Answer given by Mr Dalli on behalf of the Commission
In the context of the forthcoming review of the Tobacco Products Directive 2001/37/EC(1), the question of electronic cigarettes marketed as consumer products is currently being analysed in the ongoing impact assessment. A possible extension of the scope of the directive to include these products and regulate their ingredients is among the various options being analysed. The Commission has not, at this stage, taken a final position on the preferred policy option.
When e-cigarettes are classified as medicinal products by Member States, such products are subject to an in-depth assessment of the effect and possible adverse reactions before the marketing authorisation is granted.
Currently, there is limited data available on the effects and side-effects of e-cigarettes. Analyses of electronic cigarettes conducted by the US Food and Drug Administration (FDA) have shown that the vapour produced can contain carcinogens, including nitrosamines, toxic chemicals such as diethylene glycol and other tobacco specific components suspected of being harmful to humans(2). The World Health Organisation (WHO) Study Group on Tobacco Product Regulation has concluded that there is concern that nicotine delivery to the lung might result in strong toxicological, physiological and addictive effects(3).
(1) Directive 2001/37/EC of Parliament and of the Council of 5 June 2001 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products Commission statement, OJ L 194, 18.7.2001.
(2) FDA: Summary of Results: Laboratory Analysis of Electronic Cigarettes Conducted By FDA. US: Food and Drug Administration (FDA), July 2009,
Summary of Results: Laboratory Analysis of Electronic Cigarettes Conducted By FDA
(3) WHO Study Group on Tobacco Product Regulation, Report on the Scientific Basis of Tobacco Product Regulation: Third Report of a WHO Study Group, 2009.