The novel food application process
Qualche ora
Principiante
Descrizione del corso
The course provides essential information that a novel food applicant should be aware of before submitting an application for the authorisation to place a novel food in the EU market. It covers the following topics:
- The EU novel food regulatory framework, explaining the roles of EFSA, the European Commission and Member states, and how to determine whether a food is considered “novel”.
- The novel food application procedure.
- Obligations related to the notification of studies.
- Good Laboratory Practice requirements for toxicological studies.
- Confidentiality requirements.
- EFSA Administrative and Scientific guidance documents on novel foods.
- EFSA support services for applicants, specifically to SMEs
Pubblico di destinazione
This course is intended for applicants preparing novel food applications in the European Union under Regulation (EU) 2015/22831 and Commission Implementing Regulation (EU) 2017/2469.
It is particularly helpful for SMEs and first-time applicants, but it may also be useful for experienced applicants, consultants supporting applicants, industry associations, and other stakeholders involved in the field of novel foods.
Obiettivi formativi
By the end of this course, you will be able to confidently navigate the novel food application process by:
- Understanding the respective roles of risk managers and risk assessors in the authorisation of a novel food in the EU.
- Becoming familiar with the main steps of the application process, with a focus particularly on pre-submission activities (General pre-submission advice and Notification of studies).
- Recognising the key administrative and scientific requirements for a novel food application.
- Identifying relevant EFSA guidance documents and support services that can assist you in preparing your application.
Offerto da
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.
Programma
- Welcome
- Module 1 - Novel food regulatory framework
- Module 2 - Novel food application procedure
- Module 3 - Novel foods administrative guidance and support to applicants
- Module 4 - Novel foods scientific guidance
- Module 5 - Final remarks
