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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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The best expertise on the market
Example of Novel foods success
EFSA positive opinion for the authorisation as a novel food of AstraGin
Nutraveris obtain a new EFSA positive opinion for the authorisation as a NOVEL FOOD of AstraGin, a proprietary extract from Panax notoginseng and Astragalus membranaceus.
Novel food approvals for two innovative chia seed extracts - 2020
Nutraveris has obtained 2 new approvals for specific chia seeds extracts (Salvia hispanica L.). Submitted as soon as the new novel food regulation was in place, these two applications were related to the use of Chia seed fibers and Chia seed Proteins in food supplements and in a range of foodstuffs. In its opinion, EFSA considered that both ingredients were safe for human consumption.
Novel foods: a new success for Nutraveris – 08/01/2018
Thanks to its substantial experience in the novel food process and management in Europe, Nutraveris has just obtained a new success for the Belgian company Eytelia sprl. And their innovative source of silicon (orthosilicic acid-vanillin complex). Following a complete evaluation of the application, with deep and important discussions on all the aspects of a novel food application (i.e. characterization of the ingredient, bioavailability and safety), the European Food Safety Authority (EFSA) has recognized that this silicon source is safe for human consumption.
Korean menopause botanical blend wins EFSA backing - 26/10/2016
Nutraveris has worked with the Korean company Naturalendo Tech Co., Ltd in order to obtain the authorization to put EstroG-100® on the European market. Estro-G100® is a hot-water extract of a mixture of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz and Angelica gigas Nakai), already used in Korea, USA and Canada for the management of menopausal symptoms. EFSA has now recognized that EstroG-100® is safe for the use of food supplements intended for post-menopausal women.
US firm wins EU Novel Foods approval for vitamin K2 - 24/07/2015
After successes in health claim approval, Nutraveris experts have obtained a new European Novel Food authorization for Vitamin K2 oil from Vesta Ingredients Inc. of Indianapolis in the USA. Nutraveris has constituted and submitted for evaluation an application for an opinion under Article 3.4. of the novel food Regulation (EC No. 258/97) on the substantial equivalence of Vesta vitamin K2 oil (MK-7) 1,500 ppm to the same ingredient previously authorised to NattoPharma by Commission Decision 2009/345/EC.
Substantial equivalences for DHA rich oils from Schizochytrium sp. – 2015-2018
Nutraveris experts have obtained several European Novel Food authorizations for DHA-rich oils for various international companies, such as Fermentalg (France), Bioplus Life Sciences (India), Polaris (France) or Changsha SunnyCare Inc. (China), etc. Nutraveris has become a leader on the regulatory aspects of all microalgea products, either through the substantial equivalence procedure, but also by submitting full novel food applications.
Substantial equivalence for coriander seed oil – 2017
Following a substantial equivalence application, Nutraveris has obtained an approval for the coriander seed oil manufactured by Ovalie Innovation (France). The application, constituted and submitted in accordance with Regulation (EC) No 258/97 has been evaluated by the Food Safety Authority of Ireland. After evaluation, the coriander seed oil has been authorized for use in food supplement with a maximum dose of 600 mg/day




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