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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2013]
[CITE: 21CFR107.100]



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

PART 107 -- INFANT FORMULA

Subpart D--Nutrient Requirements

Sec. 107.100 Nutrient specifications.

(a) An infant formula shall contain the following nutrients at a level not less than the minimum level specified and not more than the maximum level specified for each 100 kilocalories of the infant formula in the form prepared for consumption as directed on the container:

NutrientsUnit of measurementMinimum levelMaximum level
ProteinGrams1.84.5
Fat do3.36.0
Percent calories3054
Linoleic acidMilligrams300
Percent calories2.7
Vitamins
Vitamin AInternational Units250750
Vitamin D do40100
Vitamin E do0.7
Vitamin KMicrograms4
Thiamine (vitamin B1) do40
Riboflavin (vitamin B2) do60
Vitamin B6 do35
Vitamin B12 do0.15
Niacin1 do250
Folic acid (folacin) do4
Pantothenic acid do300
Biotin2 do1.5
Vitamin C (ascorbic acid)Milligrams8
Choline2 do7
Inositol2 do4
Minerals
Calcium do60
Phosphorus do30
Magnesium do6
Iron do0.153.0
Zinc do0.5
ManganeseMicrograms5
CopperMicrograms60
Iodine do575
SodiumMilligrams2060
Potassium do80200
Chloride do55150

1The generic term "niacin" includes niacin (nicotinic acid) and niacinamide (nicotinamide).

2Required only for non-milk-based infant formulas.

In addition to the specifications established in the table in this paragraph for vitamins and minerals, the following also apply:

(b) Vitamin E shall be present at a level of at least 0.7 International Unit of vitamin E per gram of linoleic acid.

(c) Any vitamin K added shall be in the form of phylloquinone.

(d) Vitamin B6shall be present at a level of at least 15 micrograms of vitamin B6for each gram of protein in excess of 1.8 grams of protein per 100 kilocalories of infant formula in the form prepared for consumption as directed on the container.

(e) The ratio of calcium to phosphorus in infant formula in the form prepared for consumption as directed on the container shall be no less than 1.1 and not more than 2.0.

(f) Protein shall be present in an amount not to exceed 4.5 grams per 100 kilocalories regardless of quality, and not less than 1.8 grams per 100 kilocalories of infant formula in the form prepared for consumption as directed on the container when its biological quality is equivalent to or better than that of casein. If the biological quality of the protein is less than that of casein, the minimum amount of protein shall be increased proportionately to compensate for its lower biological quality. For example, an infant formula containing protein with a biological quality of 75 percent of casein shall contain at least 2.4 grams of protein (1.8/0.75). No protein with a biological quality less than 70 percent of casein shall be used.

[50 FR 45108, Oct. 30, 1985]

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