Frozen desserts (21 CFR 135.3-135.160)

451 Food and Drug Administration, HHS § 135.110 (d) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter, except that: (1) Enzymes of animal, plant, or mi crobial origin may be declared as ‘‘en zymes’’; and (2) The dairy ingredients may be de clared, in descending order of predomi nance, by the use of the terms ‘‘milkfat and nonfat milk’’ or ‘‘nonfat milk and milkfat’’, as appropriate. [48 FR 2746, Jan. 21, 1983; 48 FR 11426, Mar. 18, 1983, as amended at 55 FR 6795, Feb. 27, 1990; 58 FR 2895, Jan. 6, 1993] § 133.196 Swiss cheese for manufac turing. Swiss cheese for manufacturing con forms to the definition and standard of identity prescribed for swiss cheese by § 133.195, except that the holes, or eyes, have not developed throughout the en tire cheese. [55 FR 6795, Feb. 27, 1990] PART 135—FROZEN DESSERTS Subpart A—General Provisions Sec. 135.3 Definitions. Subpart B—Requirements for Specific Standardized Frozen Desserts 135.110 Ice cream and frozen custard. 135.115 Goat’s milk ice cream. 135.130 Mellorine. 135.140 Sherbet. 135.160 Water ices. AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, 379e. Subpart A—General Provisions § 135.3 Definitions. For the purposes of this part, a pas teurized mix is one in which every par ticle of the mix has been heated in properly operated equipment to one of the temperatures specified in the table in this section and held continuously at or above that temperature for the specified time (or other time/tempera ture relationship which has been dem onstrated to be equivalent thereto in microbial destruction): Temperature Time 155 °F .................................................................. 30 min. 175 °F .................................................................. 25 sec. [42 FR 19132, Apr. 12, 1977] Subpart B—Requirements for Spe cific Standardized Frozen Des serts § 135.110 Ice cream and frozen cus tard. (a) Description. (1) Ice cream is a food produced by freezing, while stirring, a pasteurized mix consisting of one or more of the optional dairy ingredients specified in paragraph (b) of this sec tion, and may contain one or more of the optional caseinates specified in paragraph (c) of this section subject to the conditions hereinafter set forth, one or more of the optional hydrolyzed milk proteins as provided for in para graph (d) of this section subject to the conditions hereinafter set forth, and other safe and suitable nonmilk-de rived ingredients; and excluding other food fats, except such as are natural components of flavoring ingredients used or are added in incidental amounts to accomplish specific func tions. Ice cream is sweetened with safe and suitable sweeteners and may be characterized by the addition of fla voring ingredients. (2) Ice cream contains not less than 1.6 pounds of total solids to the gallon, and weighs not less than 4.5 pounds to the gallon. Ice cream contains not less than 10 percent milkfat, nor less than 10 percent nonfat milk solids, except that when it contains milkfat at 1 per cent increments above the 10 percent minimum, it may contain the fol lowing milkfat-to-nonfat milk solids levels: Percent milkfat Minimum percent nonfat milk solids 10 ......................................................................... 10 11 ......................................................................... 9 12 ......................................................................... 8 13 ......................................................................... 7 14 ......................................................................... 6 Except that when one or more bulky flavors are used, the weights of milkfat and total milk solids are not less than VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00461 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 452 21 CFR Ch. I (4–1–15 Edition) § 135.110 10 percent and 20 percent, respectively, of the remainder obtained by sub tracting the weight of the bulky fla vors from the weight of the finished food; but in no case is the weight of milkfat or total milk solids less than 8 percent and 16 percent, respectively, of the weight of the finished food. Except in the case of frozen custard, ice cream contains less than 1.4 percent egg yolk solids by weight of the food, exclusive of the weight of any bulky flavoring in gredients used. Frozen custard shall contain 1.4 percent egg yolk solids by weight of the finished food: Provided, however, That when bulky flavors are added the egg yolk solids content of frozen custard may be reduced in pro portion to the amount by weight of the bulky flavors added, but in no case is the content of egg yolk solids in the finished food less than 1.12 percent. A product containing egg yolk solids in excess of 1.4 percent, the maximum set forth in this paragraph for ice