Novel foods

  • STEP I – Gap analysis (evaluation of the dossier admissibility).

    1. Scientific analysis of the data in accordance with Regulatory admissibility criteria

      • Safety data on the food/ingredients
      • Characterization data on the food/ingredients

    2. Strategy to follow

      • Strengths and weaknesses of the substantiation
      • Substantial equivalence route (this light procedure will no longer exist from 2018) or third country novel food route (this procedure will emerge from 2018) or complete novel food procedure
      • Complementary elements to provide including additional safety and/or quality studies

  • STEP II - Preparation and submission

    1. Preparation of the novel food file
    2. National authority (until end 2017) or EFSA (from 1st January 2018) submission and follow up
    3. EFSA and European Commission follow up

© 2019 Nutraveris | Contact | Legal