[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.380]

[Page 51-52]
 
                        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
 
           Subpart D_Special Dietary and Nutritional Additives
 
Sec.  172.380  Vitamin D[bdi3].

    Vitamin D3 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, 5th ed. (2004), pp. 498-499, 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, 500 
Fifth St. NW., Washington, DC 20001 (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

[[Page 52]]

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) The additive may be used as follows:
    (1) At levels not to exceed 100 International Units (IU) per 240 
milliliters (mL) in 100 percent fruit juices (as defined under Sec.  
170.3(n)(35) of this chapter) that are fortified with greater than or 
equal to 33 percent of the reference daily intake (RDI) of calcium per 
240 mL, excluding fruit juices that are specially formulated or 
processed for infants.
    (2) At levels not to exceed 100 IU per 240 mL in fruit juice drinks 
(as defined under Sec.  170.3(n)(35) of this chapter) that are fortified 
with greater than or equal to 10 percent of the RDI of calcium per 240 
mL, excluding fruit juice drinks that are specially formulated or 
processed for infants.
    (3) At levels not to exceed 140 IU per 240 mL (prepared beverage) in 
soy-protein based meal replacement beverages (powder or liquid) that are 
represented for special dietary use in reducing or maintaining body 
weight in accordance with Sec.  105.66 of this chapter.
    (4) At levels not to exceed 100 IU per 40 grams in meal replacement 
bars or other-type bars that are represented for special dietary use in 
reducing or maintaining body weight in accordance with Sec.  105.66 of 
this chapter.
    (5) At levels not to exceed 81 IU per 30 grams in cheese and cheese 
products as defined under Sec.  170.3(n)(5) of this chapter, excluding 
cottage cheese, ricotta cheese, and hard grating cheeses such as 
Parmesan and Romano as defined in Sec. Sec.  133.165 and 133.183 of this 
chapter, and those defined by standard of identity in Sec.  133.148 of 
this chapter.

[68 FR 9003, Feb. 27, 2003, as amended at 70 FR 36025, June 22, 2005; 70 
FR 37257, June 29, 2005; 70 FR 69438, Nov. 16, 2005]