Novel Food
Novel foods refer to food products or ingredients whose human consumption in the European Union was negligible before May 15, 1997. These products must comply with strict regulations to ensure their safety and conformity before being placed on the market.
Pharmanager Development, expert reconnu en réglementation Novel Food, vous accompagne dans toutes les étapes clés : de l’évaluation du statut réglementaire à la constitution de dossiers scientifiques complets, en passant par la gestion des soumissions auprès de la Commission Européenne. Grâce à notre base de données Phinn®, nous vous apportons une veille précise et des solutions adaptées à chaque projet.
Novel Food status assessment
We analyze the specifications of your ingredients and manufacturing processes to determine whether they fall under Novel Food status. This critical step allows for a quick feasibility assessment and helps structure an appropriate strategy.
Consultation with an EU Member State
We assist you in preparing and submitting a consultation dossier to an EU Member State. This process determines the Novel Food status of your product in accordance with Article 4 of Regulation (EU) No 2015/2283.
Preparation of Novel Food dossiers
We compile comprehensive scientific dossiers, including bibliographic research, toxicological evaluations, and exposure analyses for target populations. For traditional foods from third countries, we conduct in-depth studies to justify their safety.
Electronic submission to the European Commission
We handle the electronic submission of your dossier to the European Commission and monitor the evaluation process, facilitating interactions with competent authorities.
Regulatory monitoring via Phinn®
With our Phinn® database, we help you anticipate regulatory changes and quickly integrate new updates from the Novel Food catalogue, ensuring continuous compliance for your products.
Pharmanager Development vous accompagne dans :
We assist you in the market launch of your Novel Foods. With our in-depth expertise, we guide you through all necessary steps to ensure the regulatory compliance of your products. We make sure your products meet the requirements of the competent authorities, facilitating their approval and market entry.
Our approach includes evaluating the regulatory requirements specific to your products, preparing the necessary dossiers, and analyzing and validating claims and labeling. By working with us, you maximize your chances of success by ensuring your products comply with regulatory standards while optimizing their market positioning.
Our answers to your questions
Can you conduct Novel Food assessments?
Yes, Pharmanager Development evaluates whether your product falls under Novel Food status by analyzing its history of use, composition, and manufacturing process. This assessment helps anticipate necessary procedures and ensures regulatory compliance.
What are the criteria for a product to be considered Novel Food?
The Novel Food status depends on its history of use, ingredient specifications, and manufacturing processes. A scientific assessment is essential to confirm this status.
How to obtain Novel Food authorization?
A comprehensive scientific dossier must be submitted to the European Commission, including safety evidence, bibliographic research, and toxicological analyses.
Why seek expert support for Novel Foods?
Working with an expert ensures strategic guidance, reduced processing time, and higher chances of obtaining fast approval.