Allergenicity Assessment

The allergenicity section assesses whether the novel food could trigger allergic reactions in consumers. The assessment considers the source organism's allergenic potential, structural similarities between novel food proteins and known allergens, and any evidence of cross-reactivity.

For protein-containing novel foods, EFSA expects a bioinformatics analysis comparing the amino acid sequences of the novel food's proteins against allergen databases (such as AllergenOnline or the WHO/IUIS Allergen Nomenclature database). The assessment should address both IgE-mediated allergic reactions and potential cross-reactivity with known food allergens.

Allergenicity is a particularly critical section for insect-derived novel foods, given the well-documented cross-reactivity between insect proteins and crustacean/shellfish allergens. EFSA's 2015 risk profile on insects as food and feed specifically identifies tropomyosin and arginine kinase as relevant cross-reactive allergens. For algae-derived and fungal novel foods, allergenicity assessment focuses on the source organism's taxonomic relationship to known allergenic species.

The section is typically shorter than others in published opinions but carries significant weight in EFSA's overall safety conclusion — an unresolved allergenicity concern can lead to an unfavourable opinion regardless of the toxicological profile.