FSC 8940

A-A-20172C

April 4, 2012

SUPERSEDING

A-A-20172B

May 14, 2002

COMMERCIAL ITEM DESCRIPTION

FORMULA, INFANT

The U.S. Department of Agriculture (USDA) has authorized

the use of this Commercial Item Description (CID).

1. SCOPE. This CID covers infant formula, packed in commercially acceptable containers, 

suitable for use by the Federal, State, local governments, and other interested parties.

2. PURCHASER NOTES.

2.1 Purchasers shall specify the following:

- Type(s), style(s), class(es), and container and packaging size(s) of infant formula products 

desired (Sec. 3).

- When the age requirements at the time of delivery is other than specified (Sec. 5.3.4).

- When analytical requirements are different than specified (Sec. 6).

- Manufacturer’s quality assurance and plant survey (Sec. 9.1).

- Manufacturer’s/distributor’s certification (Sec. 9.2) or USDA certification (Sec. 9.4).

2.2 Purchasers may specify the following:

- Packaging requirements other than commercial (Sec. 10).

3. CLASSIFICATION. The infant formula shall conform to the following list which shall be 

specified in the solicitation, contract, or purchase order.

Types, styles, classes, and container and packaging sizes.

Type I - Infant formula with iron (21 Code of Federal Regulations (CFR) § 107.10 (b) (4) (i))

Type II - Infant formula with low-iron (21 CFR § 107.10 (b) (4) (ii)

METRIC
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Style A - Milk-based/Whey-based (for infants not allergic to milk)

Style B - Soy-based (for infants allergic to milk but not to soy)

Style C - Hypoallergenic (for infants allergic to milk and soy-based infant formulas) 

(21 CRF § 105.62)

Class 1 - Powder

Class 2 - Liquid, concentrate

Class 3 - Ready-to-use

Container and packaging sizes

a. Powder (1) - 30.05 g (1.06 oz) per packet, 16 packets per carton, 6 cartons per case

Powder (2) - 30.05 g (1.06 oz) per pouch, 48 pouches per case

Powder (3) - 340.19 g (12 oz) per can, 6 cans per case

Powder (4) - 396.89 g (14 oz) per can, 6 cans per case

Powder (5) - 453.59 g (16 oz) per can, 6 cans per case

Powder (6) - 907.18 g (32 oz) per can, 6 cans per case

Powder (7) - 1.134 kg (40 oz) per can, 4 cans per case

Powder (8) - Other

b. Liquid, concentrate (1) - 384.46 mL (13 fl oz) per can, 24 cans per case

Liquid, concentrate (2) - 384.46 mL (13 fl oz) per can, 12 cans per case

Liquid, concentrate (3) - 384.46 mL (13 fl oz) per can, 6 cans per case

Liquid, concentrate (4) - Other

c. Ready-to-use (1) - 236.59 mL (8 fl oz) per can, 24 cans per case

Ready-to-use (2) - 236.59 mL (8 fl oz) per can, 12 cans per case

Ready-to-use (3) - 946.35 mL (32 fl oz) per can, 6 cans per case

Ready-to-use (4) - Other

4. MANUFACTURER’S/DISTRIBUTOR’S NOTES. Manufacturer’s/distributor’s 

products shall meet the requirements of the:

- Salient characteristics (Sec 5).

- Analytical requirements: as specified by the purchaser (Sec. 6).

- Manufacturer’s/distributor’s product assurance (Sec. 7).

- Regulatory requirements (Sec. 8).

- Quality assurance provisions: as specified by the purchaser (Sec. 9).

- Packaging requirements other than commercial: as specified by the purchaser (Sec. 10).
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5. SALIENT CHARACTERISTICS.

5.1 Processing. The infant formula shall be processed 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:

Foods for Special Dietary Use 21 CFR § 105.65, Subpart B 

Infant Formula Quality Control Procedures 21 CFR Part 106

Infant Formula 21 CFR Part 107

5.2 Food security. The infant formula should be processed and transported in accordance with

the FDA’s Guidance for Industry: Food Producers, Processors, and Transporters: Food 

Security Preventive Measures Guidance. 

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Foo

dDefenseandEmergencyResponse/ucm083075.htm. This guidance identifies the kinds of 

preventive measures food manufacturers, processors, or handlers may take to minimize the risk 

that food under their control will be subject to tampering or other malicious, criminal, or terrorist 

actions. The implementation of enhanced food security preventive measures provides for the 

security of a plant’s production processes and includes the storage and transportation of preproduction raw materials, other ingredients, and postproduction finished product.

5.3 Finished product.

5.3.1 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, characteristic of the type, and class 

it represents.

5.3.2 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-based/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 from lumps, or graininess.

5.3.3 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.
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5.3.4 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.

5.4 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.

5.5 Dilution. At standard dilution, all classes of infant formulas shall supply 20 Kcal per fluid 

ounce.

