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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: 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:

Nutrients Unit of measurement Minimum level Maximum level
ProteinGrams1.84.5
FatDo.3.36.0
Percent calories3054
Linoleic acidMilligrams300
Percent calories2.7
Vitamins
Vitamin AInternational Units250750
Vitamin DDo.40100
Vitamin EDo.0.7
Vitamin KMicrograms4
Thiamine (Vitamin B1)Do.40
Riboflavin (Vitamin B2)Do.60
Vitamin B6Do.35
Vitamin B12Do.0.15
Niacin 1Do.250
Folic acid (Folacin)Do.4
Pantothenic acidDo.300
Biotin 2Do.1.5
Vitamin C (Ascorbic acid)Milligrams8
Choline 2Do.7
Inositol 2Do.4
Minerals
CalciumDo.60
PhosphorusDo.30
MagnesiumDo.6
IronDo.0.153.0
ZincDo.0.5
ManganeseMicrograms5
CopperDo.60
IodineDo.575
SeleniumDo.27
SodiumMilligrams2060
PotassiumDo.80200
ChlorideDo.55150

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

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

(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 B6 shall be present at a level of at least 15 micrograms of vitamin B6 for 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.

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