Eu Tobacco Products Directive: Closing Stages of Development

Update July 21, 2014

26 February 2014. The European Parliament formally approved the revised EU Tobacco Products Directive which would, once it enters into force, do the following:
- Labeling - 1) Picture and text warnings will cover 65% of the front and the back of cigarette packs; 50% of the sides of packs will also be covered with health warnings (e.g. "smoking kills – quit now"; "tobacco smoke contains over 70 substances known to cause cancer"), replacing the current printing of tar, nicotine and carbon monoxide (TNCO) levels.The packs must be in a cuboid shape with a minimum of 20 pieces.
2) Roll-your-own packages will be required to carry "65% combined health warnings on the front and back" and can be in a cuboid or cylindric shape, or be in pouch form, with each package containing a minimum of 30 grams of tobacco; Member States will have discretion regarding the labeling of less common tobacco products like pipe tobacco, cigars, cigarillos and smokeless products, but will need to ensure that the products still carry a general warning and an additional text warning.
- Plain Packaging - Some space will remain available for branding, but Member States can introduce plain packaging "where they are justified on grounds of public health, are proportionate and do not lead to hidden barriers to trade between Member States.
- Flavorings - 1) Cigarettes and RYO tobacco cannot have any distinguishable "characterizing" flavor other than tobacco; 2) Menthol will be banned after a phase-out period of four years; 3) Other tobacco products like cigars and smokeless tobacco are exempted from the flavors ban; and 4) Additives necessary for manufacturing, such as sugar lost during the curing process, can continue to be used.
- E-cigarettes - 1) The TPD will cover e-cigs containing nicotine; 2) Nicotine liquids will have to be sold in child- and tamper-proof packaging and contain only "ingredients of high purity"; 3) E-cigs must deliver nicotine doses at "consistent levels under normal conditions of use" and come with health warnings, instructions for their use, information on "addictiveness and toxicity," an ingredients list, and information on nicotine content; 4) E-cig manufacturers will be required to notify Member States before placing new products on the market, report annually to Member States on their sales volumes, types of users and their "preferences and trends," and comply with existing rules for cross-border advertising and promotion of tobacco products.
- Product information Manufacturers will be required to report on "certain frequently used substances found in cigarettes and RYO tobacco" through a standardized electronic format.
- Illicit tobacco trade: The new Directive includes strong measures against illicit trade of tobacco products to ensure that only products complying with the Directive are sold in the EU. It introduces an EU-wide tracking and tracing system for the legal supply chain and visible and invisible security features (e.g. holograms) which should facilitate law enforcement and help authorities and consumers detect illicit products. The measures foreseen in the new Directive will help to redirect tobacco trade to legal channels, and may also help Member States restore lost revenue. Tracking and tracing of tobacco products will be phased in, with cigarettes and RYO the first required to comply, followed by all other tobacco products.
- Cross-border distance sales will not be banned at EU-level, but individual Member States may choose to ban such sales. If they do, retailers may not supply consumers located in that MemberState. If they do not choose to ban these sales, retailers that wish to sell tobacco products cross-border must notify their activity prior to the first sale in the MemberState in which they are located and in those Member States to which they sell tobacco products. They also must also put in place an age-verification system to ensure that tobacco products are not sold to children and adolescents.


Therevised Tobacco Products Directivewas adopted by the Council on March 14, 2014.
Questions & Answers: New rules for tobacco products:
After Italian Member of the European Parliament Sergio Paolo Francesco Silvestristo mid April 2014 questioned whether studies had been conducted in Europe on the health risks of using waterpipes; whether the EU Commission held data on nargile use in member states; and whether there were campaigns to raise awareness about shisha use in Europe, the commission said the revised Tobacco Products Directive, which was passed by the Council of the European Union, has stronger provisions for these products, including the mandatory use of pictorial health warnings and the possibility of stricter ingredient regulation should there be a substantial increase in the sale of this product or in its use among young people, adding "[w]hile the Commission encourages Member States to inform consumers about the harmful effect of all tobacco products, it does not plan a targeted information campaign on waterpipes.".
The EU TPD was promulgated in the EU Official Journal on April 29, 2014
Entry into force will occur 20 days after the law was published in the official journal of the EU, in late May 2014. After Council adoption, each member state needs to individually ratify/approve a national law that adopts the language of the TPD and includes the new rules covering larger graphic health warnings with options for plain packaging, a ban on flavored tobacco products with menthol given a four-year phase-out period until 2020 and measures to combat illicit products, among other things.The new law introduces proper regulation of e-cigarettes for the first time: e-cigarettes will not be required to seek a medicines licence unless they are marketed as an aid to quitting smoking.E-cigarette manufacturers have the option of having their products treated like tobacco products – i.e. they can be sold freely – as long as they meet certain safeguards.
A transposition period of two years for Member States to bring national legislation into line with the revised Directive means that most of the new rules will apply in the first half of 2016. However, the Directive also foresees a transitional period for all product categories to give manufacturers and retailers time to sell off their existing stock insofar as it complies with the old Directive or other relevant legislation. A phase-out period of four years is foreseen for all products with more than a 3% market share in the EU, for example menthol cigarettes.