cream, may be marketed if labeled as specified by paragraph (e)(1) of this section. (3) When calculating the minimum amount of milkfat and nonfat milk sol ids required in the finished food, the solids of chocolate or cocoa used shall be considered a bulky flavoring ingre dient. In order to make allowance for additional sweetening ingredients needed when certain bulky ingredients are used, the weight of chocolate or cocoa solids used may be multiplied by 2.5; the weight of fruit or nuts used may be multiplied by 1.4; and the weight of partially or wholly dried fruits or fruit juices may be multiplied by appropriate factors to obtain the original weights before drying and this weight may be multiplied by 1.4. (b) Optional dairy ingredients. The op tional dairy ingredients referred to in paragraph (a) of this section are: Cream; dried cream; plastic cream (sometimes known as concentrated milkfat); butter; butter oil; milk; con centrated milk; evaporated milk; sweetened condensed milk; superheated condensed milk; dried milk; skim milk; concentrated skim milk; evaporated skim milk; condensed skim milk; superheated condensed skim milk; sweetened condensed skim milk; sweet ened condensed part-skim milk; nonfat dry milk; sweet cream buttermilk; con densed sweet cream buttermilk; dried sweet cream buttermilk; skim milk, that may be concentrated, and from which part or all of the lactose has been removed by a safe and suitable procedure; skim milk in concentrated or dried form that has been modified by treating the concentrated skim milk with calcium hydroxide and disodium phosphate; and whey and those modi fied whey products (e.g., reduced lac tose whey, reduced minerals whey, and whey protein concentrate) that have been determined by FDA to be gen erally recognized as safe (GRAS) for use in this type of food. Water may be added, or water may be evaporated from the mix. The sweet cream butter milk and the concentrated sweet cream buttermilk or dried sweet cream but termilk, when adjusted with water to a total solids content of 8.5 percent, has a titratable acidity of not more than 0.17 percent, calculated as lactic acid. The term ‘‘milk’’ as used in this sec tion means cow’s milk. Any whey and modified whey products used con tribute, singly or in combination, not more than 25 percent by weight of the total nonfat milk solids content of the finished food. The modified skim milk, when adjusted with water to a total solids content of 9 percent, is substan tially free of lactic acid as determined by titration with 0.1N NaOH, and it has a Ph value in the range of 8.0 to 8.3. (c) Optional caseinates. The optional caseinates referred to in paragraph (a) of this section that may be added to ice cream mix containing not less than 20 percent total milk solids are: Casein prepared by precipitation with gums, ammonium caseinate, calcium casein ate, potassium caseinate, and sodium caseinate. Caseinate may be added in liquid or dry form, but must be free of excess alkali. (d) Optional hydrolyzed milk proteins. One or more of the optional hydrolyzed milk proteins referred to in paragraph (a) of this section may be added as sta bilizers at a level not to exceed 3 per cent by weight of ice cream mix con taining not less that 20 percent total milk solids, provided that any whey and modified whey products used con tribute, singly or in combination, not more than 25 percent by weight of the total nonfat milk solids content of the VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00462 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 453 Food and Drug Administration, HHS § 135.110 finished food. Further, when hydrolyzed milk proteins are used in the food, the declaration of these ingre dients on the food label shall comply with the requirements of § 102.22 of this chapter. (e) Methods of analysis. The fat con tent shall be determined by the method prescribed in ‘‘Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), sections 16.287 and 16.059, under ‘‘Fat, Roese-Gottlieb Method—Official Final Action,’’ which is incorporated by ref erence. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Admin istration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. (f) Nomenclature. (1) The name of the food is ‘‘ice cream’’; except that when the egg yolk solids content of the food is in excess of that specified for ice cream by paragraph (a) of this section, the name of the food is ‘‘frozen cus tard’’ or ‘‘french ice cream’’ or ‘‘french custard ice cream’’. (2)(i) If the food contains no artificial flavor, the name on the principal dis play panel or panels of the label shall be accompanied by the common or usual name of the characterizing fla vor, e.g., ‘‘vanilla’’, in letters not less than one-half the height of the letters used in the words ‘‘ice cream’’. (ii) If the food contains both