§ 107.100. Nutrient specifications.

383 words·~2 min read·/us/cfr/t21/s§ 107.100

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(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 1 The generic term “niacin” includes niacin (nicotinic acid) and niacinamide (nicotinamide). 2 Required 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. [50 FR 45108, Oct. 30, 1985, as amended at 80 FR 35841, June 23, 2015]