21st and 22nd June 2021, 14.00-18.00 (CET)
Food enzymes are authorised for marketing in the EU in accordance with Regulation (EC) No 1331/2008, which establishes a common authorisation procedure for food additives, food enzymes and food flavourings. To support the authorisation decision, the safety of food enzymes under the intended conditions of use is evaluated by the European Food Safety Authority (EFSA). A guidance document was published in 2009 (EFSA, 2009) to support applicants in the preparation of dossiers.
EFSA is updating this guidance by incorporating the latest scientific developments and best practice in risk assessment methodology. The draft went out for public consultation from 8 March to 9 May 2021. This event is a follow-up to the public consultation.
Objectives of the meeting:
- To address doubts applicants might have on the approach taken by the CEP Panel when conducting risk assessments of food enzymes.
- To clarify the dataset that EFSA requires to perform its assessment.
- To clarify the procedural aspects of the submission of dossiers.
Structure of the event
The meeting will be held online and will comprise two sessions. Session 1 is dedicated to the comments received during the public consultation. EFSA experts will interact with stakeholders to clarify the scientific data required under the new guidance.
Session 2 is dedicated to procedural aspects related to dossier preparation and submission. Practical information including demonstrations on how to submit dossiers on food enzymes will be provided. EFSA staff will clarify the meaning of a dossier with full dataset vs reduced dataset and will explain new practical arrangements that have been put in place under the Transparency Regulation. Each session will include a Q&A session to address questions and comments from participants.
Participants are encouraged to send questions and comments using the registration form. During the online session participants can send questions via a dedicated chatbox. Questions received before the event and collected in the chatbox will be answered in the Q&A sessions. Spontaneous intervention in the Q&A sessions is subject to time availability.
All presentations will be published on the EFSA website after the event.
Who should attend?
The meeting is intended for all interested stakeholders.
Participation is free of charge, but registration is compulsory. The registration deadline is 14/06/2021. Register using the form available here.
Please note that attendance is limited to 250 participants. Registration will close once the maximum number of registrants has been reached.
Please contact online.events [at] efsa.europa.eu if you have any questions.