a nat ural characterizing flavor and an artifi cial flavor simulating it, and if the nat ural flavor predominates, the name on the principal display panel or panels of the label shall be accompanied by the common name of the characterizing flavor, in letters not less than one-half the height of the letters used in the words ‘‘ice cream’’, followed by the word ‘‘flavored’’, in letters not less than one-half the height of the letters in the name of the characterizing fla vor, e.g., ‘‘Vanilla flavored’’, or ‘‘Peach flavored’’, or ‘‘Vanilla flavored and Strawberry flavored’’. (iii) If the food contains both a nat ural characterizing flavor and an artifi cial flavor simulating it, and if the ar tificial flavor predominates, or if arti ficial flavor is used alone the name on the principal display panel or panels of the label shall be accompanied by the common name of the characterizing flavor in letters not less than one-half the height of the letters used in the words ‘‘ice cream’’, preceded by ‘‘arti ficial’’ or ‘‘artificially flavored’’, in let ters not less than one-half the height of the letters in the name of the char acterizing flavor, e.g., ‘‘artificial Va nilla’’, or ‘‘artifically flavored Straw berry’’ or ‘‘artificially flavored Vanilla and artificially flavored Strawberry’’. (3)(i) If the food is subject to the re quirements of paragraph (f)(2)(ii) of this section or if it contains any artifi cial flavor not simulating the charac terizing flavor, the label shall also bear the words ‘‘artificial flavor added’’ or ‘‘artificial lll flavor added’’, the blank being filled with the common name of the flavor simulated by the ar tificial flavor in letters of the same size and prominence as the words that precede and follow it. (ii) Wherever the name of the charac terizing flavor appears on the label so conspicuously as to be easily seen under customary conditions of pur chase, the words prescribed by this paragraph shall immediately and con spicuously precede or follow such name, in a size reasonably related to the prominence of the name of the characterizing flavor and in any event the size of the type is not less than 6 point on packages containing less than 1 pint, not less than 8-point on pack ages containing at least 1 pint but less than one-half gallon, not less than 10 point on packages containing at least one-half gallon but less than 1 gallon, and not less than 12-point on packages containing 1 gallon or over: Provided, however, That where the characterizing flavor and a trademark or brand are presented together, other written, printed, or graphic matter that is a part of or is associated with the trade mark or brand, may intervene if the re quired words are in such relationship with the trademark or brand as to be clearly related to the characterizing flavor: And provided further, That if the finished product contains more than one flavor of ice cream subject to the VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00463 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 454 21 CFR Ch. I (4–1–15 Edition) § 135.110 requirements of this paragraph, the statements required by this paragraph need appear only once in each state ment of characterizing flavors present in such ice cream, e.g., ‘‘Vanilla fla vored, Chocolate, and Strawberry fla vored, artificial flavors added’’. (4) If the food contains both a natural characterizing flavor and an artificial flavor simulating the characterizing flavor, any reference to the natural characterizing flavor shall, except as otherwise authorized by this para graph, be accompanied by a reference to the artificial flavor, displayed with substantially equal prominence, e.g., ‘‘strawberry and artificial strawberry flavor’’. (5) An artificial flavor simulating the characterizing flavor shall be deemed to predominate: (i) In the case of vanilla beans or va nilla extract used in combination with vanillin if the amount of vanillin used is greater than 1 ounce per unit of va nilla constituent, as that term is de fined in § 169.3(c) of this chapter. (ii) In the case of fruit or fruit juice used in combination with artificial fruit flavor, if the quantity of the fruit or fruit juice used is such that, in rela tion to the weight of the finished ice cream, the weight of the fruit or fruit juice, as the case may be (including water necessary to reconstitute par tially or wholly dried fruits or fruit juices to their original moisture con tent) is less than 2 percent in the case of citrus ice cream, 6 percent in the case of berry or cherry ice cream, and 10 percent in the case of ice cream pre pared with other fruits. (iii) In the case of nut meats used in combination with artificial nut flavor, if the quantity of nut meats used is such that, in relation to the finished ice cream the weight of the nut meats is less than 2 percent. (iv) In