The topic is short and compact
The MISEV2023 guideline advises against using the term exosome unless the endosomal origin of the vesicles is demonstrated; plant EV is usually the technically correct term.
Reliable characterization combines imaging, particle concentration, size distribution, and marker proteins using mutually independent methods.
The skin data on plant vesicles mostly comes from cell cultures and skin models and cannot be applied directly to a serum.
Whether vesicles are preserved in the finished formulation can only be shown by testing bulk material and the filled product alongside stability storage.
Products of human origin are banned under Annex II No. 416 of Regulation (EC) No. 1223/2009; exosomes derived from human stem cells are prohibited in EU cosmetics.
So läuft die Entwicklung bei Labtree
1
Konzeptionierung
2
Bemusterung – Standardmuster in 24 h
3
Individualisierung
4
Prototyping
5
Produktion
White Label 2–3 Monate · Private Label 3–6 Monate · Produktion ab 1.000 Stück
What are plant exosomes?
Technically speaking, these are mostly plant-derived extracellular vesicles (EVs): particles enclosed by lipid membranes that cells release. A 2025 review by Karabay et al. describes them as carriers of proteins, lipids, and nucleic acids, specifying a size range of 30 to 150 nanometers for exosomes. For skin applications, the studies reviewed there examine vesicles from lemon, beetroot, and edelweiss, among others.
The extraction method is crucial for raw material evaluation. In a call for greater care and standardization in research on plant EVs, Pinedo, de la Canal, and de Marcos Lousa point out that only a minority of studies isolate vesicles from the plant's extracellular fluid (apoplast). If plant tissue is blended or ground, artificial particles from disrupted cell membranes and released intracellular vesicles are also generated. For such fractions, the authors propose the term plant-derived nanovesicles (PDNVs) and recommend the general term plant EVs instead of exosomes.
What this means for procurement
Ask the raw material supplier about the plant species, plant part, and extraction method, as all three alter composition and size distribution.
A raw material derived from juice or homogenate is not the same as a vesicle fraction isolated from the apoplast, even if both are referred to as exosomes.
Why is the term exosome so often not substantiated?
The term exosome describes a specific origin inside the cell: vesicles released from the endosomal system. The MISEV2023 guideline of the International Society for Extracellular Vesicles advises against using this term unless this origin has been proven. Otherwise, a broad population of vesicles is typically examined rather than specifically exosomes. According to the guideline, small EVs and exosomes are explicitly not synonyms.
For particles created through cell disruption or synthesis from individual components, MISEV2023 uses the term EV mimetics and advises against designations such as exosome-like vesicles, because they imply an origin that is not proven. This explains the gap in the market: the term exosome appears on many products, but the characterization behind it is frequently missing or not disclosed.
For a product concept, this leads to a straightforward question for every raw material: What measurement data proves that vesicles are present in the specified size and quantity, and which methods were used to obtain them? Terms like True Exosomes do not describe any standard defined by MISEV2023 or EU cosmetics law.
Which analytics verify the characterization of an exosome raw material?
A single measurement is not enough. MISEV2023 states that no single method meets all characterization requirements, and identifies testing with orthogonal—meaning mutually independent—methods as critical. The following overview shows which test parameter has which limitation:
Test parameter | Typical method | Limitation according to MISEV2023 |
|---|---|---|
Morphology | Transmission electron microscopy (TEM), cryo-EM, atomic force microscopy | Low throughput, results depend on the choice of the image section |
Particle concentration | Nanoparticle tracking analysis (NTA), resistive pulse sensing (RPS, TRPS) | Many methods do not specifically detect EVs; therefore, particle concentration must be reported, not EV concentration |
Size | Imaging and particle mobility | Mobility methods such as NTA and DLS overestimate size compared to cryo-EM; the entire distribution must be reported, not just an average value |
Composition | Marker proteins, protein and lipid content | Total protein and total lipid overestimate vesicle quantity due to co-isolated accompanying substances |
According to MISEV2023, dynamic light scattering (DLS) is not suitable for quantitative statements such as the mean hydrodynamic diameter. For markers, the guideline recommends analyzing at least one protein from each of three categories, including components of typical accompanying structures as a purity control. According to Karabay et al., there are currently neither standardized extraction methods nor established markers for plant vesicles, which is why size and content vary widely between raw materials.
