An in vitro protocol to characterise the resistance of food proteins to intestinal digestion.

In vitro digestion tests provide data on the form in which dietary proteins maybe presented to the gut mucosal immune system, one of many strands of evidence used in allergenicity risk assessment. A 96-well plate format in vitro intestinal digestion protocol has been developed with a high and low enzyme activity test executed at pH 6.5 and 8.

Assessing protein digestibility in allergenicity risk assessment: A comparison of in silico and high throughput in vitro gastric digestion assays.

The susceptibility of a novel food protein to digestion in the pepsin resistance test is widely used to inform the allergenicity risk assessment process. However, it does not model the variation in the intragastric environment found in vivo. Consequently a 96-well plate format in vitro gastric digestion protocol has been developed with a high and low pepsin activity test executed at pH 1.

Can we define a level of protection for allergic consumers that everyone can accept?

Substantial progress has been made in characterising the risk associated with exposure to allergens in food. However, absence of agreement on what risk is tolerable has made it difficult to set quantitative limits to manage that risk and protect allergic consumers effectively. This paper reviews scientific progress in the area and the diverse status of allergen management approaches and lack of common standards across different jurisdictions, including within the EU.

Deriving individual threshold doses from clinical food challenge data for population risk assessment of food allergens.

Background: Food allergies are a significant public health issue, and the only effective management option currently available is strict avoidance of all foods containing the allergen. In view of the practical impossibility of limiting risks to zero, quantitative allergen risk assessment and management strategies are needed.

Objective: We sought to develop appropriate methods for informing population-based risk assessments and risk management programs to benefit all stakeholders but particularly patients with food allergy.

Evidence-based approaches to the application of precautionary allergen labelling: Report from two iFAAM workshops.

Food allergy is a major public health concern with avoidance of the trigger food(s) being central to management by the patient. Food information legislation mandates the declaration of allergenic ingredients; however, the labelling of the unintentional presence of allergens is less defined. Precautionary allergen labelling (PAL) was introduced by the food industry to help manage and communicate the risk of reaction from the unintended presence of allergens in foods.

Sensitivity analysis to derive a food consumption point estimate for deterministic food allergy risk assessment.

One of the input parameters in food allergy risk assessment is the amount of a given food consumed at an eating occasion. There is no consensus on how to use food consumption data when assessing the risk from unintended allergen presence in food products. A sensitivity analysis was performed to establish the optimal food consumption estimate for a deterministic food allergy risk assessment.

Assessing food allergy risks from residual peanut protein in highly refined vegetable oil.

Refined vegetable oils including refined peanut oil are widely used in foods. Due to shared production processes, refined non-peanut vegetable oils can contain residual peanut proteins. We estimated the predicted number of allergic reactions to residual peanut proteins using probabilistic risk assessment applied to several scenarios involving food products made with vegetable oils.

Advances in the risk management of unintended presence of allergenic foods in manufactured food products--an overview.

Food allergy is a relatively recent newcomer to the ranks of food safety issues, only being effectively recognised as such in the last 25-30 years. This recognition, allied with the near impossibility of avoiding the unintended presence of small, yet potentially dangerous residues of allergenic constituents, brought with it the need to assess and manage the resulting risk. This paper provides an overview of the development and current knowledge and thinking on risk assessment and its application to risk management of food allergens.

Development and evolution of risk assessment for food allergens.

The need to assess the risk from food allergens derives directly from the need to manage effectively this food safety hazard. Work spanning the last two decades dispelled the initial thinking that food allergens were so unique that the risk they posed was not amenable to established risk assessment approaches and methodologies. Food allergens possess some unique characteristics, which make a simple safety assessment approach based on the establishment of absolute population thresholds inadequate.

Translating reference doses into allergen management practice: challenges for stakeholders.

Risk assessment describes the impact of a particular hazard as a function of dose and exposure. It forms the foundation of risk management and contributes to the overall decision-making process, but is not its endpoint. This paper outlines a risk analysis framework to underpin decision-making in the area of allergen cross-contact.

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.

Characteristics and purchasing behaviours of food-allergic consumers and those who buy food for them in Great Britain.

Background: Buying behaviours of food-allergic consumers can affect the risk they incur. An online survey was undertaken to understand the characteristics and buying behaviours of food-allergic consumers in Great Britain (GB) and people buying food for them.

Methods: Descriptive study of food-allergic individuals in GB and their buying behaviours, based on a survey of 500 food-allergic consumers and 500 people buying for allergic individuals.

Allergen reference doses for precautionary labeling (VITAL 2.0): clinical implications.

Background: There has been a dramatic proliferation of precautionary labeling by manufacturers to mitigate the perceived risk from low-level contamination from allergens in food. This has resulted in a significant reduction in choice of potentially safe foods for allergic consumers.

Objectives: We aimed to establish reference doses for 11 commonly allergenic foods to guide a rational approach by manufacturers based on all publically available valid oral food challenge data.

Quantification and partial characterization of the residual protein in fully and partially refined commercial soybean oils.

A method has been developed to determine residual protein in refined oils, a potential trigger of allergic reactions. High-pH bicarbonate or borate buffers were found to be the most effective extractants, residual oil protein comprising a mixture of proteins of M(r) 6000-100000. Extracted protein could be quantified with superior precision using 3-(4-carboxybenzoyl)quinolone-2-carboxaldehyde (CBQCA).

Threshold dose for peanut: Risk characterization based upon diagnostic oral challenge of a series of 286 peanut-allergic individuals.

Clinical records of 286 consecutive patients reacting positively with objective symptoms to double-blind, placebo-controlled oral peanut challenges at University Hospital, Nancy, France were examined for individual No Observed Adverse Effect Levels (NOAELs) and Lowest Observed Adverse Effect Levels (LOAELs). After fitting to a log-normal probability distribution model, the ED(10) and ED(05) were 14.4 and 7.

Threshold dose for peanut: risk characterization based upon published results from challenges of peanut-allergic individuals.

Population thresholds for peanut are unknown. However, lowest- and no-observed adverse effect levels (LOAELs and NOAELs) are published for an unknown number of peanut-allergic individuals. Publications were screened for LOAELs and NOAELs from blinded, low-dose oral challenges.