[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR131.127]
[Page 295-296]
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. 131.127 Nonfat dry milk fortified with vitamins A and D.
(a) Description. Nonfat dry milk fortified with vitamins A and D
conforms to the standard of identity for nonfat dry milk, except that
vitamins A and D are added as prescribed by paragraph (b) of this
section.
(b) Vitamin addition. (1) Vitamin A is added in such quantity that,
when prepared according to label directions, each quart of the
reconstituted product contains 2000 International Units thereof.
(2) Vitamin D is added in such quantity that, when prepared
according to label directions, each quart of the reconstituted product
contains 400 International Units thereof.
(3) The requirements of this paragraph will be deemed to have been
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.
[[Page 296]]
(c) Optional ingredients. The following safe and suitable optional
ingredients may be used:
(1) Carriers for vitamins A and D.
(2) 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 flavorings.
(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 ``Nonfat dry milk
fortified with vitamins A and D''. If the fat content is over 1\1/2\
percent by weight, the name of the food on the principal display panel
or panels shall be accompanied by the statement ``Contains --%
milkfat'', the blank to be filled in to the nearest one-tenth of 1
percent with the percentage of fat contained within limits of good
manufacturing practice. The name of the food shall include a declaration
of the presence of any characterizing flavoring, as specified in Sec.
101.22 of this chapter.
(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 43 FR 19836, May 9, 1978; 43
FR 29769, July 11, 1978; 43 FR 36622, Aug. 18, 1978; 47 FR 11823, Mar.
19, 1982; 49 FR 10091, Mar. 19, 1984; 54 FR 24892, June 12, 1989; 58 FR
2890, Jan. 6, 1993]
Additives that reference this regulation: |