Novel Food safety dossiers: scientific data requirements and practical lessons from EFSA opinions
Nekaj ur
Začetnik
Podrobnosti o tečaju
This course examines the EFSA Guidance on the scientific requirements for Novel Food applications under Regulation (EU) 2015/2283. The Guidance requires a structured presentation of data, progressing from identity and composition to exposure and final safety assessment. This module focuses on the characterisation of the Novel Food, covering identity, production process, compositional data and specifications.
It combines theoretical explanations with practical examples from real EFSA scientific opinions. Participants will examine how previous applicants addressed data gaps (or not) and how proactive approaches improved the success and efficiency of dossier evaluations.
It combines theoretical explanations with practical examples from real EFSA scientific opinions. Participants will examine how previous applicants addressed data gaps (or not) and how proactive approaches improved the success and efficiency of dossier evaluations.
Ciljna skupina
This course is intended for novel food applicants from around the world who wish to introduce such products to the EU market.
Učni cilji
On successful completion of this course, you will be able to:
- Understand the structure and logic of the EFSA scientific guidance for Novel Foods (NF).
- Identify and prepare the scientific data required for the NF characterisation phase of a dossier.
- Recognize common issues raised during EFSA assessment and learn how to address them proactively.
- Enhance the scientific quality and completeness of your application to facilitate a more efficient risk assessment.
Ponuja
EFSA is an agency of the European Union set up in 2002 to serve as an impartial source of scientific advice to risk managers and to communicate on risks associated with the food chain.
Urnik
- Welcome
- Module 1 - Introduction
- Module 2 - Regulation in a nutshell
- Module 3 - EFSA Scientific Guidance on Novel Foods: from identity to specifications
- Module 4 - Bringing it all together
