Plant / Botanical
(-)-ALPHA-BISABOLOL
Skin Conditioning
Executive Regulatory & Safety Fact BoxAEO / GEO CITATION ANCHOR
What is (-)-ALPHA-BISABOLOL (CAS 23089-26-1) in cosmetics and what are its global regulatory limits?
(-)-ALPHA-BISABOLOL (CAS No. 23089-26-1) is a verified cosmetic ingredient primarily functioning as Skin Conditioning in topical formulations. Regulated under KR MFDS (Labelling / Claim) and EU 1223/2009 CosIng (Unregulated) statutory frameworks, it is typically formulated at 0.1–1% within an optimal stability window of pH 3.5–9.
7-Track Official Regulatory Label Names Matrix
Primary Statutory Gazette Only · Zero Machine Translation| Jurisdiction Track | Official Statutory Label Name | One-Click Copy |
|---|---|---|
| 1. Korea (MFDS Standard Name) | (-)-ALPHA-BISABOLOL (KR MFDS Registered) | |
| 2. Korea Former Nomenclature History | — | — |
| 3. European Union (EU CosIng Glossary) | (-)-ALPHA-BISABOLOL | |
| 4. United States (US PCPC / MoCRA INCI) | (-)-ALPHA-BISABOLOL | |
| 5. US FDA OTC Monograph Active Name | — (Cosmetic Inactive / Non-OTC) | — |
| 6. China (NMPA IECIC Standard Name) | Unlisted in CN NMPA IECIC (Do Not Machine-Translate) | — |
| 7. Japan (JCIA Standard / MHLW Quasi-Drug) | (-)-ALPHA-BISABOLOL (Standard INCI Reference) |
Layer 1 — Statutory Regulatory Limits Across 6 Regions
| Region | Status | Max Limit | Conditions & Statutory Source |
|---|---|---|---|
| Korea (MFDS) | Labelling / Claim | 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) | Unregulated | GMP | Listed in official cosmetic inventory |
| 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.
| Assessment Basis | Application Scope | Concentration Range | Verdict & Dossier Reference |
|---|---|---|---|
| CN IECIC Historical Max Use | leave_on | ≤ 2% | Safe (MoS≥100)NMPA IECIC (2025) Entry 05618 (2025) |
| CN IECIC Historical Max Use | rinse_off | ≤ 1% | Safe (MoS≥100)NMPA IECIC (2025) Entry 05618 (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
Emulsion / Creamn=64
Min 0.1% · Q1 0.2% · Median 0.5% · Q3 0.5% · Max 1%
Emulsion / Cream — KR MFDS Brightening Functional Active (0.5%) & potent anti-inflammatory enantiomer
Verified Source: MFDS Functional Cosmetics Notice Annex 4 (0.5%) & CIR Bisabolol Assessment (kr_functional_annex4) · Symrise · BASF · K-Beauty Functional
Typical Median: 0.5%
Layer 3 — Formulation Usage Guide (Quartiles n≥5) & Physicochemical Compatibility
| Formulation Group | Min – Q1 – Median – Q3 – Max (%) | Role & Mechanism | Source ID |
|---|---|---|---|
| Group B — O/W & W/O Emulsion / Lotion / Cream | 0.1% · 0.2% · 0.5% · 0.5% · 1% | KR MFDS Brightening Functional Active (0.5%) & potent anti-inflammatory enantiomer | MFDS Functional Cosmetics Notice Annex 4 (0.5%) & CIR Bisabolol Assessment |
Cutaneous Permeation Science (500 Dalton Rule)MW: 222.37 Da · LogP: 3.79
Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery
Molecular Weight & LogP Permeation Diagnosis
Low Molecular Weight (222.37 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
O/W Emulsion / Micelle
Colloid Interface, pH Spectrum & Thermal Stability
Miscible with oils, esters, ethanol; insoluble 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)≤ 75°C
Thermally stable up to 75°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.
