At present we are receiving many enquiries from companies asking the steps required in making a ‘hand sanitiser’ available on the Irish market.

Sanitising products, such as hand sanitisers, come under the Biocidal Product Regulation (BPR) and the exact steps to be followed will vary depending on the Active Substance (AS) contained in the product. The two most common active substances used in hand sanitisers are ethanol and isopropyl alcohol (IPA, propan-2-ol), and under normal circumstances these substances are regulated very differently.

Biocidal products containing ethanol fall under the transitional measures of the BPR, and to sell such a product in Ireland requires only a notification application to the PRCD. The PRCD are prioritising these applications and where complete applications are received, they are providing a very fast response time. 

There is a lot of guidance on the PRCD website on how to prepare a notification, see link

The application form is available here

Ordinarily, biocidal products containing IPA can’t be put on the market unless they go through the lengthy and expensive process of a product authorisation, since this active substance is approved at the EU level. However, the COVID-19 pandemic means that countries are allowing a so-called Article 55 derogation. The PRCD is asking companies with IPA products to submit their information using the notification form, and the derogation is considered on a case-by-case basis. See the link below for updated information from the PRCD on the derogation for disinfectant/sanitising products:

http://www.pcs.agriculture.gov.ie/biocides/biocidalproducts/disinfectantsandsanitisersforcovid-19/

If you are considering introducing a hand sanitising product to the Irish market and require assistance with your application don’t hesitate to contact us at info@kerona.ie or +353 1 849 5284.