Written answers

Tuesday, 3 November 2020

Department of Agriculture, Food and the Marine

Medicinal Products

Photo of Matt CarthyMatt Carthy (Cavan-Monaghan, Sinn Fein)
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1527. To ask the Minister for Agriculture, Food and the Marine if his Department had issued approval for the use of a product (details supplied), the date of approval; the procedures employed prior to approval; the reason for recall of the product; the dates that concerns were raised; the date that the decision was made; the procedures for notification of the recall; and if he will make a statement on the matter. [33122/20]

Photo of Charlie McConalogueCharlie McConalogue (Donegal, Fianna Fail)
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Biocidal products, including hand sanitisers, may only be marketed and used in Ireland once they are registered with the Department of Agriculture, Food and the Marine and are entered on the Biocidal Product Register” in accordance with Regulation 20 of Statutory Instrument 427 of 2013.

The hand sanitiser Virapro was first registered on 21stApril 2020 and placed on the national Product Register. The product approved by the Department fully met regulatory standards.

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 and found to contain excessive levels of methanol. The Revenue Commissioners notified my Department of this information on 25thSeptember 2020 and 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 quarantined pending the results of the laboratory analysis.

Results were received on 16thOctober and showed that 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 the 20thOctober, 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 22ndOctober, 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.

My Department is continuing to increase its testing of product on the market to provide reassurance in relation to compliance with approved product specifications. Test results available so far indicate no safety issues with other sanitiser products sampled.

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