Dáil Éireann Debate, Tuesday - 4 July 2017
402. Deputy Aindrias Moynihan asked the Minister for Health the regulations in place for approving vaping products; the time it takes to approve a product for sale here; and the stages it goes through for approval. [31236/17]
View answerThe Tobacco Products Directive 2014/40/EU ('the Directive') was transposed into Irish law by the European Union (Manufacture, Presentation and Sale of Tobacco and Related Products) Regulations 2016 (S.I. No. 271 of 2016). These Regulations were subsequently amended by the European Union (Manufacture, Presentation and Sale of Tobacco and Related Products) (Amendment) Regulations 2017 (S.I. No. 252 of 2017) in order to transpose EU Commission Implementing Act related to the Directive. In addition certain sections of the Public Health (Standardised Packaging of Tobacco) Act 2015 transposed in part Articles 13 and 14 of the Directive.
In line with the Directive, the Regulations provide that manufacturers and importers of electronic cigarettes and refill containers must notify the Health Service Executive, the competent authority, 6 months prior to placing products on the market.
The notifications, which are submitted through an EU common entry gateway, must include information on the manufacturer and/or importer, ingredients used and emissions, nicotine dose and uptake, the production process and a declaration that the manufacturer and/or importer takes full responsibility for the quality and safety of the product under normal use. Manufacturers and importers of electronic cigarettes and refill containers must also report annually on sales volumes, consumer preferences and trends.
The competent authority does not approve the products for sale. It is a matter for each manufacturer or importer to ensure that his/her products comply with the relevant provisions of the Regulations.
