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107.100 Nutrient specifications.

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[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:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 107, Section 100


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