CFR - Code of Federal Regulations Title 21

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[Code of Federal Regulations]

[Title 21, Volume 2]

[CITE: 21CFR131]

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
					
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION
					
							PART 131MILK AND CREAM

Subpart B - Requirements for Specific Standardized Milk and Cream

Sec. 131.110 Milk.

(a) Description. Milk is the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows. Milk that is in final package form for beverage use shall have been pasteurized or ultrapasteurized, and shall contain not less than 8 1/4 percent milk solids not fat and not less than 3 1/4 percent milkfat. Milk may have been adjusted by separating part of the milkfat therefrom, or by adding thereto cream, concentrated milk, dry whole milk, skim milk, concentrated skim milk, or nonfat dry milk. Milk may be homogenized.

(b) Vitamin addition (Optional). (1) If added, vitamin A shall be present in such quantity that each quart of the food contains not less than 2000 International Units thereof within limits of good manufacturing practice.

(2) If added, vitamin D shall be present in such quantity that each quart of the food contains 400 International Units thereof within limits of good manufacturing practice.

(1) Carriers for vitamins A and D.

(2) Characterizing flavoring ingredients (with or without coloring, nutritive sweetener, emulsifiers, and stabilizers) as follows:

(i) Fruit and fruit juice (including concentrated fruit and fruit juice).

(ii) Natural and artificial food flavorings.

(d) Methods of analysis. Referenced methods are from "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), 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 availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(1) Milkfat content - "Fat, Roese-Gottlieb Method - Official Final Action," section 16.059.

(2) Milk solids not fat content - Calculated by subtracting the milk fat content from the total solids content as determined by the method "Total Solids, Method I - Official Final Action," section 16.032.

(3) Vitamin D content - "Vitamin D - Official Final Action," sections 43.195-43.208.

(e) Nomenclature. The name of the food is "milk". The name of the food shall be accompanied on the label by a declaration indicating the presence of any characterizing flavoring, as specified in § 101.22 of this chapter.

(1) The following terms shall accompany the name of the food wherever it appears on the principal display panel or panels of the label in letters not less than one-half the height of the letters used in such name:

(i) If vitamins are added, the phrase "vitamin A" or "vitamin A added", or "vitamin D" or "vitamin D added", or "vitamin A and D" or "vitamins A and D added", as is appropriate. The word "vitamin" may be abbreviated "vit.".

(ii) The word "ultra-pasteurized" if the food has been ultra-pasteurized.

(2) The following terms may appear on the label:

(i) The word "pasteurized" if the food has been pasteurized.

(ii) The word "homogenized" if the food has been homogenized.

(f) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11822, Mar. 19, 1982; 49 FR 10090, Mar. 19, 1984; 54 FR 24892, June 12, 1989; 58 FR 2890, Jan. 6, 1993]

Sec. 131.111 Acidified milk.

(a) Description. Acidified milk is the food produced by souring one or more of the optional dairy ingredients specified in paragraph (c) of this section with one or more of the acidifying ingredients specified in paragraph (d) of this section, with or without the addition of characterizing microbial organisms. One or more of the other optional ingredients specified in paragraphs (b) and (e) of this section may also be added. When one or more of the ingredients specified in paragraph (e)(1) of this section are used, they shall be included in the souring process. All ingredients used are safe and suitable. Acidified milk contains not less than 3.25 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. The food may be homogenized and shall be pasteurized or ultra-pasteurized prior to the addition of the microbial culture and, when applicable, the addition of flakes or granules of butterfat or milkfat.

(b) Vitamin addition (optional). (1) If added, vitamin A shall be present in such quantity that each 946 milliliters (quart) of the food contains not less than 2,000 International Units thereof, within limits of good manufacturing practice.

(2) If added, vitamin D shall be present in such quantity that each 946 milliliters (quart) of the food contains 400 International Units thereof, within limits of good manufacturing practice.

(d) Optional acidifying ingredients. Acetic acid, adipic acid, citric acid, fumaric acid, glucono-delta- lactone, hydrochloric acid, lactic acid, malic acid, phosphoric acid, succinic acid, and tartaric acid.

(e) Other optional ingredients. (1) Concentrated skim milk, nonfat dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or whey modified by partial or complete removal of lactose and/or minerals, to increase the nonfat solids content of the food: Provided, That the ratio of protein to total nonfat solids of the food, and the protein efficiency ratio of all protein present, shall not be decreased as a result of adding such ingredients.

(2) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or cane; invert sugar (in paste or sirup form); brown sugar; refiner's sirup; molasses (other than blackstrap); high fructose corn sirup; fructose; fructose sirup; maltose; maltose sirup, dried maltose sirup; malt extract, dried malt extract; malt sirup, dried malt sirup; honey; maple sugar; or any of the sweeteners listed in part 168 of this chapter, except table sirup.

(3) Flavoring ingredients.

(4) Color additives that do not impart a color simulating that of milkfat or butterfat.

(5) Stabilizers.

(6) Butterfat or milkfat, which may or may not contain color additives, in the form of flakes or granules.

(7) Aroma- and flavor-producing microbial culture.

(8) Salt.

(9) Citric acid, in a maximum amount of 0.15 percent by weight of the milk used, or an equivalent amount of sodium citrate, as a flavor precursor.

(f) Methods of analysis. The following referenced methods of analysis are from "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), which is incorporated by reference. Copies are available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(1) Milkfat content - As determined by the method prescribed in section 16.059, "Roese-Gottlieb Method (Reference Method) (11) - Official Final Action," under the heading "Fat."

