with polysorbate 60, in the (iii) Whipped vegetable oil topping at minimum quantity required to accom- a level not to exceed 0.3 percent of the plish the intended effect, in formula- weight of the finished whipped vege- tions of white mineral oil conforming table oil topping. with § 172.878 and/or petroleum wax (3) As a conditioning agent in dehy- conforming with § 172.886 for use as pro- drated potatoes in an amount not to tective coatings on raw fruits and vege- exceed 0.5 percent by weight thereof. tables. (d) To assure safe use of the additive: (d) To assure safe use of the additive, (1) The label and labeling of the food in addition to the other information re- additive and any intermediate premix quired by the Act: prepared therefrom shall bear, in addi- (1) The label of the additive and any tion to the other information required intermediate premixes shall bear: by the act, the following: (i) The name of the additive. (i) The name of the additive.

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