CETEARYL ALCOHOL
化妆品中 鲸蜡硬脂醇 (CETEARYL ALCOHOL) 的全球法规限值与配方应用标准是什么?
鲸蜡硬脂醇(标准 INCI: CETEARYL ALCOHOL,CAS 号: 8005-44-5)是化妆品配方中主要用作遮光剂, 柔润剂, 乳化剂的核心成分。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 0.5–6%(最佳稳定窗口 pH 2.5–10)。
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) | CETEARYL ALCOHOL (KR MFDS Registered) | |
| ② 韩国旧名称历史 (301 重定向) | — | — |
| ③ 欧盟 (EU CosIng EC 1223/2009) | CETEARYL ALCOHOL | |
| ④ 美国普通化妆品 (US PCPC / MoCRA INCI) | CETEARYL ALCOHOL | |
| 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) | 鲸蜡硬脂醇 | |
| ⑦ 日本普通化妆品 / 医药部外品 (JCIA / MHLW) | セテアリルアルコール · [QD: セトステアリルアルコール] |
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 #3580 |
| 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 2 — 毒理评估与历史最高使用量 (CN IECIC / US CIR / EU SCCS)
“欧盟 SCCS 安全评估上限”代表消费者安全科学委员会判定安全边际 (MoS≥100) 的毒理阈值;“美国 CIR 市售最高报告浓度”与“中国 IECIC 最高历史使用量”代表已上市化妆品的最高实际使用浓度。
| 安全评估依据 | 适用范围与剂型 | 评估浓度范围 | 评估结论与文献档案 |
|---|---|---|---|
| 中国 IECIC 最高历史使用量 | leave_on | ≤ 15% | 安全判定 (MoS≥100)NMPA IECIC (2025) Entry 03505 (2025) |
| 中国 IECIC 最高历史使用量 | rinse_off | ≤ 12% | 安全判定 (MoS≥100)NMPA IECIC (2025) Entry 03505 (2025) |
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 B — 乳液 / 面霜 (O/W · W/O) | 0.5% · 1.5% · 2.5% · 3.8% · 6% | Lamellar gel-network structuring fatty alcohol & viscosity builder | Evonik TEGO Alkanol 1618 / Sasol NAFOL 1618 TDS & CIR |
| 剂型组 C — 淋洗类洁面 / 洗发水 / 沐浴露 | 1% · 2.5% · 4% · 5.5% · 8% | Hair conditioner lamellar structuring agent | CIR Cetearyl Alcohol Safety Assessment |
| 剂型组 E — 无水精油 / 固体膏霜 / 唇部护理 | 0.5% · 2% · 3% · 4% · 22% | Anhydrous balm, oil & stick structural emollient | Global Starter Formulation Library Statistical Distribution (n=19, EVONIK 11 · ELEMENTIS 3 · GRANT 3 · SEPPIC 2) |
| 剂型组 A — 水剂爽肤水 / 精华液 / 安瓶 | 0.2% · 0.575% · 1% · 1.75% · 3% | Aqueous serum, toner & hydrogel matrix formulation component | Global Starter Formulation Library Statistical Distribution (n=10, EVONIK 5 · ELEMENTIS 3 · GRANT 2) |
| 剂型组 D — 防晒霜 / 彩妆 / 粉底 | 0.1% · 0.6% · 1% · 2% · 5% | Sun care & color cosmetics dispersion / sensory modifier | Global Starter Formulation Library Statistical Distribution (n=41, EVONIK 27 · GRANT 10 · ELEMENTIS 3 · SEPPIC 1) |
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 2.5–10, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Thermally stable up to 85°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) (12)
Allergens in ophthalmic medicaments in New Zealand [PMID: 39714014 · 2025]
Eyelid allergic contact dermatitis (ACD) attributed to ophthalmic medications is often underreported, which can result in poor outcomes. Patch testing for eyelid ACD requires up-to-date knowledge of potential allergens. The aim of this study was to investigate allergens in ophthalmic medicaments in New Zealand. We conducted a cross-sectional review of ophthalmic medicaments available in New Zealand in October 2023. Prescription and over-the-counter products were catalogued with their respective ingredient lists according to product data sheets. Products unapproved for use as per Section 29 of the Medicines Act 1981, or that were unavailable for purchase were excluded. Ingredients were classified according to their function. Allergens in the New Zealand Baseline Series Extended (NZBSE) were recorded. Seventy-three topical ophthalmic medicaments were identified with a total of 143 formulations (brands). Twenty-eight formulations were excluded, leaving a total of 67 topical medicaments (115 formulations) for analysis. Fifty-eight per cent of formulations contained at least one NZBSE allergen. The most frequently identified NZBSE allergen was benzalkonium chloride (contained in 48% of formulations), followed by propylene glycol (6%), lanolin (4%), parabens (4%), caine anaesthetics (2%), neomycin sulphate (2%), and cetearyl alcohol (1%). The majority of ophthalmic preparations contain known allergens. Patch test series must be based on local data and revised regularly to ensure the diagnostic accuracy of patch testing. Patch testing patient's own products is imperative.
