Symptoms at population Eliciting Doses ≤ED05 for 11 priority allergenic foods are mild to moderate.

Insight into symptoms at low doses of protein from priority allergenic foods may support decision making and acceptance of harmonized reference doses for Precautionary Allergen Labeling (PAL). Symptoms were extracted from double-blind placebo-controlled food challenges underlying the full range Eliciting Dose (ED) distributions (Houben et al., 2020). Frequency and severity were analyzed at and below doses to which a maximum 10% of the allergic population is predicted to respond with objective symptoms (ED10). Detailed symptom descriptions at every dose were recorded for 1102 food challenges with 11 allergenic foods. At doses ≤ ED10, generally, 1 to 2 symptoms, either objective or subjective, occurred per positive challenge (average 1.8 ± 1.2, range 1-8). Symptoms were mostly (68%) subjective of nature. Most objective symptoms were in the skin (60-71%; e.g. flush, erythema), followed by eyes/nose and oral cavity (rhinorrhea, red eyes, lip swelling). Far less symptoms (approx. 5-8%) occurred in the gastrointestinal (vomiting) and respiratory tract (cough). Symptoms were graded mild to moderate, except for 2 cases of a severe symptom (wheeze, laryngeal edema), which occurred at a dose above the ED05 (approximately the ED08). Exposure ≤ ED05 of priority allergenic foods resulted only in mild to moderate symptoms in a small proportion of the allergic population.