KBBE.2012.2.4-03: Towards evidence-based risk management of food allergies Call: FP7-KBBE-2012-6 Anticipated call date: 20th July 2011 Anticipated closing date: 15th November 2011 Project size: €9 000 000 EC contribution per project. Composition: 15 % or more of the total estimated EU contribution to go to SMEs Expected impact: The European added value lies in providing a framework to consistently apply risk assessment and management of food allergens across the EU and beyond, which should contribute to the updating of the EU list of allergen in accordance with the procedure laid down in the EU legislation. The provision of evidence-based action levels for allergens in foods and the resulting management tools will enable the food industry to become more competitive and sustainable and promote innovation by reducing costs and helping drive harmonisation across the food chain. Consumer protection will be improved through more accurate, risk-based controls and labelling. It will contribute to further strengthening of national and EU dietary advice and public health by providing new scientific knowledge on the effect of infant feeding to prevent the development of allergies later in life.

The text (July draft – significant changes highlighted) A consistent approach to risk assessment and management of allergens across the food chain is needed. Clinically validated risk models for the risk assessment should be proposed and allergen management tools and algorithms for the food industry should be developed. Individual thresholds and population dose-distributions need to be investigated, taking into account how extrinsic factors, the food matrix and processing impact on the stability of threshold doses and clinical reactivity. Validated, evidence-based risk management strategies for allergenic foods should be proposed. Risk models will be made publicly available and associated with databases and other web-based platforms to support Europe-wide dissemination to the food industry. Exploiting results of previous studies, new data are required on the influence of maternal diet and weaning practices on the patterns and prevalence of allergies. Biomarkers to predict severe allergic reactions to food and the risk to develop such reactions should be assessed. Differences in populations across Europe should be investigated. Dietary strategies for food allergy prevention should be investigated. Analytical methodology to determine multiple allergens in foods should be further developed and their efficacy to allow measuring allergens in a wide range of foods from raw materials to commercially available products demonstrated.

Module 2 Module 1 Module 3 Module 4 Risk factors and Severity WP2.1 Biomarkers for severity WP2.2 Extrinsic factors Indicative budget: € 1.8M SMEs Budget €1.35M Module 1 Nutrition and allergy throughout life WP1.1: Birth cohort follow-up WP1.2: Dietary interventions for allergy prevention Indicative Budget:€2.3M Module 3 Validated Risk Models WP3.1 Risk models with MEDs WP3.2 Clinical validation Indicative budget: €1.6M Module 4 Tools for Allergen Management WP4.1: Multianalyte allergen analysis WP4.2: Food allergen management WP4.3: Dietary strategies for prevention Indicative budget: €1.4M Module 5: Management and Communication Indicative budget: €0.63M

WP4.1 Mutianalyte Allergen Analysis – Tool development Analytical methodology to determine multiple allergens in foods should be further developed to allow measuring allergens in a wide range of foods from raw materials to commercially available products. Participants: PEI: Andreas Reuter, Thomas Holzhauser Manchester: Clare Mills, Phil Johnson JRC: Franz Ulberth SME diagnostic companies TBC Collaborating centre: Health Canada Workplan Rapid Multianalyte immuno-based methods Development of confirmatory multianalyte MS methods Application to standard food matrices [derived from those for DBPCFC thresholds] [linked to analysis of serum though connection to WP2.2 by PEI-UoM)

WP4.2 Food Allergen Management – reduction to practice (Years 3-4) Risk models will be made publicly available and associated with databases and other web-based platforms to support Europe-wide dissemination to the food industry. Participants IFA-Tulln: Sabine Baumgartner, Rudi Krska WUR: Tiny van Bokel, Harry Wichers INRA: Adel-Patient, Wal, Tranquet Industry partners: Nestle, Kraft, Unilever Workplan Integration of risk models for allergen managements tools Transferability of allergen analysis methods [ring trials? Or in WP4.1?] Application of allergen analysis in factory environments including validation of cleaning protocols Analysis of food samples from Module 1 and WP3.2 studies [confirmation of allergen doses; analysis of food samples from population studies)