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Stakeholder event on the update of the guidance for submission of dossiers on food enzymes

EFSA organised a virtual meeting with stakeholders on the update of the scientific guidance for the submission of dossiers on food enzymes. The event took place on 21-22 June 2021 following a public consultation on the document. The new guidance is expected to be published in the fourth quarter of this year.

The overall objective of the meeting was to address questions raised during the public consultation as well as any doubts that applicants might have on the data they are required to submit with a technical dossier. A second objective was to explain procedural aspects that are specific to food enzyme dossiers under the various practical arrangements for implementing the Transparency Regulation (EU) 2019/1381. The event was organised in two sessions:

Session 1 took place on 21 June 2021. An introductory session indicating the scope and structure of the guidance was followed by a short contribution from the European Commission. Members of the Working Group on the Update of the Guidance on Food Enzymes then gave presentations highlighting the comments received on the different sections of the guidance. Discussions focused on the characteristics of food enzymes derived from plants, animals and microorganisms, the production of food enzymes, as well as the need for toxicological studies, allergenicity assessment and dietary exposure calculation. EFSA experts answered questions from stakeholders to clarify the scientific data required under the new guidance.

Session 2 took place on 22 June 2021. The session started with an explanation of how to assemble a food enzyme dossier for the purpose of pursuing modifications to an existing authorisation in the EU. Presentations and demonstrations were given by EFSA staff on the following topics: i) how to submit a dossier with and without confidential information through the e-Submission Food Chain Platform; ii) frequently missed information identified in the suitability check; iii) existing and new services offered as support initiatives; iv) how to track food enzyme dossiers submitted before and after the Transparency Regulation implementation rules in the OpenEFSA portal; and v) how confidentiality claims are checked by EFSA. The session concluded with another round of questions and answers.

The agenda, the presentations given during the meeting, and video recordings of the event are available at the links below.

Do not hesitate to contact the organising committee at online.events [at] efsa.europa.eu for more information.