Egg allergy and preparation evidence · ALG-005 (ALG-005)

Clinical recommendation

EAACI suggests egg OIT in selected children, generally above four years, and adolescents in specialist care. This concerns desensitisation, not proven universal cure. Patient, product and regimen selection belong to the clinical team.

Identity and heat processing

Specify egg white, whole egg or an identified protein material, processing and lot. Baked, pasteurised and powdered products are not assumed equivalent. Heating or acceptable appearance does not establish zero allergenic activity.

Finished-matrix evidence

Actual dose delivery needs a suitable method, uniformity and compatible device. A study of another form or food does not establish preservation of the local product. Any proposed development follows OIT-001 through OIT-008 and an agreed stability plan. No recipe or numerical BUD is provided.

Primary matrix evidence

Liu and colleagues (2024) quantified ovalbumin and ovomucoid in different baked matrices and assessed IgE binding using patient sera. Flour or other ingredient changes altered extractable allergen amounts. Matrix substitution therefore cannot be accepted solely on equal egg mass or nutritional protein. This was not a study of a local product or its dating.

Stability and representative withdrawal

The additional 2026 analytical study confirms that baking may affect allergen detection unevenly within the same food. For product development, agree separate criteria for strength, actual-withdrawal uniformity and microbiological quality. Dry-powder aw and dating do not transfer to a reconstituted suspension. The dossier’s disposition is publication of evidence without a recipe or numerical BUD.

Sources and references

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
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
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
Liu EG et al. Food Matrix Composition Affects the Allergenicity of Baked Egg ProductsJ Allergy Clin Immunol Pract. 2024;12(8):2111–2117Abstract, figures 1–3; DOI 10.1016/j.jaip.2024.04.032Primary extractable ovalbumin/ovomucoid and IgE-binding study; no generic matrix equivalence or BUD.2026-10-14
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
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