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# 52012PC0788

**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 final - 2012/0366 (COD) \*/**

  

EXPLANATORY MEMORANDUM

1.           CONTEXT OF THE PROPOSAL

Directive 2001/37/EC 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
products (Tobacco Products Directive, hereafter TPD), was adopted on 5 June
2001[1].

More than ten years have passed since the
adoption of the TPD. In line with market, scientific and international
developments it has become necessary to update and complete the TPD. A revision
is explicitly foreseen in Article 11 of the current TPD and has been repeatedly
called for by Council and Parliament[2]. The
initiative to revise the TPD is included in the Commission's Work Plan 2012[3].

The overall objective of the revision is to
improve the functioning of the internal market. In particular, the
proposal aims to:

Ÿ        Update already harmonised areas to overcome Member
States' obstacles to bring their national legislations in line with new market,
scientific and international developments[4].

Ÿ        Address product related measures not yet covered by
the TPD insofar as heterogeneous development in Member States has led to,
or is likely to lead to, fragmentation of the internal market[5].

Ÿ        Ensure that provisions of the Directive are not
circumvented by placing on the market of products not compliant with the
TPD[6].

It is also important to ensure a harmonised
implementation of international obligations following from the WHO Framework
Convention on Tobacco Control (FCTC), which is binding for the EU and all
Member States, and a consistent approach to non-binding FCTC commitments, if
there is a risk of diverging national transposition.

In line with Article 114 TFEU a high level of health
protection has been taken as a basis when choosing between different policy
options identified in the review of the TPD. In this context, the proposal seeks
to regulate tobacco products in a way that reflects their specific
characteristics (nicotine has addictive properties) and the negative
consequences of their consumption (mouth, throat and lung cancer,
cardiovascular problems including heart attacks, strokes, clogged arteries,
increased risk of blindness, impotence, lower fertility, impact on the unborn
child etc).

Tobacco is the most significant cause of
premature death in the EU, responsible for almost 700,000 deaths every year. The
proposal focuses on initiation of tobacco consumption, in particular by young
people, taking into account that 70% of the smokers start before the age of 18
and 94% before the age of 25 years[7]. This
is also reflected in the selection and focus of the proposed policy areas and
the products primarily targeted (cigarettes, roll-your-own and smokeless
tobacco products). In addition, the revision should create conditions which
allow all citizens across the EU to take informed decisions about the products,
based on accurate information on the health consequences of consuming tobacco
products. Finally, all smokers should benefit from measures contained in the
TPD (e.g. health warnings and ingredients regulation).

From a broader perspective, the revision will
contribute to the overall aim of the EU to promote the well-being of its people
(TEU Art. 3) and the Europe 2020 strategy, as keeping people healthy and active
longer, and helping people to prevent avoidable diseases and premature death,
will have a positive impact on productivity and competitiveness. An unintended,
but welcome side effect of the measures against trade of products non-complying
with the requirements of the Directive may be that the tax revenues of Member
States are better protected, as these products often also circumvent national
tax legislation.

The revision of the TPD focuses on five policy
areas: (1) Smokeless tobacco products and extension of the product scope (i.e.
nicotine containing products and herbal products for smoking), (2) packaging
& labelling, (3) ingredients/additives, (4) cross-border distance sales and
(5) traceability and security features.

While a number of elements can be maintained
from the existing Directive (e.g. tar, nicotine and carbon monoxide yields,
ingredients reporting and the ban of placing on the market of oral tobacco), in
many areas very substantial changes are proposed and some areas are added to
the Directive.

2.           Results of CONSULTATIONS with interested
parties AND IMPACT ASSESSMENT

In preparation for this proposal, a public consultation was
held between 24 September and 17 December 2010. The Commission received
more than 85,000 contributions from a wide range of stakeholders. Citizen
contributions accounted for 96% of the survey response, 57% of which are
“duplicate”/repeated responses[8] which
appear to be the result of several citizen mobilisation campaigns that took
place in some Member States[9]. The actions and efforts of these campaigns have affected the
overall quantitative data of the public consultation, which indicate that most
of the citizens responding to the consultation were against changes to the TPD.
This outcome deviates significantly from the latest Eurobarometer survey,
published in May 2012. The Eurobarometer survey indicates that EU citizens,
including smokers, are largely in favour of tobacco control measures, including
the ones hereby proposed such as putting pictorial warnings on all tobacco
packages and introducing security features.[10] Unlike
public consultations it is important to note that respondents in Eurobarometer
surveys are selected randomly. Member States representatives and - even more so
- health NGOs favour the introduction of strict tobacco control measures, while
tobacco industry and retailers are against some of the stricter measures. A
report presenting the outcome of the consultation was published on 27 July
2011, and contributions have been published online[11].

Targeted discussions with stakeholders took place throughout the revision process. A
first exchange of views with health NGOs, tobacco- and pharmaceutical
industries took place on 3 and 4 December 2009 and on 19 and 20 October 2010
and targeted discussions with NGOs, growers, cigarette producers, other tobacco
producers, distributors of tobacco products and upstream suppliers of tobacco
products have continued throughout 2011 and 2012[12]. A
number of written contributions were also received, which have been carefully
considered in assessing the impacts of different policy options. The
Commissioner for Health and Consumer Policy met with Health NGOs and economic
stakeholders in February-March 2012[13]. The
revision of TPD has also been discussed regularly in the TPD Regulatory
Committee from 2009 to 2012[14].

The policy area "traceability and security
features" was added to the revision in response to concerns put forward by
some stakeholders that the selling of contraband or counterfeit products
non-complying with the requirements of the Directive is already today a
significant problem[15].

3.           LEGAL ELEMENTS OF THE PROPOSAL[16]

3.1.        Ingredients and emissions

The maximum yields of tar, nicotine and carbon
monoxide as well as the measurement methods remain the same as in Directive
2001/37/EC.

Directive 2001/37/EC stipulates that Member
States require manufacturers and importers of tobacco products to report on the
ingredients used in such products. This proposal keeps in place this mandatory
reporting system of ingredients and, in addition, foresees a common electronic format
for the reporting and manufacturers are required to provide supporting data
(e.g. marketing reports). Fees charged by Member States for handling the
information submitted to them shall not exceed the cost attributable to those
activities. In addition, the proposal foresees that placing on the market of new
or modified tobacco products must not take place before the submission of
ingredients data. Reported data, excluding confidential information, is
published.

The harmonised reporting format and mandatory
reporting will create a level playing field and facilitate collection, analysis
and monitoring of data. It will also reduce the administrative burden of the
industry, Member States and the Commission and provide a more robust system to
handle sensitive data.

The current Directive 2001/37/EC does not
harmonise Member States regulation on additives. Some Member States have
therefore adopted legislation or concluded agreements with industry allowing or
prohibiting certain ingredients. As a result, some ingredients are forbidden in
some Member States, but not in others. The proposal foresees that tobacco
products with characterising flavours, such as fruit flavours or chocolate, are
prohibited. Test panels will assist in the decision making process. Additives associated
with energy and vitality (e.g. caffeine and taurine), or creating the impression
that products have health benefits (e.g. vitamins) are prohibited. No flavourings
are allowed in filters, papers or packages. Tobacco products with increased
toxicity or addictiveness shall not be placed on the market. Member States
shall ensure that provisions or conditions set out under REACH[17] are applied to tobacco products as appropriate.

The proposal exempts tobacco products other than
cigarettes, roll-your own tobacco and smokeless tobacco products, i.e. cigars,
cigarillos and pipe tobacco from some provisions such as the prohibition of
products with characterising flavours. This exemption is justified considering
that these products are mainly consumed by older consumers, while the focus of
this proposal is to regulate tobacco products in such a way as they do not
encourage young people to start using tobacco. The exemption shall be removed
if there is a substantial change of circumstances (in terms of sales volume or
prevalence level among young people). The proposal addresses the heterogeneous
development in Member States in relation to ingredients regulation and takes
into account international developments, such as provisions of FCTC on regulation of the contents of tobacco products and guidelines
therein. It allows industry to adapt the production
lines in one go whilst allowing industry some margin to differentiate between
products. It focuses on products particularly attractive to young people and is
estimated to reduce smoking initiation. It addresses recent market
developments, including the new technology of inserting additives (e.g.
menthol) in the filters of the cigarettes, and allows for further guidance and
developments through delegated acts.

3.2.        Labelling and packaging

The proposal foresees that combined warnings
(picture plus text) of 75% should be displayed on both sides of the packages of
tobacco products, presented in rotation. Directive 2001/37/EC already makes text health warnings mandatory and picture warnings
optional. Eight Member States have already taken the initiative to make
pictorial warnings obligatory in their territories (two will follow in 2013). Tar, nicotine and carbon monoxide (TNCO) levels on the packages, as
stipulated under Directive 2001/37/EC, are replaced with an information message
referring to harmful substances of tobacco. Display of cessation information (e.g.
quit-lines, websites) is added to the packages. Packaging of tobacco products,
or the products themselves, shall not include any elements that promote tobacco
products or mislead consumers to believe that the product is less harmful than
others, refers to flavours or tastes or resembles a food product. The proposal
also includes requirements for packages, e.g. cuboid shape for cigarette
packages and minimum number of cigarettes per package.

Under the proposal, Member States would retain
their power to regulate the area of the package not regulated by this Directive
or other Union legislation, including implementing provisions providing full
standardisation of packaging of tobacco products (including colours and font),
as far as these provisions are compatible with the Treaty. The Commission will
report on experiences gained with respect to surfaces not governed by the
Directive five years after its transposition deadline.

The proposal exempts tobacco products other than
cigarettes and roll-your own tobacco from larger health warnings. In order to
increase the visibility of the health warnings on smokeless tobacco products,
these will have to be put on both sides of the package according to the proposal,
but their size will remain unchanged compared to Directive 2001/37. Other
tobacco products (e.g. cigars and pipe tobacco) will be subject to rules
corresponding to the provisions set out in Directive 2001/37 EC, i.e. text warnings
of not less than 30% (front) plus 40% (back) of the packages[18]. The exemption shall be removed if there is a substantial change of
circumstances (in terms of sales volume or prevalence level among young
people).

The proposal seeks to ensure that the
appearance of the package reflects the characteristics of the product inside
the package - a product that has negative health consequences, is addictive,
and is not for the consumption of children and teenagers. The proposal provides
for an update of current provisions on packaging and labelling in relation to
scientific and international development and addresses the current fragmented
development in Member States, in particular as regards pictorial warnings. The
proposal will both ensure effective display of the health warnings and leave a
certain space on the package for display of trademarks. The limitation of the
product scope to cigarettes and roll-your-own tobacco in a first stage is
justified because other tobacco products (e.g. cigars and pipe tobacco) are
primarily used by older consumers. The proposal is based on new evidence
showing that bigger and pictorial warnings are more effective[19] and current indications of tar, nicotine and carbon monoxide levels
are misleading. The exact size of the warning (75%) has been suggested after
thorough analysis of scientific evidence and international experience[20] as well as international developments (Article 11 FCTC and its
guidelines call for large double sided picture warnings, and strict rules on
misleading information) as well as considerations of the impact on economic
stakeholders.

3.3.        Traceability and security
features

Directive 2001/37/EC grants a power to the
Commission to adopt technical measures related to traceability and
identification, but this power has not been used. As the concept of
traceability has developed over the past years, it is necessary to adapt and
complete the legislation in terms of traceability and security features. The
proposal foresees an EU tracking and tracing system at packet level for tobacco
products throughout the supply chain (excluding retail). Member States shall
ensure that manufacturers of tobacco products conclude data storage contracts
with independent third parties in order to ensure independence of the system
and full transparency and accessibility by Member States and the Commission at
all times. Processing of personal data should respect relevant data protection
provisions, including rules and safeguards laid down in Directive 95/46/EC[21]. In addition to tracking and tracing, visible security features shall
be put on all tobacco products placed on the EU market in order to facilitate
the identification of authentic products.

Technical standards to ensure compatibility
between the tracking and tracing systems used as well as for the contracts with
third parties shall be adopted by delegated acts. Technical standardisations
for security features shall also be adopted by the use of delegated acts.

Tobacco products other than cigarettes and
roll-your-own-tobacco are granted a transitional period of five years.

The proposal ensures compliance with the
requirements of the Directive, creates a level playing field between different
operators (currently only the biggest four tobacco manufacturers are required to
develop and use tracking and tracing systems), facilitates market surveillance
and empowers consumers in verifying the authenticity of tobacco products. The
proposal does not aim at an integration of the tracking and tracing system with
existing excise and customs system (in particular the systems responsible for
bulk movement control, such as Excise Movement and Control System (EMCS).

3.4.        Tobacco for oral use

The ban of placing on the market (including
cross-border distance sale) of tobacco for oral use (snus) as set out in
Directive 2001/37/EC is maintained (except for Sweden which has an exemption in
its Accession Treaty[22]).

