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"Plant-derived exosomes" have become a focal point in global cosmetic ingredient innovation due to their natural origin, biocompatibility, and targeted delivery capabilities. However, as an emerging bio-based ingredient, they still face significant regulatory hurdles in China—including scientific nomenclature, classification as "New Cosmetic Ingredients" (NCI), and the design of appropriate notification and registration pathways.
This article provides a structured overview of how these materials are currently understood under China’s regulatory framework, with reference to international nomenclature practices and key compliance considerations.
Under the International Nomenclature of Cosmetic Ingredients (INCI) framework, exosomes are generally defined as small extracellular vesicles derived from eukaryotic cells. With appropriate analytical characterization—such as electron microscopy, flow cytometry, and nanoparticle tracking analysis—they are typically named according to species and tissue origin (e.g., Human Adipose Stromal Cell Exosomes, Human Amniotic Fluid Induced Pluripotent Cell Exosomes).
Plants also produce small, nano-sized vesicles—structures found within or outside of a cell, consisting of liquid or cytoplasm enclosed by a lipid bilayer. However, these plant-derived vesicles have not been characterized to the same extent as those derived from mammalian cells. Due to this lower level of characterization, they are designated as "Vesicles" or "Extracellular Vesicles" rather than "Exosomes" in international nomenclature:
Standard Tissue/Cell Isolation: Named based on the specific plant source from which they are isolated, following the format Plant Latin Name + Plant Part/Tissue + Vesicles (e.g., Brassica Oleracea Italica (Broccoli) Vesicles, Dendropanax Morbiferus Leaf Vesicles).
Extracellular Release: If these vesicles are released outside the cells, they are classified as extracellular vesicles and named based on the plant source of release, following the format Plant Latin Name + Component + Extracellular Vesicles (e.g., Panax Ginseng Adventitious Root Extracellular Vesicles, Rosa Damascena Callus Extracellular Vesicles).
A search for the keyword "Vesicle" in the Personal Care Products Council (PCPC) international cosmetic ingredient dictionary reveals approximately 77 registered plant-related (including algal) vesicle ingredients. These include vesicle materials derived directly from plant tissues (fruits, leaves, stems, roots, flowers, petals, rhizomes, seeds, etc.), plant callus cultures, and plant cell cultures. Their names follow the format: Botanical Latin name + plant part/callus/cell culture + Vesicles. The plant sources for these vesicles span a broad range, including:
|
Category |
Examples / Sources |
|
Fruits and vegetables |
citrus, apple, grape, pomegranate, blueberry, tomato, potato, etc. |
|
Medicinal and herbal plants |
aloe, garlic, Salvia miltiorrhiza, Scutellaria baicalensis, ginseng-related plants, and others |
|
Flowers and specialty plants |
rose species, rosemary, pitaya (Hylocereus), etc. |
|
Other sources |
rice and plant-derived matrices such as propolis (plant resin origin) |
*PCPC INCI database search result: "Vesicle"
As a PCPC member, ZMUni Compliance Center has supported multiple companies in obtaining INCI names for exosome- and vesicle-related cosmetic ingredients, including dossier preparation, regulatory communication, and submission support.
In China's current cosmetic regulatory framework, plant-derived exosome- or vesicle-like materials are primarily considered biotechnology-derived cosmetic ingredients rather than conventional botanical extracts.
This classification is based on their production mechanism and biological origin, which typically involve cell culture, tissue engineering, or other biotechnological processes rather than simple physical extraction. This interpretation is consistent with the definition of biotechnology-derived cosmetic ingredients set out in the industry standard "General Technical Requirements for Biotechnology-Derived Cosmetic Ingredients" (April 2026).
At present, China has not established specific national or industry standards dedicated to the characterization of plant-derived exosomes or vesicles. In practice, their regulatory positioning is therefore determined on a case-by-case basis, integrating three key dimensions: raw material origin, production/manufacturing process, and final molecular or structural composition, supported by available scientific evidence.
This integrated assessment forms the basis for determining whether the ingredient should be managed as a New Cosmetic Ingredient in China.
Where a plant-derived vesicle-like material is determined to fall under the scope of a New Cosmetic Ingredient, it must comply with the Administrative Measures for Cosmetic New Ingredient Registration and Notification. Key documentation generally includes:
Basic ingredient information: Including Chinese name, INCI name, source, and manufacturing process
Safety assessment documentation (core requirement): Toxicological data and risk assessment reports
Efficacy substantiation:In vitro/in vivo efficacy data and mechanism-of-action studies for all claimed benefits
Quality control standards:Internal specifications covering physicochemical properties, characteristic markers, impurities, risk substances, microbiological limits, heavy metals, and stability studies
History of safe use (if available): Regulatory approvals or usage history in other countries/regions
Manufacturing process and other supporting materials
In addition, vesicle and exosomes materials may fall within the nanoscale range (typically ≤100 nm), which may trigger additional regulatory considerations under China's nanomaterial-related provisions for cosmetic ingredients.
Nanomaterials are defined as engineered materials that are insoluble or non-biodegradable and have at least one external dimension in the 1-100 nm range, or are composed of such structural units.
Where applicable, nanomaterial-based cosmetic ingredients are subject to enhanced toxicological data requirements, including acute toxicity, irritation, sensitization, genotoxicity, sub-chronic toxicity, long-term safety evaluation, and inhalation risk assessment when relevant exposure routes exist, as well as justification of test method applicability to nanoscale properties.
Given the full-lifecycle regulatory oversight for cosmetic ingredients and finished products in China, the principle of "compliance-by-design" (proactive compliance) is paramount. Introducing formal regulatory assessments during early R&D or the initial project scoping phase can effectively mitigate disruptive, high-impact compliance risks before significant capital investment.
Overall, while the Chinese regulatory landscape for bio-engineered and nano-scale materials is becoming increasingly structured, compliance remains highly case-specific and science-driven. As global scientific understanding of plant-derived vesicles deepens and analytical characterization technologies mature, the pathway for these materials to serve as safe, effective, and compliant cosmetic ingredients in China is becoming clearer.
