Exosome masks appear in Grazia's roundup of 2026 K-beauty trends, next to PDRN serums. In Korea, a culture medium made from human stem cells can go into a cosmetic if it meets a national safety standard. Ship the same product to the EU, ASEAN or China and the answer changes, because of where the ingredient came from rather than what it is called.
This post compares how ten markets treat cosmetic ingredients of human origin, using MFDS public data, the Korean and Taiwanese rule texts, and the EU regulation.
Korea bans human cells, with one exception
Annex 1 of Korea's Regulation on Safety Standards for Cosmetics, the list of ingredients that may not be used, includes human cells, tissues and their culture media. The same line carries an exception: culture media that meet the safety standard for human cell and tissue culture media in Annex 3 are excluded. The current text is MFDS Notice No. 2026-19, in force since March 18, 2026.
Annex 3 sets out what that standard requires. It defines a culture medium as the liquid left after human cells or tissues are cultured and the cells and tissues are removed. The donor must be a healthy adult who has been screened for hepatitis B and C, HIV, HTLV, parvovirus B19, cytomegalovirus, Epstein-Barr virus, transmissible spongiform encephalopathy, syphilis, chlamydia, gonorrhoea, tuberculosis and sepsis, with an observation period that accounts for the window period of infection. Cells and tissues must be collected at a medical institution. Culturing has to take place in a clean area of grade 1B (Class 10,000) or better, and the process must inactivate or remove bacteria, fungi and viruses.
The safety file covers nine kinds of data: single-dose and repeated-dose toxicity, primary skin irritation, eye or mucosal irritation, skin sensitisation, phototoxicity and photosensitisation, composition, genotoxicity, and a human patch test. The tests must follow Korea's GLP standard, except the human patch test, which has to be run by a university or a specialist research institution. An internal safety committee that includes outside experts reviews the results. Each batch is tested for, among other things, sterility, mycoplasma, adventitious viruses and the absence of the source cells. The rule also prohibits paying for cells or tissues and advertising that a particular person's cells were used. The responsible seller keeps all of these records for three years from the manufacturing date of the finished product.
Five export markets ban the category outright
Annex II of the EU Cosmetics Regulation, the list of prohibited substances, includes entry 416: cells, tissues or products of human origin. The entry has no exception and no concentration limit. In the MFDS export-market data, ASEAN, China, Brazil and Argentina carry a prohibition with the same wording.
A Korean product that relies on Annex 3 has no equivalent route under these entries. Meeting the Korean standard does not change the EU answer, because the EU entry covers the category regardless of how the material was screened or manufactured.
The MFDS data links 12 INCI names for human cell culture media to these entries in seven markets, Korea included. They include Human Stem Cell Conditioned Media, Human Bone Marrow Stem Cell Conditioned Media, Human Adipose Stromal Cell Conditioned Media Extract, Human Fibroblast Conditioned Media, Human Amniotic Fluid Cell Conditioned Media and Human Neural Cell Conditioned Media. For Korea, the linked entry is the Annex 1 line with its Annex 3 exception, so the Korean result for these names depends on whether the material meets the standard.
Taiwan bans the category but reviews exosomes one by one
Taiwan amended its list of prohibited cosmetic ingredients on March 21, 2024. Entry 11 reads "Cells, tissues or products of human origin", followed by an exception: the ban does not apply to an exosome from an individual company that has passed case review by the central competent authority. The change to this entry took effect the day it was announced.
On the same day, the Ministry of Health and Welfare issued the list of documents an applicant must submit for that review. It covers the donor's qualifications, the preparation process and test reports, stability tests, safety tests, and absorption, distribution, metabolism and excretion data. The attached schedule of required documents was amended on February 2, 2026, so applicants should work from the current version.
Unlike Korea's exception, it covers only exosomes derived from human cells, and each approval applies to one company's specific exosome. A human cell culture medium that is not an exosome stays under the ban. Taiwanese financial media reported in October 2025 that a local company's umbilical cord stem cell exosome had been approved as a cosmetic ingredient through this route.
Canada, the United States and Japan
In the MFDS data, Canada's entries for substances of human origin and for placental extracts are classed as restrictions rather than prohibitions. The United States and Japan have no entry in the data for any of the human-origin terms checked. As with any absent entry, that means the data has no entry, not that a product is approved for sale.
| Market | Human cells, tissues and their products | Exception |
|---|---|---|
| Korea | Prohibited (Annex 1) | Culture media meeting the Annex 3 safety standard |
| Taiwan | Prohibited (entry 11) | Exosomes approved by case review, per company |
| EU | Prohibited (Annex II/416) | None |
| ASEAN, China, Brazil, Argentina | Prohibited, same wording as the EU | None in the data |
| Canada | Restricted | Check the restriction conditions |
| United States, Japan | No entry in the data | - |
Not every exosome is human
The word "exosome" on a label does not tell you which of these rules applies. MFDS's cosmetic ingredient list has three ingredients with "Exosomes" in the INCI name, and none of them is human: Milk Exosomes, defined as extracellular vesicles isolated from milk, and Salmon Testis Exosomes and Pacific Cod Testis Exosomes, vesicles secreted into the culture medium by testis cells of the two fish. None of the three has an entry for any market in the MFDS data.
None of the names in that list describes an exosome from human cells. Those fall under the human-origin entries described above, so the source of the material, not the word on the box, decides whether those entries apply.
Before exporting a stem cell or exosome product
Start with the raw material specification and confirm the source: human cells, animal tissue, plant, or microorganism. If the source is human, a file that meets Korea's Annex 3 covers Korea. It does not cover the EU, ASEAN, China, Brazil or Argentina. For Taiwan, a human-derived exosome needs its own case approval before launch, and a culture medium that is not an exosome has no exception route. For Canada, check the conditions attached to the restriction. For the United States and Japan, the absence of an entry in this data is a reason to check the national rules directly, not a clearance.
This follows our post on EGF, where the same EU entry is linked to rh-Oligopeptide-1 but not to sh-Oligopeptide-1.
Data: MFDS public data on restricted cosmetic ingredients and export markets (31,191 entries), checked on October 17, 2026. Korean rule text from MFDS Notice No. 2026-19, Annexes 1 and 3. Taiwan from the Ministry of Health and Welfare announcements of March 21, 2024 and the amendment of February 2, 2026. EU from Regulation (EC) No 1223/2009, Annex II. An absent entry in this data means the data has no entry, not that an ingredient is safe or approved.
The K-Beauty Cosmetic Ingredients API returns the market-by-market entries described above, looked up by ingredient code.
Sources
MFDS, Regulation on Safety Standards for Cosmetics (Notice No. 2026-19), Annexes 1 and 3
Regulation (EC) No 1223/2009, Annex II
Taiwan MOHW, amendment to the list of prohibited cosmetic ingredients, March 21, 2024
Taiwan MOHW, amendment to the required-documents schedule, February 2, 2026
UAnalyze, October 3, 2025, on an approved umbilical cord stem cell exosome
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