Ice Cream and Frozen Custard. the Weight of the Milk Being Bleached, 135.115 Goat’S Milk Ice Cream

§ 133.196 21 CFR Ch. I (4–1–11 Edition)

(iv) Antimycotic agents, the cumu- PART 135—FROZEN DESSERTS lative levels of which shall not exceed good manufacturing practice, may be Subpart A—General Provisions added to the surface of the cheese. (v) Benzoyl peroxide or a mixture of Sec. benzoyl peroxide with potassium alum, 135.3 Definitions. calcium sulfate, and magnesium car- Subpart B—Requirements for Specific bonate used to bleach the dairy ingre- Standardized Frozen Desserts dients. The weight of the benzoyl peroxide is not more than 0.002 percent of 135.110 Ice cream and frozen custard. the weight of the milk being bleached, 135.115 Goat’s milk ice cream. and the weight of the potassium alum, 135.130 Mellorine. calcium sulfate, and magnesium car- 135.140 Sherbet. 135.160 Water ices. bonate, singly or combined, is not more than six times the weight of the ben- AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, zoyl peroxide used. If milk is bleached 379e. in this manner, vitamin A is added to the curd in such quantity as to com- Subpart A—General Provisions pensate for the vitamin A or its precur- sors destroyed in the bleaching process, § 135.3 Definitions. and artificial coloring is not used. For the purposes of this part, a pas- (vi) Hydrogen peroxide, followed by a teurized mix is one in which every par- sufficient quantity of catalase prepara- ticle of the mix has been heated in tion to eliminate the hydrogen per- properly operated equipment to one of oxide. The weight of the hydrogen per- the temperatures specified in the table oxide shall not exceed 0.05 percent of in this section and held continuously the weight of the milk and the weight at or above that temperature for the of the catalase shall not exceed 20 parts specified time (or other time/tempera- per million of the weight of the milk ture relationship which has been dem- treated. onstrated to be equivalent thereto in (c) Nomenclature. The name of the microbial destruction): food is ‘‘swiss cheese’’, or alternatively, ‘‘emmentaler cheese’’. Temperature Time (d) Label declaration. Each of the in- 155 °F ...... 30 min. gredients used in the food shall be de- 175 °F ...... 25 sec. clared on the label as required by the applicable sections of parts 101 and 130 [42 FR 19132, Apr. 12, 1977] of this chapter, except that: (1) Enzymes of animal, plant, or mi- Subpart B—Requirements for Spe- crobial origin may be declared as ‘‘enzymes’’; and cific Standardized Frozen Des- (2) The dairy ingredients may be de- serts clared, in descending order of predomi- § 135.110 Ice cream and frozen cus- nance, by the use of the terms ‘‘milkfat tard. and nonfat milk’’ or ‘‘nonfat milk and milkfat’’, as appropriate. (a) Description. (1) Ice cream is a food produced by freezing, while stirring, a [48 FR 2746, Jan. 21, 1983; 48 FR 11426, Mar. 18, pasteurized mix consisting of one or 1983, as amended at 55 FR 6795, Feb. 27, 1990; more of the optional dairy ingredients 58 FR 2895, Jan. 6, 1993] specified in paragraph (b) of this section, and may contain one or more of § 133.196 Swiss cheese for manufacturing. the optional caseinates specified in paragraph (c) of this section subject to Swiss cheese for manufacturing con- the conditions hereinafter set forth, forms to the definition and standard of one or more of the optional hydrolyzed identity prescribed for swiss cheese by milk proteins as provided for in para- § 133.195, except that the holes, or eyes, graph (d) of this section subject to the have not developed throughout the en- conditions hereinafter set forth, and tire cheese. other safe and suitable nonmilk-de- [55 FR 6795, Feb. 27, 1990] rived ingredients; and excluding other

