COMMISSION IMPLEMENTING REGULATION (EU) 2022/168
of 8 February 2022
authorising the placing on the market of pasteurised
Akkermansia muciniphila
as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
(Text with EEA relevance)
Article 1
Article 2
Article 3
Article 4
ANNEX
Authorised novel food |
Conditions under which the novel food may be used |
Additional specific labelling requirements |
Other requirements |
Data Protection |
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Specified food category |
Maximum levels |
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‘ Akkermansia muciniphila (pasteurised) |
Foods for special medical purposes as defined under Regulation (EU) No 609/2013 for the adult population, excluding pregnant and lactating women |
3,4 × 1010 cells/day |
The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘pasteurised Akkermansia muciniphila’. |
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Authorised on 1 March 2022. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: A-Mansia Biotech S.A., rue Granbonpré, 11, Bâtiment H, 1435 Mont-Saint-Guibert. Belgium. During the period of data protection, the novel food pasteurised Akkermansia muciniphila is authorised for placing on the market within the Union only by A-Mansia Biotech S.A., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Mansia Biotech S.A.. End date of the data protection: 1 March 2027.’ |
Food supplements as defined in Directive 2002/46/EC for the adult population, excluding pregnant and lactating women |
3,4 × 1010 cells/day |
The labelling of food supplements containing pasteurised Akkermansia muciniphila shall bear a statement that they should be consumed by adults only, excluding pregnant and lactating women. |
Authorised novel food |
Specification |
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‘ Akkermansia muciniphila (pasteurised) |
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
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