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)
The best expertise on the market
Relevant sources
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/dayYou may also like
Novel foods
Scientific serviceTo evaluate the regulatory status of the native ingredient before processing.
Procedure selection, Scientific gap analysis of the data in accordance with Regulatory admissibility criteria, Recommandations, File constitution & submission.
Regulatory texts we are working with
Regulatory Compliance
Regulatory serviceTo declare the placing on the market of your food supplements to the national authorities.
Formula analysis, labeling compliance and notification of your product for Europe and USA
- Austria
- Belgium
- Bulgaria
- Croatia
- cyprus
- Czech Republic
- Denmark
- Estonia
- Europe
- Finland
- France
- Germany
- Greece
- Hungary
- Ireland
- Italy
- Latvia
- Lithuania
- Luxembourg
- Malta
- Monaco
- Netherlands
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
- Switzerland
Health Claims
Scientific serviceDetermine whether you need a specific claim and if so, prepare and submit the claim file.
Scientific Gap analysis of the data in accordance with Regulatory admissibility criteria, reccommendations of our experts, file constitution and submission.
Regulatory texts we are working with
Food Additives
Scientific serviceEvaluation of the regulatory status of the food additive, within the European Union.
Regulatory texts we are working with
Scientific review / medical writing
Scientific serviceResearch, analysis and synthesis of all data related to the efficacy/ physiological effect/safety of ingredients when taken orally, according to existing scientific literature published in peer reviewed journals and according to regulatory requirement in force.
Quality
Regulatory serviceElaboration of specifications for manufacturing subcontracting: Standards, Rules, Responsibilities, Documentation.
Formulation
Scientific serviceFormulation development according to appropriate regulatory conditions (regulatory status, specific countries, claims), specific requirements (galenic form, quality, price), health benefits and safety
Clinical study protocol
Scientific serviceWe are recognized as one of the leaders in designing EFSA compliant clinical study protocol design aiming to substantiate Health Claim or Novel Food authorizations
Training
Regulatory & Scientific servicesThanks to its certification as a professional training organization, scientific and regulatory experts from Nutraveris offer you personalized training sessions in Nutrition and Health
Due Diligence
Regulatory & Scientific servicesRegulatory compliance review (Formulation, claims..), Scientific support compliance (efficacy, interactions, safety…), Quality insurance evaluation (process, controls, analysis…), Export feasibility in other countries, Strategic recommendations
Strategic survey
Scientific serviceStrategic Regulatory, Quality & Scientific Intelligence (Ingredients, Product categories, Health applications, Claims, Countries)