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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2020.

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

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2020]
[CITE: 21CFR172.382]



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. 172.382 Vitamin D2 mushroom powder.

Vitamin D2 mushroom powder may be used safely in foods as a source of vitamin D2 in accordance with the following prescribed conditions:

(a) Vitamin D2 mushroom powder is the substance produced by exposing an aqueous homogenate of edible cultivars of Agaricus bisporus mushrooms to ultraviolet (UV) light, resulting in the photochemical conversion of endogenous ergosterol in the mushrooms to vitamin D2 (also known as ergocalciferol or [9,10-Seco(5Z,7E,22E)-5,7,10(19),22- ergostatetraen-3-ol]).

(b) The total dose of UV light applied to the mushroom homogenate shall not exceed 12 Joules/square centimeter (J/cm 2).

(c) Vitamin D2 mushroom powder meets the following specifications:

(1) Moisture, not more than 10 percent.

(2) Negative for Salmonella, Staphylococcus aureus, and Listeria monocytogenes, and any other recognized microbial pathogen or any harmful microbial toxin.

(3) Standard plate count, not more than 5,000 colony forming units per gram (CFU/g).

(4) Yeasts and molds, not more than 100 CFU/g.

(5) Lead, not more than 0.5 milligrams per kilogram (mg/kg).

(6) Arsenic, not more than 0.3 mg/kg.

(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 (f) 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 mushroom powder," in the proper order of decreasing predominance in the finished food.

(f) Vitamin D2 mushroom powder may be used as a source of vitamin D2 in food as follows:

Table 1 to Paragraph (f)

Category of food Maximum level of vitamin D2
Breakfast cereals350 IU/100 g.
Edible plant-based beverages marketed as milk alternatives84 IU/100 g.
Edible plant-based products marketed as yogurt alternatives89 IU/100 g.
Extruded vegetable snacks80 IU/28 g.
Fruit smoothies100 IU/240 mL.
100% fruit juices that are fortified with greater than or equal to 330 mg of calcium per 240 mL, excluding fruit juices that are specially formulated or processed for infants100 IU/240 mL.
Fruit juice drinks 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 infants100 IU/240 mL.
Grain products and pastas90 IU/100 g.
Meal replacement bars or other-type bars that are represented for special dietary use in reducing or maintaining body weight100 IU/40 g.
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 D provided by the product does not exceed 1,000 IU per day500 IU/240 mL.
Plant protein products80 IU/85 g.
Soups and soup mixes, except for soup and soup mixes containing meat or poultry that are subject to regulation by the U.S. Department of Agriculture under the Federal Meat Inspection Act or the Poultry Products Inspection Act100 IU/245 mL.
Soy-based spreads marketed as butter alternatives330 IU/100 g.
Soy-based products marketed as cheese and cheese-product alternatives270 IU/100 g.
Soy beverage products89 IU/100 g.
Soy-protein based meal replacement beverages (powder or liquid) that are represented for special dietary use in reducing or maintaining body weight140 IU/240 mL.
Vegetable juices100 IU/240 mL.
Yeast-leavened baked goods and baking mixes and yeast-leavened baked snack foods400 IU/100 g.

[85 FR 41920, July 13, 2020]

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