Do hypoallergenic skincare products contain fewer potential contact allergens? [PMID: 38069640 · 2024]
Personal care products (PCPs) commonly cause allergic contact dermatitis (ACD). Skincare companies often market their products as 'hypoallergenic'; however, this term is not regulated by industry standards. To determine whether PCPs marketed as hypoallergenic are truly less likely to precipitate ACD, we conducted a study of ingredients found in 'hypoallergenic PCPs' from two major UK retailers in 2022. Of 208 products meeting the inclusion criteria, 153 (73.6%) contained at least 1 allergen or related chemical from the British Society for Cutaneous Allergy baseline series, 21 (10.1%) had 2 potential allergens and 4 PCPs (1.9%) had 3 allergens. Cetearyl alcohol was the most common -allergen identified in leave-on PCPs and parabens in rinse-off products; fragrance was the most frequent related chemical found in 85 PCPs (40.1%). A high prevalence of common allergens was found in hypoallergenic PCPs, suggesting that dermatologists and consumers should be cautious of product ingredients.
Development and quality assessment of glutathione tripeptide loaded niosome containing carbopol emulgels as nanocosmeceutical formulations [PMID: 37119885 · 2023]
This study focuses on the preparation, physicopharmaceutical and mechanical characterization of reduced glutathione tripeptide loaded niosome containing emulgels as a novel nanocosmeceutical product. Prepared emulgel formulations were mainly composed of oily phase containing different lipids such as glycerine dibehenate, cetyl alcohol, cetearyl alcohol, etc., and aqueous phase containing Carbopol934® as gelling agent. Niosomal lipidic vesicles prepared from Span 60 and cholesterol were subsequently incorporated into optimum emulgel formulations. The pH, viscosity, and textural/mechanical properties of emulgels were examined before and after the incorporation of niosomes. The viscoelasticity and morphological characterization were performed on the final formulation before the packed formulation's microbiological stability test. The hardness and compressibility results ensured easy removal of the emulgel from the container. Due to the carboxyl groups of Carbopol934®, moderate adhesiveness with good cohesiveness was achieved. The rheological characteristics of the emulgels were estimated by oscillatory testing and the data fitted with the Herschel-Bulkley model. Thus, the viscoelastic properties and shear-thinning flow of emulgels were demonstrated. The final formulation was microbiologically stable, and pathogens or skin-irritating allergens were not detected. An anti-aging cosmeceutical preparation containing glutathione tripeptide loaded lipid-based niosome dispersion, suitable for topical use due to its textural and viscosity properties, was successfully produced.
Residual film formation after emulsion application: Understanding the role and fate of excipients on skin surface [PMID: 32464232 · 2020]
This study focuses on the fate of excipients contained in topical emulsions once applied on the skin. The aim was thus to develop a methodology to characterize the residue left on the skin shortly after emulsion application. To this end, both the role and the impact of the different excipients on the formation and properties of the residue left on the skin surface once a product is applied were investigated. To that purpose, an O/W emulsion composed of an ester as oily phase, an emulsifier (alkylpolyglucoside-based vehicles), a polymer and a humectant (hydrophilic excipient) was first developed. Then, systems with fewer ingredients were prepared to understand their respective role in the residual film. This residual film was studied in vivo by means of biophysical instrumental methods, all being performed on the participants' forearm. Results highlighted the major role of the ester giving a bright and hydrophobic residue. While the surfactant structuration as the presence of glycerin and polymer provided a specific water distribution inside the residue on the skin surface. Finally, this work evidenced the ingredients organization in the residue depending on the systems composition, with a particular stratification on skin surface which could be considered in the formulation strategy for efficient active delivery and skin protection.
