植物提取 (Plant)
CANDELILLA CERA
中国 NMPA《已使用化妆品原料目录 (IECIC)》标准中文名: 小烛树(EUPHORBIA CERIFERA)蜡 (序号 #7144)
成膜剂柔润剂
[EU CosIng Official Definition] Candelilla Cera is the extract of the wax obtained from the candelilla, Euphorbia cerifera, Euphorbiaceae
核心法规与安全结论 (Executive Fact Box)AEO / GEO CITATION ANCHOR
化妆品中 小烛树(EUPHORBIA CERIFERA)蜡 (CANDELILLA CERA) 的全球法规限值与配方应用标准是什么？
小烛树(EUPHORBIA CERIFERA)蜡（标准 INCI: CANDELILLA CERA，CAS 号: 8006-44-8）是化妆品配方中主要用作成膜剂, 柔润剂的核心成分。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 2–10%（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) | CANDELILLA CERA (KR MFDS Registered) | |
| ② 韩国旧名称历史 (301 重定向) | — | — |
| ③ 欧盟 (EU CosIng EC 1223/2009) | CANDELILLA CERA | |
| ④ 美国普通化妆品 (US PCPC / MoCRA INCI) | CANDELILLA CERA | |
| 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) | 小烛树(EUPHORBIA CERIFERA)蜡 | |
| ⑦ 日本普通化妆品 / 医药部外品 (JCIA / MHLW) | CANDELILLA CERA (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 #7144 |
| 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) |
⚠️ 仅供参考 (免责声明): 本词典中的原料名称、法规限值与配比指南仅供研发参考。鉴于法规修订时差或潜在数据误差，实际配方设计、标签印制及备案前请务必核实主管部门最新官方公告原文；因使用本词典信息产生的任何问题，运营方概不承担法律责任。
Interactive Quartile Box-Plot (Min–Q1–Median–Q3–Max)
Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit
Sunscreen / Colorn=6
Min 2% · Q1 2.525% · Median 2.8% · Q3 8.25% · Max 10%
Sunscreen / Color — Sun care & color cosmetics dispersion / sensory modifier
Verified Source: Global Starter Formulation Library Statistical Distribution (n=6, EVONIK 6) (cir_safety) · EVONIK 6
Typical Median: 2.8%
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 D — 防晒霜 / 彩妆 / 粉底 | 2% · 2.525% · 2.8% · 8.25% · 10% | Sun care & color cosmetics dispersion / sensory modifier | Global Starter Formulation Library Statistical Distribution (n=6, EVONIK 6) |
Cutaneous Permeation Science (500 Dalton Rule)MW: Macro/Complex · LogP: N/A
Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery
Molecular Weight & LogP Permeation Diagnosis
Low Molecular Weight (320 Da ≤ 500 Da) — Passive Permeation Feasible
Under passive topical application, molecules diffuse tortuously through intercellular lipids. Hydrophilic compounds >500 Da remain primarily on the outer stratum corneum.
Estimated Target Depth
40–90 µm
Optimal Delivery System
Polyol Enhancer / Serum
Colloid Interface, pH Spectrum & Thermal Stability
Water or glycol phase soluble/dispersiblepH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior
Optimal Formulation pH Stability Window (0–14)pH 4.0 – 8.0
Outside pH 4–8, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Maximum Thermal Processing Limit (°C)≤ 50°C
Thermally stable up to 50°C during standard emulsification.
HLB Scale (0–20) & Colloidal Micelle / Lamellar Phase Simulator
O/W Oil-in-Water Micelle Emulsion (Lotion / Cream)
HLB 11.5
Biochemical Signaling & Mechanism Pathway
Cellular & Molecular Target Mechanism Flow
1. Epidermal Interaction→ Upregulation / Activation
Intercellular Lipid & Hydration Matrix
→TEWL Reduction & Barrier Conditioning
2. Homeostasis Modulation⊣ Inhibition / Blockade
Oxidative Stress (ROS) & Irritant Cascade
⊣Cutaneous Soothing & Homeostasis
Formulation Ontology Radial Graph
Interactive Synergy Pairings (Solid) & Incompatibility Warnings (Dashed)
Interactive Node Guide
Click any green synergy node to jump directly to its monograph, or click a red dashed node to inspect the chemical incompatibility mechanism.
