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Current status of works on the Tobacco Products Directive.


The EU Tobacco Products Directive 2001/37/EC (TPD) is the first European attempt at regulating the market of electronic cigarettes and will play a crucial role for the industry's perspectives and growth.
All of us are currently awaiting the publication of the Tobacco Products Directive that will be subject to voting in the European Parliament this year, probably in its beginning.  So far, numerous publications on the topic of legislative solutions in this document, following consultations of the Parliament, the Commission and the Council, that took place last December, were only based of unofficial sources of information. The recent official documents on the Directive's content are the European Parliament's communication dated December 18, 2013 and the official communication of the World Health Organization dated January 08, 2014.  The content of these documents lend the following assumptions of the Directive, as related to e-cigarettes:

1.    E-cigarettes have not been classified solely as medicines (nicotine replacement therapy products). Consequently, it will be possible to market electronic cigarettes as consumer or medical products.

2.    Regardless of their design, all e-cigarettes registered as consumer products will be subject to mandatory:

a.    Introduction of quality and safety standards, and health risk warnings.
b.    Limitation of the concentration of nicotine contained in liquids up to 20 mg/ml.
c.    Ban on advertising pertaining to tobacco products.
d.    Registering new products launched into the tobacco products market.
e.    Limitation of the maximal volume of replaceable cartridges and refillable liquid tanks up to 2 ml.
f.    Limitation of the maximal volume of bottles of liquid for refilling e-cigarettes up to 10 ml.
g.    Protection of bottles of liquid from children and against breaking or leaking.

3.    If a manufacturer informs that e-cigarettes support quitting smoking, such products will be subject to pharmaceutical law regulations. Similar regulations will apply to e-cigarettes and liquids whose nicotine concentration exceeds 20 mg/ml.

It is worth noting that the Directive is currently at the 24th stage of 26 legislative stages. The European Parliament's voting over the Directive, planned for this year, will only translate into accepting the document as valid in EU states, or into its rejection. During the voting stage there is no possibility of amending the content of the document, which was developed as a compromise of proposals of the European Commission, Council and their experts. We believe that the rejection of the Directive in voting in the European Parliament is very unlikely, virtually improbable at all.

•    Read the official information of the European Parliament dated December 18, 2013 on the process of passing the Tobacco Products Directive:

•    Read the official communication on the Tobacco Products Directive published on January 08, 2014 by the World Health Organization: