原料词典检索/bifida-ferment-lysate/BIFIDA FERMENT LYSATE
Tier 1 Monograph · SSOT 15 FieldsRaw .md (GEO) ↗
发酵与微生态 (Ferment)

BIFIDA FERMENT LYSATE

中国 NMPA《已使用化妆品原料目录 (IECIC)》标准中文名: 二裂酵母发酵产物溶胞产物 (序号 #2162)
皮肤调理剂
[EU CosIng Official Definition] Bifida Ferment Lysate is a lysate of the product obtained by the fermentation of Bifida
核心法规与安全结论 (Executive Fact Box)AEO / GEO CITATION ANCHOR

化妆品中 二裂酵母发酵产物溶胞产物 (BIFIDA FERMENT LYSATE) 的全球法规限值与配方应用标准是什么?

二裂酵母发酵产物溶胞产物(标准 INCI: BIFIDA FERMENT LYSATE,CAS 号: 96507-89-0)是化妆品配方中主要用作皮肤调理剂的核心成分。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 1–50%(最佳稳定窗口 pH 4.5–6.8)。

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
7-Track Official Statutory Label Names for BIFIDA FERMENT LYSATE
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)BIFIDA FERMENT LYSATE (KR MFDS Registered)
② 韩国旧名称历史 (301 重定向)——
③ 欧盟 (EU CosIng EC 1223/2009)BIFIDA FERMENT LYSATE
④ 美国普通化妆品 (US PCPC / MoCRA INCI)BIFIDA FERMENT LYSATE
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)二裂酵母发酵产物溶胞产物
⑦ 日本普通化妆品 / 医药部外品 (JCIA / MHLW)BIFIDA FERMENT LYSATE (标准 INCI 参照)

Layer 1 — 全球 6 大法域法定限值与监管状态

Layer 1 Statutory Regulatory Limits Across 6 Regions for BIFIDA FERMENT LYSATE
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GMPIECIC Entry #2162
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。

Layer 2 Toxicological & Historical Safe Use Concentrations for BIFIDA FERMENT LYSATE
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≤ 50%安全判定 (MoS≥100)NMPA IECIC (2025) Entry 02115 (2025)
中国 IECIC 最高历史使用量rinse_off≤ 10%安全判定 (MoS≥100)NMPA IECIC (2025) Entry 02115 (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=48
Min 1% · Q1 3% · Median 10% · Q3 25% · Max 50%
Emulsion / Creamn=42
Min 1% · Q1 2% · Median 5% · Q3 10% · Max 20%
Aqueous Serum / Ampoule — Postbiotic lysate enhancing UV-induced DNA repair & barrier immunity
Verified Source: CLR Repair Complex CLR PF Monograph & PubMed Clinical Trials (pubmed) · CLR Berlin 32 · K-Beauty 16
Typical Median: 10%

Layer 3 — 剂型常规配比指南与理化配伍性

Layer 3 Formulation Concentration Quartiles by Product Category for BIFIDA FERMENT LYSATE
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1% · 3% · 10% · 25% · 50%Postbiotic lysate enhancing UV-induced DNA repair & barrier immunityCLR Repair Complex CLR PF Monograph & PubMed Clinical Trials
剂型组 B — 乳液 / 面霜 (O/W · W/O)1% · 2% · 5% · 10% · 20%Night repair & microbiome barrier-strengthening cream activeCLR Berlin Technical Dossier & CN IECIC
Cutaneous Permeation Science (500 Dalton Rule)MW: Macro/Complex · LogP: N/A

Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery

Stratum Corneum (Brick & Mortar Barrier · 10–20 µm)500 Da Molecular Weight Cutoff BarrierViable Epidermis (Keratinocytes & Melanocytes · 50–100 µm)Target for Brightening (Tyrosinase/Melanosome) & Barrier LipidsPapillary Dermis (Fibroblasts & ECM Collagen · 150–300 µm)Target for Collagen I/III Synthesis, Peptides, PDRN & ExosomesEpidermal Passive Permeation (<500 Da)
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

Freely miscible with water
Optimal Formulation pH Stability Window (0–14)pH 4.5 – 6.8
0245.5791114

Outside pH 4.5–6.8, risk of hydrolysis, viscosity loss, or ionic dissociation increases.

Maximum Thermal Processing Limit (°C)≤ 45°C
25°C45°C60°C75°C85°C100°C

Thermolabile active: Must be added during post-emulsification Cool-down Phase (<40–45°C).

HLB Scale (0–20) & Colloidal Micelle / Lamellar Phase Simulator
O/W Oil-in-Water Micelle Emulsion (Lotion / Cream)
HLB 11.5
W/O (3–6)Lamellar (8–10.5)O/W Emulsion (11–15)Solubilizer (15–19)O/W Droplet
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)

+ GALACTOMYCES FERME…+ LACTOBACILLUS FERM…+ NIACINAMIDE+ ADENOSINE✕ Rich in organic acid…✕ High levels (>10%) r…BIFIDA FERMENT LYS…
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)
Repair Complex CLR™ PFBifida Ferment Lysate 100

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: 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

关联同行评审文献 (NIH PubMed) (3)

Short-term skin reactions and changes in stratum corneum following different ways of facial sheet mask usage [PMID: 38951050 · 2024]
Wang Y, Cao Y, Huang X, Zhang M, Hu J, Li L, Xiong L · J Tissue Viability (2024)

