Novel foods in Europe are defined as foods that have not been consumed to a significant degree by humans in Europe before 15 May 1997.
Before placing such foods on the market, a full marketing authorisation is required with the aim of demonstrating the safety of the food under the proposed conditions of use.
There are two authorization routes:
Traditional food from third countries applications
This application is used to authorize products that have been continuously used for at least 25 years in the customary diet of a significant number of people in at least one third country.
Full application
The applicant must demonstrate the safety of the novel food under the proposed conditions of use. The data needed to carry out the safety assessments of novel foods is presented in a dossier whose main sections includes:
- Identity of the novel food
- Production process
- Compositional data
- Specifications of the novel food
- The history of use of the novel food and/or of its source
- Proposed uses and use levels and anticipated intake
- Absorption, distribution, metabolism and excretion
- Nutritional information
- Toxicological information and allergenicity
Some examples of novel foods include new sources of nutrients, new extracts from existing foods, insects, new substances, traditional products from third countries, new production processes etc. It does not include additives, GMOs, solvents or enzymes.
The RNI team is here to support you at all stages of your project. We will guide you through the entire novel food process in the EU and UK, considering commercial, regulatory and scientific aspects in order to get your new ingredient to market efficiently, quickly, strategically and in full compliance.
Our novel food services include:
Determination of the novel food status of your ingredient including consultation with authorities
Evaluation of the nutritional value of the ingredient
Toxicological and safety review of your ingredient
Gap analysis looking at the necessary data for the development of the novel food dossier
Writing all sections of the novel food dossier
Submission of your novel food dossier to the authorities and actively manage follow up questions
Questions about the procedure in the USA? Do not hesitate to read our article on GRAS and NDI in the USA. Question about other equivalent procedures worldwide, please contact us.
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