It is not considered justified to lift the
current ban which was introduced already in 1992 and which was justified from
an internal market point of view since three Member States had already banned
or announced a ban of oral tobacco due to the harmful and addictive effects of
the product. At that point in time oral tobacco had also started to be
distributed on the market of certain Member States in such a way as to attract
young people. The harmful effect of oral tobacco has been confirmed by the
Commission's Scientific Committee on Emerging and Newly Identified Health Risks
(SCENIHR) and other studies. Given the continuous development of oral tobacco,
in particular oral tobacco flavoured in a significant manner and presented in
attractive packages in the Swedish market, there is a risk of uptake (also of
other tobacco products) in new users, including young people. The industry
confirmed that oral tobacco has huge market potential if the ban on oral
tobacco were lifted.

The current ban was seen as proportionate by
the Court of Justice of the European Union in 2004 due to the harmful effects,
the uncertainty of oral tobacco as a substitute for cigarettes, the addictive
and toxic properties of nicotine, oral tobacco's risk potential for young
people and the novelty of the product[23].
This reasoning is still valid today.

3.5.        Cross-border distance
sales of tobacco products

Cross-border distance sales of tobacco products
fall outside the scope of Directive 2001/37/EC. The proposal includes a
notification obligation for retailers of tobacco products intending to engage
in cross-border distance sales. The proposal allows Member States to require
the retailer to appoint a natural person, who ensures compliance with the Directive
of products delivered to customers in Member States concerned. Mandatory age
verification mechanism is also foreseen.

The proposal facilitates legal activity without
removing any sales channels, while allowing consumers legitimate access to
tobacco products not available on their domestic market. It reinforces the
effect on the internal market by preventing purchasing of products not
complying with the provisions of the Directive, including health warnings in
the right language and ingredients regulation. It also aims at addressing
underage purchasing. An unintended side-effect is that the proposal will reduce
the availability of cheaper products not respecting national price policies.

3.6.        Novel tobacco products

Novel tobacco products are products containing
tobacco which do not fall within any of the established product categories
(e.g. cigarette, roll-your-own tobacco, pipe tobacco, water-pipe tobacco,
cigar, cigarillo, chewing tobacco, nasal tobacco or tobacco for oral use) and which
are placed on the market after the entry into force of the Directive. These
products will have to respect requirements of the Directive (e.g. in terms of
labelling and ingredients) to ensure a level playing field, and the applicable rules will depend on whether the product involves a
combustion process or not.

The proposal also foresees a notification obligation for novel tobacco products and a report on
the market development in these products will be issued by the Commission five
years after the transposition deadline of the Directive.

The introduction of a notification system for
novel tobacco products would contribute to increasing the knowledge base as
regards these products for purpose of possible future amendments to the
Directive.

3.7.        Nicotine containing
products (NCP)

NCP fall outside the scope of
Directive 2001/37/EC and Member States have so far taken different regulatory
approaches to address these products, including regulating them as medicinal
products, applying certain provisions that are used for tobacco products or
having no specific legislation.

The proposal stipulates that NCP that either
have a nicotine level exceeding 2 mg, a nicotine concentration exceeding 4 mg
per ml or whose intended use results in a mean maximum peak plasma
concentration exceeding 4 ng per ml may be placed on the market only if they
have been authorised as medicinal products on the basis of their quality,
safety and efficacy, and with a positive risk/benefit balance[24]. NCP with nicotine levels below this threshold can be sold as
consumer products provided they feature an adapted health warning. The nicotine
threshold identified in this proposal has been established by considering the
nicotine content of medicinal products (Nicotine Replacement Therapies, NRTs)
for smoking cessation which have already received a market authorisation under
the medicinal products' legislation.

The proposal removes current legislative
divergence between Member States and the differential treatment between Nicotine
Replacement Therapies and Nicotine Containing Products, increases legal
certainty and consolidates the on-going development in Member States. It also
encourages research and innovation in smoking cessation with the aim of
maximising health gains. Given the novelty and rapid increase of the NCP market
as well as their addictive and toxic character there is an urgency to act,
before more people – unaware of the content and effects of these products –
inadvertently develop a nicotine addiction.

The labelling requirement set out in this
proposal for NCP containing nicotine below the identified threshold will better
inform consumers about the health risks associated with the products.

3.8.        Herbal products for
smoking

Herbal products for smoking fall outside the
scope of Directive 2001/37/EC and Member States regulate these products in
different ways.

The proposal foresees adapted health warnings
for herbal products for smoking to inform consumers about the adverse health
effects of these products. In addition, no promotional or misleading elements
are allowed on the packages.

The proposal ensures a more homogenous
development in the EU and creates a safety net for consumers. The proposal also
provides consumers and potential consumers with more appropriate information
about the adverse health effects of herbal products for smoking and thus allows
them to make informed choices.

3.9.        Union competence

3.9.1.     Legal base

Directive 2001/37/EC was adopted on the basis
of Article 95 of the Treaty establishing the European Community, TEC (now
Article 114 Treaty on the Functioning of the European Union, TFEU)[25]. The choice of the legal base has been confirmed by the Court of
Justice of the European Union[26]. The same legal basis is appropriate for this proposal, aiming at
revising Directive 2001/37EC. Article 114(1) TFEU empowers the European
Parliament and the Council to adopt measures for the approximation of the
provisions laid down by law, regulation or administrative action in Member
States which have as their object the establishment and functioning of the
internal market. According to Article 114(3) TFEU, the Commission should aim at
ensuring a high level of health protection in its proposal envisaged in
paragraph 1 of Article 114.

First, this legal basis is appropriate to
update, in light of scientific and international developments, the existing
level of harmonisation as regards display of tar, nicotine and carbon monoxide
levels, the size of the warnings and certain aspects in the area of
traceability features[27]. Second, approximation of national legislations on tobacco products
under Article 114 is justified when it is necessary to remove obstacles to
the free movement of goods[28]. This is particularly relevant as regards measures related to
product scope, labelling and ingredients. Third, harmonisation is justified to
ensure that certain provisions concerning the internal market are not
circumvented[29]. This is particularly relevant for the areas on cross-border
distance sales and traceability and security features. Measures foreseen in
these areas will facilitate licit activity and thus prevent sale of tobacco
products not complying with the TPD, including health warnings in the right
language and ingredients regulation.

3.9.2.     Subsidiarity

The objectives of the proposed action cannot be
sufficiently achieved by the Member States, neither at central nor at regional
or local level, but can rather be best achieved at Union level (Article 5(3)
TEU).

Some of the areas included in this proposal are
already harmonised, but need to be updated in accordance with market, scientific
and international developments. Due to the harmonisation which already exists
under Directive 2001/37/EC, Member States are prevented from acting
unilaterally, for example to increase the size of the health warnings or to
remove the display of tar, nicotine and carbon monoxide.

Other areas relevant for this proposal are
subject to different legal approaches in Member States which have led to
obstacles to the functioning of the internal market. For example, for labelling
and ingredients, the heterogeneous situations in Member States have resulted in
a situation where the industry has to produce different product lines for
different markets. Only a harmonised approach at EU-level in such areas can
remove obstacles to cross-border trade and avoid fragmentation, while ensuring
a comparable high level of health protection.

Finally, it is very difficult for a Member
State to act unilaterally in some areas due to the difficulties to enforce such
an action when other Member States have different rules. For example, it
appears almost impossible for a Member State to regulate tobacco internet
sales, e.g. regarding the minimum legal age to purchase tobacco, if such sales
are unregulated in other Member States. A legally binding and EU wide measure therefore
produces clear benefits. The same holds true for the EU tracking and tracing
system, when tobacco products regularly move across borders.

This proposal also contributes to greater consistency,
both between and within Member States, and a higher level of legal certainty,
for example in the area of nicotine containing products where the legal current
situation is complex and unclear, which undermines the level playing field.

3.9.3.     Proportionality

Under the principle of proportionality, the
content and form of the Union action shall not exceed what is necessary to
achieve the objectives of the Treaty (Article 5(4) TEU). This proposal provides
an appropriate level of margin for implementation by the Member States. It
fully respects responsibilities of the Member States to organise, finance and
deliver health services and medical care. It is a balanced proposal, which is
ambitious while respecting legitimate interests of stakeholders.

3.9.4.     Fundamental Rights

The proposal affects several fundamental rights
as laid down in the Charter of Fundamental Rights of the European Union,
notably the protection of personal data (Article 8), the freedom of expression
and information (Article 11), freedom of economic operators to conduct business
(Article 16), and the right to property (Article 17). The obligations imposed on manufacturers, importers and
distributors of tobacco products are necessary to improve the functioning of
the internal market while ensuring a high level of health and consumer
protection as set out in Articles 35 and 38 of the Charter of Fundamental
Rights of the European Union.

3.9.5.     Legal form

The proposal takes the form of a Directive
which will replace as a whole Directive 2001/37/EC.

Even though the proposed changes do not affect
all provisions of Directive 2001/37/EC, the text would have to undergo numerous
modifications which would change its current presentation. Against this
background, it is proposed to repeal Directive 2001/37/EC and, for reasons of
clarity, to replace it with a new act modelled on the Directive in force but
enriched with new elements and adjustments.

4.           Budgetary implications

The budgetary implications of the proposal are
as follows:

Ÿ        Commission staff to continue to manage and further develop
the EU regulatory framework on tobacco products’ regulation (functioning of
this Directive and drafting of delegated/implementing acts), including
Commission bodies or staff to provide scientific opinion and technical support.

Ÿ        Commission staff to continue to support Member States in
ensuring its effective and efficient implementation, including the development
of an implementation plan and a network of Member States to discuss
implementation.

Ÿ        Costs for continue organising meetings of the Committee set
up under this Directive, including reimbursement of the members appointed by
the Member States.

Ÿ        Costs for further development of a new EU wide electronic
format for ingredients reporting.

Ÿ        Costs for coordination of new test panels approved and
monitored by Member States.

Ÿ        Costs for continuing to keep the health warnings up to date,
including testing of new warnings.

Ÿ        Costs for continuing participation in international
cooperation.

Details of the costs are set out in the
legislative financial statement. The proposal allows Member States to charge a
fee for handling the ingredients reporting.

The budgetary impact is consistent with the MFF
2014-2020 as proposed by the Commission.

2012/0366 (COD)

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

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the
Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the European
Commission,

After transmission of the draft legislative
act to the national Parliaments,

Having regard to the opinion of the European
Economic and Social Committee,

Having regard to the opinion of the
Committee of the Regions,

Acting in accordance with the ordinary legislative
procedure,

Whereas:

(1)       Directive 2001/37/EC of
the European Parliament and of the Council of 5 June 2001 on the approximation
of the laws, regulations and administrative provisions of the Member States
concerning the manufacture, presentation and sale of tobacco products[30] lays down rules at Union level
concerning tobacco products. Due to scientific, market and international
developments, substantial changes are to be made to that Directive. For the
sake of clarity it is appropriate to repeal Directive 2001/37/EC and to replace
it by a new Directive.

(2)       In its reports of 2005 and
2007 on the application of Directive 2001/37/EC, submitted in accordance with
Article 11 of that Directive, the Commission identified areas in which further
action was considered useful[31].
In 2008 and 2010 the Scientific Committee on Emerging and
Newly Identified Health Risks (SCENIHR) provided
scientific advice to the Commission on smokeless tobacco products and tobacco
additives[32].
In 2010 a broad stakeholder consultation took place[33], which was followed by
targeted stakeholder consultations and accompanied by studies by external
consultants. Member States were consulted throughout the process. The European
Parliament and the Council repeatedly called on the Commission to review and
update Directive 2001/37/EC[34].

(3)       In certain areas covered
by Directive 2001/37/EC Member States are de jure or de facto prevented from effectively
adapting their legislation to new developments. This is of relevance in
particular for the labelling rules, where Member States cannot increase the
size of the health warnings, change their location on the unit packets or
replace the misleading warnings on the tar, nicotine and carbon monoxide (TNCO)
levels.

(4)       In other areas there are
still substantial differences between the Member States' laws, regulations and
administrative provisions on the manufacture, presentation, and sale of tobacco
and related products which impede the functioning of the internal market. In
the light of scientific, market and international developments these
discrepancies are expected to increase. This applies in particular to nicotine
containing products, herbal products for smoking, ingredients and emissions,
certain aspects of labelling and packaging and the cross-border distance sales
of tobacco products.

(5)       Those barriers should be
eliminated and, to this end, the rules relating to the manufacture,
presentation and sale of tobacco and related products should be further approximated.

(6)       The size of the internal
market in tobacco and related products, the increasing tendency of
manufacturers of tobacco products to concentrate production for the whole of
the Union in only a small number of production plants within the Member States
and the resulting significant cross-border trade of tobacco and related
products calls for legislative action at Union rather than national level to
achieve the smooth operation of the internal market.

(7)       Legislative action at
Union level is also necessary to implement the WHO Framework Convention on
Tobacco Control (hereinafter: "FCTC") of May 2003 to which the
European Union and its Member States are Parties[35]. Of relevance are in
particular its Articles 9 (regulation of the contents
of tobacco products), 10 (regulation
of tobacco product disclosures), 11 (packaging and labelling of tobacco products), 13 (advertising) and 15 (illicit trade in tobacco products). A set of guidelines for the implementation of FCTC provisions was
adopted by consensus during various Conferences of the Parties to the FCTC with
the support of the Union and the Member States.

