The company A-Mansia Biotech S.A. has submitted in October 2019 a novel food application on pasteurized Akkermansia muciniphilia. EFSA has just published its scientific opinion on this bacteria, and consider that its consumption is safe for consumption in food supplements and foods for special medical purpose.
EFSA notes that A. muciniphila is a well-characterized non-toxin producing, avirulent microorganism that has been reported as part of normal gut microbiota. However, the strain has not the QPS status due its increase in the gut of some patients suffering from Parkinson’s disease, multiple sclerosis, Alzheimer’s disease and autism spectrum disorders. Antiobiotic-resistance gene have been identified in the strain, and possible acquisition of such resistance is highlighted by EFSA.
A full safety evaluation has been provided by the applicant, including in vitro, animal and human evidences. The applicant requested the use of the probiotic in food supplements at max. 5 x 1010 cells/day, however, based on the NOAEL, EFSA consider that the consumption of 3.4 x 1010 cells/day is safe for human consumption, at the condition that the number of viable cells in the novel food is lower than 10 CFU/g (i.e.< limit of detection).
EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens), Turck D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Cubadda F, Frenzel T, Heinonen M, Marchelli R, Neuhauser-Berthold M, Poulsen M, Prieto Maradona M, Schlatter JR, van Loveren H, Ackerl R and Knutsen HK, 2021. Scientific Opinion on the safety of pasteurised Akkermansia muciniphila as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal 2021;19(9):6780.