Regulation 1 Definition and StandardsSection 1 Ice Cream and Frozen Custard(a) Description (1) Ice cream is a food produced by freezing, while stirring, a pasteurized mix consisting of one of the optional dairy ingredients specified in paragraph (b) of this section, 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 natural components of flavoring ingredients used and are added in incidental amounts to accomplish specific functions. Ice Cream is sweetened with nutritive carbohydrate sweeteners and may or may not be characterized by the addition of flavoring ingredients.(2) Ice cream weighs not less than 4.5 pounds to the gallon and contains not less than 36% total solids by weight. 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 percent increments above the 10 percent minimum, it may contain the following milkfat-to-nonfat milk solids levels: | Minimum percent nonfat | Percent milkfat 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 10 percent and 20 percent, respectively, of the remainder obtained by subtracting the weight of the bulky flavors 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 ingredients used. Frozen custard shall contain 1.4 percent egg yolk solids by weight of the finished food: Provided, however, that when 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 of ice cream, may be marketed if labeled as specified by paragraph (e) (l) of this section.
(3) When calculating the minimum amount of milkfat and nonfat milk solids required in the finished food, the solids of chocolate 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 by multiplied by 1.4; and the weight of partially or wholly dried 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 optional dairy ingredients referred to in paragraph (a) of this section are: cream, dried cream, plastic cream, (sometimes known as a concentrated milk fat), butter, butter oil, milk, concentrated 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, sweetened condensed part skim milk, nonfat dry milk, sweet cream buttermilk, condensed sweet cream buttermilk, dried sweet cream buttermilk, skim milk that has been concentrated and from which part of the lactose has been removed by crystallization, skim milk in concentrated or dried form which has been modified by treating the concentrated skim milk with calcium hydroxide and disodium phosphate, 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 mix. The sweet cream buttermilk and the concentrated sweet cream buttermilk or dried sweet cream buttermilk, 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 section means cow's milk. Any whey and modified whey products used contribute, 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 substantially 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 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 caseinate, potassium caseinate, and sodium caseinate. Caseinate may be added in liquid or dry form, but must be free of excess alkali.(d) Methods of analysis. Fat content shall be determined by the following methods contained in the "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th ed., 1980, (A.O.A.C. Methods). (1) Fat content shall be determined by the method: "Fat; Roese-Gottlieb Method Official Final Action," (A.O.A.C. section 16.287 ).(e) 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 custard" or "french ice cream" or "french custard ice cream".(2) (i) If the food contains no artificial flavor, the name on the principal display panel or panels of the label shall be accompanied by the common or usual name of the characterizing flavor, 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 natural characterizing flavor and an artificial flavor simulating it, and if the natural flavor predominates, the name of the principal display panel or panels of the labels 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 flavor, e.g., "Vanilla flavored", or "Peach flavored", or "Vanilla flavored and Strawberry flavored".(iii) If the food contains both a natural characterizing flavor and an artificial flavor simulating it, and if the artificial flavor predominates, or if artificial 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 "artificial" or "artificially flavored", in letters not less than one-half the height of the letters in the name of the characterizing flavor, e.g., "artificial Vanilla", "artificially flavored Strawberry" or "artificially flavored Vanilla and artificially flavored Strawberry".(3) (i) If the food is subject to the requirements of paragraph (e) (2) (ii) of this section or if it contains any artificial flavor not simulating the characterizing flavor, the label shall also bear the words "artificial flavor added" or "artificial.....flavor added", the blank being filled in with the common name of the flavor simulated by the artificial flavor in letters of the same size and prominence as the words that precede and follow it.(ii) Wherever the name of the characterizing flavor appears on the label so conspicuously as to be easily seen under customary conditions of purchase, the words prescribed by this paragraph shall immediately and conspicuously 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 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 trademark or brand, may intervene if the required 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 requirements of this paragraph, the statements required by this paragraph need appear only once in each statement of characterizing flavors present in such ice cream, e.g., "Vanilla flavored, Chocolate, and Strawberry flavored, 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 paragraph, be accompanied by a reference to the artificial flavor, displayed with substantially equal prominence, e.g., "Vanilla flavored, Chocolate, and Strawberry flavored, artificial flavors added".