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

K. Pentieva, Jacqueline Castenmiller, Stefaan de Henauw, Karen‐Ildico Hirsch‐Ernst, John Kearney, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Harry McArdle, Androniki Naska, Carmen Pelaez, Alfonso Siani, Frank Thies, Sophia Tsabouri, Dominique Turck, Marco Vinceti, Francesco Cubadda, Karl Heinz Engel, Thomas Frenzel, Marina Heinonen & 8 others Rosangela Marchelli, Monika Neuhauser-Berthold, Morten Poulsen, Yolanda Sanz, Josef Rudolf Schlatter, Henk van Loveren, Qingqing Sun, Wolfgang Gelbmann

Research output: Contribution to journalArticle

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 ≤ 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.
LanguageEnglish
Article numbere05824
Pages1-13
Number of pages13
JournalEFSA Journal
Volume17
Issue number11
Early online date11 Nov 2019
DOIs
Publication statusPublished - 30 Nov 2019

Fingerprint

novel foods
Mycobacterium
Hot Temperature
heat
Safety
Food
Capsules
exotoxins
lactating women
Exotoxins
heat inactivation
pregnant women
allergens
mannitol
gelatin
intestinal microorganisms
tuberculosis
Mannitol
antibiotic resistance
Dietary Supplements

Keywords

  • ingredient
  • Mycobacterium setense manresensis
  • novel food
  • safety
  • supplement

Cite this

Pentieva, K., Castenmiller, J., de Henauw, S., Hirsch‐Ernst, KI., Kearney, J., Knutsen, H. K., ... Gelbmann, W. (2019). Safety of heat‐killed Mycobacterium setense manresensis as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 17(11), 1-13. [e05824]. https://doi.org/10.2903/j.efsa.2019.5824
Pentieva, K. ; Castenmiller, Jacqueline ; de Henauw, Stefaan ; Hirsch‐Ernst, Karen‐Ildico ; Kearney, John ; Knutsen, Helle Katrine ; Maciuk, Alexandre ; Mangelsdorf, Inge ; McArdle, Harry ; Naska, Androniki ; Pelaez, Carmen ; Siani, Alfonso ; Thies, Frank ; Tsabouri, Sophia ; Turck, Dominique ; Vinceti, Marco ; Cubadda, Francesco ; Engel, Karl Heinz ; Frenzel, Thomas ; Heinonen, Marina ; Marchelli, Rosangela ; Neuhauser-Berthold, Monika ; Poulsen, Morten ; Sanz, Yolanda ; Schlatter, Josef Rudolf ; van Loveren, Henk ; Sun, Qingqing ; Gelbmann, Wolfgang. / Safety of heat‐killed Mycobacterium setense manresensis as a novel food pursuant to Regulation (EU) 2015/2283. In: EFSA Journal. 2019 ; Vol. 17, No. 11. pp. 1-13.
@article{c78a40154ac24b7f9441a83a35ce28e9,
title = "Safety of heat‐killed Mycobacterium setense manresensis as a novel food pursuant to Regulation (EU) 2015/2283",
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 ≤ 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.",
keywords = "ingredient, Mycobacterium setense manresensis, novel food, safety, supplement",
author = "K. Pentieva and Jacqueline Castenmiller and {de Henauw}, Stefaan and Karen‐Ildico Hirsch‐Ernst and John Kearney and Knutsen, {Helle Katrine} and Alexandre Maciuk and Inge Mangelsdorf and Harry McArdle and Androniki Naska and Carmen Pelaez and Alfonso Siani and Frank Thies and Sophia Tsabouri and Dominique Turck and Marco Vinceti and Francesco Cubadda and Engel, {Karl Heinz} and Thomas Frenzel and Marina Heinonen and Rosangela Marchelli and Monika Neuhauser-Berthold and Morten Poulsen and Yolanda Sanz and Schlatter, {Josef Rudolf} and {van Loveren}, Henk and Qingqing Sun and Wolfgang Gelbmann",
note = "Accepted (adopted) date is listed on the uploaded manuscript",
year = "2019",
month = "11",
day = "30",
doi = "https://doi.org/10.2903/j.efsa.2019.5824",
language = "English",
volume = "17",
pages = "1--13",
journal = "EFSA Journal",
issn = "1831-4732",
number = "11",

