ANHYDROXYLITOL
化妆品中 脱水木糖醇 (ANHYDROXYLITOL) 的全球法规限值与配方应用标准是什么?
脱水木糖醇(标准 INCI: ANHYDROXYLITOL,CAS 号: 53448-53-6)是化妆品配方中主要用作保湿剂, 皮肤调理剂的核心成分。受中国 NMPA(已使用/准用)、韩国 MFDS(未列管)及欧盟 CosIng(未列管)等 6 大法域法定标准监管,常规建议添加量为 1–3%(最佳稳定窗口 pH 4–8)。
全球 7 轨官方全成分标签名称对照表
严格采用各国政府官方目录原名 · 严禁机器翻译| 法域与监管轨道 | 官方公告全成分标准名称 | 一键复制 |
|---|---|---|
| ① 韩国 (MFDS 化妆品标准名称) | ANHYDROXYLITOL (KR MFDS Registered) | |
| ② 韩国旧名称历史 (301 重定向) | Former KR Nomenclature Redirect Active | — |
| ③ 欧盟 (EU CosIng EC 1223/2009) | ANHYDROXYLITOL | |
| ④ 美国普通化妆品 (US PCPC / MoCRA INCI) | ANHYDROXYLITOL | |
| ⑤ 美国 OTC 防晒/祛痘专论活性物名称 (FDA OTC) | — (非美国 OTC 专论活性成分 / 普通化妆品原料) | — |
| ⑥ 中国 (NMPA《已使用化妆品原料目录 IECIC》标准中文名) | 脱水木糖醇 | |
| ⑦ 日本普通化妆品 / 医药部外品 (JCIA / MHLW) | ANHYDROXYLITOL (标准 INCI 参照) |
Layer 1 — 全球 6 大法域法定限值与监管状态
| 法域 | 监管状态 | 法定限值 | 适用条件与法定依据来源 |
|---|---|---|---|
| 韩国 (MFDS) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 欧盟 (EU) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 美国 (FDA) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 中国 (NMPA) | 已使用/准用 | GMP | IECIC Entry #6749 |
| 日本 (MHLW) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
| 东盟 (ACD) | 未列管 | GMP | 已列入官方化妆品原料目录 (按 GMP 规范使用) |
Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit
Layer 3 — 剂型常规配比指南与理化配伍性
| 剂型分类 | Min – Q1 – Median – Q3 – Max (%) | 配方作用与机理 | Source ID |
|---|---|---|---|
| 剂型组 A — 水剂爽肤水 / 精华液 / 安瓶 | 1% · 3% · 3% · 3% · 3% | Aqueous serum, toner & hydrogel matrix formulation component | Global Starter Formulation Library Statistical Distribution (n=9, SEPPIC 9) |
| 剂型组 C — 淋洗类洁面 / 洗发水 / 沐浴露 | 1% · 1.125% · 1.75% · 2% · 3% | Rinse-off cleanser & surfactant system modifier | Global Starter Formulation Library Statistical Distribution (n=6, SEPPIC 6) |
| 剂型组 B — 乳液 / 面霜 (O/W · W/O) | 1% · 1.5% · 3% · 3% · 3% | Emulsion cream & lotion structural / conditioning agent | Global Starter Formulation Library Statistical Distribution (n=20, SEPPIC 20) |
| 剂型组 D — 防晒霜 / 彩妆 / 粉底 | 1% · 1.5% · 1.5% · 3% · 3% | Sun care & color cosmetics dispersion / sensory modifier | Global Starter Formulation Library Statistical Distribution (n=5, SEPPIC 5) |
Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery
Under passive topical application, molecules diffuse tortuously through intercellular lipids. Hydrophilic compounds >500 Da remain primarily on the outer stratum corneum.
pH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior
Outside pH 4–8, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Thermally stable up to 50°C during standard emulsification.
Cellular & Molecular Target Mechanism Flow
Interactive Synergy Pairings (Solid) & Incompatibility Warnings (Dashed)
Click any green synergy node to jump directly to its monograph, or click a red dashed node to inspect the chemical incompatibility mechanism.
商品名仅供配方师识别原料规格参考,商标权归各原厂商所有。
学术与毒理综合摘要
Tier 1 Synthesis本综述严格基于与该原料关联的 NIH PubMed 同行评审文献摘要及官方毒理学评估档案编写。
关联同行评审文献 (NIH PubMed) (4)
Safety Assessment of Anhydrogalactose, Anhydroglucitol, Anhydroxylitol, Arabinose, Psicose, Saccharide Hydrolysate, and Saccharide Isomerate as Used in Cosmetics [PMID: 41243164 · 2025]
The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 7 saccharides/saccharide derivatives as used in cosmetic products; all of these ingredients are reported to function as skin-conditioning agents-humectant in cosmetics. The Panel reviewed data relevant to the safety of these ingredients in cosmetic formulations and concluded that Anhydrogalactose, Anhydroglucitol, Anhydroxylitol, Arabinose, Psicose, Saccharide Hydrolysate, and Saccharide Isomerate are safe in cosmetics in the present practices of use and concentration described in this safety assessment.
