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Lactose Standard

v 4.0 | Effective 06/07/2023

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 human consumption complies with all provisions of the U.S. Federal Food, Drug, and Cosmetic Act.

Standard: Printable PDF
Standard: Infant Formula Grade Lactose
Parameter Units of Measure Industrial/Fermentation Grade Lactose Edible (Food Grade) Lactose Refined Edible Grade Lactose
Lactose %, dry basis 98.0 minimum 99.0 minimum 99.50 minimum
Protein %, dry basis 1.0 maximum 0.30 maximum 0.15 maximum
Ash (phosphated) %, dry basis 0.45 maximum 0.30 maximum 0.20 maximum
Total moisture (1) %, as-is basis 6.0 maximum 6.0 maximum 6.0 maximum

(1) Includes water of crystallization.

Mesh Size

Edible Lactose is often sized through a combination of pulverizing and/or screening steps to yield a suitable particle size distribution.  Mesh size requirements are variable and are determined by the individual manufacturer and/or customer.

Product Sieve Sizes (Mesh) % Pass Through
40 mesh 40 80 minimum
100 mesh 100 80 minimum
200 mesh 200 80 minimum
Other Characteristics
Physico-chemical Properties
Parameter Units of Measure Limits
Scorched particles mg/25g 15.0 maximum
pH -- 4.5 - 7.5
Color visual white to pale yellow
Flavor sensory slightly sweet; free from offensive flavors
Physical appearance visual free of lumps that do not break up under slight pressure; free of foreign material
Microbiological Analysis
Parameter Units of Measure Limits
Standard plate count CFU/g 2,500 maximum
Coliforms (2) CFU/g 10 maximum
Enterobacteriaceae (2) CFU/g 10 maximum
Salmonella CFU/25g not detected
Staphylococcus (coagulase positive) CFU/g not detected (3)
Listeria genus CFU/g not detected

(2) The food industry is trending toward Enterobacteriaceae (“EB”) as the most commonly used category of indicator organisms for gauging general process sanitation.  For compliance with this Standard, either coliforms and/or EB shall be utilized, at the discretion of the manufacturer.

(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
Parameter Reference Method
Lactose ISO 22662 / IDF 198
Protein AOAC 991.20 (N x 6.38)
Moisture ISO 5537 / IDF 26
Ash AOAC 942.05
Microbiological tests FDA BAM
Product Labeling

Recommended identification: Lactose or Milk Sugar

Lactose applications include:  infant foods, chemicals/pharmaceuticals, dairy products, prepared dry mixes, bakery products, soft drinks, special dietary foods, confections, and others.

See the separate ADPI standard for Dry Blend Infant Formula (IF) Grade Lactose for additional requirements in that specific application.

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.

This product and its derivatives are capable of sweetening foods, influencing crystallization, adding viscosity, contributing to nutrition and enhancing flavors. Lactose itself has no aftertaste and has a clean mouthfeel.

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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