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, Prieto Maradona Miguel, Marchelli Rosangela, Neuhäuser-Berthold Monika, Poulsen Morten, Schlatter Josef Rudolf, van Loveren Henk, Ackerl Reinhard, Knutsen Helle Katrine
EFSA J. 2023 May 26;21(5):e07995. doi: 10.2903/j.efsa.2023.7995. eCollection 2023 May.
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 paramylon as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Paramylon is a linear, unbranched beta-1,3-ᴅ-glucan polymer that is isolated from the single-cell microalga . The NF consists of at least 95% beta-glucan and minor amounts of protein, fat, ash and moisture. The applicant proposed to use the NF in food supplements, as a food ingredient added to a number of food categories and in foods for total diet replacement for weight control. In 2019, was attributed the qualified presumption of safety (QPS) status with the qualification 'for production purposes only', which includes food products based on microbial biomass of the microalga. Based on the information provided, is not expected to survive the manufacturing process. The submitted toxicity studies did not raise safety concerns. No adverse effects were observed in the subchronic toxicity studies, up to the highest dose tested, i.e. 5,000 mg NF/kg body weight per day. In view of the QPS status of the source of the NF, supported by the manufacturing process, compositional data and lack of toxicity observed in the toxicity studies, the Panel has no safety concerns and concludes that the NF, i.e. paramylon, is safe under the proposed uses and use levels.
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就副淀粉作为新型食品发表意见。副淀粉是一种从单细胞微藻中分离出来的线性、无分支的β-1,3-D-葡聚糖聚合物。该新型食品至少含有95%的β-葡聚糖以及少量蛋白质、脂肪、灰分和水分。申请人提议将该新型食品用于食品补充剂、作为添加到多种食品类别中的食品成分以及用于体重控制的全膳食替代食品。2019年，其被赋予了“仅用于生产目的”的合格安全推定（QPS）状态，这包括基于该微藻微生物量的食品。根据所提供的信息，预计其在制造过程中无法存活。提交的毒性研究未引发安全担忧。在亚慢性毒性研究中，直至测试的最高剂量，即每天5000毫克新型食品/千克体重，均未观察到不良反应。鉴于新型食品来源的QPS状态，在制造工艺、成分数据以及毒性研究中未观察到毒性的支持下，专家委员会不存在安全担忧，并得出结论，即该新型食品，即副淀粉，在所提议的使用方式和使用水平下是安全的。
