Update August 1, 2013

The European Parliament's Environment, Public Health, and Food Safety Committee (ENVI) on July 10, 2013
voted to back the European Commission's revised Tobacco Products Directive proposals:
-to require graphic health warnings to cover 75% of the front and back of cigarette packs
-to ban distinctive flavorings including menthol, prohibit slim cigarettes
-to classify all e-cigs as pharmaceuticals regardless of the nicotine content, rather than the Commission's proposal for such a classification only for e-cigs with "4 milligrams or more of nicotine
-to ban the sale of tobacco products through the Internet in any EU member countries
-
The Committee rejected plain packaging of tobacco products

Latest news:

▪ An article published in Polityka on July 30, 2013 said that the European Commission’s proposed ban on menthol and slim cigarettes as part of revisions to the Tobacco Products Directive will significantly hurt the

Polish economy considering that the country is the biggest cigarette producer in the EU. With menthol and slim cigarettes accounting for 40% of the domestic market, a ban on these products would lead to a

significant decline in the government's tax revenue, the article noted (6-3).

▪ Lithuanian daily Lietuvos Rytas reported July 23, 2013that even before Lithuania took over the rotating EU Council Presidency on July 1st, the country’s ambassador to the US Zygimantas Pavilionis received separate

lettersfrom US lawmakers and business representatives criticizing Lithuanian Health Minister Vytenis Andriukaitis’ unreserved support for the European Commission’s proposal to revise the Tobacco Products

Directive and warning that passage of the revised TPD in its current form would violate international trade rules and could jeopardize a potential free trade agreement (FTA) between the EU and the US, but Lithuanian

officials appear to be unaware of these developments (6-3).

Revision of the Tobacco Products Directive 2001/37 EC

The revision addresses the following main issues:
- labeling and packaging of tobacco products
- additives, such as flavourings, used in tobacco products
- how to regulate products which do not contain tobacco, but which are closely linked to smoking or tobacco consumption, for example electronic- and herbal cigarettes
- internet sales of tobacco products and tracking and tracing of these products
  1. Public consultation
On September 24, 2010, the European Commission launched a public consultation onrevising by 2012the Tobacco Products Directive (2001/37/EC)* which set minimum standards for cigarette package labeling and 'tar,' nicotine and carbon monoxide content.The current directive does not address products such as flavored products, electronic cigarettes and nicotine gum. The consultation invited stakeholders to submit their views on the types of changes they expect to see in the updated directive, and re-launches the debate on packaging by raising the question of whether more "forceful" pictorial warnings are necessary on cigarette packs, ofplain packaging and the regulation of harmful, addictive and attractive substances in tobacco products.
The European Commission's Directorate-General for Health and Consumers on July 27, 2011 published the results of its public consultation which ended December 17, 2010. The Directorate-General said the public consultation generated a record 85,000 responses, with the vast majority coming from individual citizens. The outcome of the public consultation, along with the legislative proposal to revise the directive, was presented in late 2012.
*
[On May 27, 2011, the European Commission issued a press release relating to Q&A on tobacco control in the EU saying it is currently considering strengthening the Tobacco Products Directive in 2012 by regulating ingredients, especially "those which make tobacco products more attractive and addictive and appeal especially to young people;" introducing regulatory solutions to address novel smokeless tobacco and nicotine products, among others.

