Regulatory Pathway Planner
Build a tailored regulatory timeline for your technology — EU Novel Food, US GRAS, pet food, or health claims — with cost and timeline estimates.
EU Novel Food Authorisation
Timeline
18–36 months
Est. Cost
€150K–€500K
Progress
0/5 stages
1. Pre-submission consultation with EFSA / national authority
Request a pre-submission meeting with EFSA or the relevant national competent authority (e.g., FSA in the UK, ANSES in France). Use this to validate your dossier structure and identify data gaps before you spend on studies.
This step is free or low-cost and can save 12+ months of rework. Do not skip it.
2. Safety data generation (toxicology, allergenicity, nutritional studies)
Generate the core safety data required for the dossier: 90-day repeated dose toxicity study, genotoxicity studies, allergenicity assessment, and nutritional composition analysis.
Use GFI's open-access safety data guidance for alternative proteins to scope your studies efficiently.
3. Dossier preparation and submission
Compile the full Novel Food dossier according to EFSA's guidance document. Engage a specialist regulatory consultant for dossier preparation.
EFSA's clock starts only when they accept your dossier as 'valid'. An incomplete submission can delay the process by 6–12 months.
4. EFSA scientific assessment
EFSA conducts its scientific assessment. They may issue requests for supplementary information (RSIs) during this period, which pause the clock.
Respond to RSIs as quickly as possible — delays in your response directly extend the timeline.
5. European Commission authorisation decision
Following a positive EFSA opinion, the European Commission issues the authorisation decision. This is published in the Official Journal of the EU.
The authorisation may include conditions of use (e.g., maximum levels, labelling requirements). Review these carefully before commercialisation.
The EU Novel Food process is the most rigorous in the world. The single biggest mistake is submitting an incomplete dossier — EFSA will put your application 'on the clock' only when they deem it valid. Engage a regulatory consultant before you begin.
Have I identified my regulatory pathway and included it in my Innovation Roadmap?
Have I budgeted for regulatory costs in my fundraise?
Have I engaged a specialist regulatory consultant?
Have I initiated pre-submission dialogue with the relevant authority?
Have I designed my safety studies to meet the authority's specific requirements?
Have I reviewed my label and marketing claims for compliance?
Have I considered running EU and UK processes in parallel (if relevant)?