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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 2016.

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 2]
[Revised as of April 1, 2016]
[CITE: 21CFR137.165]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION

PART 137 -- CEREAL FLOURS AND RELATED PRODUCTS

Subpart B--Requirements for Specific Standardized Cereal Flours and Related Products

Sec. 137.165 Enriched flour.

Enriched flour conforms to the definition and standard of identity, and is subject to the requirements for label statement of ingredients, prescribed for flour by 137.105, 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 may contain added calcium in such quantity that the total calcium content is 960 milligrams per pound. Enriched flour may be acidified with monocalcium phosphate within the limits prescribed by 137.175 for phosphated flour, but, if insufficient additional calcium is present to meet the 960 milligram level, no claim may be made on the label for calcium as a nutrient;

(c) The requirement 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 Reference form
Name Empirical formula Molecular weight
ThiamineThiamine chloride hydrochlorideC12H17ClN4OS.HCl337.28
RiboflavinRiboflavinC17H20N4O6376.37
NiacinNiacinC6H5NO2123.11

(d) It may contain not more than 5 percent by weight of wheat germ or partly defatted wheat germ;

(e) In determining whether the ash content complies with the requirements of this section, ash resulting from any added iron or salts of iron or calcium or wheat germ is excluded in calculating ash content.

(f) 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 substance. Niacin equivalents as derived from tryptophan content shall not be used in determining total niacin content.

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