HomeHealthAkkermansia muciniphila, green light in the EU for the new generation probiotic

Akkermansia muciniphila, green light in the EU for the new generation probiotic

The next generation probiotic Akkermansia muciniphila received the green light from the European Commission, which novel food authorized for use in food supplements and foods for special medical purposes. (1)

1) Akkermansia muciniphila, the next generation probiotic

Akkermansia muciniphila it was first isolated by Muriel Derrien and Willem de Vos, in 2004, from the feces of healthy individuals. It is therefore a microorganism residing in the intestine, and is nevertheless considered a new generation probiotic, already the subject of numerous researches. Its probiotic action is mainly attributed to its ability to strengthen the mucosa and protect the intestinal barrier (despite its mucin-degrading activity).

1.1) Scientific evidence

Scientific studies in vivo about animals and some trial clinicians have shown the effectiveness of Akkermansia muciniphila in reducing physiological parameters associated with obesity (eg waist circumference, weight reduction, fat mass). Glucose tolerance and insulin sensitivity are also improved, helping to reduce fat mass and increase lean mass, thanks to various diet- or time-dependent effects. These include the anti-inflammatory effect, stimulated by an increase in cytokines.

The assumption of live or pasteurized cells of Akkermansia muciniphila it is also associated with the modulation of the immune, metabolic and endocannabinoid systems, through various metabolites (eg short-chain fatty acids, amino acids and derivatives). Thus, an action on brain functions is also hypothesized, along thegut-brain axis. More evidence is present on the contribution to longevity and health (2,3).

1.2) Synergies with some phytocompounds

Some phytocompounds favor the presence of Akkermansia muciniphila in the intestinal microbiota:

- polyphenols. Phenolic acids, proanthocyanidins, epigallocatechins-3-gallate (EGCG), ellagitannins, anthocyanidins and / or their combination,
- alkaloids. Berberine, betaine and capsaicin,
- carbohydrates. Dietary fibers, oligofructose, inulin, stachyose, polysaccharides from algae (e.g. fucoidan from brown algae) and microalgae, cyanobacteria (e.g. spirulina),
- Traditional Chinese Medicine. The wealth of botanicals contained in decoctions and other traditional preparations provides plenty of the above elements. (4)

these phytochemicals - in the context of a balanced diet, such as we have seen - they contribute to the good functioning of the intestinal microbiota through a direct stimulus (e.g. production of intestinal mucin, metabolized by the bacterium or growth promoting factor) and indirect (e.g. favorable environment for reducing oxidative stress, reduction of competitive bacterial flora).

2) Akkermansia muciniphila, the authorization procedure Novel Food

A-Mansia Biotech SA - s Belgian with a large know-how su Akkermansia muciniphila, based on the work of two professors from the Universities of Wageningen (NL) and Louvain (B) - had requested his authorization as novel food on 24.10.19. For use as a food supplement and ingredient in foods for special medical purposes for adults only, excluding pregnant and lactating women.

2.1) EFSA assessment

EFSA was called upon to assess safety as novel food of a probiotic from A-Mansia Biotech SA consisting of a bacterial population of Akkermansia muciniphila MucT pasteurized and freeze-dried. Carbohydrates (~ 45%), proteins (~ 30%), ash (~ 18%), water (~ 6%), traces of fat.

Il panel NDA (Nutrition, Novel Foods and Food Allergens) of EFSA considered the toxicity study as fundamental in vivo submitted by the applicant, thanks to which it was possible to extrapolate a maximum dose of 3,4 x1010 cells / day.

The security di Akkermansia muciniphila was also favorably evaluated with respect to any risks of allergenicity and acquisition of AMR characters (Anti-Microbial Resistance). Also taking into account that Akkermansia muciniphila it is by its nature resident in the intestine (5,6).

2.2) Authorization novel food with exclusive

Industrial protection of the data was recognized by virtue of the numerous studies conducted and submitted to support the application, such as:

- bacterial reverse mutation test (Ames test),
– testing vitro micronucleus with mammalian cells,
- Education in vivo dosing of oral toxicity in rats, over 14 and 90 days,
- toxicity data, (7)
- flow cytometry validation study,
- study on antimicrobial resistance (AMR).

