Human milk oligosaccharides (HMOs) are a complex group of bioactive molecules largely observed in human breast milk but also occurring in limited amounts in other mammalian milks. Advances in biotechnology have enabled production of human‐identical milk oligosaccharides (HiMOs), structurally identical molecules to HMOs found naturally in human milk, intended for addition to infant formula to more closely replicate breast milk. Biosynthesis of a novel mixture of two major HMOs, lacto‐N‐fucopentaose I and 2′‐fucosyllactose (LNFP‐I/2′‐FL), recently became possible. To support the safety of LNFP‐I/2′‐FL for use in infant formula and other foods, it was subject to a safety assessment comprising a bacterial reverse mutation test, an in vitro mammalian cell micronucleus test, and a 90‐day oral gavage study in neonatal rats. In the 90‐day study (the first HiMO study to include the new endocrine‐sensitive endpoints described in the 2018 version of OECD Test Guideline 408), LNFP‐I/2′‐FL was administered by oral gavage to neonatal rats once daily (from Day 7 of age) for 90 consecutive days, at doses up to 5000 mg/kg bw/day, followed by a 4‐week recovery period. Concurrent reference controls received 5000 mg/kg bw/day of the approved infant formula ingredient oligofructose. LNFP‐I/2′‐FL was nongenotoxic in vitro. The highest dose tested (5000 mg/kg bw/day) was established as the no‐observed‐adverse‐effect level in the 90‐day study, as there were no test article‐related adverse effects on clinical observations, body weight, food consumption, clinical pathology, and organ weights nor any noteworthy macroscopic or microscopic findings. This supports the safety of LNFP‐I/2′‐FL for its intended uses in food.

中文翻译：

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人类相同的乳寡糖乳-N-岩藻糖五糖 I 和 2'-岩藻糖基乳糖的新型混合物的遗传毒性和新生儿亚慢性毒性评估

人乳寡糖 (HMO) 是一组复杂的生物活性分子，主要在人乳中观察到，但在其他哺乳动物乳汁中也有少量存在。生物技术的进步使人乳寡糖 (HiMOs) 的生产成为可能，这种分子结构与人乳中天然存在的 HMOs 相同，旨在添加到婴儿配方奶粉中以更接近地复制母乳。生物合成两种主要 HMO 的新型混合物，乳糖-N-岩藻糖五糖 I 和 2'-岩藻糖基乳糖（LNFP-I/2'-FL），最近成为可能。为了支持 LNFP-I/2'-FL 用于婴儿配方奶粉和其他食品的安全性，它接受了安全评估，包括细菌回复突变试验、体外哺乳动物细胞微核试验和新生大鼠 90 天口服管饲研究。在为期 90 天的研究（第一个 HiMO 研究，包括 2018 版 OECD 测试指南 408 中描述的新内分泌敏感终点）中，LNFP-I/2'-FL 每天一次通过口服管饲法给予新生大鼠。从第 7 天开始）连续 90 天，剂量高达 5000 毫克/千克体重/天，然后是 4 周的恢复期。同时参考对照接受了 5000 毫克/千克体重/天的批准婴儿配方奶粉成分低聚果糖。LNFP-I/2'-FL在体外无遗传毒性. 在 90 天的研究中，测试的最高剂量（5000 毫克/千克体重/天）被确定为未观察到的不良反应水平，因为在临床观察、体重、食物方面没有与试验品相关的不良反应消费、临床病理和器官重量，也没有任何值得注意的宏观或微观发现。这支持了 LNFP-I/2'-FL 在食品中的预期用途的安全性。