Food Allergy Task Force

Background

Adverse reactions (among which allergies) to food continue to be of growing concern to both consumers and to the food industry. Liability and recall issues as well as recent changes to labelling laws have a significant impact on the way food manufacturers develop and process their products.

Objectives

The Food Allergy Task Force (TF) aims to generate expert stakeholder consensus on science-based approaches, data requirements and interpretation of data in the fields of food allergen risk assessment and management.

The specific objectives of its current activities are to:

• Improve the scientific knowledge on eliciting doses for allergenic foods, as a basis for establishing thresholds that provide a high level of protection for allergic consumers while remaining achievable for the manufacturer;
• Develop and validate scientific criteria for identifying allergenic foods of public health importance;
• Develop a framework to improve the risk assessment process for food allergens by providing evidence to support targeted, effective and appropriate risk management measures;
• Compile an inventory of allergic reactions registries and make recommendations to improve their usability as tools for risk management.

Impact

There is currently a lack of information for those involved in allergen risk management upon which to base decisions on issues such as: the extent of the risk posed by specific levels of cross contamination for the allergic consumer; what are the thresholds above which precautionary labelling should be used; what level of an allergen is low enough to substantiate a ‘free from’ claim. Setting such risk-based thresholds requires a clear scientific consensus on how to assess the risk of particular levels of allergens in foods. Therefore, the acceptance of how thresholds for allergens can be determined and used in risk assessment would be a major step forward.

Activities

Allergic Reactions Registries

Incidence of allergic reactions is crucial information for managing risks related to food allergies, for instance, to estimate the potential number of allergic reactions to be expected for defined levels of residual cross-contact allergen. Estimated frequency of reactions can be extrapolated from the low dose range of dose distribution curves obtained from controlled clinical challenges, but these estimations contain significant sources of errors. Knowledge of the incidence of allergic reactions in the exposed population is necessary to validate these extrapolations. In addition, data on incidences would provide essential feedback for the assessment of the effectiveness of allergen management practices and would be helpful to set priorities for allergen management.

Existing allergic reactions reporting systems (e.g. ‘Allergovigilance Network’ in France or 'The Food Allergy Register’ in Norway) generate valuable data in this context. The objective of this activity is to review these experiences and investigate their potential developments.

The activity aims at:

• Establishing what registries already exist and the type and quality of information they are producing, by compiling an inventory of existing food allergen registries, reviewing their inclusion and exclusion criteria, exploring their effectiveness, usability and potential for further development and identifying their strengths and limitations;
• Establishing the role such information could play in food allergen risk management; in particular, identifying specific requirements in this context and formulating recommendations on the setting up of a registry able to generate necessary information.

A European wide registry (ANA-EU) could provide a powerful tool to improve the management of severe allergic reactions from both a medical and a public health perspective. Analysis of existing registers regarding the type and quality of data being collected was used to develop a plan for a pan-European registry, including the type of system to be used, the range of data to be entered and the people able to enter and analyse such data. A manuscript that presents the results of the expert group will be submitted to a peer-reviewed journal. The task force is initiating a brainstorming process whereby the document will form the basis for a possible future EC-funded project submission.

Criteria for Identifying Allergenic Foods of Public Health Importance and their Practical Application

More than 160 foods have been reported as able to provoke more or less severe allergic reactions. In 1996, the FAO/WHO (Codex Alimentarius) defined a list of eight types of foods causing hypersensitivity reactions that should be labelled even if present at very low levels in the final product. The food types chosen were based on the expert opinions and the scientific knowledge of that time based on frequency of severe reactions and estimated prevalence of allergic reactions.

In 1998, an ILSI Europe Expert Group reviewed this Codex list and concluded that the selection of these foods was justified, as they were known to cause anaphylaxis and their allergenicity was proven by double-blind, placebo-controlled food challenges (DBPCFC). In the meantime, national and supranational food authorities (the EU, USA, Canada, Australia, Japan) have set up their own lists, sometimes including additional allergenic foods.

The importance of allergen lists is to prioritise allergen management, and therefore these lists should only include allergens the control of which is critical to public health. As the number of foods reported to cause severe reactions increases (as confirmed by DBPCFC), the need arises to reconsider and improve the criteria for the definition of allergenic foods critical for public health.

The aim of the Expert Group is to:

• Establish/reaffirm scientific criteria for identification of allergenic foods that may be critical for public health;
• Consider the appropriate weight of evidence for current data available for the criteria;
• Establish a framework to combine criteria and evidence to determine whether an allergenic food is critical for public health.

The Expert Group presented a draft paper and framework on the above at a Roundtable Workshop. The final paper, revised in light of these discussions, is entitled “Criteria for Identifying Allergenic Foods of Public Health Importance”, and was published in June 2008 in the Regulatory Pharmacology and Toxicology journal. It proposes a revised set of criteria, including clinical considerations (diagnosis, potency of allergen, severity of reactions), population elements (prevalence, exposure) and modulating factors (food processing). Data providing evidence for these criteria are weighted according to quality, using a ranking derived from evidence-based medicine.

The task force has now geared to the next step of the process: the application of the scientific criteria framework described in the paper. The objective is to rigorously test the framework and assess its practicability by applying it to the data available for some allergenic foods. The ILSI Research Foundation supports the related data collection and analysis exercise from clinical, experimental, epidemiological and food processing sources.

