What are the official 7-track regulatory label names for SCLEROTIUM GUM?

Standard label names are US PCPC INCI: 'SCLEROTIUM GUM', EU CosIng: 'SCLEROTIUM GUM', KR MFDS: 'SCLEROTIUM GUM (KR MFDS Registered)', CN NMPA IECIC: '小核菌(SCLEROTIUM ROLFSSII)胶', and JP JCIA: 'SCLEROTIUM GUM'.

Is SCLEROTIUM GUM restricted or permitted in EU, US, KR, CN, and JP cosmetics?

Regulatory status summary across 6 jurisdictions — KR: none, EU: none, US: none, CN: allowed, JP: none, ASEAN: none.

What is the typical formulation concentration and optimal pH window for SCLEROTIUM GUM?

In aqueous_serum systems, SCLEROTIUM GUM is typically formulated between 0.1% and 1.5% (median 0.45%), with an optimal stability window of pH 3–10.

What are the known formulation incompatibilities and synergy pairings for SCLEROTIUM GUM?

Recommended synergy pairings include XANTHAN GUM, ACACIA SENEGAL GUM, GLYCERIN. Key incompatibilities to avoid: Requires heating to 70~80°C for complete hydration and maximum clarity.

Plant / Botanical

SCLEROTIUM GUM

Skin ConditioningViscosity ControllingEmulsion Stabilizer

[EU CosIng Official Definition] Sclerotium rolfssii gum

Executive Regulatory & Safety Fact BoxAEO / GEO CITATION ANCHOR

What is SCLEROTIUM GUM (CAS 39464-87-4) in cosmetics and what are its global regulatory limits?

SCLEROTIUM GUM (CAS No. 39464-87-4) is a verified cosmetic ingredient primarily functioning as Skin Conditioning, Viscosity Controlling, Emulsion Stabilizer in topical formulations. Regulated under KR MFDS (Unregulated) and EU 1223/2009 CosIng (Unregulated) statutory frameworks, it is typically formulated at 0.1–1.5% within an optimal stability window of pH 3–10.

7-Track Official Regulatory Label Names Matrix

Primary Statutory Gazette Only · Zero Machine Translation

7-Track Official Statutory Label Names for SCLEROTIUM GUM
Jurisdiction Track	Official Statutory Label Name	One-Click Copy
1. Korea (MFDS Standard Name)	SCLEROTIUM GUM (KR MFDS Registered)
2. Korea Former Nomenclature History	—	—
3. European Union (EU CosIng Glossary)	SCLEROTIUM GUM
4. United States (US PCPC / MoCRA INCI)	SCLEROTIUM GUM
5. US FDA OTC Monograph Active Name	— (Cosmetic Inactive / Non-OTC)	—
6. China (NMPA IECIC Standard Name)	小核菌(SCLEROTIUM ROLFSSII)胶
7. Japan (JCIA Standard / MHLW Quasi-Drug)	SCLEROTIUM GUM (Standard INCI Reference)

Layer 1 — Statutory Regulatory Limits Across 6 Regions

Layer 1 Statutory Regulatory Limits Across 6 Regions for SCLEROTIUM GUM
Region	Status	Max Limit	Conditions & Statutory Source
Korea (MFDS)	Unregulated	GMP	Listed in official cosmetic inventory
Europe (EU)	Unregulated	GMP	Listed in official cosmetic inventory
United States (FDA)	Unregulated	GMP	Listed in official cosmetic inventory
China (NMPA)	Listed / Allowed	GMP	IECIC Entry #7096
Japan (MHLW)	Unregulated	GMP	Listed in official cosmetic inventory
ASEAN (ACD)	Unregulated	GMP	Listed in official cosmetic inventory

Layer 2 — Toxicological & Historical Safe Use Concentrations (CIR / SCCS / CN IECIC / IFRA)

“EU SCCS Safe Opinion Limit” is the toxicological safe threshold (MoS≥100), whereas “US CIR Reported Max Use” and “CN IECIC Historical Max Use” represent historical maximum concentrations in commercial products.

Layer 2 Toxicological & Historical Safe Use Concentrations for SCLEROTIUM GUM
Assessment Basis	Application Scope	Concentration Range	Verdict & Dossier Reference
CN IECIC Historical Max Use	leave_on	≤ 2%	Safe (MoS≥100)NMPA IECIC (2025) Entry 07592 (2025)
CN IECIC Historical Max Use	rinse_off	≤ 1.5%	Safe (MoS≥100)NMPA IECIC (2025) Entry 07592 (2025)

⚠️ Reference Only (Legal Disclaimer): The regulatory limits, ingredient names, and formulation ranges in this dictionary are provided for R&D reference only. Because official notices may be amended or data discrepancies may exist, users must verify the latest statutory text from the competent authority before product formulation, labeling, or commercialization. UNIZ LAB assumes no legal liability for the use of this information.

