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.
Novel Food safety dossiers.png- Course Owner: Alejandro GARCIA LOPEZ