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.
Regulatory overview
Navigate through the categories of claims (authorized, pending, non-authorized), regulatory updates, and tips from our experts.
Read our full article
Health claim procedure
Do you need a claim? How do you establish a claim file? What is the point of having a specific claim?
How and why to prepare an health claim dossier
Register of health claims
Find the list of permitted, pending and prohibited claims directly on the EU website.
News on claims
- A positive opinion from EFSA on a health claim: kiwi and transit
- European case law on the need for scientific justification to be able to use on hold health claims
FAQ
Our experts answer the most frequently asked questions
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”.
229
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…).
Need help?
Our experts offer dedicated services:
Health Claims:
File constitution & submission
Scientific review/medical writing:
Efficacy & Safety literature review