Parliament adopts new eu tobacco rules

Members of the European Parliament voted today (26 February) to approve a deal reached with member states in December on new EU tobacco legislation will, controversially, tightly regulate the content and marketing of electronic cigarettes.

Today’s vote, which is expected to be rubber stamped by member states in the coming weeks, ends a long effort to revise EU tobacco rules which saw the resignation of former health commissioner John Dalli, unprecedented lobbying by tobacco companies and citizens demonstrations by so called ‘vapers’ users of electronic cigarettes.

The new legislation will require large pictorial warnings with unpleasant images covering 65% of cigarette packs. Characterising flavours including menthol will be banned.

In recent months the most controversial aspect of the revision was its effort to standardise EU regulation of new electronic cigarettes. In October members of the parliament adopted a negotiating position that called for e cigarettes to be regulated for general sale.

National governments, concerned about the unknown long term health effects, wanted them to be regulated as medicines. Member states also wanted to ban refillable cartridges over concerns about safety and nicotine content. These elements were included in the proposal put forward by the European Commission in 2012.

But MEPs, under intense pressure from e cigarette manufacturers and users who said such restrictions would kill off a valuable tool to quit smoking, refused to allow such a ban.

The compromise agreed with national governments in December, backed by MEPs today, will see e cigarettes regulated for general sale at EU level, but member states would be allowed to regulate them as medicines if they so choose. Refillable cartridges will not be banned. However member states can ban specific types of cartridges, if the ban can be justified by safety concerns.

If three member states adopt a ban on a specific cartridge, the European Commission can unilaterally impose an EU level ban, without approval by Parliament or member states. Cartridge size will be capped at 2ml.
E cigarettes will be limited to a maximum permitted nicotine concentration level of 20mg/ml, equivalent to roughly one pack of regular cigarettes.

Though the e cigarette issue became the most contested part of the legislation in its final months, the revision of the EU’s Tobacco Products Directive will mean big changes for traditional cigarettes as well.

All characterising flavours will be banned, though the menthol flavour will be given a four year derogation to 2020. Manufacturers and importers must submit reports on the use of these additives within 18 months.

Pictorial health warnings must cover 65% of both the front and back of cigarette packs. In order to address the concerns raised by manufacturers about increased ease of counterfeiting using the labels, the law will set up an EU wide tracking and tracing system to combat illicit trade of tobacco products.

Member states may ban cross border distance sales of tobacco products, for example through online purchasing. The Commission proposal to ban slim cigarettes was rejected. But perfumed ‘lipstick’ cigarettes will be banned.

Health campaign groups said they were broadly pleased with today’s result. «Today marks a genuine turning point for European tobacco control and a huge stride towards a tobacco free Europe,» said Archie Turnbull, president of the Smoke Free Partnership.» This vote will help protect young people and children across Europe, saving many lives and helping prevent young Europeans from starting to smoke.»

The Confederation of European Community Cigarette Manufacturers said the measures adopted today are «disproportionate» and are «more likely to lead to a rise in profits for criminal gangs, who sell much cheaper, unregulated products.»

«We expect diligence to be taken in allowing realistic transition
periods for member states and the industry,» said Michiel Reerink, the group’s chairman. «Due to the complexity of the numerous measures, tobacco companies, packaging manufacturers, machinery suppliers, wholesalers and retailers must imperatively be given sufficient time to comply with the Directive.

Science ‘wrong’ in eu’s proposed e-cigarette law — health — 23 january 2014 — new scientist

Fifteen prominent scientists who have investigated the health consequences of electronic cigarettes have accused European Union regulators of misinterpreting their results. The scientists say the EU aim is to draft an unjustifiably burdensome new law to regulate e cigarettes.

Their argument is made in a letter to the EU’s health commissioner Tonio Borg. The scientists state that if the newly amended Tobacco Products Directive becomes law as it stands which could happen as soon as April it will severely limit the scope for smokers of real cigarettes to give up or cut down by switching to e cigarettes, which contain nicotine but not the tobacco that contains tar and thousands of other substances harmful to health.

