By Dave Keating  –  Today, 13:32 CET

Division between Parliament and member states on whether to allow refillable cartridges could doom tobacco legislation.Members of the European Parliament and member state representatives meeting tonight (16 December) may decide to remove regulation of e-cigarettes from an overhaul of European Union tobacco legislation, to avoid having the entire package fall apart. 

The two sides have until Wednesday to come to an agreement but have locked horns on the issue of whether to allow e-cigarettes with refillable nicotine containers on the market. Member states are adamantly opposed, saying these cartridges could contain a potentially lethal dose of nicotine and could be used to smoke other drugs such as heroin. National governments want e-cigarettes to be single-use and disposable.

MEPs have said this is unacceptable, pointing out that most e-cigarettes currently on the market use refillable cartridges and that single-use e-cigarettes would be unaffordable for users. The Parliament has been under intense pressure from e-cigarette makers and users who say over-regulation could kill a valuable tool to quit smoking.

“99% of the [Tobacco Products Directive] text is now agreed, but e-cigarettes remains unresolved and given the strength of feeling among member states this threatens to be an extremely difficult issue,” said one Council source. “One solution would be to delete article 18, which would leave no regulation of e-cigarettes at EU level. This would be the worst possible outcome, because there’s no regulation whatsoever at the moment.”

Member states have compromised from their original insistence to regulate e-cigarettes as medicines, as proposed by the European Commission last year. They say they are willing to regulate e-cigarettes as consumer tobacco products, but only on the condition that they are strictly regulated. National capitals are extremely worried about the potential health effects of this new product and the possibility that it could in fact open a whole new market for smokers.

Member states including Germany, Belgium, Hungary and Poland have said refillable cartridges are a red line and under no circumstances could they vote for a tobacco law that allows them, according to sources.

One option for compromise would be to strictly limit the amount of nicotine that the refillable cartridges can contain. But on this issue the two sides are far apart. Under the Parliament position the refillable cartridges could contain 10ml of fluid, which at 20mg/ml would mean roughly 200mg of nicotine. Experts say this is equivalent to 2 packs a day for a week, and could even be lethal if taken all at once.

Member states want single-use e-cigarettes to contain nicotine levels of no more than 2mg per unit or 4mg/ml. MEPs say this figure should be 30mg/ml for single-use e-cigarettes.

Speaking at a press conference organised at the European Parliament earlier this month, professeur Bertrand Dautzenberg, president of the French office of tobacco prevention, noted that early models of e-cigarettes with low nicotine were not very popular, and the product did not really take off until the nicotine dose went up to 10mg per cigarette.

“With 20mg you get the same effect as two packs a day,” he said.

Belgian Liberal MEP Frédérique Ries, who drafted the amendment protecting e-cigarettes from classification as medicines, said at that press conference that MEPs need to be confident that the regulation won’t kill off e-cigarettes, but also won’t encourage them for first-time young smokers. “We don’t want this to be a drawbridge for young people to cross over and start smoking,” she said. “You have to make them unattractive [for young people], but you also have to make them available.”

The e-cigarette industry says a majority of current users use refillable cartridges and the vast majority of current e-cigarettes produce levels of nicotine that exceed member states’ proposed nicotine limit. A ban on adding a tobacco flavour would also negate their effectiveness in replacing tobacco, the industry says.

Wednesday (18 November) will be the last opportunity for a deal under the Lithuanian government’s presidency of the Council of Ministers, and Council sources say that if no solution can be found then the whole file could fall apart. “We’re getting to a point now where further [negotiations on e-cigarettes] would be useless,” said a Council source.