(5) An artificial flavor simulating the characterizing flavor shall be deemed to predominate: (i) In the case of vanilla beans or vanilla extract used in combination with vanillin if the amount of vanillin used is greater than 1 ounce per unit of vanilla constituent, as defined in 21 CFR 169.3(c).(ii) In the case of fruit or fruit juice used in combination with artificial fruit flavor, if the quantity of the fruit juice used is such that, in relation to the weight of the fruit or fruit juice, as the case may be (including water necessary to reconstitute partially or wholly dried fruits or fruit juices to their original moisture content) is less than 2 percent in the case of berry or cherry ice cream, and 10 percent in the case of ice cream prepared with other fruits.(iii) In the case of nut meats used in combination with artificial nut flavor, if the quantity of nut meats 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 flavors simulating the natural flavors and dispensed throughout the food, if the quantity of any fruit or fruit juice or nut meat is less than one-half the applicable percentage specified in paragraph (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 almonds it would be "artificially flavored banana-almond ice cream". However, if it contins 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 package, e.g., "Neapolitan" ice cream, the applicable provisions of this paragraph shall govern each flavor of ice cream comprising the combination.(f) Label declaration. Each of the optional ingredients used shall be declared on the label as required by the applicable section of 21 CFR 101, except that sources of milkfat or milkfat soolids 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 the appropriate sections of CFR 101.4. Pursuant to section 402(k) of the Federal Food, Drug and Cosmetic Act artificial color need not be declared in ice cream. Voluntary declaration of such color in ice cream is recommended. Section 2 Ice Milk(a) Description. Ice Milk is the food prepared from the same ingredients and in the same manner prescribed in Section 1 for ice cream and complies with all the provisions of Section 1 including the requirements for label statement of optional ingredients, except that:(1) Its content of milkfat is more than 2 percent but not more than 7 percent.(2) Its content of total milk solids is not less than 11 percent.(3) Caseinates may be added when the content of total milk solids is not less than 11 percent.(4) The provision for reduction in milkfat and nonfat milk solids content from the addition of bulky flavors in Section 1 applies, except that in no case will the milkfat content be less than 2 percent, nor the nonfat milk solids content be less than 4 percent. When the milk fat content increases in increments of 1 percent above the 2 percent minimum, it may contain the following milkfat-to-nonfat milk solids levels: | Minimum percent nonfat |
| Percent milkfat | milk solids |
2 | 9 |
3 | 8 |
4 | 7 |
5 | 6 |
6 | 5 |
7 | 4 |
(5) The quantity of food solids is not less than 30% by weight.(6) When any artificial coloring is used in ice milk, directly or as a component of any other ingredients, the label shall bear the statement "artificially colored", "artificial coloring added", "with added artificial color, or "....., an artificial color added," the blank being filled in with the common or usual name of the artificial color is a component of another ingredient, ".....artificially colored."(7) If both artificial color and artificial flavoring are used, the label statements may be combined.(b) Nomenclature. The name of the food is "ice milk". Ice milk shall be offered for sale, sold or served only in properly labeled factory-filled containers upon which shall be conspicuously printed the words, "Ice Milk" in letters not smaller than eight point type except when ice milk is sold at retail, direct from a frozen dessert dispensing freezer. No person shall sell or offer for sale any ice milk to a person who has requested ice cream.
Section 3 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 section, and may contain one or more of the optional caseinates specified in paragraph (c) of this section subject to the condition 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 components of flavoring ingredients used. Sherbet is sweetened with nutritive carbohydrate sweeteners and is characterized by the addition of one or more of the characterizing fruit ingredients specified in paragraph (d) of this section or one of the non-fruit-characterizing ingredients specified in paragraph (e) of this section.(2) Sherbet weighs not less than 6 pounds to the gallon. The milkfat content is not less than 1 percent nor more than 2 percent, the nonfat milk-derived solids content is not less than 1 percent and the total milk or milk-derived solids content is not less thaan 2 percent nor more than 5 percent by weight of the finished food. Sherbet that is characterized by a fruit ingredient shall have a titratable acidity, calculated as lactic acid, of not less than 0.55 percent.(b) Optional dairy ingredients. The optional dairy ingredients referred to in paragraph (a) of this section are: Cream, dried cream, plastic cream, (sometimes known as concentrated milk fat), butter, butter oil, milk, concentrated milk, evaporated milk, superheated condensed milk, sweetened condensed milk, dried milk, skim milk, concentrated skim milk, evaporated skim milk, condensed skim milk, superheated condensed skim milk, sweetened condensed skim milk, sweetened condensed part skim milk, nonfat dry milk, sweet cream buttermilk, condensed sweet cream buttermilk, dried sweet cream buttermilk, skim milk that has been concentrated and from which part of the lactose has been removed 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 have evaporated from the mix. The sweet cream buttermilk and the concentrated sweet cream buttermilk or dried sweet cream buttermilk, 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 section 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: Casin prepared by precipitation with gums, ammonium caseinate, calcium caseinate, potassium caseinate, and sodium caseinate. Caseinates may be added in liquid or dry form, but must be free of excess alkali. Such caseinates are not considered to be milk solids.