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
Authorities follow up & exchange (EFSA & European Commission)
Want to learn more? Read our dossier on Novel food regulations.
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.
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.).
No, the NF regulation is not applicable to: additives, flavourings, food enzymes, extraction solvents, GMOs.
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.
If a plant is included in the list of authorised plants, this does not mean that all preparations made from it are authorised.
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.
Yes, according to the Implementing Regulation (EU) 2018/456 on the steps of the consultation procedure for the determination of novel food status.
4 months, renewable once.
No, a mixture of several plant extracts, a bacterium, for example, can be the subject of an application.
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.
You are interestedContact Us
Dedicated Physiology & Toxicology PhD experts
The best expertise on the market
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.
EU & USA Regulatory Compliance & Notification
- Compliance analysis & adjustments of composition, rules of labelling, communications
- Label validation
- File development & submission to national authorities (EU only)
- Follow up & exchange through authorization
- Experts & artificial intelligence solutions
- The largest practice in the market (more than 4000 products authorized)
- Regulatory compliance (Formulation, claims..)
- Scientific support compliance (efficacy, interactions, safety...)
- Quality insurance evaluation (process, controls, analysis...)
- Export feasibility in other countries
- Strategic recommendations
- Experts in all these areas of expertise
- Regular practice for investment funds and on most recent deals