On March 21, 2024, the Ministry of Health and Welfare in Taiwan, amended the “List of Ingredients Prohibited in Cosmetic Products” by issuing a regulation titled “Requirements for the Submission of Documents for Review of Cases Applying Human Cell-Derived Exosomes for Use in Cosmetics“. The regulation is effective immediately.
This regulation means that exosomes derived from cells, tissues, or products of human origin, which have been classified as prohibited cosmetic ingredients in multiple countries and regions, can now be used in cosmetics in Taiwan, through compliant approach as stipulated by regulations.
Summary of Requirements for the Use of Human Cell-Derived Exosomes in Cosmetics in Taiwan
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Cells,tissues or products of human origin |
|
|
Included in item 11 of the List of Ingredients Prohibited in Cosmetic Products |
For cases approved through review, they are no longer subject to this restriction. (Note: Individual businesses should submit relevant documents or information to the competent authority for review, including qualifications of donors, preparation processes and test reports, stability tests, safety tests, absorption, distribution, metabolism, and excretion tests). |
*Documents and Annexes Required for the Application
of Human Cell-Derived Exosomes for Use in Cosmetic Products
| Item | Document Scope | Necessary Document |
|
Donor Qualifications |
Documentation of Donor’s Health Certification(2) 、 Pathogen Detection Report(3) |
○ |
|
Preparation and Testing(4,6) |
Physical and Chemical Properties |
○ |
|
Preparation Process |
○ | |
|
Test Specifications, Methods, and Reports(5) |
○ | |
|
Stability Test(6) |
Stability Test(7) |
○ |
|
Safety Test(6,8) |
Acute Toxicity Test |
○ |
|
Subacute Toxicity Test(9) |
△ | |
|
Chronic Toxicity Test(9) |
△ | |
|
Local Irritation Test |
○ | |
|
Antigenicity Test(10) |
○ | |
|
Genetic Toxicity Test |
○ | |
|
Carcinogenicity Test(9) |
△ |
|
|
Absorption, Distribution, Metabolism, and Excretion Test(6) |
Percutaneous Absorption Test |
○ |
|
Absorption, Distribution, Metabolism, and Excretion Test |
△ |
|
|
Notes： 1. "○" indicates that documents for the item must be submitted. "△" indicates that it depends on the case. 2. Donors must be healthy adults without infectious diseases, sepsis, congenital or chronic diseases, or cancer. 3. Pathogen detection report for donors should include tests for Hepatitis B Virus(HBV), Hepatitis C Virus(HCV), Human Immunodeficiency Virus(HIV), Human T-lymphosphere Virus(HTLV), Cytomegalovirus(CMV), Transmissible Spongiform Encephalopathy (TSE), Treponema pallidum, etc., and additional tests based on product characteristics or donor's external environment(eg. travel history or residence history). 4. Preparation Process and Quality Control Data: The physical and chemical properties should include identification of the cell source, identification of contents, and purity, along with an explanation of the intended use of exosomes. The facilities for cell/tissue cultivation and exosomes preparation must be established and comply with relevant hygiene management standards. The preparation facilities and processes for exsomes must ensure the absence of endotoxins and fungal contamination, and ensure that each batch has no risk of cross-contamination. 5. Testing reports should cover at least three consecutive batches. 6. Testing should be conducted using exosomes prepared according to the preparation process. 7. Stability test should include the method of preservation of exosomes. 8. Safety testing should preferably follow OECD guidelines or alternative testing methods recognized by other countries. Other methods should be validated or justified for their reasonableness and effectiveness. 9. Depending on the case, subacute toxicity test, chronic toxicity test, and carcinogenicity test may be required based on factors such as physical and chemical properties and other safety test results. Regulatory authorities may request relevant tests based on individual case reviews. 10.Antigenicity test includes skin allergy test, phototoxicity test (or photo-toxicity test), etc. Local irritation test includes skin irritation test and mucosal irritation test. 11.Human research testing should comply with relevant regulations on human research. |
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Next, let's progress to understand the regulations regarding the use of this ingredient in other countries/regions.
China
As of now, exosomes derived from human sources are not allowed for use in cosmetic ingredients in China. China designated [cells, tissues, or products of human origin] as number 387 in the List of Prohibited Cosmetic Ingredients, without any exemptions.
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387 |
人的细胞、组织或人源产品 |
Cells, tissues or products of human origin |
European Union
In the European Union, exosomes derived from human origin are also prohibited from being used as cosmetic ingredients. EU listed them as number 416 of prohibited cosmetic ingredients in the Regulation EC 2009/1223(as depicted in the image below).
South Korea
According to announcement MFDS-2023-73 issued by the South Korean Ministry of Food and Drug Safety (MFDS) (revised on November 30, 2023), the "Cosmetic Safety Standards Regulations" have been updated to incorporate safety standards for human cell and tissue culture fluid. According to these standards, human cell and tissue culture fluids that meet the requirements can be utilized as cosmetic ingredients (refer to details in the image below).
At last, ZMUni Compliance Centre has listed the human-derived exosomes currently included in Personal Care Products Council (PCPC) ingredient database for your reference.
|
English Name |
Chinese Name |
Korean Name |
Japanese Name |
|
Human Adipose Derived Mesenchymal Cell Exosomes |
人脂肪来源间充质细胞外泌体 |
인체지방유래중간엽세포배양엑소좀 |
ヒト脂肪由来間葉系細胞エクソソーム |
|
Human Adipose Derived Mesenchymal Stem Cell Exosomes |
人脂肪来源间充质干细胞外泌体 |
/ |
/ |
|
Human Adipose Stromal Cell Exosomes |
人脂肪基质细胞外泌体 |
인체지방기질세포배양엑소좀 |
ヒト脂肪間質細胞エクソソーム |
|
Human Amniotic Fluid Induced Pluripotent Cell Exosomes |
人羊水诱导多能细胞外泌体 |
/ |
/ |
|
Human Amniotic Fluid Mesenchymal Stem Cell/Trophoblast Cell Exosomes |
人羊水间充质干细胞/滋养细胞外泌体 |
/ |
ヒト羊水間葉幹細胞／栄養膜細胞エクソソーム |
|
Human Cord Blood Derived Stem Cell Exosomes |
人脐血来源干细胞外泌体 |
인체제대혈유래줄기세포배양엑소좀 |
ヒトサイタイ血由来幹細胞エクソソーム |
|
Human Cord Blood Induced Pluripotent Cell Exosomes |
人脐血诱导多能细胞外泌体 |
/ |
/ |
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Human Cord Blood Progenitor Cell Exosomes |
人脐血祖细胞外泌体 |
인체제대혈간세포배양엑소좀 |
/ |
|
Human Dermal Fibroblast Conditioned Media/Telomerase Exosomes |
人真皮成纤维细胞条件培养基/端粒酶外泌体 |
/ |
/ |
|
Human Dermal Fibroblast Induced Multipotent Cell Exosomes |
人真皮成纤维细胞诱导多能细胞外泌体 |
인체피부섬유아세포유도다분화능세포배양엑소좀 |
/ |
|
Human Dermal Fibroblast Telomerase Exosomes |
人真皮成纤维细胞端粒酶外泌体 |
/ |
/ |
|
Human Mononuclear Cell Induced Pluripotent Cell Exosomes |
人单核细胞诱导多能细胞外泌体 |
/ |
/ |
|
Human Umbilical Mesenchymal Stem Cell Exosomes |
人脐带间充质干细胞外泌体 |
/ |
/ |
