Turck Dominique, Castenmiller Jacqueline, De Henauw Stefaan, Hirsch-Ernst Karen Ildico, Kearney John, 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, Maradona Miguel Prieto, Schlatter Josef Rudolf, van Loveren Henk, Colombo Paolo, Knutsen Helle Katrine
EFSA J. 2021 Jan 27;19(1):e06384. doi: 10.2903/j.efsa.2021.6384. eCollection 2021 Jan.
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 the change in the conditions of use of galacto-oligosaccharides (GOS) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of GOS, consisting of different galactosyl residues (two to nine) linked to a terminal glucose by a β-glycosidic bond but also contains lactose and its monomers (galactose and glucose). The NF is a syrup containing ≥ 55% GOS (w/w dry matter) and is produced enzymatically by two β-galactosidases. GOS produced by β-galactosidases according to the same production process is already authorised and included in the EU Union list of novel foods. This application is limited to an assessment of the proposed increase of the use level as food supplement. The proposed change in the conditions of use increases the maximum level in food supplements from 0.333 kg GOS/kg food supplement (33.3%) to 0.450 kg GOS/kg food supplement (45.0%). Since it is recommended that individuals consume no more than 3 servings of 12 g/day, the maximum recommended daily intake would be no more than 16.2 g GOS. No new food uses or other increases to the already approved use levels are being proposed. The information provided on the proposed use levels and anticipated intake do not raise safety concerns. The Panel concludes that the proposed increase in the maximum level of galacto-oligosaccharides as a NF in food supplements is safe under the proposed changes in 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，就低聚半乳糖（GOS）作为新型食品（NF）的使用条件变更发表意见。该新型食品主要由低聚半乳糖组成，其由不同数量（2至9个）的半乳糖基残基通过β-糖苷键连接到末端葡萄糖上，但也含有乳糖及其单体（半乳糖和葡萄糖）。该新型食品是一种糖浆，含有≥55%的低聚半乳糖（w/w干物质），由两种β-半乳糖苷酶通过酶法生产。按照相同生产工艺由β-半乳糖苷酶生产的低聚半乳糖已获批准并列入欧盟新型食品清单。本申请仅限于对作为食品补充剂提议提高的使用水平进行评估。提议的使用条件变更将食品补充剂中的最高水平从0.333千克低聚半乳糖/千克食品补充剂（33.3%）提高到0.450千克低聚半乳糖/千克食品补充剂（45.0%）。由于建议个人每天食用不超过3份，每份12克，因此建议的每日最大摄入量不超过16.2克低聚半乳糖。未提议新的食品用途或对已批准的使用水平进行其他提高。关于提议的使用水平和预期摄入量提供的信息不存在安全问题。专家小组得出结论，在提议的使用条件变更下，作为食品补充剂的低聚半乳糖最高水平的提议提高是安全的。