What should be included in the raw material dossier
Extraction and separation methods, indicating the starting matrix.
Size distribution and particle concentration using at least two methods, plus imaging.
Marker analysis and purity control, as well as data on batch-to-batch consistency across multiple delivery batches.
Storage conditions and shelf life of the raw material, including information on freeze-thaw cycles.
What does the research show for the skin?
The data is predominantly preclinical. A 2022 review of extracellular vesicles in facial aesthetics by Kee et al. reports that findings on plant-derived EVs are based on two-dimensional and three-dimensional skin models in the laboratory and require clinical confirmation. For EVs as a cosmetic active ingredient overall, the authors counted only two human studies at the time.
Karabay et al. describe, among other things, that lemon-derived vesicles inhibited oxidative stress following UV exposure in fibroblasts, and edelweiss-derived vesicles reduced melanin formation in a cell model. Both are cell culture results. The authors note that further in vitro, in vivo, and clinical studies are required, and that the active ingredients vary depending on plant species, plant part, and isolation method.
For product development, this means: data from the raw material supplier describes the raw material under laboratory conditions. Whether a serum with the chosen proportion of raw material has any effect on intact skin cannot be deduced from this. Anyone planning efficacy claims requires independent testing of the finished product, such as instrumental measurements of skin hydration or skin appearance over a specified period of use.
What are the EU regulations for exosomes in cosmetics?
A product containing plant vesicles is a cosmetic product if, pursuant to Article 2(1)(a) of Regulation (EC) No 1223/2009, it is intended to come into contact with the external parts of the human skin exclusively or mainly to clean them, protect them, keep them in good condition, or change their appearance. From this follow the well-known obligations: responsible person, cosmetic product safety report according to Annex I, product information file, and CPNP notification. Part A of the safety report requires, among other things, information on stability under reasonably foreseeable storage conditions and on the purity of the substances.
Human and plant origin
Annex II of the Regulation lists under entry 416 cells, tissues, or products of human origin as prohibited substances. Exosomes derived from human stem cells or cell cultures of human origin are therefore excluded from EU cosmetics. Plant vesicles are not covered by this ban, but undergo the same safety assessment as any other raw material.
Nanomaterial or not
Article 2(1)(k) defines a nanomaterial as an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nanometres. For nanomaterials, Article 16(3) requires notification to the Commission six months prior to placing on the market, and Article 19(1)(g) mandates the addition of the word 'nano' in brackets following the name in the list of ingredients. Whether a vesicle raw material meets these criteria is a case-by-case question that is advisable to clarify early on with the safety assessor and the raw material supplier, as it alters both the timeline and the label.
What must a formulation with plant vesicles achieve technically?
Vesicles are lipid membranes and thus more sensitive than a dissolved active ingredient. Kee et al. describe storage and stability as key hurdles: EV preparations are not stable at room temperature, 4 °C, and −20 °C, are more stable at −80 °C, and freeze-drying is considered a promising approach. MISEV2023 also advises keeping freeze-thaw cycles to a minimum and points out that stability depends on the composition and origin of the vesicles.
Typical formulation questions
Incorporation: surfactants, high ethanol proportions, and strong shear forces can damage lipid membranes. It is therefore recommended to define the incorporation temperature, phase, and stirring intensity according to the supplier's specifications and to test them in a laboratory sample.
pH control and electrolytes: They influence particle charge and aggregation and should be coordinated with the supplier.
Preservation: The preservation system must be sufficiently effective in the preservative challenge test—the results of which belong in the safety report according to Annex I and are generally evaluated according to ISO 11930—without attacking the vesicles.
Packaging materials: Airless dispensers and opaque containers reduce air and light ingress; compatibility with the packaging material must be included in stability testing.
The crucial point is that measurement does not end with the raw material. Whether vesicles are retained in the finished formulation throughout its shelf life can only be shown by testing the bulk product and the filled product in parallel with accelerated stability storage at elevated temperatures. What constitutes a complete test series is described in the article Stability and Safety Testing for Cosmetics.