5.5.1 Powder (Class 1). Powder infant formula shall be of suitable particle size and solubility 

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 no more than 15.0 mg scorched particles 

when compared to the United States Scorched Particle Standards for Dry Milk

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELDEV3004472.

5.5.2 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.

5.5.3 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.

6. ANALYTICAL REQUIREMENTS. Unless otherwise specified in the solicitation, 

contract, or purchase order, the analytical requirements for the infant formula products shall 

comply with this CID, the current Infant Formula Program - Import and Domestic, Chapter 21 -

Food Composition, Standards, Labeling and Economics. All testing conducted on infant formula 

products shall be in compliance with the most current edition of the Official Methods of Analysis 

of the AOAC International, and the FDA Bacteriological Analytical Manual (BAM) approved 

methods specific for infant formulas currently in effect. The FDA Laboratory Information 

Bulletin (LIB) 4421, Determination of Melamine and Cyanuric Acid Residues in Infant Formula 

and FDA LIB for the Isolation and Enumeration of Enterobacter sakazakii from Dehydrated 
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Powdered Infant Formula shall be used to determine the presence of melamine and Enterobacter 

sakazakii in infant formula.

The FDA may require additional tests, as newly emerging food safety information is made 

available. Upon microbiological analysis, the test results of powder infant formula shall meet the 

following values:

Salmonella Negative

Listeria monocytogenes Negative

Coliforms Not more than 10 per gram

Fecal coliforms Not more than 3 per gram

Escherichia coli Not more than 3 per gram

Coagulase Positive Less than 3 per gram

Staphylococcus aureus

Bacillus cereus Not more than 50 per gram

Aerobic Plate Count Not more than 500 per gram

Melamine Negative

Enterobacter sakazakii Negative

7. MANUFACTURER’S/DISTRIBUTOR’S PRODUCT ASSURANCE. The manufacturer/ 

distributor shall certify that the infant formula provided shall meet the salient characteristics of 

this CID, conform to their own specifications, standards, and quality assurance practices, and be 

the same infant formula offered for sale in the commercial market. The purchaser reserves the 

right to require proof of conformance.

8. REGULATORY REQUIREMENTS. The delivered infant formula products shall comply 

with all applicable Federal, State, and local mandatory requirements and regulations relating to 

the production, transportation, receiving, processing, packaging, labeling, storage, distribution, 

and sale of infant formula products within the commercial marketplace. The infant formula 

products shall comply with all applicable provisions of the Federal Food, Drug, and Cosmetic

Act, the Infant Formula Act of 1980 and the 1986 Amendments, the Fair Packaging and Labeling 

Act, and regulations promulgated thereunder. The delivered infant formula shall comply with the 

allergen labeling requirements of the Federal Food, Drug, and Cosmetic Act.

9. QUALITY ASSURANCE PROVISIONS. All infant formula plants producing infant 

formula under this CID shall comply with all applicable requirements of the FDA Infant Formula 

Act of 1980 and the 1986 Amendments, and the current edition of the Infant Formula Program -

Import and Domestic, Chapter 21 - Food Composition, Standards, Labeling and Economics. The 

production, transportation, processing, handling, sampling, analysis, labeling, and sale of infant 

formula products shall also comply with said regulations. Purchaser shall specify 9.1, 9.2, or 

9.3.
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9.1 Manufacturer’s quality assurance and plant survey. When required in the solicitation, 

contract, or purchase order, the infant formula manufacturer shall be required to have their 

facilities inspected by USDA, Agricultural Marketing Service (AMS), Dairy Programs (DP), 

Dairy Grading Branch (DGB), and be eligible for listing in Section I of the AMS publication 

“Dairy Plants Surveyed and Approved for USDA Grading Service”. (An AMS, DP plant survey 

verifies that at the time of the survey, the manufacturer produces products in a clean sanitary 

environment in accordance with 21 CFR Part 110 - Current Good Manufacturing Practice in 

Manufacturing, Packing, or Holding Human Food and the requirements contained in 7 CFR 

Part 58 General Specification for Dairy Plants Approved for USDA Inspection and Grading 

Service.)

9.2 Manufacturer’s/distributor’s certification. When required in the solicitation, contract, or 

purchase order, the manufacturer/distributor will certify that the infant formula distributed meets 

or exceeds the requirements of this CID.

9.3 USDA certification. When required in the solicitation, contract, or purchase order that 

product quality, acceptability or both be determined, the USDA, AMS, DP, DGB, shall be the 

certifying program. DGB inspectors shall certify the quality and acceptability of the infant 

formula in accordance with DGB procedures which include: selecting random samples of the 

packaged infant formula, evaluating the samples for conformance with the salient characteristics 

of this CID and other contractual requirements, and documenting the findings on official DGB 

certificates. In addition, when required in the solicitation, contract, or purchase order, DGB 

inspectors will examine the infant formula for conformance to the United States Standards for 

Condition of Food Containers in effect on the date of the solicitation. To qualify for this option 

the plant must be listed in “Dairy Plants Surveyed and Approved for USDA Grading Service” 

(Sec. 9.1).

