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Regulatory evaluation of the native ingredient before processing (plant, animal product, other source…) in EU Member States that specifically qualify it (positive/negative lists, potential doctrines…)

Procedure selection

  • Consultation process according to Regulation (EU) 2018/456
  • Traditional food from third countries process according to Regulation (EU) 2015/2283
  • Complete procedure according to Regulation (EU) 2015/2283

Scientific gap 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

Experts Recommendations

  • Strengths and weaknesses of the substantiation
  • Complementary elements to provide including additional toxicology and/or quality studies

File constitution & submission

  • Preparation of the file.
  • EC submission and EFSA assessment

Authorities follow up & exchange (EFSA & European Commission)

Want to learn more? Read our dossier on Novel food regulations.

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Novel Food June 2020
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