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Highlights from Part Two of Atova's Navigating Novel Foods Masterclass

  • Writer: Atova
    Atova
  • Jul 30
  • 3 min read

Practical Insights into EFSA's Identity & Production Process Requirements


Following the fantastic response to the launch of our Navigating Novel Foods: EU Dossier Masterclass webinar series, we were delighted to welcome both familiar and new faces to Part Two on the 29th July. Thank you to everyone who joined us and contributed to another engaging session through your insightful questions.



Understanding Two of the Most Critical Sections of a Novel Food Dossier


Preparing a successful EU novel food dossier requires much more than simply following the guidance documents. Understanding what EFSA expects and where applicants commonly encounter challenges can play a significant role in reducing clock-stops and keeping applications moving efficiently through the risk assessment process.


Part Two of the series focused on two fundamental sections of a novel food application: Identity and Production Process. Led by Atova Regulatory Scientist, Dr Oana Kubinyecz, the webinar explored how these sections underpin the entire dossier and why providing clear, comprehensive and scientifically robust information from the outset is essential.


Throughout the session, attendees gained practical insights into:

  • EFSA's expectations for the Identity and Production Process sections

  • Common dossier mistakes that often lead to clock-stop questions

  • Practical strategies to strengthen these sections before submission

  • Examples of the types of questions EFSA frequently raises during risk assessment


Practical Experience Beyond the Guidance

Drawing on Atova's experience supporting novel food applications, Oana shared practical advice that goes beyond interpreting regulatory guidance. The webinar explored the real-world challenges applicants encounter during dossier preparation and EFSA review, highlighting ways to present data more clearly, build stronger scientific justifications, and anticipate potential questions before submission.


The session included an interactive live Q&A featuring Dr Oana Kubinyecz and Atova CEO Dr Hannah Lester, where attendees had the opportunity to discuss their own regulatory questions.


Key take home messages included:

  • Not treating sections as indivudial sections but rather building a safety narrative, taking care to be consistent throughout the dossier.

  • Ensuring the sections are comprehensive, well explained and have a clear narrative to minimise questions during risk assessment.

  • If a potentially harmful metabolite is identified in the identity section or literature review, make sure it is measured as part of the compositional data set.

  • Giving exact set-points for all operational parameters.

  • Describing every process step in full - should be reproducible by a third party

  • Making sure the HACCP plan aligns with the manufacturing process described in the dossier.


Continuing to Support Food Innovation

One of the key themes throughout the webinar was that investing time in developing strong Identity and Production Process sections early can have a significant impact on the overall efficiency of the assessment process. By understanding EFSA's expectations and taking a strategic approach to dossier preparation, applicants can help reduce unnecessary delays and build greater confidence in their submissions.


Through this webinar series, Atova continues to support food innovators by sharing practical regulatory knowledge that helps businesses navigate the EU novel food authorisation process with greater clarity and confidence.


Join Us for Part Three

Our webinar series continues on Wednesday 16th September with Part Three, where we'll turn our attention to another group of essential dossier sections:

  • Compositional Information

  • Specifications

  • Nutritional Information

  • Proposed Uses

  • Anticipated Intake


Registration will be opening soon, so keep an eye on our website, LinkedIn page and newsletter for further details.


Thank You

Thank you once again to everyone who joined Part Two of the series. We greatly appreciate your engagement, thoughtful questions and continued enthusiasm throughout the session.


If you attended the webinar, we'd love to hear your feedback. Your insights help us continue improving the series and ensure we're delivering practical, relevant content that supports the novel foods community.


We look forward to welcoming you back on 16th September for Part Three as we continue exploring the key components of a successful EU novel food dossier.




 
 
 

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