Guidance for Leave-On Alcoholic Hand Products

On 16 November 2020, the EU Commission has published its Technical Document on product claims of leave-on hydroalcoholic hand gels in the context of COVID-19. The document was agreed by the Sub-Working Group on Borderline products and it details the product claims, which would not support the classification of leave-on alcoholic hand gels as cosmetic products.

This newly published technical document complements the Guidance on the applicable legislation for leave-on hand cleaners and hand disinfectants as well as Borderline Manual (Manual of the Working Group on Cosmetic Products (Sub-group on Borderline Products) on the Scope of the Application of the Cosmetics Regulation (EC) No 1223/2009).

The technical document points out that although the classification of each product should be done on a case-by-case basis, taking into consideration all characteristics, product claims can be a strong indication of the main purpose of the product.

The guidance provides a list of claims, references or allusions and pictures or graphical elements that would not support a main cosmetic function of leave-on hydro alcoholic hand gels.

Below are the labelling elements (examples from the guidance) which are not appropriate for cosmetic products and would cause the perception that a hand gel has mainly a biocidal function.

Claims (and their variations):

  • antibacterial, antimicrobial, antiviral, virucide, antifungal (and their attributes, such as

‘antiviral properties’, ‘antibacterial ingredients’, ‘inhibits bacterial growth’);

  • disinfecting, disinfectant, disinfection, sanitizer, sanitizing;
  • antiseptic;
  • kills X% bacteria/viruses/microbes;
  • decontaminating;
  • formulation recommended by the World Health Organisation (WHO);
  • anti-COVID-19, anti-coronavirus, anti-SARS.

References or allusions to:

  • infection, pandemic, diseases;
  • COVID-19, coronavirus, SARS-CoV-2;
  • microorganisms, bacteria, viruses, pathogens, germs, fungi;
  • disinfection;
  • medical use;
  • percentage of alcohol in the product;
  • safe hands.

Pictures or graphical elements of:

  • (corona)virus, bacteria, microbes;
  • (red) cross (when suggesting a medical connotation);
  • shield (when indicating protection against microorganisms);
  • STOP sign (when indicating preventing/controlling the spread of a disease or infection or microbes);
  • any sign related to hospital, pharmacy, ambulance, first aid, etc;
  • CLP pictograms.