EU TPD final text

Latest news:
- A report commissioned by the Electronic Cigarette Industry Trade Association (ECITA) and prepared by UK-based toxicological consulting firm bibra recommends reclassifying nicotine e-liquids under the EU Regulation 1272/2008 on Classification, Labeling and Packaging (CLP) of chemicals, saying the EU has been misclassifying e-liquid as either a CLP category 2 product, alongside strychnine, or a category 3 product, alongside formaldehyde. (>6-3)
- The Polish government on July 15, 2014 filed a complaint at the European Court of Justice against certain provisions, including the menthol ban, in the revised EU Tobacco Products Directive, according to the Government Information Centre.Poland objects to the menthol ban, contending that menthol cigarettes are vital to the country's economy, given that they have been present in the local market since 1953 and could be regarded as a "traditional" product. Six factories in Poland manufacture menthol cigarettes, 70% of which are exported. (>6-3)
- Testifying before the European Court of Justice on July 7, 2014 in the case of "unfair" dismissal brought by former EU health commissioner John Dalli against the European Commission, EC President Jose Manuel Barroso said that he was a victim of slander and that Dalli's accusations were "completely unfounded and even defamatory."(>2)
- With the deadline to file complaints against the revised EU Tobacco Products Directive at the EU Court of Justice to pass July 23rd, the Polish Ministry of Foreign Affairs, which is preparing the final draft of the country's objections to certain provisions in the TPD, including the menthol ban, said it will present the document to the Committee for European Affairs by July 4, 2014.The Ministry of Health believes that the complaint is unjustified and would be ineffective. (>6-3)
- Philip Morris International announced on June 27, 2014 that it is seeking a "careful, objective review" by the EU Court of Justice (CJEU) of the revised Tobacco Products Directive, with PMI Senior Vice President and General Counsel Marc Firestone saying "[t]here is no disagreement that there should be strict regulation of tobacco products," but the TPD "includes a mix of product bans, mandates, and delegations of authority that raise serious questions under the EU Treaties about consumer choice, the free movement of goods, and competition." Philip Morris is asking the court to review whether the revised TPD complies with EU treaties in three areas. The first is whether the ban on menthol disrupts the internal market, the second is whether an apparent ban on "truthful and non-misleading claims" on packaging infringes on consumers' right to information about products, and the third is whether the delegation of powers to the European Commission complies with EU treaties. A review by the CJEU could take up to two to three years. (>6-2)
- The International Tobacco Growers Association (ITGA) mid June 2014 reiterated its opposition to the European Union's revised Tobacco Products Directive (TPD). The ITGA said the current attempts to impose plain packaging on tobacco products is a blatantly unacceptable discrimination imposed by misguided public health officials within the EU and some of the African, Caribbean and Pacific nations. The ITGA said it would remain vigilant in respect of secondary legislation pertaining to ingredients, and would ensure that no extreme measures are taken that could discriminate against certain tobacco varieties. (>6-3)
- Bernd Meyer, operations director of BAT Germany and head of manufacturing for Western Europe on April 29, 2014, said compliance with the EU's new Tobacco Products Directive is expected to cost
the company € 100-200 million (US$ 138.1 - 276.2 mn) over the next two years as it upgrades its machines to meet new packaging requirements, though it is not expecting a long-term effect on
profitability. (>6-2)
- Drago Azinovic, EU Region President for Philip Morris International on March 14, 2014, said the EU Tobacco Products Directive adopted by the EU Council on March 14th "represents a worrying departure from the EU's basic standards of proportionate, evidenced-based policymaking, which will further erode intellectual property rights,"adding that the TPD measures "will do little to improve public health and will make the EU less competitive, pushing even more consumers to the unregulated black market in tobacco."The revised TPD will harm hundreds of thousands of people working in the legal industry and EU member governments who face budget gaps, Azinovic added. " (>6-2)
- Voice of Russia reports that despite evidence showing that e-cigs help people quit smoking, the UK is expected to ban "strong re-usable" e-cigs in line with the EU's revised Tobacco Products Directive, which passed the European Parliament on February 26th and now faces a EU Council vote. Around 10 million adults in Britain smoke cigarettes, with two third of them starting before turning 18, the report said. Sweden, which negotiated an opt-out from the EU snus ban when it joined the bloc in 1995, has the lowest smoking rate among all member States and the country's lung cancer deaths in men aged over 35 is less than half the British rate, the Voice of Russia report noted. (>6-3)
- The Electronic Cigarette Industry Trade Association (ECITA) in the UK criticized the revised EU Tobacco Products Directive, which passed the European Parliament on February 26th and will introduce a number of restrictions on the sale and marketing of e-cigs, with ECITA's operations manager Katherine Devlin saying the directive "could not be challenged until the implementation stage in 2016, but it would prove unworkable and the industry will fight it."(>6-3)
- British American Tobacco's legal director Neil Withington on February 28,2014 said in an interview after the company reported its 2013 results that he was not concerned by the regulation, much of which, he noted, is already implemented elsewhere in the world, but did not believe that banning menthol was appropriate. "There is no scientific evidence that banning menthol is going to bring any real public health benefit to the population," Durante added.(>6-2)
-Commenting on the European Parliament's February 26th passage of the compromise Tobacco Products Directive, which would, once it enters into force, allow e-cigs with a nicotine content below 20 mg/ml for general sale at the European Union level, enable the EU to ban refillables if just three member States do so, while permitting member States to regulate the devices as medicines if they choose, and cap cartridge size at 2 ml, an editorial in the New York Times said the rules should serve as a model for the US Food and Drug Administration, which is expected to issue its proposed "deeming regulation" for e-cigs.(>6-1)
-After the European Parliament on February 26th approved the revised Tobacco Products Directive, Patricia Kovacevic, advisory board member of eCig Europe and director of regulatory affairs at SKYCIG, said it is unfortunate that the EP "failed to give due consideration to the harm reduction opportunity presented by electronic cigarettes and, moreover, neglected to propose a well-reasoned, product-specific regulatory framework to adequately address consumer demand." (>6-3)
-Commenting on the European Parliament's passage of the revised Tobacco Products Directive, Linda McAvan, the British Labour Party member of the European Parliament and rapporteur who guided the legislation through the chamber, said the original version of the TPD was stricter than what passed on February 26th and would have regulated e-cigs as medicines, but the passage is a victory nonetheless, as "the new law is [still] a huge step forward in tobacco control," adding that she is "totally confident that we'll be taken to court by the tobacco companies" over some issues," while British Conservative Party MEP Martin Callanan said the TPD's e-cig regulations are a "massive loss for public health in Europe" and he believes "a lot of [the details on e-cigs] will end up in the courts." . (>5)
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EU TOBACCO PRODUCTS DIRECTIVE: CLOSING STAGES OF DEVELOPMENT