the case of two or more fruits or fruit juices, or nut meats, or both, used in combination with artificial fla vors simulating the natural flavors and dispersed throughout the food, if the quantity of any fruit or fruit juice or nut meat is less than one-half the ap plicable percentage specified in para graph (e)(5) (ii) or (iii) of this section. For example, if a combination ice cream contains less than 5 percent of bananas and less than 1 percent of al monds it would be ‘‘artificially fla vored banana-almond ice cream’’. How ever, if it contains more than 5 percent of bananas and more than 1 percent of almonds it would be ‘‘banana-almond flavored ice cream’’. (6) If two or more flavors of ice cream are distinctively combined in one pack age, e.g., ‘‘Neapolitan’’ ice cream, the applicable provisions of this paragraph shall govern each flavor of ice cream comprising the combination. (7) Until September 14, 1998, when safe and suitable sweeteners other than nutritive carbohydrate sweeteners are used in the food, their presence shall be declared by their common or usual name on the principal display panel of the label as part of the statement of identity in letters that shall be no less than one-half the size of the type used in the term ‘‘ice cream’’ but in any case no smaller than one-sixteenth of an inch. If the food purports to be or is represented for special dietary use, it shall bear labeling in accordance with the requirements of part 105 of this chapter. (g) Label declaration. Each of the in gredients used shall be declared on the label as required by the applicable sec tions of parts 101 and 130 of this chap ter, except that the sources of milkfat or milk solids not fat may be declared in descending order of predominance either by the use of all the terms ‘‘milkfat and nonfat milk’’ when one or any combination of two or more of the ingredients listed in § 101.4(b)(3), (b)(4), (b)(8), and (b)(9) of this chapter are used or, alternatively, as permitted in § 101.4 of this chapter. Under section 403(k) of the Federal Food, Drug, and Cosmetic Act, artificial color need not be declared in ice cream, except as re quired by § 101.22(c) or (k) of this chap ter. Voluntary declaration of all colors used in ice cream and frozen custard is recommended. [43 FR 4598, Feb. 3, 1978, as amended at 45 FR 63838, Sept. 26, 1980; 46 FR 44433, Sept. 4, 1981; 47 FR 11826, Mar. 19, 1982; 49 FR 10096, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2896, Jan. 6, 1993; 59 FR 47079, Sept. 14, 1994; 63 FR 14035, Mar. 24, 1998; 63 FR 14818, Mar. 27, 1998] VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00464 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 455 Food and Drug Administration, HHS § 135.130 § 135.115 Goat’s milk ice cream. (a) Description. Goat’s milk ice cream is the food prepared in the same man ner prescribed in § 135.110 for ice cream, and complies with all the provisions of § 135.110, except that the only optional dairy ingredients that may be used are those in paragraph (b) of this section; caseinates and hydrolyzed milk pro teins may not be used; and paragraphs (f)(1) and (g) of § 135.110 shall not apply. (b) Optional dairy ingredients. The op tional dairy ingredients referred to in paragraph (a) of this section are goat’s skim milk, goat’s milk, and goat’s cream. These optional dairy ingredi ents may be used in liquid, con centrated, and/or dry form. (c) Nomenclature. (1) The name of the food is ‘‘goat’s milk ice cream’’ or, al ternatively, ‘‘ice cream made with goat’s milk’’, except that when the egg yolk solids content of the food is in ex cess of that specified for ice cream in paragraph (a) of § 135.110, the name of the food is ‘‘goat’s milk frozen cus tard’’ or, alternatively, ‘‘frozen custard made with goat’s milk’’, or ‘‘goat’s milk french ice cream’’, or, alter natively, ‘‘french ice cream made with goat’s milk’’, or ‘‘goat’s milk french custard ice cream’’, or, alternatively, ‘‘french custard ice cream made with goat’s milk’’. (2) Until September 14, 1998, when safe and suitable sweeteners other than nutritive carbohydrate sweeteners are used in the food, their presence shall be declared by their common or usual name on the principal display panel of the label as part of the statement of identity in letters that shall be no less than one-half the size of the type used in the term ‘‘goat’s milk ice cream’’ but in any case no smaller than one sixteenth of an inch. If the food pur ports to be or is represented for special dietary use, it shall bear labeling in ac cordance with the requirements of part 105 of this chapter. (d) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. [47 FR 41526, Sept. 21, 1982, as amended at 58 FR 2896, Jan. 6, 1993; 59 FR 47080, Sept. 14, 1994] § 135.130 Mellorine. (a) Description. (1) Mellorine is a food