Dry whole milk is the product obtained by removal of water only from pasteurized milk, as defined in 21 CFR131.110(a)(2011), 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 twenty-six per cent but less than forty per cent by weight of milkfat on an as is basis. It contains not more than five per cent 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 two thousand 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 four hundred 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;
(4) Anticaking agents;
(5) Antioxidants; or,
(6) Characterizing flavoring ingredients (with or without coloring and nutritive carbohydrate sweetener) as follows:
(a) Fruit and fruit juice, including concentrated fruit and fruit juice; or,
(b) Natural and artificial food flavoring.
(D) Methods of analysis:
The following referenced methods of analysis are from ``Official Methods of Analysis of Association of Official Analytical Chemists," 17th edition which can be found at http://www.aoac.org/:
(1) Milkfat content - appropriate test methods as specified in chapter 33;
(2) Moisture content - appropriate test methods as specified in chapter 33; and,
(3) Vitamin D content - appropriate test methods as specified in chapter 45.
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 title 21 CFR 101.22(April 2000). 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; and
(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 Title 21 CFR 101(2011) and 21 CFR 130 (2011).
Five Year Review (FYR) Dates: 11/24/2015 and 02/21/2021
Promulgated Under: 119.03
Statutory Authority: 917.02
Rule Amplifies: 917.02 ; 917.05 ; 3715.02
Prior Effective Dates: 12/16/1976, 07/22/2005