(d) Optional fruit-characterizing ingredients. The optional fruit characterizing ingredients referred to in paragraph (a) of this section are any mature fruit or 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 prepared 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 flavor volatilized during water removal may be condensed and reincorporated in the concentrated fruit of 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 exceeding that which would have been obtained if the 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 ujuice, as the case may be (including water necessary to reconstitute partially or wholly dried fruits or fruit juices to their original moisture content), is not less than 2 percent in the case of berry sherbets, and 10 percent in the case of sherbets prepared with other fruits. For the purpose of this section, tomatoes and rhubarb are considered as kinds of fruits.(e) Optional nonfruit characterizing ingredients. The optional nonfruit characterizing ingredients referred to in paragraph (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.(4) Distilled alcoholic beverage, including liqueurs or wine, in an amount not to exceed that required for flavoring the sherbet.(5) Any natural or artificial food flavoring (except any having a characteristic fruit or fruit-like flavor).(f) Nomenclature.(1) The name of each sherbet is as follows:(i) The name of each fruit sherbet is ".... sherbet", the blank being filled in with the common name of the fruit or fruits from which the fruit ingredients used are obtained. When the name of two or more fruits are included, such names shall be arranged in order of predominance, if any, by weight of the respective fruit ingredients used.(ii) The name of each nonfruit sherbet is ".... sherbet", the blank being filled in with the common or usual name of the characterizing flavor or flavors; for example, "peppermint", except that if the characterizing flavor used in vanilla, the name of the food is ".... sherbet", the blank being filled in as specified by Section 1(e) (2) and (5) (i).(2) When the optional ingredients, artificial flavoring or artificial coloring are used in sherbet, they shall be named on the label as follows: (i) If the flavoring ingredient or ingredients consists exclusively of artificial 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 artificial coloring by the statement "artificially colored", "artificial coloring added", "with added artificial coloring", or "....., an artificial color added", the blank being filled in with the name of the artificial coloring used.(g) Characterizing flavor(s). Whenever there appears on the label any representation 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 statement required by paragraph (f) (2) (i) and (ii) of this section, as appropriate, shall immediately and conspicuously precede or follow such representation, without intervening written, printed, or graphic matter (except that word "sherbet" may intervene) 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 packages containing at least 1 pint but less than one-half gallon, 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 statements 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 conspicuousness as to render them likely to be read and understood by the ordinary individual under customary conditions of purchase and use.(i) Label declarations. Each of the optional ingredients used shall be declared on the label, as required by the applicable sections of 21 CFR 101.Section 4 Non Fruit Sherbet(a) Description (1) Non fruit sherbet is a food having a characteristic fruit-like flavor but shall not contain any fruit or fruit juice. Non fruit sherbet is prepared by freezing while stirring a pasteurized mix consisting of one or more of the optional dairy ingredients specified in paragraph (b) of this section, 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 any other safe and suitable non-milk-derived ingredients; and excluding other food fats, except such as are added in small amounts to accomplish specific functions. Non fruit sherbet is sweetened with nutritive carbohydrate sweeteners and contains characteristic fruit like flavor.(2) Sherbet weighs not less than 6 pounds to the gallon. The milkfat content 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 solids content is not less than 2 percent nor more than 5 percent by weight of the finished product.(b) Optional dairy ingredients. The optional dairy ingredients referred to in paragraph (a) of this section are: Cream, dried cream, plastic cream (sometimes known as concentrated milk fat), butter, butter oil, milk, concentrated milk, evaporated milk, superheated condensed milk, sweetened condensed milk, dried milk, skim milk, concentrated skim milk, evaporated skim milk, condensed skim milk, superheated condensed skim milk, sweetened condensed skim milk, sweetened condensed part skim milk, nonfat dry milk, sweet cream buttermilk, condensed sweet cream buttermilk, dried sweet cream buttermilk, skim milk that has been concentrated and from which part of the lactose has been removed by crystallization, and whey and those modified whey products (e.g., reduced lactose whey, reduced minerals whey, and whey protein concentrate) that has 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 buttermilk and the concentrated sweet cream buttermilk or dried sweet cream buttermilk, when adjusted with water to be 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 section means cow's milk.