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, Marchelli Rosangela, Neuhäuser-Berthold Monika, Poulsen Morten, Prieto Maradona Miguel, Schlatter Josef Rudolf, van Loveren Henk, Colombo Paolo, Noriega Fernández Estefanía, Knutsen Helle Katrine
EFSA J. 2022 May 25;20(5):e07331. doi: 10.2903/j.efsa.2022.7331. eCollection 2022 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 3'-sialyllactose (3'-SL) sodium salt as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human-identical milk oligosaccharide (HiMO) 3'-SL, but it also contains d-lactose, 3'-sialyllactulose, sialic acid, N-acetyl-d-glucosamine and a small fraction of other related oligosaccharides. The NF is produced by fermentation with two genetically modified strains of BL21 (DE3), the production strain and the optional degradation strain. The information provided on the manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF to a variety of foods, including infant formula and follow-on formula, food for infants and young children, food for special medical purposes and food supplements. The target population is the general population. The anticipated daily intake of 3'-SL from both proposed and combined (authorised and proposed) uses at their respective maximum use levels in all population categories does not exceed the highest intake level of 3'-SL from human milk in infants on a body weight basis. The intake of 3'-SL in breastfed infants on a body weight basis is expected to be safe also for other population groups. The intake of other carbohydrate-type compounds structurally related to 3'-SL is also considered of no safety concern. Food supplements are not intended to be used if other foods with added 3'-SL or human milk are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use.
应欧盟委员会的要求，欧洲食品安全局（EFSA）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3'-唾液酸乳糖（3'-SL）钠盐作为新型食品（NF）发表意见。该新型食品主要由与人乳相同的低聚糖（HiMO）3'-SL组成，但也含有d-乳糖、3'-唾液酸乳酮糖、唾液酸、N-乙酰-d-葡萄糖胺和一小部分其他相关低聚糖。该新型食品是通过使用两种基因改造的BL21（DE3）菌株发酵生产的，即生产菌株和可选的降解菌株。所提供的关于该新型食品制造工艺、成分和规格的信息不存在安全问题。申请人打算将该新型食品添加到多种食品中，包括婴儿配方奶粉和后续配方奶粉、婴幼儿食品、特殊医学用途食品和食品补充剂。目标人群为普通人群。在所有人群类别中，按各自最大使用水平计算，拟议使用和联合使用（已批准和拟议）的3'-SL每日摄入量均不超过婴儿从母乳中摄入3'-SL的最高体重基础摄入量。以体重计，母乳喂养婴儿摄入3'-SL对其他人群组预计也是安全的。与3'-SL结构相关的其他碳水化合物类化合物的摄入量也被认为不存在安全问题。如果同一天食用了添加了3'-SL的其他食品或母乳，则不建议使用食品补充剂。专家小组得出结论，在拟议的使用条件下，该新型食品是安全的。