(2) Milk solids not fat content - Calculated by subtracting the milkfat content from the total solids content as determined by the method prescribed in section 16.032, "Method I - Official Final Action," under the heading "Total Solids."

(3) Titratable acidity - As determined by the method prescribed in section 16.023, "Acidity (2) - Official Final Action," or by an equivalent potentiometric method.

(g) Nomenclature. The name of the food is "acidified milk". The full name of the food shall appear on the principal display panel of the label in type of uniform size, style, and color. The name of the food shall be accompanied by a declaration indicating the presence of any characterizing flavoring as specified in § 101.22 of this chapter, and may be accompanied by a declaration such as a traditional name of the food or the generic name of the organisms used, thereby indicating the presence of the characterizing microbial organisms or ingredients when used, e.g., "acidified kefir milk", "acidified acidophilus milk", or when characterizing ingredients such as those in paragraphs (e) (6), (7), (8), and (9) of this section are used, the food may be named "acidified buttermilk".

(1) The following terms shall accompany the name of the food wherever it appears on the principal display panel or panels of the label in letters not less than one-half of the height of the letters used in such name:

(i) The phrase "vitamin A" or "vitamin A added", or "vitamin D" or "vitamin D added", or "vitamins A and D added", as appropriate. The word "vitamin" may be abbreviated "vit.".

(ii) The word "sweetened" if nutritive carbohydrate sweetener is added without the addition of characterizing flavoring.

(2) The term "homogenized" may appear on the label if the dairy ingredients used are homogenized.

(h) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

[46 FR 9934, Jan. 30, 1981, as amended at 47 FR 11822, Mar. 19, 1982; 47 FR 41523, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24892, June 12, 1989; 58 FR 2890, Jan. 6, 1993]

Sec. 131.112 Cultured milk.

(a) Description. Cultured milk is the food produced by culturing one or more of the optional dairy ingredients specified in paragraph (c) of this section with characterizing microbial organisms. One or more of the other optional ingredients specified in paragraphs (b) and (d) of this section may also be added. When one or more of the ingredients specified in paragraph (d)(1) of this section are used, they shall be included in the culturing process. All ingredients used are safe and suitable. Cultured milk contains not less than 3.25 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. The food may be homogenized and shall be pasteurized or ultra-pasteurized prior to the addition to the microbial culture, and when applicable, the addition of flakes or granules of butterfat or milkfat.

(2) If added, vitamin D shall be present in such quantity that each 946 milliliters (quart) of the food contains 400 International Units thereof, within limits of good manufacturing practice.

(d) Other optional ingredients. (1) Concentrated skim milk, nonfat dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or whey modified by partial or complete removal of lactose and/or minerals, to increase the nonfat solids content of the food: Provided, That the ratio of protein to total nonfat solids of the food, and the protein efficiency ratio of all protein present, shall not be decreased as a result of adding such ingredients.

(3) Flavoring ingredients.

(4) Color additives that do not impart a color simulating that of milkfat or butterfat.

(5) Stabilizers.

(6) Butterfat or milkfat, which may or may not contain color additives, in the form of flakes or granules.

(7) Aroma- and flavor-producing microbial culture.

(8) Salt.

(9) Citric acid, in a maximum amount of 0.15 percent by weight of the milk used, or an equivalent amount of sodium citrate, as a flavor precursor.

(e) Methods of analysis. The following referenced methods of analysis are from "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(1) Milkfat content - section 16.059, "Roese-Gottlieb Method (Reference Method) (11) - Official Final Action," under the heading "Fat."

(3) Titratable acidity - As determined by the methods prescribed in section 16.023 "Acidity (2) - Official Final Action," or by an equivalent potentiometric method.

(f) Nomenclature. The name of the food is "cultured milk". The full name of the food shall appear on the principal display panel in type of uniform size, style, and color. The name of the food shall be accompanied by a declaration indicating the presence of any characterizing flavoring as specified in § 101.22 of this chapter, and may be accompanied by a declaration such as a traditional name of the food or the generic name of the organisms used, thereby indicating the presence of the characterizing microbial organisms or ingredients, e.g., "kefir cultured milk", "acidophilus cultured milk", or when characterizing ingredients such as those in paragraphs (d) (6), (7), (8), and (9) of this section, and lactic acid-producing organisms are used the food may be named "cultured buttermilk".

(i) The phrase "vitamin A" or "vitamin A added", or "vitamin D" or "vitamin D added", or "vitamin A and D added", as appropriate. The word "vitamin" may be abbreviated "vit.".

(ii) The word "sweetened" if nutritive carbohydrate sweetener is added without the addition of characterizing flavoring.

(2) The term "homogenized" may appear on the label if the dairy ingredients used are homogenized.

(g) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

[46 FR 9934, Jan. 30, 1981, as amended at 47 FR 11822, Mar. 19, 1982; 47 FR 41523, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24892, June 12, 1989; 58 FR 2890, Jan. 6, 1993]

Sec. 131.115 Concentrated milk.

(a) Description. Concentrated milk is the liquid food obtained by partial removal of water from milk. The milkfat and total milk solids contents of the food are not less than 7.5 and 25.5 percent, respectively. It is pasteurized, but is not processed by heat so as to prevent spoilage. It may be homogenized.

(b) Vitamin addition (Optional). If added, vitamin D shall be present in such quantity that each fluid ounce of the food contains 25 International Units thereof, within limits of good manufacturing practice.