produced by freezing, while stirring, a pasteurized mix consisting of safe and suitable ingredients including, but not limited to, milk-derived nonfat solids and animal or vegetable fat, or both, only part of which may be milkfat. Mellorine is sweetened with nutritive carbohydrate sweetener and is charac terized by the addition of flavoring in gredients. (2) Mellorine contains not less than 1.6 pounds of total solids to the gallon, and weighs not less than 4.5 pounds to the gallon. Mellorine contains not less than 6 percent fat and 2.7 percent pro tein having a protein efficiency ratio (PER) not less than that of whole milk protein (108 percent of casein) by weight of the food, exclusive of the weight of any bulky flavoring ingredi ents used. In no case shall the fat con tent of the finished food be less than 4.8 percent or the protein content be less than 2.2 percent. The protein to meet the minimum protein requirements shall be provided by milk solids, not fat and/or other milk-derived ingredi ents. (3) When calculating the minimum amount of milkfat and protein required in the finished food, the solids of choc olate or cocoa used shall be considered a bulky flavoring ingredient. In order to make allowance for additional sweetening ingredients needed when certain bulky ingredients are used, the weight of chocolate or cocoa solids used may be multiplied by 2.5; the weight of fruit or nuts used may be multiplied by 1.4; and the weight of partially or wholly dried fruits or fruit juices may be multiplied by appro priate factors to obtain the original weights before drying and this weight may be multiplied by 1.4. (b) Fortification. Vitamin A is present in a quantity which will ensure that 40 international units (IU) are available for each gram of fat in mellorine, with in limits of good manufacturing prac tice. (c) Methods of analysis. Fat and pro tein content, and the PER shall be de termined by following the methods contained in ‘‘Official Methods of Anal ysis of the Association of Official Ana lytical Chemists,’’ 13th Ed. (1980), VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00465 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 456 21 CFR Ch. I (4–1–15 Edition) § 135.140 which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the avail ability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. (1) Fat content shall be determined by the method: ‘‘Fat, Roese-Gottlieb Method—Official Final Action,’’ sec tion 16.287. (2) Protein content shall be deter mined by one of the following methods: ‘‘Nitrogen—Official Final Action,’’ Kjeldahl Method, section 16.285, or Dye Binding Method, section 16.286. (3) PER shall be determined by the method: ‘‘Biological Evaluation of Pro tein Quality—Official Final Action,’’ sections 43.212–43.216. (d) Nomenclature. The name of the food is ‘‘mellorine’’. The name of the food on the label shall be accompanied by a declaration indicating the pres ence of characterizing flavoring in the same manner as is specified in § 135.110(c). (e) Label declaration. Each of the in gredients used shall be declared on the label as required by the applicable sec tions of parts 101 and 130 of this chap ter, except that sources of milkfat or milk solids not fat may be declared in descending order of predominance ei ther by the use of the terms ‘‘milkfat and nonfat milk’’ when one or any combination of two or more of the in gredients listed in § 101.4(b)(3), (b)(4), (b)(8), and (b)(9) of this chapter are used, or alternatively as permitted in § 101.4 of this chapter. [42 FR 19137, Apr. 12, 1977, as amended at 47 FR 11826, Mar. 19, 1982; 49 FR 10096, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 58 FR 2896, Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] § 135.140 Sherbet. (a) Description. (1) Sherbet is a food produced by freezing, while stirring, a pasteurized mix consisting of one or more of the optional dairy ingredients specified in paragraph (b) of this sec tion, and may contain one or more of the optional caseinates specified in paragraph (c) of this section subject to the conditions hereinafter set forth, and other safe and suitable nonmilk derived ingredients; and excluding other food fats, except such as are added in small amounts to accomplish specific functions or are natural com ponents of flavoring ingredients used. Sherbet is sweetened with nutritive carbohydrate sweeteners and is charac terized by the addition of one or more of the characterizing fruit ingredients specified in paragraph (d) of this sec tion or one or more of the nonfruit characterizing ingredients specified in paragraph (e) of this section. (2) Sherbet weighs not less than 6 pounds to the gallon. The milkfat con tent is not less than 1 percent nor more than 2 percent, the nonfat milk-derived solids content not less than 1 percent, and the total milk