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.


New Financial support up to 25K€ from BPI France to submit a novel food application : learn more


 

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
  • Novel Food : An aqueous ethanolic extract of Labisia pumila recognized as safe by EFSA

    Novel Food : An aqueous ethanolic extract of Labisia pumila recognized as safe by EFSA
    A new novel food application managed by Nutraveris/FoodChain ID recognized as safe by EFSA The company Medika Natura Sdn. Bhd., based in Malaysia, has submitted a novel food application to request the authorization to put on the EU market an aqueous ethanolic extract of Labisia pumila (Trade name of the extract: SKF7®). This application, managed by …
  • EFSA recognizes cellobiose as safe for human consumption

    EFSA recognizes cellobiose as safe for human consumption
    Cellobiose is a disaccharide consisting of two glucose monomers linked by a β-(1-4) glucosidic bond. The company SAVANNA Ingredients GmbH has submitted in May 2020 a novel food application to request the use of cellobiose in a range of food categories. In its opinion, EFSA notes that the manufacturing process, compliant with GMP and HACCP principles, …
  • How to avoid a negative opinion from EFSA on a novel food application : case study

    How to avoid a negative opinion from EFSA on a novel food application : case study
    EFSA has just published a scientific opinion on the safety of β-hydroxybutyrate (BHB) salts as novel foods. Safety of b-hydroxybutyrate salts as a novel food pursuant to Regulation (EU) 2015/2283 Abstract from the EFSA Scientific Opinion Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver …
  • 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 …

*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.