What are the rulings in the UK & EU on the use of human-derived Exosomes – All you need to know
The EU regulation on human-derived exosomes for cosmetic treatments falls under EU Cosmetic Regulation (EC) No 1223/2009, which governs the safety, labelling and marketing of cosmetic products within the European Union. Human-derived biological materials, such as exosomes, face stringent controls under this regulation due to safety concerns.
Key Aspects of the Regulation:
1. Prohibition of Unapproved Substances:
Human-derived exosomes are not specifically approved for cosmetic use under the EU Cosmetics Regulation. This means that they cannot legally be used in cosmetic formulations unless they pass rigorous safety evaluations and are added to the list of allowed ingredients, which has not yet happened for human-derived exosomes.
2. Safety Concerns:
The use of human-derived biological materials is tightly regulated due to concerns about contamination, immune reactions, and transmission of diseases. Exosomes fall under this category, and their use in cosmetic treatments raises red flags regarding their safety and potential side effects.
3. Biotechnology and Medicinal Classification:
In some cases, treatments involving human-derived substances could be classified as medicinal products rather than cosmetics. If a product is considered to have a therapeutic or medical purpose, it falls under much stricter regulations, requiring clinical trials and approval from the European Medicines Agency (EMA).
As a result, the use of human-derived exosomes in cosmetic treatments remains prohibited in both the EU and the UK under current regulations.
About E-50 Exosomes
E-50™ Exosomes are marine-derived, sourced from salmon testes cells, selected for both their safety profile and biocompatibility.
All products within our E-50™ Exosomes portfolio hold a UK Certificate of Cosmetics Notification, which is the legal requirement for an Exosome brand to be approved for use in the UK.
All products within our E-50™ Exosomes portfolio are kFDA approved (Korean Food & Drug Administration).