Turck Dominique, Bohn Torsten, Castenmiller Jacqueline, De Henauw Stefaan, Hirsch-Ernst Karen Ildico, Maciuk Alexandre, Mangelsdorf Inge, McArdle Harry J, Naska Androniki, Pelaez Carmen, Pentieva Kristina, Siani Alfonso, Thies Frank, Tsabouri Sophia, Vinceti Marco, Aguilera-Gómez Margarita, Cubadda Francesco, Frenzel Thomas, Heinonen Marina, Marchelli Rosangela, Neuhäuser-Berthold Monika, Poulsen Morten, Prieto Maradona Miguel, Siskos Alexandros, Schlatter Josef Rudolf, van Loveren Henk, Muñoz González Alejandra, Rossi Annamaria, Ververis Ermolaos, Knutsen Helle Katrine
EFSA J. 2023 Jul 12;21(7):e08072. doi: 10.2903/j.efsa.2023.8072. eCollection 2023 Jul.
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 an ethanolic extract of the dried biomass of the microalga as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is an ethanolic extract of the dried biomass of the microalga diluted in a medium-chain triglyceride oil carrier, with standardised fucoxanthin and tocopherol content. The main component of the NF is fat (78% on average), followed by crude protein (10% on average). The Panel is of the view that a consistent and safe production process has not been demonstrated. Additionally, the Panel considers that the information provided on the composition of the NF is not complete and may raise safety concerns. The applicant proposed to use the NF as a food supplement at the use level of 437 mg/day, with the target population being adults, excluding pregnant and breastfeeding women. There is no history of use of the NF or of its source, i.e. . The Panel notes that the source of the NF, , was not granted the qualified presumption of safety (QPS) status by the EFSA Panel on Biological Hazards (BIOHAZ), due to the lack of a safe history of use in the food chain and on its potential for production of bioactive compounds with toxic effects. There were no concerns regarding genotoxicity of the NF. In the 90-day study provided, a number of adverse effects were observed, some of them seen already at the lowest dose tested (750 mg/kg body weight (bw) day), which was identified by the Panel as the lowest-observed-adverse-effect-level (LOAEL). The potential phototoxicity of pheophorbide A and pyropheophorbide A in the NF was not addressed in this study. Although noting the uncertainties identified by the Panel regarding the analytical determination of these substances in the NF and the limitations in the publicly available toxicity data, a low margin of exposure (MoE) was calculated for these substances at the proposed use levels. The Panel concludes that the safety of the NF under the proposed uses and use levels has not been established.
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委员会（NDA）被要求根据欧盟法规（EU）2015/2283，就微藻干生物质的乙醇提取物作为新型食品（NF）发表意见。该新型食品是微藻干生物质的乙醇提取物，稀释于中链甘油三酯油载体中，岩藻黄质和生育酚含量标准化。该新型食品的主要成分是脂肪（平均78%），其次是粗蛋白（平均10%）。专家委员会认为，尚未证明其生产过程一致且安全。此外，专家委员会认为，所提供的关于该新型食品成分的信息不完整，可能引发安全担忧。申请人提议将该新型食品作为食品补充剂使用，使用水平为437毫克/天，目标人群为成年人，孕妇和哺乳期妇女除外。该新型食品或其来源，即……没有使用历史。专家委员会指出，由于该新型食品的来源……在食物链中缺乏安全使用历史，且有可能产生具有毒性作用的生物活性化合物，因此欧洲食品安全局生物危害专家委员会（BIOHAZ）未赋予其安全合格假定（QPS）地位。对该新型食品的遗传毒性没有担忧。在提供的90天研究中，观察到了一些不良反应，其中一些在测试的最低剂量（750毫克/千克体重/天）时就已出现，专家委员会将其确定为最低观察到不良反应水平（LOAEL）。该研究未涉及该新型食品中叶卟吩和焦脱镁叶绿酸A的潜在光毒性。尽管注意到专家委员会在该新型食品中这些物质的分析测定方面发现的不确定性以及公开可得毒性数据的局限性，但在提议的使用水平下计算出这些物质的暴露边际（MoE）较低。专家委员会得出结论，在提议的用途和使用水平下，该新型食品的安全性尚未确立。
