Lactose

Lactose is not one interchangeable powder. Food-grade lactose may be anhydrous, contain one molecule of crystallisation water, or be a mixture of both forms, while pharmaceutical, infant-formula and other controlled uses need their own applicable specifications. Atlas fixes grade and intended use, hydrate form, source stream, purity basis, moisture or loss on drying, ash, pH, microbiological and contaminant evidence, package, lot, origin and delivery terms before comparing offers.

Editorial evidence reviewedReviewed 2026-09-16Release 2026-09-19-batch-230
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Latest reviewed evidence

Codex CXS 212-1999 defines food lactose as a natural milk constituent normally obtained from whey with at least 99.0 percent anhydrous lactose on a dry basis. Its voluntary commercial annex lists sulphated ash no more than 0.3 percent dry basis, loss on drying no more than 6.0 percent and pH 4.5 to 7.0. CXS 234-1999 names methods for anhydrous lactose, loss on drying, pH and sulphated ash. These are standard boundaries and methods, not lot results, current supply or a live physical price.

Codex food-lactose anhydrous content floor
99
percent mass by mass, minimum on dry basis · CXS 212-1999 amended 2022
Codex lactose sulphated-ash ceiling
0.3
percent mass by mass, maximum on dry basis · CXS 212-1999 voluntary commercial annex
Codex lactose loss-on-drying ceiling
6
percent mass by mass, maximum · CXS 212-1999 voluntary commercial annex
Codex lactose pH lower bound
4.5
pH in 10 percent mass-by-mass solution · CXS 212-1999 voluntary commercial annex
Codex lactose pH upper bound
7
pH in 10 percent mass-by-mass solution · CXS 212-1999 voluntary commercial annex

Anhydrous, monohydrate and mixed-form lactose stay explicit

Codex describes lactose as anhydrous, containing one molecule of water of crystallisation, or a mixture of both forms. The hydrate form changes the relationship between as-is mass and anhydrous-lactose content. Atlas therefore retains the declared form, assay basis, water or loss-on-drying result and method rather than treating every lactose powder or assay percentage as directly comparable.

Food, pharmaceutical and controlled-use grades are separate scopes

CXS 212-1999 applies to sugars intended for human consumption without further processing, including ingredients in food. It does not establish pharmaceutical-compendial conformance, infant-formula suitability or a buyer's functional grade. Atlas records intended use, governing specification and edition, regulatory market, allergen and milk-origin declaration, manufacturing and quality certifications, microbiological and contaminant criteria, and claim disposition. A food-standard result cannot be relabelled as pharmaceutical grade.

Purity, drying loss, ash and pH require named methods

Codex CXS 234 identifies ICUMSA titrimetry for anhydrous lactose, USP General Chapter 731 gravimetry at 120 degrees Celsius for 16 hours for loss on drying, ICUMSA potentiometry for pH and ISO 5809 for sulphated ash. Atlas keeps the analyte, method and edition, basis, sample and lot, laboratory, result, uncertainty or reporting limit where relevant, certificate and test date together. A certificate value detached from method and lot does not verify another shipment.

A compositional standard does not establish a delivered lactose price

Codex identity and composition limits do not establish mesh or particle-size distribution, flow, colour, solubility, microbiological status, source-plant approval, present availability, transaction value, freight or destination cost for a current lot. A delivered comparison still needs permitted current observations for the exact grade, hydrate form and use, specification and test evidence, package, origin, quantity, currency, Incoterm, destination, delivery window, route costs and information vintage. Atlas withholds a physical estimate when those observations or usage rights are missing.

Questions procurement teams ask

Are lactose monohydrate and anhydrous lactose the same trade form?

No. Codex allows anhydrous lactose, lactose with one molecule of crystallisation water, or a mixture, but the form and analytical basis must remain attached to the lot.

Does 99 percent lactose mean 99 percent as received?

Not under the Codex identity statement. The 99.0-percent minimum is anhydrous lactose content on a dry basis. Atlas preserves both the assay basis and the water or loss-on-drying result.

Does food-grade evidence prove pharmaceutical-grade conformance?

No. CXS 212-1999 covers food use. Pharmaceutical or another controlled use requires the applicable separate specification, edition, test methods and lot certificate.

Which fields make lactose offers comparable?

Grade and intended use, anhydrous, monohydrate or mixed form, source stream, anhydrous assay and basis, water or loss on drying, ash, pH, particle size and functional fields where specified, microbiological and contaminant evidence, allergen and origin declaration, method, package and lot, quantity, currency, Incoterm, destination, delivery window and evidence date.

Sources and provenance

Figures retain their source, period and review date. Corroboration is not promoted to primary evidence.

CXS 212-1999 — Standard for Sugars
Codex Alimentarius Commission, FAO/WHO · Primary Codex standard, amended through 2022, defining food-lactose identity and its voluntary commercial composition factors; it is not pharmaceutical scope or a lot certificate · accessed 2026-09-16
CXS 234-1999 — Recommended Methods of Analysis and Sampling
Codex Alimentarius Commission, FAO/WHO · Primary Codex methods register naming methods for anhydrous lactose, loss on drying, pH and sulphated ash; method listing does not prove a lot was sampled or tested · accessed 2026-09-16
Directive 2001/114/EC — Certain partly or wholly dehydrated preserved milk for human consumption
European Union, EUR-Lex · Primary consolidated EU legal text repeating the 99.0-percent dry-basis lactose identity in its defined context; it is not a universal grade or lot result · accessed 2026-09-16
Dairy Plants Surveyed and Approved for USDA Grading Service
United States Department of Agriculture, Agricultural Marketing Service · Primary USDA list dated September 1, 2026 identifying W5 Lactose as eligible for grading or inspection at approved operations while warning that plant approval alone is not product-quality endorsement · accessed 2026-09-16
Codex Committee on Sugars — Related Standards
Codex Alimentarius Commission, FAO/WHO · Primary Codex register confirming CXS 212-1999 and its 2022 modification status; a standards register is not shipment evidence · accessed 2026-09-16
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