Recently, the National Health Commission of China officially accepted a new food ingredient application for inactivated Akkermansia muciniphila (hereinafter referred to as “AKK bacteria”), with the ingredient named “Inactivated Akkermansia muciniphila YGMCC2645.” Industry insiders believe this marks a key step towards compliance for the AKK bacteria industry in China.
As a highly specialized Gram-negative anaerobic bacterium in the human gut, Akkermansia muciniphila accounts for 1% to 5% of the gut microbiota in healthy individuals. Its unique physiological functions have made it a focus of microbiological research in recent years. It occupies a unique ecological niche by specifically degrading intestinal mucin and stimulates goblet cells in the gut to produce new mucin. This dual action maintains the health of the intestinal mucus layer, building a “protective wall” for the intestinal barrier function. In addition, the short-chain fatty acids such as acetate and propionate produced by its metabolism not only serve as an “energy source” for intestinal cells but also regulate the balance of the gut microbiota and participate in host energy metabolism. It shows great potential in multiple core health areas including metabolic health, immune enhancement, blood lipid regulation, and sleep improvement. These related effects have been validated through animal experiments and human clinical studies.
In 2022, the European Union became the first to approve pasteurized inactivated AKK bacteria as a novel food for market release. This year, it further expanded the applicable population to adolescents aged 12–18 and established a daily intake limit, broadening the boundaries for its commercial application. The U.S. market has accepted multiple AKK strains through its Generally Recognized as Safe (GRAS) certification system. China’s Shankang Biotechnology Co., Ltd. achieved a global first with its product AKK PROBIO, securing GRAS certification for both live and inactivated forms. Subsequently, strains like Muen Bio’s AKM Lab-01 and and Xianle Health’s AKK ONE, among others cultivated by Chinese companies, have also obtained certification. Some enterprises have secured market access in the U.S. through Self-GRAS certification.
In fact, domestic Chinese enterprises have established a robust raw material supply system through their accumulated expertise in strain screening, fermentation process optimization, and large-scale production. Industry insiders believe that as the approval process for new food ingredients progresses in China, the AKK bacteria industry will enter a “compliance dividend period.”
(Cover image source: unsplash)
