Four years after submitting its application, the Dutch microbiome health ingredient developer has received a positive opinion from the European Food Safety Authority (EFSA) on the safety of A. soehngenii CH106, at the proposed daily amount (2.0 × 10⁹ active fluorescent units) for adults, excluding pregnant and breastfeeding women.
This is a major milestone for the industry, according to Caelus, as it is the first positive EU Novel Food scientific opinion given to a live commensal bacterium developed de novo as a new food ingredient.
“EFSA’s scientific opinion marks a defining moment for Caelus,” said Jos Seegers, director of operations at Caelus. “It shows that a live bacterium from the human gut can meet Europe’s demanding safety standards, validating more than 15 years of scientific research. It brings the company a significant step closer to making the strain available to consumers as part of a new, microbiome-based approach to cardiometabolic health.”
After submission of the Novel Food application in July 2022, the four-year process involved an extensive dossier review, additional testing and several rounds of scientific questions and clarification.
The next step toward commercialization will be full authorization from the European Commission and inclusion of A. soehngenii on the Union list of authorized novel foods.
To support this next phase, Caelus has partnered with Winclove Probiotics to advance entry into the European market.
A new generation of beneficial microbes
A. soehngenii is a bacterium that lives naturally in the human gut, where it thrives in an oxygen-free environment. Unlike many familiar probiotics, it is one of the gut’s own native residents.
The strain occupies a distinctive metabolic niche: It can convert lactate and acetate into butyrate and can also produce propionate. These short-chain fatty acids are important microbial metabolites involved in communication between the gut microbiota and the host.
This ability to consume lactate while producing butyrate is particularly relevant in the context of impaired glucose metabolism, where altered microbial and host lactate metabolism has been observed. These metabolic properties have subsequently been investigated in the context of cardiometabolic health.
Human research backing
Published clinical trials have examined the safety and metabolic effects of the bacterium in several populations. These include people with metabolic syndrome, adults with type 2 diabetes on stable metformin treatment, and adults at increased risk of developing type 2 diabetes.
Across these studies, reported outcomes included positive changes in insulin sensitivity, day-to-day blood-sugar variability, HbA1c (a measure of longer-term blood sugar) and blood pressure.
A separate mechanistic study also found the strain could increase production of GLP-1, a hormone the gut makes naturally.
Taken together, these clinical trials provide a solid scientific basis for the strain’s continued development in the field of cardiometabolic health, according to Seegers.
