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Food and Drug Administration, HHS § 172.846

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Food and Drug Administration, HHS § 172.846 Food and Drug Administration, HHS § 172.846 (i) Polysorbate 65. § 172.844 Calcium stearoyl-2-lactylate. (ii) Polysorbate 60. The food additive calcium stearoyl-2- When used alone, the maximum lactylate may be safely used in or on amount of sorbitan monostearate shall food in accordance with the following not exceed 0.7 percent of the weight of prescribed conditions: the cake icing or cake filling. When (a) The additive, which is a mixture used with polysorbate 65 and/or poly- of calcium salts of stearoyl lactylic sorbate 60, it shall not exceed 0.7 per- acids and minor proportions of other calcium salts of related acids, is manu- cent, nor shall the polysorbate 65 ex- factured by the reaction of stearic acid 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. (5) As an emulsifier in solid-state, ed- Acid number, 50–86. 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 (c) It is used or intended for use as without one or a combination of the follows: following: (1) As a dough conditioner in yeast- (i) Polysorbate 60. leavened bakery products and prepared (ii) Polysorbate 65. 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: (i) Liquid and frozen egg white at a (6) It is used alone as a rehydration level not to exceed 0.05 percent. aid in the production of active dry (ii) Dried egg white at a level not to yeast in an amount not to exceed 1 per- exceed 0.5 percent. cent by weight of the dry yeast. (iii) Whipped vegetable oil topping at (7) As an emulsifier, alone or in com- a level not to exceed 0.3 percent of the bination with polysorbate 60, in the weight of the finished whipped vege- minimum quantity required to accom- table oil topping. plish the intended effect, in formula- (3) As a conditioning agent in dehy- tions of white mineral oil conforming drated potatoes in an amount not to with § 172.878 and/or petroleum wax exceed 0.5 percent by weight thereof. conforming with § 172.886 for use as pro- (d) To assure safe use of the additive: tective coatings on raw fruits and vege- (1) The label and labeling of the food tables. additive and any intermediate premix (d) To assure safe use of the additive, prepared therefrom shall bear, in addi- in addition to the other information re- tion to the other information required quired by the Act: by the act, the following: (1) The label of the additive and any (i) The name of the additive. intermediate premixes shall bear: (ii) A statement of the concentration (i) The name of the additive. or strength of the additive in any in- (ii) A statement of the concentration termediate premixes. or strength of the additive in any in- (2) The label or labeling of the food termediate premixes. additive shall also bear adequate direc- tions of use to provide a finished food (2) The label or labeling shall bear that complies with the limitations pre- adequate directions to provide a final scribed in paragraph (c) of this section. product that complies with the limita- tions prescribed in paragraph (c) of this § 172.846 Sodium stearoyl lactylate. section. The food additive sodium stearoyl [42 FR 14491, Mar. 15, 1977, as amended at 43 lactylate (CAS Reg. No. 25–383–997) may FR 2871, Jan. 20, 1978] be safely used in food in accordance 97 VerDate Nov<24>2008 14:38 May 05, 2009 Jkt 217067 PO 00000 Frm 00107 Fmt 8010 Sfmt 8010 Y:\SGML\217067.XXX 217067 cprice-sewell on PRODPC61 with CFR § 172.848 21 CFR Ch. I (4–1–09 Edition) with the following prescribed condi- to exceed 0.2 percent by weight of the tions: finished food. (a) The additive, which is a mixture (7) As an emulsifier, stabilizer, or of sodium salts of stearoyl lactylic texturizer in sauces or gravies, and the acids and minor proportions of sodium products containing the same, in an salts of related acids, is manufactured amount not to exceed 0.25 percent by by the reaction of stearic acid and lac- weight of the finished food. tic acid and conversion to the sodium (8) In prepared mixes for each of the salts. foods listed in paragraphs (c) (1) (b) The additive meets the specifica- through (7) of this section, provided the tions of the ‘‘Food Chemicals Codex,’’ additive is used only as specified in 3d Ed. (1981), pp. 300–301, which is incor- each of those paragraphs. porated by reference. Copies may be (9) As an emulsifier, stabilizer, or obtained from the National Academy texturizer in cream liqueur drinks, at a Press, 2101 Constitution Ave. NW., level not to exceed 0.5 percent by Washington, DC 20418, or may be exam- weight of the finished product. ined at the National Archives and Records Administration (NARA). For [45 FR 51767, Aug. 5, 1980, as amended at 49 information on the availability of this FR 10105, Mar. 19, 1984; 50 FR 49536, Dec. 3, material at NARA, call 202–741–6030, or 1985; 51 FR 1495, Jan. 14, 1986; 51 FR 3333, Jan. go to: http://www.archives.gov/ 27, 1986; 65 FR 60859, Oct. 13, 2000] federallregister/ codeloflfederallregulations/ § 172.848 Lactylic esters of fatty acids. ibrllocations.html. Lactylic esters of fatty acids may be (c) It is used or intended for use as safely used in food in accordance with follows when standards of identity es- the following prescribed conditions: tablished under section 401 of the Act (a) They are prepared from lactic do not preclude such use: acid and fatty acids meeting the re- (1) As a dough strengthener, emulsi- quirements of § 172.860(b) and/or oleic fier, or processing aid in baked prod- acid derived from tall oil fatty acids ucts, pancakes, and waffles, in an meeting the requirements of § 172.862. amount not to exceed 0.5 part for each (b) They are used as emulsifiers, plas- 100 parts by weight of flour used. ticizers, or surface-active agents in the (2) As a surface-active agent, emulsi- following foods, when standards of fier, or stabilizer in icings, fillings, identity do not preclude their use: puddings, and toppings, at a level not to exceed 0.2 percent by weight of the Foods Limitations finished food. (3) As an emulsifier or stabilizer in Bakery mixes ................................ Baked products ............................. liquid and solid edible fat-water emul- Cake icings, fillings, and toppings sions intended for use as substitutes Dehydrated fruits and vegetables for milk or cream in beverage coffee, at Dehydrated fruit and vegetable a level not to exceed 0.3 percent by juices. weight of the finished edible fat-water Edible vegetable fat-water emul- As substitutes for milk or sions. cream in beverage cof- emulsion. fee. (4) As a formulation aid, processing Frozen desserts ............................ aid, or surface-active agent in dehy- Liquid shortening .......................... For household use. drated potatoes, in an amount not to Pancake mixes ............................. exceed 0.5 percent of the dry weight of Precooked instant rice .................. Pudding mixes .............................. the food. (5) As an emulsifier, stabilizer, or (c) They are used in an amount not texturizer in snack dips, at a level not greater than required to produce the to exceed 0.2 percent by weight of the intended physical or technical effect, finished product. and they may be used with shortening (6) As an emulsifier, stabilizer, or and edible fats and oils when such are texturizer in cheese substitutes and required in the foods identified in para- imitations and cheese product sub- graph (b) of this section. stitutes and imitations, at a level not 98 VerDate Nov<24>2008 14:38 May 05, 2009 Jkt 217067 PO 00000 Frm 00108 Fmt 8010 Sfmt 8010 Y:\SGML\217067.XXX 217067 cprice-sewell on PRODPC61 with CFR.
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