§ 184.1950 - Vitamin D.

§ 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 chapter	350 (IU/100 grams)	Nutrient supplement, § 170.3(o)(20) of this chapter.
Grain products and pastas, § 170.3(n)(23) of this chapter	90(IU/100 grams)	Do.
Milk, § 170.3(n)(30) of this chapter	42 (IU/100 grams)	Do.
Milk products, § 170.3(n)(31) of this chapter	89 (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]