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EU Tobacco Directive E-Cig Regulation

EU Tobacco Directive E-cig Regulation

The text for the EU tobacco directive has been finalized. The EU parliament is set to vote on the final text in spring 2014. I’ll be posting up a follow up article with some analysis and my own personal opinions, for now though I’m going to concentrate on giving readers the facts and how this will affect vapers across Europe.

E-Liquid Bottle Limits and Nicotine Concentration Levels

The maximum size for bottles will be set at 10ml, but there will be no limits on the number of bottles you can purchase. In addition e-liquids containing anything above 20mg nicotine content will be banned.


There will be no major changes to current flavorings regulation. This means that freedom of cross border movement remains intact. While each EU State has their own regulatory framework for flavorings, other member States will not be permitted to ban flavors that are available in other member States.

E-cigarette Devices

Refillable devices narrowly escaped an outright ban but there will be a review of refillable devices in 2 years. There will be a new limit of 2ml maximum capacity for e-cig devices. Realistically speaking, if the worst case scenario transpired and a ban on refillables was introduced, it would take at least 5-7 years to come into effect.

The Three State Ban

This part of the text has been widely misinterpreted. It has been claimed that if three States ban refillable devices that the EU could then enforce an outright ban, however this is not the case.

If three member States can prove there is a safety issue with any particular refillable brand or model then the EU will have the power to impose a ban, but only on the specific brand or model in question. The EU also retains the right to veto any ban proposals.

Medical or Pharmaceutical Regulation

Despite having escaped medical regulation, each EU State will still have the power to classify e-cigs as pharmaceutical products. The EU however has implemented a different legal framework for e-cigs. If any Government opted to adopt pharmaceutical regulation, they would potentially leave themselves open to a legal challenge. Precedents have already been set with several Dutch and German court rulings.

E-cigarette manufacturers will be permitted to make health claims about their products, but in order to do so they will be required to apply for a medicinal license.

These are the main points that will be of interest to vapers. Aside from the above there will also be changes to advertising standards (severe restrictions), consumer information and health and safety regarding labeling and packaging.

Yes we have come a long way since the original draft that proposed medical regulation of e-cigs, but by no stretch of the imagination could the final text be described as reasonable or sensible. There are obviously some sensible aspects to the proposed framework, but the main sticking points of nicotine concentration levels, bottle sizes and the looming potential for a future ban on refillables are mind boggling to say the least.

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