In an interview with the German daily Die Welt on October 12, 2010, European Union Health Commissioner John Dalli said that the Commission may attempt to reduce the amount of nicotine and other toxic substances contained in the product. ]
The revision of the European Union's Tobacco Products Directive 2001/37/EC on the manufacture, presentation and sale of tobacco products was delayed until late 2012, a delay that was reported to be partly due to the "extremely complicated" impact study and Philip Morris International's challenge of Australia's plan to require plain cigarette packaging from January 2012, Europolitics reported on September 1, 2011.
  1. EU Tobacco bribery scandal
On October 16, 2012, EU Health Commissioner John Dalli resigned after an investigation by the EU's anti-fraud office OLAFconnected him to an attempt by a Maltese businessman to influence EU tobacco legislation: Swedish Match filed a complaint to the EU Commission about receiving a proposal to influence the outcome of the ongoing review of the Tobacco Products Directive, in exchange for financial compensation: comments by Swedish Match
OLAF's chief Giovanni Kessler comments.
John Dalli on December 13, 2012 filed a defamation lawsuit in the Brussels Court of First Instance against Swedish Match, accusing the company of having circulated false information, particularly a false chronology of the facts of the case, to members of the European Parliament's Committee on Budgetary Control, among others.
European Parliament President Martin Schulz requested to see EU anti-fraud body OLAF's report that led to the resignation of John Dalli as health commissioner, Schulz also invited European Commission President José Manuel Barroso and OLAF Director General Giovanni Kessler to meet in the next Conference of Presidents, a spokesman for the Greens said. The Greens proposed that a special committee investigate issues including the commission's relationship with tobacco lobbyists and the role of Michel Petite as chief legal adviser to Commission Presidents Jacques Delors, Romano Prodi and José Manuel Barroso before joining in 2008 the international law firm Clifford Chance, which has acted as an adviser to Philip Morris International. The commission reappointed Petite to its ethics committee on lobbying on December 28, 2012.
Transparency watchdog Corporate Europe Observatory filed a complaint with the Transparency Register secretariat against Swedish Match, claiming that the company violated the EU Code of Conduct for lobbyists by going to Malta to find former EU health commissioner John Dalli's personal contacts, hiring unregistered lobbyists, and "[lying] to MEPs about Dalligate" concerning the EU Tobacco Products Directive, while the watchdog also filed a complaint with the European Ombudsman against EU anti-fraud office OLAF for denying access to the investigation report on the Dalli case, Malta Today reported on April 2, 2013.
A European Commission spokesperson said on June 10, 2013 that the EC’s position regarding Dalli remains unchanged despite the Maltese police’s announcement, noting that Dalli’s resignation was based not on whether legal proceedings would be launched against him or not, but on the fact that his position became “politically untenable” after the OLAF investigation connected him to a bribery scandal involving revisions to the EU Tobacco Products Directive.
Former EU health commissioner John Dalli said he is considering launching cases for human rights violations before the European Court of Human Rights, as well as other cases against individuals in their personal capacities. He has also filed a defamation lawsuit against Swedish Match, Malta Independent reported on June 16, 2013. "The pressures of the ordeal were enormous," and "I have also suffered serious health problems as a result of all this, after having been ridiculed and my reputation smeared globally," Dalli said. The Maltese Police Commissioner's statement that there was no evidence to incriminate him came as "a big relief," Dalli added. He also said he does not rule out the possibility of his reinstatement to the European Commission as a result of a case he has filed in the European Court of Justice challenging his October 2012 dismissal, but, if there is no reinstatement, he could seek material damages, such as loss of salary and pension, and also moral damages.
