21 CFR 172.379 - Vitamin D 2.

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§ 172.379 Vitamin D 2.

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, 7th ed. (2010), pp. 1080-1081, 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 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 Food Maximum Levels in Food (as Served)
Soy beverages 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 270 IU/100 g
[74 FR 11022, Mar. 16, 2009, as amended at 78 FR 71463, Nov. 29, 2013]

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United States Code

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 172 after this date.

  • 2015-10-28; vol. 80 # 208 - Wednesday, October 28, 2015
    1. 80 FR 65978 - Grocery Manufacturers Association; Filing of Food Additive Petition
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notice of petition.
      This food additive petition was filed on October 1, 2015. Submit either electronic or written comments on the petitioner's environmental assessment by November 27, 2015.
      21 CFR Part 172