Members of the European Parliament and member states reached a provisional deal on revised European Union tobacco rules last night (16 December), with a tentative settlement on the controversial issue of e cigarettes.
The e cigarette agreement goes beyond the negotiating mandate given to the Lithuanian government, which holds the rotating presidency of the Council of Ministers, and must be approved at a meeting of member states tomorrow (17 December). It is possible the provisional deal could be rejected, according to Council sources.
The deal would allow e cigarettes with a nicotine content below 20mg/ml (or 18mg per unit) to be regulated for general sale, rather than treating them as medicinal products as proposed by the European Commission according to sources who were at the meeting.
This was a key demand of the European Parliament, as member states were demanding a limit of 3mg/ml. However, individual member states will be free to regulate all e cigarettes as pharmaceuticals if they so choose.
The deal would allow refillable cartridges, but they must be in self contained packets that would avoid spilling. Cartridges could have a maximum size of 1ml containing up to 20mg of nicotine, roughly equivalent to one pack of cigarettes.
However member states will be free to enact national bans on refillable e cigarettes, as long as these bans can be justified on safety grounds. If more than three member states choose to do so, then the Commission can impose an EU ban in order to maintain the integrity of the single market. This would not need the approval of the European Parliament or member states. The Commission will review the situation in 2016.
EU national governments have been concerned about the future health impacts of ‘light touch’ regulation of these new products and favour a heavily restrictive approach. This has been resisted by the European Parliament, which has been under intense pressure from the makers and users of e cigarettes who say draconian restrictions would kill off a valuable tool for quiting smoking.
British Liberal MEP Chris Davies, who has been an advocate for e cigarettes in the Parliament, said the restrictions on their sale are a price worth paying to secure agreement across the whole of Europe.
“We have seen a massive turnaround in the approach towards e cigs and that is very much to be welcomed, he said. These things can save lives because smokers find them pleasurable to use.
Green MEPs, who have been more sceptical about e cigarettes, gave a cautious welcome to the deal. “E cigarettes will finally be regulated in the near future, said Swedish Green MEP Carl Schlyter. Member states will be free to decide whether they want to subject them to authorisation as medicines or apply new rules that should ensure the quality and safety of these products. Either way should ensure that e cigarettes can be used safely to help smokers stop smoking, and not act as a gateway product for non smokers.
As the new rules do not regulate the use of flavours in e cigarettes, it is important that member states that will not apply pharma legislation act quickly to ban the current range of flavours that deliberately target younger users, he added.
The overall deal confirms an earlier agreement between the two sides to require cigarette packs to have picture warnings covering 65% of a pack. It bans all characterising flavours, with a derogation of four years for menthol.
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