21 CFR 172.379 - Vitamin D 2.

§ 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 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 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)
Edible plant-based beverages intended as milk alternatives 84 IU/100 g.
Edible plant-based yogurt alternatives 89 IU/100 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; 81 FR 46581, July 18, 2016]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code

Title 21 published on 10-May-2017 03:43

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

  • 2016-07-18; vol. 81 # 137 - Monday, July 18, 2016
    1. 81 FR 46578 - Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D 2 and Vitamin D 3
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective July 18, 2016. See section VIII for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by August 17, 2016. The Director of the Federal Register approves the incorporation by reference of certain publications listed in the rule as of July 18, 2016.
      21 CFR Part 172