Dr. Jérôme Le Bloch, head of scientific affairs at FoodChain ID and an expert in food ingredient authorization, said the decision represents “a significant opportunity for the probiotic sector.”
“C. butyricum is not only effective in supporting digestive health and immunity, but emerging research also suggests potential benefits for conditions like asthma and mental health,” he told NutraIngredients. “There is therefore an opportunity to propose new products, with higher C. butyricum concentrations of up to 3.2 x 10(8) CFU/day for adults.”
“We’re now waiting for the final decision from the European Commission, but it’s likely to be authorized under the conditions proposed by EFSA,” he added.
Clostridium butyricum as a food supplement
C. butyricum TO-A is a butyrate-producing bacterium that is primarily used as a probiotic. Butyrate is a short-chain fatty acid that is widely reported as being beneficial for gut health, with research showing it may improve diarrhea, constipation and other gastrointestinal disturbances.
A recent study on C. butyricum TO-A found that the probiotic strain efficiently produces butyrate utilizing lactate and acetate, and could therefore be an efficient butyrate supplier in the intestinal tract.
The research was carried out by Japan-based probiotic and pharmaceutical manufacturer TOA Biopharma, which submitted the application. The company planned to market the novel food as supplement for the general population, excluding infants under the age of three months.
However, due to the critical role of early gut microbiota development and the focus of previous studies on adults, EFSA recommends restricting the use of the novel food to individuals over the age of three years. It is also not recommended for pregnant and lactating women.
In addition, dosing requirements are age-dependent, with a maximum dose of 3.2 × 108 CFU/day for adults.
Safety of Clostridium butyricum
Given that many species of Clostridium can produce toxins and cause diseases in humans and animals, EFSA conducted a thorough safety analysis of this novel food.
This included full genome sequencing of the strain and its plasmids, alongside an analysis of genotoxicity studies, the production process, composition and stability. No safety concerns were identified.
Dr. Le Bloch said he expects the supplement industry to embrace this ruling as it has done with another species of Clostridium (CBM588), which is already authorized in food supplements.
“While some Clostridium species are known to be pathogenic, EFSA thoroughly assessed this particular strain and found no concerning virulence factors,” he added. “In fact, experts specifically evaluated the genetic markers associated with pathogenic Clostridium strains and confirmed these are absent in TO-A.
“EFSA’s comprehensive review of the strain’s identity, characteristics and safety concluded that it poses no safety concerns for use.”