§ 172.380 - Vitamin D3.

§ 172.380 Vitamin D₃.

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 “Vitamin D₃,” Food Chemicals Codex, 13th edition, effective June 1, 2022, 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 U.S. Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852; website: https://www.usp.org. Copies may be examined at the FDA or the National Archives and Records Administration (NARA). Contact FDA at: the Dockets Management Staff (HFA-305HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500, between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. For information on inspecting this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations.html or email [e-mail].

(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 330 milligrams (mg) 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 100 mg 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.

(6) At levels not to exceed 500 IU per 240 mL (prepared beverage) in meal replacement beverages that are not intended for special dietary use in reducing or maintaining body weight and that are represented for use such that the total amount of Vitamin D₃ provided by the product does not exceed 1,000 IU per day.

(7) At levels not to exceed 1.0 IU per kilocalorie in foods represented for use as a sole source of nutrition for enteral feeding.

(8) At levels not to exceed 84 IU per 100 g (800 IU/quart) in milk that contains more than 42 IU vitamin D per 100 g (400 IU/quart) and that meets the requirements for foods named by use of a nutrient content claim and a standardized term in accordance with § 130.10 of this chapter.

(9) At levels not to exceed 560 IU per 100 g in breakfast cereals (as defined under § 170.3(n)(4) of this chapter).

(10) At levels not to exceed 400 IU per 100 g in grain-based bars (e.g., breakfast bars, granola bars, rice cereal bars).

[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; 78 FR 71463, Nov. 29, 2013; 79 FR 46996, Aug. 12, 2014; 81 FR 46582, July 18, 2016; 83 FR 47559, Sept. 20, 2018; 88 FR 749, Jan. 5, 2023; 88 FR 17719, Mar. 24, 2023]