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food fats, except such as are natural (3) When calculating the minimum components of flavoring ingredients amount of milkfat and nonfat milk sol- used or are added in incidental ids required in the finished food, the amounts to accomplish specific func- solids of chocolate or cocoa used shall tions. Ice cream is sweetened with safe be considered a bulky flavoring ingre- and suitable sweeteners and may be dient. In order to make allowance for characterized by the addition of fla- additional sweetening ingredients voring ingredients. needed when certain bulky ingredients (2) Ice cream contains not less than are used, the weight of chocolate or 1.6 pounds of total solids to the gallon, cocoa solids used may be multiplied by and weighs not less than 4.5 pounds to 2.5; the weight of fruit or nuts used the gallon. Ice cream contains not less may be multiplied by 1.4; and the than 10 percent milkfat, nor less than weight of partially or wholly dried 10 percent nonfat milk solids, except fruits or fruit juices may be multiplied that when it contains milkfat at 1 per- by appropriate factors to obtain the cent increments above the 10 percent original weights before drying and this minimum, it may contain the fol- weight may be multiplied by 1.4. lowing milkfat-to-nonfat milk solids (b) Optional dairy ingredients. The op- levels: tional dairy ingredients referred to in Minimum paragraph (a) of this section are: percent Cream; dried cream; plastic cream Percent milkfat nonfat milk solids (sometimes known as concentrated milkfat); butter; butter oil; milk; con- 10 ...... 10 centrated milk; evaporated milk; 11 ...... 9 sweetened condensed milk; superheated 12 ...... 8 13 ...... 7 condensed milk; dried milk; skim milk; 14 ...... 6 concentrated skim milk; evaporated skim milk; condensed skim milk; Except that when one or more bulky superheated condensed skim milk; flavors are used, the weights of milkfat sweetened condensed skim milk; sweet- and total milk solids are not less than ened condensed part-skim milk; nonfat 10 percent and 20 percent, respectively, dry milk; sweet cream buttermilk; con- of the remainder obtained by sub- densed sweet cream buttermilk; dried tracting the weight of the bulky fla- sweet cream buttermilk; skim milk, vors from the weight of the finished that may be concentrated, and from food; but in no case is the weight of which part or all of the lactose has milkfat or total milk solids less than 8 been removed by a safe and suitable percent and 16 percent, respectively, of procedure; skim milk in concentrated the weight of the finished food. Except or dried form that has been modified by in the case of frozen custard, ice cream treating the concentrated skim milk contains less than 1.4 percent egg yolk with calcium hydroxide and disodium solids by weight of the food, exclusive phosphate; and whey and those modi- of the weight of any bulky flavoring in- fied whey products (e.g., reduced lac- gredients used. Frozen custard shall tose whey, reduced minerals whey, and contain 1.4 percent egg yolk solids by whey protein concentrate) that have weight of the finished food: Provided, been determined by FDA to be gen- however, That when bulky flavors are erally recognized as safe (GRAS) for added the egg yolk solids content of use in this type of food. Water may be frozen custard may be reduced in pro- added, or water may be evaporated portion to the amount by weight of the from the mix. The sweet cream butter- bulky flavors added, but in no case is milk and the concentrated sweet cream the content of egg yolk solids in the buttermilk or dried sweet cream but- finished food less than 1.12 percent. A termilk, when adjusted with water to a product containing egg yolk solids in total solids content of 8.5 percent, has excess of 1.4 percent, the maximum set a titratable acidity of not more than forth in this paragraph for ice cream, 0.17 percent, calculated as lactic acid. may be marketed if labeled as specified The term ‘‘milk’’ as used in this sec- by paragraph (e)(1) of this section. tion means cow’s milk. Any whey and

