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 rule.
(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 two thousand international units thereof.
(2) Vitamin D is added in such quantity that when prepared according to the label directions, each quart of the reconstituted product contains four hundred 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.
(C) Optional ingredients:
The following safe and suitable optional ingredients may be used:
(1) Carriers for vitamins A and D; or
(2) Characterizing flavoring ingredients, with or without coloring and nutritive carbohydrate sweetener, as follows:
(a) Fruit and fruit juice, including concentrated fruit and fruit juices; or
(b) Natural and artificial food flavorings.
(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 " nonfat dry milk fortified with vitamins A and D." If the fat content is over 1.5 per cent 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 one per cent 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 Title 21 CFR 101.22(April 2000).
(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