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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2018]
[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 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. Vitamin D2 resin and vitamin D3 resin 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 food Maximum 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, as amended at 73 FR 8608, Feb. 14, 2008]

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