Regulatory evaluation of the native ingredient before processing (plant, animal product, other source, etc) in EU Member States that specifically qualify it (positive/negative lists, potential doctrines, etc.).
Why do I need to submit a novel foods application?
Foods that were not consumed ‘to a significant degree’ in the EU before 15 May 1997 require an application for use. These foods must be safe for human consumption, and not mislead the customer in relation to nutritional value if there is the intention that this food will replace another.
The application requires:
– A complete description of the manufacturing process, safety protocols, and certifications
– A full analysis of the ingredient
– A calculation of human exposure (mean and 95th percentile exposure)
– Genotoxicity testing (a minimum of 2 studies)
– A 90-day sub-chronic toxicity study
– An evaluation of the potential allergenicity (if the ingredient contains proteins)
Unfortunately, the novel foods application process is very technical and requires expertise and time that’s not often available within an organization. Relying on our team of experts to assist with this process allows your team to focus on other objectives. Our knowledge of—and experience in—novel food applications ensures your application will meet all the regulatory requirements that EFSA and the European Commission need to approve your submission.
At FoodChain ID we work with you to select the right service for your product, from regulatory analysis to a consultation process and any submissions or follow-ups with EFSA. This removes the strain from your business, and at 50% of the typical cost, it allows budget to be made available for other projects.
From start to finish, using an expert to support your novel food application means you benefit from the knowledge we have gained from our years of experience.
- 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 Data in Accordance with Regulatory Admissibility Criteria
- Characterization data for the food/ingredients
- History of consumption for the food/ingredients
- Pharmacokinetic data for the food/ingredients
- Allergenicity data for the food/ingredients
- Safety/toxicological data for the food/ingredients
- Strengths and weaknesses of the substantiation
- Complementary elements to provide including additional toxicology and/or quality studies
File Preparation & Submission
- Preparation of the file
- EC submission
Communications with Authorities (EFSA & European Commission)
Bpifrance financial support
Bpifrance helps stimulate French business’ growth by offering loans, and awarding buyer and supplier credit to encourage business abroad. Of their latest packages, BPIfrance are offering support to entrepreneurs of the country to the value of up to 25k€ which can be utilised to support your Novel Foods project.
This support can enable you to gain the ability to utilise an organisation like FoodChainID and pay just 50%* of the costs that would typically be owed.
How to submit your dossier to Bpifrance
The application for funding must be done here https://app.bel.bpifrance.fr/subscribe/diag-accompagnement-innovation/company. After creating an account, you will have to provide the following documents:
– A description of the project
– An unsigned quote from FoodChain ID
– Your tax certificate of less than 3 months
– Your social security certificate of less than 3 months
– Your certificate of tax regularity
The amount of the service is fixed and amounts to a maximum of €50,000 excluding tax, of which 50% will be paid by Bpifrance (these 50% will be invoiced to Bpifrance by the consultant at the end of the service). The remaining 50% will be paid by the beneficiary company of the diagnosis.
In concrete terms, the system allows your company to pay only 50% of the investment without bearing the overall cost, the BPI taking the remaining 50% directly into account.