Safety of pasteurised Akkermansia muciniphila as a novel food pursuant to Regulation (EU) 2015/2283.
Résumé
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)
Domaines
Sciences du Vivant [q-bio]
Fichier principal
EFSA Journal - 2021 - - Safety of pasteurised Akkermansia muciniphila as a novel food pursuant to Regulation EU 2015.pdf (1.88 Mo)
Télécharger le fichier
| Origine | Fichiers éditeurs autorisés sur une archive ouverte |
|---|
