Title :

Safety of pasteurised <i>Akkermansia muciniphila</i> as a novel food pursuant to Regulation (EU) 2015/2283.

Author(s) :

Turck, Dominique [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Bohn, T. [Auteur]
European Food Safety Authority [EFSA]
Castenmiller, J. [Auteur]
De Henauw, S. [Auteur]
Hirsch-Ernst, K. I. [Auteur]
Maciuk, A. [Auteur]
Mangelsdorf, I. [Auteur]
Mcardle, H. J. [Auteur]
Naska, A. [Auteur]
Pelaez, C. [Auteur]
Pentieva, K. [Auteur]
Siani, A. [Auteur]
Thies, F. [Auteur]
Tsabouri, S. [Auteur]
Vinceti, M. [Auteur]
Cubadda, F. [Auteur]
Frenzel, T. [Auteur]
Heinonen, M. [Auteur]
Marchelli, R. [Auteur]
Neuhäuser-Berthold, M. [Auteur]
Poulsen, M. [Auteur]
Prieto Maradona, M. [Auteur]
Schlatter, J. R. [Auteur]
Van Loveren, H. [Auteur]
Ackerl, R. [Auteur]
Knutsen, H. K. [Auteur]

Journal title :

EFSA Journal

Abbreviated title :

EFSA J

Volume number :

19

Pages :

e06780

Publication date :

2021-09-13

ISSN :

1831-4732

English keyword(s) :

Akkermansia muciniphila
novel food
food supplement
gut microbiota
safety

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods andFood Allergens (NDA) was asked to deliver an opinion on pasteurisedAkkermansia muciniphilaas anovel food (NF) pursuant to ...
Show more >Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods andFood Allergens (NDA) was asked to deliver an opinion on pasteurisedAkkermansia muciniphilaas anovel food (NF) pursuant to Regulation (EU) 2015/2283.A. muciniphilais a well-characterised non-toxin producing, avirulent microorganism that has been reported as part of normal gut microbiota. TheNF, pasteurisedA. muciniphila, is proposed by the applicant to be used as a food supplement at max.591010cells/day by adults excluding pregnant and lactating women, and in foods for special medicalpurposes. The Panel considers that the production process of the NF is sufficiently described and thatthe information provided on the composition of the NF is sufficient for its characterisation. Taking intoaccount the composition of the NF and the proposed conditions of use, the consumption of the NF isnot nutritionally disadvantageous. Based on literature data, and by applying an uncertainty factor of200 to the no observed adverse effect level (NOAEL) of a 90-day repeated dose oral toxicity study inrats, the Panel concludes that the consumption of 3.491010cells/day is safe for the target populationunder the provision that the number of viable cells in the NF is<10 colony forming units (CFU)/g (i.e.limit of detection)Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
Inserm
CHU Lille

Collections :

• Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286

Submission date :

2024-01-12T06:05:07Z
2024-03-01T13:32:17Z