BACKGROUND: Precautionary labeling is used to warn consumers of the presence of unintended allergens, but the lack of agreed allergen thresholds can result in confusion and risk taking by patients with food allergy. The lack of data on threshold doses below which subjects are unlikely to react is preventing the development of evidence-based allergen management strategies that are understood by clinician and patient alike. OBJECTIVE: We sought to define threshold dose distributions for 5 major allergenic foods in the European population. METHODS: Patients with food allergy were drawn from the EuroPrevall birth cohort, community surveys, and outpatient clinic studies and invited to undergo a food challenge. Low-dose, double-blind, placebo-controlled food challenges were undertaken with commercially available food ingredients (peanut, hazelnut, celery, fish, and shrimp) blinded into common matrices. Dose distributions were modeled by using interval-censoring survival analysis with 3 parametric approaches. RESULTS: Of the 5 foods used for challenge, 4 produced similar dose distributions, with estimated doses eliciting reactions in 10% of the allergic population (ED10), ranging from 1.6 to 10.1 mg of protein for hazelnut, peanut, and celery with overlapping 95% CIs. ED10 values for fish were somewhat higher (27.3 mg of protein), although the CIs were wide and overlapping between fish and plant foods. Shrimp provided radically different dose distributions, with an ED10 value of 2.5 g of protein. CONCLUSION: This evidence base will contribute to the development of reference doses and action levels for allergens in foods below which only the most sensitive subjects might react.

Allergy Department 2nd Pediatric Clinic University of Athens Athens Greece

Allergy Department Hospital Clinico San Carlos IdISSC Madrid Spain

Allergy Unit Department of Dermatology University Hospital Zurich Zurich Switzerland

Ambulatorio di Allergologia Clinica San Carlo Paderno Dugnano Milan Italy

Chest Clinics Allergology and Radiology Medical Faculty Vilnius University Vilnius Lithuania

Chest Disease Department University Hospital Federation of Translational Medicine University of Strasbourg Strasbourg France

Children's Hospital Iceland Landspitali University Hospital Reykjavik Iceland

Department of Experimental Immunology and Department of Otorhinolaryngology Academic Medical Center University of Amsterdam Amsterdam The Netherlands

Department of Immunology Rheumatology and Allergy Medical University of Lodz Lodz Poland

Department of Paediatric Pneumology and Immunology Charité University Medical Center Berlin Germany

Department of Pediatric Respiratory Medicine and Allergy Emma Children's Hospital Academic Medical Center University of Amsterdam Amsterdam The Netherlands

Faculty Hospital Bulovka Department of Pediatrics Prague Czech Republic

Human Development and Health Academic Unit University of Southampton Faculty of Medicine Southampton United Kingdom

Institute of Food Research Norwich Research Park Colney Norwich United Kingdom

Institute of Food Research Norwich Research Park Colney Norwich United Kingdom; Institute of Inflammation and Repair Manchester Academic Health Science Centre Manchester Institute of Biotechnology University of Manchester Manchester United Kingdom

Institute of Population Health University of Manchester Manchester United Kingdom

Medical University Clinical Centre of Allergology of the Alexandrovska Hospital Sofia Bulgaria

Paul Ehrlich Institute Langen Germany

Unilever Safety and Environmental Assurance Centre Colworth Science Park Sharnbrook United Kingdom

University College Cork Cork Ireland

University Medical Center Utrecht Department of Dermatology Allergology Utrecht The Netherlands

J Allergy Clin Immunol. 2016 Mar;137(3):967. doi: 10.1016/j.jaci.2015.09.046. PubMed

J Allergy Clin Immunol. 2016 Mar;137(3):967-9. doi: 10.1016/j.jaci.2015.09.045. PubMed

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