Commission Implementing Regulation (EU) 2026/391 of 23 February 2026 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use and the specific labelling requirements of the novel food pasteurised Akkermansia muciniphila

Official Journal EN of the European Union L series 2026/391 24.2.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/391 of 23 February 2026 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use and the specific labelling requirements of the novel food pasteurised Akkermansia muciniphila (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001(1), and in particular Article 12 thereof,

Whereas:

(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 muciniphilaas 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 muciniphilaas 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

(1) OJ L 327, 11.12.2015, p. 1. ELI: http://data.europa.eu/eli/reg/2015/2283/oj.

(2) Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72, ELI:

http://data.europa.eu/eli/reg_impl/2017/2470/oj).

(3) 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 (OJ L 28, 9.2.2022, p. 5, ELI: http://data.europa.eu/eli/reg_impl/ 2022/168/oj).

(4) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51, ELI: http://data.europa.eu/eli/dir/2002/46/oj).

(5) Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35, ELI: http:// data.europa.eu/eli/reg/2013/609/oj).

ELI: http://data.europa.eu/eli/reg_impl/2026/391/oj 1/4EN OJ L, 24.2.2026 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 3,0×1010cells/day.

For food supplements and food for special medical purposes intended for pregnant and lactating women, the applicant proposed a maximum use level of 3,4×1010cells/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 muciniphilawill 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 muciniphilaas 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,

(6) EFSA Journal2025; 23:e9632 (https://doi.org/10.2903/j.efsa.2025.9632).

2/4 ELI: http://data.europa.eu/eli/reg_impl/2026/391/ojEN OJ L, 24.2.2026

HAS ADOPTED THIS REGULATION:

Article 1 The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 23 February 2026.

For the Commission The President Ursula VON DER LEYEN

ELI: http://data.europa.eu/eli/reg_impl/2026/391/oj 3/4ANNEX In Table 1 (Authorised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470, the entry for ‘Akkermansia muciniphila (pasteurised)’ is replaced by the following:

Authorised novel food Conditions under which the novel food may be used Additional specific labelling Other Data Protection requirements require­ ‘Akkermansia muciniphila Specified food category Maximum levels ments

(pasteurised) Foods for special medical purposes In accordance with the The designation of the novel Authorised on 1 March 2022. This as defined under Regulation (EU) particular nutritional food on the labelling of the inclusion is based on proprietary No 609/2013, excluding foods for requirements of the foodstuffs containing it shall be scientific evidence and scientific special medical purposes intended persons for whom the ‘pasteurised Akkermansia data protected in accordance with for infants, children younger than 12 products are intended, but muciniphila’. Article 26 of Regulation (EU) years of age, pregnant and lactating no higher than: 2015/ 2283. Applicant: the The labelling of food women — 2,1 × 1010cells/day for Akkermansia Company SA., rue supplements containing the general Granbonpré, 11, Bâtiment H, 1435 pasteurised Akkermansia population older than Mont-Saint-Guibert. Belgium.

muciniphilashall bear a 12 years of age, During the period of data statement that those food — 3,0 × 1010cells/day for protection, the novel food supplements should not be the general pasteurised Akkermansia

consumed by: population older than muciniphila is authorised for a) pregnant and lactating 14 years of age. placing on the market within the women; — 3,4 × 1010cells/day for Union only by the Akkermansia b) by infants and children the adult population Company SA, unless a subsequent under 12 years of age / applicant obtains authorisation for Food supplements as defined in 2,1 × 1010cells/day for infants, children and the novel food without reference to Directive 2002/46/EC, excluding the general population adolescents under 14 years the proprietary scientific evidence infants and children younger than 12 older than 12 years of of age/ infants, children and or scientific data protected in years of age, pregnant and lactating age, adolescents under 18 years accordance with Article 26 of women of age depending on the age 3,0 × 1010cells/day for Regulation (EU) 2015/2283 or groups the food the general population with the agreement of the supplement is intended for. older than 14 years of Akkermansia Company SA. End age. date of the data protection:

1 March 2027.’ 3,4 × 1010cells/day for the adult population 4/4

ELI:

http://data.europa.eu/eli/reg_impl/2026/391/oj EN OJ L,

24.2.2026