化学合成 (Synthetic)
SODIUM PHYTATE
中国 NMPA《已使用化妆品原料目录 (IECIC)》标准中文名: 植酸钠 (序号 #8594)
螯合剂口腔护理剂
[EU CosIng Official Definition] Myo-Inositol, hexakis(dihydrogen phosphate), sodium salt
核心法规与安全结论 (Executive Fact Box)AEO / GEO CITATION ANCHOR
化妆品中 植酸钠 (SODIUM PHYTATE) 的全球法规限值与配方应用标准是什么？
植酸钠（标准 INCI: SODIUM PHYTATE，CAS 号: 14306-25-3）是化妆品配方中主要用作螯合剂, 口腔护理剂的核心成分。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 0.05–0.3%（最佳稳定窗口 pH 3.5–9）。
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) | SODIUM PHYTATE (KR MFDS Registered) | |
| ② 韩国旧名称历史 (301 重定向) | — | — |
| ③ 欧盟 (EU CosIng EC 1223/2009) | SODIUM PHYTATE | |
| ④ 美国普通化妆品 (US PCPC / MoCRA INCI) | SODIUM PHYTATE | |
| 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) | 植酸钠 | |
| ⑦ 日本普通化妆品 / 医药部外品 (JCIA / MHLW) | SODIUM PHYTATE (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 #8594 |
| 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 | ≤ 1% | 安全判定 (MoS≥100)NMPA IECIC (2025) Entry 08612 (2025) |
| 中国 IECIC 最高历史使用量 | rinse_off | ≤ 0.5% | 安全判定 (MoS≥100)NMPA IECIC (2025) Entry 08612 (2025) |
⚠️ 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
Aqueous Serum / Ampoulen=88
Min 0.05% · Q1 0.05% · Median 0.1% · Q3 0.15% · Max 0.3%
Emulsion / Creamn=112
Min 0.05% · Q1 0.05% · Median 0.1% · Q3 0.2% · Max 0.5%
Aqueous Serum / Ampoule — 100% bio-based biodegradable chelating agent (Clean-beauty EDTA replacement)
Verified Source: Evonik Dermofeel PA-3 TDS & CIR Phytic Acid/Salts Assessment (cir_safety) · Evonik 54 · SEPPIC 34
Typical Median: 0.1%
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 | 0.05% · 0.05% · 0.1% · 0.15% · 0.3% | 100% bio-based biodegradable chelating agent (Clean-beauty EDTA replacement) | Evonik Dermofeel PA-3 TDS & CIR Phytic Acid/Salts Assessment |
| 剂型组 B — 乳液 / 面霜 (O/W · W/O) | 0.05% · 0.05% · 0.1% · 0.2% · 0.5% | COSMOS-approved metal-ion sequestrant & antioxidant synergist | Evonik Dermofeel PA-3 Technical Dossier |
Cutaneous Permeation Science (500 Dalton Rule)MW: 923.8 Da · LogP: N/A
Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery
Molecular Weight & LogP Permeation Diagnosis
Macromolecule (923.8 Da > 500 Da) — Transdermal Booster Required
Co-formulating with 0.1–0.5% Hydrolyzed Sponge (Bio-Spicule, 180–250 µm) creates transient micro-channels across the stratum corneum, delivering actives directly into the papillary dermis (PMID: 34112845).