or milk-derived sol ids content is not less than 2 percent nor more than 5 percent by weight of the finished food. Sherbet that is char acterized by a fruit ingredient shall have a titratable acidity, calculated as lactic acid, of not less than 0.35 per cent. (b) Optional dairy ingredients. The op tional dairy ingredients referred to in paragraph (a) of this section are: Cream, dried cream, plastic cream (sometimes known as concentrated milkfat), butter, butter oil, milk, con centrated milk, evaporated milk, superheated condensed milk, sweetened condensed milk, dried milk, skim milk, concentrated skim milk, evaporated skim milk, condensed skim milk, sweetened condensed skim milk, sweet ened condensed part-skim milk, nonfat dry milk, sweet cream buttermilk, con densed sweet cream buttermilk, dried sweet cream buttermilk, skim milk that has been concentrated and from which part of the lactose has been re moved by crystallization, and whey and those modified whey products (e.g., reduced lactose whey, reduced minerals whey, and whey protein concentrate) that have been determined by FDA to be generally recognized as safe (GRAS) for use in this type of food. Water may be added, or water may be evaporated from the mix. The sweet cream butter milk and the concentrated sweet cream buttermilk or dried sweet cream but termilk, when adjusted with water to a VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00466 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 457 Food and Drug Administration, HHS § 135.140 total solids content of 8.5 percent, has a titratable acidity of not more than 0.17 percent calculated as lactic acid. The term ‘‘milk’’ as used in this sec tion means cow’s milk. (c) Optional caseinates. The optional caseinates referred to in paragraph (a) of this section which may be added to sherbet mix are: Casein prepared by precipitation with gums, ammonium caseinate, calcium caseinate, potas sium caseinate, and sodium caseinate. Caseinates may be added in liquid or dry form, but must be free of excess al kali, such caseinates are not consid ered to be milk solids. (d) Optional fruit-characterizing ingre dients. The optional fruit-character izing ingredients referred to in para graph (a) of this section are any ma ture fruit or the juice of any mature fruit. The fruit or fruit juice used may be fresh, frozen, canned, concentrated, or partially or wholly dried. The fruit may be thickened with pectin or other optional ingredients. The fruit is pre pared by the removal of pits, seeds, skins, and cores, where such removal is usual in preparing that kind of fruit for consumption as fresh fruit. The fruit may be screened, crushed, or otherwise comminuted. It may be acidulated. In the case of concentrated fruit or fruit juices, from which part of the water is removed, substances contributing fla vor volatilized during water removal may be condensed and reincorporated in the concentrated fruit or fruit juice. In the case of citrus fruits, the whole fruit, including the peel but excluding the seeds, may be used, and in the case of citrus juice or concentrated citrus juices, cold-pressed citrus oil may be added thereto in an amount not exceed ing that which would have been ob tained if the whole fruit had been used. The quantity of fruit ingredients used is such that, in relation to the weight of the finished sherbet, the weight of fruit or fruit juice, as the case may be (including water necessary to reconsti tute partially or wholly dried fruits or fruit juices to their original moisture content), is not less than 2 percent in the case of citrus sherbets, 6 percent in the case of berry sherbets, and 10 per cent in the case of sherbets prepared with other fruits. For the purpose of this section, tomatoes and rhubarb are considered as kinds of fruit. (e) Optional nonfruit characterizing in gredients. The optimal nonfruit charac terizing ingredients referred to in para graph (a) of this section include but are not limited to the following: (1) Ground spice or infusion of coffee or tea. (2) Chocolate or cocoa, including sirup. (3) Confectionery. (4) Distilled alcoholic beverage, in cluding liqueurs or wine, in an amount not to exceed that required for fla voring the sherbet. (5) Any natural or artificial food fla voring (except any having a char acteristic fruit or fruit-like flavor). (f) Nomenclature. (1) The name of each sherbet is as follows: (i) The name of each fruit sherbet is ‘‘lll sherbet’’, the blank being filled in with the common name of the fruit or fruits from which the fruit ingredi ents used are obtained. When the names of two or more fruits are in cluded, such names shall be arranged in order of predominance, if any, by weight of the respective fruit ingredi ents used. (ii) The name of each nonfruit sher bet is ‘‘lll sherbet’’, the blank being filled