The EFSA scientific opinion, adopted last July, concluded on the safety of a preparation obtained from Akkermansia muciniphila. Orchidali resumes and comments the topic.
On 7 July 2021, an EFSA opinion on the safety of pasteurized Akkermansia muciniphila as a novel food was adopted. The opinion is the result of a 21-month process that started in October 2019, when the Belgium-based company A-mansia Biotech S.A. submitted to the European Commission a request on the evaluation of a specific preparation obtained from cells of the Gram-negative bacterium Akkermansia muciniphila, belonging to the Verrucomicrobia phylum and normally present in the human gut.
As the ingredient does not possess any history of use in human nutrition, it clearly belongs to the novel food category and its use is subject to a safety assessment prior its authorization. To conduct the evaluation, the EFSA analyzed multiple toxicological studies and a human clinical trial (see the summary of the application ); it also asked for more information by contacting the applicant on two occasions. The final result was a positive opinion on the safety of the preparation.
It is essential to underline how the positive conclusions of the assessment cannot be extended to the Akkermansia muciniphila species in general, but only to a well-defined application of one A. muciniphila strain. The evaluation only concerns the type strain of the species, Akkermansia muciniphila MucT (deposited in the American Type Culture Collection under the code ATCC BAA-835T and in the Collection de l’Institut Pasteur as CIP 107961T), undergoing specific treatment: after a fermentation step, it must be pasteurized and then freeze-dried.
The EFSA, in its opinion, declared the ingredient safe for use in food for special medical purposes and in food supplements addressed to the adult population, excluding pregnant and breastfeeding women, at a maximum daily dose of 3.4 x 1010 cells per day, a limit suggested by the EFSA Panel in response to the value of 5 x 1010 cells suggested by the applicant. Moreover, the importance of the pasteurization process must not be underestimated: a key requirement that must not be ignored is the fact that the ingredient shouldn’t virtually contain any viable A. muciniphila cells, as the threshold value has been set at 10 CFU/g, that is actually the detection limit (albeit, according to the EFSA document, the applicant initially suggested a higher cutoff value). Indeed, rather than being a probiotic (as we are not addressing live cells) the ingredient could fall, in our opinion, under the postbiotic category, defined by the International Scientific Association for Probiotics and Prebiotics (ISAPP) in 2019 as “a preparation of inanimate microorganisms and/or their components that confers a health benefit on the host”.
It can be interesting to specify that, after a 2020 assessment by the EFSA Scientific Panel on Biological Hazards (BIOHAZ), Akkermansia muciniphila was not recommended for QPS status; this circumstance, however, didn’t hinder the novel food safety assessment, that can be considered as more specifically-targeted as it focuses on a particular strain, under strictly determined conditions of use: an application that was proved to be safe.
The next step, following the EFSA positive safety assessment, will be the European Commission formal recognition of pasteurized Akkermansia muciniphila, under the described conditions, as an authorized novel food. This should happen within a few months.
Orchidali can help you identifying a strategy for your novel food ingredients.
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EFSA Scientific Opinion on the safety of pasteurized Akkermansia muciniphila as a novel food: a commented overview
The EFSA scientific opinion, adopted last July, concluded on the safety of a preparation obtained from Akkermansia muciniphila. Orchidali resumes and comments the topic.
On 7 July 2021, an EFSA opinion on the safety of pasteurized Akkermansia muciniphila as a novel food was adopted. The opinion is the result of a 21-month process that started in October 2019, when the Belgium-based company A-mansia Biotech S.A. submitted to the European Commission a request on the evaluation of a specific preparation obtained from cells of the Gram-negative bacterium Akkermansia muciniphila, belonging to the Verrucomicrobia phylum and normally present in the human gut.
As the ingredient does not possess any history of use in human nutrition, it clearly belongs to the novel food category and its use is subject to a safety assessment prior its authorization. To conduct the evaluation, the EFSA analyzed multiple toxicological studies and a human clinical trial (see the summary of the application ); it also asked for more information by contacting the applicant on two occasions. The final result was a positive opinion on the safety of the preparation.
It is essential to underline how the positive conclusions of the assessment cannot be extended to the Akkermansia muciniphila species in general, but only to a well-defined application of one A. muciniphila strain. The evaluation only concerns the type strain of the species, Akkermansia muciniphila MucT (deposited in the American Type Culture Collection under the code ATCC BAA-835T and in the Collection de l’Institut Pasteur as CIP 107961T), undergoing specific treatment: after a fermentation step, it must be pasteurized and then freeze-dried.
The EFSA, in its opinion, declared the ingredient safe for use in food for special medical purposes and in food supplements addressed to the adult population, excluding pregnant and breastfeeding women, at a maximum daily dose of 3.4 x 1010 cells per day, a limit suggested by the EFSA Panel in response to the value of 5 x 1010 cells suggested by the applicant. Moreover, the importance of the pasteurization process must not be underestimated: a key requirement that must not be ignored is the fact that the ingredient shouldn’t virtually contain any viable A. muciniphila cells, as the threshold value has been set at 10 CFU/g, that is actually the detection limit (albeit, according to the EFSA document, the applicant initially suggested a higher cutoff value). Indeed, rather than being a probiotic (as we are not addressing live cells) the ingredient could fall, in our opinion, under the postbiotic category, defined by the International Scientific Association for Probiotics and Prebiotics (ISAPP) in 2019 as “a preparation of inanimate microorganisms and/or their components that confers a health benefit on the host”.
It can be interesting to specify that, after a 2020 assessment by the EFSA Scientific Panel on Biological Hazards (BIOHAZ), Akkermansia muciniphila was not recommended for QPS status; this circumstance, however, didn’t hinder the novel food safety assessment, that can be considered as more specifically-targeted as it focuses on a particular strain, under strictly determined conditions of use: an application that was proved to be safe.
The next step, following the EFSA positive safety assessment, will be the European Commission formal recognition of pasteurized Akkermansia muciniphila, under the described conditions, as an authorized novel food. This should happen within a few months.
Orchidali can help you identifying a strategy for your novel food ingredients.
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