(8)       In accordance with Article
114(3) of the Treaty of the Functioning of the European Union (hereinafter:
"Treaty"), a high level of health protection should be taken as a
basis, regard being had, in particular, to any new developments based on
scientific facts. Tobacco products are not ordinary commodities and in view of
the particularly harmful effects of tobacco, health protection should be given high
importance, in particular to reduce smoking prevalence among young people. .

(9)       Directive 2001/37/EC established
maximum limits for tar, nicotine and carbon monoxide yields that should be
applicable also for products which are exported from the Union. These maximum
limits and this approach remain valid.

(10)     For measuring the tar,
nicotine and carbon monoxide yields of cigarettes, reference should be made to
ISO standards 4387, 10315 and 8454, which are internationally recognised
standards. For other emissions there are no internationally agreed standards or
tests for quantifying the yields, but efforts are ongoing to develop them.

(11)     In relation to the fixing
of maximum yields, it might be necessary and appropriate at a later date to adapt
the yields fixed or to fix maximum thresholds for emissions, taking into
consideration their toxicity or addictiveness.

(12)     In order to exercise their
regulatory function, Member States and the Commission require comprehensive
information on ingredients and emissions to assess the attractiveness,
addictiveness and toxicity of tobacco products and the risks to health
associated with the consumption of such products. To this end, the existing
reporting obligations for ingredients and emissions should be reinforced. This
is consistent with the obligation placed on the Union to ensure a high level of
protection for human health.

(13)     The current use of
different reporting formats makes it difficult for manufacturers and importers to
fulfil their reporting obligations and burdensome for the Member States and the
Commission to compare, analyse and draw conclusions from the information
received. In this light there should be a common mandatory format for the
reporting of ingredients and emissions. The greatest possible transparency of
product information should be ensured for the general public, while ensuring
that appropriate account is taken of the commercial and intellectual property
rights of the manufacturers of tobacco products.

(14)     The lack of a harmonised
approach on ingredients regulation affects the functioning of the internal
market and impacts on the free movement of goods across the EU. Some Member
States have adopted legislation or entered into binding agreements with the
industry allowing or prohibiting certain ingredients. As a result, some
ingredients are regulated in some Member States, but not in others. Member
States are also taking different approaches as regards additives integrated in
the filter of cigarettes as well as additives colouring the tobacco smoke. Without
harmonisation, the obstacles on the internal market are expected to increase in
the coming years taking into account the implementation of the FCTC and its
guidelines and considering experience gained in other jurisdictions outside the
Union. The guidelines on Articles 9 and 10 FCTC call in particular for the
removal of ingredients that increase palatability, create the impression that
the tobacco products have health benefits, are associated with energy and
vitality or have colouring properties.

(15)     The likelihood of diverging
regulation is further increased by concerns over tobacco products, including
smokeless tobacco products, having a characterising flavour other than tobacco,
which may facilitate uptake of tobacco consumption or affect consumption
patterns. For example, in many countries, sales of mentholated products
gradually increased even as smoking prevalence overall declined. A number of
studies indicated that mentholated tobacco products can facilitate inhalation
as well as smoking uptake among young people. Measures introducing unjustified
differences of treatment between flavoured cigarettes (e.g. menthol and clove
cigarettes) should be avoided[36].

(16)     The prohibition of tobacco
products with characterising flavours does not prohibit the use of individual
additives altogether, but obliges the manufactures to reduce the additive or
the combination of additives to such an extent that the additives no longer
result in a characterising flavour. The use of additives necessary for
manufacturing of tobacco products should be allowed, as long as they do not
result in a characterising flavour.. The Commission should ensure uniform
conditions for the implementation of the provision on characterising flavour.
Independent panels should be used by the Member States and by the Commission to
assist in such decision making. The application of this Directive should not
discriminate between different tobacco varieties.

(17)     Certain additives are used
to create the impression that tobacco products have health benefits, present
reduced health hazards or increase mental alertness and physical performance. These
additives should be prohibited in order to ensure uniform rules and a high
level of health protection.

(18)     Considering the Directive's
focus on young people, tobacco products other than cigarettes, roll-your-own
tobacco and smokeless tobacco which are mainly consumed by older consumers, should
be granted an exemption from certain ingredients requirements as long as there
is no substantial change of circumstances in terms of sales volumes or consumption
patterns in relation to young people.

(19)     Disparities
still exist between national provisions regarding the labelling of tobacco
products, in particular with regard to the use of combined health warnings
consisting of a picture and a text, information on cessation services and
promotional elements in and on packets.

(20)     Such disparities are liable
to constitute a barrier to trade and to impede the operation of the internal
market in tobacco products, and should therefore be eliminated. Also, consumers
in some Member States may be better informed about the health risks of tobacco
products than in others. Without further action at
Union level, the existing disparities are likely to increase in the coming years.

(21)     Adaptation
of the labelling provisions is also necessary to align the rules at Union level
with international developments. For example the
guidelines on Article 11 FCTC call for large picture warnings on both principal
display areas, mandatory cessation information and strict rules on misleading
information. The provisions on misleading information will complement the
general ban on misleading business to consumer commercial practices laid down
in Directive 2005/29/EC of the European Parliament and of the Council of 11 May
2005 concerning unfair buiness-to-consumer commercial practices in the internal
market[37].

(22)     The labelling provisions also
need to be adapted to new scientific evidence. For example the indication of
the yields for tar, nicotine and carbon monoxide on cigarette packets have
proven to be misleading as it makes consumers believe that certain cigarettes
are less harmful than others. Evidence also suggests that large combined health
warnings are more effective than text-only warnings. In this light combined
health warnings should become mandatory throughout the Union and cover
significant and visible parts of the packet surface. A minimum size should be
set for all health warnings to ensure their visibility and effectiveness.

(23)     In order to ensure the
integrity and the visibility of health warnings and maximise their efficacy,
provisions should be made regarding the dimension of the warnings as well as
regarding certain aspects of the appearance of the tobacco package, including
the opening mechanism. The package and the products may mislead consumers, in
particular young people, suggesting that products are less harmful. For
instance, this is the case with certain texts or features, such as ‘low-tar’,
‘light’, ‘ultra-light’, ‘mild’, 'natural', 'organic', ‘without additives’, ‘without
flavours’, 'slim', names, pictures, and figurative or other signs. Likewise,
the size and appearance of individual cigarettes can mislead consumers by
creating the impression that they are less harmful. A recent study has also
shown that smokers of slim cigarettes were more likely to believe that their
own brand might be less harmful. This should be addressed.

(24)     Tobacco
products for smoking, other than cigarettes and roll-your-own tobacco products,
which are mainly consumed by older consumers, should be granted an exemption
from certain labelling requirements as long as there is no substantial change of circumstances in terms
of sales volumes or consumption patterns in relation to young people. The labelling of
these other tobacco products should follow specific rules. The visibility of
the health warnings on smokeless tobacco products needs to be ensured. Warnings
should therefore be placed on the two main surfaces of smokeless tobacco
product packaging.

(25)     Member
States apply different rules on minimum number of cigarettes per packet. Those
rules should be aligned in order to ensure free circulation of the concerned
products.

(26)     Considerable
volumes of illicit products, which do not comply with the requirements laid
down in Directive 2001/37/EC, are placed on the market and indications are that these volumes might increase. Such products
undermine the free circulation of compliant products and the protection provided for by tobacco control legislations. In
addition, the FCTC obliges the Union to fight against illicit products, as part
of a comprehensive tobacco control policy. Provision should thus be made for
unit packets of tobacco products to be marked in a unique and secure way and
their movements to be recorded so that these products can be tracked and traced
in the Union and their compliance with this Directive can be monitored and
better enforced. In addition, provision should be made for the introduction of
security features that will facilitate the verification of whether or not products
are authentic.

(27)     An
interoperable tracking and tracing system and a common security feature should
be developed. For an initial period only cigarettes and roll-your-own tobacco
should be subjected to the tracking and tracing system and the security
features. This would allow producers of other tobacco products to benefit from
the experiences gained in the meantime.

(28)     In
order to ensure independence and transparency, manufacturers of tobacco
products should conclude data storage contracts with independent third parties,
under the auspices of an external auditor. The data related to the tracking and
tracing system should be kept separate from other company related data and be
under the control of and accessible at all times by the competent authorities
from Member States and the Commission.

(29)     Council
Directive 89/622/EEC of 13 November 1989 on the approximation of the laws,
regulations and administrative provisions of the Member States concerning the
labelling of tobacco products and the prohibition of the marketing of certain
types of tobacco for oral use[38] prohibited the sale in the Member States of
certain types of tobacco for oral use. Directive 2001/37/EC confirmed this
prohibition. Article 151 of the Act of Accession of Austria, Finland and Sweden
grants the Kingdom of Sweden derogation from this prohibition[39]. The prohibition of the sale
of oral tobacco should be maintained in order to prevent the introduction to
the internal market of a product that is addictive, has adverse health effects
and is attractive to young people. For other smokeless tobacco products that
are not produced for the mass market, a strict labelling and ingredients
regulation is considered sufficient to contain market expansion beyond their traditional
use.

(30)     Cross-border
distance sales of tobacco facilitate access to tobacco products of young people
and risk to undermine compliance with the requirements provided for by tobacco
control legislation and in particular by this Directive. Common rules on a
notification system are necessary to ensure that this Directive achieves its
full potential. The provision on notification of cross-border distance sales of
tobacco in this Directive should apply notwithstanding the notification
procedure set out in Directive 2000/31/EC of the European Parliament and of the
Council of 8 June 2000 on
certain legal aspects of information society services[40]. Business to consumer distance
sale of tobacco products is further regulated by Directive 97/7/EC of the
European Parliament and the Council of 20 May 1997 on the protection of
consumers in respect of distance contracts, which will be replaced by Directive
2011/83/EU of the European Parliament and the Council of 25 October 2011 on consumer
rights, as of 13 June 2014.[41]

(31)     All
tobacco products have the potential to cause mortality, morbidity and
disability and their consumption should be contained. It is therefore important
to monitor developments as regards novel tobacco products. A notification
obligation for novel tobacco products should be put on manufacturers and
importers, without prejudice to the power of the Member States to ban or to
authorise them. The Commission should monitor the development and submit a
report 5 years after the transposition deadline of this Directive, in order to
assess whether amendments to this Directive are necessary.

(32)     In
order to ensure a level playing field, novel tobacco products, which are
tobacco products in the sense of this Directive, should respect the
requirements provided for in this Directive.

(33)     Nicotine-containing
products are sold on the Union market. The different regulatory approaches
taken by Member States to address health and safety concerns associated with
these products have a negative impact on the functioning of the internal market,
in particular considering that these products are subject to significant cross-border
distance sales including via the internet.

(34)     Directive
2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products
for human use[42] provides a legal framework to assess
the quality, safety and efficacy of medicinal products including nicotine containing
products. A significant number of nicotine-containing products were already
authorised under this regulatory regime. The authorisation takes into account
the nicotine content of the product in question. Subjecting all nicotine-containing
products, whose nicotine content equals or exceeds the content of a nicotine
containing product previously authorised under Directive 2001/83/EC, to the same
legal framework clarifies the legal situation, levels out differences between
national legislations, ensures equal treatment of all nicotine containing
products usable for smoking cessation purposes and creates incentives for
research and innovation in smoking cessation. This should be without prejudice
to the application of Directive 2001/83/EC to other products covered by this
Directive if the conditions set by Directive 2001/83/EC are fulfilled.

(35)     Labelling provisions should
be introduced for nicotine containing products below the threshold set out in
this Directive drawing the attention of consumers to potential health risks.

(36)     The
regulation of herbal products for smoking differs between Member States and
these products are often perceived as harmless or less harmful despite the
health risk caused by their combustion. In order to ensure the proper
functioning of the internal market and improve information to consumers, common
labelling rules should be introduced at Union level.

(37)     In
order to ensure uniform conditions for the implementation of this Directive, in
particular concerning the format of ingredients reporting, the determination of
products with characterising flavours or with increased levels of toxicity and addictiveness
and the methodology for determining whether a tobacco product has
characterising flavour, implementing powers should be conferred on the
Commission. Those powers should be exercised in accordance with Regulation (EU)
No 182/2011[43].

(38)     In
order to make this Directive fully operational and to keep up with technical,
scientific and international developments in tobacco manufacture, consumption
and regulation, the power to adopt acts in accordance with Article 290 of the
Treaty on the Functioning of the European Union should be delegated to the
Commission, in particular in respect of adopting and adapting maximum yields
for emissions and their measurement methods, setting maximum levels for
ingredients that increase toxicity, addictiveness or attractiveness, , the use
of health warnings, unique identifiers and security features in the labelling
and packaging, defining key elements for contracts on data storage with
independent third parties, reviewing certain exemptions granted to tobacco
products other than cigarettes, roll-your-own tobacco and smokeless tobacco
products and reviewing the nicotine levels for nicotine containing products. It
is of particular importance that the Commission carries out appropriate
consultations during its preparatory work, including at expert level. The
Commission, when preparing and drawing up delegated acts, should ensure a
simultaneous, timely and appropriate transmission of relevant documents to the
European Parliament and Council.

(39)     The
Commission should monitor the developments and submit a report 5 years after
the date of transposition of this Directive, in order to assess whether
amendments to this Directive are necessary.

