In the context of Regulation (EU) 2015/2283 and after an extensive scientific review, the EFSA panel has published its decision that pasteurised Akkermansia muciniphila is considered safe as a food ingredient at the specified conditions of use and intake levels (NF 2019/1366, EFSA-Q-2019-00767).
The decision is a pivotal milestone for applicant A-Mansia Biotech, which submitted its application for authorisation of pasteurised Akkermansia muciniphila as a Novel Food to the European Commission in October 2019.
Akkermansia is the first next-generation beneficial bacteria with important health effects in humans 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 shelflife 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.
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.
“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.” says Michael Oredsson, CEO.