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Webinar | Navigating EU novel food regulation: an investor's guide
Europe’s novel food sector offers a key opportunity to unite technological progress and economic growth with the transition to a more sustainable food system. To address this, Invest-NL and Forward Food Law, in partnership with GFI Europe, have developed a regulatory framework that maps the various routes to market access, including alternative pathways such as pet food or non-EU markets.
This webinar covers different pathways to commercialising a novel food on the European market and includes insights on costs, timelines, practical tips, and concrete examples.
Link to the framework: https://www.invest-nl.nl/en/news/new-framework-on-european-regulations-for-innovative-foods
Contact us with any further questions: europe@gfi.org
00:00 Intro
03:35 Why this framework
8:13 The core challenge
10:48 Strategic insights
12:13 All regulatory routes
13:30 Route 1: Food ingredients with a long history of consumption
22:47 Route 4C: Novel food dossier under Article 10
31:29 Alternative scenarios
32:02 GMO products
32:51 Supporting tools & resources
35:23 Q&A session
35:23 What is the breakdown of the €1M costs for the Route 4C?
37:05 How can we make sure we have better dossiers from the get-go?
38:30 Does having a GRAS notification help obtain novel food approval in the EU? And what about the other way around?
40:24 Are there big differences in the cost amounts between the different jurisdictions?
42:00 How is it judged whether a food does or does not fall under the novel foods framework?
42:52 Will the BioTech Act change anything?
44:05 Any considerations on gene-edited ingredients which were modified through gene silencing/deletion (CRISPR) - is it considered a detectable DNA modification or could it pass as non-GMO?
45:06 If the food has a non-novel status, but the current conventional process is not publicly accessible through EFSA, what can one do to confidently guarantee (investors/RA) that no significant changes between their processes and the conventional one are in place?
46:24 Can I get advice from the EC or EFSA?
48:08 Same question, but for other jurisdictions?
49:20 Within the framework of research projects in the European Union, can one submit projects for funding, in which one of the substances used is obtained by precision fermentation (cellular) and is currently not authorised as a novel food ingredient?
50:53 If a traditionally processed plant ingredient is labelled as ‘protein’ rather than ‘flour’ or ‘seed’, could that naming alone influence a Novel Food assessment, even if the production process itself is not novel?
51:59 What are the analytical needs in the regulatory journey that are currently not met or frequently raise questions by EFSA?
54:03 Is the list of approved novel foods public?
55:32 How can companies prevent their competitors from selling their novel foods?
56:42 What does it mean if a food is described in the EU Novel Food status Catalogue as ‘Not novel food Whole (as a characteristic ingredient)’
58:15 Comparison of the costs between jurisdictions
59:00 What would be your number 1 recommendation to startups in the novel food space?
01:01:40 If a company has already received an approval, can this serve as a guideline for another startup to shift their solution toward something similar, to make the approval process easier?
01:02:52 Could you comment on how the data should be made availble in the company for EFSA to consult it during a diligence on a self-stated non-novel status assessment?
01:05:10 Outro
