On February 26, 2014, the European Parliament approved the revised Tobacco Products Directive (the Revised Directive ), which governs the manufacture, presentation and sale of tobacco and related products in the European Union. This Revised Directive was passed by the European Parliament more than ten years after approval of the Tobacco Products Directive (the Directive ). Prior to approval by the European Parliament, the Revised Directive was recommended by the European Union Member States. The Revised Directive will now be reviewed by the European Council, and is scheduled to take effect in 2016.
With an overall effort to limit the appeal of tobacco products, the Revised Directive regulates various areas, including labeling, remote sales and disclosure of ingredients. In particular, the scope of the Revised Directive is broader than the Directive, covering electronic cigarettes.
Electronic cigarettes that contain nicotine, and that are not for medicinal purposes, are covered by the Revised Directive. However, electronic cigarettes that do not contain nicotine are not covered by the Revised Directive.
For those electronic cigarettes covered by the Revised Directive, manufacturers will be required to report annually, to the various Member States, the sales volume of the products as well as the types of users, user preferences and trends. Manufacturers must notify Member States of the ingredients used in their products. There will also be limitations on advertising. The Revised Directive also mandates that health warnings appear on the packaging of electronic cigarettes. There will be a cap on the maximum nicotine concentration level for electronic cigarettes as well as a cap on the maximum volumes for cartridges.
For questions and/or comments, please contact Bryan Haynes, Troutman Sanders practice partner, at 804.697.1420 or by email.
Eu rules to ban menthol cigarettes
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Health warnings covering 65% of cigarette packs are to be introduced and menthol cigarettes banned under new EU rules approved today PA
The European Parliament in Strasbourg voted on a raft of measures to help curb smoking but stopped short of introducing plain packaging for cigarettes and tobacco.
Legislators put new limits on advertising for electronic cigarettes but have so far rejected proposals for them to be regarded as medicinal products.
Menthol and other flavours will be banned but there is to be no ban on packs of slim cigarettes.
Some campaigners had called for e cigarettes to be subjected to the same regulation as nicotine replacement therapies (NRT) such as patches and gum.
E cigarettes consist of a battery, a cartridge containing nicotine, a solution of propylene glycol or glycerine mixed with water, and an atomiser to turn the solution into a vapour.
While nicotine is the addictive substance that keeps smokers hooked, Cancer Research UK said it is the toxic cocktail of chemicals in tobacco smoke that kills half of all long term smokers.
The lack of tobacco in e cigarettes means they are “almost certainly” a much safer way of getting a nicotine hit than smoking cigarettes, it added.
Liberal Democrat MEP Chris Davies said after the vote “E cigs can be a game changer in the fight against smoking. Hundreds of former smokers have written to tell me that they have helped them give up cigarettes when nothing else worked.
“They are successful because they are not medicines but products that smokers enjoy using as an alternative to cigarettes.
“Every year 700,000 people in Europe die of smoking related disease. We should not do anything that makes e cigs harder to obtain than tobacco cigarettes.”
Adrian Everett, chief executive of e cigarette brand E Lites, said “This is a fantastic result for public health and the millions of smokers around Europe who are switching to e cigarettes.
“We would have been in the absurd position of the Department of Health making it much easier to make and sell tobacco cigarettes than e cigarettes which are vastly less harmful.
“Following the European Parliament’s decision, we hope to work with the UK Government to agree a regulatory framework for e cigarettes which reinforces the existing consumer protection regulations.”
Conservative MEP Martin Callanan said ” Forcing e cigs off the shelves would have been totally crazy.
“These are products that have helped countless people stop smoking more harmful cigarettes and yet some MEPs wanted to make them harder to manufacture than ordinary tobacco.
“I have received countless emails and calls from ‘vapers’ which were individual personal pleas, not a standard letter copied and pasted from an NGO website as we MEPs often see.
“Many electronic cigarettes are produced by small businesses who would simply not have been able to afford the strict authorisation demands the EU would place on them.
“We could not stand by and allow MEPs to put companies out of business and people out of work.”
