Leave-on hydroalcoholic hand gels: which claims are not authorized?

The Sub-Working Group on Borderline Products has published on November 12, 2020 an extensive guide for product claims for leave-on hydroalcoholic hand gels in the context of COVID-19 pandemic.

Since March 2020, the EU national Competent Authorities have detected an increase of notifications of hydroalcoholic hand gels as cosmetic products. This rise can be explained by the gray area in the definition of the main function of a hand gel product, depending on the intended use or formulation, which is the key element to classify a product as a cosmetic or a biocide.

This uncertainty has led to the use of product claims in hand gels intended to be used as cosmetic products, which can normally be considered suitable only for biocidal products, such as ‘kills bacteria’ or ‘antiviral’. Consequently, the consumers can be misled, due to an incorrect marketing strategy, as these functions would not be supported as a main cosmetic function.


Therefore, the recently released guide gives a comprehensive list of claims to be avoided in cosmetic products. Their use will make the product fall under the BPR*, a regulation with additional restrictions and longer pre-market authorizations steps.

  • The  product claims not unauthorized in cosmetics, are displayed below 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.

Although not legally binding, it is important to point out that this document serves as a reference in a case-by-case approach for National Authorities and agencies.


Victor Pastor Martin

R&D Department, Obelis Group

15/12/2020


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References:


*BPR: Biocidal Product Regulation 528/2012