(c) Optional caseinates. The optional caseinates referred to in paragraph (a) of this section that may be added to non fruit sherbet are: Casin prepared by prescripitation with gums, ammonium caseinate, calcium caseinate, potassium caseinate, and sodium caseinate. Caseinates may be added in liquid or dry form, but must be free of excess alkali. Such caseinates are not considered to be milk solids.(d) Nomenclature. The name of the food is "non fruit sherbet".(e) In addition to all other required information, the label shall: (1) Contain a complete list of ingredients, in accordance with provision of 21 CFR 101.4.(2) Comply with the provisions of 21 CFR 101.22.(3) Contain the following statement "Imitation .... sherbet". The blank is to be filled in by the characterizing flavor used. The letters in the word imitation shall be the same size, type and color and on the same contrasting background as the name of the characterizing flavor and the word sherbet.(4) The statement required in paragraph (3) of this subsection shall be followed immediately by the words "contains no fruit sherbet, it shall contain the same information as required in paragraphs three and four of this subsection.(5) When a sign is used at the point of purchase to advertise non fruit sherbet, it shall contain the same information as required in paragraphs three and four of this subsection.(6) When non fruit sherbet is sold other than in properly labeled factory filled containers a sign must be conspicuously displayed on the sale premises or vehicle where it can be clearly read by customers under normal conditions of purchase, stating the information required in paragraphs 3 and 4 above. The letters on such sign shall be bold face capitals at least three inches in height and in contrasting color to the background.(7) The sign required as per paragraph 6 above need not be used if each customer is provided with a menu stating the information required by paragraph 3 and 4 above in bold face capitals as large as those used in listing most food items.Section 5 Water Ice (a) Description. Water ices are the foods each of which is prepared from the same ingredients and in the same manner prescribed in Section 3 for sherbets, except that the mix need not be pasteurized, and complies with all the provisions of Section 3 including the requirements for label statement of optional ingredients except that no milk or milk derived ingredient and no egg ingredient, other than egg white, is used.(b) Nomenclature. The name of the food is ".... ice", the blank being filled in, in the manner as specified in Section 3(f) (1) (i) and (ii) as appropriate. Section 6 Non Fruit Water Ice Non fruit water ice is an ice having a characteristic fruit-like flavor, but shall not contain any fruit or fruit juice. Non-fruit water ice is prepared while stirring a mix composed of:
(a) Characteristic fruit-like flavors.(b) One or more nutritive sweeteners.(c) Any other safe and suitable ingredient approved by the Department. The finished non fruit water ice weighs not less than six pounds per gallon. In addition to all other required information of the label shall:
(1) Contain a complete list of ingredients, in accordance with the provisions of 21 CFR 101.4.(2) Comply with the provisions of 21 CFR 101.22.(3) Contain the following statement "Imitation .... water ice". The blank to be filled in by the characterizing flavor used. The letters in the word imitation shall be the same size, type and color and on the same contrasting background as the name of the characterizing flavor and the word sherbet.(4) The statement required in paragraph (3) of this subsection shall be followed immediately by the words "contains no fruit or fruit juice" in letters at least half the size of those used in statement three above.(5) When a sign is used at the point of purchase to advertise non fruit sherbet, it shall contain the same information as required in paragraphs three and four of this subsection.(6) When non fruit water ice is sold other than in properly labeled factory filled containers a sign must be conspicuously displayed on the sale premises or vehicle where it can be clearly read by customers under normal conditions of purchase, stating the information required in paragraphs 3 and 4 above. The letters on such sign shall be bold face capitals at least three inches in height and in contrasting color to the background.(7) The sign required as per paragraph 6 above need not be used is each customer is provided with a menu stating the information required by paragraph 3 and 4 above in bold face capitals as large as those used in listing most food items.Section 7 Mellorine (a) Description. (1) Mellorine is a food produced by freezing, while stirring, a pasteurized mix consisting of safe 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 characterized by the addition of flavoring ingredients.(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 protein having a protein efficiency ratio (PER) not less than that of whole milk protein (108 percent of casine) by weight of the food, exclusive of the weight of any bulky flavoring ingredients used. In no case shall the fat content 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 milk-derived ingredients.(3) When calculating the minimum amount of milkfat and protein required in the finished food, the solids of chocolate or cocoa used shall be considered a bulky flavoring ingredient. In order to make allowance for additional sweetener 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 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) 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, within limits of good manufacturing practice.