(40)     A
Member State that deems it necessary to maintain more stringent national
provisions for aspects falling inside the scope of this Directive should be
allowed to do so, for all products alike, on grounds of overriding needs
relating to the protection of public health. A Member State should also be
allowed to introduce more stringent provisions, applying to all products alike,
on grounds relating to the specific situation of this Member State and provided
the provisions are justified by the need to protect public health. More
stringent national provisions should be necessary and proportionate, not
constitute a means of arbitrary discrimination or a disguised restriction on
trade between Member States. Stricter national provisions require prior
notification to, and approval from, the Commission taking into account the high
level of health protection achieved through this Directive.

(41)     Member States should remain
free to maintain or introduce national legislations applying to all products
alike for aspects falling outside the scope of this Directive, provided they
are compatible with the Treaty and do not jeopardise the full application of
this Directive. Accordingly, Member States could, for instance, maintain or
introduce provisions providing standardisation of packaging of tobacco products
provided that those provisions are compatible with the Treaty, with WTO
obligations and do not affect the full application of this Directive. A prior
notification is required for technical regulations pursuant to Directive
98/34/EC of the European Parliament and of the Council of 22 June 1998 laying
down a procedure for the provision of information in the field of technical
standards and regulations and on rules on Information Society services[44].

(42)     Member
States should ensure that personal data are only processed in accordance with the
rules and safeguards laid down in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the
protection of individuals with regard to the processing of personal data and on
the free movement of such data[45].

(43)     The
provisions of this Directive are without prejudice to Union legislation
governing the use and labelling of genetically modified organisms.

(44)     In
accordance with the Joint Political Declaration of Member States and the
Commission of 28 September 2011 on explanatory documents, Member States have
undertaken to accompany, in justified cases, the notification of their
transposition measures with one or more documents explaining the relationship
between the components of a directive and the corresponding parts of national
transposition instruments. With regard to this Directive, the legislator
considers the transmission of such documents to be
justified.

(45)     The proposal affects
several fundamental rights as laid down in the Charter of Fundamental Rights of
the European Union, notably the protection of personal data (Article 8), the
freedom of expression and information (Article 11), freedom of economic
operators to conduct business (Article 16), and the right to property (Article 17).
The obligations imposed on manufacturers, importers and distributors of tobacco
products are necessary to improve the functioning of the internal market while
ensuring a high level of health and consumer protection as set out in Articles
35 and 38 of the Charter of Fundamental Rights of the European Union. The application of this Directive should respect the EU law and
relevant international obligations.

HAVE ADOPTED THIS DIRECTIVE:

TITLE I –
COMMON PROVISIONS

Article 1

Aim

The aim of
this Directive is to approximate the laws, regulations and administrative
provisions of the Member States concerning:

(a)
the ingredients and emissions of tobacco
products and related reporting obligations including the maximum yields for tar,
nicotine and carbon monoxide for cigarettes;

(b)
the labelling and packaging of tobacco products
including the health warnings to appear on unit packets of tobacco products and
any outside packaging as well as traceability and security features to ensure
compliance with this Directive;

(c)
the prohibition to place on the market tobacco
for oral use;

(d)
cross-border distance sales of tobacco products;

(e)
the notification obligation for novel tobacco
products;

(f)
the placing on the market and the labelling of
certain products, which are related to tobacco products, namely
nicotine-containing products and herbal products for smoking;

in order to
facilitate the functioning of the internal market in tobacco and related
products, taking as a basis a high level of health protection.

Article 2

Definitions

For the purposes of this Directive, the
following definitions shall apply:

(1)
'addictiveness' means the pharmacological
potential of a substance to cause addiction, a state which affects an
individual’s ability to control behaviour typically by instilling a reward or a
relief from withdrawal symptoms, or both;

(2)
'additive' means substance contained in a tobacco
product, its unit packet or any outside packaging with the exception of tobacco
leaves and other natural or unprocessed parts of tobacco plants;

(3)
'age verification system' means a computing system
that unambigouisly confirms the consumer's age in electronic form according to
national requirements;

(4)
'characterising flavour' means a distinguishable
aroma or taste other than tobacco, resulting from an additive or combination of
additives, including but not limited to fruit, spice, herb, alcohol, candy,
menthol or vanilla observable before or upon intended use of the tobacco
product;

(5)
'chewing tobacco' means a smokeless tobacco product
exclusively designed for the purpose of chewing;

(6)
'cigar' means a roll of tobacco consumed via a
combustion process and further defined in Article 4(1) of Council Directive
2011/64/EU of 21 June 2011 on the structure and rates of excise duty applied to
manufactured tobacco[46];

(7)
'cigarette' means a roll of tobacco consumed via a
combustion process and further defined in Article 3(1) of Council Directive
2011/64/EU;

(8)
'cigarillo' means a small type of cigar with a
diameter of up to 8 mm;

(9)
'combined health warning' means a health warning
provided for in this Directive and consisting of a combination of a text
warning and a corresponding photograph or illustration;

(10)
'consumer' means a natural person who is acting for
purposes which are outside his trade, business, craft or profession;

(11)
'cross-border distance sales' means a distance
sales service where, at the time the consumer orders the product, the consumer
is located in a Member State other than the Member State or the third country
where the retail outlet is established; a retail outlet is deemed to be
established in a Member State:

(a)
in the case of a natural person - if he/she has
his/her place of business in that Member State;

(b)
in other cases - if it has its statutory seat,
central administration or place of business, including a branch, agency or any
other establishment in that Member State;

(12)
'emissions' means substances that are released when
a tobacco product is used as intended, such as substances found in smoke, or
substances released during the process of using smokeless tobacco products;

(13)
'flavouring' means an additive that imparts aroma
and/or taste;

(14)
'health warning' means a warning provided for in
this Directive, including text warnings, combined health warnings, general
warnings and information messages;

(15)
'herbal product for smoking' means a product based
on plants or herbs which contains no tobacco and is consumed via a combustion
process;

(16)
'import of tobacco and related products' means the
entry into the territory of the Union of such products unless the products upon
their entry into the Union are placed under a customs suspensive procedure or
arrangement, as well as their release from a customs suspensive procedure or
arrangement;

(17)
'importer of tobacco and related products' means the
owner or a person having the right of disposal over tobacco and related
products that have been brought into the territory of the Union;

(18)
'ingredient' means an additive, tobacco (leaves and
other natural, processed or unprocessed parts of tobacco plants including
expanded and reconstituted tobacco), as well as any substance present in a
finished tobacco product including paper, filter, inks, capsules and adhesives;

(19)
'maximum level' or 'maximum yield' means the
maximum content or emission, including 0, of a substance in a tobacco product
measured in grams;

(20)
'nasal tobacco' means a smokeless tobacco product consumed
via the nose;

(21)
'nicotine' means nicotinic alkaloids;

(22)
'nicotine-containing product' means a product
usable for consumption by consumers via inhalation, ingestion or in other forms
and to which nicotine is either added during the manufacturing process or
self-administered by the user before or during consumption;

(23)
'novel tobacco product' means a tobacco product
other than a cigarette, roll-your-own tobacco, pipe tobacco, water-pipe
tobacco, cigar, cigarillo, chewing tobacco, nasal tobacco or tobacco for oral
use placed on the market after entry into force of this Directive;

(24)
'outside packaging' means any packaging in which
products are placed on the market and which include a unit packet or an
aggregation of unit packets; transparent wrappers are not regarded as outside
packaging;

(25)
'place on the market' means to make products available
to consumers located in the Union, with or without payment, including by means
of distance sale; in case of cross-border distance sales the product is deemed
to be placed on the market in the Member State where the consumer is located;

(26)
'pipe tobacco' means tobacco consumed via a
combustion process and exclusively designed for the purpose of being used in a
pipe;

(27)
'retail outlet' means any outlet where tobacco
products are placed on the market including by a natural person;

(28)
'roll-your-own tobacco' means tobacco which can be
used for making cigarettes by consumers or retail outlets;

(29)
'smokeless tobacco product' means a tobacco product
not involving a combustion process, including chewing tobacco, nasal tobacco
and tobacco for oral use;

(30)
'substantial change of circumstances' means an
increase of the sales volumes by product category, such as pipe tobacco, cigar,
cigarillo, by at least 10% in at least 10 Member States based on sales
data transmitted in accordance with Article 5(4); or an increase of the
prevalence level in the consumer group under 25 years of age by at least 5 percentage
points in at least 10 Member States for the respective product category based
on \_\_\_\_ [this date will be set at the moment of adoption of the Directive]
Eurobarometer report or equivalent prevalence studies;

(31)
'tar' means the raw anhydrous nicotine-free
condensate of smoke;

(32)
'tobacco for oral use' means all products for oral
use, except those intended to be inhaled or chewed, made wholly or partly of
tobacco, in powder or in particulate form or in any combination of those forms,
particularly those presented in sachet portions or porous sachets;

(33)
'tobacco for smoking' means a tobacco product other
than a smokeless tobacco product;

(34)
'tobacco products' means products usable for
consumption by consumers and consisting of, even partly, tobacco, whether
genetically modified or not;

(35)
'toxicity' means the degree to which a substance
can cause harmful effects in the human organism, including effects occuring
over time, usually upon repeated or continuous consumption or exposure;

(36)
'unit packet' means the smallest individual
packaging of a product that is placed on the market.

TITLE II –
TOBACCO PRODUCTS

Chapter I:
Ingredients and emissions

Article 3

Maximum
tar, nicotine, carbon monoxide and other yields

1.           The yield of cigarettes placed
on the market or manufactured in the Member States shall not be greater than:

(a)
10 mg per cigarette for tar,

(b)
1 mg per cigarette for nicotine,

(c)
10 mg per cigarette for carbon monoxide.

2.           The Commission shall be
empowered to adopt delegated acts in accordance with Article 22 to adapt the
maximum yields laid down in paragraph 1, taking into account scientific
development and internationally agreed standards.

3.           Member States shall notify
the Commission of the maximum yields that they set for other emissions of
cigarettes and for emissions of tobacco products other than cigarettes. Taking
into account internationally agreed standards, where available, and based on
scientific evidence and on the yields notified by Member States, the Commission
shall be empowered to adopt delegated acts in accordance with Article 22
to adopt and adapt maximum yields for other emissions of cigarettes and for
emissions of tobacco products other than cigarettes that increase in an
appreciable manner the toxic or addictive effect of tobacco products beyond the
threshold of toxicity and addictiveness stemming from the yields of tar,
nicotine and carbon monoxide fixed in paragraph 1.

Article 4

Measurement
methods

1.           The tar, nicotine and
carbon monoxide yields of cigarettes shall be measured on the basis of ISO
standards 4387 for tar, 10315 for nicotine, and 8454 for carbon monoxide.

The accuracy of the tar and nicotine indications
shall be verified in accordance with ISO standard 8243.

2.           The measurement referred
to in paragraph 1 shall be carried out or verified by testing laboratories
which are approved and monitored by the competent authorities of the Member
States.

Member States shall send the Commission a list
of approved laboratories, specifying the criteria used for approval and the
methods of monitoring applied, and update it whenever any change is made. The
Commission shall make the list of approved laboratories as indicated by Member
States publicly available.

3.           The Commission shall be
empowered to adopt delegated acts in accordance with Article 22 to adapt the
methods of measurement of the tar, nicotine and carbon monoxide yields, taking
into account scientific and technical developments and internationally agreed
standards.

4.           Member States shall notify
the Commission of the methods of measurement that they use for other emissions of
cigarettes and for emissions of tobacco products other than cigarettes. Based
on these methods, and taking into account scientific and technical developments
as well as internationally agreed standards the Commission shall be empowered
to adopt delegated acts in accordance with Article 22 to adopt and adapt
methods of measurement.

Article 5

Reporting
of ingredients and emissions

1.           Member States shall
require manufacturers and importers of tobacco products to submit to their
competent authorities a list of all ingredients, and quantities thereof, used
in the manufacture of the tobacco products by brand name and type, as well as
their emissions and yields. Manufacturers or importers
shall also inform the competent authorities of the concerned Member States if
the composition of a product is modified affecting the information provided
under this Article. Information required under this Article shall be submitted
prior to the placing of the market of a new or modified tobacco product.

The list shall be
accompanied by a statement setting out the reasons for the inclusion of such
ingredients in those tobacco products. The list shall indicate their status,
including whether the ingredients have been registered under Regulation (EC) No 1907/2006 of the European Parliament and of the
Council of 18 December 2006
concerning the Registration, Evaluation, Authorisation and Restriction of
Chemicals (REACH)[47]
as well as their classification under Regulation (EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on classification, labelling and packaging of substances and
mixtures[48]. The list shall also be accompanied by the toxicological data
available to the manufacturer or importer regarding these ingredients in burnt
or unburnt form as appropriate, referring in particular to their effects on
health of consumers and taking into account, inter alia, any addictive
effects. The list shall be established in descending order of the weight of
each ingredient included in the product. Other than for tar, nicotine and
carbon monoxide and for emissions referred to in Article 4 paragraph 4, the
manufacturers and importers shall indicate the measurement methods used. Member States may also require manufacturers or importers to carry
out other tests as may be laid down by the competent national authorities in
order to assess the effects of substances on health, taking into account, inter
alia, their addictiveness and toxicity.

