[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR131.147]

[Page 297-298]
 
                        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. 131.147  Dry whole milk.

    (a) Description. Dry whole milk is the product obtained by removal 
of water only from pasteurized milk, as defined

[[Page 298]]

in Sec. 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.
    (c) Optional ingredients. The following safe and suitable optional 
ingredients may be used:
    (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.
    (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 Association of Official 
Analytical Chemists International, 481 North Frederick Ave., suite 500, 
Gaithersburg, MD 20877-2504, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC.
    (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 Sec. 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]