v 4.0 | Effective 06/07/2023
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
|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.
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|
|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|
|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|
|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
|Lactose||ISO 22662 / IDF 198|
|Protein||AOAC 991.20 (N x 6.38)|
|Moisture||ISO 5537 / IDF 26|
|Microbiological tests||FDA BAM|
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 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.