2.           Member States shall ensure
the dissemination of information submitted in accordance with paragraph 1 on a
dedicated website, which is available to the general public. In doing so Member
States shall take due account of the need to protect information which
constitues a trade secret.

3.           The
Commission shall, by means of implementing acts, lay down and if necessary
update the format for the submission and dissemination of the information
specified in paragraphs 1 and 2. Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 21.

4.           Member
States shall require manufacturers and importers to submit internal and external
studies available to them on market research and preferences of various consumer
groups, including young people, relating to ingredients and emissions. Member
States shall also require manufacturers and importers to report the sales
volume data per product, reported in sticks or kilograms, and per Member State
on a yearly basis starting from the full calendar year following that of the
entry into force of this Directive. Member States shall provide alternative or
additional sales data, as appropriate, to ensure that information on sales
volume requested under this paragraph is reliable and complete.

5.           All
data and information to be provided to and by Member States under this Article
shall be provided in electronic form. Member States shall store the information
electronically and shall ensure that the Commission has access to the
information at all times. Other Member States shall have access to this
information upon justified request. Member States and the Commission shall
ensure that trade secrets and other confidential information are treated in a
confidential manner.

6.           Fees
charged by Member States for receiving, storing, handling, analysing and
publishing the information submitted to them under this Article, if any, shall
not exceed the cost attributable to those activities.

Article 6

Regulation of ingredients

1.           Member
States shall prohibit the placing on the market of tobacco products with a
characterising flavour.

Member States shall not prohibit the use of
additives which are essential for the manufacture of tobacco products, as long
as the additives do not result in a product with a
characterising flavour.

Member States shall notify the Commission of
measures taken pursuant to this paragraph.

2.           The Commission shall at
the request of a Member State or may on its own initiative determine by means
of implementing acts whether a tobacco product falls within the scope of
paragraph 1. Those implementing acts shall be adopted in accordance with the
examination procedure referred to in Article 21.

The Commission shall adopt by means of
implemeting acts uniform rules on the procedures for determining whether a
tobacco product falls within the scope of paragraph 1. Those implementing acts
shall be adopted in accordance with the examination procedure referred to in
Article 21.

3.           In case
the experience gained in the application of paragraphs 1 and 2 shows that a
certain additive or a combination thereof typically impart a characterising
flavour when it exceeds a certain level of presence or concentration the
Commission shall be empowered to adopt delegated acts in accordance with
Article 22 to set maximum levels for those additives or combination of
additives that cause the characterising flavour.

4.           Member
States shall prohibit the use of the following additives in tobacco products:

(a)     vitamins and other additives that create
the impression that a tobacco product has a health benefit or presents reduced
health hazards, or

(b)     caffeine and taurine and other additives
and stimulant compounds that are associated with energy and vitality, or

(c)     additives having colouring properties for
emissions.

5.           Member
States shall prohibit the use of flavourings in the components of tobacco
products such as filters, papers, packages, capsules or any technical features
allowing modification of flavour or smoke intensity. Filters and capsules shall
not contain tobacco.

6.           Member
States shall ensure that provisions or conditions set out under Regulation (EC)
No 1907/2006 are applied to tobacco products as appropriate.

7.           Member
States shall, based on scientific evidence, prohibit the placing on the market
of tobacco products with additives in quantities that increase in an
appreciable manner at the stage of consumption the toxic or addictive effect of
a tobacco product.

Member States shall notify to the Commission
measures taken pursuant to this paragraph.

8.           The
Commission shall at the request of a Member State or may on its own initiative
determine by means of an implementing act whether a tobacco product falls
within the scope of paragraph 7. Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 21 and shall
be based on the latest scientific evidence.

9.           In
case scientific evidence and the experience gained in the application of
paragraphs 7 and 8 shows that a certain additive or a certain quantity thereof
amplify in an appreciable manner at the stage of consumption the toxic or
addictive effect of a tobacco product the Commission shall be empowered to
adopt delegated acts in accordance with Article 22 to set maximum levels for those
additives.

10.         Tobacco
products other than cigarettes, roll-your-own tobacco and smokeless tobacco
products shall be exempted from the prohibitions laid down in paragraphs 1 and
5. The Commission shall be empowered to adopt delegated acts in accordance with
Article 22 to withdraw this exemption if there is a substantial change of
circumstances as established in a Commission report.

Chapter II: Labelling and packaging

Article 7

General provisions

1.           Each
unit packet of tobacco products and any outside packaging shall carry health
warnings in the official language or languages of the Member State where the
product is placed on the market.

2.           Health
warnings shall occupy the entire surface reserved for them and they shall not
be commented on, paraphrased or referred to in any form.

3.           In order to ensure their
graphic integrity and visibility, health warnings shall be irremovably printed,
indelible and in no way hidden or interrupted, including by tax stamps, price
marks, tracking and tracing marks, security features or by any type of wrapper,
pouch, jacket, box or other device or by the opening of the unit packet.

4.           Member
States shall ensure that the health warnings of the main surface of the unit packet
and any outside packaging are fully visible, including not being partially or
totally hidden or interrupted by wrappers, pouches, jacket, boxes or other
devices when tobacco products are placed on the market.

5.           The
health warnings shall in no way hide or interrupt the tax stamps, price marks,
tracking and tracing marks, or security features on unit packets.

6.           Member
States shall not increase the size of the health warnings including by
introduction of an obligation to surround the health warnings by a border. The
actual size of the health warnings shall be calculated in relation to the
surface on which they are placed before the unit packet is opened.

7.           Images
of unit packets and any outside packaging targeting consumers in the Union
shall comply with the provisions of this chapter.

Article 8

Text
warnings for tobacco for smoking

1.           Each
unit packet and any outside packaging of tobacco for smoking shall carry the
following general warning:

Smoking kills – quit now

2.           Each
unit packet and any outside packaging of tobacco for smoking shall carry the
following information message:

Tobacco smoke contains over 70 substances known
to cause cancer

3.           For
cigarette packets the general warning and the information message shall be
printed on the lateral sides of the unit packets. These warnings shall have a
width of not less than 20 mm and a height of not less than 43 mm. For
roll-your-own tobacco the information message shall be printed on the surface
that becomes visible when opening the unit packet. Both the general warning and
the information message shall cover 50% of the surface on which they are
printed.

4.           The
Commission shall be empowered to adopt delegated acts in accordance with Article
22:

(a)
to adapt the wording of the health warnings laid
down in paragraphs 1 and 2 to scientific and market developments;

(b)
to define the position, format, layout and design of
the health warnings laid down in this Article, including their font type and
background colour.

Article 9

Combined health warnings for tobacco for smoking

1.           Each
unit packet and any outside packaging of tobacco for smoking shall carry
combined health warnings. The combined health warnings shall:

(a)
be comprised of a text warning listed in Annex I
and a corresponding colour photograph specified in the picture library;

(b)
include smoking cessation information such as phone
numbers, e-mail addresses and/or Internet sites designed to inform consumers
about the programmes available to support those who want to stop smoking;

(c)
cover 75 % of the external area of both the front
and back surface of the unit packet and any outside packaging;

(d)
show the same text warning and corresponding colour
photograph on both sides of the unit packets and any outside packaging;

(e)
be positioned at the top edge of the unit packet
and any outside packaging, and in the same direction as any other information
appearing on the packaging;

(f)
be reproduced in accordance with the format,
layout, design and proportions specified by the Commission pursuant to
paragraph 3;

(g)
for unit packets of cigarettes, respect the
following dimensions:

(i)      height: not less than 64 mm;

(ii)      width: not less than 55 mm.

2.           The
combined health warnings shall be divided into three sets rotating on an annual
basis. Member States shall ensure that each combined health warning is
displayed as nearly as possible on equal numbers of each brand.

3.           The
Commission shall be empowered to adopt delegated acts in accordance with
Article 22 to:

(a)
adapt the text warnings listed in Annex I to this
Directive taking into account scientific and technical developments;

(b)
establish and adapt the picture library referred to
in point (a) of paragraph 1 of this Article taking into account scientific and
market developments;

(c)
define the position, format, layout, design,
rotation and proportions of the health warnings;

(d)
by way of derogation from Article 7(3), lay down
the conditions under which health warnings may be broken during unit packet
opening in a manner that ensures the graphical integrity and visibility of the
text, photographs and cessation information.

Article 10

Labelling
of tobacco for smoking other than cigarettes and roll-your-own tobacco

1.           Tobacco
for smoking other than cigarettes and roll-your-own tobacco shall be exempted
from the obligations to carry the information message laid down in
Article 8(2) and the combined health warnings in Article 9. In addition to
the general warning specified in Article 8(1), each unit packet and any outside
packaging of these products shall carry a text warning listed in Annex I. The
general warning specified in Article 8(1) shall include a reference to the
cessation services in accordance with Article 9(1)(b).

The general warning shall be printed on the
most visible surface of the unit packet and any outside
packaging. The text warnings listed in Annex I shall be
rotated in such a way as to guarantee their regular appearance. These warnings
shall be printed on the other most visible surface of the unit packet and any outside packaging.

2.           The general warning referred
to in paragraph 1 shall cover 30 % of the external area of the
corresponding surface of the unit packet and any outside packaging. That
proportion shall be increased to 32 % for Member States with two official
languages and 35 % for Member States with three official languages.

3.           The text warning referred
to in paragraph 1 shall cover 40 % of the external area of the
corresponding surface of the unit packet and any outside packaging. That
proportion shall be increased to 45 % for Member States with two official
languages and 50 % for Member States with three official languages.

4.           The general warning and
the text warning referred to in paragraph 1 shall be:

(a)
printed in black Helvetica bold type on a white
background. In order to accommodate language requirements, Member States may determine
the point size of the font, provided that the font size specified in their
legislation is such as to occupy the greatest possible proportion of the area
set aside for the text required;

(b)
centred in the area in which they are required
to be printed, parallel to the top edge of the unit packet and any outside
packaging;

(c)
surrounded by a black border not less than 3 mm
and not more than 4 mm in width inside the surface reserved for the text of the
warning.

5.           The
Commission shall be empowered to adopt delegated acts in accordance with Article
22, to withdraw the exemption laid down in paragraph 1 if there is a
substantial change of circumstances as established in a Commission report.

Article 11

Labelling of smokeless tobacco products

1.           Each unit packet and any
outside packaging of smokeless tobacco products shall carry the following
health warning:

This tobacco product can damage your health
and is addictive

2.           The
health warning laid down in paragraph 1 shall comply with the requirements
specified in Article 10(4). In addition, it shall:

(a)
be printed on the two largest surfaces of the unit
packet and any outside packaging;

(b)
cover 30 % of the external area of the
corresponding surface of the unit packet and any outside packaging. That
proportion shall be increased to 32 % for Member States with two official
languages and 35 % for Member States with three official languages.

3.           The
Commission shall be empowered to adopt delegated acts in accordance with
Article 22 to adapt the requirements in paragraphs 1 and 2 taking into account
scientific and market developments.

Article 12

Product description

1.           The labelling of a unit
packet and any outside packaging and the tobacco product itself shall not
include any element or feature that:

(a)     promotes a tobacco product by means that are
false, misleading, deceptive or likely to create an erroneous impression about
its characteristics, health effects, hazards or emissions;

(b)     suggests that a particular tobacco
product is less harmful than others or has vitalising, energetic, healing, rejuvenating,
natural, organic or otherwise positive health or social effects;

(c)     refers to flavour, taste, any flavourings
or other additives or the absence thereof;

(d)     resembles a food product.

2.           Prohibited
elements and features may include but are not limited to texts, symbols, names,
trade marks, figurative or other signs, misleading colours, inserts or other
additional material such as adhesive labels, stickers, onserts, scratch-offs
and sleeves or relate to the shape of the tobacco product itself. Cigarettes
with a diameter of less than 7.5 mm shall be deemed to be misleading.

Article 13

Appearance
and content of unit packets

1.           A
unit packet of cigarettes shall have a cuboid shape. A unit packet of
roll-your-own tobacco shall have the form of a pouch, i.e. a rectangular pocket
with a flap that covers the opening. The flap of the pouch shall cover at least
70% of the front of the packet. A unit packet of cigarettes shall include at
least 20 cigarettes. A unit packet of roll-your-own tobacco shall contain
tobacco weighing at least 40 g.

2.           A
cigarette packet can be of carton or soft material and shall not contain an
opening that can be re-closed or re-sealed after the opening is first opened,
other than the flip-top lid. The flip-top lid of a cigarette packet shall be
hinged only at the back of the packet.

3.           The
Commission shall be empowered to adopt delegated acts in accordance with
Article 22 to define more detailed rules for the shape and size of unit packets
in so far as these rules are necessary to ensure the full visibility and
integrity of the health warnings before the first opening, during the opening
and after reclosing of the unit packet.

4.           The
Commission shall be empowered to adopt delegated acts in accordance with
Article 22 to make either cuboid or cylindric shape mandatory for unit packets
of tobacco products other than cigarettes and roll-your-own tobacco if there is
a substantial change of circumstances as established in a Commission report.

