Panoramic Analysis: Current Regulatory Status and Compliance Challenges of Exosome Cosmetics Worldwide

Globally, the regulatory landscape for exosome cosmetics exhibits significant variability. This article systematically reviews the management measures, regulations, and ethical standards concerning exosome cosmetics in various countries/regions, including the United States, the European Union, Japan, South Korea, Taiwan, and mainland China. It explores the context of compliance and prohibitions, as well as their impact on industry development, providing comprehensive global regulatory compliance guidance for cosmetic companies.

Definition of Exosomes

Human-derived stem cell-derived exosomes (Exosomes) are a type of extracellular vesicles (EVs) secreted during the culture process of stem cells. They are not the stem cells themselves but are rich in cell signaling molecules and are anticipated to show potential in tissue repair, immune regulation, and anti-inflammatory effects. Exosomes are not solely derived from stem cells; current research also focuses on exosomes from human mesenchymal stem cells (MSCs) sourced from tissues such as dental pulp, bone marrow, adipose tissue, and umbilical cord.

Regulatory Status of Exosomes in Major Countries/Regions

United States

In the U.S., novel cosmetic ingredients, including exosomes from various sources, must be reported to the Personal Care Products Council (PCPC) and included in the International Nomenclature of Cosmetic Ingredients (INCI) Handbook. A search in the official INCI database for "exosomes" reveals 59 novel exosome ingredients. Currently, the majority of reported exosomes are plant-derived, while human-derived exosomes primarily consist of mesenchymal stem cell exosomes. The U.S. has the highest number of exosome cosmetics on the market, with diverse product forms including cryopreserved liquids, freeze-dried powders, and serums. Several companies specializing in stem cell exosomes have successfully launched their products.

European Union

The EU Cosmetics Regulation (Regulation (EC) No 1223/2009) explicitly prohibits the use of certain types of ingredients in cosmetics, including human tissues and animal-derived components, particularly those with a risk of disease transmission. This regulation imposes strict requirements for the safety and ethics of cosmetics, banning animal testing and mandating that all cosmetics undergo safety assessments before market entry. Additionally, all ingredient information must be disclosed to ensure consumer rights and product transparency.

Japan

In Japan, the commonly used term is "stem cell culture supernatant," where exosomes are considered the core functional components of this supernatant. While stem cell culture supernatant can be used as a cosmetic raw material, it must strictly adhere to the "Guidelines for Biological-Derived Materials" (Notification No. 210 of the Ministry of Health, Labour and Welfare, 2003), which outlines special requirements for "human-derived product materials." Advertising and other promotional activities are also subject to strict regulations.

South Korea

In South Korea, the use of human-derived exosomes must comply with the relevant provisions of the "Cosmetics Act," particularly Article 8, Appendix 3, which addresses the "Safety Standards for Human Cell and Tissue Culture Liquids." These standards are designed to ensure the safety and efficacy of human-derived exosomes, imposing strict requirements on ingredient sourcing, production processes, and quality control.

Taiwan, China

On March 21, 2024, Taiwan's Ministry of Health and Welfare (TFDA) issued regulations titled "Documents Required for the Case Review of Using Exosomes Derived from Human Cells in Cosmetics," which revised the list of prohibited cosmetic ingredients. The document includes restrictions on human cells, tissues, or human-derived products in the list of banned cosmetic ingredients. However, exosomes from human cells, tissues, or human-derived products may be exempt from these restrictions if approved by the relevant authorities for specific cases.

On February 2, 2026, the Taiwan Ministry of Health and Welfare (TFDA) announced the revision of the supplementary tables in the "Documentation Required for Case Review of Human Cell-Derived Exosomes Used in Cosmetics," which will take effect immediately upon the announcement.

In this revision, the documentation requirements for the "Acute Toxicity Test" under the "Safety Testing" section have been updated. The previous requirement to "submit the relevant documentation for this item" has been changed to "case-by-case basis." This change is further elaborated and clarified in Note 9.

Mainland China

According to the "Safety and Technical Standards for Cosmetics" (2015 edition), human cells, tissues, or products of human origin are prohibited from being used as cosmetic ingredients. Furthermore, the National Medical Products Administration (NMPA) has not included "exosome" as a cosmetic ingredient in the "Catalog of Approved Cosmetic Ingredients," nor has any new cosmetic ingredient related to exosomes been approved or registered by the national drug regulatory authority.

Regarding the limitations on the application of human-derived stem cell exosome materials, in September 2024, the NMPA responded to Proposal No. 00971 (Medical and Health Category 065) from the Second Session of the 14th National Committee of the Chinese People's Political Consultative Conference. The response highlighted that major cosmetic-producing countries and regions worldwide are cautious about using human-derived substances in cosmetics. For example, the EU Cosmetics Regulation (Regulation (EC) No 1223/2009) includes human cells, tissues, or products in its list of prohibited substances. Japan's "Standards for Biologically Derived Materials" prohibits the use of extracts from human placenta and mandates bacterial and viral testing for materials derived from human blood and urine to ensure their safety and non-toxicity. Similarly, South Korea's "Cosmetic Safety Standards and Related Regulations" classify human cells, tissues, and their culture media, as well as substances derived from human placenta, as prohibited ingredients. Cosmetic registrants and filers, as responsible parties for the safety and efficacy claims of cosmetics, are required to enhance their research on cosmetic safety and efficacy, which must be supported by sufficient scientific evidence.

Further Information: China NMPA

In June 2025, the NMPA's Center for Drug Evaluation (CDE) included extracellular vesicles (including exosomes) in the Advanced Therapy Medicinal Products (ATMP) framework. In December of the same year, it further defined dressings containing exosomal membranes as combination products (Class III medical devices). This indicates that any direct use of the term "exosome" or promotion of related effects in cosmetics is considered non-compliant.

CIRS Reminder

The global regulatory landscape for exosome cosmetics is complex and rapidly evolving. The differences in compliance and prohibition policies among countries directly impact industry development and market access. Companies facing these challenges must continuously monitor policy dynamics in various regions and timely adjust their compliance strategies to align with local regulatory requirements, thereby promoting the industry towards a more standardized, safe, and innovative direction.

About CIRS

The CIRS cosmetic team is dedicated to ensuring that cosmetic products meet stringent global regulatory standards. We are able to provide one-stop services covering the whole life-cycle of a personal care product, which includes cosmetic ingredient development, physical/chemical tests, toxicological tests (in vivo & in vitro), efficacy studies (in vivo & in vitro), ingredient registration, and product registration.

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