Exosomes in Cosmetics
Trending! Exosomes are the new it-ingredient but what are the regulatory constraints?
Exosomes have rapidly emerged as one of the most recent innovations in cosmetic science, particularly in the premium and dermo-cosmetic skincare segment. As consumer interest shifts toward scientifically-driven formulations, exosome-based ingredients are attracting attention for their advanced delivery potential and enhanced visible effects on the skin. With growing interest for exosome-containing products among brands and consumers alike, it’s important to assess the regulatory considerations that accompany their use. From ingredient origin and safety to claims and product classification, exosome-containing formulations require careful navigation to ensure compliance under UK and EU cosmetic regulations.
Firstly, what are exosomes?
Exosomes are small, membrane-bound extracellular vesicles that are released by cells into the extracellular environment. Exosomes contain a variety of biomolecules, including proteins, lipids, RNAs (such as mRNA and microRNA), and DNA. Their content reflects the cell of origin and can vary based on the cell type and its physiological state. Exosomes can be found in a wide variety of organisms across different domains of life, including humans, other animals, plants, fungi, and even some microorganisms.
How are exosomes regulated in the EU and UK?
In the EU/UK, non-human source exosomes may be permitted in cosmetics providing the level of the ingredient used is not scientifically considered an active pharmacological level that would significantly affect the human physiological processes (this would mean that the product is instead classified under the medicines definition). All cosmetics must be safe when placed on the EU and UK market and the party placing the product on the market is responsible for the safety of their products. The overall presentation of the product should indicate that the product is intended for cosmetic use.
What challenges do brands face when making claims on exosome-containing cosmetics?
Under UK Cosmetic Regulation (Schedule 34 of the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019) and EU Regulation (EC) No 1223/2009, a cosmetic product is defined any substance or mixture intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition
Exosomes, depending on their origin and mechanism of action, may challenge this definition, especially if they are claimed to regenerate skin, stimulate cell repair, or alter gene expression. Such claims could push a product outside the cosmetic definition.
Bloom key tips for brands formulating exosome-based cosmetics for the EU and UK markets
When developing cosmetic products containing exosomes, brands should:
Ensure formula compliance: The formulation complies with the EU and UK cosmetics regulations.
Define the primary cosmetic function: This means that any claims about the product should be applied on the external part of the body and focus on enhancing appearance, such as moisturising, cleansing, or improving the look of the skin. Avoid making claims that suggest physiological or pharmacological benefits, as these could lead to the product being classified as a non-compliant medicine.
Select an appropriate cosmetic format: avoid presentation forms such as injectables, ampoules with syringes, or clinical-style droppers, that could resemble products for medical use or fall outside of the definition of a cosmetic.
Ensure clear cosmetic presentation: The overall presentation of the product should clearly indicate that it is intended for cosmetic use. This includes packaging, labelling, and marketing materials that reflect cosmetic purposes and avoid any implication of medical or therapeutic use.
Exosomes represent an exciting and fast-developing category in cosmetics, and with the right approach to formulation and claims, brands can bring innovative products to market with confidence. If you are thinking of developing a product containing exosomes and need support ensuring your formulations and claims meet UK and EU requirements, our team is here to support you in navigating compliance every step of the way. Please contact info@bloomregulatory.com.
Laila Manshi