(1) Carrier for vitamin D.

(2) Characterizing flavoring ingredients, with or without coloring, as follows:

(i) Fruit and fruit juice, including concentrated fruit and fruit juice.

(ii) Natural and artificial food flavoring.

(1) Milkfat content - "Fat - Official Final Action," section 16.172.

(2) Total milk solids - "Total Solids - Official Final Action," section 16.169.

(3) Vitamin D content - "Vitamin D in Milk - Official Final Action," sections 43.195-43.208.

(e) Nomenclature. The name of the food is "Concentrated milk" or alternatively "Condensed milk". If the food contains added vitamin D, the phrase "vitamin D" or "vitamin D added" shall accompany the name of the food wherever it appears on the principal display panel or panels of the label in letters not less than one-half the height of the letters used in such name. The word "homogenized" may appear on the label if the food has been homogenized. The name of the food shall include a declaration of the presence of any characterizing flavoring, as specified in § 101.22 of this chapter.

(f) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11822, Mar. 19, 1982; 48 FR 13024, Mar. 29, 1983; 49 FR 10090, Mar. 19, 1984; 54 FR 24892, June 12, 1989; 58 FR 2890, Jan. 6, 1993]

Sec. 131.120 Sweetened condensed milk.

(a) Description. Sweetened condensed milk is the food obtained by partial removal of water only from a mixture of milk and safe and suitable nutritive carbohydrate sweeteners. The finished food contains not less than 8 percent by weight of milkfat, and not less than 28 percent by weight of total milk solids. The quantity of nutritive carbohydrate sweetener used is sufficient to prevent spoilage. The food is pasteurized and may be homogenized.

(b) Optional ingredients. The following safe and suitable characterizing flavoring ingredients, with or without coloring and nutritive carbohydrate sweeteners, may be used:

(1) Fruit and fruit juice, including concentrated fruit and fruit juice.

(2) Natural and artificial food flavoring.

(c) Methods of analysis. The milkfat content is determined by the method prescribed in "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), section 16.185, under "Fat - Official Final Action," 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 availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(d) Nomenclature. The name of the food is "Sweetened condensed milk." The word "homogenized" may appear on the label if the food has been homogenized. The name of the food shall include a declaration of the presence of any characterizing flavoring, as specified in § 101.22 of this chapter.

(e) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

[43 FR 21670, May 19, 1978, as amended at 47 FR 11823, Mar. 19, 1982; 49 FR 10091, Mar. 19, 1984; 54 FR 24892, June 12, 1989; 58 FR 2890, Jan. 6, 1993]

Sec. 131.125 Nonfat dry milk.

(a) Description. Nonfat dry milk is the product obtained by removal of water only from pasteurized skim milk. It contains not more than 5 percent by weight of moisture, and not more than 1 1/2 percent by weight of milkfat unless otherwise indicated.

(b) Optional ingredients. Safe and suitable characterizing flavoring ingredients (with or without coloring and nutritive carbohydrate sweetener) as follows:

(1) Fruit and fruit juice, including concentrated fruit and fruit juice.

(2) Natural and artificial food flavorings.

(c) Methods of analysis. The following referenced methods of analysis are from "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), 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 availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(1) Milkfat content - "Fat in Dried Milk - Official Final Action," sections 16.199-16.200.

(2) Moisture content - "Moisture - Official Final Action," section 16.192.

(d) Nomenclature. The name of the food is "Nonfat dry milk". If the fat content is over 1 1/2 percent by weight, the name of the food on the principal display panel or panels shall be accompanied by the statement "Contains __% milkfat", the blank to be filled in with the percentage to the nearest one-tenth of 1 percent of fat contained, within limits of good manufacturing practice. The name of the food shall include a declaration of the presence of any characterizing flavoring, as specified in § 101.22 of this chapter.

(e) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

[42 FR 14360, Mar. 15, 1977, as amended at 43 FR 19836, May 9, 1978; 47 FR 11823, Mar. 19, 1982; 49 FR 10091, Mar. 19, 1984; 54 FR 24892, June 12, 1989; 58 FR 2890, Jan. 6, 1993]

Sec. 131.127 Nonfat dry milk fortified with vitamins A and D.

(a) Description. Nonfat dry milk fortified with vitamins A and D conforms to the standard of identity for nonfat dry milk, except that vitamins A and D are added as prescribed by paragraph (b) of this section.

(b) Vitamin addition. (1) Vitamin A is added in such quantity that, when prepared according to label directions, each quart of the reconstituted product contains 2000 International Units thereof.

(2) Vitamin D is added in such quantity that, when prepared according to label directions, each quart of the reconstituted product contains 400 International Units thereof.

(3) The requirements of this paragraph will be deemed to have been met if reasonable overages, within limits of good manufacturing practice, are present to ensure that the required levels of vitamins are maintained throughout the expected shelf life of the food under customary conditions of distribution.

(1) Carriers for vitamins A and D.

(2) Characterizing flavoring ingredients, with or without coloring and nutritive carbohydrate sweetener, as follows:

(i) Fruit and fruit juice, including concentrated fruit and fruit juice.

(ii) Natural and artificial food flavorings.

(d) Methods of analysis. The following referenced methods of analysis are from "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), 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 availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(1) Milkfat content - "Fat in Dried Milk - Official Final Action," sections 16.199-16.200.

(2) Moisture content - "Moisture - Official Final Action," section 16.192.

(3) Vitamin D content - "Vitamin D - Official Final Action," sections 43.195-43.208.

