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Infant Formula (IF) Grade Lactose for Dry Blending

Infant Formula (IF) Grade Lactose Standard for Dry Blending

v 3.1 | Effective 08/18/2023

Product Definition

Lactose (Milk Sugar) is a white to creamy white crystalline product, possessing a mildly sweet taste.  It may be anhydrous; contain one molecule of water of hydration; or may be a mixture of both forms.  It is manufactured from whey or permeate by evaporating, crystallizing, refining and then drying the lactose crystals.  Lactose for infant consumption complies with all provisions of the U.S. Federal Food, Drug, and Cosmetic Act as well as any foreign regulatory requirements of the nations in which it is consumed.

Standard: Printable PDF
Parameter Units of Measure Limits
Lactose %, dry basis 99.0 minimum
Protein %, dry basis 0.30 maximum
Ash (sulphated) %, dry basis 0.30 maximum
Total moisture (1) %, as-is basis 6.0 maximum

(1) Includes water of crystallization.

Mesh Size

IF Grade Lactose for Dry Blending can be milled to produce various mesh sizes.

Other Characteristics
Physico-chemical Properties
Parameter Units of Measure Limits
Scorched particles mg/25g 7.5 maximum
pH 10% solution 4.5 - 7.5
Aluminum (Al) mg/kg 1.00 maximum
Tin (Sn) mg/kg 10.00 maximum
Arsenic (As) mg/kg 0.05 maximum
Lead (Pb) mg/kg 0.02 maximum
Mercury (Hg) mg/kg 0.03 maximum
Manganese (Mn) mg/kg 0.20 maximum
Copper (Cu) mg/kg 2.00 maximum
Cadmium (Cd) mg/kg 0.02 maximum
Nitrites mg/kg 2 maximum
Nitrates mg/kg 50 maximum
Aflatoxin M1 µg/kg not detected (2)
Quaternary ammonium compounds (BAC & DDAC) µg/kg 10 maximum
Radionuclides Bq/kg 50 maximum
Nonylphenol ethoxylate (NPE) µg/kg 50 maximum
Color visual white to cream white powder
Flavor sensory slightly sweet

(2) Where the effective limit of quantitation for the test is 0.1 µg/kg (ppb) then the test result must be not detected in order to comply with this Standard.  Where the testing method is capable of quantifying the toxin below 0.1 µg/kg (ppb), then a compliant result must be a value less than 0.1 µg/kg (ppb).

Microbiological Analysis

Any microbiological test result, outside of specification throughout a given lot of production, eliminates all product from that lot as IF Grade Lactose for Dry Blending:

Parameter Units of Measure Limits
Standard plate count CFU/g 500 maximum
Yeast and mold CFU/g 10 maximum
Escherichia coli CFU/g not detected (3)
Enterobacteriaceae CFU/100g not detected
Salmonella CFU/1500g not detected
Staphylococcus (coagulase positive) CFU/g not detected (3)
Bacillus cereus CFU/g 100 maximum
Clostridia (sulfite-reducing) CFU/g 100 maximum
Cronobacter sakazakii CFU/300g not detected

(3) Where the effective limit of quantitation for the test is 10 CFU/g (such as when a dilution factor of 10 is applied) then the test result must be not detected in order to comply with this Standard.  Where the testing method is capable of quantifying microbial counts below 10 CFU/g, then a compliant result must be a value less than 10 CFU/g.

Methods of Analysis
Criteria Reference Method
Lactose ISO 22662/IDF 198
Protein AOAC 991.20 (N x 6.38)
Moisture ISO 5537/IDF 26
Ash AOAC 942.05
Metals ICP-AES
Standard plate count AOAC
Yeast & mold AOAC
Escherichia coli AOAC
Enterobacteriaceae ISO 21528
Salmonella AOAC or FDA BAM
Staphylococcus AOAC
Bacillus cereus FDA BAM
Clostridia ISO 15213
Cronobacter sakazakii ISO 22964
Product Labeling

Recommended identifications: Lactose or Milk Sugar

Infant Formula Grade Lactose for Dry Blending is specifically suited for use in infant formula manufacturing processes where ingredients are combined “as is” (dry) rather than via rehydration.

Product should be stored, shipped, and utilized according to the manufacturer’s established recommendations.  As guidance, product should be stored and shipped in a cool, dry environment with temperature below 80°F and relative humidity below 65%.  Stocks should be rotated and utilized in accordance with the manufacturer’s established date of expiration or retest.

Multiwall kraft bags with polyolefin inner liner, or other suitable closed containers (e.g., totes) are typical.

Additional Resources

Additional resources including the Dried Dairy Ingredients Handbook and more are available for ADPI members. Click the button to log-in to access these resources.

In no event shall ADPI be liable for any direct, indirect, incidental, special, exemplary, or consequential damages (including, but not limited to: the need to procure substitute goods or services; loss of use, data, or profits; or business interruption) however caused and on any theory of liability, whether in contract, strict liability, or tort (including negligence or otherwise) arising in any way out of the publication, use of, or reliance upon any standard, even if advised of the possibility of such damage and regardless of whether such damage was foreseeable.



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