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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: 21CFR131.147]



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 in § 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 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 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 § 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]