CASE STUDY: Supporting a Major Food Ingredient Company in Obtaining a Novel Food Approval by EFSA
The Challenge
A major player in the food and feed ingredients industry has developed a new supplement. Its aim is to enhance human nutritional intake.
Since this product was derived through a new process, it qualified as a Novel Food in Europe. The supplement required authorization from the EU Food Safety Authority (EFSA) before it could get to the market. The authorization process can be complex and time-consuming, with several back-and-forth with EFSA.
The company needed a partner that could handle the approval process from A to Z. From understanding the requirements and dialoguing with Food safety authorities to providing experts advice and analytical results.
The Action
Mérieux NutriSciences’ Novel Food Experts and Project Managers worked jointly with the company Innovation Centre to:
- Assess the required information for the Dossier and validate an analytical plan;
- Perform functionality studies : genetic modification steps description, bioavailability of the molecules, nanocharacterization of the product through all phases of the human digestion;
- Perform a comprehensive risk assessment, encompassing toxicological assessment and determining the TDI (Total Daily Intake) through in vivo and clinical studies;
- Compile the necessary data and technical information requested by EFSA for the Dossier;
- Address any additional inquiries from EFSA and manage discussions related to the risk assessment.
The Results
With the help of Mérieux NutriSciences’ expertise, the company got a successful and swift product approval. This enabled them to enter the market promptly. The main benefits of this collaboration included:
- PRODUCT EXPERTISE: Our scientific team comprehends the complexity of new products and processes and adapts the analytical plan and information accordingly to deliver the most suitable solutions.
- ANALYTICAL AND SPECIFIC STUDIES: We possess state-of-the-art capabilities specifically tailored for such studies, including in vitro absorption modeling and nanocharacterization.
- FAST TRACK: Our experts actively participate in numerous associations and workgroups associated with Food Safety Authorities, which grants them a wealth of knowledge regarding the information that is likely to be requested. As a result, this reduces the need for back-and-forth discussions and inquiries during the approval process.