The European Commission recognized the essential value of these studies for EFSA's assessment and therefore granted the applicant an exclusive authorization for a period of 5 years.

3) Provisional conclusions

Availability market for this new probiotic on the market represents a promising opportunity, in the hope that Akkermansia muciniphila for it can contribute to the contrast of numerous non-communicable and chronic-degenerative diseases. (8, 9). Further studies will help to understand its mechanisms of action and design more effective and targeted formulations.

 it may also allow the identification of new strains, with enhanced and more specific biological activities that better adapt to the diseases that this probiotic could mitigate. In the hope that interventions to support the microbiota and intestinal eubiosis can counteract the effects, among other things, antibiotic resistance.

Dario Dongo and Andrea Adelmo Della Penna

Cover image from https://www.a-mansia.com/preclinical-observation /


(1) Commission EU Reg. 2022/168, authorizing the placing on the market of pasteurized Akkermansia muciniphila as a new food in accordance with reg. EU 2015/2283 and amending reg. EU 2017/2470. EUR-Lex, http://data.europa.eu/eli/reg_impl/2022/168/oj

(2) Xu et al. (2022). The role of the probiotic Akkermansia muciniphila in brain functions: insights underpinning therapeutic potential. Critical Reviews in Microbiology, https://doi.org/10.1080/1040841X.2022.2044286

(3) Abuqwider et al. (2021). Akkermansia muciniphila, a New Generation of Beneficial Microbiota in Modulating Obesity: A Systematic Review. Microorganims 9: 1098, https://doi.org/10.3390/microorganisms9051098

(4) Yue et al. (2022). Dietary strategies to promote the abundance of intestinal Akkermansia muciniphila, a focus on the effect of plant extracts. Journal of Functional Foods 93: 105093, https://doi.org/10.1016/j.jff.2022.105093

(5) EFSA, NDA Panel  Safety of pasteurized Akkermansia muciniphila as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal 19 (9): 6780, https://doi.org/10.2903/j.efsa.2021.6780

(6) EFSA's BIOHAZ panel had already recently evaluated Akkermansia muciniphila as a candidate for the List of Biological Agents with Qualified Presumption of Safety (QPS. V. previous article), taking into account its presence in the colon and in human milk. Uncertainties about the relative abundance of Akkermansia muciniphila in various conditions of health and disease (especially in the neurological field), however, did not allow the panel to recommend the inclusion of this organism in the QPS list. In view of this, the panel EFSA NDA considered it necessary to impose a number of live cells <10 CFU / g (the limit of determination) among the novel food specifications

(7) Druart et al. (2020). Toxicological safety evaluation of pasteurized Akkermansia muciniphila. J. Appl. Toxicol. 41: 276-290, https://doi.org//10.1002/jat.4044

(8) Ouyang J, Lin J, Isnard S, Fombuena B, Peng X, Marette A, Routy B, Messaoudene M, Chen Y, Routy JP. (2020). The Bacterium Akkermansia muciniphila: A Sentinel for Gut Permeability and Its Relevance to HIV-Related Inflammation.Front Immunol. 2020 Apr 9; 11: 645. doi: 10.3389 / fimmu.2020.00645. PMID: 32328074; PMCID: PMC7160922

(9) Naito Y, Uchiyama K, Takagi T. A next-generation beneficial microbe: Akkermansia muciniphila. J Clin Biochem Nutr. 2018 Jul; 63 (1): 33-35. doi: 10.3164 / jcbn.18-57. Epub 2018 Jun 20. PMID: 30087541; PMCID: PMC6064808.

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Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.

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Graduated in Food Technologies and Biotechnologies, qualified food technologist, he follows the research and development area. With particular regard to European research projects (in Horizon 2020, PRIMA) where the FARE division of WIISE Srl, a benefit company, participates.

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