According to Article 20 of Regulation (EC) No 1223/2009, labelling and advertising must not imply that the product has characteristics or functions which it does not have. The Annex to Regulation (EU) No 655/2013 specifies this with common criteria: If an ingredient is claimed, it must be deliberately present. Statements about the properties of an ingredient must not give the impression that the finished product has the same properties, and such an extrapolation requires verifiable evidence, such as an effective concentration in the product. Studies must be relevant to the product and the claimed benefit.
The term exosomes on the label or website requires that the raw material is appropriately characterized. Without proof of origin, plant vesicles or plant extract is the more cautious formulation.
Cell culture data on collagen formation or melanin inhibition describe the raw material, not the serum.
Medical terms such as cell renewal in a therapeutic sense, tissue regeneration, or wound healing do not belong in the claims of a cosmetic product.
Statements regarding skin feel and skin appearance can be substantiated through user tests on the finished product.
How the common criteria are examined in detail is explored further in the article Cosmetic Advertising Claims in the EU.
Labtree is a B2B cosmetics developer and manufacturer based in Hamburg with its own laboratory, covering formulation development, in-house laboratory work, sampling, manufacturability testing, and cosmetics production. For an active ingredient such as plant-based vesicles, the process begins with reviewing the raw material dossier, followed by laboratory samples in which incorporation, viscosity, pH management, and sensory profile are coordinated with the raw material.
The usual timelines apply for planning: Samples of pre-qualified Labtree formulations generally leave the sample warehouse within 24 hours; whether one of these is suitable as a base for a vesicle raw material is only determined by the laboratory sample. An adapted, tested Labtree formulation under white label is usually deliverable in standard packaging within 2 to 3 months, whereas a new development under private label typically takes 3 to 6 months. For a sensitive raw material, stability testing, safety assessment, and packaging availability determine where a project falls within this timeframe. The minimum order quantity is generally 1,500 units per product, depending on product type, filling volume, and packaging. How to separate active ingredients with substance from mere trend terms is described in the article Active Ingredient Strategy in Cosmetics; the development process is detailed on the page Have Cosmetics Developed.
Quellen
More useful links
FAQ
Are exosomes derived from human stem cells allowed in EU cosmetics?
No. Under entry 416, Annex II of Regulation (EC) No 1223/2009 bans cells, tissues, or products of human origin in cosmetic products. Therefore, products containing exosomes derived from human cell cultures or stem cells are not an option for the EU cosmetics market; plant-based raw materials, however, are not covered by this ban.
What documentation should a supplier provide for an exosome raw material?
Information on the plant species, plant part and extraction method, size distribution and particle concentration obtained from at least two methods, electron microscopy imaging, marker analysis, and data on batch consistency are useful. In addition, storage conditions, shelf life, and the standard safety data for the safety report are required.
What needs to be reported to the Commission regarding a nanomaterial classification?
Under Article 16(3) of Regulation (EC) No 1223/2009, the responsible person must notify cosmetic products containing nanomaterials six months prior to placing them on the market. This notification includes, among other things, the identification and specification of the nanomaterial (including particle size), the estimated annual quantity, the toxicological profile, safety data, and foreseeable exposure conditions. Whether a vesicle raw material is considered a nanomaterial at all is determined on a case-by-case basis and should be clarified early on with the safety assessor and supplier.
What is the difference between exosomes and liposomes?
Exosomes and other extracellular vesicles are released by cells and carry their proteins, lipids, and nucleic acids. Liposomes are specifically assembled from individual lipids and have a defined composition. The MISEV2023 guidelines classify artificially produced vesicle-like particles as EV mimetics rather than exosomes.
Can exosomes be listed on the label?
An ingredient may be claimed if it is intentionally included and the claim does not promise more than the product delivers. For exosomes, this requires a verifiable characterization of the raw material; in addition, the INCI designation in the list of ingredients must be accurate. Without proof of origin, a more cautious term such as plant vesicles is the safer choice.
How long does it take to develop a serum with plant exosomes?
If an existing, tested Labtree formulation can be adapted as a basis (white label), the timeframe with standard packaging is usually 2 to 3 months; a new development under private label typically takes 3 to 6 months. For sensitive raw materials, additional measurements in the finished product and stability testing are more likely to extend the schedule rather than shorten it. The individual time factors are detailed in the Labtree magazine article on realistic timelines in cosmetics development.
