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

• CELEX: Implementing Regulation (EU) 2026/391
• Articles: 3

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 .

Schedules & Appendices

ANNEX

ANNEX

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 requirements

Other requirements

Data Protection

‘

Akkermansia muciniphila (pasteurised)

Specified food category

Maximum levels

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 × 10 10 cells/day for the general population older than 12 years of age,

—

3,0 × 10 10 cells/day for the general population older than 14 years of age.

—

3,4 × 10 10 cells/day for the adult population

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.

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: the Akkermansia Company SA., 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 the Akkermansia Company SA, 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 the Akkermansia Company SA. End date of the data protection: 1 March 2027.’

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 × 10 10 cells/day for the general population older than 12 years of age,

3,0 × 10 10 cells/day for the general population older than 14 years of age.

3,4 × 10 10 cells/day for the adult population