The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. Disclosure of potential conflict of interest: M. H. Shamji has received grants from ALK-Abell o, Regeneron, Merck, ASIT Biotech.sa, and the Immune Tolerance Network and has received personal fees from ASIT Biotech.sa, ALK-Abell o, Allergopharma, and UCB. E. N.

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Background There is increasing interest in the use of eliciting doses (EDs) to inform allergen risk management. The ED can be estimated from the distribution of threshold doses for allergic subjects undergoing food challenges within a specified population. Estimated ED05 values for cow's milk (the dose expected to cause objective allergic symptoms in 5% of the milk‐allergic population) range from 0.5 mg to 13.9 mg cow's milk protein. We undertook a single‐dose challenge study to validate a predicted ED05 for cow's milk of 0.5 mg protein. Methods Participants were recruited from 4 clinical centres. Predetermined criteria were used to identify patients reacting to 0.5 mg cow's milk protein (approximately 0.015 mL of fresh cow's milk). Children over 1 year underwent formal challenge to cow's milk to confirm clinical reactivity. Results 172 children (median age 6.0 (IQR 0.7‐11) years, 57% male) were included in this analysis. Twelve (7.0%, 95% CI 3.7%‐11.9%) children experienced objective symptoms that met the predetermined criteria. One participant had mild anaphylaxis that responded to a single dose of adrenaline, the remainder experienced only mild symptoms with no treatment required. We did not identify any baseline predictors of sensitization that were associated with objective reactivity to the single‐dose challenge using 0.5 mg cow's milk protein. Conclusions These data support an estimated ED05 for cow's milk of 0.5 mg protein. Values for ED05 above 0.5 mg for cow's milk protein proposed for allergen risk management need to be reviewed.

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