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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2013]
[CITE: 21CFR131.110]



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

PART 131 -- MILK 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 81/4percent milk solids not fat and not less than 31/4percent 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.

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

(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]

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