EFSA

Dossier for EFSA: Proving Health Claims with Confidence

How can a health claim for a product be scientifically validated? The gold standard for such proof is a multitude of multicentric, randomized, placebo-controlled, double blind intervention studies lasting several decades. However, this method is rarely feasible due to the immense time and financial investment required. Instead, EFSA (European Food Safety Authority) accepts  scientifically established alternatives: evaluating specific effect-related biomarkers. These biomarkers provide credible evidence that a desired health effect is likely triggered by consuming a particular substance. For example: The reduction of F2-isoprostanes excretion after consuming vitamin C is recognized as valid proof  for its antioxidant effect.
This approach relies on identifying and measuring a single biomarker in human subjects (in vivo) to support health claims.

Our Innovative Approach

At Institut Kurz, we take this one step further. Instead of solely relying on a single biomarker, we propose a more comprehensive, scientifically robust method:

In Vitro Testing

We analyze the full range of responses that human organ cells exhibit when exposed to the active compounds in your product.
This allows us to capture a broad spectrum of potential effects at the cellular level.

 In Silico Modeling

Using the in vitro results, we employ advanced computational models to simulate the body-wide response to the tested compounds.
This approach integrates data across multiple systems, providing a holistic understanding of the substance’s potential effects on the human body.

Why This Approach Matters

Comprehensive Insights
Unlike a single biomarker, our method evaluates a multitude of cellular responses, offering a more complete picture of a product’s efficacy.

Credibility 
The combined in vitro and in silico testing approach is as reliable—if not more reliable—as short-term in vivo studies using isolated biomarkers.

Efficiency 
This approach provides robust data for health claim validation in a fraction of the time and cost of traditional long-term studies.

EFSA-Ready
Data  Our results meet the high scientific standards required by EFSA, ensuring your claims are backed by credible, cutting-edge evidence.

Let’s Build Your EFSA Dossier

At Institut Kurz, we specialize in helping you navigate the complex regulatory landscape and provide the scientific data needed to support your health claims. Contact us to discuss how our innovative testing methods can streamline your path to EFSA approval.

info@institut-kurz.com