Article 14

Traceability
and security features

1.           Member
States shall ensure that all unit packets of tobacco products shall be marked
with a unique identifier. In order
to ensure their integrity, unique identifiers shall be irremovably
printed/affixed, indelible and in no way hidden or interrupted in any form,
including through tax stamps and price marks, or by the opening of the packet.
In relation to products manufactured outside the Union the obligations laid
down in this Article apply only to those destined to or placed on the Union
market.

2.           The
unique identifier shall allow determining:

(a)     the date and place of manufacturing;

(b)     the manufacturing facility;

(c)     the machine used to manufacture the
products;

(d)     the production shift or time of
manufacture;

(e)     the product name;

(f)      the intended market of retail sale;

(g)     the intended shipment route;

(h)     where applicable, the importer into
the Union;

(i)      the actual shipment route from
manufacturing to the first retail outlet, including all warehouses used;

(j)      the identity of all purchasers from
manufacturing to the first retail outlet;

(k)     the invoice, order number and payment
records of all purchasers from manufacturing to the first retail outlet.

3.           Member
States shall ensure that all economic operators involved in the trade of tobacco
products from the manufacturer to the last economic operator before the first
retail outlet, record the entry of all unit packets into their possession, as
well as all intermediate movements and the final exit from their possession. This
obligation can be fulfilled by recording in aggregated form, e.g. of outside
packaging, provided that tracking and tracing of unit packets remains possible.

4.           Member
States shall ensure that manufacturers of tobacco products provide all economic
operators involved in the trade of tobacco products from the manufacturer to
the last economic operator before the first retail outlet, including importers,
warehouses and transporting companies with the necessary equipment allowing for
the recording of the tobacco products purchased, sold, stored, transported or
otherwise handled. The equipment shall be able to read and transmit the data
electronically to a data storage facility pursuant to paragraph 6.

5.           Recorded
data cannot be modified or deleted by any economic operator involved in the
trade of tobacco products, but the economic operator that introduced the data
and other economic operators directly concerned by the transaction such as the
supplier or the recipient can comment on previously introduced data. The economic
operator concerned shall add the correct data and a reference to the previous
entry which requires rectification in their view. In exceptional circumstances
and upon submission of adequate evidence, the competent authority in the Member
State in which the recording took place or if the recording took place outside the
Union the competent authority in the Member State of importation, can authorise
the modification or deletion of data previously registered.

6.           Member
States shall ensure that manufacturers and importers of tobacco products conclude
data storage contracts with an independent third party, which shall host the data
storage facility for data relating to the manufacturer and importer concerned.
The data storage facility shall be physically located on the territory of the Union.
The suitability of the third party, in particular its independence and
technical capacities, as well as the contract, shall be approved and monitored
by an external auditor, who is proposed and paid by the tobacco manufacturer
and approved by the Commission. Member States shall ensure full transparency
and accessibility of the data storage facilities for the competent authorities
of the Member States, the Commission and the independent third party on a
permanent basis. In duly justified cases Member States or the Commission can
provide manufacturers or importers access to this information, provided
commercially sensitive information remains adequately protected in conformity
with the relevant national and Union legislations.

7.           Member
States shall ensure that personal data are only processed in accordance with the
rules and safeguards laid down in Directive 95/46/EC.

8.           In
addition to the unique identifier, Member States shall require that all unit
packets of tobacco products which are placed on the market carry a visible,
tamper proof security feature of at least 1 cm², which shall be irremovably
printed or affixed, indelible and in no way hidden or interrupted in any form,
including through tax stamps and price marks, or other elements mandated by
legislation.

9.           The
Commission shall be empowered to adopt delegated acts in accordance with
Article 22:

(a)     to define
the key elements (such as duration, renewability, expertise required,
confidentiality) of the contract referred to in paragraph 6, including its
regular monitoring and evaluation;

(b)     to define the
technical standards to ensure that the systems used for the unique identifiers
and the related functions are fully compatible with each other across the Union
and

(c)     to define the technical standards for the
security feature and their possible rotation and to adapt them to scientific, market
and technical development.

10.         Tobacco
products other than cigarettes and roll-your-own tobacco shall be exempted from
the application of paragraph 1 to 8 during a period of 5 years following the
date referred to in paragraph 1 of Article 25.

Chapter III: Tobacco for oral use

Article 15

Tobacco for oral use

Member States shall prohibit the placing on
the market of tobacco for oral use, without prejudice to Article 151 of the Act
of Accession of Austria, Finland and Sweden.

Chapter IV:
Cross-border distance sales of tobacco products

Article 16

Cross-border distance sales of tobacco products

1.           Member States shall oblige
retail outlets intending to engage in cross-border distance sales to consumers
located in the Union to register with the competent authorities in the Member
State where the retail outlet is established and in the Member State where the
actual or potential consumer is located. Retail outlets established outside the
Union have to register with the competent authorities in the Member State where
the actual or potential consumer is located. All retail outlets intending to
engage in cross-border distance sales shall submit at least the following
information to the competent authorities:

(a)     name or corporate name and permanent
address of the place of activity from where the tobacco products are supplied;

(b)     the starting date of the activity of
offering tobacco products for cross-border distance sales to the public by
means of information society services;

(c)     the address of the website/-s used for
that purpose and all relevant information necessary to identify the website.

2.           The competent authorities
of the Member States shall publish the complete list of all retail outlets
registered with them in accordance with the rules and safeguards laid down in
Directive 95/46/EC Retail outlets may only start placing tobacco products on
the market in form of distance sales as of the moment the name of the retail
outlet is published in the relevant Member States.

3.           If it is necessary in
order to ensure compliance and facilitate enforcement, Member States of
destination may require that the retail outlet nominates a natural person who
is responsible for verifying the tobacco products before reaching the consumer
comply with the national provisions adopted pursuant to this Directive in the
Member State of destination.

4.           Retail outlets engaged in
distance sales shall be equipped with an age verification system, which
verifies at the time of sale, that the purchasing consumer respects the minimum
age foreseen under the national legislation of the Member State of destination.
The retailer or nominated natural person shall report to the competent
authorities a description of the details and functioning of the age
verification system.

5.           Personal data of the
consumer shall only be processed in accordance with Directive 95/46/EC and not
be disclosed to the manufacturer of tobacco products or companies forming part
of the same group of companies or to any other third parties. Personal data shall
not be used or transferred beyond the purpose of this actual purchase. This
also applies if the retail outlet forms part of a manufacturer of tobacco
products.

Chapter V:
Novel tobacco products

Article 17

Notification of novel tobacco products

1.           Member States shall
require that manufacturers and importers of tobacco products notify the
competent authorities of Member States of any novel tobacco product they intend
to place on the markets of the Member States concerned. The notification shall
be submitted in electronic form six months before the intended placing on the
market and shall be accompanied by a detailed description of the product in question
as well as information on ingredients and emissions in accordance with Article
5. The manufacturers and importers notifying a novel tobacco product shall also
provide the competent authorities in question with:

(a)     available scientific studies on toxicity,
addictiveness and attractiveness of the product, in particular as regards its
ingredients and emissions;

(b)     available studies and market research on
preferences of various consumer groups, including young people and

(c)     other available and relevant
information, including a risk/benefit analysis of the product, the expected
effects on cessation of tobacco consumption, the expected effects on initiation
of tobacco consumption and other predicted consumer perception.

2.           Member States shall require
that manufacturers and importers of tobacco products inform their competent
authorities of any new or updated information referred to in point (a) to (c)
of paragraph 1. Member States shall be entitled to require tobacco
manufacturers or importers to carry out additional tests or submit additional
information. Member States shall make available to the Commission all
information received pursuant to this Article. Member States shall be entitled
to introduce an authorisation system and charge a
proportionate fee.

3.           Novel
tobacco products placed on the market shall respect the requirements set out in
this Directive. The provisions applicable depend on whether the products fall
under the definition of smokeless tobacco product in point (29) of Article 2 or
tobacco for smoking in point (33) of Article 2.

TITLE III – NON
TOBACCO PRODUCTS

Article 18

Nicotine-containing products

1.           The following
nicotine-containing products may only be placed on the market if they were
authorised pursuant to Directive 2001/83/EC:

(a)     products with a nicotine level
exceeding 2 mg per unit, or

(b)     products with a nicotine concentration
exceeding 4 mg per ml or

(c)     products whose intended use results in
a mean maximum peak plasma concentration exceeding 4 ng of nicotine per ml.

2.           The Commission shall be
empowered to adopt delegated acts in accordance with Article 22 to update the
nicotine quantities set out in paragraph 1 taking into account scientific
developments and marketing authorisations granted to nicotine- containing
products pursuant to Directive 2001/83/EC.

3.           Each unit packet and any
outside packaging of nicotine-containing products below the thresholds set out
in paragraph 1 shall carry the following health warning:

This product contains nicotine and can
damage your health.

4.           The
health warning referred to in paragraph 3 shall comply with the requirements
specified in Article 10(4). In addition, it shall:

(a)     be printed on the two largest surfaces of
the unit packet and any outside packaging;

(b)     cover 30 % of the external area of the
corresponding surface of the unit packet and any outside packaging. That
proportion shall be increased to 32 % for Member States with two official
languages and 35 % for Member States with three official languages.

5.           The
Commission shall be empowered to adopt delegated acts in accordance with
Article 22 to adapt the requirements in paragraphs 3 and 4 taking into account
scientific and market developments and to adopt and adapt the position, format,
layout, designand rotation of the health warnings.

Article 19

Herbal
products for smoking

1.           Each
unit packet and any outside packaging of herbal products for smoking shall carry the following health warning:

This product can damage your health

2.           The
health warning shall be printed on the front and back external surface of the
unit packet and on any outside packaging.

3.           The
health warning shall comply with the requirements laid down in Article 10(4).
It shall cover not less than 30 % of the area of the corresponding surface of
the unit packet and of any outside packaging. That proportion shall be
increased to 32 % for Member States with two official languages and 35 % for
Member States with three official languages.

4.           Unit
packets and any outside packaging of herbal products for smoking shall not
include elements or features referred to in points (a), (b) and (d) of Article
12 and shall not state that the product is free of additives or flavourings.

TITLE IV – FINAL PROVISIONS

Article 20

Cooperation and enforcement

1.           Member
States shall ensure that manufacturers and importers provide competent national
authorities and the Commission with complete and correct information requested
pursuant to this Directive and within the time limits set. The obligation to provide the requested
information lies primarily with the manufacturer, if the manufacturer is
established in the Union. The obligation to provide the requested information
lies primarily with the importer, if the manufacturer is established outside
the Union and the importer is established inside the Union. The obligation to
provide the requested information lies jointly with the manufacturer and the
importer if both are established outside the Union.

2.           Member
States shall ensure that products which do not comply with this Directive, including
its implementing and delegated acts, are not placed on the market.

3.           Member
States shall lay down the rules on penalties applicable to infringements of the
national provisions adopted pursuant to this Directive and shall take all
measures necessary to ensure that they are enforced. The penalties provided for
shall be effective, proportionate and dissuasive.

Article 21

Committee procedure

1.           The
Commission shall be assisted by a committee. That committee shall be a
committee within the meaning of Regulation (EU) No 182/2011.

2.           Where
reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011
shall apply.

3.           Where
the opinion of the committee is to be obtained by written procedure, that
procedure shall be terminated without result when, within the time-limit for
delivery of the opinion, the chair of the committee so decides or a simple
majority of committee members so request.

Article 22

Exercise of the delegation

1.           The
power to adopt delegated acts is conferred on the Commission subject to the
conditions laid down in this Article.

2.           The
power to adopt delegated acts referred to in Articles 3(2), 3(3), 4(3), 4(4), 6(3),
6(9), 6(10), 8(4), 9(3), 10(5), 11(3), 13(3), 13(4), 14(9), 18(2) and 18(5) shall be conferred on the Commission for an indeterminate
period of time from [Office
of Publications: please insert the date of the entry into force of this
Directive].

3.           The
delegation of powers referred to in Articles 3(2), 3(3), 4(3), 4(4), 6(3), 6(9),
6(10), 8(4), 9(3), 10(5), 11(3), 13(3), 13(4), 14(9), 18(2) and 18(5) may be
revoked at any time by the European Parliament or by the Council. A decision to
revoke shall put an end to the delegation of the power specified in that
decision. It shall take effect the day following the publication of the
decision in the Official Journal of the European Union or at a later date
specified therein. It shall not affect the validity of any delegated acts
already in force.

4.           As
soon as it adopts a delegated act, the Commission shall notify it simultaneously
to the European Parliament and to the Council.

5.           A
delegated act pursuant to Articles 3(2), 3(3), 4(3), 4(4), 6(3), 6(9), 6(10),
8(4), 9(3), 10(5), 11(3), 13(3), 13(4), 14(9), 18(2) and 18(5) shall enter into force only if no objection has
been expressed either by the European Parliament or the Council within a period
of two months of notification of that act to the European Parliament and the
Council or if, before the expiry of that period, the European Parliament and
the Council have both informed the Commission that they will not object. That
period shall be extended by two months at the initiative of the European
Parliament or of the Council.

