Safety of an extension of use of pasteurised Akkermansia muciniphila as a novel food pursuant to Regulation (EU) 2015/2283
2025
EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) | Dominique Turck | Torsten Bohn | Montaña Cámara | Jacqueline Castenmiller | Stefaan De Henauw | Ángeles Jos | Alexandre Maciuk | Inge Mangelsdorf | Breige McNulty | Androniki Naska | Kristina Pentieva | Alfonso Siani | Frank Thies | Margarita Aguilera‐Gómez | Thomas Frenzel | Francesca Marcon | Harry J. McArdle | Peter Moldeus | Monika Neuhäuser‐Berthold | Morten Poulsen | Miguel Prieto Maradona | Josef Rudolf Schlatter | Henk vanLoveren | Reinhard Ackerl | Karen Ildico Hirsch‐Ernst
Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of an extension of use of pasteurised Akkermansia muciniphila as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The extension pertains to the use of the NF in food supplements and Foods for Special Medical Purposes (FSMPs) for adolescents from 12 to < 18 years of age and to pregnant and lactating women. The maximum proposed daily doses of the NF correspond to about 4.8 × 108 cells/kg bodyweight per day, which was the safe dose as established for the NF by the Panel in 2021. The newly identified toxicological and human studies with A. muciniphila from various strains, including the strain to which the NF belongs, do not raise safety concerns in view of the extension of use of the NF for adolescents from 12 years of age. However, no evidence was provided for the safety of the NF in pregnant and lactating women. The Panel concludes that the NF, pasteurised A. muciniphila, is safe at doses up to 2.1 × 1010 cells/day for adolescents from 12 to < 14 years and 3.0 × 1010 cells/day for adolescents from 14 years until < 18 years. The safety of the NF in pregnant and lactating women has not been established.
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