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modified whey products used con- (f) Nomenclature. (1) The name of the tribute, singly or in combination, not food is ‘‘ice cream’’; except that when more than 25 percent by weight of the the egg yolk solids content of the food total nonfat milk solids content of the is in excess of that specified for ice finished food. The modified skim milk, cream by paragraph (a) of this section, when adjusted with water to a total the name of the food is ‘‘frozen cus- solids content of 9 percent, is substan- tard’’ or ‘‘french ice cream’’ or ‘‘french tially free of lactic acid as determined custard ice cream’’. by titration with 0.1N NaOH, and it has (2)(i) If the food contains no artificial a Ph value in the range of 8.0 to 8.3. flavor, the name on the principal dis- (c) Optional caseinates. The optional play panel or panels of the label shall caseinates referred to in paragraph (a) be accompanied by the common or of this section that may be added to ice usual name of the characterizing fla- cream mix containing not less than 20 vor, e.g., ‘‘vanilla’’, in letters not less percent total milk solids are: Casein than one-half the height of the letters prepared by precipitation with gums, used in the words ‘‘ice cream’’. ammonium caseinate, calcium casein- (ii) If the food contains both a nat- ate, potassium caseinate, and sodium ural characterizing flavor and an artifi- caseinate. Caseinate may be added in cial flavor simulating it, and if the nat- liquid or dry form, but must be free of ural flavor predominates, the name on excess alkali. the principal display panel or panels of (d) Optional hydrolyzed milk proteins. the label shall be accompanied by the One or more of the optional hydrolyzed common name of the characterizing milk proteins referred to in paragraph flavor, in letters not less than one-half (a) of this section may be added as sta- the height of the letters used in the bilizers at a level not to exceed 3 per- words ‘‘ice cream’’, followed by the cent by weight of ice cream mix con- word ‘‘flavored’’, in letters not less taining not less that 20 percent total than one-half the height of the letters milk solids, provided that any whey in the name of the characterizing fla- and modified whey products used con- vor, e.g., ‘‘Vanilla flavored’’, or ‘‘Peach tribute, singly or in combination, not flavored’’, or ‘‘Vanilla flavored and more than 25 percent by weight of the Strawberry flavored’’. total nonfat milk solids content of the (iii) If the food contains both a nat- finished food. Further, when ural characterizing flavor and an artifi- hydrolyzed milk proteins are used in cial flavor simulating it, and if the ar- the food, the declaration of these ingre- tificial flavor predominates, or if arti- dients on the food label shall comply ficial flavor is used alone the name on with the requirements of § 102.22 of this the principal display panel or panels of chapter. the label shall be accompanied by the (e) Methods of analysis. The fat con- common name of the characterizing tent shall be determined by the method flavor in letters not less than one-half prescribed in ‘‘Official Methods of the height of the letters used in the Analysis of the Association of Official words ‘‘ice cream’’, preceded by ‘‘arti- Analytical Chemists,’’ 13th Ed. (1980), ficial’’ or ‘‘artificially flavored’’, in let- sections 16.287 and 16.059, under ‘‘Fat, ters not less than one-half the height Roese-Gottlieb Method—Official Final of the letters in the name of the char- Action,’’ which is incorporated by ref- acterizing flavor, e.g., ‘‘artificial Va- erence. Copies may be obtained from nilla’’, or ‘‘artifically flavored Straw- the AOAC INTERNATIONAL, 481 North berry’’ or ‘‘artificially flavored Vanilla Frederick Ave., suite 500, Gaithersburg, and artificially flavored Strawberry’’. MD 20877, or may be examined at the (3)(i) If the food is subject to the re- National Archives and Records Admin- quirements of paragraph (f)(2)(ii) of istration (NARA). For information on this section or if it contains any artifi- the availability of this material at cial flavor not simulating the charac- NARA, call 202–741–6030, or go to: http:// terizing flavor, the label shall also bear www.archives.gov/federallregister/ the words ‘‘artificial flavor added’’ or codeloflfederallregulations/ ‘‘artificial lll flavor added’’, the ibrllocations.html. blank being filled with the common

