Community Research and Development Information Service - CORDIS


IFAAM Report Summary

Project ID: 312147
Funded under: FP7-KBBE
Country: United Kingdom

Periodic Report Summary 3 - IFAAM (Integrated Approaches to Food Allergen and Allergy Risk Management)

Project Context and Objectives:
It has been estimated that up to 20 million European citizens suffer from food allergy. However management of both food allergy (by patients and health practitioners) and allergens (by industry) is thwarted by lack of evidence to either prevent food allergy developing or protect adequately those who are already allergic. iFAAM will develop evidence-based approaches and tools for MANAGEMENT of ALLERGENS in FOOD and integrate knowledge derived from their application and new knowledge from intervention studies into FOOD ALLERGY MANAGEMENT plans and dietary advice. The resulting holistic strategies will reduce the burden of food allergies in Europe and beyond, whilst enabling the European food industry to compete in the global market place. Our approach will build on e-Health concepts to allow full exploitation of complex data obtained from the work in this proposal and previous and on going studies, maximising sharing and linkage of data, by developing an informatics platform “Allerg-e-lab”. This will enable us to
(1) Extend and integrate existing cohorts from observation and intervention studies to provide evidence as to how maternal diet and infant feeding practices (including weaning) modulate the patterns and prevalence of allergies across Europe;
(2) Establish risk factors for the development of severe reactions to food and identify associated biomarkers;
(3) Develop a clinically-validated tiered risk assessment and evidence-based risk management approach for food allergens for allergens in the food chain;
(4) Develop clinically-relevant multi-analyte methods of analysis suited to allergen management across the food chain.

Stakeholders will be integrated into iFAAM to deliver harmonised integrated approaches, including RISK ASSESSORS AND MANAGERS managing population risk, the FOOD INDUSTRY who manage allergens to ensure consumer safety, HEALTH CARE PRACTITIONERS to provide food allergy management plans and dietary advice and ALLERGIC CONSUMERS to manage individual risk.

The iFAAM overall objectives will be addressed through an integrated set of specific objectives through a set of interacting subsidiary objectives delivered through five complimentary Modules as follows:

Module 1 - Early Life Nutrition and Allergy: This Module seeks to assess the influence of dietary strategies such as maternal diet, weaning practices and infant feeding, on the patterns and prevalence of allergies with an emphasis on food allergy.

Module 2 - Risk factors and Severity: Through this Module risk factors associated with causing severe food allergic reactions will be studied, including extrinsic factors (e.g. medication such as ant-acids and viral infections) and intrinsic host-related factors (e.g. associated with effector cell functioning in allergic individuals).

Module 3 - Risk Models: A comprehensive approach is taken in Module 3 which addresses the issues of managing allergens in foods to prevent reactions, treatment of the patient, and the psychosocial dimensions of reactions and includes the development and clinical validation of risk models.

Module 4 - Analysis of Allergens in Food: Activities in this Module will uniquely link the development of effective multianalyte analysis tools potentially suitable for in-factory testing (e.g. immunobased) or confirmatory in-laboratory analysis (e.g. mass spectrometry-based) with a thorough characterisation of how the performance of these tools relates to the nature of the allergenic hazard they are attempting to quantify.

Module 5 - Food Allergen and Allergy Management Knowledge Base: This module will integrate the data and methods used for food allergen management by the food industry, within the wider framework of allergy diagnosis, treatment and management in the clinic and efforts to use dietary strategies for the prevention of allergies (food allergy management).

These activities are underpinned by a platform of scientific and administrative management of the project (Module 6) which includes an informatics platform, Allerg-e-Lab which will drive integration of data and knowledge. It will also support the collection of study data and provide a platform for researchers to access this data and share their research activities and discoveries through:
• An online archive for storage of and access to completed EuroPrevall and intervention studies (Module 1);
• A web-based set of questionnaires for in-clinic collection of new patient data (Modules 1, 2, 3 and 4);
• A web-based tool for collection of patient reported outcomes for the Module 3 community study.

A full description of the aims and objectives of the project and information about the project partners can be found on the project website (

Project Results:
The original consortium was modified during the second year by the withdrawal of Eurofins and in the third year by the withdrawal of OUH. The accession of five new partners also took place – Imperial and Australian partners MCRI, UWA, SCHN and SAHMRI. As a consequence of these changes the partnership now has 11 industrial partners, including 9 SMEs and collaborations forged with public analysts in Ireland and Mondelez during the second year.

Through the activities of Module 1 a school-age follow-up of the EuroPrevall birth cohort is being undertaken. The application of the Langual indexing software to the food consumption data collected in EuroPrevall has been assessed. The FAO/INFOODS guidelines for matching foods have been adopted, alongside relevant food consumption surveys, to support recoding. Mapping of data from interventional studies in the UK, Germany and Australia has been undertaken and is being used to inform the set-up of the Allerg-e-lab database. Two trials (STAR in Australia and LEAP in the UK) have been completed and the remainder are on track for completion in 2015-2016, allowing data to be made available for meta-analysis.

In Module 2 two severity scoring algorithms have been developed using data collected in the EuroPrevall project and then mapped against severity phenotypes. This has allowed a number of risk factors and biomarkers to be identified which will be validated in iFAAM patients. Mechanistic studies into the role of non-IgE isotypes (IgG, IgG4 and IgA) in severity of allergic reactions to peanut are being finalised and a comparison between basophil tests and patients own mast cells is underway in a cohort of peanut and tree nut allergic patients. A study investigating the impact of proton pump inhibitors on the reactivity of walnut allergic patients following oral food challenge is underway and an investigation into the impact of viral infection on reactivity to foods is nearing completion.

