Scientific Gap analysis of the data in accordance with Regulatory admissibility criteria
- EFSA opinions and guidance on the same applications/ingredients.
- Clinical studies on the applications/ingredients
- Characterization data on the applications/ingredients
- Strengths and weaknesses of the substantiation
- Suggestion of alternative claims to apply, in line with your expectations, general EFSA requirements and available scientific data.
- Complementary elements to provide including additional clinical studies.
File constitution & submission
- Preparation of the health claim file.
- National then EFSA authority submission
Authorities follow up & exchange (Member states, EFSA & European Commission
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