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§107.100 婴儿配方粉营养素水平要求(Nutrient specifications)

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放大字体  缩小字体 2011-04-22 16:39:11  来源:GPO  浏览次数:3664
核心提示:婴儿配方粉必须含有下列营养素,当按容器上标注的使用方法制备时,每100kcal婴儿配方粉中各种营养素的含量不低于规定的最小值,但不大于规定的最大值。
发布单位
FDA
FDA
发布文号 50 FR 45108
发布日期 1985-10-30 生效日期 暂无
有效性状态 废止日期 暂无
备注 婴儿配方粉必须含有下列营养素,当按容器上标注的使用方法制备时,每100kcal婴儿配方粉中各种营养素的含量不低于规定的最小值,但不大于规定的最大值。

       更多关于婴儿配方粉的法规,请详见美国FDA 21 CFR 第107部分关于婴儿配方粉的法规汇总

  § 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
Protein Grams 1.8 4.5
Fat Grams 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 International Units 40 100
  International Units 0.7  
Vitamin K Micrograms 4  
Thiamine (vitamin B1) Micrograms 40  
Riboflavin (vitamin B2) Micrograms 60  
Vitamin B6 Micrograms 35  
Vitamin B12 Micrograms 0.15  
Niacin1 Micrograms 250  
Folic acid (folacin) Micrograms 4  
Pantothenic acid Micrograms 300  
Biotin2 Micrograms 1.5  
Vitamin C (ascorbic acid) Milligrams 8  
Choline2 Milligrams 7  
Inositol2 Milligrams 4  
Minerals
Calcium Milligrams 60  
Phosphorus Milligrams 30  
Magnesium Milligrams 6  
Iron Milligrams 0.15 3.0
Zinc Milligrams 0.5  
Manganese Micrograms 5  
Copper Micrograms 60  
Iodine Micrograms 5 75
Sodium Milligrams 20 60
Potassium Milligrams 80 200
Chloride Milligrams 55 150


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

  2Required 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 B6shall be present at a level of at least 15 micrograms of vitamin B6for 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]

 

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