21 CFR § 172.379 - Vitamin D.

---
identifier: "/us/cfr/t21/s172.379"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 172.379 - Vitamin D."
title_number: 21
title_name: "Food and Drugs"
section_number: "172.379"
section_name: "Vitamin D."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "FOOD FOR HUMAN CONSUMPTION"
part_number: "172"
part_name: "FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 341, 342, 348, 371, 379e."
regulatory_source: "42 FR 14491, Mar. 15, 1977, unless otherwise noted."
cfr_part: "172"
---


# 172.379 Vitamin D.

Vitamin D<sub>2</sub> 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 D<sub>2</sub>, also known as ergocalciferol, is the chemical 9,10-seco(5Z,7E,22E)-5,7,10(19),22-ergostatetraen-3-ol. Vitamin D<sub>2</sub> is produced by ultraviolet irradiation of ergosterol isolated from yeast and is purified by crystallization.

(b) Vitamin D<sub>2</sub> 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 Dockets Management Staff (HFA-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, 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; 88 FR 17719, Mar. 24, 2023]