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ALG-004 / 2.0

Milk allergy and preparation evidence

A new profile separating milk clinical recommendations from quality of an individual laboratory preparation.

Collection and scientific editing: Stasinos Chr. SikaliasContent edition: 2.0Record editorial review date: 2026-10-14

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Clinical-evidence scope

EAACI suggests milk OIT in selected children, generally above four years, and adolescents, under a clinical team experienced in treatment and anaphylaxis. The intended outcome is desensitisation. The recommendation does not define a local formula, process or dating.

Different materials

Liquid milk, milk powder, protein fractions and differently heat-treated products are not identical materials. Absence of lactose does not establish absence of milk proteins. The clinical order must identify exact material and strength basis.

Required technical assessment

Require identity, lot, transport conditions, analytical concentration in the matrix, uniformity, microbiology and packaging. A food’s dating does not automatically transfer to a differently diluted compounded product. This source profile assigns neither recipe nor BUD.

Caseins, whey and heat-processed matrix

The primary study by Bloom and colleagues (2014) found different heating behaviour for caseins and whey proteins and an effect of wheat matrix on IgE binding. A total-protein value or a heat treatment therefore does not uniformly describe all milk allergens. Justify the relevant analytes for the exact material.

Analytical detection and BUD

Bermingham and colleagues (2026) found differences in allergen detection after baking and by sampling location. They did not measure BUD or this milk preparation. The technical application is suitable extraction and representative sampling; reduced ELISA signal does not establish zero clinical activity. Powder aw or unopened milk expiry does not establish dating of a reconstituted/diluted matrix.

Sources and references

  1. Santos AF et al. EAACI guidelines on the management of IgE-mediated food allergyAllergy. 2025;80:14–36; online 2024Recommendations 8, 9, 12 and 13; desensitisation versus remission/continued treatmentSpecialist clinical recommendations; not stability evidence for local syrups or suspensions2026-10-14
  2. EMA — Guideline on Allergen Products: Production and Quality IssuesEMEA/CHMP/BWP/304831/2007; adopted 20 November 2008; effective 20 May 2009; remains current effective quality version on EMASections 2, 4.1.1, 4.2.4.4, 4.4.3–4.4.5; document pp. 4–13Industrial biological-allergen quality guidance; principles adapted explicitly, not a compounding authorisation or a food-OIT recipe2026-10-14
  3. NIH NIDDK — Definition & Facts for Lactose IntoleranceReviewed February 2018; accessed 2026-09-12What is lactose intolerance?Lactose is milk sugar; lactose intolerance differs from immune-mediated milk allergy2026-09-12
  4. EMA — Guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populationsEMA/161669/2025; adopted 10 June 2025; effective 1 January 2026Sections 2, 4 and 4.1 (Type I allergy quality aspects); pp. 4–6; section 8.4 for food-allergy endpointsIndustrial allergen development and quality guidance; complements 2008 guideline. Section 4.2 Type IV patch-test exceptions are not transferred to food OIT.2026-10-14
  5. Bloom KA et al. Effect of heat treatment on milk and egg proteins allergenicityPediatr Allergy Immunol. 2014;25(8):740–746Author-institution abstract; PMID 25251921; DOI 10.1111/pai.12283Primary laboratory heat/matrix work with patient sera; not a dating study for a compounded liquid.2026-10-14
  6. Bermingham MD et al. Baking results in impaired detection of clinically relevant food allergensFront Allergy. 2026;7:1796342; published 21 May 2026Methods 2.1–2.2; Results 3.1–3.2; Discussion (analytical detection versus clinical reactivity); DOI 10.3389/falgy.2026.1796342Primary model-biscuit immunoassay study. Supports extraction/sampling caution; clinical reactivity differences and BUD were not established.2026-10-14
  7. USP — Compounding Standards and Beyond-Use Dates, 2022 updateNovember 2022, published by USP; public copy hosted by Mississippi Boardpp. 1–2; nonsterile tableRisk-based default categories; not product-specific stability or Greek law2026-10-14