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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

Authorities follow up & exchange (EFSA & European Commission)

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

What is a novel food?

A novel food is defined as a food for which human consumption remained negligible in the European Union before 15 May 1997, when the first regulation (Reg. 258/97) on novel foods came into force.

How do you market a novel food in the EU?

The marketing of a novel food/ingredient requires a prior European authorisation which stipulates the specifications of the novel food and its conditions of use (dose, food matrix, etc.).

Can the novel food procedure be followed for new additives, flavourings, food enzymes, extraction solvents, GMOs?

No, the NF regulation is not applicable to: additives, flavourings, food enzymes, extraction solvents, GMOs.

What are the only 3 possible options for a food ?

The ingredient is not “new” in the sense of Regulation (EU) 2015/2283, it is, or the ingredient is a traditional food in a third country.

Is any preparation whose plate is on a national list allowed?

If a plant is included in the list of authorised plants, this does not mean that all preparations made from it are authorised.

A low hydroalcoholic preparation of an authorised plant and plant part is necessarily traditional and not NF ?

No, it must be possible to prove on a case-by-case basis that this type of preparation was significantly consumed before 1997 in the EU.

In case of doubt about the NF status of an ingredient, can the authorities help me?

Yes, according to the Implementing Regulation (EU) 2018/456 on the steps of the consultation procedure for the determination of novel food status.

How long is the consultation procedure?

4 months, renewable once.

Is an NF necessarily an extract of a plant?

No, a mixture of several plant extracts, a bacterium, for example, can be the subject of an application.

Are extracts of Cannabis sativa or cannabinoids authorised because they are already on the market?

No, the Commission is very clear, extracts of Cannabis sativa L. and derived products containing cannabinoids are considered as novel foods because no history of consumption has been demonstrated.

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Novel Food June 2020
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