Turck Dominique, Castenmiller Jacqueline, De Henauw Stefaan, Hirsch-Ernst 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, Heinonen Marina, Marchelli Rosangela, Neuhäuser-Berthold Monika, Poulsen Morten, Sanz Yolanda, Schlatter Josef Rudolf, van Loveren Henk, Sun Qingqing, Gelbmann Wolfgang, Knutsen Helle Katrine
EFSA J. 2019 Nov 11;17(11):e05824. doi: 10.2903/j.efsa.2019.5824. eCollection 2019 Nov.
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 as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is an encapsulated ingredient composed of 200 mg mannitol and ≤ 10 heat-killed, freeze-dried . The information provided on the efficacy of the heat inactivation process demonstrates that the applied thermal process effectively kills all . 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 heat-killed, freeze-dried ) for 14 consecutive days and a minimum of 6 months with no consumption of the NF, before another intake for fourteen days may follow. 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 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.
应欧盟委员会的要求，欧洲食品安全局营养、新型食品和食品过敏原专家小组（NDA）被要求根据欧盟法规（EU）2015/2283就热灭活[具体微生物名称未给出]作为新型食品（NF）发表意见。该新型食品是一种胶囊化成分，由200毫克甘露醇和≤10个热灭活、冻干的[具体微生物名称未给出]组成。关于热灭活过程有效性提供的信息表明，所应用的热处理有效地杀死了所有[具体微生物名称未给出]。专家小组认为该新型食品已得到充分描述和表征。申请人打算将该新型食品仅作为食品补充剂（明胶胶囊）在普通成年人群中销售，不包括儿童、孕妇和哺乳期妇女。该新型食品并非旨在替代结核病的标准治疗方法。申请人提议连续14天每天摄入一粒胶囊（含≤10个热灭活、冻干的[具体微生物名称未给出]），在再次摄入14天之前，至少6个月不食用该新型食品。[具体微生物名称未给出]不被认为是适合进行安全合格假定（QPS）的微生物物种。对其基因组的遗传分析表明其缺乏产生外毒素的能力。专家小组认为，食用热灭活的[具体微生物名称未给出]不会增加肠道微生物群中已存在的可传播抗菌抗性基因库。专家小组得出结论，在所提议的使用条件下，该新型食品是安全的。
