Olivia Mitchell (Dublin South, Fine Gael)
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Question 461: To ask the Minister for Health if he will instruct the Irish Medicines Board to accept the EU-backed pan-European classification of products as a cosmetic, biocide or medicine rather than its own guidelines which will either increase the costs of products to consumers here or deprive these consumers of basic products such as shampoos, soaps, washes, deodorants and which will impact, in addition, on the many pharmaceutical firms giving employment in Ireland; and if he will make a statement on the matter. [38877/11]

Róisín Shortall (Dublin North West, Labour)
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The Irish Medicines Board (IMB) and the Department of Agriculture, Food and the Marine (DAFM) have developed draft joint guidance on the classification of consumer products that are borderline between cosmetics and biocides. This draft guidance has been prepared following a request from industry for guidance in this area and has been the subject of public consultation. The IMB and DAFM are currently in the process of taking on board comments received from Industry and stakeholders in relation to this guidance.

Under EU legislative frameworks relating to biocides and to cosmetics, the relevant Competent Authorities are responsible for assessing borderline products to determine, based on the product's characteristics, whether a product should be regulated as a cosmetic or as a biocide. No formal pan-European guidance has been developed regarding the classification of borderline products as either cosmetics or biocides. It has, therefore, been necessary to develop guidance at national level to ensure the safety of such products for consumers. The European Commission and other Member States have welcomed the draft guidance developed by the IMB and DAFM as assisting towards EU harmonisation.