21 CFR 107.100 - Nutrient specifications.

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§ 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
1 The generic term “niacin” includes niacin (nicotinic acid) and niacinamide (nicotinamide).
2 Required only for non-milk-based infant formulas.
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
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 acid) Milligrams 8
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
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]

Title 21 published on 2013-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-02-19; vol. 79 # 33 - Wednesday, February 19, 2014
    1. 79 FR 9412 - Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula; Correction
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Interim final rule; request for comments; correction.
      Effective Date: This correction is effective February 19, 2014.
      21 CFR Parts 106 and 107

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United States Code

Title 21 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 107 after this date.

  • 2014-02-19; vol. 79 # 33 - Wednesday, February 19, 2014
    1. 79 FR 9412 - Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula; Correction
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Interim final rule; request for comments; correction.
      Effective Date: This correction is effective February 19, 2014.
      21 CFR Parts 106 and 107