(e) Nomenclature. The name of the food is "Nonfat dry milk fortified with vitamins A and D". If the fat content is over 1 1/2 percent by weight, the name of the food on the principal display panel or panels shall be accompanied by the statement "Contains __% milkfat", the blank to be filled in to the nearest one-tenth of 1 percent with the percentage of fat contained within limits of good manufacturing practice. The name of the food shall include a declaration of the presence of any characterizing flavoring, as specified in § 101.22 of this chapter.

(f) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

[42 FR 14360, Mar. 15, 1977, as amended at 43 FR 19836, May 9, 1978; 43 FR 29769, July 11, 1978; 43 FR 36622, Aug. 18, 1978; 47 FR 11823, Mar. 19, 1982; 49 FR 10091, Mar. 19, 1984; 54 FR 24892, June 12, 1989; 58 FR 2890, Jan. 6, 1993]

Sec. 131.130 Evaporated milk.

(a) Description. Evaporated milk is the liquid food obtained by partial removal of water only from milk. It contains not less than 6.5 percent by weight of milkfat, not less than 16.5 percent by weight of milk solids not fat, and not less than 23 percent by weight of total milk solids. Evaporated milk contains added vitamin D as prescribed by paragraph (b) of this section. It is homogenized. It is sealed in a container and so processed by heat, either before or after sealing, as to prevent spoilage.

(b) Vitamin addition. (1) Vitamin D shall be present in such quantity that each fluid ounce of the food contains 25 International Units thereof within limits of good manufacturing practice.

(2) Addition of vitamin A is optional, If added, vitamin A shall be present in such quantity that each fluid ounce of the food contains not less than 125 International Units thereof within limits of good maufacturing practice.

(1) Carriers for vitamins A and D.

(2) Emulsifiers.

(3) Stabilizers, with or without dioctyl sodium sulfosuccinate (when permitted by and complying with the provisions of § 172.810 of this chapter) as a solubilizing agent.

(4) Characterizing flavoring ingredients, with or without coloring and nutritive carbohydrate sweeteners, as follows:

(i) Fruit and fruit juice, including concentrated fruit and fruit juice.

(ii) Natural and artificial food flavoring.

(1) Milkfat content - "Fat - Official Final Action," section 16.172.

(2) Total milk solids - "Total Solids - Official Final Action," section 16.169.

(3) Vitamin D content - "Vitamin D in Milk - Official Final Action," sections 43.195-43.208.

(e) Nomenclature. The name of the food is "Evaporated milk." The phrase "vitamin D" or "vitamin D added", or "vitamins A and D" or "vitamins A and D added", as is appropriate, shall immediately precede or follow the name of the food wherever it appears on the principal display panel or panels of the label in letters not less than one-half the height of the letters used in such name. The name of the food shall include a declaration of a the presence of any characterizing flavoring, as specified in § 101.22 of this chapter.

(f) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

[43 FR 21670, May 19, 1978, as amended at 47 FR 11823, Mar. 19, 1982; 49 FR 10091, Mar. 19, 1984; 54 FR 24892, June 12, 1989; 58 FR 2890, Jan. 6, 1993; 59 FR 17691, Apr. 14, 1994]

Sec. 131.147 Dry whole milk.

(a) Description. Dry whole milk is the product obtained by removal of water only from pasteurized milk, as defined in § 131.110(a), which may have been homogenized. Alternatively, dry whole milk may be obtained by blending fluid, condensed, or dried nonfat milk with liquid or dried cream or with fluid, condensed, or dried milk, as appropriate, provided the resulting dry whole milk is equivalent in composition to that obtained by the method described in the first sentence of this paragraph. It contains the lactose, milk proteins, milkfat, and milk minerals in the same relative proportions as the milk from which it was made. It contains not less than 26 percent but less than 40 percent by weight of milkfat on an as is basis. It contains not more than 5 percent by weight of moisture on a milk solids not fat basis.

(b) Vitamin addition. (1) Addition of vitamin A is optional. If added, vitamin A shall be present in such quantity that, when prepared according to label directions, each quart of the reconstituted product shall contain not less than 2,000 International Units thereof.

(2) Addition of vitamin D is optional. If added, vitamin D shall be present in such quantity that, when prepared according to label directions, each quart of the reconstituted product shall contain 400 International Units thereof.

(3) The requirements of this paragraph will be met if reasonable overages, within limits of good manufacturing practice, are present to ensure that the required levels of vitamins are maintained throughout the expected shelf life of the food under customary conditions of distribution.

(1) Carriers for vitamins A and D.

(2) Emulsifiers.

(3) Stabilizers.

(4) Anticaking agents.

(5) Antioxidants.

(6) Characterizing flavoring ingredients (with or without coloring and nutritive carbohydrate sweetener) as follows:

(i) Fruit and fruit juice, including concentrated fruit and fruit juice.

(ii) Natural and artificial food flavoring.

(1) Milkfat content - "Fat in Dried Milk - Official Final Action," sections 16.199-16.200.

(2) Moisture content - "Moisture - Official Final Action," section 16.192.

(3) Vitamin D content - "Vitamin D - Official Final Action," sections 43.195-43.208.

(e) Nomenclature. The name of the food is "Dry whole milk." The name of the food shall appear on the principal display panel of the label in type of uniform size, style, and color. The name of the food shall be accompanied by a declaration indicating the presence of any characterizing flavoring as specified in § 101.22 of this chapter. The following phrases in type size not less than one-half the height of the type size used in such name shall accompany the name of the food wherever it appears on the principal display panel or panels.