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name of the flavor simulated by the ar- is greater than 1 ounce per unit of va- tificial flavor in letters of the same nilla constituent, as that term is de- size and prominence as the words that fined in § 169.3(c) of this chapter. precede and follow it. (ii) In the case of fruit or fruit juice (ii) Wherever the name of the charac- used in combination with artificial terizing flavor appears on the label so fruit flavor, if the quantity of the fruit conspicuously as to be easily seen or fruit juice used is such that, in rela- under customary conditions of pur- tion to the weight of the finished ice chase, the words prescribed by this cream, the weight of the fruit or fruit paragraph shall immediately and con- juice, as the case may be (including spicuously precede or follow such water necessary to reconstitute par- name, in a size reasonably related to tially or wholly dried fruits or fruit the prominence of the name of the juices to their original moisture con- characterizing flavor and in any event tent) is less than 2 percent in the case the size of the type is not less than 6- of citrus ice cream, 6 percent in the point on packages containing less than case of berry or cherry ice cream, and 1 pint, not less than 8-point on pack- 10 percent in the case of ice cream pre- ages containing at least 1 pint but less pared with other fruits. than one-half gallon, not less than 10- (iii) In the case of nut meats used in point on packages containing at least combination with artificial nut flavor, one-half gallon but less than 1 gallon, if the quantity of nut meats used is and not less than 12-point on packages such that, in relation to the finished containing 1 gallon or over: Provided, ice cream the weight of the nut meats however, That where the characterizing is less than 2 percent. flavor and a trademark or brand are (iv) In the case of two or more fruits presented together, other written, or fruit juices, or nut meats, or both, printed, or graphic matter that is a used in combination with artificial fla- part of or is associated with the trade- vors simulating the natural flavors and mark or brand, may intervene if the re- dispersed throughout the food, if the quired words are in such relationship quantity of any fruit or fruit juice or with the trademark or brand as to be nut meat is less than one-half the ap- clearly related to the characterizing plicable percentage specified in para- flavor: And provided further, That if the graph (e)(5) (ii) or (iii) of this section. finished product contains more than For example, if a combination ice one flavor of ice cream subject to the cream contains less than 5 percent of requirements of this paragraph, the bananas and less than 1 percent of al- statements required by this paragraph monds it would be ‘‘artificially fla- need appear only once in each state- vored banana-almond ice cream’’. How- ment of characterizing flavors present ever, if it contains more than 5 percent in such ice cream, e.g., ‘‘Vanilla fla- of bananas and more than 1 percent of vored, Chocolate, and Strawberry fla- almonds it would be ‘‘banana-almond vored, artificial flavors added’’. flavored ice cream’’. (4) If the food contains both a natural (6) If two or more flavors of ice cream characterizing flavor and an artificial are distinctively combined in one pack- flavor simulating the characterizing age, e.g., ‘‘Neapolitan’’ ice cream, the flavor, any reference to the natural applicable provisions of this paragraph characterizing flavor shall, except as shall govern each flavor of ice cream otherwise authorized by this para- comprising the combination. graph, be accompanied by a reference (7) Until September 14, 1998, when to the artificial flavor, displayed with safe and suitable sweeteners other than substantially equal prominence, e.g., nutritive carbohydrate sweeteners are ‘‘strawberry and artificial strawberry used in the food, their presence shall be flavor’’. declared by their common or usual (5) An artificial flavor simulating the name on the principal display panel of characterizing flavor shall be deemed the label as part of the statement of to predominate: identity in letters that shall be no less (i) In the case of vanilla beans or va- than one-half the size of the type used nilla extract used in combination with in the term ‘‘ice cream’’ but in any vanillin if the amount of vanillin used case no smaller than one-sixteenth of

