[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR107.100]
[Page 194-195]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 107_INFANT FORMULA--Table of Contents
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:
------------------------------------------------------------------------
Minimum Maximum
Nutrients Unit of measurement level level
------------------------------------------------------------------------
Protein Grams 1.8 4.5
Fat do 3.3 6.0
Percent calories 30 54
Linoleic acid Milligrams 300 .......
Percent calories 2.7 .......
------------------------------------------------------------------------
Vitamins
------------------------------------------------------------------------
Vitamin A International Units 250 750
[[Page 195]]
Vitamin D do 40 100
Vitamin E do 0.7 .......
Vitamin K Micrograms 4 .......
Thiamine (vitamin B1) do 40 .......
Riboflavin (vitamin B2) do 60 .......
Vitamin B6 do 35 .......
Vitamin B12 do 0.15 .......
Niacin \1\ do 250 .......
Folic acid (folacin) do 4 .......
Pantothenic acid do 300 .......
Biotin \2\ do 1.5 .......
Vitamin C (ascorbic Milligrams 8 .......
acid)
Choline \2\ do 7 .......
Inositol \2\ do 4 .......
------------------------------------------------------------------------
Minerals
------------------------------------------------------------------------
Calcium do 60 .......
Phosphorus do 30 .......
Magnesium do 6 .......
Iron do 0.15 3.0
Zinc do 0.5 .......
Manganese Micrograms 5 .......
Copper Micrograms 60 .......
Iodine do 5 75
Sodium Milligrams 20 60
Potassium do 80 200
Chloride do 55 150
------------------------------------------------------------------------
\1\ The generic term ``niacin'' includes niacin (nicotinic acid) and
niacinamide (nicotinamide).
\2\ Required 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 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.
[50 FR 45108, Oct. 30, 1985]
Additives that reference this regulation: |
