Turck Dominique, Bohn Torsten, Cámara Montaña, Castenmiller Jacqueline, De Henauw Stefaan, Jos Ángeles, Maciuk Alexandre, Mangelsdorf Inge, McArdle Harry J, Mcnulty Breige, Moldeus Peter, Naska Androniki, Pentieva Kristina, Siani Alfonso, Thies Frank, Aguilera-Gómez Margarita, Cubadda Francesco, Frenzel Thomas, Heinonen Marina, Knutsen Helle Katrine, Neuhäuser-Berthold Monika, Poulsen Morten, Maradona Miguel Prieto, Schlatter Josef Rudolf, van Loveren Henk, Albert Océane, Annamaria Rossi, Schmierer Hanna, Roldán-Torres Ruth, Precup Gabriela, Hirsch-Ernst Karen Ildico
EFSA J. 2025 Sep 8;23(9):e9536. doi: 10.2903/j.efsa.2025.9536. eCollection 2025 Sep.
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 the safety of the fungal biomass from species strain as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF as the frozen form of the sp. str. (named by the applicant), which is proposed by the applicant to be used as an ingredient in several food categories, is sufficiently characterised. The information provided on the production process, composition, stability and specifications of the NF is sufficient and does not raise safety concerns. Based on the findings of a repeated dose 90-day oral toxicity study in rats conducted with the dehydrated NF, and considering the evidence for thyroidal effects along with the lack of robustness of other findings at the low dose tested, the Panel considers the lowest dose tested as the no observed adverse effect level (NOAEL), i.e. 2744 mg/kg bw per day of the NF in a dehydrated form, corresponding to approximately 10,400 mg/kg bw per day NF. Under the proposed conditions of use, the highest intake estimates of the NF range from 189 to 556 mg/kg bw per day. Applying a default uncertainty factor of 200 to the NOAEL, the Panel considers that the margins of exposure (i.e. 55 in adolescents and 19 in infants) between the intake of the NF at the proposed use and use levels and the NOAEL from the 90-day study are insufficient. The Panel considers that it is likely that the NF may trigger allergic reactions in allergic subjects. The Panel concludes that, based on the available data, the safety of the NF, i.e. biomass of strain (F. sp. strain flavolapis) fungus, cannot be established.
应欧盟委员会的要求，欧洲食品安全局（EFSA）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，就物种菌株的真菌生物质作为新型食品（NF）的安全性发表意见。作为申请人提议用作多种食品类别成分的冷冻形式的NF（申请人命名为sp. str.），其特征已得到充分描述。关于NF的生产工艺、成分、稳定性和规格提供的信息足够，且未引发安全问题。基于对脱水NF进行的大鼠重复剂量90天口服毒性研究的结果，并考虑到甲状腺效应的证据以及在低剂量测试时其他结果缺乏稳健性，专家小组将测试的最低剂量视为未观察到不良影响水平（NOAEL），即脱水形式的NF每天2744 mg/kg体重，相当于约每天10400 mg/kg体重的NF。在提议的使用条件下，NF的最高摄入量估计为每天189至556 mg/kg体重。将默认不确定性系数200应用于NOAEL，专家小组认为，在提议的使用和使用水平下NF的摄入量与90天研究中的NOAEL之间的暴露边际（即青少年中为55，婴儿中为19）不足。专家小组认为，NF很可能会在过敏个体中引发过敏反应。专家小组得出结论，根据现有数据，无法确定NF（即菌株（F. sp. strain flavolapis）真菌的生物质）的安全性。
