Charlie McConalogue (Donegal, Fianna Fail) | Oireachtas source

It is certainly good to see so many in the Chamber this late in the evening. I have no doubt that by the time we finish these questions, we will know a little more about what is in store across the Atlantic than we do now.

Biocidal products, including hand sanitisers, may only be marketed and used in Ireland once they have been registered with the Department of Agriculture, Food and the Marine and entered on the biocidal product register in accordance with Regulation 20 of SI 427 of 2013.

The hand sanitiser ViraPro was approved by our biocides unit and registered on 21 April 2020. Administrative checks applied at registration included the provision of a safety data sheet for the ViraPro product from the supplier which was submitted with the application for registration. As this is an administrative process, no samples were required as part of the approval process. The product was approved on the basis that it contained 70% ethanol, which is a common standard for hand sanitiser products and fully complies with World Health Organization guidelines.

Following international notification of potential concerns regarding a consignment imported into Ireland, my Department took immediate steps to quarantine, investigate and test this consignment. Following investigations, laboratory results received on 16 October showed that the products did not meet the standards for approval, particularly with regard to the presence of methanol. The consignment being investigated remained under quarantine throughout this process. The company was immediately instructed to retain all product in its possession and recall all remaining product under the ViraPro name from the market or in use by the public. On 20 October, ViraPro hand sanitiser was removed from the Department's biocides register.

The primary responsibility for the withdrawal of products rests with the company concerned. On Thursday, 22 October, it became evident on the basis of communication from the company that the recall of products had not yet commenced. At that point, my Department took the additional step of issuing a statement outlining the possible risks posed by ViraPro and advising members of the public not to use it. I was informed of the situation by my Department for the first time on the evening of 22 October.

Additional information not given on the floor of the House

We are taking this matter seriously and will continue to follow up and investigate as appropriate. My Department is continuing to increase its testing of product on the market to provide reassurance in respect of compliance with approved product specifications. Test results available so far indicate no safety issues with other sanitiser products sampled. I have asked my Department to review this matter to ensure that lessons are learned regarding communication of the incident.

See this speech in context