EU Health Commissioner Tonio Borg maintained that his predecessor John Dalli's resignation in October 2012 amid an alleged bribery scandal did not derail the directive, despite claims to that effect by some MEPs, Malta Today reported on July 3, 2013. Furthermore, in a July 1st letter to Members of the European Parliament, John Dalli, who resigned as EU health commissioner in October 2012 after an OLAF investigation connected him to a € 60 million (US$ 78.2 mn) bribery scandal involving revisions to the EU Tobacco Products Directive, denied having transferred up to US$ 100 million in the Bahamas.
Tobacco for oral use
In May 1992, the European Union (EU) prohibited the placing on the market of tobacco for oral use,excepted those destined to be smoked or chewed(including Swedish snus). The prohibition was introduced byDirective 92/41/EEC amendingDirective 89/622/EEC
In early September 2011, EU Health Commissioner John Dalli said the European Commission does not believe changes should be made to the EU ban on snus except in Sweden. read more
Pierre Schellekens, head of the European Commission's representation in Sweden on April 19, 2012 rejected rumors in Swedish media that snuff will be banned under the revised EU Tobacco Directive, explaining that the current focus is on additives used in cigarettes.
Swedish Match's head of corporate information Patrik Hildingsson said on September 12, 2012 that the company is not particularly concerned about the European Commission's proposal to continue its ban on smokeless tobacco products outside Sweden, as the final version of the proposal, due in November or December, is unlikely to be presented in its current form.
Under its new Tobacco Products Directive (TPD), the European Commission reportedly wants all tobacco products to contain at least 85% tobacco, with Swedish snus containing about 50%, and wants to ban "added aromas" like herbs or fruits, according to documents obtained by Aftonbladet, though Maria Larsson, Swedish Minister for Children and the Elderly, called them "rumours" since the "Commission hasn't taken a decision" about the TPD and the Swedish government has yet to see it.Larsson should meet EU Health Commissioner Tonio Borg in Brussels. Many snus manufacturers in Sweden have added flavors like orange, juniper berries, mint, licorice and eucalyptus in recent years. Commenting on the Aftonbladet report, Swedish MEP Christoffer Fjellner said the commission "[does] not object to any potential health risks of snus, just to snus." (Source: TheLocal.se December 5/2012).
After Swedish newspaper Dagens Nyheter reported that the European Commission is considering restricting the use of flavorings in snus as part of the revision of the 2001 Tobacco Products Directive, Swedish Match AB spokesman Johan Wredberg said if the media report was accurate, it indicated an indirect attempt to ban the product in Sweden, which is the only country to enjoy an exemption from EU's existing ban on snus.Banning or restricting the use of flavors would prevent Swedish Match from producing snus in the way it wanted to and which was best for consumers, he said. "To allow Sweden's exception (from the ban) on paper, but make manufacturing impossible via law, can only be interpreted as a way also to try to ban snus in Sweden," Wredberg added. According to Dagens Nyheter, the EC proposal would allow national regulators to decide if the content of flavorings is too high, but the EC could intervene if necessary, Reuters reported on December 5, 2012.
Sweden's Minister for Public Health Maria Larsson said December 7, 2012 that Swedish snus must be exempt from the new EU Tobacco Products Directives' regulations on additives if the export ban remains.The minister said it is illogical that a product that is excluded from the EU's inner market is still subject to its controls, adding that the government would agree to follow regulations on snus content if the export ban is lifted.
Under the proposal for revising the 2001 Tobacco Products Directive that was issued on December 19, 2012, the ban on oral tobacco products (snus) is maintained, except for Sweden which has an exemption.

