NutriClaim’s Health Claims performance at a glance

Up to date (May. 2014) NutriClaim is/has been involved in approx. 30 health claim projects, for 13 of which a full dossier has been submitted to EFSA. The current status of the 13 submissions is presented in the table below.

Article 13.5 & Article 14 Health Claim submissions to EFSA

EFSA evaluations

  • Positive evaluations


  Success rate


Evaluation in progress  0
Submitted – under evaluation*  4
Submission after second opinion

  • Positive evaluation


Total 14
* concerns article 14 children claims that were put on hold
in 2008 and for which evaluation is now proceeding.

In addition, NutriClaim delivered 2 second opinions/pre-submission checks to third-parties. One of them proceeded towards submission. A cause and effect relationship was established!

Getting into the ‘mindset’ of EFSA
Adopting an ‘EFSA view’ on the science backing your Health Claim is at least as important as the science itself. There is more to a successful health claim application than science alone. Getting into the mindset of EFSA greatly enhances your chances of success.

Double-faced Science?
Science is not always that conclusive as it may appear. Nor is it always inconclusive as EFSA may judge. The balance between cause and effect relationship established/not established is a delicate one. Data are what they are – they cannot be changed. However, an independent and creative interpretation may change their message such as to tip the scales.

‘Hole-in-one’ vs. ‘Learning by doing’?
The proverb ‘Learning from Error’ was introduced by Karl Popper, one of the greatest philosophers of science, to describe the process of the advance of scientific knowledge.

Notwithstanding the attractiveness of his theory in general, you want your health claim application to be a hole-in-one. A ‘learning-by-doing’ approach not only is far to costly – it will also substantially delay your competitive advantage.

Redoing peer-review!?
A successful scientific study is more than a statistically significant outcome! For sure, the scientific literature contains a host of very sound science. Still, however, the mere fact that a scientific paper is published in a peer-reviewed journal is not a guarantee for the paper being accepted by EFSA in the context of  health claim substantiation.

Important aspects, such as study design & statistics, biomarker/risk factor, methods/tests applied to measure primary endpoint, etc.  may be percieved differently which, as experience has learned, may cripple your RCT in the eyes of EFSA’s NDA-panel.