(1) The phrase "Contains __% milkfat", the blank to be filled in with the whole number closest to the actual fat content of the food.

(2) If vitamins are "added", the phrase "vitamin A", or "vitamin A added", or "vitamin D", or "vitamin D added", or "vitamins A and D", or "vitamins A and D added", as appropriate. The word "vitamin" may be abbreviated "vit."

(f) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

[43 FR 19836, May 9, 1978, as amended at 47 FR 11824, Mar. 19, 1982; 49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, Jan. 6, 1993]

Sec. 131.149 Dry cream.

(a) Description. Dry cream is the product obtained by removal of water only from pasteurized milk or cream or a mixture thereof, which may have been homogenized. Alternatively, dry cream may be obtained by blending dry milks as defined in §§ 131.125(a) and 131.147(a) with dry cream as appropriate: Provided, That the resulting product is equivalent in composition to that obtained by the method described in the first sentence of this paragraph. It contains not less than 40 percent but less than 75 percent by weight of milkfat on an as is basis. It contains not more than 5 percent by weight of moisture on a milk solids not fat basis.

(b) Optional ingredients. The following safe and suitable optional ingredients may be used:

(1) Emulsifiers.

(2) Stabilizers.

(3) Anticaking agents.

(4) Antioxidants.

(5) Nutritive carbohydrate sweeteners.

(6) Characterizing flavoring ingredients, with or without coloring, as follows:

(i) Fruit and fruit juice, including concentrated fruit and fruit juice.

(ii) Natural and artificial food flavoring.

(1) Milkfat content - "Fat in Dried Milk - Official Final Action," sections 16.199-16.200.

(2) Moisture content - "Moisture - Official Final Action," section 16.192.

(d) Nomenclature. The name of the food is "Dry cream." The name of the food shall appear on the principal display panel of the label in type of uniform size, style, and color. The name of the food shall be accompanied by a declaration indicating the presence of any characterizing flavoring as specified in § 101.22 of this chapter. The following terms shall accompany the name of the food wherever it appears on the principal display panel or panels of the label, in letters not less than one-half of the height of the letters used in such name:

(1) The phrase "Contains __% milkfat", the blank to be filled in with the whole number closest to the actual fat content of the food.

(2) The word "sweetened" if no characterizing flavoring ingredients are used but nutritive carbohydrate sweetener is added.

(e) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

[43 FR 19836, May 9, 1978, as amended at 44 FR 3965, Jan. 19, 1979; 47 FR 11824, Mar. 19, 1982; 48 FR 13024, Mar. 29, 1983; 49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, Jan. 6, 1993; 61 FR 59002, Nov. 20, 1996]

Sec. 131.150 Heavy cream.

(a) Description. Heavy cream is cream which contains not less than 36 percent milkfat. It is pasteurized or ultra-pasteurized, and may be homogenized.

(b) Optional ingredients. The following safe and suitable optional ingredients may be used:

(1) Emulsifiers.

(2) Stabilizers.

(3) Nutritive sweeteners.

(4) Characterizing flavoring ingredients (with or without coloring) as follows:

(i) Fruit and fruit juice (including concentrated fruit and fruit juice).

(ii) Natural and artificial food flavoring.

(c) Methods of analysis. The milkfat content is determined by the method prescribed in "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), sections 16.156 and 16.059, under "Fat, Roese-Gottlieb Method - Official Final Action," 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 availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(d) Nomenclature. (1) The name of the food is "Heavy cream" or alternatively "Heavy whipping cream". The name of the food shall be accompanied on the label by a declaration indicating the presence of any characterizing flavoring, as specified in § 101.22 of this chapter. The following terms shall accompany the name of the food wherever it appears on the principal display panel or panels of the label in letters not less than one-half the height of the letters used in such name:

(i) The word "ultra-pasteurized" if the food has been ultra-pasteurized.

(ii) The word "sweetened" if no characterizing flavoring ingredients are used, but nutritive sweetener is added.

(2) The following terms may appear on the label:

(i) The word "pasteurized" if the food has been pasteurized.

(ii) The word "homogenized" if the food has been homogenized.

(e) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11824, Mar. 19, 1982; 49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, Jan. 6, 1993]

Sec. 131.155 Light cream.

(a) Description. Light cream is cream which contains not less than 18 percent but less than 30 percent milkfat. It is pasteurized or ultra-pasteurized, and may be homogenized.

(b) Optional ingredients. The following safe and suitable ingredients may be used:

(1) Stabilizers.

(2) Emulsifiers.

(3) Nutritive sweeteners.

(4) Characterizing flavoring ingredients (with or without coloring) as follows:

(i) Fruit and fruit juice (including concentrated fruit and fruit juice).

(ii) Natural and artificial food flavoring.

(c) Methods of analysis. The milkfat content is determined by the method prescribed in "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), sections 16.156 and 16.059, under "Fat, Roese-Gottlieb Method - Official Final Action," 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 availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(d) Nomenclature. The name of the food is "Light cream", or alternatively "Coffee cream" or "Table cream". The name of the food shall be accompanied on the label by a declaration indicating the presence of any characterizing flavoring, as specified in § 101.22 of this chapter.

(i) The word "ultra-pasteurized" if the food has been ultra-pasteurized.

(ii) The word "sweetened" if no characterizing flavoring ingredients are used, but nutritive sweetener is added.

(2) The following terms may appear on the label:

(i) The word "pasteurized" if the food has been pasteurized.