- 22 January 2014. Compromise passed by the Parliamentary Committee on the Environment and Public Health (ENVI)
The compromise on the revised EU Tobacco Products Directive, which the European Parliament reached on December 16, 2013, passed the Parliamentary Committee on the Environment and Public Health (ENVI) on January 22nd in a 49-7 vote with 4 abstentions, with the agreed text to be debated and put to a plenary vote.The compromise version, confirmed on December 18, 2013, by the permanent committee of member States' representatives (COREPER), would ban the sale of cigarettes in packs containing fewer than 20 pieces and require combined textual and graphic health warnings on 65% of the front and back of cigarette packaging. The majority of member States do not require pictorial warnings at present. The draft TPD would regulate e-cigs as medicinal products if they are marketed as a quit aid, or alternatively as tobacco products, in which case, their nicotine concentration should not be more than 20 mg/ml. Refillable cartridges and e-cig flavorings would be allowed. E-cigs should be childproof and carry health warnings. E-cigs would be subject to the same advertising restrictions as traditional tobacco products. The legislation would ban the use of a "characterizing flavor" in cigarettes and roll-your-own tobacco. Menthol would be banned effective 2020. The European Commission would establish a "priority list" of additives allowed in cigarettes and RYO tobacco. The TPD would authorize additives essential to produce tobacco, such as sugar.
At a meeting of the European Union Economic and Financial Council on January 28, 2014, EU ministers decided not to oppose the European Commission's directive to postpone for another two years the introduction of new larger health warnings on cigarette packs.The directive would require EU nations to remove non-compliant cigarette packs by March 28, 2018. "In view of the complexity of the process of updating the electronic library of selected source documents and amending Decision C(2005)1452, there is a danger that the process will not be completed before the deadline," the European Commission said.
- 18 December 2013. European Council approves compromise on tobacco directive*
On December 18, 2013, in the Committee of Permanent Representatives (COREPER I) the EU Member States backed the final compromise text negotiated by the Lithuanian Presidency and the European Parliament on the Tobacco products Directive.The final agreement* includes regulation of electronic cigarettes.The agreed text will be debated and put to votes in the Health Committeeand theplenaryearly next year.
The compromise text includes the following key measures to be brought into national law by member states:
–A ban on theplacing on the market of cigarettes and roll-your-own tobacco with characterising flavours such as fruit flavours, menthol or vanilla.
–The ban on mentholated products will apply only four years after the directive being transposed by the member states.
Member states will also have to ban the placing on the market of tobacco products containing additives in quantities that increase in a significant or measurable manner the toxic or addictive effect, or the carcinogenic, mutagenic or reprotoxic properties.
–Combined picture and text health warnings would have to cover 65 % of the front and the back of packages of tobacco products for smoking. In addition, each packet of smoking tobacco must carry a general warning (such as "Smoking kills - quit now") and the information message: "Tobacco smoke contains over 70 substances known to cause cancer".
–A ban on any misleading labelling (such as "natural" or "organic").
-Packs of fewer than 20 cigarettes would be banned.
–Introduction of a tracking and tracing system, together with safety features in order to strengthen the fight against illicit trade and falsified products.
- Member states may decide to ban cross-border distance sales (through the Internet).
– Member states may introduce more stringent rules on additives or on packaging of tobacco products (such as plain-packaging), subject to certain conditions (such as notification of the Commission).
– The scope of the directive is extended to electronic cigarettes which will be subject of a number of safeguards:maximum concentration of nicotine of 20 mg/ml, maximum single use cartridge size of 2 ml). As regards to refillable electronic cigarettes, the Commission will have to report on their potential risk to public health at the latest two years after the entry into force of the directive. If for justified reasons related to a serious risk to human health at least three member states have banned refillable electronic cigarettes the Commission is allowed to extend the ban to all member states.A single cartridge should contain the equivalent in nicotine of a pack of cigarettes.
E-cigarettes should be regulated either as medicinal products, if they are presented as havingcurative or preventive properties, or alternatively as tobacco products.
Electronic cigarettes should be childproof and carry health warnings. They would be subject to the same advertising restrictions as tobacco products.
*