The contract to undertake the data collection was signed in September 2008 and the final report is expected. The expert group members may envisage to evaluate the results in a roundtable workshop, bringing together a broad spectrum of stakeholders, including risk managers from different sectors and geographical regions.

Determination of Minimum Eliciting Dose and Allergen Risk Assessment

A major issue in food allergy is whether one can define a dose below which no (or very few) allergic reactions occur – the so-called population minimum eliciting dose (MED) for a food allergen. The distribution of the ED within the food allergic population spans many orders of magnitude and it is difficult to predict which individuals will react to very low doses. In order to develop a sound scientific basis for protecting those individuals, tools are required to describe the population distribution of minimum eliciting doses. This would allow the development of a model to estimate the proportion of the allergic population who may react to any specified amount of a given allergen.

An Expert Group (EG) has defined a tool for allergen risk assessment. Despite significant differences between chemical toxicity and allergenicity, the general principles of the methodology for chemical risk assessment can be applied to allergens. The EG has published an article entitled ‘Hazard characterisation in food allergen risk assessment: the application of statistical approaches and the use of clinical data’ in Food and Chemical Toxicology. The paper reviews statistical approaches that contribute to allergen risk assessment and management.

Also published in May 2008, in Food and Chemical Toxicology, is an article entitled ‘Probabilistic risk assessment model for allergens in food: sensitivity analysis of the minimum eliciting dose and food consumption’. It uses probabilistic modelling of relevant parameters, such as population sensitivity and threshold doses, inadvertent consumption of food allergens, the amount of allergen in a portion of food and the amount of a food consumed, to show how the incidence of reactions in the population at risk can be predicted and which variables influence it most.

A final collated review, ‘Dealing with allergens in food: an approach based on risk analysis’, covers all the work of the EG in one comprehensive paper. It will be submitted for publication in February 2009 in Food and Chemical Toxicology.

Europrevall

The task force is a collaborating centre of the EC-funded project Europrevall – The Prevalence, Costs and Basis of Food Allergy across Europe. Europrevall is a multi-disciplinary integrated project coordinated by the Institute of Food Research, Norwich (UK). The aim is to characterise the prevalence of food allergy, determine minimum eliciting doses (thresholds) for the most common allergens, identify risk factors and markers, improve clinical diagnosis, investigate the impact of processing on the food matrix and to determine the impact of food allergies on quality of life. The data gathered and knowledge gained will inform allergen risk management in Europe and beyond.

The task force is represented in Work Package 5 on Managing Food Allergies across Europe - horizontal collaborations and will give input to the consensus documents on food allergy management that will be communicated to the stakeholders (allergic consumers, regulators and the agro-food industry).

The added value of ILSI Europe is to provide (i) scientific expertise in harmonisation of methodologies, (ii) a scientific platform to evaluate results, and (iii) a non-competitive and non-profit platform for categorisation of foods. For instance, in May 2007, a workshop on ‘Approaches to risk assessment in food allergy’ was organised by the Europrevall project and the UK Food Standards Agency, with the support and input of the TF. In 2008, a website was developed in collaboration with the task force (www8.ifr.ac.uk/foodallergens). The end of the project is planned on 31 December 2009.

2009 – The year ahead

Proposals for future new activities include:

• Evaluating the relationship between food allergenicity and processing;
• Evaluating how ranges of concentrations of carry-over residual allergic foods could be used for risk management purposes: provide the scientific basis to support “safe” levels and to contribute to the identification of quantitative decision points.
• Joint Europrevall and Food Allergy task force workshop in 2010.

Task Force Collaborators

Members - 2009

Expert Group on Allergic Reactions Registries

Expert Group on Scientific Criteria for Identifying Allergenic Foods Critical for Public Health

Expert Group on the Application of the Criteria for Identifying Allergenic Foods Critical for Public Health

 Expert Group on Eliciting Dose

Publications

B. Björkstén, R. Crevel et al. Criteria for Identifying Allergenic Foods of Public Health Importance. Regulatory Toxicology and Pharmacology 2008;51:42–52.

A.G. Kruizinga, D. Briggs, R.W.R. Crevel, A.C. Knulst, L.M.C. van den Bosch, G.F. Houben. Probabilistic Risk Assessment Model for Allergens in Food: Sensitivity Analysis of the Minimum Eliciting Dose and Food Consumption. Food and Chemical Toxicology 2008;46:1437-1443.

R. Crevel, D. Briggs, S. Hefle, A. Knulst and S. Taylor. Hazard Characterisation in Food Allergen Risk Assessment: The Application of Statistical Approaches and the Use of Clinical Data. Food and Chemical Toxicology 2007;45:691-701.

C. Hischenhuber, R. Crevel, B. Jarry et al. Safe Amounts of Gluten for Patients with Wheat Allergy or Coeliac Disease. Alimentary Pharmacology and Therapeutics 2006;23(5):559-575.

W.F. Jackson. Food Allergy. ILSI Europe Concise Monograph Series 2003:1-40.

C. Bindslev-Jensen, D. Briggs and M. Osterballe. Can We Determine a Threshold Level for Allergenic Foods by Statistical Analysis of Published Data in the Literature? Allergy 2002;57(8):741-746.

J. Bousquet, B. Björksten, C.A.F.M. Bruijnzeel-Koomen et al. Scientific Criteria and the Selection of Allergenic Foods for Product Labelling. Allergy 1998;53:2-21.

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