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Electronic Code of Federal Regulations

e-CFR data is current as of December 5, 2019

Title 21Chapter ISubchapter BPart 172Subpart D → §172.379


Title 21: Food and Drugs
PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION
Subpart D—Special Dietary and Nutritional Additives


§172.379   Vitamin D2.

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 2015 Food Chemical Codex, 9th edition (through Third Supplement), effective December 1, 2015, pp. 1260-1261, which is incorporated by reference. The Director of the Office 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 copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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/cfr/ibr-locations.html.

(c) The additive may be used as follows:

Category of FoodMaximum Levels in Food (as Served)
Edible plant-based beverages intended as milk alternatives84 IU/100 g.
Edible plant-based yogurt alternatives89 IU/100 g.
Soy beverage products89 IU/100 g
Soy-based butter substitute spreads330 IU/100 g
Soy-based cheese substitutes and soy-based cheese substitute products270 IU/100 g

[74 FR 11022, Mar. 16, 2009, as amended at 78 FR 71463, Nov. 29, 2013; 81 FR 46581, July 18, 2016]

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