A Review on Allergens, Allergenicity Assessment Methods, and Specific Allergenicity Assessment Strategies for Novel Foods

Food allergy presents a significant global health challenge. Addressing population growth necessitates developing sustainable innovative foods (natural or synthetic), which may harbor allergens. Premarket assessment of their allergenic potential is therefore critical. This paper systematically reviewed potential allergens in novel foods and associated allergenicity assessment methods and developed an innovative dedicated allergenicity risk assessment decision tree based on Codex (2009) and EFSA (2010; 2017) guidance. This framework takes the degree of allergenicity into account and integrates core assessment pillars─gene and amino acid sequence homology, serological screening (IgE cross-reactivity), digestive stability, animal experiments, and skin prick tests. When gene sequence data is unavailable, protein identity, taxonomic relationships, exposure history, and intended use were incorporated. The review identifies gaps in current strategies for predicting novel foods’ allergenicity, enhances analysts’ understanding in utilizing bioinformatics, in vitro, and in vivo methods, improves novel foods risk assessment efficacy, and highlights future research priorities.