Article 23

Report

1.           No later than five years from the date specified in Article 25
paragraph 1, the Commission shall submit to the
European Parliament, the Council, the European Economic and Social Committee and
the Committee of the Regions a report on the application of this Directive.

With a view to drafting the report, the
Commission shall be assisted by scientific and technical experts in order to
have all the necessary information available.

2.           In the report, the
Commission shall indicate in particular the features which should be reviewed
or developed in the light of developments in scientific and technical
knowledge, including the development of internationally agreed rules and
standards on products, and shall pay special heed to:

(a)     the experience gained with respect to
the design of package surfaces not governed by this Directive taking into
account national, international, legal, economic and scientific developments;

(b)     market developments in novel tobacco products
considering, inter alia, notifications received under Article 17;

(c)     market developments which amount to a
substantial change of circumstances.

The Member States shall provide the Commission
with assistance and all available information for carrying out the assessment
and preparing the report.

3.           The report shall be
accompanied by any proposals for amendments to this Directive which the Commission
deems necessary to adapt it to developments in the field of tobacco and related
products, to the extent necessary for the operation of the internal market, and
to take into account any new developments based on scientific facts and
developments on internationally agreed product standards.

Article 24

Import, sale and consumption of
tobacco and related products

1.           Member States shall not
prohibit or restrict the import, sale or consumption of tobacco or related products
which comply with this Directive.

2.           However, a Member State
may maintain more stringent national provisions, applicable to all products
alike, in areas covered by the Directive, on grounds of overriding needs
relating to the protection of public health. A Member
State may also introduce more stringent provisions, on grounds relating to the
specific situation of this Member State and provided the provisions are justified by the need to protect public health.
Such national provisions shall be notified to the
Commission together with the grounds for maintaining or introducing them. The
Commission shall, within six months from the date of receiving the notification,
approve or reject the provisions after having verified, taking
into account the high level of health protection achieved through this
Directive, whether or not they are
justified, necessary and proportionate to their aim and whether or not they are
a means of arbitrary discrimination or a disguised restriction on trade between
the Member States. In the absence of a decision by the Commission within this
period the national provisions shall be deemed to be approved.

3.           This Directive shall not
affect the right of Member States to maintain or introduce, in accordance with
the Treaty, national provisions concerning aspects not regulated by this
Directive. These national provisions must be justified by overriding reasons of
public interest and be necessary and proportionate to their aim. They must not
be a means of arbitrary discrimination or a disguised restriction on trade
between the Member States and must not jeopardise the full application of this
Directive.

Article 25

Transposition

1.           Member
States shall bring into force the laws, regulations and administrative
provisions necessary to comply with this Directive by [Publications Office,
please insert the exact date: entry into force + 18 months] at the latest. They
shall forthwith communicate to the Commission the text of those provisions.

2.           When Member States adopt
these provisions, they shall contain a reference to this Directive or be
accompanied by such reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.

3.           Member States shall
communicate to the Commission the text of the main provisions of national law
which they adopt in the field covered by this Directive.

Article 26

Transitional provision

Member States may allow the following
products, which are not in compliance with this Directive, to be placed on the
market until [Publications Office, please insert the exact date: entry into
force + 24 months]:

(a)          tobacco products;

(b)          nicotine containing products
below the threshold set out in Article 18(1);

(c)          herbal products for smoking.

Article 27

Repeal

Directive
2001/37/EC is repealed.

References
to the repealed Directive shall be construed as references to this Directive
and read in accordance with the correlation table in Annex II.

Article 28

Entry into force

This Directive shall enter into force on
the twentieth day following that of its publication in the Official Journal of
the European Union.

Article 29

Addressees

This
Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament                       For
the Council

The President                                                 The
President

ANNEX I

List of text warnings
(referred to in Article 9 and Article 10(1))

(1)          Smoking causes 9 out of 10 lung
cancers

(2)          Smoking causes mouth and throat
cancer

(3)          Smoking damages your lungs

(4)          Smoking causes heart attacks

(5)          Smoking causes strokes and
disability

(6)          Smoking clogs your arteries

(7)          Smoking increases the risk of
blindness

(8)          Smoking damages your teeth and
gums

(9)          Smoking can kill your unborn
child

(10)        Your smoke harms your children,
family and friends

(11)        Smokers’ children are more likely
to start smoking

(12)        Quit smoking – stay alive for
those close to you

(13)        Smoking reduces fertility

(14)        Smoking increases the risk of
impotence

ANNEX II

CORRELATION TABLE

Directive 2001/37/EC || This Directive ||

Article 1 || Article 1 ||

Article 2 || Article 2 ||

Article 3 || Article 3 ||

Article 4(1) and (2) and Article 9(1) || Article 4 ||

Article 6 and Article 4(3)-(5) || Article 5 ||

Article 12 || Article 6 ||

Article 5 || Article 7 ||

Article 5(1) and (2) || Article 8 ||

Article 5(3) and Article 9(2) || Article 9 ||

Article 5 || Article 10 ||

Article 5(4) || Article 11 ||

Article 7 || Article 12 ||

|| Article 13 ||

Article 5(9) || Article 14 ||

Article 8 and Article 9(3) || Article 15 ||

|| Article 16 ||

|| Article 17 ||

|| Article 18 ||

|| Article 19 ||

|| Article 20 ||

Article 10 || Article 21 ||

|| Article 22 ||

Article 11 || Article 23 ||

Article 13 || Article 24 ||

Article 14 || Articles 25 and 26 ||

Article 15 || Article 27 ||

Article 16 || Article 28 ||

Article 17 || Article 29 ||

|| ||

Annex I || Annex I ||

Commission Decision 2003/641/EC and Commission Decision C(2005) 1452 final || Annex II ||

Annex III || Annex III ||

LEGISLATIVE FINANCIAL STATEMENT

1.           FRAMEWORK OF THE PROPOSAL/INITIATIVE

              1.1.    Title of the proposal/initiative

              1.2.    Policy
area(s) concerned in the ABM/ABB structure

              1.3.    Nature
of the proposal/initiative

              1.4.    Objective(s)

              1.5.    Grounds
for the proposal/initiative

              1.6.    Duration
and financial impact

              1.7.    Management
method(s) envisaged

2.           MANAGEMENT MEASURES

              2.1.    Monitoring
and reporting rules

              2.2.    Management
and control system

              2.3.    Measures
to prevent fraud and irregularities

3.           ESTIMATED FINANCIAL IMPACT OF THE
PROPOSAL/INITIATIVE

              3.1.    Heading(s)
of the multiannual financial framework and expenditure budget line(s) affected

              3.2.    Estimated
impact on expenditure

              3.2.1. Summary of
estimated impact on expenditure

              3.2.2. Estimated impact
on operational appropriations

              3.2.3. Estimated impact
on appropriations of an administrative nature

              3.2.4. Compatibility
with the current multiannual financial framework

              3.2.5. Third-party
participation in financing

              3.3.    Estimated impact on revenue

LEGISLATIVE FINANCIAL STATEMENT

1.           FRAMEWORK OF THE PROPOSAL/INITIATIVE

1.1.        Title of the
proposal/initiative

Proposal for a directive of the European Parliament and the Council
on the approximation of laws, regulations and administrative provisions of the
Member States concerning the manufacture, presentation and sale of tobacco and
related products

1.2.        Policy area(s) concerned
in the ABM/ABB structure[49]

Health for Growth

1.3.        Nature of the
proposal/initiative

¨ The
proposal/initiative relates to a new action

¨ The
proposal/initiative relates to a new action following a pilot
project/preparatory action[50]

X The proposal/initiative relates to the
extension of an existing action

¨ The
proposal/initiative relates to an action redirected towards a new action

1.4.        Objectives

1.4.1.     The Commission's
multiannual strategic objective(s) targeted by the proposal/initiative

The overall objective of the revision is to improve the functioning
of the internal market, while ensuring a high level of health protection.

1.4.2.     Specific objective(s) and
ABM/ABB activity(ies) concerned

The proposal aims to:

(1)     Update already harmonised areas to overcome Member States'
obstacles to bring their national legislations in line with new market,
scientific and international developments.

(2)     Address product related measures not yet covered by the
Tobacco Product Directive (TPD) insofar as heterogeneous development in Member
States has led to, or is likely to lead to, fragmentation of the internal
market.

(3)     Ensure that provisions of the Directive are not circumvented
by placing on the market of products not compliant with the TPD.

The Commission's Proposal for a Regulation of the European
Parliament and of the Council on establishing a Health for Growth Programme for
the period 2014-2020 (COM[2011]709) lists supporting measures which have as
their direct objective the protection of public health regarding tobacco
products and advertisement required by or contributing to the objectives of EU
legislation in this field.

1.4.3.     Expected result(s) and
impact

Specify the effects
which the proposal/initiative should have on the beneficiaries/groups targeted.

The impacts of the proposal on all relevant stakeholders (economic
stakeholders including the tobacco farmers, the manufacturers of tobacco
products, their upstream suppliers and the distribution chain, governments,
society, consumers, employers) are summarised in Chapter 6.2 of the impact
assessment report.

1.4.4.     Indicators of results and
impact

Specify the
indicators for monitoring implementation of the proposal/initiative.

Key indicators for achievement of the proposal's objectives are
outlined in section 7 of the impact assessment report.

1.5.        Grounds for the
proposal/initiative

1.5.1.     Requirement(s) to be met in
the short or long term

More than ten years have passed since the adoption of the current
TPD. In line with market, scientific and international developments it has
become necessary from an internal market perspective to update and complete the
TPD. From a health perspective the revision aims to ensure that the ingredients
and packaging of the products do not encourage or facilitate initiation, in
particular by young people. This should lead to a drop of tobacco consumption.

1.5.2.     Added value of EU involvement

Section 2.4.2 of the impact assessment report describes the added
value of the EU involvement. The assessment is further exemplified for each
policy area.

1.5.3.     Lessons learned from
similar experiences in the past

Not applicable.

1.5.4.     Coherence and possible
synergy with other relevant instruments

The proposal provides for a consistent implementation of obligations
stemming from the WHO Framework Convention on Tobacco Control (FCTC) and a
harmonised approach to non-binding FCTC commitments. Enhanced coherence is
expected with other legislation concerning tobacco policy and other areas (e.g.
medicinal products, GPSD, REACH, food).

1.6.        Duration and financial
impact

¨ Proposal/initiative of limited
duration

–
¨  Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY

–
¨  Financial impact from YYYY to YYYY

X Proposal/initiative of unlimited
duration

–
Implementation with a start-up period from YYYY
to YYYY,

–
followed by full-scale operation.

1.7.        Management mode(s) envisaged[51]

X Centralised direct management
by the Commission

¨ Centralised indirect management with the delegation of implementation tasks to:

–
¨    executive agencies

–
¨    bodies set up by the Communities[52]

–
¨    national public-sector bodies/bodies with public-service mission

–
¨  persons entrusted with the implementation of specific actions
pursuant to Title V of the Treaty on European Union and identified in the
relevant basic act within the meaning of Article 49 of the Financial Regulation

¨ Shared management with the Member States

¨ Decentralised management with third countries

¨ Joint management with international organisations (to be specified)

If more than one
management mode is indicated, please provide details in the
"Comments" section.

Comments

The
Commission will centrally manage the administrative, technical and scientific support
to the Regulatory Committee and its technical working groups.

2.           MANAGEMENT MEASURES

2.1.        Monitoring and reporting
rules

Specify frequency
and conditions.

The monitoring and reporting rules are set in section 7 of the
impact assessment report. In addition the use of certain delegated acts calls
for a prior Commission report (see Art. 22 of the legislative proposal).

2.2.        Management and control
system

2.2.1.     Risk(s) identified

No major risks in particular with respect to budgetary implications
were identified. At this stage the main risk for the Commission is of
reputational nature.

2.2.2.     Control method(s) envisaged

A network of Member States representatives will provide a regular
platform to discuss issues related to the implementation of the Directive.
Complaints of the citizens and non-governmental organisations which could
identify possible weaknesses in the implementation of the new directive will be
carefully analysed.

Article 23 of the draft legislative proposal requires the Commission
to submit a report on the application of this Directive not later than five
years from transposition.

2.3.        Measures to prevent fraud
and irregularities

Specify existing or
envisaged prevention and protection measures.

The proposal foresees antifraud measures which are described and
assessed in section 5.6 of the impact assessment.

In addition to the application of all regulatory control mechanisms,
the responsible Commission's services will devise an anti-fraud strategy in
line with the Commission's new anti-fraud strategy (CAFS) adopted on 24 June
2011 in order to ensure inter alia that its internal anti-fraud related
controls are fully aligned with the CASF and that its fraud risk management
approach is geared to identify fraud risk areas and adequate responses. Where
necessary, networking groups and adequate IT tools dedicated to analysing fraud
cases related to the financing implementing activities of the Tobacco Product
Directive will be set up. In particular a series of measures will be put in
place such as:

–
decisions, agreements and contracts resulting
from the financing implementing activities of the Tobacco Product Directive
will expressly entitle the Commission, including OLAF, and the Court of
Auditors to conduct audits, on-the-spot checks and inspections;

–
during the evaluation phase of a call for
proposals/tender, the proposers and tenderers are checked against the published
exclusion criteria based on declarations and the Early Warning System (EWS);

–
the rules governing the eligibility of costs will
be simplified in accordance with the provisions of the Financial Regulation;

–
regular training on issues related to fraud and
irregularities is given to all staff involved in contract management as well as
to auditors and controllers who verify the beneficiaries' declarations on the
spot.

