This service is part of our scientific and regulatory expertise in health nutrition to help you design and launch your products in Europe, USA and Asia, through a panel of services : novel food consulting evaluation, regulatory compliance and notification, health claims, etc.
A claim is any message or representation, not required by international or national legislation, including representation in the form of pictorial, graphic or symbolic matter in any form, which states, suggests or implies that a food has particular characteristics. A health claim is any claim which states, suggests or implies a relationship between a category of food, a food or one of its constituents and health. Finally, a nutrition claim is, for example, when a source of, or rich in, is indicated for a nutrient or substance.
We provide service to help you understand what you have the right to say about your product and his relationship between ingredients and health benefit. We analyze if you can use a already known and authorized claim, or if you need to do an health claim dossier to obtain a new one.
Our health claim service is structured as following :
Scientific Gap Analysis of Data in Accordance with Regulatory Admissibility Criteria
- EFSA/FDA opinions and guidance on the same applications/ingredients
- Clinical studies on the applications/ingredients
- Characterization data on the applications/ingredients
Expert Recommendations
- Strengths and weaknesses of the substantiation
- Suggestion of alternative claims to apply, in line with your expectations, general EFSA requirements and available scientific data.
- Complementary elements to provide including additional clinical studies.
File Constitution & Submission
- Preparation of the health claim file.
- National then EFSA authority submission.
Authorities Follow-up and Exchange (Member states, EFSA & European Commission, FDA)
A claim is any message or representation, not required by international or national legislation, including representation in the form of pictorial, graphic or symbolic matter in any form, which states, suggests or implies that a food has particular characteristics. A health claim is any claim which states, suggests or implies a relationship between a category of food, a food or one of its constituents and health. Finally, a nutrition claim is, for example, when a source of, or rich in, is indicated for a nutrient or substance.
