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…)
- 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
- 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 and EFSA assessment
Authorities follow up & exchange (EFSA & European Commission)
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What is a Novel Food ?
Novel Food is defined as food that has not been consumed to a significant degree by humans in the EU prior to 1997, when the first Regulation on novel food (Reg 258/97) came into force.
Novel Food can be newly developed, innovative food or food produced using new technologies and production processes as well as food traditionally eaten outside of the EU.
Examples of Novel Food include agriculture products from third countries (chia seeds), newly produced nutrients (synthetic zeaxanthin) or extracts from existing food (rapeseed protein).
The marketing of a novel food requires a prior European authorization that stipulates the specifications of the novel food and its conditions of use (dose, food matrix, etc.).
There are only 3 possible options for an ingredient:
OPTION 1 The ingredient is not "novel" under Regulation (EC) No 2015/2283:
YES: no need to apply for an authorization BUT justification could be required
(novel food list, novel food catalogue, national lists, etc...)
NO: option 2.
OPTION 2 The ingredient is "novel" under Regulation (EC) N0 2018/2283:
Ingredient not authorized: full Novel Food procedure
Ingredient consumed in a third country: option 3
OPTION 3 The ingredient is a traditional food third countries:
YES: traditional food from third countries procedure
NO: option 2
EU Novel Food CatalogueAuthorize Food supplement Forbidden information required
Nutraveris in EFSA Journal
With our Novel Food success. Source https://efsa.onlinelibrary.wiley.com/
Abstract The present scientific opinion deals with the safety of orthosilicic acid‐vanillin complex (OSA‐VC) as a novel food ingredient for use as a source of silicon (Si) in food supplements and with the bioavailability of Si from this source. OSA‐VC is stable in liquid solution at low pH values. OSA from OSA‐VC was available as revealed by the increase in plasma Si concentrations after oral ingestion in human volunteers. The toxicological data provided in support of the current application were not in accordance with the Tier 1 requirement of the ‘Guidance for submission for food additive evaluations’; however, this was considered justified by the Panel given that OSA‐VC at pH 6.8 dissociates into orthosilicic acid and vanillin. The daily consumption of OSA‐VC at the dose recommended by the applicant would provide a supplemental intake of Si of approximately 10–18 mg Si/day which would result in an estimated total intake of roughly 30–70 mg Si/day. The maximum vanillin intake resulting from the consumption of OSA‐VC would be less than 5% of the acceptable daily intake (ADI) value for vanillin of 10 mg/kg body weight (bw) per day established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 2002. The Panel concluded that there would be no safety concern with the proposed use and use level of OSA‐VC as a novel food ingredient intended to be used as a source of Si in food supplements for the adult population. The Panel concluded that OSA, measured as Si, is bioavailable following ingestion of OSA‐VC and appears similar to values reported in the literature for other established sources of OSA.EFSA Journal, Volume 16, Issue 1, January 2018.
Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on heat‐killed Mycobacterium setense manresensis as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is an encapsulated ingredient composed of 200 mg mannitol and ≤ 105 heat‐killed, freeze‐dried M. setense manresensis. The information provided on the efficacy of the heat inactivation process demonstrates that the applied thermal process effectively kills all M. setense manresensis. The Panel considers that the NF is sufficiently described and characterised. The NF is intended by the applicant to be marketed exclusively in food supplements (gelatine capsules) for the general adult population excluding, children, pregnant and lactating women. The NF is not intended to be an alternative to standard treatment against tuberculosis. The applicant proposed an intake of one capsule (with ≤ 105 heat‐killed, freeze‐dried M. setense manresensis) for 14 consecutive days and a minimum of 6 months with no consumption of the NF, before another intake for fourteen days may follow. M. setense is not considered to be a suitable microorganism species for the qualified presumption of safety (QPS). Genetic analyses of the genome indicate the absence of the ability to produce exotoxins. The Panel considers that consumption of heat‐killed M. setense manresensis would not contribute to the pool of transmissible antimicrobial resistance genes already present in the intestinal microbiota. The Panel concludes that the NF is safe under the proposed conditions of use.EFSA Journal, Volume 17, Issue 11, November 2019.
I would highly recommend Nutraveris. They have delivered regulatory service beyond what was expected (and quoted!). I trust the Nutraveris team to deliver the most up to date and relevant information. During a very challenging EU Novel Food application – the Nutraveris team, particularly my individual consultant, was able to navigate a strategy with positive results. In fact, our project was completed within budget and ahead of schedule. I would not hesitate to engage Nutraveris on any of our future EU projects.
Nutraveris offered tailored support to find optimal solutions for the challenges that our company needed to face, offering accurate and up-to-date advice in the continually evolving regulatory environment of the food supplements. Nutraveris experienced team, successfully provided guidance along the way and acted as a contact with EFSA. Our experience working with Nutraveris has been outstanding from beginning to end. We strongly recommend considering Nutraveris services in any challenge your company may face in the future.
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