(c) Methods of analysis. Fat and protein content, and the PER shall be determined by the following methods contained in the "Official Methods of Analysis of the Association of Official Analytical Chemists," 12th ed., 1975 (A.O.A.C. Methods).(1) Fat content shall be determined by the method: "Fat, Roese-Gottlieb Method-Official Final Action," (A.O.A.C., section 16.228).(2) Protein content shall be determined by the method: "Biological Evaluation of Protein Quality-Official Final Action" sections 39.166 - 39-170.(3) PER shall be determined by the method: "Biological Evaluation of Protein Quality-Official Final Action" sections 39-166 - 39.170.(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 presence of characterizing flavoring in the same manner as is specified in Section 1, paragraph (e).(e) Label declaration. The common or usual name of each of the ingredients used shall be declared on the label, in accordance with section 21 CFR 101.4 except that sources of milkfat or milk solids not fat may be declared, in descending order or predominance, either or the use of the terms "milkfat, and nonfat milk" when one or any combination of two or more ingredients listed in 21 CFFR 101.4. Mellorine shall be sold, held, offered for sale by any manufacturer, wholesaler, retailer, or any other seller only in factory-filled containers not larger than one-half gallon. Section 8 Goats Milk Ice Cream and Goats Milk Ice Milk(a) Goat's milk ice cream.(1) Description. Goats milk ice cream is a food prepared in the same manner prescribed in Section 1 for ice cream, and complies with all the provisions o Section 1, except that the only optional dairy ingredients that may be used are those in paragraph (2) of this section; casinates may not be used; and paragraphs (e) (1) and (f) of Section 1 shall not apply.(2) Optional dairy ingredients. The optional dairy ingredients referred to in paragraph (1) of this section are goat's skim milk, goat's milk, and goat's cream. These optional dairy ingredients may be used in liquid, concentrated, and/or dry form.(3) Nomenclature. The name of the food is "goat's milk ice cream" or, alternatively, "ice cream made with goat's milk", except that when the egg yolk solids content of the food is in excess of that specified for ice cream in paragraph (2) of Section 1, the name of the food is "goat's milk frozen custard" or alternatively, "frozen custard made with goat's milk", or "goat's milk french ice cream" or, "goat's milk french custard ice cream", or alternatively, "french custard ice cream made with goat's milk".(4) Label declaration. Each of the optional ingredients used shall be declared on the label as required by the applicable sections of Regulation 1 of these regulations.(b) Goat's milk ice milk. (1) Description. Goat's milk ice milk is the food prepared in the same manner prescribed in section (a) for goat's milk ice cream, except that paragraph (3) shall not apply, and which complies with all the requirements of Section (a) (1), (2), (4), (5), (6) and (7) for ice milk.(2) Nomenclature. The name of the food is "goat's milk ice milk" or, alternatively, "ice milk made with goat's milk".Section 9 Frozen Yogurt Frozen yogurt is the food which is prepared by freezing while stirring a pasteurized mix consisting of the ingredients permitted for ice cream in Section 1. Such ingredients are cultured after pasteurization by one or more strains of Lactobacillus bulgaricus and Streptococcus thermophilus, provided, however, fruit, nuts, or flavoring materials may be added before and after the mix is pasteurized and cultured. The standard plate count requirement for frozen desserts shall apply to the mix prior to culturing. Frozen yogurt, exclusive of any flavoring contains not less than 8.25 percent milk solids not fat and has a titratable acidity of not less than 0.5 percent expressed as lactic acid. This characteristic acidity is developed as a result of the bacterial activity and no heat or bacteriostatic treatment, other than refrigeration, which results in destruction or partial destruction of the organisms, shall be applied to the product after such culturing. The finished yogurt shall weigh not less than five pounds per gallon. The name of the food is frozen yogurt. In addition to all other required information, the label shall contain a complete list of ingredients, in accordance with the provisions of 21 CFR 101.4, and comply with the provisions of subdivision (h) and (i) of 21 CFR 101.22. On the label of frozen yogurt the strains of bacteria may be collectively referred to as yogurt culture.
Section 10 Frozen Lowfat or Lowfat Frozen Yogurt Frozen lowfat yogurt or lowfat frozen yogurt is the food which is prepared by freezing while stirring a pasteurized mix consisting of the ingredients permitted for ice cream in Section 1. Such ingredients are cultured after pasteurization by one or more strains of Lactobacillus bulgaricus and Streptococcus thermophilus, provided however, fruit, nuts, and other flavoring materials may be added before or after the mix is pasteurized and cultured. The standard plate count requirement for frozen desserts shall apply only to the mix prior to culturing. The food, exclusive of any flavoring, contains not less than 0.5 percent nor more than 2 percent milkfat and not less than 8.25 percent milk solids not fat, and has a titratable acidity of not less than 0.5 percent, expressed as lactic acid. This characteristic acidity is developed as a result of the bacterial activity and no heat or bacteriostatic treatment, other than refrigeration, which results in destruction or partial destruction of the organisms, shall be appplied to the product after such culturing. The finished food shall weigh not less than five pounds per gallon. The name of the food is frozen lowfat yogurt or lowfat frozen yogurt.
