Toxicological studies for the submission of a dossier on food enzymes

Toxicological studies for the submission of a dossier on food enzymes

EFSA held a virtual meeting with stakeholders on the toxicological studies requirements for the submission of dossiers on food enzymes. The event, held on 29 March 2021, supported the update of the scientific guidance on the submission of dossiers on food enzymes that is expected to be published later this year.

The overall aim of the meeting was to clarify to interested stakeholders the toxicological dataset required by EFSA to perform risk assessment of food enzymes and to clarify the cases in which such studies might be waived.

The background to the update of the guidance as well as its scope was given in an introductory session. Subsequently presentations covered the test item for toxicological studies and its characterisation, the genotoxicity testing approach, the repeated dose 90-day toxicity study requirements and the conditions for waiving the toxicological studies.

A question and answer session allowed a fruitful interaction among the participants and EFSA staff. The questions and answers for each topic were summarised and a general conclusion and take-home message shared with the audience in the concluding session.

The agenda and presentations are available at the link below.

Please contact the organising committee at FMB_events [at] efsa.europa.eu (FMB_events[at]efsa[dot]europa[dot]eu) if you require more information.