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[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR131.110]

[Page 296-297]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 131 MILK AND CREAM--Table of Contents
 
     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.
    (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 Sec.  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

[[Page 297]]

``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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