CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 3]

[CITE: 21CFR172.381]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 172 -- FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION

Subpart D - Special Dietary and Nutritional Additives

Sec. 172.381 Vitamin D2 bakers yeast.

Vitamin D2 bakers yeast may be used safely in foods as a source of vitamin D2 and as a leavening agent in accordance with the following prescribed conditions:

(a) Vitamin D2 bakers yeast is the substance produced by exposing bakers yeast (Saccharomyces cerevisiae ) to ultraviolet light, resulting in the photochemical conversion of endogenous ergosterol in bakers yeast to vitamin D2 (also known as ergocalciferol or (9,10-seco(5Z,7E,22E)-5,7,10(19),22-ergostatetraen-3-ol)).

(b) Vitamin D2 bakers yeast may be used alone as an active dry yeast concentrate or in combination with conventional bakers yeast.

(c) The additive may be used in yeast-leavened baked goods and baking mixes and yeast-leavened baked snack foods at levels not to exceed 400 International Units of vitamin D2 per 100 grams in the finished food.

(d) To assure safe use of the additive, the label or labeling of the food additive container shall bear, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act, adequate directions for use to provide a final product that complies with the limitations prescribed in paragraph (c) of this section.

(e) Labels of manufactured food products containing the additive shall bear, in the ingredient statement, the name of the additive, "vitamin D2 bakers yeast," in the proper order of decreasing predominance in the finished food.

[77 FR 52231, Aug. 29, 2012]