(ii) The word "homogenized" if the food has been homogenized.

(e) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11824, Mar. 19, 1982; 49 FR 10092, Mar. 1, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, Jan. 6, 1993]

Sec. 131.157 Light whipping cream.

(a) Description. Light whipping cream is cream which contains not less than 30 percent but less than 36 percent milkfat. It is pasteurized or ultra-pasteurized, and may be homogenized.

(b) Optional ingredients. The following safe and suitable optional ingredients may be used:

(1) Emulsifiers.

(2) Stabilizers.

(3) Nutritive sweeteners.

(4) Characterizing flavoring ingredients (with or without coloring) as follows:

(i) Fruit and fruit juice (including concentrated fruit and fruit juice).

(ii) Natural and artificial food flavoring.

(c) Methods of analysis. The milkfat content is determined by the method prescribed in "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), sections 16.156 and 16.059, under "Fat, Roese-Gottlieb Method - Official Final Action," 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 availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(d) Nomenclature. The name of the food is "Light whipping cream" or alternatively "Whipping cream". The name of the food shall be accompanied on the label by a declaration indicating the presence of any characterizing flavoring, as specified in § 101.22 of this chapter.

(i) The word "ultra-pasteurized" if the food has been ultra-pasteurized.

(ii) The word "sweetened" if no characterizing flavoring ingredients are used, but nutritive sweetener is added.

(2) The following terms may appear on the label:

(i) The word "pasteurized" if the food has been pasteurized.

(ii) The word "homogenized" if the food has been homogenized.

(e) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11824, Mar. 19, 1982; 49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, Jan. 6, 1993]

Sec. 131.160 Sour cream.

(a) Description. Sour cream results from the souring, by lactic acid producing bacteria, of pasteurized cream. Sour cream contains not less than 18 percent milkfat; except that when the food is characterized by the addition of nutritive sweeteners or bulky flavoring ingredients, the weight of the milkfat is not less than 18 percent of the remainder obtained by subtracting the weight of such optional ingredients from the weight of the food; but in no case does the food contain less than 14.4 percent milkfat. Sour cream has a titratable acidity of not less than 0.5 percent, calculated as lactic acid.

(b) Optional ingredients. (1) Safe and suitable ingredients that improve texture, prevent syneresis, or extend the shelf life of the product.

(2) Sodium citrate in an amount not more than 0.1 percent may be added prior to culturing as a flavor precursor.

(3) Rennet.

(4) Safe and suitable nutritive sweeteners.

(5) Salt.

(6) Flavoring ingredients, with or without safe and suitable coloring, as follows:

(i) Fruit and fruit juice (including concentrated fruit and fruit juice).

(ii) Safe and suitable natural and artificial food flavoring.

(c) Methods of analysis. Referenced methods in paragraph (c) (1) and (2) of this section are from "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), 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 availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(1) Milkfat content - "Fat - Official Final Action," section 16.172.

(2) Titratable acidity - "Acidity - Official Final Action," section 16.023.

(d) Nomenclature. The name of the food is "Sour cream" or alternatively "Cultured sour cream". The full name of the food shall appear on the principal display panel of the label in type of uniform size, style, and color. The name of the food shall be accompanied by a declaration indicating the presence of any flavoring that characterizes the product, as specified in § 101.22 of this chapter. If nutritive sweetener in an amount sufficient to characterize the food is added without addition of characterizing flavoring, the name of the food shall be preceded by the word "sweetened".

(e) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11824, Mar. 19, 1982; 49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, Jan. 6, 1993]

Sec. 131.162 Acidified sour cream.

(a) Description. Acidified sour cream results from the souring of pasteurized cream with safe and suitable acidifiers, with or without addition of lactic acid producing bacteria. Acidified sour cream contains not less than 18 percent milkfat; except that when the food is characterized by the addition of nutritive sweeteners or bulky flavoring ingredients, the weight of milkfat is not less than 18 percent of the remainder obtained by subtracting the weight of such optional ingredients from the weight of the food; but in no case does the food contain less than 14.4 percent milkfat. Acidified sour cream has a titratable acidity of not less than 0.5 percent, calculated as lactic acid.

(b) Optional ingredients. (1) Safe and suitable ingredients that improve texture, prevent syneresis, or extend the shelf life of the product.

(2) Rennet.

(3) Safe and suitable nutritive sweeteners.

(4) Salt.

(5) Flavoring ingredients, with or without safe and suitable coloring, as follows:

(i) Fruit and fruit juice, including concentrated fruit and fruit juice.

(ii) Safe and suitable natural and artificial food flavoring.

(c) Methods of analysis. Referenced methods in paragraphs (c) (1) and (2) of this section are from "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), 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 availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(1) Milkfat content - "Fat - Official Final Action," section 16.172.

(2) Titratable acidity - "Acidity - Official Final Action," section 16.023.

(d) Nomenclature. The name of the food is "Acidified sour cream". The full name of the food shall appear on the principal display panel of the label in type of uniform size, style, and color. The name of the food shall be accompanied by a declaration indicating the presence of any flavoring that characterizes the product, as specified in § 101.22 of this chapter. If nutritive sweetener in an amount sufficient to characterize the food is added without addition of characterizing flavoring, the name of the food shall be preceded by the word "sweetened".

(e) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11825, Mar. 19, 1982; 49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, Jan. 6, 1993]

Sec. 131.170 Eggnog.

