Health Claims

Service Details

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. A nutrition claim states, suggests or implies that a food has particular beneficial nutritional properties (e.g. high fibre, low fat, source of protein).

We can help you understand what you can legally say about your product and the relationship between ingredients and health benefits. We can also evaluate whether or not you can use an existing authorized claim, or if you need to do a health claim dossier to obtain approval to a new claim.

Our health claim service includes:

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 EFSA authority submission.

Authorities Communication Exchanges (Member states, EFSA & European Commission, FDA)