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Questions and answers: Towards a new EU law on Tobacco Products

Commission Européenne - MEMO/12/1005   19/12/2012

Autres langues disponibles: FR DE DA ES NL IT SV PT FI EL CS ET HU LT LV MT PL SK SL BG RO

European Commission

Memo

Brussels, 19 December 2012

Questions and answers: Towards a new EU law on Tobacco Products

Today, the European Commission has adopted a landmark proposal to revise the Tobacco Products Directive. The proposal is a substantial revision of the current EU law and proposes new and strengthened rules on tobacco products.

What is regulated in the current Tobacco Products Directive?

The current Tobacco Products Directive, adopted in 2001, replacing the original Directive of 1989, foresees measures on the manufacture, presentation and sale of tobacco products. Tobacco Products include cigarettes, roll-your-own (RYO) tobacco, pipe tobacco, cigars, cigarillos as well as various forms of smokeless tobacco. The Directive sets maximum limits for tar, nicotine and carbon monoxide yields of cigarettes and obliges manufacturers to report on the ingredients they use. It bans oral tobacco and the use of misleading descriptors such as ‘light’, ‘mild’, or ‘low tar’. Health warning messages have to appear on tobacco products. A library of pictorial warnings has been developed to complement the textual warnings and is being used by an increasing number of Member States.

Why is the Commission revising the Tobacco Products Directive?

The main objective of the revision is to improve the functioning of the internal market, whilst assuring a high level of public health. Since the adoption of the Tobacco Products Directive in 2001, several market, scientific and international developments have taken place. For example, new evidence on flavourings used in tobacco products and effectiveness of health warnings has become available. In some areas, laws differ substantially between Member States who have taken different regulatory approaches. New products such as electronic cigarettes have entered the market and some of the current provisions of the Directive have become outdated. The legislative proposal aims at making tobacco products and tobacco consumption less attractive, and thus to discourage young people from starting to smoke.

Furthermore, the EU and all Member States are parties to the WHO Framework Convention on Tobacco Control (FCTC) which entered into force in February 2005 and entails a legal obligation to implement the Convention.

Finally, both the Council and the European Parliament have repeatedly called for a revision of the current Directive.

Is tobacco a major health issue in the EU and worldwide ?

Yes. Every year, smoking kills almost 700,000 people in Europe (a city the size of Frankfurt), making tobacco consumption the largest avoidable health risk. Millions of EU citizens suffer from diseases associated with smoking, including cancers, cardiovascular and respiratory diseases. Around 50% of smokers die prematurely on average 14 years earlier and smokers have more life years that are characterised by poor health condition. At global level, the World Health Organization (WHO) estimates that currently tobacco use is killing nearly six million people each year. This figure could reach eight million by 2030 if steps are not taken to reverse this worrying trend.

The Commission is committed to a strong tobacco control policy to ensure a high level of public health in the EU internal market. With tobacco being highly addictive, it is important to prevent young people from taking up tobacco use. 70% of the smokers start before the age of 18 and 94% before the age of 25 years.

What is the main content of the revision?

The proposal foresees major revisions of the current Directive. It addresses in particular the following areas and provisions:

  • Ingredients: A harmonised electronic reporting format for ingredients and emissions will be introduced. The proposal foresees a prohibition for cigarettes, roll your own (RYO) tobacco and smokeless tobacco products with characterising flavours and a prohibition of products with additives which increase its toxicity and addictiveness.

  • Labelling and Packaging: All cigarette and RYO packages must carry a combined picture and text health warning covering 75% of the front and the back of the package, including information on cessation services. Promotional elements are prohibited. Certain aspects of the pack and cigarette appearance are standardised, e.g. the size of a cigarettes packet to ensure the full visibility of pictorial warnings. The current information on tar, nicotine and carbon monoxide is replaced by an information message on the side of the pack. Member States remain free to introduce plain packaging in duly justified cases.

  • Smokeless tobacco: The ban on oral tobacco products (snus) is maintained except for Sweden which has an exemption pursuant to its Accession Treaty. All smokeless tobacco products must carry health warnings on both sides. Novel tobacco products must comply with the Directive and require prior notification before being placed on the market.

  • Extension of the product 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; products above this threshold are only allowed if authorised as medicinal products like nicotine replacement therapies (e.g. nicotine patches). Herbal products for smoking (e.g. herbal cigarettes) will have to carry health warnings.

  • Cross border distance sales: Retailers engaging in cross-border distance sales must notify their activities to the competent authorities and must introduce age verification mechanisms.

  • Illicit trade: A tracking and tracing system and security features (e.g. holograms) are foreseen.

For a comparison of the new proposal versus the current Directive, please see the table in the Annex.

What are the rules for pipe tobacco, cigars and cigarillos?

