Scientific and technical assistance report on the evaluation of human-identical milk oligosaccharides (HiMOs) as novel foods

European Food Safety Authority (EFSA), Dominique Turck, Paolo Colombo, Estefanía Noriega Fernández, Pablo Rodríguez Fernández, Helle Katrine Knutsen
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Abstract

EFSA was asked by the European Commission to provide scientific and technical assistance on the evaluation of human-identical milk oligosaccharides (HiMOs) as novel foods (NFs). In recent years, the number of authorisations of HiMOs as NFs has markedly increased, which may lead to situations of multiple concurrent uses. Since the safety assessment of HiMOs is based on the comparison with the ‘natural’ intake of human milk oligosaccharides (HMOs), i.e. the HMO intake from human milk in exclusively breastfed infants, a scoping literature review was outsourced to update the database of mean concentrations of single and total HMOs in human milk, and relevant HMO intakes were thus updated. It is noted that in infants up to 16 weeks of age exclusively fed with infant formula, when adding all the assessed HiMOs at their highest maximum use levels across production methods, the resulting highest daily intakes of single HiMOs and the sum of HiMOs are within the natural HMO intake range. These intakes were also estimated (DietEx) for the most exposed population groups (i.e., infants and young children) considering the highest maximum use levels in those food categories with the highest contribution to the overall HiMO intake (i.e., infant and follow-on formulae, ready-to-eat meals, yoghurt and cow milk). The resulting highest P95 daily HiMO intakes were unlikely to be higher than the highest mean daily HMO intakes. However, any possible higher intake would not necessarily imply a safety concern since such natural intake estimates represent an upper end of average natural intakes. It can be concluded that currently there are no safety concerns resulting from the authorised or assessed HiMO intakes from their concurrent combined uses. Nonetheless, in consideration of the increased interest in the use of HiMOs as NFs, a simplified but realistic approach for the intake assessment is proposed in the case of new HiMOs or extensions of use of already authorised HiMOs.

关于评估作为新型食品的人体同源牛奶低聚糖(HiMOs)的科学和技术援助报告
欧盟委员会要求欧洲食品安全局提供科学和技术援助,对作为新食品(NFs)的人体同源牛奶低聚糖(HiMOs)进行评估。近年来,HiMOs 作为 NF 的授权数量显著增加,这可能会导致多种用途同时存在的情况。由于对 HiMOs 的安全性评估是基于与母乳低聚糖(HMOs)"天然 "摄入量的比较,即纯母乳喂养婴儿从母乳中摄入的 HMOs,因此外包了一项范围界定文献审查,以更新母乳中单个和总 HMOs 平均浓度的数据库,从而更新相关的 HMO 摄入量。值得注意的是,对于 16 周以下完全以婴儿配方奶粉喂养的婴儿,如果将所有被评估的 HMO 按不同生产方法的最高最大使用量相加,得出的单一 HMO 最高日摄入量和 HMO 总摄入量均在天然 HMO 摄入量范围内。考虑到对总体 HiMO 摄入量贡献最大的食品类别(即婴幼儿配方奶粉、即食餐、酸奶和牛奶)的最高最大使用量,还对暴露量最高的人群(即婴幼儿)的这些摄入量进行了估算(DietEx)。由此得出的最高 P95 每日 HiMO 摄入量不太可能高于最高 HMO 每日平均摄入量。不过,任何可能的较高摄入量并不一定意味着存在安全问题,因为这种自然摄入量估计值代表了平均自然摄入量的上限。由此可以得出结论,目前,HiMO 的授权或评估摄入量与它们的同时合并使用不会产生安全问题。尽管如此,考虑到人们对使用HiMO作为非营养素的兴趣日益浓厚,我们建议在使用新的HiMO或延长已获授权的HiMO的使用期限时,采用简化但现实的方法进行摄入量评估。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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