A-A-20172 Formula, InfantThis Commercial Item Description (CID) covers infant formula packed in commercially acceptable containers, suitable for use by the Federal, State local governments, and other interested parties.

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A-A-20172B

5. SALIENT CHARACTERISTICS.

5.1 Processing. The infant formula products shall be formulated and packaged in accordance with current good manufacturing practices (21 CFR Part 110). The liquid formulas shall also comply with Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (21 CFR Part 113). The infant formulas shall comply with Food and Drug Administration (FDA) Infant Formula Act of 1980 and the 1986 Amendments, the Infant Formula Program - Import and Domestic, Chapter 21- Food Composition, Standards, Labeling and Economics, and with the following applicable CFRS:

5.2 Finished product.

5.2.1 Appearance and color. The infant formula shall be of medium viscosity, be free flowing, and have a uniform consistency and appearance. All infant formulas shall possess a white to light cream color and shall be uniformly colored throughout, characterize the type, and class it represents.

5.2.2 Body and texture. The infant formula shall be free from gelation, which includes such factors as surface ripple, unevenness of flow, and lumpiness. The infant formula shall be free from creaming (the separation of fat), protein agglomeration (the cohesion of microscopic protein particles of sufficient size to be visible), and extraneous material. Milk-base/whey-based infant formula shall be free from coarse milk and whey-based solids precipitate or sedimentation. The powder formula shall be smooth, uniform, free horn lumps, or graininess.

5.2.3 Odor and taste. At standard dilution, as applicable, ALL CLASSES of infant formulas shall have the normal characteristic odor and taste, free from rancidity and other undesirable odors and tastes.

5.2.4 Age requirement and shelf life. The age requirement of the infant formula at the time of shipment shall comply with FDA’s regulations and requirements after packaging. Cans and can coatings shall meet FDA’s requirements for safe contact with packaged infant formula. All classes of infant formulas shall have a minimum of one-year shelf life from the packaged date. Each infant formula container shall declare a “use by” date. The ’’use by” date is to inform purchasers and users that the infant formula, until that declared date, will contain the quantity of each nutrient as specified on the label and that the formula is otherwise of an acceptable quality. The infant formula product should be discarded when the calendar current date is after the “use by” date.