The European Commission has adopted Regulation (EU) 2026/391, amending Implementing Regulation (EU) 2017/2470 to revise the conditions of use and specific labelling requirements for the novel food pasteurised Akkermansia muciniphila. The amendment updates the Union list of authorised novel foods under Regulation (EU) 2015/2283 on Novel Foods.
The regulatory update follows an application submitted on 19 December 2023 by The Akkermansia Company SA requesting an extension of the permitted uses of pasteurised Akkermansia muciniphila. Initially, the applicant proposed broadening the novel food’s use as an ingredient in a wide range of foods, food supplements as defined in Directive 2002/46/EC, and foods for special medical purposes as defined in Regulation (EU) No 609/2013, targeting adolescents as well as pregnant and lactating women. During the risk assessment process, however, the company withdrew its request concerning use in general food categories.
Following evaluation, the European Food Safety Authority (EFSA) issued a scientific opinion on 27 August 2025 assessing the safety of extending the use of pasteurised Akkermansia muciniphila as a novel food. EFSA concluded that the proposed use is safe for the general population aged 12 to under 18 years under specified intake levels. However, the Authority determined that safety for pregnant and lactating women could not be established based on the available data.
Based on EFSA’s assessment and the supporting evidence provided by the applicant, the European Commission approved amendments to the conditions of use. Under the updated rules, pasteurised Akkermansia muciniphila may now be used in food supplements and foods for special medical purposes intended for individuals aged 12 to less than 18 years, subject to defined maximum intake levels.
The authorised maximum daily intake levels include:
2.1 × 10¹? cells/day for individuals aged 12 to under 14 years, and
3.0 × 10¹? cells/day for individuals aged 14 to under 18 years.
The amendment also updates labelling requirements associated with the novel food. Previously, food supplements containing pasteurised Akkermansia muciniphila were required to include a statement restricting use to adults and excluding pregnant and lactating women. With the revised conditions of use, the labelling provisions have been updated to reflect the newly authorised age group while maintaining safety considerations identified during EFSA’s risk assessment.
Overall, the Commission concluded that the changes meet the requirements of Article 12 of the EU Novel Foods Regulation and are therefore suitable for inclusion in the Union list of authorised novel foods.
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