News Category: Regulatory news
Updated information regarding the regulation of hand sanitisers is available below.
Products with a primary function of hand sanitisation, or which by virtue of their presentation imply a function of sanitisation, are not considered to meet the definition of a cosmetic product. Such products, or those that make general claims in relation to an antibacterial action or killing of germs (and do not make medicinal claims or contain substances exerting a medicinal effect), are likely to be classified as biocides. Biocidal products are regulated by the Pesticides Registration and Control Division in the Department of Agriculture, Food and the Marine. Please contact biocides@agriculture.gov.ie if you have any queries on registration of biocidal products for hand sanitisation.
Soaps intended to clean and/or moisturise the hands are likely to be considered as cosmetic products, regulated under European Regulation (EC) No. 1223/2009.
Hand sanitisers that contain medicinal substances and/or are presented as treating a disease or preventing an infection, such as an infection caused by a virus, should be classified as a medicine.
European Commission Covid-19 guidance related to hand sanitisers
The European Commission published guidance (30 March 2020) on the applicable legislation for leave-on cleaners and hand disinfectants (gel, solution, etc.) for operators including small and medium-sized enterprises. Further guidance was published 12 November 2020 in the Borderline working document on leave on hand gels. Both of these documents can be found on the European Commission website.
Contact details
COVID-19 related classification queries concerning cosmetics, medicines or medical devices can be sent to covid19@hpra.ie. Please include COVID-19 in the subject line.
Please contact biocides@agriculture.gov.ie for queries regarding biocidal products for hand sanitisation.
Please note, queries received by the HPRA in relation to classification of hand products, soaps or similar products of a borderline nature may be shared with the Pesticides Registration and Control Division in the Department of Agriculture, Food and the Marine if considered necessary to enable the provision of appropriate guidance.