The label on a package of this food, in addition to all other required information shall:
(1) Contain a complete list of ingredients, in accordance with the provisions of 21 CFR 101.4.(2) Contain nutrition information as required by 21 CFR 101.9.(3) Comply with the provisions of subdivision (h) & (i) of 21 CFR 101.22 On the label, the strains of bacteria may be collectively referred to as yogurt culture.Section 11 Frozen Nonfat Yogurt or Nonfat Frozen Yogurt Frozen nonfat yogurt or nonfat frozen yogurt is the food which is prepared by freezing while stirring a pasteurized mix consisting of the ingredients permitted for ice cream in Section 1. Such ingredients are cultured after pasteurization by one or more strains of Lactobacillus bulgaricus and Streptococcus thermophilus, provided, however, fruit, nuts, or other flavoring materials may be added before and after the mix is pasteurized and cultured. The standard plate count requirement for frozen desserts shall apply only to the mix prior to culturing. The food, exclusive of any flavoring, contains less than 0.5 percent milkfat, not less than 8.25 percent milk solids not fat and has a titratable acidity of not less than 0.5 percent expressed as lactic acid. This characteristic acidity is developed as a result of the bacterial activity and no heat or bacteriostatic treatment other than refrigeration, which results in destruction or partial destruction of the organisms, shall be applied to the product after such culturing. The finished food shall weigh not less than five pounds per gallon. The name of the food is frozen nonfat yogurt or nonfat frozen yogurt. The label on a package of this food in addtiion to all other information shall:
(1) Contain a complete list of ingredients, in accordance with the provisions of 21 CFR 101.4.(2) Contain nutrition information as required by 21 CFR 101.9.(3) Comply with the provisions of subdivision (h) & (i) of 21 CFR 101.22. On the label, the strains of bacteria may be collectively referred to as yogurt culture.
Section 12 Quiescently Frozen Confection Quiescently frozen confection means the frozen product made from sweetening agent, harmless natural or artificial flavoring, water, and it may contain milk solids, harmless coloring, organic acids, and any safe and suitable functional ingredient approved by the Department. The finished product shall contain not less than seventeen per centum by weight of total food solids. The name of the food is quiescently frozen confection. In the manufacture of this product, freezing has not been accomplished by stirring or agitation (generally known as quiescent freezing.) In the production of this quiescently frozen confection, no processing or mixing prior to quiescent freezing shall be used that develops in the finished confection mix any physical expansion in excess of ten per centum. This confection must be manufactured in the form of servings, individually packaged, bagged or otherwise wrapped, properly labeled and purveyed to the consumer in its original factory-filled package. The individually wrapped confection need not be labeled if it contained in a multiple package which is properly labeled if it is contained in a multiple package which is properly labeled and is purveyed unopened to the consumer. In addition to all other required information, the label shall contain a complete list of ingredients, in accordance with the provisions of 21 CFR 101.4, and comply with the provisions of subdivision (h) & (i) of 21 CFR 101.22.
Section 13 Quiescently Frozen Dairy Confection Quiescently frozen dairy confection means the frozen product made from milk products, sweetening agents, harmless natural or artificial flavoring, water and it may contain harmless coloring, and any safe and suitable functional ingredient approved by the Department. The finished product contains not less than thirteen per centum by weight of total milk solids, not less than thirty-three per centum by weight of total food solids. The name of the food is quiescently frozen dairy confection. In the manufacture of this product, freezing has not been accompanied by stirring or agitation (generally known as quiescently freezing.) In the production of this quiescently frozen dairy confection, no processing or mixing prior to quiescent freezing shall be used that develops in the finished confection mix any physical expansion in excess of ten per centum. This confection must be manufactured in the form of servings, individually packaged, bagged or otherwise wrapped, properly labeled and purveyed to the consumer in it's original factory-filled package. The individually wrapped confection need not be labeled if it is contained in a multiple package which is properly labeled and is purveyed unopened to the consumer. In addition to all other required information, the label shall contain a complete list of ingredients, in accordance with the provisions of 21 CFR 101.4, and comply with the provisions of subdivision (h) and (i) of 21 CFR 101.22.