Interactive Quartile Box-Plot (Min–Q1–Median–Q3–Max)

Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit

Aqueous Serum / Ampoulen=42

Min 0.1% · Q1 0.25% · Median 0.45% · Q3 0.75% · Max 1.5%

Emulsion / Creamn=65

Min 0.1% · Q1 0.2% · Median 0.3% · Q3 0.5% · Max 1%

Aqueous Serum / Ampoule — Clean-beauty non-stringy silky hydrogel builder

Verified Source: Alban Muller Amigel / SEPPIC SOLAGUM AX TDS (cir_safety) · SEPPIC 28 · Alban Muller 14

Typical Median: 0.45%

Layer 3 — Formulation Usage Guide (Quartiles n≥5) & Physicochemical Compatibility

Layer 3 Formulation Concentration Quartiles by Product Category for SCLEROTIUM GUM
Formulation Group	Min – Q1 – Median – Q3 – Max (%)	Role & Mechanism	Source ID
Group A — Aqueous Toner / Serum / Ampoule	0.1% · 0.25% · 0.45% · 0.75% · 1.5%	Clean-beauty non-stringy silky hydrogel builder	Alban Muller Amigel / SEPPIC SOLAGUM AX TDS
Group B — O/W & W/O Emulsion / Lotion / Cream	0.1% · 0.2% · 0.3% · 0.5% · 1%	Natural emulsion thermal & suspension stabilizer	CIR Sclerotium Gum Safety Assessment

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

pH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior

Hydrates optimally at 70~80°C in water

Optimal Formulation pH Stability Window (0–14)pH 3.0 – 10.0

Outside pH 3–10, 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)

Simulate HLB: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.

+ XANTHAN GUM + ACACIA SENEGAL GUM + GLYCERIN

Nominative Trade Name References (Trademark Act Art. 90(1)(2))

Amigel®SOLAGUM™ AXActigum™ CS 11

Trade names are provided strictly for descriptive identification of polymer/emulsifier grades under Article 90(1)(2) of the Trademark Act. All trademarks belong to their respective owners.

Academic & Toxicological Synthesis

Tier 1 Synthesis

Synthesized strictly from peer-reviewed PubMed abstracts and official toxicological dossiers linked to this ingredient.

■ [1. Chemical Identity & International Labeling Nomenclature] - INCI Name: SCLEROTIUM GUM | CAS No.: 39464-87-4 | EC No.: 254-464-6 - Origin: PLANT | Functions: Skin Conditioning, , - Physicochemical Profile: Formula | MW /(Polymer/Complex) | / | Ionic Nature: non-ionic | CosIng/MFDS - Official Regional Label Names: US [SCLEROTIUM GUM] · EU [SCLEROTIUM GUM] · CN [小核菌(SCLEROTIUM ROLFSSII)胶] · JP [-] · JP Quasi-Drug [-] ■ [2. Dermatological Mechanism of Action & Functional Role] - Sclerotium rolfssii gum 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. 7096 (小核菌(SCLEROTIUM ROLFSSII)胶)) - 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 2.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 1.5% ■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)] - [aqueous_serum] Typical range: 0.1 ~ 1.5% (Median 0.45%, Ref: Alban Muller Amigel / SEPPIC SOLAGUM AX TDS) — Clean-beauty non-stringy silky hydrogel builder - [emulsion_cream] Typical range: 0.1 ~ 1.0% (Median 0.3%, Ref: CIR Sclerotium Gum Safety Assessment) — Natural emulsion thermal & suspension stabilizer ■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)] - Addition Phase: Water Phase (Heat to 70~80°C with homogenization for full hydration) - Optimal pH Range: pH 3.0 ~ 10.0 | Max Process Temp: Max 85°C | Electrolyte Tolerance: HIGH - Incompatibility / Caution: Requires heating to 70~80°C for complete hydration and maximum clarity - Synergy Pairings: XANTHAN GUM, ACACIA SENEGAL GUM, GLYCERIN | Reference Trade Names: Amigel®, SOLAGUM™ AX, Actigum™ CS 11 ■ [6. Peer-Reviewed Literature & Official Compendia Evidence] - Validated against official regulatory compendia (MFDS/CosIng/CIR/SCCS) and physicochemical standards.

Linked Peer-Reviewed Literature (NIH PubMed) (0)

Statutory toxicology dossier verified via CosIng / MFDS / CIR compendia.

Frequently Asked Questions (AEO Position 0)

Q1. What are the official 7-track regulatory label names for SCLEROTIUM GUM?: Standard label names are US PCPC INCI: 'SCLEROTIUM GUM', EU CosIng: 'SCLEROTIUM GUM', KR MFDS: 'SCLEROTIUM GUM (KR MFDS Registered)', CN NMPA IECIC: '小核菌(SCLEROTIUM ROLFSSII)胶', and JP JCIA: 'SCLEROTIUM GUM'.
Q2. Is SCLEROTIUM GUM restricted or permitted in EU, US, KR, CN, and JP cosmetics?: Regulatory status summary across 6 jurisdictions — KR: none, EU: none, US: none, CN: allowed, JP: none, ASEAN: none.
Q3. What is the typical formulation concentration and optimal pH window for SCLEROTIUM GUM?: In aqueous_serum systems, SCLEROTIUM GUM is typically formulated between 0.1% and 1.5% (median 0.45%), with an optimal stability window of pH 3–10.
Q4. What are the known formulation incompatibilities and synergy pairings for SCLEROTIUM GUM?: Recommended synergy pairings include XANTHAN GUM, ACACIA SENEGAL GUM, GLYCERIN. Key incompatibilities to avoid: Requires heating to 70~80°C for complete hydration and maximum clarity.