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”.

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.

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.

The skin microbiota plays a vital role in maintaining the skin's integrity and functionality. It contributes to the proper regulation of organisms and organs, allowing the skin to perform its essential functions, including acting as a barrier. See our latest article "Why preservce the skin microbiota ?"

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