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 Dec 14;20(12):e07647. doi: 10.2903/j.efsa.2022.7647. eCollection 2022 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 2'-fucosyllactose (2'-FL) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human-identical milk oligosaccharide (HiMO) 2'-FL, but it also contains d-lactose, l-fucose, 3-fucosyllactose, difucosyllactose, d-glucose and d-galactose. The NF is produced by fermentation with a genetically modified strain (APC199) of ATCC 13032. 2'-FL, when chemically synthesised or produced by fermentation with derivative strains of K-12 DH1 or BL21 (DE3), is already authorised and included in the EU list of NFs. This application refers to a change in the production process and specifications, while target population, conditions of use and consequently, the anticipated intake remain unchanged. The information provided on the identity, production process, composition and specifications of the NF does not raise safety concerns. The intake of other carbohydrate-type compounds structurally related to 2'-FL is also considered of no safety concern. In line with other milk oligosaccharides that are natural components of human milk, the safety assessment of this NF is mainly based on the comparison between the intake of breastfed infants and the estimated intake as NF. Given that the NF would be consumed at the same extent as the already authorised 2'-FL, the Panel considers that the consumption of the NF at the proposed uses and use levels does not raise safety concerns. 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2'-岩藻糖基乳糖（2'-FL）作为新型食品（NF）发表意见。该新型食品主要由与人类母乳中相同的低聚半乳糖（HiMO）2'-FL组成，但也含有d-乳糖、l-岩藻糖、3-岩藻糖基乳糖、二岩藻糖基乳糖、d-葡萄糖和d-半乳糖。该新型食品是通过与美国典型培养物保藏中心（ATCC）13032的基因改造菌株（APC199）发酵生产的。当2'-FL通过化学合成或与K-12 DH1或BL21（DE3）的衍生菌株发酵生产时，已获得授权并被列入欧盟新型食品清单。本申请涉及生产工艺和规格的变更，而目标人群、使用条件以及预期摄入量保持不变。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未引发安全担忧。与2'-FL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。与作为人乳天然成分的其他低聚半乳糖一致，该新型食品的安全性评估主要基于母乳喂养婴儿的摄入量与作为新型食品的估计摄入量之间的比较。鉴于该新型食品的消费程度将与已获授权的2'-FL相同，专家小组认为，在建议的使用方式和使用水平下食用该新型食品不会引发安全担忧。专家小组得出结论，在建议的使用条件下，该新型食品是安全的。