in with the common or usual name or names of the characterizing flavor or flavors; for example, ‘‘pepper mint’’, except that if the character izing flavor used is vanilla, the name of the food is ‘‘lll sherbet’’, the blank being filled in as specified by § 135.110(e) (2) and (5)(i). (2) When the optional ingredients, ar tificial flavoring, or artificial coloring are used in sherbet, they shall be named on the label as follows: (i) If the flavoring ingredient or in gredients consists exclusively of artifi cial flavoring, the label designation shall be ‘‘artificially flavored’’. (ii) If the flavoring ingredients are a combination of natural and artificial flavors, the label designation shall be ‘‘artificial and natural flavoring added’’. (iii) The label shall designate artifi cial coloring by the statement ‘‘artifi cially colored’’, ‘‘artificial coloring added’’, ‘‘with added artificial color ing’’, or ‘‘lll, an artificial color VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00467 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 458 21 CFR Ch. I (4–1–15 Edition) § 135.160 added’’, the blank being filled in with the name of the artificial coloring used. (g) Characterizing flavor(s). Wherever there appears on the label any rep resentation as to the characterizing flavor or flavors of the food and such flavor or flavors consist in whole or in part of artificial flavoring, the statment required by paragraph (f)(2) (i) and (ii) of this section, as appro priate, shall immediately and con spicuously precede or follow such rep resentation, without intervening writ ten, printed, or graphic matter (except that the word ‘‘sherbet’’ may inter vene) in a size reasonably related to the prominence of the name of the characterizing flavor and in any event the size of the type is not less than 6 point on packages containing less than 1 pint, not less than 8-point on pack ages containing at least 1 pint but less than one-half gallon, not less than 10 point on packages containing at least one-half gallon but less than 1 gallon, and not less than 12-point on packages containing 1 gallon or over. (h) Display of statements required by paragraph (f)(2). Except as specified in paragraph (g) of this section, the state ments required by paragraph (f)(2) of this section shall be set forth on the principal display panel or panels of the label with such prominence and con spicuousness as to render them likely to be read and understood by the ordi nary individual under customary con ditions of purchase and use. (i) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. [43 FR 4599, Feb. 3, 1978, as amended at 46 FR 44434, Sept. 4, 1981; 58 FR 2896, Jan. 6, 1993] § 135.160 Water ices. (a) Description. Water ices are the foods each of which is prepared from the same ingredients and in the same manner prescribed in § 135.140 for sher bets, except that the mix need not be pasteurized, and complies with all the provisions of § 135.140 (including the re quirements for label statement of in gredients), except that no milk or milk-derived ingredient and no egg in gredient, other than egg white, is used. (b) Nomenclature. The name of the food is ‘‘lll ice’’, the blank being filled in, in the same manner as speci fied in § 135.140(f)(1) (i) and (ii), as ap propriate. [42 FR 19132, Apr. 12, 1977, as amended 58 FR 2876, Jan. 6, 1993] PART 136—BAKERY PRODUCTS Subpart A—General Provisions Sec. 136.3 Definitions. Subpart B—Requirements for Specific Standardized Bakery Products 136.110 Bread, rolls, and buns. 136.115 Enriched bread, rolls, and buns. 136.130 Milk bread, rolls, and buns. 136.160 Raisin bread, rolls, and buns. 136.180 Whole wheat bread, rolls, and buns. AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, 379e. Subpart A—General Provisions § 136.3 Definitions. For purposes of this part, the fol lowing definitions apply: (a) The word bread when used in the name of the food means the unit weighs one-half pound or more after cooling. (b) The words rolls and buns when used in the name of the food mean the unit weighs less than one-half pound after cooling. Subpart B—Requirements for Spe cific Standardized Bakery Products § 136.110 Bread, rolls, and buns. (a) Bread, white bread, and rolls, white rolls, or buns, and white buns are the foods produced by baking mixed yeast-leavened dough prepared from one or more of the farinaceous ingredi ents listed in paragraph (c)(1) of this section and one or more of the moist ening ingredients listed in paragraphs (c) (2), (6), (7), and (8) of this section and one or more of the leavening agents provided for by paragraph (c)(3) of this section. The food may contain additional ingredients as provided for by paragraph (c) of this section. Each VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00468 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B