Safety of heat‐killed Mycobacterium setense manresensis as a novel food pursuant to Regulation (EU) 2015/2283

Mycobacterium setense manresensis, supplement, novel food, ingredient, safety (max. seven keywords)
First published in the EFSA Journal
11 Noviembre 2019
19 Septiembre 2019
Scientific Opinion


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 ≤ 105 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 ≤ 105 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.

Panel members at the time of adoption

Jacqueline Castenmiller, Stefaan de Henauw, Karen‐Ildico Hirsch‐Ernst, John Kearney, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri, Dominique Turck and Marco Vinceti.
Panel on Nutrition, Novel Foods and Food Allergens
nda [at]
EFSA Journal 2019;17(11):5824
Question Number
On request from
European Commission following an application by Laboratorio Reig Jofre, S.A.