Estimated Target Depth
180–250 µm
Optimal Delivery System
Bio-Spicule + Liposome
Colloid Interface, pH Spectrum & Thermal Stability
Freely soluble in waterpH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior
Optimal Formulation pH Stability Window (0–14)pH 3.5 – 9.0
Outside pH 3.5–9, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Maximum Thermal Processing Limit (°C)≤ 85°C
Thermally stable up to 85°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)
dermofeel® PA-3
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: SODIUM PHYTATE | CAS No.: 14306-25-3 | EC No.: 238-242-6
- Origin: SYNTHETIC | Functions: ,
- Physicochemical Profile: Formula C6H6Na12O24P6 | MW 923.8 g/mol | / | Ionic Nature: anionic | PubChem CID 23676745
- Official Regional Label Names: US [SODIUM PHYTATE] · EU [SODIUM PHYTATE] · CN [植酸钠] · JP [-] · JP Quasi-Drug [-]
■ [2. Dermatological Mechanism of Action & Functional Role]
- Myo-Inositol, hexakis(dihydrogen phosphate), sodium salt Classified under origin 'synthetic', 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. 8594 (植酸钠))
- 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): CN_IECIC_2025 (cn_iecic_max, leave_on): Max 1.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 0.5%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
- [aqueous_serum] Typical range: 0.05 ~ 0.3% (Median 0.1%, Ref: Evonik Dermofeel PA-3 TDS & CIR Phytic Acid/Salts Assessment) — 100% bio-based biodegradable chelating agent (Clean-beauty EDTA replacement)
- [emulsion_cream] Typical range: 0.05 ~ 0.5% (Median 0.1%, Ref: Evonik Dermofeel PA-3 Technical Dossier) — COSMOS-approved metal-ion sequestrant & antioxidant synergist
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
- Addition Phase: Water Phase (Add before pH adjustment)
- Optimal pH Range: pH 3.5 ~ 9.0 | Max Process Temp: Max 85°C | Electrolyte Tolerance: NONE
- Incompatibility / Caution: Strongly alkaline in raw solution (pH ~11); adjust final batch pH with Citric Acid
- Incompatibility / Caution: Do not use with Copper Tripeptide-1 (GHK-Cu), as it chelates Cu2+ away from the peptide
- Synergy Pairings: TOCOPHEROL, 3-O-ETHYL ASCORBIC ACID, BAKUCHIOL, HYDROXYACETOPHENONE | Reference Trade Names: dermofeel® PA-3
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
- PMID 39046084 (2024, Int J Toxicol): Safety Assessment of Polyol Phosphates as Used in Cosmetics.
关联同行评审文献 (NIH PubMed) (1)
Safety Assessment of Polyol Phosphates as Used in Cosmetics. [PMID: 39046084 · 2024]
Johnson W, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG, Shank RC, Slaga TJ, Snyder PW, Fiume M, Heldreth B · Int J Toxicol (2024)
The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 10 polyol phosphates. Some of the possible functions in cosmetics that are reported for this ingredient group are chelating agents, oral care agents, and skin conditioning agents. The Panel reviewed relevant data relating to the safety of these ingredients under the intended conditions of use in cosmetic formulations, and concluded that Sodium Phytate, Phytic Acid, Phytin, and Trisodium Inositol Triphosphate are safe in cosmetics in the present practices of use and concentration described in the safety assessment. The Panel also concluded that the data are insufficient to determine the safety of the following 6 ingredients as used in cosmetics: Disodium Glucose Phosphate, Manganese Fructose Diphosphate, Sodium Mannose Phosphate, Trisodium Fructose Diphosphate, Xylityl Phosphate, and Zinc Fructose Diphosphate.
常见问题解答 (FAQ)
- Q1. 植酸钠 (SODIUM PHYTATE) 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 '植酸钠'，美国 PCPC 与欧盟 CosIng 标准 INCI 为 'SODIUM PHYTATE'，日本 JCIA 表示名称为 'SODIUM PHYTATE'。
- Q2. 植酸钠 (SODIUM PHYTATE) 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. 植酸钠 (SODIUM PHYTATE) 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 0.05%–0.3%（中位数 0.1%），最佳稳定 pH 范围为 3.5–9。
- Q4. 植酸钠 (SODIUM PHYTATE) 有哪些配伍禁忌 (Incompatibilities) 与协同增效组合？
- 推荐协同组合包括 TOCOPHEROL, 3-O-ETHYL ASCORBIC ACID, BAKUCHIOL, HYDROXYACETOPHENONE；配伍禁忌注意：Strongly alkaline in raw solution (pH ~11); adjust final batch pH with Citric Acid; Do not use with Copper Tripeptide-1 (GHK-Cu), as it chelates Cu2+ away from the peptide。