10. PACKAGING. Preservation, packaging, packing, labeling, and case marking shall be 

commercial unless otherwise specified in the solicitation, contract, or purchase order. Primary 

containers shall be packed in corrugated fiberboard shipping containers or corrugated fiberboard 

trays with plastic shrink wrap that will provide infant formula protection against loss and damage 

during multiple shipment, handling, and storage. Each powder infant formula container shall 

include a measuring scoop and be equipped with a plastic lid for use after opening. Cans of 

infant formula shall be free of excessive dents and distortions and free from rust or other 

evidence of improper storage.

11. REFERENCE NOTES.

11.1 USDA certification contact. For USDA, AMS certification, contact the Branch Chief, 

DGB, DP, AMS, USDA, STOP 0230, 1400 Independence Avenue, SW, Washington, DC 

20250-0230, telephone (202) 720-3171, Fax (202) 720-2643, or via E-mail: 

Ken.Vorget@ams.usda.gov.
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11.2 Sources of documents.

11.2.1 Source of information for nongovernmental document is as follows:

Copies of the Official Methods of Analysis of the AOAC International may be obtained from: 

AOAC International, 481 North Frederick Avenue, Suite 500, Gaithersburg, MD 20877, 

telephone (301) 924-7077. Internet address: http://www.aoac.org.

11.2.2 Sources of information for governmental documents are as follows:

Applicable provisions of the Fair Packaging and Labeling Act are contained in 16 CFR, Parts 500

to 503, and the Federal Food, Drug, and Cosmetic Act are contained in 21 CFR Parts 1 to 199. 

These documents may be purchased from: Superintendent of Documents, New Orders, P.O. 

Box 979050 St. Louis, MO 63197-9000. Credit card (Visa, MasterCard, Discover/NOVUS, 

and American Express) purchases may be made by calling the Superintendent of 

Documents on (866) 512-1800, (202) 512-1800 or on the Internet at: 

http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR.

Copies of the Bacteriological Analytical Manual (BAM) are available from: FDA, Center of 

Food Safety and Applied Nutrition (CFSAN) on the Internet at: 

http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalM

anualBAM/default.htm.

Copies of Guidance for Industry - Food Producers, Processors, and Transporters: Food Security 

Preventive Measures Guidance is available online from: FDA, CFSAN on the Internet at: 

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocument

s/FoodDefenseandEmergencyResponse/ucm083075.htm.

Copies of the United States Scorched Particle Standards for Dry Milk and the photographic aid of 

four prepared scorched particle filter disks are available from: Standardization Branch, DP, 

AMS, USDA, STOP 0230, 1400 Independence Avenue, S.W., Washington, DC 20250-0230, 

telephone (202) 720-7473, Fax (202) 720-2643, or on the Internet at: 

http://www.ams.usda.gov/dairy/grade.htm.

Copies of this CID, the United States Standards for Condition of Food Containers, and beneficial 

comments, recommendations, additions, deletions, clarifications, etc. and any data which may 

improve this CID are available from and/or provided to: Director, PPD, FV, AMS, USDA, 

STOP 0247, 1400 Independence Avenue, SW, Washington, DC 20250-0243, telephone (202) 

720-9939, Fax (202) 690-1527, via E-mail: FQAStaff@ams.usda.gov or on the Internet at: 

http://www.ams.usda.gov/FQAS.
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CIVIL AGENCY COORDINATING ACTIVITIES:

DOJ - BOP

HHS - NIH, FDA

USDA - FSA

USDA - FNS

USDA - FV

PREPARING ACTIVITY:

USDA - FV

The U.S. Department of Agriculture (USDA) prohibits discrimination in all of its programs and activities on the 

basis of race, color, national origin, age, disability, and where applicable, sex (including gender identity and 

expression), marital status, familial status, parental status, religion, sexual orientation, political beliefs, genetic 

information, reprisal, or because all or part of an individual's income is derived from any public assistance program. 

(Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for 

communication of program information (Braille, large print, audiotape, etc.) should contact USDA's TARGET 

Center at (202) 720-2600 (voice and TDD).

To file a complaint of discrimination, write to USDA, Assistant Secretary for Civil Rights, Office of the Assistant 

Secretary for Civil Rights, 1400 Independence Avenue, S.W., Stop 9410, Washington, DC 20250-9410, or call tollfree at (866) 632-9992 (English) or (800) 877-8339 (TDD) or (866) 377-8642 (English Federal-relay) or (800) 845-

6136 (Spanish Federal-relay). USDA is an equal opportunity provider and employer.