Pasteurised Akkermansia muciniphila in supplements and foods for special medical purposes now also for adolescents from 12 years: from 2.1 × 10¹⁰ to 3.4 × 10¹⁰ cells per day, viable cells below 10 CFU/g, no extension to pregnant women
Commission Implementing Regulation (EU) 2026/391, published on 24 February 2026, amends the conditions of use of the novel food “pasteurised Akkermansia muciniphila”: food supplements and foods for special medical purposes with these bacteria may now also be intended for people aged 12–18. The application also covered pregnant and lactating women, but EFSA concluded that safety for them had not been established. The authorisation holder changed its name from A-Mansia Biotech S.A. to the Akkermansia Company SA.
- Maximum levels in food supplements and foods for special medical purposes: 2.1 × 10¹⁰ cells/day for people over 12, 3.0 × 10¹⁰ cells/day over 14 and 3.4 × 10¹⁰ cells/day for adults. According to EFSA each of these doses corresponds on a body-weight basis to about 4.8 × 10⁸ cells/kg bw per day — the dose found safe in 2021.
- Specification from the 2022 authorisation, quoted by EFSA (strain ATCC BAA-835, CIP 107961, anaerobic growth, pasteurisation, concentration, cryopreservation and freeze-drying): total A. muciniphila cell count 2.5 × 10¹⁰ – 2.5 × 10¹² cells/g, viable cells < 10 CFU/g (limit of detection), water activity ≤ 0.43, moisture ≤ 12.0 %; aerobic mesophilic count ≤ 500 CFU/g, sulphite-reducing anaerobes ≤ 50 CFU/g, Listeria and Salmonella absent in 25 g, E. coli absent in 1 g.
- The supplement label must state that it should not be consumed by pregnant and lactating women and — depending on the group the supplement is intended for — by children under 12, adolescents under 14 or adolescents under 18. During the assessment the applicant withdrew the part of the application for use as an ingredient in many other foods together with the request for data protection of the intake assessment.
- For pregnant women the applicant submitted three mouse studies; EFSA considered that no conclusions could be drawn — in the study with the same strain live bacteria were given to 10 females without reference to OECD guidelines or good laboratory practice. The applicant’s data protection runs until 1 March 2027.