Evaluation of a new connected portable camera for the analysis of skin microrelief and the assessment of the effect of skin moisturisers [PMID: 36541033 · 2023]
Silicone replicas and non-contact methods are effective methods to analyse the micrometric scale of the skin microrelief. Yet, they imply data capture in research facilities. The capabilities of a new connected portable camera were evaluated to analyse microrelief under nomadic conditions, also studying the effect of moisturisers. 3D depth maps were constructed using shape-from-shading algorithms. Roughness heterogeneity (Spa) was computed, and skin profiles were extracted to calculate roughness amplitude (Ra, Rq), as well as furrows/plateaus characteristics. Validation of the connected camera was performed on tanned cowhide leather and on the inner forearm skin of a single subject. The forearms of 18 subjects (23-60 years old) were also evaluated. While living their regular life, they self-performed triplicate acquisitions at various times. The effects of a placebo and of cream containing moisturisers-saccharide isomerate, urea or xylitylglucoside-anhydroxylitol-xylitol-were investigated, using untreated control skin as a reference. Validation of the device on leather and forearm skin shows high repeatability. The 18 subjects show the known correlation between age and changes in microrelief. While testing formulas, 8 h after a single application, all decreased Spa (-1.6/-2.1 folds). Only saccharide isomerate and xylitylglucoside-anhydroxylitol-xylitol decreased Ra (-2.4/-2.8 folds). The sectional area of plateaus was reduced from -1.5 (urea) to -2.1 folds (xylitylglucoside-anhydroxylitol-xylitol). The height of plateaus is also decreased by all moisturisers, from -1.5 (urea) to -2.1 folds (xylitylglucoside-anhydroxylitol-xylitol). This novel camera device enables microrelief analysis under nomadic conditions, allowing monitoring its changes along the day and upon moisturisers' application.
Hydrating effects of moisturizer active compounds incorporated into hydrogels: in vivo assessment and comparison between devices [PMID: 19250164 · 2009]
Water is an important factor on the appearance and function of the skin and, when dehydrated, it becomes rough and flaky. The measurement of stratum corneum hydration is widely employed to verify the moisture effect of topical products. This study has evaluated in vivo the stratum corneum hydration, by the electrical measurements of skin, after treatment with different moisturizers presented in gel base. MoistureMeter and Corneometer were used as bio-instruments. Urea, the herbal extract (Imperata cylindrical), the NMF components and the carbohydrate derivate compound (xylityglucoside, anhydroxylitol, and xylitol) were used as the active substances. The study protocol was carried out according to the three-factor factorial design. The gels were applied on both forearms of eight female volunteers. However, each volunteer had one untreated skin area as the skin moisture control. The electrical capacitance of the skin was measured by both instruments in different times: after application (0 time), 30, 60, 120, 240 and 360 min. Gel base, gel containing herbal extract, and gel containing NMF components statistically have equal moisture effect measurements, according to both bio-instruments. However, the values obtained for urea, carbohydrate derivate compound, and untreated skin (control) have statically different results in both devices. The gel containing urea and the carbohydrate derivate compound gel have promoted the most intense moisture effect compared with the other formulations. The measurements of hydration between the devices generated different absolute values; however, the statistical analysis has shown similar precision among the measurements.
Kinetic studies of Mg(2+)-, Co(2+)- and Mn(2+)-activated D-xylose isomerases [PMID: 1831974 · 1991]
The kinetic parameters for the interconverting substrates D-xylose in equilibrium D-xylulose and D-glucose in equilibrium D-fructose were determined for several D-xylose isomerases, with Mg2+, Co2+ and Mn2+ as metal ion activators. The Km, kcat. and kcat./Km values are tabulated for the anomeric mixtures (observed parameters) as well as for the respective reactive species, i.e. the alpha-pyranose anomers of D-xylose and D-glucose and the alpha-furanose forms of D-xylulose and D-fructose (real parameters). The real Km values and catalytic efficiencies are more favourable for the ketose sugars (reverse reaction) than for the aldose sugars (forward reaction). Comparisons of the kinetic parameters further support the existence of two distinct groups of D-xylose isomerases. Inhibition constants for the cyclic substrate analogues 5-thio-alpha-D-xylopyranose and alpha-D-xylopyranosyl fluoride and for the acyclic substrate analogue xylitol and its dehydrated form 1,5-anhydroxylitol were determined and are discussed.
常见问题解答 (FAQ)
- Q1. 脱水木糖醇 (ANHYDROXYLITOL) 在全球 7 大法域的官方全成分标签名称是什么?
- 中国 NMPA《已使用化妆品原料目录 (IECIC)》标准中文名为 '脱水木糖醇',美国 PCPC 与欧盟 CosIng 标准 INCI 为 'ANHYDROXYLITOL',日本 JCIA 表示名称为 'ANHYDROXYLITOL'。
- Q2. 脱水木糖醇 (ANHYDROXYLITOL) 在中、韩、欧、美、日、东盟的法定监管状态 (Layer 1) 如何?
- 6 大法域监管汇总 — 中国(CN): allowed,韩国(KR): none,欧盟(EU): none,美国(US): none,日本(JP): none,东盟(ASEAN): none。
- Q3. 脱水木糖醇 (ANHYDROXYLITOL) 的常规配方添加量 (Layer 3) 与最佳稳定 pH 窗口是多少?
- 在代表性剂型 (aqueous_serum) 中常规添加量为 1%–3%(中位数 3%),最佳稳定 pH 范围为 4–8。
- Q4. 脱水木糖醇 (ANHYDROXYLITOL) 有哪些配伍禁忌 (Incompatibilities) 与协同增效组合?
- 推荐协同组合包括 GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL;配伍禁忌注意:Verify phase compatibility under extreme pH or high electrolyte loads。