Standardization and Regulation of Allergen Products in the European Union

Immunologic/Diagnostic Tests in Allergy (M Chapman and A Pomés, Section Editors)
Part of the following topical collections:
  1. Topical Collection on Immunologic/Diagnostic Tests in Allergy


Product-specific standardization is of prime importance to ensure persistent quality, safety, and efficacy of allergen products. The regulatory framework in the EU has induced great advancements in the field in the last years although national implementation still remains heterogeneous. Scores of methods for quantification of individual allergen molecules are developed each year and also the challenging characterization of chemically modified allergen products is progressing. However, despite the unquestionable increase in knowledge and the subsequent improvements in control of quality parameters of allergen products, an important aim has not been reached yet, namely cross-product comparability. Still, comparison of allergen product potency, either based on total allergenic activity or individual allergen molecule content, is not possible due to a lack of standard reference preparations in conjunction with validated standard methods. This review aims at presenting the most recent developments in product-specific standardization as well as activities to facilitate cross-product comparability in the EU.


Allergen product Product-specific standardization Cross-product comparability Allergen quantification Allergoid characterization EU regulatory aspects 


Compliance with Ethical Standards

Conflict of Interest

Dr. Kaul reports non-financial support from European Academy of Allergy and Clinical Immunology and European Directorate for the Quality of Medicines and Health Care and grants from European Directorate for the Quality of Medicines and Health Care.

Dr. Vieths reports personal fees from the Food Allergy Resource and Research Program, Lincoln, NE, USA, personal fees from the Medical University of Vienna, Austria, grants from the Monsanto Company, personal fees from the American Academy of Asthma, Allergy and Immunology, personal fees from the Deutsche Dermatologische Gesellschaft, personal fees from the Westdeutsche Arbeitsgemeinschaft für pädiatrische Pneumologie und Allergologie e.V., Köln, Germany, personal fees from the Gesellschaft für pädiatrische Allergologie und Umweltmedizin, personal fees from the Ärzteverband Deutscher Allergologen, personal fees from the Swiss Society for Allergy and Immunology, personal fees from the Schattauer Allergologie Handbuch, personal fees from the Elsevier Nahrungsmittelaller-gien und Intoleranzen, personal fees from the Karger Food Allergy: Molecular Basis and Clinical Practice, and non-financial support from the German Research Foundation, from the Federal Institute for Risk Assessment, from the European Directorate for the Quality of Medicines and Health Care, from the European Academy of Allergy and Clinical Immunology , from the Deutscher Allergie- und Asthmabund, from the Association Monégasque pour le Perfectionnement des Connaissances des Médicins, from the Federal Office of Consumer Protection and Food Safety , from the German Chemical Society (GDCh), from the AKM Allergiekongress, and from the International Union of Immunological Societies. Dr. Vieths also reports grants from the European Directorate for the Quality of Medicines and Health Care.

Dr. Zimmer reports grants from the European Directorate for the Quality of Medicines and Health Care.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.


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Copyright information

© Springer Science+Business Media New York 2016

Authors and Affiliations

  1. 1.Division of AllergologyPaul-Ehrlich-InstitutLangenGermany

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