Pasteurised Akkermansia muciniphila, also known as inactivated AKK, is a heat-treated, non-viable beneficial gut bacterium associated with metabolic improvement and enhanced intestinal barrier function. As a representative “postbiotic”, it has attracted significant attention.
In the EU, pasteurised AKK (strain ATCC BAA-835, CIP 107961) was approved in 2022 as a novel food for use in foods for special medical purposes and food supplements, applicable to adults (excluding pregnant and breastfeeding women), with a maximum intake of 3.4 × 1010 cells/day (Regulation (EU) 2022/168).
On February 23, 2026, based on new scientific evidence, the EU approved an extension of its use to the general population aged 12–18, with differentiated maximum intake levels by age group (Regulation (EU) 2026/391).
Table 1. Updated Conditions of Use for Pasteurised AKK in the EU
|
Food Category |
Maximum Intake |
|
Foods for special medical purposes (as defined in EU Regulation (EU) 609/2013), excluding products for infants, children under 12, and pregnant or breastfeeding women |
Ages≥12: 2.1×1010 cells/day Ages≥14: 3.0×1010 cells/day Adults: 3.4 × 1010 cells/day |
|
Food supplements (as defined in Directive 2002/46/EC), excluding infants, children under 12, and pregnant or breastfeeding women |
Ages≥12: 2.1×1010 cells/day Ages≥14: 3.0×1010 cells/day Adults: 3.4 × 1010 cells/day |
Note: The content highlighted in red indicates the newly added scope in this update.
This evaluation was initiated following an application submitted in December 2023 by The Akkermansia Company SA to extend the scope of use. The European Food Safety Authority Panel concluded that newly identified toxicological and human studies, involving multiple strains including the novel food strain, did not raise safety concerns for extending use to adolescents aged 12 and above. In 2024, the Food Standards Agency and Food Standards Scotland conducted a risk assessment supporting use in individuals aged above 12, with evaluated doses up to 4 × 10¹⁰ cells/day. Based on the safety threshold established in 2021 (4.8 × 10¹⁰ cells/kg body weight/day), the EFSA Panel recommended age-specific maximum daily intake levels for adolescents (12–14 and 14–18 years). However, safety for pregnant and lactating women remains unestablished.
The expansion of the target population and the introduction of age-stratified intake limits reflect a more refined and comprehensive scientific understanding of pasteurised AKK in the EU. This regulatory development is expected to create new growth opportunities for AKK-based products and further drive innovation in the postbiotic sector.
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