Novel foods

We are used to work on pre-market authorisation of Novel Foods on the basis of an evaluation in line with principles edicted by European Union : your ingredient is safe for consumers, proprely labelled and not nutritionally disadvantageous versus another food it replace.

Service details

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

Authorities follow up & exchange (EFSA & European Commission)

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