The global facial mask market grows steadily at 8.5&#xa0;% annually. However, prolonged use may lead to skin inflammation. To investigate how various mask types and wearing durations impact skin physiology and aquaporins3 (AQP3) expression in healthy subjects. We used a randomized controlled design to investigate the effects of three types of facial masks (pure water, hyaluronan, and bifida ferment lysate) and four different duration(5, 15, 25, and 40&#xa0;min) on various skin parameters in volunteers, assessing moisture content, transepidermal water loss (TEWL), sebum, corneocyte size, and AQP3 expression before and after mask application, while also evaluating adverse reactions, discomfort, and noncompliance. Hydration and TEWL increased at first, then decreased. Sebum increased with all types of masks, particularly after 40&#xa0;min. Vasodilation and AQP3 expression were linked to mask duration. Corneocyte sizes remained constant. The main adverse reactions were redness (10.71&#xa0;%, n&#xa0;=&#xa0;28) and dryness (57.14&#xa0;%, n&#xa0;=&#xa0;28), especially with pure water masks lasting over 25&#xa0;min. Short-term use of facial sheet masks (&lt;25&#xa0;min) benefits skin with improved hydration, reduced redness, and AQP3 activation, while prolonged use can lead to increased dryness and redness.

The pivotal role of Bifida Ferment Lysate on reinforcing the skin barrier function and maintaining homeostasis of skin defenses in vitro [PMID: 37218728 · 2023]
Wang R, Yan S, Ma X, Zhao J, Han Y, Pan Y, Zhao H · J Cosmet Dermatol (2023)

The semiactive or inactive probiotics or their extracts used in dermatology have interesting properties to ameliorate signs of irritated skin and enhance the skin barrier. Bifidobacterium, as the most common probiotics, which has been found to be effective in reducing acne and improving the skin barrier function of atopic dermatitis. Bifida Ferment Lysate (BFL) can be obtained from Bifidobacterium by fermentation and extraction. In this study, we investigated the effect of a topically used BFL on the skin using in vitro evaluation methods. The results showed that upregulation of skin physical barrier gene (FLG, LOR, IVL, TGM1, and AQP3) and antimicrobial peptide gene (CAMP and hBD-2) in HaCaT cells by BFL might be responsible for skin barrier resistance. In addition, BFL had strong antioxidant properties representing a dose-dependent increasing of the scavenging capacity of DPPH, ABTS, hydroxyl, and superoxide radicals. BFL treatment also fundamentally inhibited the intracellular ROS and MDA production and improved the activities of antioxidant enzymes (CAT and GSH-Px) in H 2 O 2 -stimulated HaCaT cells. As a good immunomodulatory factor, BFL efficiently decreased the secretion of IL-8 and TNF-&#x3b1; cytokines, and COX-2 mRNA expression in LPS-induced THP-1 macrophages. BFL can strengthen the skin barrier function and stimulate skin barrier resistance, to reinforce the skin against oxidative stress and inflammatory stimuli.

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 [PMID: 35861908 · 2022]
Fabbrocini G, Ferrillo M, Donnarumma M, Papale A, Pinto D, Rinaldi F · Dermatol Ther (Heidelb) (2022)

Several options are available to treat acne lesions, including topical benzoyl peroxide, topical retinoids, topical antibiotics, oral antibiotics, hormonal therapy, isotretinoin, and procedural therapies, such as light and laser therapies, although these cause side effects. This study aimed to establish the efficacy and tolerability of a class IIa medical device containing lactic acid, azelaic acid/polyglyceryl-3 copolymer, azelamidopropyl dimethyl amine, and bifida ferment lysate for the treatment of mild and moderate acne lesions. A randomized, double-blind, placebo-controlled, multicentric study was carried out in which 60 persons of both genders aged&#x2009;&#x2265;&#x2009;16&#xa0;years affected by mild or moderate acne were enrolled. Each person used the product twice daily for 2&#xa0;months. The clinical score (classified as absent, mild, moderate, and severe) of lesions such as blackheads, whiteheads, papules and pustules, erythema, desquamation, sebum secretion, and porphyrins production by a wood lamp was evaluated on the basis of a dermatologist's visual assessment at baseline (t 0 ) and after 2&#xa0;months of treatment (t 1 ), and the results were compared between groups. Digital photographic images were also taken. Sixty subjects concluded the trial. It was observed that subjects treated with the medical device (group I) showed overall improvement in the analyzed acne lesions compared with placebo (group II) after 2&#xa0;months of treatment. The efficacy of the treatment was also expressed as partial and total clearance. The medical device produced higher percentages of both partial and total clearance in all analyzed parameters, compared with the placebo group. The study was safe and well tolerated. It was observed that the participants showed an overall improvement of the analyzed lesions in comparison with the placebo group, without adverse events during the trial. Hence, the medical device was found to be safe and effective in the treatment of mild or moderate acne.

常见问题解答 (FAQ)

Q1. 二裂酵母发酵产物溶胞产物 (BIFIDA FERMENT LYSATE) 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 '二裂酵母发酵产物溶胞产物',美国 PCPC 与欧盟 CosIng 标准 INCI 为 'BIFIDA FERMENT LYSATE',日本 JCIA 表示名称为 'BIFIDA FERMENT LYSATE'。
Q2. 二裂酵母发酵产物溶胞产物 (BIFIDA FERMENT LYSATE) 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. 二裂酵母发酵产物溶胞产物 (BIFIDA FERMENT LYSATE) 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 1%–50%(中位数 10%),最佳稳定 pH 范围为 4.5–6.8。
Q4. 二裂酵母发酵产物溶胞产物 (BIFIDA FERMENT LYSATE) 有哪些配伍禁忌 (Incompatibilities) 与协同增效组合?
推荐协同组合包括 GALACTOMYCES FERMENT FILTRATE, LACTOBACILLUS FERMENT LYSATE, NIACINAMIDE, ADENOSINE;配伍禁忌注意: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)。