Caelus welcomes the publication by the European Food Safety Authority (EFSA) of its scientific opinion on the safety of gut bacterium Anaerobutyricum soehngenii CH106 (A. soehngenii) for use in food supplements.
EFSA concluded that the freeze-dried, live form of A. soehngenii is safe to consume at the proposed daily amount (2.0 × 10⁹ active fluorescent units) for the general adult population, other than women who are pregnant or breastfeeding. The opinion completes the scientific safety-assessment stage of the EU Novel Food procedure.
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, selected through microbiome research and developed through a dedicated programme of strain development, clinical research, safety assessment and industrial scale-up. In the gut, the bacterium converts lactate and acetate into butyrate and produces propionate. These short-chain fatty acids play a central role in the metabolic communication between the gut’s microbes and the rest of the body.
What the human studies show
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, A. soehngenii was reported to be safe and well tolerated. The 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 increased production of GLP-1, a hormone the gut makes naturally. Taken together, these clinical trials point consistently in the same direction and provide a solid scientific basis for the strain’s continued development in the field of cardiometabolic health.
These are findings reported in scientific publications; they have not been assessed or authorised as health claims in the European Union.
More than fifteen years in the making
The work that led to A. soehngenii began more than 15 years ago and involved extensive research and development, including clinical trials and careful development of the strain and the conditions used to cultivate it. Caelus submitted its Novel Food application in July 2022. The assessment that followed examined the strain’s identity, how it is manufactured, its composition and stability, and a full package of toxicology and human safety data. EFSA’s Panel on Nutrition, Novel Foods and Food Allergens adopted its scientific opinion on 1 July 2026. The next step is consideration by the European Commission and Member States, which may result in a regulation adding the strain to the EU list of authorised novel foods.
To support this next phase, Caelus has partnered with Winclove Probiotics on the commercialisation pathway for A. soehngenii, with the shared ambition of making this scientifically validated, next-generation microbiome strain accessible to the European market following final regulatory approval.
“EFSA’s scientific opinion marks a defining moment for Caelus. It shows that a live bacterium from the human gut can meet Europe’s demanding safety standards, validating more than fifteen 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.”
Jos Seegers, Director of Operations, Caelus
About Caelus
Caelus develops microbiome-based ingredients that originate from the human gut. Its work combines strain discovery, clinical research, regulatory development and industrial-scale production to turn next-generation beneficial microbes into safe, scientifically substantiated products.
Scientific opinion
The full EFSA scientific opinion is available on: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2026.10255.