Info Session | Rethinking Food Enzyme Safety: New Perspectives on Systemic Toxicity Testing and Allergen Homology Search

According to the latest EFSA Scientific Guidance for the submission of dossiers on Food Enzymes (CEP Panel, 2021), the safety assessment of food enzymes includes the evaluation of potential systemic toxicity and allergenicity. Systemic toxicity has traditionally been assessed through a 90-day oral toxicity study in rodents following OECD TG 408, while allergenicity is evaluated primarily by comparing the amino acid sequence of the enzyme with known allergens, source of the food enzyme and substances used to manufacture the food enzyme. Together with dietary exposure, these data support EFSA's conclusion on the safety of the food enzyme under its intended conditions of use.

In line with EU objectives and EFSA policy to reduce animal testing, the EFSA Panel on Food Enzymes initiated a self‑task to investigate the possibility to further reduce 90-day studies for the safety assessment of FE. In parallel, the Panel has developed a new allergenicity bioinformatics pipeline, aiming to provide a harmonised and standardised way to report sequence matches identified during allergenicity assessment. Outputs produced from these two self-tasks will be made available for consultation in November 2026.

To facilitate the public consultation, EFSA is convening a stakeholder meeting to review past systemic toxicity tests and allergenicity homology searches, aiming to reshape the future landscape of food enzyme safety assessment.

The event offers a comprehensive overview of the established principles, insights gained from field work, and future perspective regarding food enzyme safety assessment.

Session 1 | 25 November 2026 (14:00-18:00 CET)

Session 2 | 26 November 2026 (09:00-13:00 CET)

EFSA will publish the presentations shared after the event.