Information session: Review of 90-day toxicity studies for regulatory assessment of food enzymes
Background
Repeated dose 90‑day oral toxicity studies in rats following OECD TG 408 are a part of the EU risk assessment framework of food enzymes (FE) with some exemptions. 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 and replace these studies for the safety assessment of food enzymes.
Objectives of the meeting
The aim of this event is to present the preliminary results of the retrospective review of a collection of repeated dose 90‑day oral toxicity studies in rodents, which were submitted to EFSA between 2014-2026 as part of the food enzyme applications for regulatory assessment. The event also aims to brainstorm on how these findings can inform future assessment approaches, including opportunities to reduce reliance on animal studies and to explore alternative and complementary methodologies in line with the EU roadmap.
Who should attend?
This Information session is free of charge and open to anyone with expertise, knowledge and interest in food enzymes safety assessments. Anyone willing to contribute to the reflections on development’s needs and the discussions on the challenges and recommendations for food enzymes safety assessments are encouraged to participate.
Structure of the meeting
Following the opening plenary session where introductory speeches will be shared, participants will break into two discussion groups on specific topics:
Break-out Group 1 | Protein toxicity for enzymes, incl. exploring alternative methods
Break-out Group 2 | Toxicity linked to non-protein microbial constituents and chemical agents used in enzyme manufacturing process, incl. exploring alternative methods
The outcome of the discussion groups will be presented and wrapped up in a common plenary session.
After the information session, EFSA will issue a short report summarising the discussions, which will be published together with the presentations shared in the session.
Who should attend?
This Information session is free of charge and open to anyone with expertise, knowledge and interest in food enzymes safety assessments. Anyone willing to contribute to the reflections on development’s needs and the discussions on the challenges and recommendations for food enzymes safety assessments are encouraged to participate.
A selection will ensure a sufficient representation of the various fields of expertise, as well as representation of stakeholder groups and geographical balance.
On-line registration
The registration form can be found at: https://events.efsa.europa.eu/event/ar/1057/online-stakeholder-meeting-on-food-enzymes
Please note that registration will close on 07 May 2026 at 12.00 CEST:
By the 14th of May, registrants will be informed whether they have been selected or rejected for participation.
Organisational details
The event will be held online on 18 May 2026, 14:00-18:00 CEST.
Further details will be communicated to selected participants. English will be the language of the event, and no translation will be provided.
Contact
Do not hesitate to contact the organising committee at webinars [at] efsa.europa.eu for more information.