How to scientifically and regulatory validate a probiotic or postbiotic Strain (EFSA, FDA)?

What are the requirements for marketing a probiotic or postbiotic strain?

Developing supplements or functional foods containing a biotic strain involves much more than simply demonstrating their effectiveness. This process is essential for obtaining regulatory approvals from authorities such as the European Food Safety Authority (EFSA) and the U.S. Food and Drug Administration (FDA) :

From prebiotic to LBP: Measuring functional effects in the gut microbiome

An imbalanced microbiome is not only characterized by a lack of diversity or abundance of species. What truly matters are the functions expressed:

How to prove the efficacy of a probiotic or postbiotic using genomics?

Biotics — whether prebiotics, probiotics, or postbiotics — are at the core of nutritional and therapeutic strategies aimed at preserving or restoring gut microbiota balance. However, with increasing regulatory requirements (EFSA, FDA) and growing market competition, it is crucial to demonstrate their efficacy through robust scientific evidence.

GenoScreen and Clear Labs Announce the Launch of Clear Dx™ Deeplex® Myc-TB, an Automated Genomic Solution for Mycobacterium Characterization and TB Drug Resistance Detection

GenoScreen announces the launch of Clear Dx™ Deeplex® Myc-TB, developed in collaboration with Clear Labs.

What is the QPS list?

The European Food Safety Authority (EFSA ) plays a crucial role in ensuring the safety of the food and feed supply chain. A key element in this process is the Qualified Presumption of Safety (QPS) list.

Updated guidelines for Novel Food submissions (EU) 2015/2283

The 1st of February 2025 entered into force the “Guidance on the scientific requirements for an application of a novel food in the context of Regulation (EU) 2015/2283”.

What is EFSA?

EFSA stands for the European Food Safety Authority. It is essentially the scientific supervisor of the European Union when it comes to food.
EFSA’s purpose is to ensure that the food Europeans eat is safe and meets high quality standards.
To do so, they provide objective and unbiased scientific assessment of food-related risks.

Subcategories

GenoScreen is a partner in collaborative research projects that bring together startups, multinationals and public-sector organizations. Our R&D teams provide their knowledge and expertise in the molecular microbiology of isolated agents and complex communities. This allowed our teams to develop our own projects for elaborating innovative products and services.

Our projects are designed to:

  • Improve the diagnosis and management of acute/chronic diseases on humans and animals,
  • Characterize and monitor microbial biodiversity, with applications in agronomy, agrifood and environment.

The common feature of these projects is the development of molecular tools for the characterization, monitoring and diagnosis of microbial communities. The key objective is to market simple analytical solutions and (ultimately) preventive, corrective or even therapeutic products based on microorganisms.

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