Guidance for placing hand sanitizing products on the UK market
In May 2020, the Office for Product Safety & Standards issued a guidance for the placement on the UK of hand cleaning and sanitising products.
The demand for these type of products has risen, as a consequence of the COVID-19 pandemic, and it is common for manufacturers and importers to be confused when it comes to which legislation these products fall under.
The classification of these products is dependent on their intended use, function, composition and how they are described and marketed. As per these characteristics, the guidance offers valuable clarification on the different categories these products may fall under, and, accordingly, how they are regulated in the EU. The classification of borderline cases for each of these categories should be determined on a case by case approach by the Competent Authorities.
If product claims to perform any sort of cosmetic enhancement (example: cleaning, protecting, conditioning the skin) while providing a secondary antimicrobial effect, it will be considered a cosmetic product, and thus, subject to the EU Cosmetics Regulation 1223/2009.
If the product primarily claims to kill germs, sanitize or disinfect using an active microbial ingredient, it is to be considered a biocide. The UK Health and Safety Executive (HSE) is responsible for regulating biocides in the UK, as per the applicable Biodical product Regulation and has issued additional guidelines and advice on the authorization process of hand sanitizing product in UK, which can be found here.
Finally, products that claim to treat and/or prevent infections associated with specifically named pathogens (such as COVID-19) and surgical scrubs for use in operating theatres are classified as medicines. These are regulated in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA).
Additionally, the Guidance cautions manufacturers to be aware of further requirements relating to weights, measures and packaging requirements, imposed by the respective local Trading Standards service.
Ana Rita Falcão
Regulatory Affairs Department
If you are not sure on how your products fits into one of these categories, or if you already know and are you’re interested in placing it as a cosmetic or biocide product on the EU market, please contact us! Our consultants will gladly assist you in the classification process or with placing your products on the EU market.Get in touch