Initial allergenicity assessment of Ulva sp. seaweed flour

Ulva sp. is a green marine macroalga and a promising yet underexplored sustainable food source, with limited research on its allergenicity. This study evaluated the allergenic potential of Ulva sp. demineralized biomass flour (Ulva-DBF) using a weight-of-evidence approach inspired by regulatory assessments for novel foods, combining literature review, proteomic analysis, and a pilot clinical trial. Literature revealed no documented Ulva allergenicity. Proteomic analysis identified a few putative allergens, with estimated allergenic potential below 0.02%. In a pilot clinical trial (registered at ClinicalTrials.gov, Identifier: NCT06452381; First Posted Date: June 11, 2024), 31 participants consumed Ulva-DBF. No allergic reactions occurred, although 16.6% reported gastrointestinal discomfort. These findings represent a preliminary evaluation phase before widespread exposure. Nevertheless, large-scale consumption remains the most effective way to assess public health risks associated with any food. As we seek innovative and sustainable food solutions, post-marketing monitoring is vital to ensure their safety.