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, Cubadda Francesco, Frenzel Thomas, Heinonen Marina, Maradona Miguel Prieto, Marchelli Rosangela, Neuhäuser-Berthold Monika, Poulsen Morten, Schlatter Josef Rudolf, van Loveren Henk, Kouloura Eirini, Knutsen Helle Katrine
EFSA J. 2021 Dec 22;19(12):e06938. doi: 10.2903/j.efsa.2021.6938. eCollection 2021 Dec.
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 powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. is an aquatic plant, one out of the 38 species of the water lentil family which is composed by five genera (i.e. , , , and ). The NF is produced by cultivation of plants under controlled conditions, washing with hot water and drying. The main constituents of the NF are protein, fibre and fat. The Panel notes that the concentration of trace elements and contaminants in the NF is highly dependent on the conditions of cultivation of the plant and the fertiliser composition. The NF is intended to be used as food ingredient in a variety of food categories and as food supplement. The target population is the general population except for food supplements which are intended to be consumed exclusively by adults. The Panel considers that with the exception of concerns related to the manganese intake, taking into account the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. The subchronic toxicity study provided with the NF revealed a number of significant findings and the Panel considers the middle dose (6.5 g/kg body weight (bw) per day) as the no observed adverse effect level (NOAEL). Based on the protein concentration, the Panel considers that the consumption of the NF may trigger allergic reactions. The Panel concluded that an increase in manganese intake from the NF used as food ingredient or food supplements is of safety concern and the safety of the NF cannot be 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小组(NDA)被要求根据欧盟法规(EU)2015/2283就[某种水生植物粉末]作为新型食品(NF)发表意见。[该水生植物]是水扁豆科38个物种之一,水扁豆科由五个属(即[具体属名1]、[具体属名2]、[具体属名3]、[具体属名4]和[具体属名5])组成。该新型食品是通过在受控条件下种植[该水生植物]、用热水洗涤并干燥而生产的。该新型食品的主要成分是蛋白质、纤维和脂肪。专家小组指出,该新型食品中微量元素和污染物的浓度高度依赖于植物的种植条件和肥料成分。该新型食品拟用作多种食品类别的食品配料和食品补充剂。目标人群是普通人群,但食品补充剂仅适用于成年人食用。专家小组认为,除了与锰摄入量有关的问题外,考虑到该新型食品的成分和建议的使用条件,食用该新型食品在营养方面并无不利之处。随该新型食品提供的亚慢性毒性研究揭示了一些重要发现,专家小组将中剂量(每天6.5克/千克体重)视为未观察到不良反应水平(NOAEL)。基于蛋白质浓度,专家小组认为食用该新型食品可能引发过敏反应。专家小组得出结论,作为食品配料或食品补充剂使用该新型食品导致锰摄入量增加存在安全问题,且该新型食品的安全性无法确定。