Thresholds or 'How Much Is Too Much?'

Thresholds for allergenic foods constitute a key element in characterizing the hazard and assessing the risk to allergic consumers from those foods. Threshold determination for key allergenic foods in Europe was identified as a major element and deliverable in the EuroPrevall work program. The value of this work was based on the twin foundations of value to the individual patient and the use of threshold data to improve risk management of allergenic foods. This chapter will discuss the results of EuroPrevall and analyze them from a public health perspective, linking them to preexisting data and discussing proposals for their use in risk assessment. It will also identify remaining data gaps and suggest how they may be addressed

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. Variables considered were: a) the estimated production scale of refined peanut oil, b) estimated cross-contact between refined vegetable oils during production, c) the proportion of fat in representative food products and d) the peanut protein concentration in refined peanut oil. For all products examined the predicted risk of objective allergic reactions in peanut-allergic users of the food products was extremely low. The number of predicted reactions ranged depending on the model from a high of 3 per 1000 eating occasions (Weibull) to no reactions (LogNormal). Significantly, all reactions were predicted for allergen intakes well below the amounts reported for the most sensitive individual described in the clinical literature. We conclude that the health risk from cross-contact between vegetable oils and refined peanut oil is negligible. None of the food products would warrant precautionary labelling for peanut according to the VITAL® programme of the Allergen Bureau. © 2017 Elsevier Lt

The prevalence, cost and basis of food allergy across Europe

Abstract The development of effective management strategies to optimize the quality of life for allergic patients is currently hampered by a lack of good quality information. Estimates of how many individuals suffer from food allergy and the major foods involved vary widely and inadequacies of in vitro diagnostics make food challenges the only reliable means of diagnosis in many instances. The EuroPrevall project brings together a multidisciplinary partnership to address these issues. Cohorts spanning the main climatic regions of Europe are being developed in infants through a birth cohort, community surveys in school-age children and adults and an outpatient clinic study. Confirmatory double-blind placebo-controlled food challenge diagnosis is being undertaken using foods as they are eaten with titrated doses to allow no-effect and lowest-observable effect levels for allergenic foods to be determined. The cohorts will also facilitate validation of novel in vitro diagnostics through the development of the EuroPrevall Serum Bank. Complementary studies in Ghana, western Siberia, India and China will allow us to gain insights into how different dietary patterns and exposure to microorganisms affect food allergies. New instruments to assess the socioeconomic impact of food allergy are being developed in the project and their application in the clinical cohorts will allow, for the first time, an assessment to be made of the burden this disease places on allergy sufferers and their communities. IgE-mediated food allergy is a disease affecting all age groups and because the only treatment is still avoidance (1), it changes quality of life in a profoundly negative way (2). Allergy sufferers have to deal with disbelief about their condition and face difficulties in managing their social life. Patients¿ (or allergic children¿s parents¿) anxiety about severe reactions can lead to social isolation and mental health problems (3). Everyday activities become complicated, requiring forethought and preparation, even extending to the need for special diets during hospitalization. Clear food labelling regarding food allergens is essential to help allergic consumers manage their condition, although precautionary labelling can lead to unnecessary restrictions (4). Such social problems are compounded by the fact that, whilst knowledge of the diagnosis and treatment of food allergy by health professionals and dieticians should be standard, it is frequently inadequate (5). The majority of food allergies are IgE-mediated, but sensitization to a specific food does not always lead to clinical reactivity. Consequently serological tests for food-specific IgE cannot be used alone for diagnosis. As a consequence of inadequate diagnostic procedures, food allergy is sometimes over-diagnosed (6). On the other hand, food allergy is also often not recognized or incorrectly treated. Therefore, patients still leave the hospital without either a prescription for self-injectable adrenaline or even referral to an allergy specialist after treatment for acute anaphylaxis (7). Within this context it is the objective of the EU-funded integrated project EuroPrevall (http://www.europrevall.org) to deliver the information and tools necessary for policy makers, regulators, clinicians and allergic consumers, together with the food industry, to effectively manage food allergies and the allergens that cause them. This is being undertaken in a pan-European manner with a view of improving the quality of life of food allergic consumers. The project includes 56 partners from 21 different countries (from 19 European countries, Ghana, India and China) with additional collaborating centres and partners from the USA, Australia and New Zealand

Information provision for allergic consumers - where are we going with food allergen labelling?

As the current treatment for food allergy involves dietary exclusion of the problem food, information for food-allergic consumers provided on food labels about the nature of allergenic ingredients is important to the management of their condition. The members of an EU-funded networking project, InformAll, focusing on developing strategies for the provision of credible, reliable sources of information for food allergy sufferers, regulators and the food industry, have been considering these matters with respect to food labelling. This paper presents an overview of the genesis of the new EU directive on food labelling, its relevance to food-allergic consumers and the problems that might arise if precautionary labelling becomes more widespread in response to concerns regarding inadvertent allergen contamination in foods. International efforts to define threshold levels of allergens able to trigger a reaction coupled with validated allergen detection methods are essential if the food industry is to implement effective hazard control procedures and address the problems of cross-contact allergens without devaluing the information provided to consumers on food labels

Allergenicity assessment of new or modified protein-containing food sources and ingredients

The growing world population, changing dietary habits, and increasing pressure on agricultural resources are drivers for the development of novel foods (including new protein sources as well as existing protein sources that are produced or used in an alternative way or in a different concentration). These changes, coupled with consumer inclination to adopt new dietary trends, may heighten the intake of unfamiliar proteins, or escalate consumption of specific ones, potentially amplifying the prevalence of known and undiscovered food allergies. Assessing the allergenicity of novel or modified protein-based foods encounters several challenges, including uncertainty surrounding acceptable risks and assessment criteria for determining safety. Moreover, the available methodological tools for gathering supportive data exhibit significant gaps. This paper synthesises these challenges, addressing the varied interpretations of "safe" across jurisdictions and societal attitudes towards allergenic risk. It proposes a comprehensive two-part framework for allergenicity assessment: the first part emphasises systematic consideration of knowledge and data requirements, while the second part proposes the application of a generic assessment approach, integrating a Threshold of Allergological Concern. This combined framework highlights areas that require attention to bridge knowledge and data gaps, and it delineates research priorities for its development and implementation

Approaches to risk assessment in food allergy:Report from a workshop ''developing a framework for assessing the risk from allergenic foods"

A workshop was organised to investigate whether risk assessment strategies and methodologies used in classical/conventional toxicology may be used for risk assessment of allergenic foods, to discuss the advantages and limitations of different approaches and to determine the research needed to move the area forward. Three possible approaches to safety assessment and risk assessment for allergenic foods were presented and discussed: safety assessment using NOAEL/LOAEL and uncertainty factors, safety assessment using Benchmark Dose and Margin of Exposure (MoE), and risk assessment using probabilistic models. The workshop concluded that all the three approaches to safety and risk assessment of allergenic foods should continue to be considered. A particular strength of the MoE and probabilistic approaches is that they do not rely on low-dose extrapolations with its inherent issues. Probabilistic modelling is considered to be the most promising approach for use in population risk assessment (which is a particular focus for risk managers). For all approaches, further improvement of input data is desirable, particularly data on consumption patterns/food choices in food allergic consumers, data on minimum eliciting doses and data that can be used to evaluate whether the whole population at risk has been modelled accurately. Specific research topics were identified. © 2008 Elsevier Ltd. All rights reserved

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 Author