After an extensive scientific review, EFSA has published its decision that pasteurised Akkermansia muciniphila is considered safe as a food ingredient.
The decision is a pivotal milestone for applicant A-Mansia Biotech, Belgium-based microbiome spinoff from Wageningen University, The Netherlands, which submitted its application for authorisation of the ingredient as a Novel Food to in October 2019.
This makes Akkermansia the first next-generation beneficial bacteria with health effects in humans to be approved by the EFSA.
The bacteria was first discovered, isolated and characterised from the human gut microbiota in 2004, in the laboratory of Prof. Willem M de Vos (Wageningen University, The Netherlands), a co-founder of A-Mansia.
Shortly thereafter, Prof. Patrice D. Cani’s team (UCLouvain, Brussels, Belgium), another co-founder of A-Mansia, discovered the beneficial effects of the bacteria. It restores the gut barrier function, thereby leading to reduced inflammation and eventually better control of fat storage, glucose metabolism and energy expenditure.
More strikingly, the pasteurisation process raises the effectiveness of Akkermansia. Pasteurised Akkermansia is stable, has a long shelf-life and is easy to administer to humans.
The collaboration led to dozens of scientific articles and a human study demonstrating the ability of pasteurised Akkermansia muciniphila to prevent the deterioration of the health status of the subjects (pre-diabetes, cardiovascular risks), with a decrease in inflammation markers in the liver, insulin resistance or hypercholesterolemia.
A-Mansia claims the ingredients is the first effective and natural dietary supplement containing pasteurized Akkermansia muciniphila to tackle diabetes and obesity.
The patented production process for pasteurised Akkermansia muciniphila is based on anaerobic fermentation followed by pasteurisation of the bacterial cells and freeze-drying.
The novel food ingredient is intended to be marketed as a food supplement in 2022.
Michael Oredsson, A-Mansia CEO, says: "Products based on Akkermansia muciniphila open the door to a new generation of nutritional supplements, rooted in a deep understanding of microbiome function. This EFSA authorisation is a crucial milestone which will enable A-Mansia to progress towards the launch in Europe of our first product in 2022."
Akkermansia muciniphila is a gram-negative anaerobic bacterium belonging to the phylum Verrucomicrobia. It is a ‘commensal’ bacterium, meaning that it is naturally found in the gastrointestinal tract of humans and animals in relatively important quantities. In fact, it represents between 0.5 and 5% of all the bacteria colonizing the intestine.
One key characteristic of Akkermansia muciniphila is its capacity to live in the mucus and use it. It expresses a large panel of specific mucus-degrading enzymes and so it does not rely on dietary substances to feed itself. This ability provides Akkermansia muciniphila with a competitive advantage compared to other bacteria that do rely on fibres and other food particles as their main nutrient source.
Akkermansia muciniphila cells have even been detected in human breast milk. The capacity of the bacterium to use human milk oligosaccharides as the only source of energy, carbon and nitrogen could explain its presence in breast milk and the breast tissue of lactating women. In fact, human milk may act as a carrier for Akkermansia muciniphila and transfer it from mother to infant which explains why it can already be found in the infant intestine very early in life.