All tobacco products are covered by the Tobacco Products Directive. However, pipe tobacco, cigars and cigarillos are currently not used in significant quantities for smoking initiation. Therefore the proposal foresees less stringent rules for these products, e.g. no mandatory pictorial health warnings and no prohibition of characterizing flavours. This exemption will be removed if there is a substantial change in circumstances (in terms of sales volumes or prevalence level among young people).

Will cigarette packages be different in the future?

Yes. The proposal foresees mandatory picture warnings on the front and the back of a package covering 75% of the respective surfaces. On the lateral sides further health warnings ("smoking kills – quit now"; "tobacco smoke contains over 70 substances known to cause cancer" etc…) will be added covering 50% of the respective surfaces. Considering the entire surface of a cigarette package, this means that health warnings will cover less than 60% of the total surface. In addition the cigarette manufacturers will have to comply with obligations on tracking and tracing, security features and tax stamps. For normal cigarette packages this means that 30% of the package will remain for branding, unless a Member State opts for plain packaging and can justify its choice.

Is the Commission proposing to keep the ban on snus (oral tobacco)?

Yes. In the EU, oral tobacco (including snus) has been banned since 1992. Sweden has an exemption under its Accession Treaty. Snus is addictive and has adverse health effects. Already before 1992, a number of Member States had started banning the product taking into account its significant growth potential and attractiveness for young people. In the public consultation preceding the legislative proposal most Member States rejected the idea of lifting the ban on snus. Snus could be an entry gate for new smokers developing a tobacco/nicotine addiction, while established smokers could engage in dual use (cigarettes and snus). The decision not to lift the ban is also in line with the recommendation of the Swedish National Institute of Public Health.

Will the new law ban flavourings – like menthol – and other ingredients?

The proposal will not ban specific flavourings but prohibits tobacco products with a so-called characterising flavour, including menthol. Concretely, menthol in small quantities can be used, but not in large quantities, which give the tobacco product a distinguishable flavour other than tobacco. Test panels will assist the Member States and the Commission to decide whether or not a product has such a characterising flavour. Additives which are necessary for the manufacture of tobacco products can continue to be used. This includes sugar. The proposal does not discriminate between tobacco varieties such as Virginia, Burley or Oriental tobacco.

Will the new Tobacco Products Directive increase the fight against illicit trade?

Yes. The legislative proposal contains strong measures against illicit tobacco products to ensure that only products complying with the Directive are sold in the EU. The Directive introduces a tracking and tracing system for the legal supply chain and security features which should facilitate law enforcement and empower consumers to detect illicit products. The proposal also raises the awareness of consumers that illicit products are sold by organised crime. Tobacco products other than cigarettes and RYO are granted a transitional period of five years.

Is the Commission proposing to ban cross-border distance sales ?

No. Nevertheless the issue needs to be tackled as it has been observed that products bought e.g. via the internet are often not compatible with the rules set out in the Directive (i.e. labelling and ingredients). The proposal foresees that retailers that wish to sell tobacco products cross-border must notify their activity prior to the first sale to the Member State in which they are located and in those to which they sell tobacco products. .They also must ensure that tobacco products are not sold to children and adolescents.

Is this proposal about smoking in public places?

No. Though the European Commission supports the introduction of smoke free environments, decision on this issue remains a competence of the Member States. At EU level, smoke free environments are addressed only in a Council Recommendation on Smoke Free Environments of 2009. The Commission will report on how Member States are implementing this Recommendation in the first half of 2013.

How will the proposal affect the health of EU citizens? Who will benefit from the revision?

All citizens will benefit from the revision foreseen as they will receive more accurate information about the products. Young people will be discouraged from taking up tobacco consumption, as the possibilities to render the products "attractive" will be limited. Current tobacco users will benefit from the measures proposed in the Directive as they will be in a better position to take informed decisions about the products and on quitting if they so wish and thus benefit in terms of health.

Governments and the society as a whole will benefit from improved public health such as more healthy life years. Apart from being a value in its own right and of great importance to all citizens, a healthy population is essential for productivity and prosperity and a key factor for economic growth. Annual EU public healthcare expenditure on treating smoking attributable diseases is – on a conservative basis - estimated to amount to 25,3 bn EUR. In addition, society loses 8,3 bn EUR per year due to productivity losses (including early retirements/deaths and absenteeism) linked to smoking. The burden on governments to implement international commitments and regulations will be reduced as Member States will benefit from learning from each other's experiences.

Manufacturers of tobacco products will benefit from clearer rules, an improved functioning of the internal market and a level playing field. The new rules take particular account of the specific needs of small and medium-sized companies.

What are the next steps?

The legislative proposal will be transferred to the Council and the European Parliament, the European institutions responsible for adopting binding legislation. Ideally, the new Directive will be adopted no later than 2014 and would come into effect from 2015-2016.

IP/12/1391

Annex

Policy Area

Current situation

Proposal

Scope

Smokeless tobacco products (STP)

Oral tobacco prohibited (derogation for Sweden). All STP must carry health warnings and undergo ingredients reporting.

