TY - JOUR
T1 - Safety of pasteurised Akkermansia muciniphila as a novel food pursuant to Regulation (EU) 2015/2283
AU - Turck, Dominique
AU - Bohn, Torsten
AU - Castenmiller, Jacqueline
AU - De Henauw, Stefaan
AU - Hirsch-Ernst, Karen Ildico
AU - Maciuk, Alexandre
AU - Mangelsdorf, Inge
AU - McArdle, Harry J.
AU - Naska, Androniki
AU - Pelaez, Carmen
AU - Pentieva, Kristina
AU - Siani, Alfonso
AU - Thies, Frank
AU - Tsabouri, Sophia
AU - Vinceti, Marco
AU - Cubadda, Francesco
AU - Frenzel, Thomas
AU - Heinonen, Marina
AU - Marchelli, Rosangela
AU - Neuhauser-Berthold, Monika
AU - Poulsen, Morten
AU - Maradona, Miguel Prieto
AU - Schlatter, Josef Rudolf
AU - van Loveren, Henk
AU - Ackerl, Reinhard
AU - Knutsen, Helle Katrine
PY - 2021/9/1
Y1 - 2021/9/1
N2 - Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on pasteurised Akkermansia muciniphila as a novel food (NF) pursuant to Regulation (EU) 2015/2283. A. muciniphila is a well-characterised non-toxin producing, avirulent microorganism that has been reported as part of normal gut microbiota. The NF, pasteurised A. muciniphila, is proposed by the applicant to be used as a food supplement at max. 5 × 1010 cells/day by adults excluding pregnant and lactating women, and in foods for special medical purposes. The Panel considers that the production process of the NF is sufficiently described and that the information provided on the composition of the NF is sufficient for its characterisation. Taking into account the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. Based on literature data, and by applying an uncertainty factor of 200 to the no observed adverse effect level (NOAEL) of a 90-day repeated dose oral toxicity study in rats, the Panel concludes that the consumption of 3.4 × 1010 cells/day is safe for the target population under the provision that the number of viable cells in the NF is < 10 colony forming units (CFU)/g (i.e. limit of detection).
AB - Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on pasteurised Akkermansia muciniphila as a novel food (NF) pursuant to Regulation (EU) 2015/2283. A. muciniphila is a well-characterised non-toxin producing, avirulent microorganism that has been reported as part of normal gut microbiota. The NF, pasteurised A. muciniphila, is proposed by the applicant to be used as a food supplement at max. 5 × 1010 cells/day by adults excluding pregnant and lactating women, and in foods for special medical purposes. The Panel considers that the production process of the NF is sufficiently described and that the information provided on the composition of the NF is sufficient for its characterisation. Taking into account the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. Based on literature data, and by applying an uncertainty factor of 200 to the no observed adverse effect level (NOAEL) of a 90-day repeated dose oral toxicity study in rats, the Panel concludes that the consumption of 3.4 × 1010 cells/day is safe for the target population under the provision that the number of viable cells in the NF is < 10 colony forming units (CFU)/g (i.e. limit of detection).
KW - Akkermansia muciniphila
KW - novel food
KW - food supplement
KW - gut microbiota
KW - safety
UR - https://pubmed.ncbi.nlm.nih.gov/34484452
U2 - 10.2903/j.efsa.2021.6780
DO - 10.2903/j.efsa.2021.6780
M3 - Article
C2 - 34484452
SN - 1831-4732
VL - 19
JO - EFSA Journal
JF - EFSA Journal
IS - 9
M1 - e06780
ER -