Eu Tobacco Products Directive: Closing Stages of Development

Update August 25, 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:
- British e-cig manufacturer Totally Wicked Ltd. Said mid August 2014 it received permission from the UK's Administrative Court to seek a judicial review by the EU Court of Justice (CJEU) of the revised Tobacco Products Directive, specifically Article 20 pertaining to e-cigs, which the company claims "represents a disproportionate impediment to the free movement of goods and the free provision of services, places electronic cigarettes at an unjustified competitive disadvantage to tobacco products, fails to comply with the general EU principle of equality, and breaches the fundamental rights of electronic cigarette manufacturers."
British Secretary of State for Heath Jeremy Hunt was reported to be backing e-cig maker Totally Wicked's plan to challenge the EU Tobacco Products Directive in what appears to be something of a volte-face for Hunt. Breitbart columnist Donna Rachel Edmunds, who is also the founder and editor of UKIPDaily.com, on August 23, 2014 said Hunt's stance is surprising given that he wrote a letter to British MEPs calling for regulating e-cigs and other nicotine-containing products as medicines. During the TPD revision process, Hunt's party colleague Martin Callanan, then leader of the Conservative delegation in Brussels, spearheaded the initiative to defeat a proposal to regulate e-cigs like medicines, Edmunds noted. UKIP and Liberal Democrat MEPs also opposed that proposal. (>6-3)
- As reported in early August 2014, in a letter sent recently to Irish Prime Minister Enda Kenny, 27 European People's Party MEPs from Germany, Spain, Italy, Luxembourg and Austria expressed concerns about Ireland's plan to introduce plain packaging for tobacco products, claiming that the measure would violate international agreements, fuel illicit trade and counterfeiting, restrict fair competition, and set a "dangerous" precedent for other industries and products.The letter pointed out that during the process of revising the EU Tobacco Products Directive, the European Parliament rejected plans to require member States to introduce plain tobacco packaging as it would undermine trademark protections and "result in a loss of investment and jobs." (>6-3)
- 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)
- 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)

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