Turck Dominique, Bohn Torsten, Castenmiller Jacqueline, De Henauw Stefaan, Hirsch-Ernst Karen Ildico, Maciuk Alexandre, Mangelsdorf Inge, McArdle Harry J, Naska Androniki, Pentieva Kristina, Siani Alfonso, Thies Frank, Tsabouri Sophia, Vinceti Marco, Aguilera-Gómez Margarita, Cubadda Francesco, Frenzel Thomas, Heinonen Marina, Marchelli Rosangela, Neuhäuser-Berthold Monika, Peláez Carmen, Poulsen Morten, Prieto Maradona Miguel, Schlatter Josef Rudolf, Siskos Alexandros, van Loveren Henk, Colombo Paolo, Noriega Fernández Estefanía, Knutsen Helle Katrine
EFSA J. 2023 Sep 21;21(9):e08224. doi: 10.2903/j.efsa.2023.8224. eCollection 2023 Sep.
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 (sodium salt), but it also contains sialic acid, d-glucose, d-lactose, 3'-sialyllactulose and 6'-sialyllactose sodium salts and a small fraction of other related saccharides. The NF is produced by fermentation by a genetically modified strain ( NEO3) of W (ATCC 9637). The information provided on the identity, 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 special medical purposes and food supplements (FS). The target population is the general population. The applicant applies for the same uses and use levels as already assessed for 3'-SL sodium salt produced by a genetically modified strain of K-12 DH1, with the exception for the use in FS, which is proposed to be higher (from 0.5 to 1.0 g/day) in individuals from 3 years of age. Since the NF as a food ingredient would be consumed at the same extent as the already assessed 3'-SL sodium salt, no new estimates of the intakes have been carried out. The Panel notes that the maximum daily intake of 3'-SL from the proposed use of the NF in FS for individuals from 3 years of age (1.0 g/day) is lower than the estimated highest mean daily intake of 3'-SL in breastfed infants. FS are not intended to be used if other sources of 3'-SL 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中相同的低聚糖（HiMO）3'-SL（钠盐）组成，但也含有唾液酸、d-葡萄糖、d-乳糖、3'-唾液酸乳糖ulose和6'-唾液酸乳糖钠盐以及一小部分其他相关糖类。该新型食品由基因改造菌株（NEO3）的W（ATCC 9637）发酵生产。关于该新型食品的特性、生产工艺、成分和规格所提供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、特殊医学用途食品和食品补充剂（FS）。目标人群为普通人群。申请人申请的用途和使用水平与已评估的由基因改造的K-12 DH1菌株生产的3'-SL钠盐相同，但食品补充剂中的使用除外，对于3岁及以上个体，其使用量建议更高（从0.5克/天提高到1.0克/天）。由于作为食品成分的该新型食品的消费量将与已评估的3'-SL钠盐相同，因此未进行新的摄入量估计。专家委员会指出，3岁及以上个体在食品补充剂中使用该新型食品时3'-SL的最大每日摄入量（1.0克/天）低于母乳喂养婴儿中3'-SL的估计最高平均每日摄入量。如果同一天食用了其他3'-SL来源，则不建议使用食品补充剂。专家委员会得出结论，在建议的使用条件下，该新型食品是安全的。
