Regulation of hand sanitisers in the EU and US

Hand hygiene has never been as important as now in the midst of the coronavirus disease 2019 (COVID-19). Washing hands with soap and water for at least 20 seconds is essential to help stop the spread of this virus. If soap and water are not available then using an alcohol based hand sanitiser is recommended.1 This article looks at the regulatory requirements for placing on to the market hand sanitisers in the European Union. It considers whether products are biocides or cosmetics. It then looks at the requirements of the European Biocides Regulation (EU) 528/2012. The second part of this article looks at how hand sanitisers are regulated in the United States of America and the temporary policy that the Food and Drug Administration (FDA) has adopted for hand sanitisers.

European Union

Antibacterial products can be classed as cosmetics, biocides or medicines based on their function, the way they are presented and the claims made. For an antibacterial product to be a cosmetic it must have a cosmetic primary function (e.g. moisturising, protecting, perfuming skin). The antibacterial claim has to be a secondary claim and it must be made clear that this is a secondary claim. This can be done by making the antibacterial claim less prominent than the cosmetic claim or by stating the cosmetic claim first followed by the antibacterial claim. An antibacterial hand wash would be regarded as a cosmetic product as its primary function is cleansing. A moisturising hand gel with antibacterial properties would be a cosmetic product providing that moisturising is the primary claim and antibacterial the secondary claim. An antibacterial hand gel would be a biocidal product as the primary claim is for a biocide