21 C.F.R. § 184.1950 Vitamin D.
Title 21 - Food and Drugs
(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.php. 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 §184.1(b)(2), the ingredients are used in food as the sole source of added vitamin D only within the following specific limitations: (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]
Title 21: Food and Drugs
PART 184—DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
Subpart B—Listing of Specific Substances Affirmed as GRAS
§ 184.1950 Vitamin D.
------------------------------------------------------------------------ Maximum levels in Category of food food (as served) Functional use------------------------------------------------------------------------Breakfast cereals, § 350 (IU/100 grams) Nutrient 170.3(n)(4) of this chapter. supplement, § 170.3(o)(20) of this chapter.Grain products and pastas, 90(IU/100 grams).. Do. § 170.3(n)(23) of this chapter.Milk, § 170.3(n)(30) of 42 (IU/100 grams). Do. this chapter.Milk products, § 89 (IU/100 grams). Do. 170.3(n)(31) of this chapter.------------------------------------------------------------------------
