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;
- kills X% bacteria/viruses/microbes;
- 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;
- 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.