Oral tobacco prohibited (derogation for Sweden remains). All STP must carry health warnings on the two most visible surfaces of the pack. STP with characterising flavours are prohibited (including for oral tobacco in Sweden).

Nicotine containing products (NCPs)

NCPs not covered by Tobacco Products Directive (TPD). Different regulation in MS, with about half of Member States (MS) reporting that they consider at least some NCP as medicinal products by function.1

NCPs above a certain nicotine threshold are only allowed if authorised as medicinal products. NCP below the threshold must carry health warnings.

Novel tobacco products

Novel tobacco products (typically heated/non-combusted products allegedly causing less harm) are covered by the general provisions of the TPD.

Manufacturers must notify MS before placing novel tobacco products on the EU market. Commission report after 5 years. TPD provisions apply for novel products placed on the market.

Herbal products for smoking

Herbal products for smoking (e.g. herbal cigarettes) not covered by the TPD and subject to different national legislations.

Herbal cigarettes must carry health warnings.

Packaging and Labelling

Health warnings and messages

Text warnings of 30-35% on one side and 40%-50% plus border on the other side required on all tobacco products except STP. MS may introduce combined (picture + text) warnings on the back of the packaging2. Tar, Nicotine and Carbon Monoxide (TNCO) levels are displayed on packages.

Mandatory combined health warnings required on 75% of the front and back of cigarette and Roll Your Own (RYO) packages. TNCO levels replaced by information message on the side of the pack that tobacco smoke contains more than 70 substances causing cancer. Information on cessation services displayed on the pack as part of health warning.

Promotional and misleading elements

Products descriptors suggesting that a tobacco product is less harmful than others, such as 'light' and 'mild', are prohibited.3

Promotional and misleading elements (such as “natural”, “organic”, references to flavours and misleading colours) on tobacco packages or the product itself prohibited. Slim cigarettes ( < 7.5 mm in diameter) are considered misleading.

Pack shape and size

No requirement in the current TPD but 14 MS require a minimum pack size of 20 cigarettes4 and 4 a minimum pack size of 19 cigarettes5 plus specific provisions in some other MS6. Some MS also have requirements for RYO tobacco7

Cigarette packages must have a cuboid shape and contain at least 20 cigarettes. RYO tobacco may not be sold in pouches with less than 40g. Minimum height, width and depth of cigarette packages to ensure full visibility of health warnings.

Plain packaging

No provision in current TPD, but recommended by Framework Convention on Tobacco Control guidelines and under discussion in some Member States.8

MS may introduce standardised packaging provided it is compatible with the Treaty and notified under Directive 98/34.

Ingredients

Reporting

Reporting is mandatory but no harmonised EU reporting format exists.

Mandatory reporting remains but now in a common electronic format to facilitate comparison and enforcement.

Additives

Addictive and toxic additives must be reported. MS prohibit and/or permit additives at their discretion (negative and positive list for additives)9.

Cigarettes, RYO and STP with characterising flavours are prohibited.. Additives which create a misleading impression (e.g. vitamins) and flavours in components of tobacco products (e.g. filters, papers) are prohibited. Products with increased toxicity or addictiveness are prohibited.

Sales arrangements

Cross-border distance sales of tobacco

Regulation left to MS, nine MS prohibit internet sales of tobacco.10

Retailers that wish to sell tobacco products cross-border must notify the country of origin and destination to facilitate enforcement. They must also ensure the age of the purchaser is verified at sale.

Tracking and tracing

Trace-ability

Tobacco product shall be marked to enable the place and time of manufacture to be determined. Technical rules to, be adopted by comitology, but such decision has not yet been taken.

Common EU tracking and tracing system is introduced. Tobacco products must be scanned and movements recorded as they move through the supply chain (except retail). Tobacco products other than cigarettes and RYO are granted a transitional period of five years.

Security Features

Not foreseen in the current TPD

Security features (e.g. holograms or other marks) are placed on products so that consumers can identify their authenticity. Tobacco products other than cigarettes and RYO are granted a transitional period of five years.

1 :

AT, BE, DE, DK, EE, FI, FR, HU, LU, NL, PT, RO, SE, SK

2 :

BE, DK, ES, FR, LV, MT, RO, UK; IE, HU from 2013

3 :

FR bans use of promotional elements on packs.

4 :

AT, CZ, DK, EE, EL, FI, FR, IE, LU, LT, PL, PT, RO, ES

5 :

DE, HU, NL, SE

6 :

UK has minimum pack size of 10, IT requires pack size of 10 or 20, LV, SI prohibit sale of single cigarettes

7 :

FR; DE, IT

8 :

BE, FI, FR, UK

9 :

e.g. positive lists in BE, FR, RO, UK, negative list in LT, combination in BG, CZ, DE, HU, SK; other provisions in FI, FR, ES, PL, SE. BE bans ingredient capable of coloring the smoke blue, DE bans use of flavored capsules.

10 :

AT, BG, ES, FR, HU, IT, LT, LV, SK


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