Vitamin D2 inactive bakers yeast may be safely used in foods as a source of vitamin D2 under the following conditions:
(a) Vitamin D2 inactive 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), and then inactivating the bakers yeast using heat.
(b) Vitamin D2 inactive bakers yeast can be used alone or in combination with conventional bakers yeast.
(c) Vitamin D2 inactive bakers yeast meets the following specifications:
(1) Moisture, less than 7 percent.
(2) Negative for Salmonella, Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa.
(3) Coliforms, less than 10 colony forming units per gram (CFU/g).
(4) Total plate count, less than 3,000 CFU/g.
(5) Yeasts and molds, less than 300 CFU/g.
(6) Lead, not more than 0.5 milligrams per kilogram (mg/kg).
(7) Arsenic, not more than 0.3 mg/kg.
(8) Cadmium, not more than 0.5 mg/kg.
(9) Mercury, not more than 0.1 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 (e) of this section.
(e) Vitamin D2 inactive bakers yeast may be used as a source of vitamin D2 in food as follows:
Category
of food
| Maximum level of
vitamin D2
|
|---|
| Breakfast cereals | 350 IU/100 g.
|
| Edible plant-based beverages marketed as milk alternatives | 84 IU/100 g.
|
| Edible plant-based products marketed as yogurt alternatives | 89 IU/100 g.
|
| Extruded vegetable snacks | 80 IU/28 g.
|
| Fruit smoothies | 100 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 infants | 100 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 infants | 100 IU/240 mL.
|
| Grain products and pastas | 90 IU/100 g.
|
| Meal replacement bars or other-type bars that are represented for special dietary use in reducing or maintaining body weight. | 100 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 day | 500 IU/240 mL.
|
| Plant protein products | 80 IU/85 g.
|
| Soups and soup mixes, except for soup and soup mixes that are subject to regulation by the U.S. Department of Agriculture under the Federal Meat Inspection Act or the Poultry Products Inspection Act | 100 IU/245 mL.
|
| Soy-based spreads marketed as butter alternatives | 330 IU/100 g.
|
| Soy-based products marketed as cheese and cheese-product alternatives | 270 IU/100 g.
|
| Soy beverage products | 89 IU/100 g.
|
| Soy-protein based meal replacement beverages (powder or liquid) that are represented for special dietary use in reducing or maintaining body weight | 140 IU/240 mL.
|
| Vegetable juices | 100 IU/240 mL.
|
| Yeast-leavened baked goods and baking mixes and yeast-leavened baked snack foods | 400 IU/100 g. |