Billy Kelleher (Cork North Central, Fianna Fail)
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162. To ask the Minister for Health if he will not permit the introduction of any novel tobacco product such as heated tobacco products here unless it can be independently proven that it cannot be smoked like a traditional cigarette and the product does not release second hand-smoke emissions as the World Health Organization warns that there is no safe level of exposure to tobacco smoke; and if he will make a statement on the matter. [18640/16]

Marcella Corcoran Kennedy (Offaly, Fine Gael)
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Novel tobacco products are regulated under the European Union (Manufacture, Presentation and Sale of Tobacco and Related Products) Regulations 2016 which transposed the European Tobacco Products Directive 2014/40/EU. The Regulations do not provide for an authorisation system for novel products but manufacturers or importers of these products are required to notify the Health Service Executive (the Executive) of any such product they intend to place on the market in Ireland. The notification must be submitted 6 months prior to placing the novel product on the market and be accompanied by a detailed description of the product concerned as well as instructions for its use and information on its ingredients and emissions.

A manufacturer or importer of a novel tobacco product must also submit available scientific studies on toxicity, addictiveness and attractiveness of the product and studies and market research on the preferences of various consumer groups, including young people and current smokers. They must also provide a risk-benefit analysis of the product, its expected effects on cessation of tobacco consumption, initiation of tobacco consumption and predicted consumer perception.

Furthermore, a novel tobacco product must comply with all other relevant provisions of the European Union (Manufacture, Presentation and Sale of Tobacco and Related Products) Regulations 2016 and other existing Irish tobacco control legislation.