Health claim dossier

Objective

The objective of a health claim dossier is to provide scientific evidence (randomized, double-blind, placebo-controlled clinical study(s)) of the efficacy (ingredient + dosage + target population + statistically significant results + validated marker/method + health benefit) of a food or a well characterized ingredient.
A relationship is established between the consumption of the food/ingredient and the claimed effect (for the target group under the proposed conditions of use).

The 3 main criteria for evaluation of a claim application dossier by EFSA

Characterization of the ingredient

Characterization Specifications, stability, variability, production process, quality, bioavailability…

Only a minority of cases are rejected for insufficient characterization.

Beneficial health effect

The consumption of the product must provide a beneficial effect on health, measured on a target population.

Only a few health relationships (diuretic, increase in breast size) are not accepted by EFSA.

The scientific justification

Clinical evidence that the product, at its dosage, for the target population, provides a beneficial, statistically significant effect, as measured by validated methods and markers.

This is the main reason for the rejection of claims.

Which markers, measured by which methods?

It is necessary to cross-reference EFSA’s guidelines and opinions on the targeted health effect.

Guidance on scientific requirements for health claims :

  • the functions of the nervous system, including psychological functions
  • physical performance
  • bone, joint, skin and mouth health
  • appetite assessment, weight management and blood glucose levels
  • the immune system, the gastrointestinal tract and defense against pathogenic microorganisms
  • antioxidants, oxidative damage and cardiovascular health

How to assess the quality of clinical data?

Study design :

Clinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research involving humans.

Characteristics of participants

Settings

Interventions

Outcomes

Sample size calculation and primary outcome(s)

Randomization

Blinding

Identification of winning applications

For the claims in Art 13.5 and 14, these are the applications for which it is possible to measure an effect:

  • In healthy subjects (not treated with medication) (with blood pressure, cholesterol, bone mineral density, glycemia, …)
  • With markers and methods (those above)
  • Nutrients (vitamins, minerals, fatty acids, amino acids…)

For example, for a request for a claim related to nutrients and cardiovascular, bone and digestive health, a priori there is a strong chance of being accepted.

Specific case of probiotics

Almost all requests for generic claims (art.13.1) on probiotics were systematically rejected due to insufficient characterization (in 2009). A few claims nevertheless remain outstanding.

However, since then (as of 2010 and even in art. 13.1), probiotics have been sufficiently characterized (the reason for the negative opinion relates to evidence of efficacy):

The food constituent that is the subject of the health claim is Lactobacillus fermentum CECT5716. The Panel considers that Lactobacillus fermentum CECT5716 is sufficiently characterised.

The EFSA guide 2016 [4367] defines how to characterize a microorganism (bacterium or yeast).

In terms of efficacy: Probiotics are “live microorganisms that, when administered in adequate amounts, confer a health benefit on the host” (Hill, 2014).
Like any active ingredient (plants, substances…), efficacy is strain-, dose-, subject-dependent.

Conclusion

Do you need a health claim?

Maybe not if :

  • a generic claim is sufficient
  • Your health product is not a food but depends on another regulatory status (MD, FSMP, drug…).
  • Your brand is sufficiently strong or evocative


To claim easily, you can use generic claims 13.1 or 14 (disease risk, children), or pending claims (+2000) and being able to justify it through a scientific dossier

To differentiate from competitors, use specific claims 13.5 and 14 and file a claim file.

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