On February 2, 2026, the Taiwan Food and Drug Administration (TFDA), under the Ministry of Health and Welfare, announced a revision to the annex of the Documentation Required for Case-by-Case Review of Applications for the Use of Human Cell-Derived Exosomes in Cosmetics. The revised annex takes effect immediately upon the date of announcement.
Background of the Revision
On March 21, 2024, the Taiwan Food and Drug Administration (TFDA) under the Ministry of Health and Welfare issued a regulatory document titled “Documentation Requirements for Case-by-Case Applications for the Use of Exosomes Derived from Human Cells in Cosmetics”. This document also amends the List of Prohibited Ingredients in Cosmetics, adding specific restrictions on the use of human cells, tissues, or human-derived products.
According to the updated regulation, exosomes derived from human cells, tissues, or human-origin materials are prohibited in cosmetics unless they are approved on a case-by-case basis by the competent authority. Applicants who obtain such approval for the use of exosomes from human-derived materials will be exempt from this prohibition. This regulation came into effect on March 21, 2024 and the annex specifies the required documents for applications involving the use of exosomes derived from human cells in cosmetics.
Revised Documentation Requirements
In this revision, the documentation requirement for "Acute Toxicity Test" under the "Safety Testing" section has been updated. The original requirement, which stated "documents for this item shall be submitted," has been amended to "case-by-case basis." This change is further clarified in Note 9.
Note: The updated content is highlighted in yellow.
| Item | Scope of Documentation | Documents to be Submitted (Note 1) |
| Donor Qualification | Donor health certification (Note 2), pathogen test reports (Note 3) | ○ |
| Preparation & Testing (Notes 4, 6) | Physicochemical properties | ○ |
| Manufacturing process | ○ | |
| Specifications, test methods, and test reports (Note 5) | ○ | |
| Stability Testing (Note 6) | Stability testing (Note 7) | ○ |
| Acute toxicity test (Note 9) | △ | |
| Subacute toxicity test (Note 9) | △ | |
| Chronic toxicity test (Note 9) | △ | |
| Local irritation test | ○ | |
| Antigenicity test (Note 10) | ○ | |
| Genotoxicity test | ○ | |
| Carcinogenicity test (Note 9) | △ | |
| Absorption, Distribution, Metabolism, and Excretion Testing (Note 6) |
Percutaneous absorption test | ○ |
| Absorption, distribution, metabolism, and excretion | △ |
1. “○” indicates that the corresponding document must be submitted. “△” indicates that submission is case-dependent.
2. Donors must be healthy adults without infectious diseases, sepsis, or congenital/chronic illnesses and cancers that may affect cells/tissues.
3. Donor pathogen test reports should include the following items, such as: Hepatitis B virus (HBV), Hepatitis C virus (HCV), Human Immunodeficiency Virus (HIV), Human T-lymphotropic Virus (HTLV), Cytomegalovirus (CMV), Transmissible Spongiform Encephalopathy, Treponema pallidum (syphilis), etc. Additional screening and/or testing should be considered based on product characteristics or the donor’s external environment (e.g., travel history or residence history).
4. Preparation process and quality control data: Physicochemical properties should include identification of the cell source/type, characterization of contents, and purity, along with a description of the intended use of the exosomes. The facility for culturing cells/tissues and the exosome preparation site must establish and comply with relevant hygiene management standards. The exosome preparation site and process must ensure the absence of endotoxins and mycoplasma contamination, and ensure that each batch is free from cross-contamination risk.
5. Test reports must be submitted for at least three consecutive batches.
6. All tests must be conducted using exosomes prepared through the intended manufacturing process.
7. Stability testing methods must include the storage method of the exosomes.
8. Safety testing of cosmetics or cosmetic ingredients by individual applicants should preferably follow the OECD Guidelines for the Testing of Chemicals, or alternative test methods published by other countries. If other methods are used, their validation or a rationale for the design and effectiveness of the method must be provided in advance.
9. Acute toxicity test, Subacute toxicity, chronic toxicity, and carcinogenicity tests should be evaluated by individual applicants based on the case, such as physicochemical properties and results of other safety tests. The competent authority may require relevant tests based on the case review.
10. Antigenicity tests include skin sensitization tests and photosensitization or phototoxicity tests; local irritation tests include skin irritation and mucosal irritation tests.
11. If human studies are conducted, they must comply with the relevant provisions of the Human Subjects Research Act.
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