By Allergen Bureau

Protecting the population: food allergen risk assessment using individual threshold dose data

Accurate food allergen labelling relies on evidence-based risk assessment. This process helps predict whether or not the amount of an allergen that may be present in a product due to cross-contact could pose a danger to someone with food allergy. New work has been published that describes the use of individual food allergen threshold dose data to assess risk for whole populations.

Food allergen threshold doses are ideally determined through double-blind, placebo-controlled food challenges (DBPCFCs). However, enough data are not always available from such ‘gold standard’ trials. Threshold dose data – collected from ‘open’ food challenges performed on food allergic individuals in an allergy clinic – are more widely available. When collected and used correctly, this information can also be used in assessing risk for the wider population.

The Netherlands Organisation for Applied Scientific Research (TNO) and The Food Allergy Research and Resource Program (FARRP) at the University of Nebraska have worked together since 2011 to devise standard methodology for collecting individual maximum tolerable doses and minimum eliciting doses from ‘open’ food challenges.

Through applying their methodology, TNO and FARRP have created a joint Food Allergen Threshold Database. This has been used to create a model-based prediction of population-based threshold dose distributions for different food allergens.

When applying the model to each allergen, relevant datasets (from 60 or more patients is ideal) map the estimated population-based threshold dose distribution. By segmenting the data, this model could be used to assess risk in certain subpopulations, such as specific ethnic groups, geographic regions, or in children versus adults.

This work is helping to generate risk assessment data for specific allergens where threshold dose data has been limited, such as many of the tree nuts, and lupin. The collaborating researchers behind the work hope their methods and models will promote global standardisation of collection and use of data for risk assessment. This will help bring greater choice and safety for food allergic consumers who rely on accurate allergen labelling

Reference: Westerhout et al. 2019 Journal of Allergy and Clinical Immunology. Doi: 10.1016/j.jaci.2019.07.046

The results of this work are utilised within the 2019 VITAL Scientific Expert Panel Recommendations that are implemented in the VITAL Program Version 3.0, as reported in the September 2019 Allergen Bureau eNews.