Why can’t I market my hand gel as cosmetic product?
As a rule, disinfectants are covered by the Biocidal Products Regulation. However, a product intended be placed in contact with the human skin or with the teeth and the mucous membranes of the oral cavity (and for which no therapeutic claims are made) may classify as a cosmetic if the antiseptic properties are secondary to the main purpose of the product. This is primarily determined based on the product composition, presentation and claims. As will be discussed in the next sections, most sanitising hand gels must be considered as biocidal product.
The following products are considered biocidal products:
- Products for which no claims are made, but which do contain at least one active substance, and which are apparently intended for use as a biocide, as no other effect of the product is known.
- Products for which no claims are made, but which have a composition identical or comparable to that of authorised biocides.
An example of the latter is a leave-on hydro alcoholic hand gel with an alcohol concentration of 60 – 80% (v/v), as this is the recommended concentration to obtain a disinfecting effect.
Product presentation and claims
In order to clarify which product presentation elements and claims are not permissible on cosmetic leave-on hand gels, the European Commission has issued a new technical guidance in November 2020. The guidance complements the Coronavirus Crisis Guidance as adopted by the European Commission earlier the same year, and serves as a harmonising tool for the case-by-case application of EU legislation by the national competent authorities and national courts. The following labelling elements have been agreed not to be permissible for use on cosmetic products:
Claims (and their variations):
- antibacterial, antimicrobial, antiviral, virucide, antifungal (and their attributes, including but not limited to 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); and
- 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; and
- 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; and
- CLP pictograms.
Sanitising hand gels labelled with any of the above classify as biocidal products. Biocidal products generally require authorisation prior to being placed on the market (unless otherwise stipulated under transitional law).
Please note: under the Biocidal Products Regulation, studies to support the product efficacy claims must be included in the biocidal product dossier.
The Chemical Compliance Coach can help you to place your biocidal product on the market in full compliance in the EEA, Switzerland and the UK. Contact us and request an initial consult to discuss your product and market.