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Alcohol hand gels – classification and claims

Due to the persistent COVID-19 pandemics, the use of hand gels is still very spread in Italy. This is a practical and convenient product, that can be used on any occasion, as it does not require to be rinsed.

Such products are marketed with different claims and indications as well as different regulatory classification, but unfortunately not all products comply with the regulations. Let’s clarify them a little, then, for the benefit of consumers who, ignoring the specific regulations, could find difficult to choose one product or another based on labels that are not always appropriate and truthful.

Alcoholic hand gels as PMC

Alcohol hand gels can be classified as cosmetic products or as PMCs (presidi medico chirurgici, medical surgical aids). The elements to be considered for a correct classification are essentially the composition and the properties to be attributed to the product. Ethanol is, in fact, an ingredient that is admitted in cosmetic products as well as in PMCs. However, high concentrations and disinfecting properties can only be attributed to products preliminarily registered as PMCs.

The PMC regulation is national, therefore it applies only in Italy, and imposes the submission of a dossier of the product to be registered as PMC. The other documents also include efficacy studies carried out in accordance with the specific European regulations to demonstrate the properties attributed to the product. The label of a PMC is approved by the Italian authorities, and should indicate the registration number issued by the Ministry of Health.

Alcoholic hand gels as cosmetics

On the other hand, the regulation applied to cosmetic products is different. The reference legislation for these products is a European regulation. Cosmetics should be notified before their marketing, and no authorisation is issued; however, the responsible person marketing the product should ensure the safety and efficacy of the product in the conditions of use indicated. To this aim, a dossier should be prepared to be submitted to the authority on demand.

The indications that can be attributed to a cosmetic product also differ from those admitted for a PMC, and therefore no reference to disinfection is admitted for cosmetics, but only cosmetic properties. However, many alcohol hand gels currently on the market as cosmetics are labelled in an uncompliant way, as they attribute properties that could not be associated to a cosmetic product.

In order to make things clearer and provide more indications to companies, a technical document was published, approved by the working group on borderline products, specifying the claims (to be also intended as pictures or hints) that cannot be reported on cosmetic labels. Forbidden elements include any reference to disinfection, antibacterial and virucidal properties as well as indications on the alcohol concentration of the product.

It is therefore important to classify and label correctly the product to be marketed, following the appropriate regulatory procedure, in order to always ensure consumers’ safety and comply with the regulations.

Written by: Federica Montozzi

Foto di Chesna da Pixabay