Approaches to assess IgE mediated allergy risks (sensitization and cross-reactivity) from new or modified dietary proteins

The development and introduction of new dietary protein sources has the potential to improve food supply sustainability. Understanding the potential allergenicity of these new or modified proteins is crucial to ensure protection of public health. Exposure to new proteins may result in de novo sensitization, with or without clinical allergy, or clinical reactions through cross-reactivity. In this paper we review the potential of current methodologies (in silico, in vitro degradation, in vitro IgE binding, animal models and clinical studies) to address these outcomes for risk assessment purposes for new proteins, and especially to identify and characterise the risk of sensitization for IgE mediated allergy from oral exposure. Existing tools and tests are capable of assessing potential crossreactivity. However, there are few possibilities to assess the hazard due to de novo sensitization. The only methods available are in vivo models, but many limitations exist to use them for assessing risk. We conclude that there is a need to understand which criteria adequately define allergenicity for risk assessment purposes, and from these criteria develop a more suitable battery of tests to distinguish between proteins of high and low allergenicity, which can then be applied to assess new proteins with unknown risks. © 2017 The Authors Chemicals/CAS: immunoglobulin E, 37341-29-

Food allergy population thresholds: an evaluation of the dosing scheme and number of oral food challenges on the accuracy of threshold dose studies

The availability of clinically established DBPCFC minimal eliciting doses determined in food-allergic individuals is increasing and previous work has shown these data can be used to determine population based reference doses for allergen risk management. Despite the large amount of data for peanut, milk, egg and hazelnut, EU and US public health authorities have not established population thresholds for any of the allergenic foods. In the absence of regulatory guidance regarding thresholds, food producers have attempted to manage risk through the widespread application of precautionary “may contain” labelling. In turn, food-allergic consumer quality-of-life has decreased and some food-allergic individuals are ignoring these advisory statements

Quantitative risk assessment of UK food products cross-contaminated with allergens

Allergens in food pose a risk to allergic consumers, especially if they are present in food without declaration or warning. While there is EU regulation for allergens present as an ingredient, this is not the case for unintended allergen presence (UAP). Food companies use precautionary “may contain” labels to inform allergic individuals of a potential risk from UAPs. However, the use or absence of precautionary label has a limited correlation with the level of UAP and consequently the risk of an unexpected allergic reaction. Allergen risk assessment using probabilistic techniques enables estimation of the residual risk after the consumption of a product that unintendedly contains an allergen

A procedure for grouping food consumption data for use in food allergen risk assessment

Food allergic subjects need to avoid the allergenic food that triggers their allergy. However, foods can also contain unintended allergens. Food manufacturers or authorities need to perform a risk assessment to be able to decide if unintended allergen presence constitutes a risk to food allergic consumers. One of the input parameters in risk assessment is the amount of a given food consumed in a meal. There has been little emphasis on how food consumption data can be used in food allergen risk assessment. The aim of the study was to organize the complex datasets from National Food Consumption Surveys from different countries (France, Netherlands and Denmark) to be manageable in food allergen risk assessment. To do this, a two-step method was developed. First, based on initial groups of similar food items, the homogeneity of consumption was evaluated using a customized clustering method. Then, the risk was calculated for each initial food group and its subgroups to verify if it also represents a relevant difference in risk. Forty-eight food groups were designated in Denmark (53 in the Netherlands, 54 in France). Finally, summary statistics and names for each food group for the Danish data illustrate the results when applying the procedure. © 2017 Elsevier Inc

Establishment of Reference Doses for residues of allergenic foods: report of the VITAL Expert Panel.

In 2011, an expert panel was assembled to establish appropriate Reference Doses for allergenic food residues as a part of the VITAL (Voluntary Incidental Trace Allergen Labeling) program of The Allergen Bureau of Australia & New Zealand (ABA). These Reference Doses would guide advisory labeling decisions for use on food labels. Individual NOAELs and LOAELs were obtained from clinical challenges of food-allergic subjects. Statistical dose-distribution models (log-normal, log-logistic, Weibull) were applied to the individual NOAELs and LOAELs for each allergenic food. The Reference Doses, in terms of mg of total protein from the allergenic food, were based upon either the ED01 (for peanut, cow's milk), the 95% lower confidence interval of the ED05 (for wheat, soybean, cashew, shrimp, sesame seed, mustard, and lupine), or both (egg, hazelnut) using all appropriate statistical dose-distribution models. Reference Doses were established for 11 allergenic foods ranging from 0.03mg for egg protein to 10mg for shrimp protein. Reference Doses were not established for fish or celery due to poor model fits with existing data. Reference Doses were not established for other tree nuts beyond hazelnut and cashew because of the absence of data on NOAELs and LOAELs from individual subjects. © 2013 Elsevier Ltd