Catalina Manieu
Federico Morreale
Rescheduled to 15 October at 17:30
This workshop, delivered by the European Food Safety Authority (EFSA), is intended for organisations developing novel food products. It aims to equip them as early as possible with the key information needed to prepare a market authorisation application under the EU framework, within which EFSA is responsible for the scientific evaluation.The workshop will be structured in two parts: the first one will broadly be applicable to all products requiring EFSA’s evaluation (food and feed additives, food enzymes, food contact materials, etc.), whereas the second one is specific for novel foods.Part 1 will provide a general introduction to the application process, including the roles of EFSA and risk managers, relevant regulatory obligations, available guidance documents, the digital platforms to be used, and the support services offered to applicants, with a particular focus on SMEs.Part 2 will explore in more detail the scientific requirements for preparing a novel food application, helping developers understand what is expected and how to plan effectively.The content will be delivered in an interactive format, featuring practical tips and opportunities for engagement and clarification, with the goal of ensuring that participants are well prepared and able to approach the application process with clarity and confidence from the outset.In this context, participants will also receive all the necessary information to request and receive, as a follow-up to the workshop, EFSA’s General Pre-submission Advice, supporting them in preparing their specific applications, with confidentiality ensured. This tailored advice may be provided in a tele-meeting upon receipt of a detailed list of questions.