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, Knutsen Helle Katrine
EFSA J. 2021 Oct 27;19(10):e06844. doi: 10.2903/j.efsa.2021.6844. eCollection 2021 Oct.
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 extension of use of galacto-oligosaccharides (GOS) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a syrup containing ≥ 57% w/w GOS (w/w dry matter), consisting of different galactosyl residues linked to a terminal glucose by a β-glycosidic bond and also containing lactose and the constituent monomers of lactose (galactose and glucose). The NF is already authorised and included in the Union list of NFs and is produced according to the same production process. This application is limited to an assessment of the extension of use as a food ingredient in dairy confectionary, cheese and processed cheese, butter and spreads. There is a 10-30% increase in total GOS intake from the requested extension of use compared to the currently authorised uses at the highest 95th percentile. It is noted that the total intake at the highest mean (8.7-22.0 g/day) is below the adequate intake (AI) of 25 g/day for dietary fibre set to ensure a normal laxation in adults, while the highest 95th percentile (27.2-41.6 g/day) is higher than the AI. When the maximum use as a food supplement is added to the highest 95th percentile combined intake from all proposed and authorised food categories a total intake up to 58 g GOS/day is estimated. This highest intake level would exceed the AI for dietary fibre; however, no tolerable upper intake level for dietary fibre has been set and only transient gastrointestinal symptoms may be related to high intake of fibre. The Panel concludes that the NF, that is composed of ≥ 57% GOS dry matter, lactose and related saccharides, is safe under the proposed extension 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）的使用范围扩展发表意见。该新型食品是一种糖浆，含有≥57%（w/w）的GOS（w/w干物质），由通过β-糖苷键连接到末端葡萄糖的不同半乳糖基残基组成，还含有乳糖以及乳糖的组成单体（半乳糖和葡萄糖）。该新型食品已获授权并列入欧盟新型食品清单，且采用相同的生产工艺生产。本申请仅限于评估其作为食品成分在乳制糖果、奶酪和再制奶酪、黄油及涂抹酱中的使用范围扩展。与目前授权使用的最高第95百分位数相比，因申请的使用范围扩展导致GOS总摄入量增加了10%-30%。需要注意的是，最高平均摄入量（8.7-22.0克/天）低于为确保成年人正常排便而设定的膳食纤维适宜摄入量（AI）25克/天，而最高第95百分位数（27.2-41.6克/天）高于AI。当将作为食品补充剂的最大使用量添加到所有提议和授权食品类别中最高第95百分位数的总摄入量中时，估计GOS的总摄入量高达58克/天。这个最高摄入量水平将超过膳食纤维的AI；然而，尚未设定膳食纤维的可耐受最高摄入量，且只有短暂的胃肠道症状可能与高纤维摄入有关。专家小组得出结论，由≥57%GOS干物质、乳糖及相关糖类组成的新型食品，在提议的使用范围扩展下是安全的。
