A-A-20172B
5.3 Foreign material. Infant formula products shall be clean, sound, wholesome, and be free from foreign material such as, but not limited to, dirt, insect parts, hair, wood, glass, or metal.
5.4 Dilution. At standard dilution, all classes of infant formulas shall supply 20 Kcal per fluid ounce.
5.4.1 Powder (Class 1). Powder infant formula shall be of suitable particle size and volubility such that it will readily disperse in warm water. Manufacturer’s instructions are required for the amount of powder infant formula and water to make up a standard dilution. When prepared in accordance with label instructions, the infant formula shall supply the labeled nutritional requirements. When tested, a 25 g sample shall contain not more than 15.0 mg scorched particles when compared to the American Dairy Products Institute Scorched Particle Standards for Dry Milks.
The microbiological determinations of powder infant formula shall be in accordance with the following referenced methods. The FDA may require additional tests, as newly emerging food safety information is made available.
Methods in the Official Methods of Analysis of the AOAC or the FDA, Bacteriological Analytical Manual (BAM) specified for infant formula currently in effect on the date of solicitation shall be used. Upon microbiological analysis, the test results of powder infant formula shall meet the following values:
Salmonella - Negative
Listeria monocytogenes - Negative
Colifonns - Not more than 10 per gram
Fecal coliforms - Not more than 3 per gram
Escherichia coli - Not more than 3 per gram
Coagulase Positive Staphylococcus aureus - Less than 3 per gram
Bacillus cereus - Not more than 50 per gram
Aerobic Plate Count - Not more than 500 per gram
5.4.2 Liquid concentrate (Class 2). The concentrated liquid infant formula shall be a commercially sterile product. Standard dilution is equal parts of concentrated liquid infant formula and water. When prepared in accordance with label instructions, the infant formula shall supply the labeled nutritional requirements.
5.4.3 Ready-to-use (Class 3). The ready-to-use infant formula shall be a commercially sterile product. Ready-to-use infant formula product is ready-to-use from the primary container. The infant formula shall supply the labeled nutritional requirements.
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