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[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2007]
[CITE: 21CFR184.1950]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 184 -- DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE

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 D 2 (C 28 H 44 O, 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 D 3 (C 27 H 44 O, 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 D 3 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 D 3 is the vitamin D form that is produced endogenously in humans through sunlight activation of 7-dehydrocholesterol in the skin.

(3) Vitamin D 2 resin and vitamin D 3 resin are the concentrated forms of irradiated ergosterol (D 2 ) and irradiated 7-dehydrocholesterol (D 3 ) 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 D 2 and vitamin D 3 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 D 2 resin and vitamin D 3 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 184.1(b)(2), the ingredients are used in food as the sole source of added vitamin D only within the following specific limitations:

Category of foodMaximum levels in food (as served)Functional use
Breakfast cereals, 170.3(n)(4) of this chapter350 (IU/100 grams)Nutrient supplement, 170.3(o)(20) of this chapter.
Grain products and pastas, 170.3(n)(23) of this chapter90(IU/100 grams) Do.
Milk, 170.3(n)(30) of this chapter42 (IU/100 grams) Do.
Milk products, 170.3(n)(31) of this chapter89 (IU/100 grams) Do.

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

Database Updated April 1, 2007

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