«If wisely regulated, e cigarettes have the potential to make cigarettes obsolete and save millions of lives worldwide,» the signatories say in the letter, which was also sent to members of the European Parliament, European Commission and the Council of Ministers the three bodies that will decide the fate of the directive. «Excessive regulation, on the contrary, will perpetuate the existing levels of smoking related disease, death and health care costs,» it continues, pointing out that smoking currently kills 700,000 Europeans each year.

The British Medical Association told New Scientist that longer trials are needed to learn more about the long term effects of e cigarettes. «Better regulation of e cigarettes is essential,» a spokesperson says. «Studies have shown that they are unreliable in the levels of nicotine they provide and there’s a lack of evidence regarding their safety.»

Ethical imperative

The signatories of the letter say regulation must be built on robust science. The cited errors relate to the strength of nicotine solutions allowed, the doses needed to match the nicotine «hit» from real cigarettes, an overstatement of the known dangers from nicotine and unwarranted assumptions that e cigarettes will become «gateway products», tempting non smokers and young people to try real cigarettes.

As it stands, say the scientists, the draft would unnecessarily restrict nicotine content in the liquids that are vapourised in e cigarettes to deliver the drug to users when they suck on the devices.

Currently, the draft would restrict content to 20 milligrams of nicotine per millilitre of fluid, on the grounds that this matches the dose from a real cigarette over the same period of smoking. An estimated 20 to 30 per cent of e cigarette users prefer higher doses than this, and so could potentially return to smoking real cigarettes unless stronger e cigarettes are allowed, warn the researchers.

Outdated, overestimated

One of the signatories, Konstantinos Farsalinos of the University Hospital in Gasthuisberg in Leuven, Belgium, says his own research on e cigarettes was used to reach this figure, but that it has been misinterpreted. His work shows that 20 milligrams is less than half of what is required to match the output from a real cigarette, equivalent to roughly 50 milligrams per millilitre.

Much of the misinterpretation of results comes from outdated information and overestimation of the toxicity of nicotine, say the researchers.

The EU’s current assumption that 60 milligrams of nicotine is lethal is incorrect, they say, and dates from self experiments reported in a pharmacology textbook published in 1856. «This is not the case, and people have ingested doses 60 times higher, which only led to nausea and vomiting,» says the scientists’ letter. «Poisoning from tobacco, nicotine replacement medications or e cigarette liquid is extremely rare, and there is no risk of overdosing through inhalation,» they say.

Deep breath

Another gripe with the current draft of the Tobacco Products Directive is its insistence that electronic cigarettes deliver nicotine doses «consistently». This is nonsensical, they say, because «vapers» the users of e cigarettes dictate for themselves how much nicotine they breathe in.

Research shows, for example, that individual users of the same electronic cigarette differ in nicotine intake by as much as 20 fold because they inhale different amounts at different rates.

The scientists also take issue with wording in the directive implying that there is strong evidence that e cigarettes lead to nicotine addiction and in turn the smoking of real cigarettes. «Existing data do not suggest that electronic cigarettes are having any such effects,» they go on to say that the evidence suggests the use of e cigarettes helps smokers of all ages reduce or give up smoking.

Dog’s breakfast

Supporters of e cigarettes argue that they could help smokers avoid disease and premature death. Proponents are lobbying either for further amendments to the draft directive to ease the restrictions, or for the e cigarettes component of the directive to be removed altogether and re drafted as an independent regulation.

«Otherwise, we’ll end up with a dog’s breakfast that will set the direction of e cigarette legislation for decades,» says Clive Bates, former director of UK public health charity Action on Smoking and Health (ASH), and a prominent campaigner for harm reduction through e cigarettes.

But time to amend the directive is limited because it will be read in the European Parliament in March. If passed, it could be rubber stamped into law by the Council of Ministers a month later.

The EU’s Environment, Public Health and Food Safety committee met 22 January in Brussels, Belgium, to consider the latest draft.

«My main issue with the directive is that it is unbalanced in its treatment of e cigarettes compared to tobacco products,» says signatory Chris Bullen of the University of Auckland in New Zealand. Last year Bullen headed a trial demonstrating that e cigarettes are at least as effective as nicotine patches in helping people quit smoking or cut down. «Proportionate regulation is what’s needed, sufficient to give consumers confidence in the quality, reliability and safety of e cigarettes,» he says.


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