Open AccessSafety of heat‐killed Mycobacterium setense manresensis as a novel food pursuant to Regulation ( EU ) 2015/2283
Author(s) -
Turck Dominique,
Castenmiller Jacqueline,
De Henauw Stefaan,
HirschErnst Karen Ildico,
Kearney John,
Maciuk Alexandre,
Mangelsdorf Inge,
McArdle Harry J,
Naska Androniki,
Pelaez Carmen,
Pentieva Kristina,
Siani Alfonso,
Thies Frank,
Tsabouri Sophia,
Vinceti Marco,
Cubadda Francesco,
Engel Karl Heinz,
Frenzel Thomas,
Hein Marina,
Marchelli Rosangela,
NeuhäuserBerthold Monika,
Poulsen Morten,
Sanz Yolanda,
Schlatter Josef Rudolf,
van Loveren Henk,
Sun Qingqing,
Gelbmann Wolfgang,
Knutsen Helle Katrine
Publication year - 2019
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2019.5824
Subject(s) - european commission , food safety , presumption , population , food science , biology , medicine , microbiology and biotechnology , business , environmental health , european union , political science , international trade , law
Abstract 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 heat‐killed Mycobacterium setense manresensis as a novel food ( NF ) pursuant to Regulation ( EU ) 2015/2283. The NF is an encapsulated ingredient composed of 200 mg mannitol and ≤ 10 5 heat‐killed, freeze‐dried M. setense manresensis . The information provided on the efficacy of the heat inactivation process demonstrates that the applied thermal process effectively kills all M. setense manresensis . The Panel considers that the NF is sufficiently described and characterised. The NF is intended by the applicant to be marketed exclusively in food supplements (gelatine capsules) for the general adult population excluding, children, pregnant and lactating women. The NF is not intended to be an alternative to standard treatment against tuberculosis. The applicant proposed an intake of one capsule (with ≤ 10 5 heat‐killed, freeze‐dried M. setense manresensis ) for 14 consecutive days and a minimum of 6 months with no consumption of the NF , before another intake for fourteen days may follow. M. setense is not considered to be a suitable microorganism species for the qualified presumption of safety ( QPS ). Genetic analyses of the genome indicate the absence of the ability to produce exotoxins. The Panel considers that consumption of heat‐killed M. setense manresensis would not contribute to the pool of transmissible antimicrobial resistance genes already present in the intestinal microbiota. The Panel concludes that the NF is safe under the proposed conditions of use.