21/01/2026 — Staphyt, a leading contract research organization (CRO) and regulatory affairs consultant for agricultural experimentation and risk assessment, and GenoScreen, a pioneer and specialist in genomic and bioinformatics solutions, are pleased to announce the signing of a strategic collaboration agreement.

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.

Following its agenda to regulate the Food and Feed industry with up-to-date regulatory texts, the EFSA significantly raised the technical expectations for the characterisation and risk assessment of microorganisms used in food and feed. As of November 4th, 2025, dossiers that rely on outdated genomic analysis, incomplete resistance screening or legacy databases may no longer meet regulatory expectations.

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) :

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.

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

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”.

By continuing your visit to this site, you accept the use of statistics cookies