Turck Dominique, Bresson Jean-Louis, Burlingame Barbara, Dean Tara, Fairweather-Tait Susan, Heinonen Marina, Hirsch-Ernst Karen Ildico, Mangelsdorf Inge, McArdle Harry J, Naska Androniki, Neuhäuser-Berthold Monika, Nowicka Grażyna, Pentieva Kristina, Sanz Yolanda, Siani Alfonso, Sjödin Anders, Stern Martin, Tomé Daniel, Vinceti Marco, Willatts Peter, Engel Karl-Heinz, Marchelli Rosangela, Pöting Annette, Poulsen Morten, Schlatter Josef Rudolf, Amundsen Mathias, van Loveren Henk
EFSA J. 2018 Jul 27;16(7):e05360. doi: 10.2903/j.efsa.2018.5360. eCollection 2018 Jul.
Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on whey basic protein isolate as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is obtained by ion exchange chromatography of skimmed cow's milk. The applicant intends to market the NF in infant and follow-on formulae and meal replacement beverages, dietary foods for special medical purposes and as food supplements. The highest estimated intake of the NF based on the proposed uses and use levels would be 24.8 mg/kg body weight (bw) per day in infants and 27.8 in toddlers. The information provided on composition, specifications, production process and stability of the NF do not raise safety concerns. Taking into account the composition of the NF and the intended use levels, the Panel considers that the consumption of the NF is not nutritionally disadvantageous. The Panel considers that there is no concern with respect to genotoxicity. The no observed adverse effect level (NOAEL) of a subchronic 13-week rat study was 2000 mg/kg bw per day. Considering the source, the production process and nature of the NF, the Panel considers the margin of exposure (MOE) of 154 to be sufficient for the adult population (on a high-estimated intake of 13 mg/kg bw). For infants and toddlers, the MOE would be at least 81 and 72, respectively. Taking into account the composition of the NF, its source, the history of consumption of the main components of the NF, the production process and that the NOAEL in a subchronic rat study was the highest dose tested the Panel considers that also the MOE for infants and toddlers are sufficient. The Panel concludes that the novel food ingredient, whey basic protein isolate, is safe under the proposed uses and use levels.
应欧盟委员会的要求，根据欧盟法规（EU）2015/2283，欧洲食品安全局（EFSA）的营养产品、营养和过敏专家组（NDA）被要求就乳清碱性分离蛋白作为新型食品（NF）发表意见。该新型食品通过对脱脂牛奶进行离子交换色谱法获得。申请人打算将该新型食品投放于婴儿配方奶粉、较大婴儿配方奶粉和代餐饮料、特殊医学用途的膳食食品以及作为食品补充剂进行销售。基于提议的用途和使用水平，该新型食品的最高估计摄入量在婴儿中为每天24.8毫克/千克体重（bw），在幼儿中为27.8毫克/千克体重。所提供的关于该新型食品的成分、规格、生产工艺和稳定性的信息不存在安全问题。考虑到该新型食品的成分和预期使用水平，专家组认为食用该新型食品在营养方面并无不利影响。专家组认为不存在基因毒性方面的担忧。一项为期13周的大鼠亚慢性研究的未观察到有害作用水平（NOAEL）为每天2000毫克/千克体重。考虑到该新型食品的来源、生产工艺和性质，专家组认为对于成年人群（在最高估计摄入量为13毫克/千克体重的情况下），暴露边际（MOE）为154是足够的。对于婴儿和幼儿，MOE分别至少为81和72。考虑到该新型食品的成分、来源、该新型食品主要成分的消费历史、生产工艺以及大鼠亚慢性研究中的NOAEL是所测试的最高剂量，专家组认为婴儿和幼儿的MOE也是足够的。专家组得出结论，在提议的用途和使用水平下，新型食品成分乳清碱性分离蛋白是安全的。
