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根据欧盟法规(EU)2015/2283,将2'-岩藻糖基乳糖(2'-FL)作为新型食品延长使用期限的安全性。

Safety of the extension of use of 2'-fucosyllactose (2'-FL) as a novel food pursuant to Regulation (EU) 2015/2283.

作者信息

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, Prieto Maradona Miguel, Marchelli Rosangela, Neuhäuser-Berthold Monika, Peláez Carmen, Poulsen Morten, Schlatter Josef Rudolf, Siskos Alexandros, van Loveren Henk, Colombo Paolo, Noriega Fernández Estefanía, Knutsen Helle Katrine

出版信息

EFSA J. 2023 Nov 9;21(11):e08334. doi: 10.2903/j.efsa.2023.8334. eCollection 2023 Nov.

Abstract

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 safety of the extension of use of 2'-fucosyllactose (2'-FL) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is already authorised as ingredient in several food categories, including infant formula (IF) and follow-on formula (FOF). The applicant proposed to increase the maximum use levels of the NF in IF and FOF. EFSA estimated the anticipated daily intake of the NF from the proposed extension of use, including the already authorised conditions of use in other food categories. Additionally, a new intake estimate limited to the already authorised conditions of use of the NF was carried out following EFSA's current approach. The estimated daily intake of the NF from high consumption of IF alone at the proposed maximum use level in infants < 16 weeks of age is similar to the estimated natural highest mean daily intake of 2'-FL from human milk in breastfed infants. The estimated highest P95 daily intakes of the NF from the proposed extension of use in IF and FOF (including the authorised uses in other food categories) and from the already authorised conditions of use, are comparable and both higher than the estimated natural highest mean daily intake of 2'-FL from human milk in infants and to a lesser extent in young children. The Panel considers that the proposed extension of use of the NF in IF and FOF only marginally affects the highest P95 daily intake estimate from the authorised conditions of use, and therefore does not affect the safety of the NF. The Panel concludes that the NF, 2'-FL, is safe under the proposed conditions of use.

摘要

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)扩大使用范围的安全性发表意见。该新型食品已被批准作为几种食品类别的成分,包括婴儿配方奶粉(IF)和后续配方奶粉(FOF)。申请人提议提高IF和FOF中该新型食品的最大使用量。EFSA估计了因提议扩大使用范围(包括已批准的在其他食品类别中的使用条件)而导致的该新型食品的预期每日摄入量。此外,按照EFSA目前的方法,对仅基于该新型食品已批准使用条件的新摄入量进行了估计。对于16周龄以下婴儿,仅以提议的最大使用量大量食用IF时,该新型食品的估计每日摄入量与母乳喂养婴儿从母乳中摄入的2'-FL的估计天然最高平均每日摄入量相似。从IF和FOF中提议扩大使用范围(包括在其他食品类别中的批准用途)以及已批准使用条件下该新型食品的估计最高P95每日摄入量具有可比性,且均高于婴儿以及在较小程度上幼儿从母乳中摄入的2'-FL的估计天然最高平均每日摄入量。该小组认为,在IF和FOF中提议扩大该新型食品的使用范围仅对已批准使用条件下的最高P95每日摄入量估计产生轻微影响,因此不会影响该新型食品的安全性。该小组得出结论,在提议的使用条件下,新型食品2'-FL是安全的。

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