Novel strategy for allergenicity risk assessment of proteins in regulated food and feed products

Allergenicity risk assessment (RA) is a relevant cross-cutting issue for most EFSA Scientific Panels. As current strategies for allergenicity RA of proteins in regulated food and feed products are primarily informed by 2003 Codex Alimentarius guidelines, it is of utmost importance to take into account recent scientific advances in allergenicity RA. An open call (single framework contract with, indicatively, four specific contracts) will be launched to support EFSA in the development of a novel strategy for fit-for-purpose allergenicity RA of proteins in food and feed, building on state-of-the-art knowledge, accumulated experience, and ongoing interactions with the European Commission. This project foresees: 1) the development of an open-source in silico prediction/appraisal tool for clinically-relevant cross-reactivity, supported by a curated allergen database ranked according to clinical relevance, and by integrated phylogenetics analysis, sequence homology and structural similarity; 2) the development of an open-source in silico prediction/appraisal tool for de novo sensitisation based on the protein binding capacity to antigen-presenting cells and other aspects informing on potential sensitisation capacity; 3) the verification of the tools with experimental in vitro and in vivo data; 4) the assessment of future prospects for in silico tools to account for the impact of factors such as protein digestibility, food matrix, or processing on protein properties and allergenic potential; 5) the estimation of thresholds of allergological concern; and 6) the development of a systematic tiered/stepwise approach including a decision-making framework with defined criteria or scenarios that trigger each of the tiers. This novel strategy will enhance the reliability and speed of allergenicity RA, support process simplification and harmonisation, and ultimately enable better-informed decision-making.