- October 8, 2013. European Parliament Approves Revised Tobacco Products Directive, which would:
-increase the size of cigarette health warnings to at least 65% of the front and back of packs, up from the current requirement of at least 30% of the front and 40% of the back, and require the brand image to appear on the bottom of the pack;
-ban packs containing fewer than 20 cigarettes;
-regulate e-cigs, but *not* subject them to the same rules as medicinal products unless they are presented as having “curative or preventive properties,” with products with no such claims to contain under 30 mg/ml of nicotine, carry health warnings and sold only to consumers aged 18 and over;
-subject e-cigs to the same advertising restrictions as tobacco products;
-require e-cig manufacturers and importers to supply authorities with a list of all ingredients in their products;
-ban flavors including menthol, with a 3-year deadline to phase out flavors except menthol, which has 8 years;
-authorize “additives essential to produce tobacco,” such as sugar and other “explicitly listed substances in stated concentrations”; andrequire “single packets and transport packaging” to be identified with a mark to enable supply chain track-and-trace to combat illegal trade.
Members of the European Parliament rejected a ban on slim cigarettes.
* Amendments adopted by the European Parliament on 8 October 2013 on the 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 (COM(2012)0788 – C7-0420/2012 – 2012/0366(COD)) (1)

EU members have 18 months to translate the TPD into national laws. The deadline for phasing out flavours in general is three years, with five additional years for menthol (total eight years). Tobacco products that do not comply with the directive will be tolerated on the market for 24 months, and e-cigarettes for 36 months.
- July 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, ryo and water pipe tobacco
-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
A report published on July 24, 2013 provides the opinions of six European Parliamentary committees on the draft TPD. Three of them recommend that combined health warnings cover 50% of the front and back surface, rather than 75% as proposed.
Report on the 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
(COM(2012)0788 – C7-0420/2012 – 2012/0366(COD)), 24 July 2013

Revision of the Tobacco Products Directive 2001/37 EC