# POTASSIUM SORBATE (potassium-sorbate) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/potassium-sorbate
- **Standard INCI**: `POTASSIUM SORBATE`
- **KR MFDS Standard Name**: `포타슘솔베이트`
- **CAS No.**: `24634-61-5`
- **EC / EINECS No.**: `246-376-1`
- **Origin**: `synthetic`
- **Functions**: 향료, 방부제
- **Molecular Formula / MW**: `—` (— g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 포타슘솔베이트 |
| KR (Former Names) | 포타슘소르베이트 |
| EU (CosIng 1223/2009) | POTASSIUM SORBATE |
| US (PCPC / MoCRA INCI) | POTASSIUM SORBATE |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 山梨酸钾 |
| JP (JCIA / MHLW QD) | ソルビン酸Ｋ (QD: ソルビン酸カリウム) |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `restricted`
- **EU (1223/2009)**: `restricted`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `5911`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`



## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **cn_iecic_max** (leave_on): ≤ 2% — NMPA IECIC (2025) Entry 05845 (2025)
- **cn_iecic_max** (rinse_off): ≤ 0.6% — NMPA IECIC (2025) Entry 05845 (2025)

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 4 – 8
- **Max Process Temp**: ≤ 50°C
- **Synergy Pairings**: GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL
- **Incompatibilities**: Verify phase compatibility under extreme pH or high electrolyte loads

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: POTASSIUM SORBATE | CAS No.: 24634-61-5 | EC No.: 246-376-1
  - Origin: SYNTHETIC | Functions: , 
  - Physicochemical Profile: Formula      | MW /(Polymer/Complex) | /   | Ionic Nature: non-ionic | CosIng/MFDS 
  - Official Regional Label Names: US [POTASSIUM SORBATE] · EU [POTASSIUM SORBATE] · CN [山梨酸钾] · JP [ソルビン酸Ｋ] · JP Quasi-Drug [ソルビン酸カリウム]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Potassium Sorbate is the organic salt that conforms generally to the formula: 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: RESTRICTED | EU: RESTRICTED | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. 5911 (山梨酸钾))
  - [KR / COMPOSITION / limited] (Max 0.6%): 
  - [EU / COMPOSITION / limited] (Max 0.6%): 
  - 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 0.6%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [aqueous_serum] Typical range: 0.1 ~ 1.0% (Median 0.4%, Ref: Global Starter Formulation Library Statistical Distribution (n=5, SEPPIC 3 · GRANT 2)) — Aqueous serum, toner & hydrogel matrix formulation component
■ [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: POTASSIUM SORBATE
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 41638886 (2026, Contact Dermatitis): Preservatives in Leave-On Cosmetics Available on the Dutch Market
  - PMID 39098762 (2024, Ocul Surf): Preservatives and ocular surface disease: A review
  - PMID 36729161 (2023, Dermatologie (Heidelb)): Impact of preservatives in topicals on the cutaneous microbiota

## 6. Linked PubMed Literature
- [PMID: 41638886] Preservatives in Leave-On Cosmetics Available on the Dutch Market — *Contact Dermatitis* (2026)
- [PMID: 39098762] Preservatives and ocular surface disease: A review — *Ocul Surf* (2024)
- [PMID: 36729161] Impact of preservatives in topicals on the cutaneous microbiota — *Dermatologie (Heidelb)* (2023)
- [PMID: 33998748] Development of Hinoline® as a natural preservative for cosmetic product using bioinspiration and Greenpharma Database — *J Appl Microbiol* (2021)
- [PMID: 33656744] Allergic contact dermatitis from potassium sorbate and sorbic acid in topical pharmaceuticals and medical devices — *Contact Dermatitis* (2021)
- [PMID: 33624850] Integrated approaches to testing and assessment as a tool for the hazard assessment and risk characterization of cosmetic preservatives — *J Appl Toxicol* (2021)
- [PMID: 41948045] Potassium sorbate induces developmental and microbiome changes in Drosophila melanogaster with attenuated trans-generational toxicity — *Front Microbiol* (2026)
- [PMID: 40515405] Potassium sorbate-enriched chitosan coatings enhance antioxidant stability and preserve postharvest quality of lemons (Citrus limon) — *J Sci Food Agric* (2025)
- [PMID: 39336671] Toxicity Evaluation of Potassium Sorbate In Vivo with Drosophila Melanogaster — *Insects* (2024)
- [PMID: 32229329] Surface activity and foaming properties of saponin-rich plants extracts — *Adv Colloid Interface Sci* (2020)
- [PMID: 31975717] The effect of active coating and refrigerated storage on the quality of avocado cultivar, Quintal — *J Food Sci Technol* (2020)
- [PMID: 31041411] Skin safety and health prevention: an overview of chemicals in cosmetic products — *J Prev Med Hyg* (2019)