Section 14 Frozen Dietary Dairy Dessert(1) Frozen dietary dessert means a frozen dessert prepared for persons who wish to restrict their intake of ordinary sweetening ingredients. It is produced by freezing while stirring a pasteurized mix consisting of the ingredients permitted for ice cream in Section 1. The minimum fat content shall be three percent, it shall contain no sugars other than those naturally present in milk solids or flavoring agents which have been added thereto, and it may contain edible carbohydrates other than sugars. The edible carbohydrates must be approved by the Department.(2) The name of the food is frozen dietary dairy dessert.(3) The label on a package of frozen dietary dairy dessert in addition to other required information shall: (a) Contain a complete list of ingredients, in accordance with the provisions of 21 CFR 101.4.(b) Contain a statement as follows: (Diabetics: This product may be useful in your diet on the advice of physician. This food is not a reduced calorie food).
(c) Immediately preceding or following the name of the product a statement as follows: "Contains .....% milkfat". The blank to be filled in with the percentage of milkfat in the product.(d) Comply with the provisions of 21 CFR 101.9 and subdivision (h) and (i) of 21 CFR 101.22.(4) The product shall not be sold in any manner other than in sealed or unbroken packages or containers.Section 15 Dietary Frozen Dessert or Low Fat Frozen Dairy Dessert(a) Dietary frozen dessert is the food prepared by freezing while stirring, a pasteurized mix consisting of the ingredients permitted for ice cream in Section 1. The finished product contains less than two percent by weight of either extractable fat, its' content of total milk solids consisting of ingredients listed in paragraph (b) of Section 1 is not less than seven percent by weight. The product weighs no less than 4.5 pounds per gallon and the quantity of food solids per gallon is not less than 1.1 pounds nor more than 1.55 pounds, exclusive of any microcrystalline cellulose used as an ingredient.(b) One or more vitamins and/or minerals listed in CFR Title 21, Section 101.9(c) (7) (iv) may be added to the product. If vitamins and/or minerals are added, the name of the food on the principal display panel and each alternate principal display panel shall be immediately preceded or followed by the word "fortified" in the same style and at least one-half the size of the type used for the name "dietary frozen dessert" and on the same contrasting background. If vitamins and/or minerals are added, then each four fluid ounce serving of finished product shall provide no less than eight percent nor more than 20 percent of the U.S. Recommended Daily Allowance for such vitamins and/or minerals.(c) The name of the food is dietary frozen dessert.(d) The label on dietary frozen dessert, in addition to all other required information shall: (1) Contain a complete list of ingredients, in accordance with the provisions of 21 CFR 101.22.(2) Comply with the provisions of 21 CFR 101.9 and subdivision (h) and (i) of 21 CFR 101.22.(e) Dietary frozen dessert may be sold in properly labeled factory-filled containers, except it may be served directly from a dispensing freezer at the time of a direct request from a customer. When dietary frozen dessert is sold directly from a dispensing freezer at the time of a direct request from the customer, the name of the food, nutrition information required by 21 CFR 101.9, and a complete listing of ingredients in accordance with the provisions of 21 CFR 101.4 shall appear on the container used.Section 16 Lactose Reduced Ice Cream and Lactose Reduced Ice Milk Lactose reduced ice cream is the product resulting from the treatment of ice cream, as defined in section 1 of these regulations, by the addition of safe and suitable enzymes to convert sufficient amounts of lactose to glucose and/or galactose so that the remaining lactose is less than thirty percent of the lactose in ice cream.
The name of the food is "lactose reduced ice cream."
Wherever the name appears on the container, the words lactose reduced shall be in the same type style and size and in the same color and contrasting background as the words ice cream.
Section 17 Manufactured Desserts Mix "Manufactured desserts mix", whipped cream confection, bisque tortoni means a frozen dessert made with milk product, sweetening agents, flavoring agents, with or without harmless coloring or any other safe and suitable ingredients approved by the Commissioner. The product must contain not less than eighteen per centum by weight of milk fat, and not more than twelve per centum of milk solids not fat, and may be packaged with harmless gas causing it to fluff upon ejection from the package or container.
In addition to all other required information, the label shall contain a complete list of ingredients in accordance with the provisions of 21 CFR 101.4.