Tom Rolfe, president of the Skycig brand of e cigarettes said “Skycig welcome any regulations which will help us to ensure that under 18s cannot access electronic cigarettes and to ensure that all e cigarette companies must produce products of a high standard, in the same way that Skycig and other reputable e cigarette companies do.”
Today marked the European Parliament’s first reading of a draft tobacco directive which could become law in 2014.
MEPs voted to put health warnings on 65% of each cigarette pack, as opposed to the proposed 75%.
At present, warnings should cover at least 30% of the front and 40% of the back of cigarette packs, with a border surrounding them.
The Medicines and Healthcare products Regulatory Agency (MHRA) has said it intends to make e cigarettes medicinal products but today’s decision could alter those plans.
An MHRA spokesman said “The UK Government’s position is that the public health priority of reducing the harms of smoking can best be achieved by the regulation of nicotine containing products (NCPs), including electronic cigarettes, under the medicines framework and supports the European Commission’s Tobacco Products Directive.”
Once agreed, all 28 EU countries will have to make the measures law.
The ban on menthol cigarettes will come into force in 2022.
Deborah Arnott, chief executive of Action on Smoking and Health, said “We are pleased that MEPs recognised the importance of increasing the size of health warnings and that these will be placed at the top of the packs to make them more visible.
“Despite unprecedented levels of lobbying by the tobacco industry to undermine the directive it is gratifying that MEPs stood firm on many of the key measures.
“We now urge the Council, the Commission and the Parliament to strongly defend the directive in ongoing negotiations.”
Angela Harbutt, campaigns manager of the smokers’ group Forest, said ” Consumers will have mixed feelings.
“We welcome the fact that some products have been reprieved while menthol cigarettes have been given a stay of execution, but consumers are still angry that the EU is trying to restrict or ban products they have purchased and enjoyed for many years.
“Prohibition doesn’t work and products that are banned will almost certainly be available on the unregulated black market.
“Law abiding consumers will be at a serious disadvantage and it won’t help children because criminal gangs don’t care who they sell to.”
A spokesman for British American Tobacco said “We’ve always said that we support sensible, balanced regulation that takes into account all the people it will impact before being decided on and implemented.
“We have made it clear throughout this process that many of the proposals on the table were not proportionate, were unlikely to succeed in addressing public health objectives, and would lead to an increase in black market sales.
“Although there are clearly many differing opinions among MEPs when it comes to this directive, it appears as if some sensible modifications have been made.
“However, much of this directive remains disproportionate and could be in breach of European law.
“For example, health warnings covering more than half of the cigarette pack goes well beyond what is needed to fully inform consumers of the health risks and a ban on mentholated cigarettes will only increase the demand for black market goods.
“In banning menthols, the European Union has forced millions of consumers to turn to the black market to get access to the product they want.
“The weight of evidence shows that smokers of menthol cigarettes face no higher risk of tobacco related diseases than smokers of non menthol cigarettes, that they find it no more difficult to quit and that the availability of menthol cigarettes does not increase youth initiation of smoking.
“Banning menthol in cigarettes is not justifiable based on the available scientific evidence.”
On graphic warnings, the spokesman added “We strongly oppose the standardisation of our products. No evidence has been presented to justify why it is deemed necessary to restrict the dimensions or colours of a package or the way in which it can be opened.”
Maura Gillespie, policy programme director at the British Heart Foundation, said “MEPs have missed an opportunity to make real inroads into curbing the number of young people taking up smoking.
“It’s positive news that cigarette warnings are getting substantially bigger but MEPs could and should have gone further.
“Research shows health warnings that take up 75% or more of a cigarette box are more effective at reducing the attractiveness of products among our young people.
“The ban on flavoured tobacco is also welcome but it’s extremely disappointing slim cigarettes have not been banned.
“They’re dangerous products often targeted at young women that can mislead p
eople about the harms of smoking.
“Now it’s up to the UK Government to show they’re made of stronger stuff and introduce standardised packs, stripped of attractive branding, without delay.”