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184.1950 Vitamin D.

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[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR184.1950]

[Page 576-577]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 184_DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS 
SAFE--Table of Contents
 
        Subpart B_Listing of Specific Substances Affirmed as GRAS
 
Sec.  184.1950  Vitamin D.

    (a) Vitamin D is added to food as the following food ingredients:
    (1) Crystalline vitamin D2 
(C28H44O, CAS Reg. No. 50-14-6), also known as 
ergocalciferol, is the chemical 9,10-seco(5Z,7E,22E)-5,7,10(19),22-
ergostatetraen-3-ol. The ingredient is produced by ultraviolet 
irradiation of ergosterol isolated from yeast and related fungi and is 
purified by crystallization.
    (2) Crystalline vitamin D3 
(C27H44O, CAS Reg. No. 67-97-0), 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 is also manufactured by ultraviolet 
irradiation of 7-dehydrocholesterol produced from cholesterol. It is 
purified by crystallization. Vitamin D3 is the vitamin D form 
that is produced endogenously in humans through sunlight activation of 
7-dehydrocholesterol in the skin.
    (3) Vitamin D2 resin and vitamin D3 resin are 
the concentrated forms of irradiated ergosterol (D2) and 
irradiated 7-dehydrocholesterol (D3) that are separated from 
the reacting materials in paragraphs (a) (1) and (2) of this section. 
The resulting products are sold as food sources of vitamin D without 
further purification.
    (b) Vitamin D2 and vitamin D3 as crystals meet 
the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 344 
and 345, which is incorporated by reference. Copies are available from 
the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 
20418, or available for inspection 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. 
FDA is developing food-grade specifications for vitamin D2 
resin and vitamin D3 resin in cooperation with the National 
Academy of Sciences. In the interim, these resins must be of a purity 
suitable for their intended use.
    (c)(1) In accordance with Sec.  184.1(b)(2), the ingredients are 
used in food as the sole source of added vitamin D only within the 
following specific limitations:

------------------------------------------------------------------------
                                   Maximum levels in
        Category of food           food (as served)     Functional use
------------------------------------------------------------------------
Breakfast cereals, Sec.           350 (IU/100 grams)  Nutrient
 170.3(n)(4) of this chapter.                          supplement, Sec.
                                                        170.3(o)(20) of
                                                       this chapter.
Grain products and pastas, Sec.   90(IU/100 grams)..   Do.
  170.3(n)(23) of this chapter.
Milk, Sec.   170.3(n)(30) of      42 (IU/100 grams).   Do.
 this chapter.
Milk products, Sec.               89 (IU/100 grams).   Do.
 170.3(n)(31) of this chapter.
------------------------------------------------------------------------

    (2) Vitamin D may be used in infant formula in accordance with 
section 412(g) of the Federal Food, Drug, and

[[Page 577]]

Cosmetic Act (the act) or with regulations promulgated under section 
412(a)(2) of the act.
    (3) Vitamin D may be used in margarine in accordance with Sec.  
166.110 of this chapter.
    (d) Prior sanctions for these ingredients different from the uses 
established in this section do not exist or have been waived.

[50 FR 30152, July 24, 1985]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 184, Section 1950


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