Vitamin D2 may be used safely in foods as a nutrient supplement defined under § 170.3(o)(20) of this chapter in accordance with the following prescribed conditions:
(a) Vitamin D2, also known as ergocalciferol, is the chemical 9,10-seco(5Z,7E,22E)-5,7,10(19),22-ergostatetraen-3-ol. Vitamin D2 is produced by ultraviolet irradiation of ergosterol isolated from yeast and is purified by crystallization.
(b) Vitamin D2 meets the specifications of the Food Chemicals Codex, 6th ed. (2008), pp. 1013 and 1014, which is incorporated by reference. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C 552(a) and 1 CFR part 51. You may obtain a copy from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address: http://www.usp.org). You may inspect a copy at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1071, or 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.
(c) The additive may be used as follows:
Category of Food
Maximum Levels in Food (as Served)
50 International Units (IU)/100 grams (g)
Soy beverage products
89 IU/100 g
Soy-based butter substitute spreads
330 IU/100 g
Soy-based cheese substitutes and soy-based cheese substitute products