The European Commission on November 30, 2012 launched an inter-service consultation on the revision of the 2001 Tobacco Products Directive.

3.Publication of the proposal
The European Commission onDecember 19, 2012 publishedthe proposal for revising the 2001 Tobacco Products Directive*.
Main elements of the proposal:
The proposal foresees major revisions of the current Directive. It addresses in particular the following areas:
Labeling and Packaging: All cigarette and Roll Your Own packages must contain a combined picture and text health warning covering 75% of the front and theback of the package and must carry no promotional elements. The current information on tar, nicotine and carbon monoxide, which is perceived as misleading, is replaced by an information message on the side of the pack that tobacco smoke contains more than 70 substances causing cancer.
Plain packaging. Member States remain free to introduce plain packaging in duly justified cases.
• Ingredients: An electronic reporting format for ingredients and emissions will be introduced. The proposal foresees a prohibition for cigarettes, roll your own tobacco and smokeless tobacco that have characterising flavours and a prohibition of products with increased toxicity and addictiveness.
Smokeless tobacco: The ban on oral tobacco products (snus) is maintained, except for Sweden which has an exemption. All smokeless tobacco productsmust carry health warnings on the main surfaces of the package and productswith characterising flavours cannot be sold. Novel tobacco products require prior notification.
Extension of the scope of the Directive : Nicotine Containing Products (e.g. electronic cigarettes) below a certain nicotine threshold are allowed on the market, but must feature health warnings; above this threshold such products are only allowed if authorised as medicinal products, like nicotine replacement therapies.
Herbal cigarettes will have to carry health warnings.
• Cross border distance sales: A notification for internet retailers and age verification mechanism are foreseen to ensure that tobacco products are notsold to children and adolescents.
• Illicit trade: A tracking and tracing system and security features (e.g. holograms) are foreseen to ensure that only products complying with the Directive are sold in the EU.
* Proposal for a Directive of the European Parliament and Of the Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products, 19 December 2012
Proposal for a Directive - COM(2012) 788 final
European Parliament
Forecasts: Indicative plenary sitting date, 1st reading/single reading: 8 October 213
►At a European Parliament hearing on November 13, 2012,EU health commissioner-designate Dr. Tonio Borg vowed not to water down the EU Tobacco Products Directive, although he noted that he
personally does not favor plain packaging for cigarettes. Dr. Borg said if elected, his top priority would include an "ambitious" tobacco products directive which could be delivered in January 2013.
EU Health Commissioner Tonio Borg on February 25, 2013 said at a European Parliament Environment and Public Health Committee hearingabout the draftTobacco Products Directive that the economic benefits of the tougher directive would outweigh its costs. "This is a balanced directive. Balanced but ambitious," he added. However, it would be up to the EU member States to adopt plain packaging, Borg said.
Commenting on the snus ban, Borg said Sweden was given an exception during membership negotiations on the condition that they would not market the product in any other EU nation. Changing this stipulation "would require a treaty change," he said. Supporting the plan to continue the EU ban on snus, Swedish Greens MEP Carl Schlyter said he was "one of the few Swedes who did not want to export the product." Schlyter called on the EC to regulate any type of nicotine product, whether it is cigarettes, e-cigarettes or smokeless tobacco.
EU lawmakers ready to confront tobacco industry “Goliath”. A majority of European lawmakers appear to back further EU proposal for tobacco regulation but face opposition from tobacco pro-industry colleagues and the 100-strong cohort of Brussels tobacco lobbyists nicknamed ‘Goliath” by anti-smoking campaigners, Euractiv reported on February 27, 2013.

EU Health Commissioner Tonio Borg said in an interview with EurActiv on March 5, 2013 that while "[i]t is not directly my responsibility" to find replacement jobs for workers if they are left unable to grow tobacco because of new rules in the revised EU Tobacco Products Directive, he said that one possible area for compromise is on the issue of "additives" in burley tobacco, much of which is grown in Romania, Bulgaria and Portugal, as "the definition of 'additives' will be determined by experts appointed within the individual member states, and supervised by the Commission."Burley tobacco requires more additives than Virginia tobacco because the former loses more sugar during the drying process, according to Hermanus Versteijlen, director of the economics of agricultural markets at the European Commission. Versteijlen said in August 2011 that banning the addition of sugars and flavors to burley tobacco could cause large losses to the European market. Borg said "characterising flavours in tobacco products will be prohibited, but not all flavours or additives will be prohibited." He also said "we can find compromises so long as there is a basic understanding that tobacco should look and taste like tobacco."
During an informal meeting of the EU Health Council on March 4-5, 2013 inDublin, Ireland, ministers for Poland, Italy, the CzechRepublic and Greece called on the European Commission to consider the impact of the revised Tobacco Products Directive proposal on memberStates and regions where tobacco is cultivated.However, no memberState openly opposed the proposed directive, according to a diplomatic source. Twelve ministers were in favor of the directive, while Finland, Belgium, Slovenia and France said the proposed revisions do not go far enough. Health ministers also discussed their experience of implementing smoke-free environments in line with a 2009 Council recommendation.
► Europolitics reported on March 19, 2013 that the draft of the revised EU Tobacco Products Directive has passed the "subsidiary test" - the principle that the EU may make laws only when action of individual countries is insufficient - as only eight national parliaments sent a reasoned opinion claiming non-conformity of the text with the principles of subsidiarity, which was 11 short of the required number to give the European Commission a yellow card and force it to re-examine the proposal.