Health Claims

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

FAQ

Our experts answer the most frequently asked questions

What is a health claim?

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”.

How many generic health claims are allowed?

229

How to use outstanding generic health claims?

For most European countries, they can be used as long as they can be justified in case of control.

Must the wording of a claim be strictly adhered to?

It is recommended that operators should use as close as possible to the authorised wording. The wording cannot be “stronger” than the authorised claim.

How to make a claim on probiotics, as this term is considered as a health claim and is not authorized?

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).

What clinical data are necessary to apply/justify a health claim 13.5 or 14 to EFSA?

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.

Which health effects are most likely to win a positive opinion from EFSA?

Applications for which it is possible to measure an effect such as lipemia, blood glucose, bone mineral density, intestinal transit…

Does a health claim necessarily have to target a single ingredient?

No, as shown by the positive opinion of the Limicol® complex formulation.

How long does it take to evaluate a claim file?

It is on a case-by-case basis and generally 9-12 months.

Is it possible to communicate without a proprietary health claim?

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