异麦芽酮糖作为功能性代糖，风味和理化性质与蔗糖相似，在抗酸、微生物发酵和晶体结构方面稳定，吸湿性和溶解性相对较低，适合应用于不同的食品配方。经大量研究证明，其安全性和耐受性在亚慢性毒性、胚胎毒性、致突变性和人体研究等方面都有所保障。国内外异麦芽酮糖的生产方式主要为操作稳定可重复的固定化微生物转化或显著催化的固定化酶转化，通过重结晶来提纯，利用高效液相色谱定量检测。其具有血糖指数低、消化吸收速度相对缓慢、改善胰岛素反应、益生元特性、低致龋潜力、调节肠道菌群等健康功效，在特殊医学用途食品（FSMP）、儿童食品、普通食品（包括乳制品、谷物制品等）、营养运动食品中都有深入研究和实际应用，该文还结合现有监管政策提出重新梳理其食品添加剂和新食品原料双重身份的建议。

As a functional substitute for sugar, isomaltulose has similar flavor, physical, and chemical properties as sucrose. Isomaltulose is stable in terms of acid resistance, microbial fermentation, and crystal structure, and has relatively low hygroscopicity and solubility, making it suitable for use in different food formulations. Furthermore, several studies have demonstrated its safety and tolerability in subchronic toxicity, embryotoxicity, mutagenicity, and human studies. The production methods of isomaltulose domestically and internationally are predominantly consistent, utilizing reproducible immobilized microbial transformation or highly catalyzed immobilized enzymatic conversion, followed by purification through recrystallization. The resulting products can be quantitatively detected using high performance liquid chromatography. Isomaltulose has a low glycemic index, low caries potential, and relatively slow digestion and absorption. In addition, it improves insulin responses, prebiotic properties, and regulates the intestinal flora. Extensive research has been conducted on the practical utilization of isomaltulose in foods for special medical purposes (FSMP), children’s foods, general foods (including dairy products and cereal products), and nutritional sports foods. This study evaluates current regulatory policies and integrates their findings to propose recommendations for re-evaluating the dual identity of isomaltulose in its application as a food additives and as a potential new food ingredient.