Novel Food Authorization and Regulatory Context
Introduction
Akkermansia muciniphila — a mucin‑degrading bacterium originally isolated from the human gut — has attracted significant scientific and regulatory interest due to its potential effects on human metabolism and gut health. While research continues on its clinical benefits (see Nature, PubMed), a major milestone in the regulatory landscape occurred in the European Union with the adoption of Commission Implementing Regulation (EU) 2022/168, which authorises its use as a novel food under EU law. EUR-Lex
This blog presents a scientifically grounded regulatory overview of the status of pasteurised A. muciniphila in the EU, including the EU’s novel food framework, the rationale for approval, and implications for industry and research.
What Is Implementing Regulation (EU) 2022/168?
In February 2022, the European Commission adopted Regulation (EU) 2022/168, which authorises the placing on the market of pasteurised Akkermansia muciniphila as a novel food in the EU. This Regulation amended the Union list of authorised novel foods under Regulation (EU) 2015/2283, which governs novel food safety and approval in the Union. EUR-Lex
Under EU law, a novel food is defined as a food that has not been widely consumed within the EU before May 1997, and it requires a safety assessment and formal authorisation before being marketed. Regulation (EU) 2015/2283 sets out the requirements for scientific evidence, safety data, labelling conditions, and post‑market controls for such foods.
Key Provisions of Regulation (EU) 2022/168
The Regulation:
- Authorises pasteurised A. muciniphila for use in food supplements and foods for special medical purposes (FSMPs) intended for adults, excluding pregnant or lactating women, at a maximum intake of 3.4 × 10¹⁰ cells/day. EUR-Lex
- Includes the novel food in the Union list established under the Implementing Regulation (EU) 2017/2470.
- Protects certain proprietary data submitted by the applicant (A‑Mansia Biotech S.A.) for a period of five years, restricting use of that data by subsequent applicants unless authorised.
- Defines labelling requirements and target population constraints to ensure accurate consumer information and safety.
This authorisation marked a significant regulatory precedent as A. muciniphila became one of the first microbiome‑derived bacterial ingredients authorised under the EU novel food regime.
Scientific Basis: EFSA Safety Assessment
The regulatory approval under Regulation 2022/168 is grounded in a rigorous scientific safety assessment by the European Food Safety Authority (EFSA).
EFSA NDA Panel Opinion (2021)
In July 2021, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) concluded that pasteurised A. muciniphila, when consumed at levels not exceeding 3.4 × 10¹⁰ cells/day, is safe for adults (excluding pregnant and lactating women) when used in food supplements or FSMPs. The assessment was based on:
- Toxicological studies (including 90‑day repeated dose oral toxicity in rats).
- Genotoxicity and mutagenicity testing.
- Comprehensive characterisation of the manufacturing process and composition of the pasteurised bacterial preparation.
The Panel also applied uncertainty factors to account for interspecies differences and variability in human sensitivity. Crucially, the safety conclusion depended on limits of viable cells (viable count <10 CFU/g) to ensure non‑viability of the organism in the final product. European Food Safety Authority+1
The resulting Scientific Opinion was published in the EFSA Journal (2021:19(9):6780) and is widely cited in both regulatory and scientific literature. EFSA Journal
Recent Extension of Use (2025)
Further EFSA evaluation in 2025 examined an extension of use to adolescents (12 to <18 years). The Panel found that pasteurised A. muciniphila remains safe at defined daily doses for adolescents but highlighted insufficient evidence for safety in pregnant and lactating women, indicating ongoing evaluation needs for broader population groups. European Food Safety Authority
Regulatory and Market Implications
Novel Food Status and Union List Inclusion
The inclusion of pasteurised A. muciniphila in the Union list of authorised novel foods means that it may be marketed across all EU Member States within the specified conditions. The regulatory framework under EU Regulation 2015/2283 provides harmonised safety and labelling standards, lowering trade barriers and enabling consistent market access. EUR-Lex
The data protection clause under Regulation 2022/168 also illustrates how proprietary safety data can be safeguarded, offering a period of market exclusivity tied to the initial applicant’s dossier.
Comparative Regulatory Context
It is important to distinguish the EU novel food pathway from other frameworks such as the U.S. FDA’s Generally Recognized As Safe (GRAS) process or dietary supplement regulations. In the U.S., A. muciniphila has not received an equivalent GRAS affirmation or FDA approval for use as a food ingredient, and the regulatory pathway remains distinct from the EU model.
Scientific Research and Future Directions
While regulatory authorisation establishes safety under defined conditions, A. muciniphila continues to be the subject of ongoing scientific research. Numerous studies explore its potential roles in metabolic regulation, obesity, gut barrier function, and immune interactions, as reflected in clinical and preclinical literature across PubMed and Nature‑indexed journals. Wikipedia
Future regulatory developments may stem from:
- New clinical efficacy data supporting broader populations.
- Additional safety evidence in specific subgroups (e.g., adolescents, pregnant women).
- Updated science on live versus pasteurised formulations.
Conclusion
Implementing Regulation (EU) 2022/168 represents a landmark regulatory decision, authorising pasteurised Akkermansia muciniphila as a novel food in the EU based on comprehensive safety assessment by EFSA. This regulatory framework creates a clear pathway for market access while setting stringent safety and labelling requirements that reflect current scientific understanding. Continued research and regulatory evaluation are expected as the science and applications of this novel microbial ingredient evolve.
Key References
- EU Implementing Regulation 2022/168 – authorising A. muciniphila as a novel food. EUR-Lex
- EFSA Scientific Opinion (2021) – safety assessment of pasteurised A. muciniphila. EFSA Journal
- EFSA Opinion on Extended Use (2025) – updated safety conclusions for adolescents. European Food Safety Authority
- Scientific context on A. muciniphila from microbiome research literature. Wikipedia