Background
Adverse physical reactions (among which allergies) to food are 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 are both safe for allergic consumers and feasible 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 explore their usability as tools for risk management.
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. The knowledge of the incidence of allergic reactions in the exposed population is necessary to validate these extrapolations. In addition, data on incidences would also 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.
The EG had the first meeting in December and is now working on a document that summarizes the object and criteria of an allergic database management system.
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 will be published beginning of 2008 in the Regulatory Pharmacology and Toxicology journal. It proposes a revised set of criteria, including clinical issues (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, which is the application of this Scientific Criteria framework. The objective is to rigorously test the framework and assess its practicability by applying it on the real data available for some cases of allergenic foods. The ILSI Research Foundation supports the related data collection exercise from clinical, experimental, epidemiological and food processing sources.
A new Expert Group has been set up to implement this second phase. In 2009, the results will be evaluated at a roundtable workshop, bringing together a broad spectrum of stakeholders, including risk managers from different sectors and geographical regions.
Determination of Minimum Eliciting Dose
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 and allergen risk assessment, certain aspects of the methodology of 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 basis of this paper is a review of statistical approaches that contribute to allergen risk assessment and management.
Also to come out beginning of 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 predict the likely incidence of reaction in the population at risk.
A final collated review covering all the work of the EG in one comprehensive paper will be submitted in Autumn 2008.
Europrevall
The TF is a collaborating centre of the EC-funded 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 TF is represented in Work Package 5 on 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.
10th International Symposium on Clinical, Chemical and Immunological Problems of Food Allergy
The TF will organise a session and support the publication of the 10th International Symposium on Clinical, Chemical and Immunological Problems of Food Allergy to be held in May 2008, Parma, Italy.
Impact
There is currently a lack of information for those involved in allergen risk management, upon which to base decisions on issues as: whether or not specific levels of cross contamination represent a hazard for the allergic consumer; what are the thresholds above which advisory 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.
2008 – The year ahead
Proposals for future new activities include:
- addressing the dilemma relating to allergen elimination from allergic patient’s diet, as some reports indicate that it could increase the risk of allergic reactions when the patient is inadvertently re-exposed;
- evaluating existing methodologies for the collection of food consumption and composition data in view of exposure assessment to food allergens;
- reviewing the current status quo on allergen detection methods.
Task Force Collaborators
The scientists below participate in the task force and expert groups:
Experts from supporting member companies
Dr. Ron Colwell, H J Heinz (UK)
Dr. René Crevel, Unilever (UK)
Dr. Marcel Feys, Syral (BE)
Dr. Corinne Herouet-Guicheney, Bayer CropScience BioScience (FR)
Dr. Claudia Hischenhuber, Nestlé (CH)
Dr. Brett Jeffery, Mars (UK)
Dr. Leon Knippels, Royal Numico (NL)
Dr. Marianne Lindblom, Kraft Foods (SE)
Ms. Camilla Melegari Barilla G. & R. Fratelli (IT)
Dr. Gladys Ouédraogo-Arras, L’Oréal (FR)
Dr. Fabrice Peladan, Groupe Danone (FR)
Dr. Marie-Claude Robert, Nestlé (CH)
Mr. Stefan Ronsmans, Coca-Cola European Union Group (BE)
Dr. Ditte Sidelmann, Novozymes (DK)
Dr. Rachel Ward, PepsiCo International (UK)
Experts from public institutes
Prof. Bengt Björkstén, Karolinska Institute (SE)
Prof. Per Bruun Brokhoff, Technical University of Denmark (DK)
Dr. Lutz Edler, German Cancer Research Centre (DE)
Dr. Geert Houben, TNO Nutrition and Food Research Institute (NL)
Dr. Jonathan Hourihane, University College Cork (IE)
Dr. André Knulst, State University Hospital Utrecht (NL)
Prof. Martinus Lovik, Norwegian Institute of Public Health (NO)
Dr. Ingrid Malmheden-Yman, National Food Administration (SE)
Dr. Antonella Muraro, University of Padua (IT)
Prof Denise A. Moneret-Vautrin, Centre Hospitalier de Nancy - Hôpital Central (FR)
Prof. Hildegard Przyrembel (DE)
Prof. Roberto Rona, King’s College London (UK)
Dr. Josef Schlatter, Swiss Federal Office of Public Health (CH)
Prof. Stephan Strobel, Peninsula Medical School (UK)
Prof. Stephen Taylor, University of Nebraska (USA)
Mr. Frans Timmermans, Dutch Anafylaxis Network (NL)
Dr. Jean-Michel Wal, National Institute for Agricultural Research (FR)
Dr. Margitta Worm, Charité Universitätsmedizin Berlin (DE)
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.
For more information contact info@ilsieurope.be