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Title 21: Food and Drugs
CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
SUBCHAPTER B: FOOD FOR HUMAN CONSUMPTION
PART 137: CEREAL FLOURS AND RELATED PRODUCTS
Subpart B: Requirements for Specific Standardized Cereal Flours and Related Products
137.185 - Enriched self-rising flour.
Enriched self-rising flour conforms to the definition and standard of identity, and is subject to the requirements for label statement of ingredients, prescribed for self-rising flour by ? 137.180, except that:
(a) It contains in each pound 2.9 milligrams of thiamin, 1.8 milligrams of riboflavin, 24 milligrams of niacin, 0.7 milligrams of folic acid, and 20 milligrams of iron.
(b) It contains added calcium in such quantity that the total calcium content is 960 milligrams per pound. If a calcium compound is added for technical purposes to give self-rising characteristics to the flour, the amount of calcium per pound of flour may exceed 960 milligrams provided that the excess is no greater than necessary to accomplish the intended effect. However, if such calcium is insufficient to meet the 960-milligram level, no claim may be made on the label for calcium as a nutrient.
(c) The requirements of paragraphs (a) and (b) of this section will be deemed to have been met if reasonable overages of the vitamins and minerals, within the limits of good manufacturing practice, are present to insure that the required levels of the vitamins and minerals are maintained throughout the expected shelf life of the food under customary conditions of distribution and storage. The quantitative content of the following vitamins shall be calculated in terms of the following chemically identifiable reference forms:
| Vitamin | Referemce form | Name | Empirical formula | Molecular weight |
| Thiamine | Thiamine chloride hydrochloride | C12H17ClN4OS?HCl | 337.28 |
| Riboflavin | Riboflavin | C17H20N4O6 | 376.37 |
| Niacin | Niacin | C6H5NO2 | 123.11 |
(d) It may contain not more than 5 percent by weight of wheat germ or partly defatted wheat germ;
(e) When calcium is added as dicalcium phosphate, such dicalcium phosphate is also considered to be an acid-reacting substance;
(f) When calcium is added as carbonate, the method set forth in ? 137.180(c) does not apply as a test for carbon dioxide evolved; but in such case the quantity of carbon dioxide evolved under ordinary conditions of use of the enriched self-rising flour is not less than 0.5 percent of the weight thereof;
(g) All ingredients from which the food is fabricated shall be safe and suitable. The vitamins and minerals added to the food for enrichment purposes may be supplied by any safe and suitable substances. Niacin equivalents as derived from tryptophan content shall not be used in determining total niacin content.
[42 FR 14402, Mar. 15, 1977, as amended at 43 FR 38578, Aug. 29, 1978; 46 FR 43414, Aug. 28, 1981; 58 FR 2877, Jan. 6, 1993; 61 FR 8796, Mar. 5, 1996]
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