Charlie McConalogue (Donegal, Fianna Fail) | Oireachtas source

I welcome the opportunity to update the House on a notice issued by my Department for the hand sanitiser product, Virapro.

The Department of Agriculture, Food and the Marine is the national competent authority for the approval and registration of biocide products, including sanitisers. Biocidal products, including hand sanitisers, may only be marketed and used in Ireland once they are registered with the Department and are entered on the biocidal product register in accordance with Regulation No. 20 of SI 427/2013. The process for registering biocidal products aims to ensure that their use does not result in harmful effects on human animal health or the environment. The approval process also checks that applications comply with all legislation on contents and efficacy.

The hand sanitiser, Virapro, was approved by our biocide unit and placed in the approved register of biocide products on 21 April 2020. The product had been registered on the basis of a documentary application, including a technical specification that it contained 70% ethanol, a common standard for hand sanitiser products, and fully complied with regulations.

OLAF, the European Anti-Fraud Office, notified the Revenue Commissioners regarding the import of a hand sanitiser product from Turkey to Ireland from the same supplier of a product that had been tested in Denmark. It was found to contain excessive levels of methanol. The Revenue Commissioners notified the Department of this information on 25 September and arrangements were made to test the consignment, along with several other consignments imported into Ireland from the same supplier. All consignments tested were detained pending the results of the laboratory analysis.

Concerns regarding the sanitiser related to varying and inadequate levels of ethanol in the product, as well as the detection of methanol at varying levels in some samples. Inadequate levels of ethanol would render the product ineffective. More importantly, frequent use of a hand sanitiser containing methanol can cause nausea, dermatitis, eye irritation, upper respiratory tract irritation and headaches. Departmental officials took samples of batches of product at different storage locations between 30 September and 2 October. These samples were submitted to the Department's own laboratory in Backweston on 2 October.

Preliminary results were received on 8 October. While these results had to be viewed as indicative only, since the test method was still in the process of validation, they gave sufficient reason to believe that this product should not be released on the market pending further investigation. On 8 October, compliance notices were issued to all four of the warehouses that had product from the identified consignments requiring them to retain all products on site. Six additional samples of product were taken for testing, covering all product, irrespective of source, from the company bearing the name Virapro. All six of these additional samples were submitted for testing to the Department's laboratory on 9 October.

It became clear that some of this product was not alcohol-based and, therefore, had not been approved for use by my Department. Following a necessary period of validation of the test method of the laboratory, results were received on 16 October and showed the products did not meet the standards for approval, particularly with regard to the presence of methanol. 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 biocide register. On the same day, officials had informal contact with the Department of Education and Skills procurement service on the matter. On 21 October, my Department contacted the HSE with results relating to Virapro product samples from the earlier consignments which were owned by HSE. The primary responsibility for the withdrawal of products rests with the company concerned.

On Thursday, 22 October, yesterday, 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. It also issued formal notification to the Departments of Education and Skills, Health and Children and Youth Affairs.

The Department is taking this matter seriously and will continue to follow up investigating the matter. I was informed of the situation yesterday for the first time. Having reviewed the matter today, I am clear that it would be much more appropriate for my Department to have followed up with a public notice and communications with other Departments immediately upon issuing the withdrawal notice to the company on 16 October.

Some of the products Virapro were supplying were working off a PCS registration number although it had not received approval from my Department. Accordingly, I directed my Department this evening to follow up further with all Departments and also to make it clear to the public that anyone with any Virapro product should not use it and withdraw it immediately.

I am conducting a full review of the handling of this particular issue to ensure our system of regulation is robust and lessons are learned in terms of the communication of it over the past several days.

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