Novel foods

Consultation process

Evaluation of the novel food status of an ingredient according to the Commission Implementing Regulation (EU) 2018/456

  • STEP I – Gap analysis (evaluation of the dossier admissibility).
    1. Scientific analysis of the data in accordance with Regulatory admissibility criteria
      • Characterization data on the food/ingredients
      • History of consumption on the food/ingredients
    1. Strategy to follow
      • Strengths and weaknesses of the substantiation
      • Complementary elements to provide
  • STEP II - Preparation and submission
    1. Preparation of the novel food status analysis 
    2. Submission and follow up with authorities (national and Commission).

 

Novel Food third countries / Traditional food from third countries

Novel ingredients according to Regulation (EU) 2015/2283 but with a history of safe use as foods in third countries

  • STEP I – Gap analysis (evaluation of the dossier admissibility).
    1. Scientific analysis of the data in accordance with Regulatory admissibility criteria
      • Characterization data on the food/ingredients
      • History of consumption on the food/ingredients
    1. Strategy to follow
      • Strengths and weaknesses of the substantiation
      • Complementary elements to provide
  • STEP II - Preparation and submission
    1. Preparation of the novel food third countries application 
    2. Submission and follow up with authorities (Commission and EFSA).

 

Novel Foods

Novel ingredients according to Regulation (EU) 2015/2283

  • STEP I – Gap analysis (evaluation of the dossier admissibility).
    1. Scientific analysis of the data in accordance with Regulatory admissibility criteria
      • Characterization data on the food/ingredients
      • History of consumption on the food/ingredients
      • Pharmacokinetic data on the food/ingredients
      • Allergenicity data on the food/ingredients
      • Safety/toxicological data on the food/ingredients
    1. Strategy to follow
      • Strengths and weaknesses of the substantiation
      • Complementary elements to provide including additional safety and/or quality studies
  • STEP II - Preparation and submission
    1. Preparation of the novel food file
    2. Submission and follow up with authorities (Commission and EFSA).

 

 

 

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