Section 18 Freezer Made Shake - Freezer Made Milk Shake(a) Freezer made milk shake means a pure, clean, wholesome semi-viscous drink prepared by stirring while freezing a pasteurized mix consisting of the ingredients prescribed for ice milk in Section 2 of these regulations except that:(1) It shall contain not less than three and one-fourth percent and not more than six percent milk fat.(2) Its' content of milk solids not fat shall not be less than than ten percent.(b) Other freezer made shakes including jumbo shake, thick shake, T.V. shake, or any coined or trade name containing the word "shake" shall meet the requirements of paragraph (a), except that the minimum percent of milk fat may be less than three and one-fourth percent.(c) "Shakes" not meeting the requirement for "milk shakes" shall not be advertised, sold or served as milk shakes.(d) When any freezer made milk shake or other freezer made shake purports to be or is represented for any special dietary use by man, it shall be sold only in a container with an ingredient listing in accordance with the provisions of 21 CFR 101.4, and nutrition information as required by 21 CFR 101.9.Section 19 Parevine (a) Parevine is the food which is prepared by freezing while stirring a pasteurized mix composed of (1) one or more edible vegetable oils or fats;(2) protein and carbohydrate food ingredients from other than milk or meat sources;(3) nutritive sweeteners other than lactose;(4) characterizing ingredients except any containing meat or milk; and(5) any other safe and suitable ingredient which is not milk or meat or a product or derivative of milk or meat. This product shall not contain any milk, milk product, meat or meat products of any of their derivatives of any kind.
(b) Its' fat content shall not be less than 10 percent except that when bulky optional characterizing ingredients are used, the fat content may be reduced, as a result of the addition of such ingredients, but shall in no case be less than eight percent.(c) Its' content of food solids shall not be less than 1.3 pounds per gallon of the finished product.,(d) The name of the food is "parevine".(e) Parevine shall be sold, held, offered for sale by any manufacturer, wholesaler, retailer, or any other seller only in properly labeled factory-filled containers, except parevine may be served other than in a properly labeled factory filled container if a sign is conspicuously displayed where it can easily be read under normal conditions of purchase stating "PAREVINE SOLD HERE". Letters on such sign shall be bold face capitals at least three inches in height and in contrasting color to the background. No such sign need be displayed if each customer is provided with a menu on which there is stated "PAREVINE SERVED HERE" in bold face capitals as large as those used in listing most food items.(f) The label on packages of parevine shall, in addition to all other required information include a complete list of all ingredients, in accordance with the provisions of 21 CFR 101.4.Section 20 Lo-Mel (a) "Lo-mel" means a pure, clean, wholesome semi-viscious drink prepared by stirring while freezing in a dispensing freezer a pasteurized mix composed of edible fats or oils other than milk fat, milk solids not fat, and water. It may contain optional sweetening ingredients and any other safe and suitable ingredients approved by the department.(b) Lo-mel may only be served or sold directly from a dispensing freezer and may not be sold hard frozen.(c) When Lo-mel is sold a sign must be prominently and conspicuously displayed not more than 18 inches above each dispensing freezer, where it can be clearly read by customers under normal condition of purchase, stating "LO-MEL SERVED HERE", in bold face capitals at least three inches in height and in contrasting color to the background. Such sign shall include a list of all ingredients in a manner acceptable to the department, provided, however, that the name of the edible fats or oils used must be specified. The letters on such sign to be of sufficient size to be read by consumers under normal conditions of purchase. No such list of ingredients need be included on the sign if the list of ingredients is printed on the side of the container in which the product is served to the customer.(d) When any lo-mel purports to be or is represented for any special dietary use by man, it shall be sold only in a container with an ingredient listing in accordance with the provisions of 21 CFR 101.4 and nutrition information as required by 101.9. Regulation 5 Manufacturing Plant "Frozen dessert plant" shall mean the premises or plant where frozen desserts and frozen dairy products are defined in this regulation are assembled, processed, manufactured or converted into form for distribution or sale, and rooms or premises where such frozen products manufacturing equipment is washed, sanitized or stored.
The building in which frozen desserts, and frozen dessert mix and ingredients for same are manufactured, stored or handled, and the surroundings, shall be maintained in a clean and orderly manner, with the yards well drained, free from refuse, odors or other insanitary conditions.
Regulation 6 Rooms Rooms in which frozen desserts and frozen dessert mix are manufactured or handled shall be well ventilated and well lighted. Walls and ceilings shall have smooth, washable light colored surfaces and shall be kept clean. The floor shall be smooth, impervious to water, in good repair, and clean. Sufficient floor slope to trapped drains shall be provided to prevent pools of water on the floor, except that cold storage rooms need not be provided with drains. All outside openings shall be adequately screened and all rooms kept free from flies. Storage rooms, boxes and cabinets shall be so structed that they can be maintained in a clean and sanitary condition and free from objectionable odors. All cartons, supplies, materials and ingredients shall be protected in storage against dust, dirt, moisture, rodents and vermin. Such ingredients as are subject to deterioration due to a lack of refrigeration shall be refrigerated properly. All ingredients, except those in water tight containers, shall be stored on shelves or racks above the floor and kept covered to prevent contamination.