Akkermansia muciniphila (pasteurised): authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• Foods for special medical purposes as defined under Regulation (EU) No 609/2013, excluding foods for special medical purposes intended for infants, children younger than 12 years of age, pregnant and lactating women: In accordance with the particular nutritional requirements of the persons for whom the products are intended, but no higher than: - 2,1 × 1010 cells/day for the general population older than 12 years of age, - 3,0 × 1010 cells/day for the general population older than 14 years of age. - 3,4 × 1010 cells/day for the adult population
• Food supplements as defined in Directive 2002/46/EC, excluding infants and children younger than 12 years of age, pregnant and lactating women: 2,1 × 1010 cells/day for the general population older than 12 years of age, 3,0 × 1010 cells/day for the general population older than 14 years of age. 3,4 × 1010 cells/day for the adult population

Additional specific labelling requirements

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘pasteurised Akkermansia muciniphila’. The labelling of food supplements containing pasteurised Akkermansia muciniphila shall bear a statement that those food supplements should not be consumed by: a) pregnant and lactating women; b) by infants and children under 12 years of age / infants, children and adolescents under 14 years of age/ infants, children and adolescents under 18 years of age depending on the age groups the food supplement is intended for.

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

Description:

Pasteurised Akkermansia muciniphila (strain ATCC BAA-835, CIP 107961) is produced by anaerobic growth of the bacteria followed by pasteurisation, concentration of the cells, cryopreservation, and freeze drying.

Characteristics/Composition:

Total A. muciniphila cell count (cells/g): 2,5 × 1010 to 2,5 × 1012

Viable A. muciniphila cell count (CFU/g): < 10 (LoD)(*)

Water activity: ≤ 0,43

Moisture (%): ≤ 12,0

Protein (%): ≤ 35,0

Fat (%): ≤ 4,0

Crude ash (%): ≤ 21,0

Carbohydrates (%): 36,0 - 86,0

Microbiological criteria:

Aerobic mesophilic total count: ≤ 500 CFU(**)/g

Sulphite reducing anaerobes: ≤ 50 CFU/g

Coagulase+ Staphylococci: ≤ 10 CFU/g

Enterobacteriaceae: ≤ 10 CFU/g

Yeast: ≤ 10 CFU/g

Mould: ≤ 10 CFU/g

Bacillus cereus: ≤ 100 CFU/g

Listeria spp.: Absence in 25 g

Salmonella spp.: Absence in 25 g

Escherichia coli: Absence in 1 g

(*) LoD: Limit of Detection;

(**) Colony Forming Units.

Source and version

Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.

• Consolidated text on EUR-Lex

Want the whole list as one table?

If we publish the Union list as one table (name, food category, maximum level), we write to you once. We use the email for nothing else.