Nominative Trade Name References (Trademark Act Art. 90(1)(2))
Candeia Natural (-)-Alpha-Bisabolol
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 SynthesisSynthesized strictly from peer-reviewed PubMed abstracts and official toxicological dossiers linked to this ingredient.
■ [1. Chemical Identity & International Labeling Nomenclature]
- INCI Name: (-)-ALPHA-BISABOLOL | CAS No.: 23089-26-1 | EC No.: 245-423-3
- Origin: PLANT | Functions: SKIN CONDITIONING
- Physicochemical Profile: Formula C15H26O | MW 222.37 g/mol | LogP 3.79 | Ionic Nature: non-ionic | PubChem CID 442343
- Official Regional Label Names: US [(-)-ALPHA-BISABOLOL] · EU [(-)-ALPHA-BISABOLOL] · CN [-] · JP [-] · JP Quasi-Drug [-]
■ [2. Dermatological Mechanism of Action & Functional Role]
- Enantiomerically pure levorotatory isomer ((-)-alpha-Bisabolol, CAS 23089-26-1), strictly distinguished from racemic Bisabolol (CAS 515-69-5). Exhibits approximately twice the anti-inflammatory bioactivity of the racemate via COX-2/iNOS inhibition and cAMP-mediated melanogenesis attenuation.
■ [3. Global 6-Jurisdiction Regulatory Status & Safety Limits (Layer 1 & Layer 2)]
- Regional Summary: KR: NOTED | EU: NONE | US: NONE | CN: NONE | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. Unlisted (-))
- [KR / CLAIM / noted]:
- 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 1.0%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
- [emulsion_cream] Typical range: 0.1 ~ 1.0% (Median 0.5%, Ref: MFDS Functional Cosmetics Notice Annex 4 (0.5%) & CIR Bisabolol Assessment) — KR MFDS Brightening Functional Active (0.5%) & potent anti-inflammatory enantiomer
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
- Addition Phase: Cool-down Phase (< 60°C) or Oil Phase
- Optimal pH Range: pH 3.5 ~ 9.0 | Max Process Temp: Max 75°C | Electrolyte Tolerance: HIGH
- Incompatibility / Caution: For KR MFDS brightening functional claim (0.5%), must specifically use (-)-Alpha-Bisabolol meeting optical rotation purity standards rather than racemic Bisabolol
- Synergy Pairings: NIACINAMIDE, ALPHA-ARBUTIN, RETINOL, PANTHENOL | Reference Trade Names: Candeia Natural (-)-Alpha-Bisabolol
■ [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 (-)-ALPHA-BISABOLOL?
- Standard label names are US PCPC INCI: '(-)-ALPHA-BISABOLOL', EU CosIng: '(-)-ALPHA-BISABOLOL', KR MFDS: '(-)-ALPHA-BISABOLOL (KR MFDS Registered)', CN NMPA IECIC: 'Unlisted in CN IECIC', and JP JCIA: '(-)-ALPHA-BISABOLOL'.
- Q2. Is (-)-ALPHA-BISABOLOL restricted or permitted in EU, US, KR, CN, and JP cosmetics?
- Regulatory status summary across 6 jurisdictions — KR: noted, EU: none, US: none, CN: none, JP: none, ASEAN: none.
- Q3. What is the typical formulation concentration and optimal pH window for (-)-ALPHA-BISABOLOL?
- In emulsion_cream systems, (-)-ALPHA-BISABOLOL is typically formulated between 0.1% and 1% (median 0.5%), with an optimal stability window of pH 3.5–9.
- Q4. What are the known formulation incompatibilities and synergy pairings for (-)-ALPHA-BISABOLOL?
- Recommended synergy pairings include NIACINAMIDE, ALPHA-ARBUTIN, RETINOL, PANTHENOL. Key incompatibilities to avoid: For KR MFDS brightening functional claim (0.5%), must specifically use (-)-Alpha-Bisabolol meeting optical rotation purity standards rather than racemic Bisabolol.