Module 3 activities have delivered a method for food grouping which has been used to compare food consumption patterns of allergic and non-allergic individuals using data from the MIRABEL and INCA studies. It was difficult to draw conclusions on differences in consumption between these groups and so national food consumption data was used in the Tier 1 and Tier 2 risk assessment tools. Contamination models and an allergen tracking tool have been developed . The single-dose challenge trials for hazelnut have been completed with studies for egg and milk are ongoing; preliminary analysis indicate data are consistent with the threshold dose distributions underpinning the tiered risk assessment approaches. Real time reporting of reacitons and analysis of submitted food samples have revealed high levels of meal contamination with allergen and intriguing data about the food choices consumers make, especially around take away food. A shortened on-line reporting tool, AllerREACT has been developed with patient groups from across Europe.

Module 4 is focussed on developing clinically relevant multianalyte analysis for allergens in food. The development of a high resolution mass spectrometry (MS) multianalyte method for the quantification of milk, egg, peanut, hazelnut and walnut in a chocolate matrix, using multiple reaction monitoring experiments is mearing completion. A selection of peptide targets are being taken forward for final assay development. A multiallergen MS method for peanut in chocolate dessert has been finalised and a ring trial is being undertaken to compare MS and immunoassay methods for peanut analysis involving more than 20 laboratories from across the world. Further validation of a complementary food allergen multiplex immunoassay has been undertaken.The allergenic activity of peanut and hazelnut foods and matrices used for method development has been confirmed and the effect of polyphenols on allergen analysis has been investigated. A healthy volunteer study of bioaccessibility has been completed and tools for analysis of allergen uptake are being validated. Challenges using peanut in a cookie matrix in allergic patients are largely complete.
Module 5 integrates the outputs of iFAAM activities from across Modules 1-4. The analysis of food allergen recalls has not been finalised and published whilst best practice guides to allergen management and analysis together with approaches to precautionary allergen labelling are being developed. Workshops for stakeholder engagement will be a major activity in the final year of the project to disseminate project outputs.

Potential Impact:
Impact on Public Health: The World Health Organisation and other food safety authorities recognise food allergy as a significant public health concern due to its prevalence and potential severity of the condition and the impact it has on the quality of life of allergic consumers. Data from the EuroPrevall birth cohort and analysis of data sets from the EuroPrevall project undertaken in iFAAM will broaden the evidence base to support efforts of regulators, such as the NDA panel of EFSA, to revise and update the list of allergenic ingredients in Annex II of the EU Food Information Regulation. The pan-European nature of the data in EuroPrevall-iFAAM will ensure that differences in the patterns and prevalence of allergies in Europe can be taken account of. For example, the challenges faced in Southern Europe where food allergies to a wide range of foods that cause severe reactions are mediated by a particular allergen molecule known as the lipid transfer proteins (LTP). They h contrast completely to the patterns of foods causing severe reactions in the north of Europe.
Two stakeholder workshops will be held in the final year to obtain feedback and assess the utility of the tiered risk assessment approach and its validation that can support the food industry in applying precautionary labelling in a consistent and transparent manner. These are being developed in parallel with development of clinically relevant analytical tools, including ingredients and foods that have a defined allergenic activity, providing analysts with much needed quality control samples with potential to be developed into properly validated reference materials in the future. These tools will also support efforts to assess and predict both the impact of novel processes on the allergenic potential of foods and the allergenic activity of novel foods. The iFAAM project will also deliver a knowledge base that is needed by public health authorities to develop new guidance with respect to dietary advice to pregnant and breast feeding mothers and with regards infant feeding practices (including weaning). The data sets we will gather and analyse are unique in the world and will be published in the final year of the project.

Impact of consumers: iFAAM specifically addresses the needs of the food industry to work within regulatory frameworks to protect the environment, health and safety of consumers in relation to the allergenic hazards presented by foods. It is unique in engaging with allergic consumer groups in executing the research, and is delivering tools that these advocacy groups can use to collect data on allergic reactions experienced in the community. The results of the project, in particular the delivery of the evidence base to support delivery of transparent labelling of foods, will ease the burden placed on allergic consumers when shopping or eating out of the home with regards the burden of existing food allergies. Data supporting evidence-based guidelines on maternal diet during pregnancy and infant feeding will benefit consumers in general and have the potential to prevent development of allergies. Through this activity iFAAM outputs will directly address the priorities for a socially inclusive and healthy Europe. The pan-European nature of the project will also enable this to be achieved in a coherent way across the Union.

Impact on the European Food Industry and the Innovation Union initiative: iFAAM will generate the new knowledge required to allow the food industry to deliver foods that are safe for allergic consumers whilst remaining competitive and able to develop new and more innovative products (novel foods and processing procedures) whilst not compromising on allergenic safety. Technology transfer is underway between an academic and SME business partner in the project whilst a spin-out company has been formed based on innovation arising from the EuroPrevall studies. Support in delivery of the tiered risk assessment process will support SME partners delivering risk consulting and training to the food sector. More efficient and effective food allergen management will support the European food industry in becoming a low carbon and resource efficient industry by reducing waste and finding sustainable means of implementing food allergen hazard management, through effective hazard control procedures and cleaning strategies.

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