[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: 21CFR131.147]
[Page 303-304]
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 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 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/
[[Page 304]]
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 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]
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