# BIFIDA FERMENT LYSATE (bifida-ferment-lysate) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/bifida-ferment-lysate
- **Standard INCI**: `BIFIDA FERMENT LYSATE`
- **KR MFDS Standard Name**: `비피다발효용해물`
- **CAS No.**: `96507-89-0`
- **EC / EINECS No.**: `306-168-4`
- **Origin**: `ferment`
- **Functions**: 피부컨디셔닝제
- **Molecular Formula / MW**: `—` (— g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 비피다발효용해물 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | BIFIDA FERMENT LYSATE |
| US (PCPC / MoCRA INCI) | BIFIDA FERMENT LYSATE |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 二裂酵母发酵产物溶胞产物 |
| JP (JCIA / MHLW QD) | BIFIDA FERMENT LYSATE  |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `none`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `2162`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`



## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **cn_iecic_max** (leave_on): ≤ 50% — NMPA IECIC (2025) Entry 02115 (2025)
- **cn_iecic_max** (rinse_off): ≤ 10% — NMPA IECIC (2025) Entry 02115 (2025)

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 4.5 – 6.8
- **Max Process Temp**: ≤ 45°C
- **Synergy Pairings**: GALACTOMYCES FERMENT FILTRATE, LACTOBACILLUS FERMENT LYSATE, NIACINAMIDE, ADENOSINE
- **Incompatibilities**: Rich in organic acid metabolites and amino-acid electrolytes that collapse standard Carbomer gels; use SEPIMAX ZEN or Xanthan Gum; High levels (>10%) require robust preservation (e.g., 2.0% 1,2-Hexanediol + 0.05% Ethylhexylglycerin)

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: BIFIDA FERMENT LYSATE | CAS No.: 96507-89-0 | EC No.: 306-168-4
  - Origin: FERMENT | Functions: Skin Conditioning
  - Physicochemical Profile: Formula      | MW /(Polymer/Complex) | /   | Ionic Nature: amphoteric | CosIng/MFDS 
  - Official Regional Label Names: US [BIFIDA FERMENT LYSATE] · EU [BIFIDA FERMENT LYSATE] · CN [二裂酵母发酵产物溶胞产物] · JP [-] · JP Quasi-Drug [-]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Bifida Ferment Lysate is a lysate of the product obtained by the fermentation of Bifida Classified under origin 'ferment', 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. 2162 (二裂酵母发酵产物溶胞产物))
  - 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 50.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 10.0%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [aqueous_serum] Typical range: 1.0 ~ 50.0% (Median 10.0%, Ref: CLR Repair Complex CLR PF Monograph & PubMed Clinical Trials) — Postbiotic lysate enhancing UV-induced DNA repair & barrier immunity
  - [emulsion_cream] Typical range: 1.0 ~ 20.0% (Median 5.0%, Ref: CLR Berlin Technical Dossier & CN IECIC) — Night repair & microbiome barrier-strengthening cream active
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
  - Addition Phase: Cool-down Phase (< 40°C)
  - Optimal pH Range: pH 4.5 ~ 6.8 | Max Process Temp: Max 45°C | Electrolyte Tolerance: NONE
  - Incompatibility / Caution: Rich in organic acid metabolites and amino-acid electrolytes that collapse standard Carbomer gels; use SEPIMAX ZEN or Xanthan Gum
  - Incompatibility / Caution: High levels (>10%) require robust preservation (e.g., 2.0% 1,2-Hexanediol + 0.05% Ethylhexylglycerin)
  - Synergy Pairings: GALACTOMYCES FERMENT FILTRATE, LACTOBACILLUS FERMENT LYSATE, NIACINAMIDE, ADENOSINE | Reference Trade Names: Repair Complex CLR™ PF, Bifida Ferment Lysate 100
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 38951050 (2024, J Tissue Viability): Short-term skin reactions and changes in stratum corneum following different ways of facial sheet mask usage
  - PMID 37218728 (2023, J Cosmet Dermatol): The pivotal role of Bifida Ferment Lysate on reinforcing the skin barrier function and maintaining homeostasis of skin d
  - PMID 35861908 (2022, Dermatol Ther (Heidelb)): A Randomized, Double-Blind, Placebo-Controlled, Multicentric Study to Evaluate the Efficacy and the Tolerability of a Cl

## 6. Linked PubMed Literature
- [PMID: 38951050] Short-term skin reactions and changes in stratum corneum following different ways of facial sheet mask usage — *J Tissue Viability* (2024)
- [PMID: 37218728] The pivotal role of Bifida Ferment Lysate on reinforcing the skin barrier function and maintaining homeostasis of skin defenses in vitro — *J Cosmet Dermatol* (2023)
- [PMID: 35861908] A Randomized, Double-Blind, Placebo-Controlled, Multicentric Study to Evaluate the Efficacy and the Tolerability of a Class II Medical Device in the Treatment of Mild and Moderate Acne — *Dermatol Ther (Heidelb)* (2022)