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)

• CELEX: Implementing Regulation (EU) 2022/168
• Articles: 5

Article 1

1.   Pasteurised Akkermansia muciniphila as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.

2.   For a period of five years from the date of entry into force of this Regulation only the initial applicant:

company: A-Mansia Biotech S.A.;

address: rue Granbonpré, 11 Bâtiment H 1435 Mont-Saint-Guibert, Belgium,

is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for that novel food without reference to the data protected pursuant to Article 2 or with the agreement of A-Mansia Biotech S.A.

3.   The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex.

Article 2

The scientific data contained in the application file on the basis of which the novel food referred to in Article 1 have been assessed by the Authority, claimed by the applicant as proprietary and without which the novel food could not have been authorised, shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of A-Mansia Biotech S.A.

Article 3

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Schedules & Appendices

ANNEX

ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

(1)

in Table 1 (Authorised novel foods), the following entry is inserted:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data Protection

Specified food category

Maximum levels

‘

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 × 10 10 cells/day

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘pasteurised Akkermansia muciniphila ’.

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 × 10 10 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.

(2)

in Table 2 (Specifications), the following entry is inserted:

Authorised novel food

Specification

‘

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 × 10 10 to 2,5 × 10 12

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.’