}

Pentieva, K, Castenmiller, J, de Henauw, S, Hirsch‐Ernst, KI, Kearney, J, Knutsen, HK, Maciuk, A, Mangelsdorf, I, McArdle, H, Naska, A, Pelaez, C, Siani, A, Thies, F, Tsabouri, S, Turck, D, Vinceti, M, Cubadda, F, Engel, KH, Frenzel, T, Heinonen, M, Marchelli, R, Neuhauser-Berthold, M, Poulsen, M, Sanz, Y, Schlatter, JR, van Loveren, H, Sun, Q & Gelbmann, W 2019, 'Safety of heat‐killed Mycobacterium setense manresensis as a novel food pursuant to Regulation (EU) 2015/2283', EFSA Journal, vol. 17, no. 11, e05824, pp. 1-13. https://doi.org/10.2903/j.efsa.2019.5824

Safety of heat‐killed Mycobacterium setense manresensis as a novel food pursuant to Regulation (EU) 2015/2283. / Pentieva, K.; Castenmiller, Jacqueline; de Henauw, Stefaan ; Hirsch‐Ernst, Karen‐Ildico ; Kearney, John ; Knutsen, Helle Katrine ; Maciuk, Alexandre ; Mangelsdorf, Inge ; McArdle, Harry; Naska, Androniki ; Pelaez, Carmen ; Siani, Alfonso ; Thies, Frank ; Tsabouri, Sophia ; Turck, Dominique ; Vinceti, Marco ; Cubadda, Francesco ; Engel, Karl Heinz ; Frenzel, Thomas; Heinonen, Marina; Marchelli, Rosangela; Neuhauser-Berthold, Monika; Poulsen, Morten; Sanz, Yolanda; Schlatter, Josef Rudolf; van Loveren, Henk; Sun, Qingqing; Gelbmann, Wolfgang.

In: EFSA Journal, Vol. 17, No. 11, e05824, 30.11.2019, p. 1-13.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Safety of heat‐killed Mycobacterium setense manresensis as a novel food pursuant to Regulation (EU) 2015/2283

AU - Pentieva, K.

AU - Castenmiller, Jacqueline

AU - de Henauw, Stefaan

AU - Hirsch‐Ernst, Karen‐Ildico

AU - Kearney, John

AU - Knutsen, Helle Katrine

AU - Maciuk, Alexandre

AU - Mangelsdorf, Inge

AU - McArdle, Harry

AU - Naska, Androniki

AU - Pelaez, Carmen

AU - Siani, Alfonso

AU - Thies, Frank

AU - Tsabouri, Sophia

AU - Turck, Dominique

AU - Vinceti, Marco

AU - Cubadda, Francesco

AU - Engel, Karl Heinz

AU - Frenzel, Thomas

AU - Heinonen, Marina

AU - Marchelli, Rosangela

AU - Neuhauser-Berthold, Monika

AU - Poulsen, Morten

AU - Sanz, Yolanda

AU - Schlatter, Josef Rudolf

AU - van Loveren, Henk

AU - Sun, Qingqing

AU - Gelbmann, Wolfgang

N1 - Accepted (adopted) date is listed on the uploaded manuscript

PY - 2019/11/30

Y1 - 2019/11/30

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 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.

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 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.

KW - ingredient

KW - Mycobacterium setense manresensis

KW - novel food

KW - safety

KW - supplement

UR - http://www.scopus.com/inward/record.url?scp=85076047447&partnerID=8YFLogxK

U2 - https://doi.org/10.2903/j.efsa.2019.5824

DO - https://doi.org/10.2903/j.efsa.2019.5824

M3 - Article

VL - 17

SP - 1

EP - 13

JO - EFSA Journal

T2 - EFSA Journal

JF - EFSA Journal

SN - 1831-4732

IS - 11

M1 - e05824

ER -

Pentieva K, Castenmiller J, de Henauw S, Hirsch‐Ernst KI, Kearney J, Knutsen HK et al. Safety of heat‐killed Mycobacterium setense manresensis as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal. 2019 Nov 30;17(11):1-13. e05824. https://doi.org/10.2903/j.efsa.2019.5824