Regulation of Hand Sanitisers

News Category: Regulatory news

Date: 06/04/2020

Hand sanitisers that make general claims in relation to an antibacterial action or killing of germs (and do not make medicinal claims or contain medicinal substances) are classified as biocides and 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 moisture 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 are presented as treating a disease or preventing a virus or an infection should be classified as a medicine.

European Commission Covid-19 Guidance related to hand sanitisers

The European Commission has 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, which 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. 

 



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