Hydro-alcoholic gel: a borderline product? by Eurofins Cosmetics & Personal Care

Some products must adhere to various legal requirements and therefore there are a number of obligations of the producer responsible for placing such products on the market. Indeed, it is common that a product, which may have been previously categorised as cosmetic, may come to fall under the scope of other legislation depending on its intended use of purpose. These products are known as borderline products. Depending on the type of product, these products may need to adhere to regulation covering medicinal products, medical devices, toys or biocides.

This is the case with hydro-alcoholic gels. A hydro-alcoholic gel is a gelling agent containing water and alcohol (=mixture of substances) for application to the skin (=contact with the superficial parts of the human body). Today, by European regulatory definition, a hydro-alcoholic gel is a cosmetic product.

This product falls within the scope of cosmetic regulation if its exclusive or main function is to clean hands or to improve the appearance of hands (in so that they are visually clean). Nevertheless, a cosmetic product may well comprise other non-cosmetic secondary functions; in particular biocidal functions. It is important to pay attention to product communication – carefully thought out marketing communication can make a product appear to have another field of application other than cosmetic application.

A product that clearly claims to have disinfecting properties and should be used to disinfect hands, i.e. protection of public health through biocidal action, will be considered as a biocidal product and will fall under Regulation (EU) N°528/2012.

It is therefore the presentation of the product that establishes its legal status as well as the consumer’s perception of the way it should be used.

European Commission publications have indicated these guidelines. However, member have the flexibility to determine the status of hydro-alcoholic gels, on a case-by-case basis for each member state; and for each product.

Eurofins supports customers on their product development journey, in particular when developing hydro-alcoholic products, by reviewing on a case-by-case basis all the elements necessary to categorise such products (product presentation, ingredients, operating mode, claims…) in line with regulatory requirements.

Moreover, Eurofins helps its clients through testing services, e.g.: basic quality control, in vitro testing, efficacy testing standards, to claim the product’s efficacy (bactericidal, fungicidal / yeasticidal, virucidal activities including coronavirus), based on the client’s benchmark and the regulations of the targeted country.

cosmetics@eurofins.com

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