I propose to take Questions Nos. 492 and 507 together.
The EU Tobacco Products Directive 2014/14/EU introduced new rules for tobacco products and for nicotine-containing e-cigarettes and refill containers. The EU Commission indicated that as nicotine is an addictive and toxic substance, safety and quality requirements for nicotine-containing e-cigarettes were necessary. Reporting obligations were also needed so that public authorities could monitor and learn more about these products.
A proposal for a new Tobacco Products Directive was adopted and published by the EU Commission in 2012 following extensive consultation of stakeholders, including a public consultation which generated 85,000 responses. During the proposal's preparation, an extensive impact assessment was carried out by the EU Commission evaluating economic, social and health effects of several policy options under consideration and several external studies were commissioned during the process. The 2012 proposal was then discussed in the European Parliament and in the Council of Ministers and was formally adopted as a Directive in 2014.
As a Member of the EU Ireland was obliged to transpose this Directive into Irish law. These new rules were transposed by the European Union (Manufacture, Presentation and Sale of Tobacco and Related Products) Regulations 2016 (S.I. No. 271 of 2016) and subject to Regulation 47 (transitional provisions), have been effective from 20th May 2016. The guidelines mentioned by the Deputy refer to a number of guidance documents issued to assist manufacturers, importers, distributors and retailers of e-cigarettes or refill containers to comply with this new legislation.