(a) Description. Eggnog is the food containing one or more of the optional dairy ingredients specified in paragraph (b), one or more of the optional egg yolk-containing ingredients specified in paragraph (c) of this section, and one or more of the optional nutritive carbohydrate sweeteners specified in paragraph (d) of this section. One or more of the optional ingredients specified in paragraph (e) of this section may also be added. All ingredients used are safe and suitable. Eggnog contains not less than 6 percent milkfat and not less than 8.25 percent milk solids not fat. The egg yolk solids content is not less than 1 percent by weight of the finished food. The food shall be pasteurized or ultra-pasteurized and may be homogenized. Flavoring ingredients and color additives may be added after the food is pasteurized or ultra-pasteurized.

(b) Optional dairy ingredients. Cream, milk, partially skimmed milk, or skim milk, used alone or in combination.

(c) Egg yolk-containing ingredients. Liquid egg yolk, frozen egg yolk, dried egg yolk, liquid whole eggs, frozen whole eggs, dried whole eggs, or any one or more of the foregoing ingredients with liquid egg white or frozen egg white.

(d) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or cane; invert sugar (in paste or sirup form); brown sugar; refiner's sirup; molasses (other than blackstrap); high fructose corn sirup; fructose; fructose sirup; maltose; maltose sirup, dried maltose sirup; malt extract, dried malt extract; malt sirup, dried malt sirup; honey; maple sugar; or any of the sweeteners listed in part 168 of this chapter, except table sirup.

(e) Other optional ingredients. (1) Concentrated skim milk, nonfat dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or whey modified by partial or complete removal of lactose and/or minerals, to increase the nonfat solids content of the food: Provided, That the ratio of protein to total nonfat solids of the food, and the protein efficiency ratio of all protein present shall not be decreased as a result of adding such ingredients.

(2) Salt.

(3) Flavoring ingredients.

(4) Color additives that do not impart a color simulating that of egg yolk, milkfat, or butterfat.

(5) Stabilizers.

(1) Milkfat content - As determined by the method prescribed in section 16.059, "Roese-Gottlieb Method (Reference Method) (11) - Official Final Action," under the heading "Fat."

(g) Nomenclature. The name of the food is "eggnog". The name of the food shall be accompanied by a declaration indicating the presence of any characterizing flavoring as specified in § 101.22 of this chapter. If the food is ultra-pasteurized, the phrase "ultra-pasteurized" shall accompany the name of the food wherever it appears on the label in letters not less than one-half of the height of the letters used in the name. The following terms may accompany the name of the food on the label:

(1) The word "pasteurized" if the food has been pasteurized.

(2) The word "homogenized" if the food has been homogenized.

(h) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

[46 FR 9938, Jan. 30, 1981, as amended at 47 FR 11825, Mar. 19, 1982; 47 FR 41524, Sept. 21, 1982; 47 FR 49638, Nov. 2, 1982; 48 FR 24869, June 3, 1983; 54 FR 24893, June 12, 1989; 58 FR 2891, Jan. 6, 1993]

Sec. 131.180 Half-and-half.

(a) Description. Half-and-half is the food consisting of a mixture of milk and cream which contains not less than 10.5 percent but less than 18 percent milkfat. It is pasteurized or ultra-pasteurized, and may be homogenized.

(b) Optional ingredients. The following safe and suitable optional ingredients may be used:

(1) Emulsifiers.

(2) Stabilizers.

(3) Nutritive sweeteners.

(4) Characterizing flavoring ingredients (with or without coloring) as follows:

(i) Fruit and fruit juice (including concentrated fruit and fruit juice).

(ii) Natural and artificial food flavoring.

(c) Methods of analysis. The milkfat content is determined by the method prescribed in "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), in sections 16.156 and 16.059, under "Fat, Roese-Gottlieb Method - Official Final Action," which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(d) Nomenclature. The name of the food is "Half-and-half". The name of the food shall be accompanied on the label by a declaration indicating the presence of any characterizing flavoring, as specified in § 101.22 of this chapter.

(i) The word "ultra-pasteurized" if the food has been ultra-pasteurized.

(ii) The word "sweetened" if no characterizing flavor ingredients are used, but nutritive sweetener is added.

(2) The following terms may appear on the label:

(i) The word "pasteurized" if the food has been pasteurized.

(ii) The word "homogenized" if the food has been homogenized.

(e) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11825, Mar. 19, 1982; 49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989; 58 FR 2891, Jan. 6, 1993]

Sec. 131.200 Yogurt.

(a) Description. Yogurt is the food produced by culturing one or more of the basic dairy ingredients specified in paragraph (b) of this section and any of the optional dairy ingredients specified in paragraph (c) of this section with a characterizing bacterial culture that contains the lactic acid-producing bacteria, Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus. The ingredients specified in paragraphs (b) and (c) of this section may be homogenized and must be pasteurized or ultra-pasteurized before the addition of the characterizing bacterial culture. One or more of the other optional ingredients specified in paragraph (d) of this section may also be added. Yogurt contains not less than 3.25 percent milkfat, except as provided for in paragraph (g) of this section, and not less than 8.25 percent milk solids not fat and has a pH of 4.6 or lower measured on the finished product within 24 hours after filling. To extend the shelf life of the food, yogurt may be treated after culturing to inactivate viable microorganisms.

(b) Basic dairy ingredients. Cream, milk, partially skimmed milk, skim milk, or the reconstituted versions of these ingredients may be used alone or in combination.