Allergic contact dermatitis caused dexpanthenol-But is that all? [PMID: 31231804 · 2019]
Cetearyl isononanoate, an underestimated contact allergen? [PMID: 29785791 · 2018]
Confocal Raman microspectroscopy as an alternative to differential scanning calorimetry to detect the impact of emulsifiers and formulations on stratum corneum lipid conformation [PMID: 29775655 · 2018]
The purpose of this study was to investigate the impact of emulsifiers and formulations on stratum corneum (SC) lipid conformation and evaluate confocal Raman microspectroscopy (CRM) as an alternative method to differential scanning calorimetry (DSC) in this research context. To this end, four different formulations were used: three conventional creams that contained ionic and/or non-ionic emulsifiers and one surfactants-free emulsion stabilized by a polymeric emulsifier. Additionally, all emulsifiers were tested in aqueous solutions/dispersions in the respective concentrations as present in the formulations. In this study, emulsifiers and formulations were applied onto excised porcine skin during incubation in Franz diffusion cells. Subsequently, SC was isolated, dried and subjected to CRM and DSC measurement to analyse lipid structural changes after treatment. In CRM measurement, 1080 cm -1 /(1130 cm -1  + 1070 cm -1 ) peak ratio, which represents the C-C skeleton vibration and trans-gauche conformation order of lipids, was investigated. Various emulsifiers and formulations showed different impact on SC lipid conformation. Specifically, cetearyl alcohol and sodium cetearyl sulfate mixture dispersion showed the strongest ability among all studied emulsifiers, followed by glycerol monostearate, polyoxyethylene-20-glycerol monostearate as well as their mixture. Polysorbate 60, cetyl stearyl alcohol and their mixture did not affect SC lipid structure. The results of CRM and DSC correlated very well, indicating CRM, as an alternative to DSC, can be a reliable method to investigate SC lipid conformation.
Allergic contact dermatitis caused by sodium cetearyl sulfate [PMID: 29464717 · 2018]
Allergenic Ingredients in Facial Wet Wipes [PMID: 28338538 · 2017]
Allergic contact dermatitis commonly occurs on the face. Facial cleansing wipes may be an underrecognized source of allergens. The aim of this study was to determine the frequency of potentially allergenic ingredients in facial wet wipes. Ingredient lists from name brand and generic facial wipes from 4 large retailers were analyzed. In the 178 facial wipes examined, a total of 485 ingredients were identified (average, 16.7 ingredients per wipe). Excluding botanicals, the top 15 potentially allergenic ingredients were glycerin (64.0%), fragrance (63.5%), phenoxyethanol (53.9%), citric acid (51.1%), disodium EDTA (44.4%), sorbic acid derivatives (39.3%), tocopherol derivatives (38.8%), polyethylene glycol derivatives (32.6%), glyceryl stearate (31.5%), sodium citrate (29.8%), glucosides (27.5%), cetearyl alcohol (25.8%), propylene glycol (25.3%), sodium benzoate (24.2%), and ceteareth-20 (23.6%)/parabens (23.6%). Of note, methylisothiazolinone (2.2%) and methylchloroisothiazolinone (1.1%) were uncommon. The top potential allergens of botanical origin included Aloe barbadensis (41.0%), chamomile extracts (27.0%), tea extracts (21.3%), Cucumis sativus (20.2%), and Hamamelis virginiana (10.7%). Many potential allergens are present in facial wet wipes, including fragrances, preservatives, botanicals, glucosides, and propylene glycol.
The current spectrum of contact sensitization in patients with chronic leg ulcers or stasis dermatitis - new data from the Information Network of Departments of Dermatology (IVDK) [PMID: 28194803 · 2017]
Patients with lower leg dermatitis, chronic venous insufficiency or chronic leg ulcers have a high prevalence of contact sensitization. To identify the current spectrum of contact allergens in these patients. Data of the Information Network of Departments of Dermatology on 5264 patients with the above diagnoses from the years 2003 to 2014 (study group) were compared with data on 4881 corresponding patients from 1994 to 2003 (historical control group) and with a current control group without these diagnoses (n = 55 510). Allergic contact dermatitis was diagnosed less frequently in the study group than in the historical control group (25.9% versus 16.9%; p < 0.001), and contact sensitization to most allergens had declined. The allergen spectrum, however, was largely unchanged. Important allergens are Myroxylon pereirae (balsam of Peru) (14.8% positive reactions), fragrance mix I (11.4%), lanolin alcohol (7.8%), colophonium (6.6%), neomycin sulfate (5.0%), cetearyl alcohol (4.4%), oil of turpentine (3.1%), and paraben mix (2.6%). Patch testing with additional series showed sensitization to Amerchol L-101 (9.7%), tert-butyl hydroquinone (8.7%), framycetin sulfate (5.0%), and gentamicin sulfate (3.1%). Topical preparations for treating the above-mentioned conditions should not contain fragrances, Myroxylon pereirae, and colophonium. The special allergen spectrum has to be considered in patch testing.
