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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 2]
[CITE: 21CFR131.112]



Subpart B - Requirements for Specific Standardized Milk and Cream

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.

(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.

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

(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.

(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.

(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."

(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 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".

(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 "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]