Charlie McConalogue (Donegal, Fianna Fail) | Oireachtas source

I welcome this opportunity to update the committee on the recall issued by the Department for Virapro sanitiser products. I will briefly recount the specific issue that arose with ViraPro. In the first instance, the European Anti-Fraud Office, OLAF, 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 and found to contain excessive levels of methanol. Arrangements were made to test the consignment and a number of other consignments that had already been imported into Ireland from the same supplier.

All consignments that were tested were detained, pending the results of the laboratory analysis. Indicative test results were received on 6 October.

I wish to take this opportunity to correct one point in my statement to Dáil Éireann of 23 October. When using information provided to me at the time I stated that results had been received on 8 October. I should have said that preliminary results were received on 6 October. Following receipt of these results, my Department informed the HSE of initial concerns about the safety of the detained consignments of sanitiser. These concerns were based on indicative results only, without confirmatory results from a validated test method.

Confirmatory results were received on 16 October. These confirmed that the composition of the registered product was not consistent with the approved specification and, therefore, there were concerns around efficacy and public health. A compliance notice to recall this product from the market and from public use was issued to the supplier on Friday, 16 October. The product was officially removed from the official register of biocides on Tuesday, 20 October and contact was made with the procurement service of the Department of Health the same day. Then, on 22 October, my Department issued formal notification to the Department of Education and the HSE and apprised the Department of Children, Equality, Disability, Integration and Youth. My Department also took the additional step of issuing a public statement outlining the possible risks posed by ViraPro and advising the public not to use it. I was advised of the issue that evening.

Since affected ViraPro sanitiser was removed from the national biocides register in October, my Department has been proactively engaging with the supplier to ensure its instructions to recall product are complied with in full and that no further sanitiser product from the original Turkish supplier is supplied and placed on the market. My Department has also made arrangements with the Revenue Commissioners to detain any further consignments from the Turkish manufacturer in question and notify the Department. At the same time, to assist with a wider EU level examination of how this product came to breach compliance with regulations on content, all confirmatory laboratory results are being shared with the European Anti-Fraud Office, OLAF.

Responsibility for the withdrawal of products rests with the company concerned. It had become clear by 22 October that the recall of products had not yet commenced. Officials in the pesticide controls division continued to engage actively with the company to ensure a full recall could be made. However, while the company demonstrated some compliance with the recall instruction, further deadlines of 28 October and, most recently, 12 November for a full and verified recall of affected ViraPro sanitiser products have not been met to my Department's satisfaction. Officials of the pesticide controls division continue to engage with the supplier to ensure that the recall of all product concerned is fully completed. I have taken the added step of asking the investigations division of the Department to carry out a full investigation into the circumstances around the importation of this product.

I regard the protection of public health as our key priority. To ensure this, the Department continues to sample and test biocide products currently on the market to ensure their continued compliance with regulatory standards and thereby provide the necessary assurance of public safety. In this regard, 75 sanitiser products have been sampled and analysed since the end of October. I am happy to report that no safety issues have been found with any of the products checked. I believe our actions, together with the arrangements made with the Office of the Revenue Commissioners to detain consignments of concern from Turkey at the earliest stage were fully appropriate.

I am mindful of the need to ensure new sanitiser products are evaluated and registered in a timely fashion to ensure a wide range of safe products are always available to the public. Accordingly, the number of staff members in the biocides unit dealing with product registrations is being increased significantly to ensure processing times of new applications are reduced.

Committee members will be aware that there has been a large increase in applications since the onset of the Covid-19 pandemic, with approximately 500 hand sanitiser applications compared with a normal 50 per year. I am, however, satisfied that there are sufficient supplies of sanitiser available to the public to support the Government's actions on Covid-19, with more than 450 products currently approved and listed on the national register of biocides.

I made it clear in respect of the chronology of the engagement and the notification of the public that there are lessons to be learned from the point of view of the Department. Given the nature of the recall, there should have been public notification when confirmatory results were available on 16 October and the issue should have been escalated in the Department at that stage.

There are lessons to be learned there. I am also awaiting a report on the chronology around this and ensuring those lessons are learned for the future. Certainly there is confidence regarding the sanitiser and what is available. As a Department, we are taking strong efforts to ensure there is appropriate oversight of that, ensuring the available products are doing exactly what is required, and ensuring the issue which arose regarding ViraPro is expedited and completed to our satisfaction. We continue to engage in that regard.