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, Frenzel Thomas, Heinonen Marina, Marchelli Rosangela, Neuhäuser-Berthold Monika, Poulsen Morten, Maradona Miguel Prieto, Schlatter Josef Rudolf, van Loveren Henk, Gelbmann Wolfgang, Knutsen Helle Katrine
EFSA J. 2021 Jan 15;19(1):e06346. doi: 10.2903/j.efsa.2021.6346. eCollection 2021 Jan.
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 water extract of Cistanche tubulosa stems as a novel food (NF) for its use in food supplements (FS) and foods for special medical purposes (FSMP). The target population is the general adult population excluding pregnant and lactating women. The applicant proposes a maximum daily intake of 2 g for FS and a maximum use level of 10% in FSMP. The characteristic components of the extract are phenylethanoid glycosides (at least 70% of the NF), in particular, echinacoside (25-45% of the NF). The NF has been authorised as a prescription drug in China in 2005 for the treatment of vascular dementia. The Panel notes that an integrated analysis of three studies covering 1,076 patients with vascular dementia treated with the proposed NF at a daily dose of 1,800 mg, reported that 12 adverse events (AEs) were classified to be 'definitely', 'probably' or 'possibly related' to the exposure to the NF. Two of these AE were classified as severe (cerebral haemorrhage and epilepsy). The Panel considers that the reported AEs raise safety concerns. The Panel also notes the limitations of the provided toxicological studies, in particular the non-compliance with the EFSA approach on the genotoxicity testing strategy and the non-compliance with good laboratory practice (GLP) and the respective OECD Guidance documents of the repeated dose toxicity studies. In view of the AEs in the human studies, the Panel considers that additional toxicological studies, following testing guidelines would not be able to overcome the concerns raised from the human studies. The Panel concludes that the safety of the NF has not been established.
应欧盟委员会的要求，欧洲食品安全局（EFSA）营养、新型食品及食品过敏原专家委员会（NDA）被要求就管花肉苁蓉茎水提取物作为新型食品（NF）用于食品补充剂（FS）和特殊医学用途食品（FSMP）发表意见。目标人群为普通成年人群，不包括孕妇和哺乳期妇女。申请人提议食品补充剂的最大日摄入量为2克，特殊医学用途食品中的最大使用水平为10%。该提取物的特征成分是苯乙醇苷（至少占新型食品的70%），特别是松果菊苷（占新型食品的25 - 45%）。该新型食品于2005年在中国被批准为处方药，用于治疗血管性痴呆。专家委员会注意到，对三项涉及1076例血管性痴呆患者的研究进行的综合分析报告称，有12起不良事件（AE）被归类为与接触该新型食品“肯定”、“可能”或“或许”相关。其中两起不良事件被归类为严重事件（脑出血和癫痫）。专家委员会认为报告的这些不良事件引发了安全担忧。专家委员会还指出了所提供毒理学研究的局限性，特别是不符合欧洲食品安全局关于遗传毒性测试策略的方法，以及不符合良好实验室规范（GLP）和重复剂量毒性研究各自的经合组织指导文件。鉴于人体研究中的不良事件，专家委员会认为按照测试指南进行额外的毒理学研究无法消除人体研究引发的担忧。专家委员会得出结论，该新型食品的安全性尚未确立。