Grape Pomace Extract-Loaded Liposomes Enriched Cream Formulations for Skincare [PMID: 42072063 · 2026]
This study aims to develop and characterize novel dermatocosmetic formulations designed to hydrate the skin, improve its appearance, reduce wrinkles, and provide antioxidant, anti-ageing, antimicrobial, and anti-inflammatory benefits, along with potential protection against UVA and UVB radiation. The formulations contain the following ingredients: xanthan gum (0.5%), Calendula officinalis oil (5%), Argania spinosa oil (5%), Helianthus annuus oil (5%), liposomes containing a hydroalcoholic extract of pomace from local red or white grapes (2%), an olive oil-based emulsifier (6%), vitamin E (0.5%), cetearyl alcohol (3%), propylene glycol (8%), and purified water (up to 100%). The natural ingredients used in these formulations, i.e., the red or white grape pomace extract from the aforementioned Romanian varieties, the oils of Calendula officinalis , Argania spinosa , and Helianthus annuus , xanthan gum, and the olive oil-based emulsifier (Olliva), promote the concept of 'green cosmetics'. The use of liposomes to deliver bioactive substances from hydroalcoholic extracts allows the gradual release of active ingredients into the skin. An alternative for incorporating grape pomace extract into a cream-type matrix involves the use of liposomes. Liposomes loaded with red or white grape pomace extract were prepared using the thin-film hydration technique, followed by ultrasonication and extrusion. The obtained formulations were characterized using bio-physico-chemical analysis procedures in terms of consistency, colour, homogeneity, aroma, pH, stretch, texture, stability, and antioxidant activity/free radical scavenging capacity, as well as in vitro polyphenol release behaviour. These newly developed dermatocosmetic formulations were the subject of a patent application in Romania.
Spontaneous Emulsification as a Low-Energy Strategy for Designing and Optimizing Resveratrol-Loaded Nanostructured Lipid Carriers [PMID: 41768678 · 2026]
Nanostructured lipid carriers (NLCs) have proven to be effective for the delivery of lipophilic drugs by combining high encapsulation capacity with controlled release properties. In this study, NLCs were developed using spontaneous emulsification, a low-energy, simple method that is free of organic solvents. Cetearyl alcohol and Kolliphor RH 40 were employed as the solid lipid and surfactant, respectively. The formulation and process were optimized through a Box-Behnken design, considering mean particle size and size uniformity, as determined by laser diffraction. Colloidal stability was improved by the addition of sodium lauryl sulfate and adjustments to the dispersion polymer. Resveratrol (RVL), used as a model bioactive compound, achieved an encapsulation efficiency of 99%, with a mean particle size of 90 nm, a polydispersity index of 0.2, and a zeta potential of -37 mV, remaining stable for 90 days at 8 °C. Characterization by differential scanning calorimetry/thermogravimetry, Fourier transform infrared, and transmission electron microscopy confirmed the incorporation of the active compound as well as the composition and morphology of the nanocarriers. The system exhibited a delayed and sustained release of RVL, highlighting its potential as a platform for the delivery of bioactive compounds. Overall, the results demonstrate that spontaneous emulsification is a viable and sustainable alternative to the high-energy methods predominantly reported in the literature, enabling the production of stable and efficient NLCs for pharmaceutical and cosmetic applications.
常见问题解答 (FAQ)
- Q1. 鲸蜡硬脂醇 (CETEARYL ALCOHOL) 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 '鲸蜡硬脂醇',美国 PCPC 与欧盟 CosIng 标准 INCI 为 'CETEARYL ALCOHOL',日本 JCIA 表示名称为 'セテアリルアルコール'。
- Q2. 鲸蜡硬脂醇 (CETEARYL ALCOHOL) 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. 鲸蜡硬脂醇 (CETEARYL ALCOHOL) 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 (emulsion_cream) 中常规添加量为 0.5%–6%(中位数 2.5%),最佳稳定 pH 范围为 2.5–10。
- Q4. 鲸蜡硬脂醇 (CETEARYL ALCOHOL) 有哪些配伍禁忌 (Incompatibilities) 与协同增效组合?
- 推荐协同组合包括 CETEARYL GLUCOSIDE, GLYCERYL STEARATE, BEHENTRIMONIUM CHLORIDE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE;配伍禁忌注意:Gradual cooling with moderate agitation recommended to allow stable α-crystalline gel network equilibration。