(c) Optional dairy ingredients. Other safe and suitable milk-derived ingredients may be used to increase the milk solids not fat content of the food above the minimum of 8.25 percent required in paragraph (a) of this section, provided that the ratio of protein to total nonfat solids of the food, and the protein efficiency ratio of all protein present must not be decreased as a result of adding such ingredients.

(d) Other optional ingredients. The following safe and suitable ingredients may be used:

(1) Cultures, in addition to the characterizing bacterial culture specified in paragraph (a) of this section.

(2) Sweeteners.

(3) Flavoring ingredients.

(4) Color additives.

(5) Stabilizers.

(6) Emulsifiers.

(7) Preservatives.

(8) Vitamin addition (optional).

(i) If added, vitamin A must be present in such quantity that the food contains not less than 10 percent Daily Value per Reference Amount Commonly Consumed (RACC) thereof, within limits of current good manufacturing practice.

(ii) If added, vitamin D must be present in such quantity that the food contains not less than 10 percent Daily Value per Reference Amount Commonly Consumed (RACC) thereof, within limits of current good manufacturing practices.

(e) Methods of analysis - (1) Milk - (i) Milkfat content. As determined by the method prescribed in section 33.2.26, AOAC Official Method 989.05, Fat in Milk Modified Mojonnier Ether Extraction Method.

(ii) Milk solids not fat. Calculated by subtracting the milkfat content from the total solids content using the method prescribed in section 33.2.45, AOAC Official Method 990.21, Solids-Not-Fat in Milk by Difference between Total Solids and Fat Contents.

(2) pH. As determined by the potentiometric method described in § 114.90(a) of this chapter.

(3) Live and active cultures. As determined by the method described in ISO 7889:2003(E)/IDF 117:2003(E), Yogurt - Enumeration of Characteristic Microorganisms - Colony-Count Technique at 37 deg.C.

(f) Nomenclature. The name of the food is "yogurt." The name of the food must be accompanied by a declaration indicating the presence of any characterizing flavoring as specified in § 101.22 of this chapter.

(1) The following term(s) must accompany the name of the food wherever it appears on the principal display panel or panels of the label in letters not less than one-half of the height of the letters used in such name:

(i) The word "sweetened" if a nutritive carbohydrate sweetener is added without the addition of characterizing flavor.

(ii) The phrase "does not contain live and active cultures" if the dairy ingredients have been treated after culturing to inactivate viable microorganisms.

(iii) The phrase "vitamin A" or "vitamin A added", or "vitamin D" or "vitamin D added", or "vitamins A and D added", as appropriate. The word "vitamin" may be abbreviated "vit".

(2) The name of the food may be accompanied by the phrase "contains live and active cultures" or another appropriate descriptor if the food contains a minimum level of live and active cultures of 10 ⁷ colony forming units per gram (CFU/g) at the time of manufacture with a reasonable expectation of 10 ⁶ CFU/g through the manufacturer's assigned shelf life of the product.

(3) The term "homogenized" may appear on the label if the dairy ingredients used are homogenized.

(g) Yogurt containing less than 3.25 percent milkfat. (1) Yogurt may contain less than 3.25 percent milkfat and at least 2.44 percent milkfat. If the milkfat content is below 2.44 percent, the product is considered a modified food and is covered under § 130.10 of this chapter.

(2) Yogurt with milkfat content less than 3.25 percent and at least 2.44 percent milkfat, must be labeled with the following two phrases in the statement of identity, which must appear together:

(i) The word "yogurt" in type of the same size and style.

(ii) The statement "__ percent milkfat," the blank being filled in with the nearest half percent to the actual milkfat content of the product. This statement of milkfat content must appear in letters not less than one-half of the height of the letters in the phrase specified in paragraph (g)(2)(i) of this section, but in no case less than one-eighth of an inch in height.

(3) Yogurt with milkfat less than 3.25 percent and at least 2.44 percent milkfat must comply with this standard, except that it may deviate as described in § 130.10 (b), (c), and (d) of this chapter.

(h) Label declaration. Each of the ingredients used in the food must be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

(i) Incorporation by reference. The standards required in this section are incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, FDA must publish a document in the Federal Register, and the material must be available to the public. All approved material is available for inspection at the Food and Drug Administration's Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, and is available from the sources indicated in this paragraph (i). It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fedreg.legal@nara.gov or go to www.archives.gov/federal-register/cfr/ibr-locations.html.

(1) AOAC INTERNATIONAL, 2275 Research Blvd., Suite 300, Rockville, MD 20850-3250:

(i) AOAC Official Method 989.05, Fat in Milk Modified Mojonnier Ether Extraction Method, Section 33.2.26, Official Methods of Analysis, 21st edition, 2019, Vol. 1.

(ii) AOAC Official Method 990.21, Solids-Not-Fat in Milk by Difference between Total Solids and Fat Contents, Section 33.2.45, Official Methods of Analysis, 21st edition, 2019, Vol. 1.

(2) ISO, ISO Central Secretariat, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland.

(i) ISO 7889:2003(E), Yogurt - Enumeration of Characteristic Microorganisms - Colony-Count Technique at 37 deg.C, First edition, 2003-02-01.

(ii) [Reserved]

ISO 7889:2003(E) is co-published as IDF 117:2003(E).

Note 1 to paragraph (h)(2)(i):

[86 FR 31137, June 11, 2021, as amended at 87 FR 76568, Dec. 15, 2022; 88 FR 22910, Apr. 14, 2023]

Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
Source: 42 FR 14360, Mar. 15, 1977, unless otherwise noted.

CFR - Code of Federal Regulations Title 21

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