• Home (current)
  • The Society
    About Us Collective Members Partners
  • Regional sections
  • Meetings and Education
    SINU Events Other Events Endorsements
  • Newsletters
  • Search
  • Italian Version
  • Skip to main content

SINU

Società Italiana di Nutrizione Umana

EFSA - Safety of pasteurised Akkermansia muciniphila as a novel food

Following a request from the European Commission, the EFSA NDA Panel 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).

Refer to the document


HOME

LARN IV Revision
NMCD
Less Salt more Health
Questionnaires
Focus on...
National Congress
SINU Publications

THE SOCIETY

About us
Sponsor
Partners
Financial Statement

EDUCATION

SINU Events
Other Events
Patronage

NEWS

Highlight
Recent News

CONTACTS

Regional Sections
Working Groups
Privacy policy

SINU SECRETARIAT

BioMedia srl
Libero Temolo 4, street
20126 Milan
(+39 02 45498282
(+39) 02 45498199
info@sinu.it

Copyright © 2019 SINU - All rights reserved
Designed by: BioMedia srl.

Available soon