更多关于已证实属于一般公认为安全（GRAS）的可直接加入食品中的物质种类，请点击美国FDA 21 CFR 第184部分已证实属于一般公认为安全（GRAS）的可直接加入食品中的物质种类汇总
§ 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 D3occurs 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 D3is the vitamin D form that is produced endogenously in humans through sunlight activation of 7-dehydrocholesterol in the skin.
（3） Vitamin D2resin and vitamin D3resin 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 D2and vitamin D3as 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 D2resin and vitamin D3resin 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]
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