[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.380]

[Page 52]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 172_FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION--Table of Contents
 
           Subpart D_Special Dietary and Nutritional Additives
 
Sec. 172.380  Vitamin D[bdi3].

    The food additive may be used safely in foods as a nutrient 
supplement defined under Sec. 170.3(o)(20) of this chapter in 
accordance with the following prescribed conditions:
    (a) Vitamin D3, also known as cholecalciferol, is the 
chemical 9,10-seco(5Z,7E)-5,7,10(19)-cholestatrien-3-ol. Vitamin 
D3 occurs in and is isolated from fish liver oils. It also is 
manufactured by ultraviolet irradiation of 7-dehydrocholesterol produced 
from cholesterol and is purified by crystallization.
    (b) Vitamin D3 meets the specifications of the Food 
Chemicals Codex, 4\th\ ed. (1996), p. 434, which is incorporated by 
reference. The Director of the Office of the Federal Register approves 
this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. You may obtain copies from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418 (Internet address http://
www.nap.edu. Copies may be examined at the Center for Food Safety and 
Applied Nutrition's Library, Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or 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.
    (c) Vitamin D3 may be added, at levels not to exceed 100 
International Units (IU) per serving, to 100 percent fruit juices, as 
defined under Sec. 170.3(n)(35) of this chapter, excluding fruit juices 
that are specially formulated or processed for infants, that are 
fortified with greater than 33 percent of the Recommended Daily Intake 
(RDI) of calcium per Reference Amount Customarily Consumed (RACC).
    (d) Vitamin D3 may be added, at levels not to exceed 100 
IU per serving, to fruit drinks, as defined under Sec. 170.3(n)(35) of 
this chapter, excluding fruit drinks that are specially formulated or 
processed for infants, that are fortified with greater than 10 percent 
of the RDI of calcium per RACC.

[68 FR 9003, Feb. 27, 2003]