Tuesday, 3 November 2020
Department of Agriculture, Food and the Marine
40. To ask the Minister for Agriculture, Food and the Marine the process used to grant approval to products (details supplied); the plans being put in place to rectify this process; and if he will make a statement on the matter. [33563/20]
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 approval process also checks that applications comply with all legislation on contents and efficacy.
The hand sanitiser Virapro was approved by our Biocides Unit and registered on the 21st April 2020 on the basis of the documentary application, including a technical specification that it contained 70% ethanol which is a common standard for hand sanitiser products and fully complies with regulations.
Following investigations, laboratory results received on 16thOctober 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 also issued formal notification to Departments of Education, Health and Children. I was informed of the situation by my Department for the first time on the evening of 22ndOctober.
We are taking this matter very 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 relation to compliance with approved product specifications. Test results available so far indicate no safety issues with other sanitiser products sampled.