Novel Food: the regulatory principles and European legislation

The course offers a detailed analysis of European Novel Food regulation, with a particular focus on Regulation (EU) 2015/2283 and authorisation procedures. Identification criteria, safety assessments required by EFSA and submission guidelines for dossiers will be explored. Practical aspects of application management, post-market surveillance and market opportunities for innovative products will be covered. Through case studies and concrete applications, the course will provide essential operational tools for companies, professionals and consultants in the food sector.

TOPICS COVERED

– Introduction to Novel Foods
– The EU Regulation 2015/2283
– Authorisation and notification procedures
– Safety assessment and toxicological studies
– Post-marketing surveillance and risk management
– Specific insights and case studies

GOALS

The main objective is to provide participants with the technical and regulatory skills necessary to confidently tackle the complex authorisation process for Novel Foods in Europe. The course will enable participants to understand the regulatory implications for companies, anticipate critical issues in dossiers and optimise the management of authorisation requests. The scientific criteria required by EFSA for safety assessment will be explored, with a focus on toxicological studies and demonstration of significant consumption. Participants will learn how to distinguish between different authorisation procedures, correctly interpret documentation requirements and structure effective strategies for placing on the market. Finally, practical guidance on post-marketing surveillance and opportunities for innovation in an evolving field will be provided.

WHO IT IS AIMED AT

The course is aimed at laboratory managers, risk managers, regulatory affairs, product safety managers, R&D managers, quality managers, innovation managers, R&D specialists, process engineers, food technologists, toxicologists and ecotoxicologists, compliance managers and all those who are required to apply the relevant regulatory provisions.