Scientific Gap analysis of the data in accordance with Regulatory admissibility criteria
- EFSA opinions and guidance on the same applications/ingredients.
- Clinical studies on the applications/ingredients
- Characterization data on the applications/ingredients
- 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 & exchange (Member states, EFSA & European Commission
A health claim is “any claim which states, suggests or implies a relationship between a food category, a food or any of its constituents and health”.
For most European countries, they can be used as long as they can be justified in case of control.
It is recommended that operators should use as close as possible to the authorised wording. The wording cannot be “stronger” than the authorised claim.
It is possible to use “contains + [name of the microorganism]”, provided that the beneficial nutritional or physiological nature of the microorganism and the presence of a significant amount of the microorganism to produce the beneficial effect can be substantiated (dossier for substantiation of a nutrition claim contains).
Confirmatory clinical studies are required, all conducted on the same ingredient, at the same dosage, in a target population of subjects representative of the healthy general population, giving statistically significant results, on validated markers measured by validated methods, all demonstrating a benefit to human health.
Applications for which it is possible to measure an effect such as lipemia, blood glucose, bone mineral density, intestinal transit…
No, as shown by the positive opinion of the Limicol® complex formulation.
It is on a case-by-case basis and generally 9-12 months.
Of course thanks to generic claims, or by changing regulatory status (FSMP, drug…).
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