21 CFR 172.380 - Vitamin D 3 ;.

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There are 2 Updates appearing in the Federal Register for 21 CFR 172. View below or at eCFR (GPOAccess)
§ 172.380 Vitamin D 3;.
Vitamin D3 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 D3, also known as cholecalciferol, is the chemical 9,10-seco(5Z,7E)-5,7,10(19)-cholestatrien-3-ol. Vitamin D3 occurs in and is isolated from fish liver oils. It also is manufactured by ultraviolet irradiation of 7-dehydrocholesterol produced from cholesterol and is purified by crystallization.
(b) Vitamin D3 meets the specifications of the Food Chemicals Codex, 5th ed. (2004), pp. 498-499, 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 National Academy Press, 500 Fifth St. NW., Washington, DC 20001 (Internet address http://www.nap.edu ). Copies may be examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 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:
(1) At levels not to exceed 100 International Units (IU) per 240 milliliters (mL) in 100 percent fruit juices (as defined under § 170.3(n)(35) of this chapter) that are fortified with greater than or equal to 33 percent of the reference daily intake (RDI) of calcium per 240 mL, excluding fruit juices that are specially formulated or processed for infants.
(2) At levels not to exceed 100 IU per 240 mL in fruit juice drinks (as defined under § 170.3(n)(35) of this chapter) that are fortified with greater than or equal to 10 percent of the RDI of calcium per 240 mL, excluding fruit juice drinks that are specially formulated or processed for infants.
(3) At levels not to exceed 140 IU per 240 mL (prepared beverage) in soy-protein based meal replacement beverages (powder or liquid) that are represented for special dietary use in reducing or maintaining body weight in accordance with § 105.66 of this chapter.
(4) At levels not to exceed 100 IU per 40 grams in meal replacement bars or other-type bars that are represented for special dietary use in reducing or maintaining body weight in accordance with § 105.66 of this chapter.
(5) At levels not to exceed 81 IU per 30 grams in cheese and cheese products as defined under § 170.3(n)(5) of this chapter, excluding cottage cheese, ricotta cheese, and hard grating cheeses such as Parmesan and Romano as defined in §§ 133.165 and 133.183 of this chapter, and those defined by standard of identity in § 133.148 of this chapter.
[68 FR 9003, Feb. 27, 2003, as amended at 70 FR 36025, June 22, 2005; 70 FR 37257, June 29, 2005; 70 FR 69438, Nov. 16, 2005]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

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  • 2014-08-12; vol. 79 # 155 - Tuesday, August 12, 2014
    1. 79 FR 46993 - Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D 3
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective August 12, 2014. See section VII “Objections” for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by September 11, 2014. The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of August 12, 2014.
      21 CFR Part 172

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United States Code

Title 21 published on 2014-04-01

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

  • 2014-09-02; vol. 79 # 169 - Tuesday, September 2, 2014
    1. 79 FR 51922 - Richard C. Theuer; Withdrawal of Food Additive Petition and Citizen Petition
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Withdrawal of petitions.
      The food additive petition and the citizen petition were withdrawn on July 30, 2014.
      21 CFR Parts 172 and 182