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

Experts Recommendations

  • 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

White Paper
Health Claim June 2020
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