(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.

(2)

Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) has established a Union list of novel foods.

(3)

Commission Implementing Regulation (EU) 2022/168 (3) authorised, in accordance with Regulation (EU) 2015/2283, the placing on the market of pasteurised Akkermansia muciniphila as a novel food to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (4) and in foods for special medical purposes as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (5), intended for the adult population, excluding pregnant and lactating women.

(4)

The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 therefore includes pasteurised Akkermansia muciniphila as an authorised novel food.

(5)

On 19 December 2023, the company ‘the Akkermansia Company SA’ (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for a change of the conditions of use for ‘pasteurised Akkermansia muciniphila’. The applicant initially proposed extending the conditions of use of the novel food to use as an ingredient in a broad range of foods, in food supplements as defined in Directive 2002/46/EC and food for special medical purposes as defined in Regulation (EU) No 609/2013 intended for the general population from 12 to less than 18 years of age, and to pregnant and lactating women. During the risk assessment process, the applicant withdrew the part of the request concerning the use of the novel food as an ingredient in a broad range of foods. The applicant requested for the novel food to be used in food supplements and food for special medical purposes for the general population from 12 to less than 14 years of age at a maximum use level of 2,1×1010 cells/day. For food supplements and food for special medical purposes intended for the general population from 14 to less than 18 years of age, the applicant proposed a maximum use level of 3,0×1010 cells/day. For food supplements and food for special medical purposes intended for pregnant and lactating women, the applicant proposed a maximum use level of 3,4×1010 cells/day. Finally, the applicant requested to amend the existing additional labelling requirements, as the statement indicating that food supplements containing pasteurised Akkermansia muciniphila should be consumed by adults only, excluding pregnant and lactating women is no longer appropriate as the level of pasteurised Akkermansia muciniphila will be harmonised across all population groups.

(6)

Following a request by the Commission, the applicant provided legal documentation demonstrating that the existing authorisation holder ‘A-Mansia Biotech S.A’ for pasteurised Akkermansia muciniphila has changed its name to the applicant’s name, the Akkermansia Company SA. It is therefore appropriate to update the name of the authorisation holder in the Annex to Implementing Regulation (EU) 2017/2470.

(7)

On 19 December 2023, the applicant submitted to the Commission a request for the protection of proprietary data for the study ‘Intake assessment report’, which supported the proposed use of the novel food as an ingredient in a broad range of foods, in accordance with Article 26 of Regulation (EU) 2015/2283. During the risk assessment process, the applicant withdrew this request for data protection, as that proposed use was no longer within the scope of the application.

(8)

In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 12 February 2024, requesting it to provide a scientific opinion on the changes of the conditions of use of ‘pasteurised Akkermansia muciniphila’ as a novel food.

(9)

On 27 August 2025, the Authority adopted its scientific opinion on the ‘Safety of an extension of use of pasteurised Akkermansia muciniphila as a novel food’ (6) in accordance with Article 11 of Regulation (EU) 2015/2283.

(10)

In its scientific opinion, the Authority concluded that the proposed changes are safe for the general population from 12 to less than 18 years of age. However, the Authority also concluded that the safety of the novel food in the case of pregnant and lactating women cannot be established. Therefore, it is appropriate to amend the conditions of use of ‘pasteurised Akkermansia muciniphila’ to include the general population from 12 to less than 18 years of age.

(11)

The information provided by the applicant and the Authority’s opinion give sufficient grounds to establish that the changes to the conditions of use of ‘pasteurised Akkermansia muciniphila’ are in accordance with the conditions of Article 12 of Regulation (EU) 2015/2283 and should be approved.

(12)

It is also appropriate to amend the labelling requirements of the novel food pasteurised Akkermansia muciniphila, in line with the changed conditions of use and the findings of the Authority’s opinion.

(13)

The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

(14)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,