EFSA Evaluates Extended Use of Pasteurised Akkermansia muciniphila as a Novel Food

On September 25, 2025, the European Food Safety Authority (EFSA) announced that its Panel on Nutrition, Novel Foods and Food Allergens (NDA) had published a scientific opinion regarding the extension of use of pasteurised Akkermansia muciniphila as a novel food (NF) under Regulation (EU) 2015/2283.

This latest assessment was conducted at the request of the European Commission and focused on expanding the NF’s intended use to include food supplements and Foods for Special Medical Purposes (FSMPs) for two additional population groups: 

• Adolescents aged 12 to <18 years, and

• Pregnant and lactating women.

The proposed maximum daily dose corresponds to approximately 4.8 × 10⁸ cells per kilogram of body weight per day, which aligns with the safe level previously established in 2021 by the same EFSA Panel.

After reviewing new toxicological and human studies on A. muciniphila (including the specific strain used in the NF), EFSA concluded that no new safety concerns were identified for its use in adolescents. Accordingly, the NF is considered safe at doses up to 2.1 × 10¹⁰ cells/day for adolescents aged 12 to <14 years, and 3.0 × 10¹⁰ cells/day for those aged 14 to <18 years.

However, EFSA emphasized that no sufficient evidence was provided to establish the safety of the NF in pregnant or lactating women. Therefore, its use in these populations cannot be recommended based on the current data.

This opinion reaffirms EFSA’s cautious but science-based approach toward microbiome-related novel foods, ensuring that extended uses remain within well-characterized and safe exposure limits.