代表性商品名参考 (商标法第90条第1款第2项说明性标示)
CANDELILLA CERA
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。
■ [1. Chemical Identity & International Labeling Nomenclature]
- INCI Name: CANDELILLA CERA | CAS No.: 8006-44-8 | EC No.: 232-347-0
- Origin: PLANT | Functions: ,
- Physicochemical Profile: Formula | MW /(Polymer/Complex) | / | Ionic Nature: non-ionic | CosIng/MFDS
- Official Regional Label Names: US [CANDELILLA CERA] · EU [CANDELILLA CERA] · CN [小烛树(EUPHORBIA CERIFERA)蜡] · JP [-] · JP Quasi-Drug [-]
■ [2. Dermatological Mechanism of Action & Functional Role]
- Candelilla Cera is the extract of the wax obtained from the candelilla, Euphorbia cerifera, Euphorbiaceae Classified under origin 'plant', it acts within the cosmetic vehicle or stratum corneum to deliver , performance and structural formulation stability.
■ [3. Global 6-Jurisdiction Regulatory Status & Safety Limits (Layer 1 & Layer 2)]
- Regional Summary: KR: NONE | EU: NONE | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. 7144 (小烛树(EUPHORBIA CERIFERA)蜡))
- No specific Annex prohibition or numeric restriction across the 6 major jurisdictions (Permitted under general GMP safety assessment).
- Official Safety & Historical Use Concentration (Layer 2): Quantum satis (QS) within standard cosmetic safety margins
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
- [sun_color] Typical range: 2.0 ~ 10.0% (Median 2.8%, Ref: Global Starter Formulation Library Statistical Distribution (n=6, EVONIK 6)) — Sun care & color cosmetics dispersion / sensory modifier
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
- Addition Phase: Water Phase or Cool-down Phase (< 45°C)
- Optimal pH Range: pH 4.0 ~ 8.0 | Max Process Temp: Max 50°C | Electrolyte Tolerance: MEDIUM
- Incompatibility / Caution: Verify phase compatibility under extreme pH or high electrolyte loads
- Synergy Pairings: GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL | Reference Trade Names: CANDELILLA CERA
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
- PMID 36582047 (2023, Contact Dermatitis): Severe contact cheilitis from cera alba and other cosmetic oils, fats and waxes in lip balms
- PMID 31400015 (2020, Contact Dermatitis): A peculiar case of sensitization to Candelilla Cera and sucrose (di)stearate in a toddler
关联同行评审文献 (NIH PubMed) (2)
Severe contact cheilitis from cera alba and other cosmetic oils, fats and waxes in lip balms [PMID: 36582047 · 2023]
Aerts O, Pyl J, Mangodt E, Dendooven E · Contact Dermatitis (2023)
A peculiar case of sensitization to Candelilla Cera and sucrose (di)stearate in a toddler [PMID: 31400015 · 2020]
Darrigade AS, Dendooven E, Mangodt E, Vermander E, Hagendorens M, Aerts O · Contact Dermatitis (2020)
常见问题解答 (FAQ)
- Q1. 小烛树(EUPHORBIA CERIFERA)蜡 (CANDELILLA CERA) 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 '小烛树(EUPHORBIA CERIFERA)蜡'，美国 PCPC 与欧盟 CosIng 标准 INCI 为 'CANDELILLA CERA'，日本 JCIA 表示名称为 'CANDELILLA CERA'。
- Q2. 小烛树(EUPHORBIA CERIFERA)蜡 (CANDELILLA CERA) 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. 小烛树(EUPHORBIA CERIFERA)蜡 (CANDELILLA CERA) 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 (sun_color) 中常规添加量为 2%–10%（中位数 2.8%），最佳稳定 pH 范围为 4–8。
- Q4. 小烛树(EUPHORBIA CERIFERA)蜡 (CANDELILLA CERA) 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。