ZMUni Compliance Centre

With the rapid development of precision fermentation, synthetic biology, and microbial manufacturing technologies, an increasing number of novel food ingredients involving microorganisms, fungi, or algae are entering the EU market. For these products, companies need not only to determine whether they fall within the scope of the EU Novel Food Regulation, but also to demonstrate their safety under the proposed conditions of use.

In this ZMUni × BaseClear joint webinar, we will provide a practical overview of the current EU regulatory framework and the latest EFSA guidance for Novel Food applications, covering both regulatory strategy and laboratory testing. The webinar will help companies better understand the application pathway, identify potential data gaps, and improve the efficiency of regulatory and technical preparation.

• EU Novel Food Classification, Regulatory Framework & Application Pathways
• Core Data Requirements for EFSA Scientific Dossiers & Building a Robust Evidence Package
• Characterisation, Testing & Analytical Requirements for Microorganisms and Production Strains
• Common Application Deficiencies, Risks of Additional Data Requests & Project Planning Considerations

ZMUNI SESSION:

Overview of the EU Novel Food Application Process and Dossier Preparation

(*presented in Chinese)

BASECLEAR SESSION:

Balancing Innovation and Safety: Assessing Microbial Additives in Our Food Chain

(*presented in English)

Hua Zhu, PhD

Senior Regulatory Affairs Scientist at BASECLEAR

Zhenghai Xu (Max)

Senior Food Regulatory Consultant At ZMUni

ZMUni Compliance Centre × BaseClear

If you have any questions, please contact us:
+86 571-86592517
+86 18058418258
info@zmuni.com

*If you are unable to attend the live webinar, we still encourage you to register. We will promptly send you the webinar materials as soon as they become available.