Novel Food Application

Supplements Services

This service is part of our scientific and regulatory expertise in health nutrition to help you design and launch your products in Europe, USA and Asia, through a panel of services : novel food consulting evaluation, regulatory compliance and notificationhealth claims, etc.

Novel Food Application Services

We have significant experience in pre-market authorisation of Novel Foods on the basis of an evaluation in line with the European Union requirements that ingredients must be safe for consumers, properly labelled and not nutritionally disadvantageous versus another food it replaces.

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, etc)

Procedure Selection

Scientific Gap Analysis of 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

Expert 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)

Why us ?
  • Dedicated Physiology & Toxicology PhD experts
  • The best expertise on the market
Examples of Success in Novel Foods Dossiers

This first EFSA opinion obtained by Nutraveris* on curcuminoids demonstrates that some of the turmeric preparations currently on the market are clearly novel and should be authorized in accordance with the novel food regulation.

Nutraveris* obtained a new EFSA positive opinion for the authorisation as a NOVEL FOOD of AstraGin, a proprietary extract from Panax notoginseng and Astragalus membranaceus.

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.

Thanks to its substantial experience in the novel food process and management in Europe, Nutraveris* 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.

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. We have become a leader in the regulatory aspects of all microalgea products, either through the substantial equivalence procedure, but also by submitting full novel food applications.

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

Nutraveris* has worked with 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.

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. We have 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.

What are Novel Foods ?

A Novel Food remains defined in Regulation (EU) 2015/2283 as a food for which human consumption was negligible in the European Union before 15 May 1997, when the first novel food regulation came into force with Regulation (EC) 258/97.

The sources from which novel foods are derived are plants, animals, microorganisms, cell cultures, minerals, etc. Novel foods may come from specific categories of foods (insects, vitamins, minerals, food supplements, etc.), foods resulting from production processes and advanced practices and technologies (e.g. new or intentionally modified molecular structure, nanomaterials), which were not produced or used before 1997 and can therefore be considered as novel foods.

Latest news about Novel Food
  • Justification of the non-novel food character of each plant extract

    Justification of the non-novel food character of each plant extract
    Recently in Europe, many discussions recall the need to be able to justify the non-novel food character of each plant extract used in food supplements. On 27 May 2022, the Italian Authorities published a circular on “Indications on the use of plants and their parts in food supplements to ensure the safety and protection of citizens”, which …
  • EFSA: Cannabidiol novel food evaluations on hold pending new data

    EFSA: Cannabidiol novel food evaluations on hold pending new data
    Following the submission of numerous applications for cannabidiol (CBD) under the novel food regulation (19 received by EFSA, but more than 150 sent to the Commission), the Commission asked EFSA to give its opinion on whether CBD consumption is safe for humans. According to its statement published on 7 June 2022, EFSA cannot currently establish the safety of …
  • Positive opinion on the dried mycelia of Antrodia camphorata as novel food

    Positive opinion on the dried mycelia of Antrodia camphorata as novel food
    Antrodia camphorata (syn: A. cinnamomea) is a fungus species from Taiwan, described in 1995, but consumed for centuriesas food and beverages. Following a request from Golden Biotechnology Corp (), EFSA has evaluated the safety of freeze-dried mycelia from A. camphorata for human consumption. The novel food is intended to be used in food supplements at a …
  • Authorization of tetrahydrocurcuminoids marketed by Sabinsa as novel food

    Authorization of tetrahydrocurcuminoids marketed by Sabinsa as novel food
    A successful application managed by Nutraveris. The Commission implementing regulation (EU) 2022/961 of 20 June 2022 authorizes the use of tetrahydrocurcuminoids as novel food, known under the trademark Curcumin C3 Reduct®. This application prepared by Nutraveris, and submitted on behalf of Sabinsa Europe GmbH, has been submitted in January 2020. This regulation authorizes the use of …
  • EFSA validates the safety of vitamin D2 mushroom powder from Agaricus bisporus

    The EFSA Panel on Nutrition, Novel Food and Food Allergens has validated the safety of vitamin D2 mushroom powder from Agaricus bisporus. The Novel Food contains levels of vitamin D in the form of vitamin D2 in the range of 125–375μg/g and was intended to be used as ingredient in variety of foods and beverages, …

*Nutraveris became a FoodChain ID company in 2020. All the services, expertises and tools provided by Nutraveris are now available under the unique brand FoodChain ID.