Efficacy and safety
The Novel Food status, defined by European regulations, applies to foods or ingredients not significantly consumed within the European Union before May 15, 1997. To obtain this status, a product undergoes rigorous safety evaluation by the European Food Safety Authority (EFSA), including analyses of its composition, mechanism of action, safety, and absence of health risks.
Clostridium butyricum CBM588® has achieved Novel Food status, allowing its commercialization in Europe, supported by a scientific dossier demonstrating its non-pathogenicity and safety as a probiotic strain. Toxicological and clinical studies confirm its safety, even at high doses. This status ensures the product complies with the highest European standards