§ 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)