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an inch. If the food purports to be or is tard’’ or, alternatively, ‘‘frozen custard represented for special dietary use, it made with goat’s milk’’, or ‘‘goat’s shall bear labeling in accordance with milk french ice cream’’, or, alter- the requirements of part 105 of this natively, ‘‘french ice cream made with chapter. goat’s milk’’, or ‘‘goat’s milk french (g) Label declaration. Each of the in- custard ice cream’’, or, alternatively, gredients used shall be declared on the ‘‘french custard ice cream made with label as required by the applicable sec- goat’s milk’’. tions of parts 101 and 130 of this chap- (2) Until September 14, 1998, when ter, except that the sources of milkfat safe and suitable sweeteners other than or milk solids not fat may be declared nutritive carbohydrate sweeteners are in descending order of predominance used in the food, their presence shall be either by the use of all the terms declared by their common or usual ‘‘milkfat and nonfat milk’’ when one or name on the principal display panel of any combination of two or more of the the label as part of the statement of ingredients listed in § 101.4(b)(3), (b)(4), identity in letters that shall be no less (b)(8), and (b)(9) of this chapter are than one-half the size of the type used used or, alternatively, as permitted in in the term ‘‘goat’s milk ice cream’’ § 101.4 of this chapter. Under section but in any case no smaller than one- 403(k) of the Federal Food, Drug, and sixteenth of an inch. If the food pur- Cosmetic Act, artificial color need not ports to be or is represented for special be declared in ice cream, except as re- dietary use, it shall bear labeling in ac- quired by § 101.22(c) or (k) of this chap- cordance with the requirements of part ter. Voluntary declaration of all colors 105 of this chapter. used in ice cream and frozen custard is (d) Label declaration. Each of the in- recommended. gredients used in the food shall be declared on the label as required by the [43 FR 4598, Feb. 3, 1978, as amended at 45 FR applicable sections of parts 101 and 130 63838, Sept. 26, 1980; 46 FR 44433, Sept. 4, 1981; of this chapter. 47 FR 11826, Mar. 19, 1982; 49 FR 10096, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2896, [47 FR 41526, Sept. 21, 1982, as amended at 58 Jan. 6, 1993; 59 FR 47079, Sept. 14, 1994; 63 FR FR 2896, Jan. 6, 1993; 59 FR 47080, Sept. 14, 14035, Mar. 24, 1998; 63 FR 14818, Mar. 27, 1998] 1994]

§ 135.115 Goat’s milk ice cream. § 135.130 Mellorine. (a) Description. Goat’s milk ice cream (a) Description. (1) Mellorine is a food is the food prepared in the same man- produced by freezing, while stirring, a ner prescribed in § 135.110 for ice cream, pasteurized mix consisting of safe and and complies with all the provisions of suitable ingredients including, but not § 135.110, except that the only optional limited to, milk-derived nonfat solids dairy ingredients that may be used are and animal or vegetable fat, or both, those in paragraph (b) of this section; only part of which may be milkfat. caseinates and hydrolyzed milk pro- Mellorine is sweetened with nutritive teins may not be used; and paragraphs carbohydrate sweetener and is charac- (f)(1) and (g) of § 135.110 shall not apply. terized by the addition of flavoring in- (b) Optional dairy ingredients. The op- gredients. tional dairy ingredients referred to in (2) Mellorine contains not less than paragraph (a) of this section are goat’s 1.6 pounds of total solids to the gallon, skim milk, goat’s milk, and goat’s and weighs not less than 4.5 pounds to cream. These optional dairy ingredi- the gallon. Mellorine contains not less ents may be used in liquid, con- than 6 percent fat and 2.7 percent pro- centrated, and/or dry form. tein having a protein efficiency ratio (c) Nomenclature. (1) The name of the (PER) not less than that of whole milk food is ‘‘goat’s milk ice cream’’ or, al- protein (108 percent of casein) by ternatively, ‘‘ice cream made with weight of the food, exclusive of the goat’s milk’’, except that when the egg weight of any bulky flavoring ingredi- yolk solids content of the food is in ex- ents used. In no case shall the fat con- cess of that specified for ice cream in tent of the finished food be less than 4.8 paragraph (a) of § 135.110, the name of percent or the protein content be less the food is ‘‘goat’s milk frozen cus- than 2.2 percent. The protein to meet

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