Moreover, the Commission will control a strict application of the
rules on conflict of interests provided in the proposal.

3.           ESTIMATED FINANCIAL IMPACT OF THE
PROPOSAL/INITIATIVE

3.1.        Heading(s) of the
multiannual financial framework and expenditure budget line(s) affected

· Existing expenditure budget lines

In order of
multiannual financial framework headings and budget lines.

Heading of multiannual financial framework || Budget line || Type of expenditure || Contribution

Number [Description…Health for Growth] || Diff./non-diff. ([53]) || from EFTA[54] countries || from candidate countries[55] || from third countries || within the meaning of Article 18(1)(aa) of the Financial Regulation

3 || 17.0301[56] || Diff/non- || YES/NO || YES/NO || YES/NO || YES/NO

· New budget lines requested

In order of multiannual financial framework
headings and budget lines.

Heading of multiannual financial framework || Budget line || Type of expenditure || Contribution

Number [Heading……………………………………..] || Diff./non-diff. || from EFTA countries || from candidate countries || from third countries || within the meaning of Article 18(1)(aa) of the Financial Regulation

|| || || YES/NO || YES/NO || YES/NO || YES/NO

3.2.        Estimated impact on
expenditure

3.2.1.     Summary of estimated impact
on expenditure

EUR million (to 3 decimal places)

Heading of multiannual financial framework: || Number || Health for Growth Programme

DG: SANCO || || || Year 2014 || Year 2015 || Year 2016 || Year 2017 || Years 2018 and esq || TOTAL 2014-2018

Ÿ Operational appropriations || || || || || || || ||

Number of budget line 17.03.XX || Commitments || (1) || 0.900 || 0.900 || 0.900 || 0.900 || 0.900 || || || 4.500

Payments || (2) || 0.450 || 0.900 || 0.900 || 0.900 || 1.350 || || || 4.500

Number of budget line || Commitments || (1a) || || || || || || || ||

Payments || (2a) || || || || || || || ||

Appropriations of an administrative nature financed  from the envelope for specific programmes[57] || || || || || || || ||

Number of budget line || || (3) || || || || || || || ||

TOTAL appropriations for DG SANCO || Commitments || =1+1a +3 || 0.900 || 0.900 || 0.900 || 0.900 || 0.900 || || || 4.500

Payments || =2+2a +3 || 0.450 || 0.900 || 0.900 || 0.900 || 1.350 || || || 4.500

Ÿ TOTAL operational appropriations || Commitments || (4) || 0.900 || 0.900 || 0.900 || 0.900 || 0.900 || || || 4.500

Payments || (5) || 0.450 || 0.900 || 0.900 || 0.900 || 1.350 || || || 4.500

Ÿ TOTAL appropriations of an administrative nature financed from the envelope for specific programmes || (6) || || || || || || || ||

TOTAL appropriations under HEADING 3 of the multiannual financial framework || Commitments || =4+ 6 || 0.900 || 0.900 || 0.900 || 0.900 || 0.900 || || || 4.500

Payments || =5+ 6 || 0.450 || 0.900 || 0.900 || 0.900 || 1.350 || || || 4.500

If more than one heading is affected by the proposal /
initiative:

Ÿ TOTAL operational appropriations || Commitments || (4) || || || || || || || ||

Payments || (5) || || || || || || || ||

Ÿ TOTAL appropriations of an administrative nature financed from the envelope for specific programmes || (6) || || || || || || || ||

TOTAL appropriations under HEADINGS 1 to 4 of the multiannual financial framework (Reference amount) || Commitments || =4+ 6 || || || || || || || ||

Payments || =5+ 6 || || || || || || || ||

Heading of multiannual financial framework: || 5 || " Administrative expenditure "

EUR million (to 3 decimal places)

|| || || Year 2014 || Year 2015 || Year 2016 || Year 2017 || Years 2018 and esq || TOTAL

DG: SANCO ||

Ÿ Human resources || 0.571 || 0.571 || 0.571 || 0.508 || 0.508 || || || 2.729

Ÿ Other administrative expenditure || 0.018 || 0.165 || 0.168 || 0.172 || 0.136 || || || 0.659

TOTAL DG SANCO || Appropriations || 0.589 || 0.736 || 0.739 || 0.68 || 0.644 || || || 3.388

TOTAL appropriations under HEADING 5 of the multiannual financial framework || (Total commitments = Total payments) || 0.589 || 0.736 || 0.739 || 0.68 || 0.644 || || || 3.388

EUR million (to 3 decimal places)

|| || || Year 2014 || Year 2015 || Year 2016 || Year 2017 || Years 2018 and esq || TOTAL

TOTAL appropriations under HEADINGS 1 to 5 of the multiannual financial framework || Commitments || 1.489 || 1.636 || 1.639 || 1.58 || 1.544 || || || 7.888

Payments || 1.039 || 1.636 || 1.639 || 1.58 || 1.994 || || || 7.888

3.2.2.     Estimated impact on
operational appropriations

–
¨    The proposal/initiative does not require the use of operational appropriations

–
X     The proposal/initiative requires the use
of operational appropriations, as explained below:

Commitment appropriations in EUR million (to 3 decimal
places)

Indicate objectives and outputs ò || || || Year 2014 || Year 2015 || Year 2016 || Year 2017 || Year 2018 and sq years || TOTAL

OUTPUTS

Type of output[58] || Ave­rage cost of the out­put || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Total number of outputs || Total cost

SPECIFIC OBJECTIVE No 1[59]… || Establish mechanisms to ensure harmonised implementation of the rules by all Member States with a sustainable, efficient and credible management at EU level with access to internal and external technical and scientific expertise, allowing improved coordination and resource-sharing between Member States (applicable for both main objectives in Section 1.4.2)

- Output || Techni­cal, market and scienti­fic reports || 0.233 || 3 || 0.800 || 3 || 0.800 || 3 || 0.800 || 3 || 0.800 || 3 || 0.800 || || || || || ||

- Output || Up-to date IT tool for analysis of ingre­dients data || 0.100 || 1 || 0.100 || 1 || 0.100 || 1 || 0.100 || 1 || 0.100 || 1 || 0.100 || || || || || ||

Sub-total for specific objective N°1 || || || || || || || || || || || || || || || ||

SPECIFIC OBJECTIVE No 2… || || || || || || || || || || || || || || || ||

- Output || || || || || || || || || || || || || || || || || ||

Sub-total for specific objective N°2 || || || || || || || || || || || || || || || ||

TOTAL COST || 4 || 0.900 || 4 || 0.900 || 4 || 0.900 || 4 || 0.900 || 4 || 0.900 || || || || || 20 || 4.500

3.2.3.     Estimated impact on
appropriations of an administrative nature

3.2.3.1.  Summary

–
¨    The proposal/initiative does not require the use of administrative
appropriations

–
X     The proposal/initiative requires the use
of administrative appropriations, as explained below:

EUR million (to 3
decimal places)

|| Year 2014 || Year 2015 || Year 2016 || Year 2017 || Years 2018 and esq || TOTAL

HEADING 5 of the multiannual financial framework || || || || || || || ||

Human resources || 0.571 || 0.571 || 0.571 || 0.508 || 0.508 || || || 2.729

Other administrative expenditure || 0.018 || 0.165 || 0.168 || 0.172 || 0.136 || || || 0.659

Subtotal HEADING 5 of the multiannual financial framework || 0.589 || 0.736 || 0.739 || 0.68 || 0.644 || || || 3.388

Outside HEADING 5[60] of the multiannual financial framework || || || || || || || ||

Human resources || || || || || || || ||

Other expenditure of an administrative nature || || || || || || || ||

Subtotal outside HEADING 5 of the multiannual financial framework || || || || || || || ||

TOTAL || 0.589 || 0.736 || 0.739 || 0.68 || 0.644 || || || 3.388

3.2.3.2.  Estimated requirements of
human resources

–
¨    The proposal/initiative does not require the use of human
resources

–
X     The proposal/initiative requires the use
of human resources, as explained below:

Estimate to be expressed in full amounts
(or at most to one decimal place)

|| Year 2014 || Year 2015 || Year 2016 || Year 2017 || Years 2018 and esq

Ÿ Establishment plan posts (officials and temporary agents)

XX 01 01 01 (Headquarters and Commission’s Representation Offices) || 4.5 || 4.5 || 4.5 || 4 || 4 || ||

XX 01 01 02 (Delegations) || || || || || || ||

XX 01 05 01 (Indirect research) || || || || || || ||

10 01 05 01 (Direct research) || || || || || || ||

Ÿ External personnel (in Full Time Equivalent unit: FTE)[61]

XX 01 02 01 (CA, INT, SNE from the "global envelope") || || || || || || ||

XX 01 02 02 (CA, INT, JED, LA and SNE in the delegations) || || || || || || ||

XX 01 04 yy [62] || - at Headquarters[63] || || || || || || ||

- in delegations || || || || || || ||

XX 01 05 02 (CA, INT, SNE - Indirect research) || || || || || || ||

10 01 05 02 (CA, INT, SNE - Direct research) || || || || || || ||

Other budget lines (specify) || || || || || || ||

TOTAL || 4.5 || 4.5 || 4.5 || 4 || 4 || ||

XX is the
policy area or budget title concerned.

The human
resources required will be met by staff from DG SANCO who are already assigned
to the management of the action and who will be redeployed within DG SANCO,
together if necessary with any additional allocation which may be granted to
the managing DG under the annual allocation procedure and in the light of
budgetary constraints (estimated needs: 4.0 AD/FTE and 0.5 AST/FTE). Description of tasks to be carried out:

Officials and temporary agents ||

External personnel ||

3.2.4.     Compatibility with the
current multiannual financial framework

–
X     Proposal/initiative is compatible with the
new multiannual financial framework 2014-2020. The actions will be covered by
the proposed Health Programme 2014-2020.

–
¨    Proposal/initiative will entail reprogramming of the relevant
heading in the multiannual financial framework.

Explain what reprogramming is required,
specifying the budget lines concerned and the corresponding amounts.

…

–
¨    Proposal/initiative requires application of the flexibility
instrument or revision of the multiannual financial framework[64].

Explain what is required, specifying the
headings and budget lines concerned and the corresponding amounts.

…

3.2.5.     Third-party contributions

–
X     The proposal/initiative does not provide
for co-financing by third parties

–
The proposal/initiative provides for the
co-financing estimated below:

Appropriations in EUR million (to 3 decimal places)

|| Year N || Year N+1 || Year N+2 || Year N+3 || … enter as many years as necessary to show the duration of the impact (see point 1.6) || Total

Specify the co-financing body || || || || || || || ||

TOTAL appropriations cofinanced || || || || || || || ||

3.3.        Estimated impact on
revenue

–
X     Proposal/initiative has no financial
impact on revenue.

–
¨    Proposal/initiative has the following financial impact:

¨         on own resources

¨         on miscellaneous revenue

EUR million (to 3 decimal places)

Budget revenue line: || Appropriations available for the ongoing budget year || Impact of the proposal/initiative[65]

Year N || Year N+1 || Year N+2 || Year N+3 || … insert as many columns as necessary in order to reflect the duration of the impact (see point 1.6)

Article …………. || || || || || || || ||

For miscellaneous
assigned revenue, specify the budget expenditure line(s) affected.

…

Specify the method for
calculating the impact on revenue.

[1]               OJ L 194, 18.7.2001, p. 26–35.

[2]               Council Recommendation of 30 November 2009 on smoke
free environments; Council Conclusions of 1-2 December 2011 on prevention,
early diagnosis and treatment of chronic respiratory diseases in children; EP
Resolution of 15 September 2011 on European Union position and commitment
in advance to the UN high-level meeting on the prevention and control of
non-communicable diseases; EP Resolution of 24 October 2007 on the Green Paper
'Towards a Europe free from tobacco smoke: policy options at EU level; EP
Resolution of 26 November 2009 on smoke free environments.

[3]               Annex 1 to the Commission work programme 2012 –
forthcoming initiatives 2012. COM(2011)777 final
http://ec.europa.eu/atwork/key-documents/index\_en.htm (accessed on 17 December 2012)

[4]               Without an update, Member States cannot, for example,
increase the size of the health warnings, change their location of the package
or replace the display of tar, nicotine and carbon monoxide levels.

[5]               For example, at this stage, eight Member States have
adopted pictorial health warnings and the regulations of ingredients differ
between Member States.

[6]               For example, measures on cross-border distance sales
and traceability will facilitate legal activity and thus prevent sale of
tobacco products not complying with the TPD (e.g. health warnings and
ingredients).

[7]               Special Eurobarometer 385, 2012:
http://ec.europa.eu/health/eurobarometers/index\_en.htm

[8]               A response considered “duplicate” in the public
consultation was a response fulfilling the following criteria: 1. At least six
responses containing the same text. 2. Text box containing more than three
words. 3. Text box not containing text directly copied from the consultation
document.

[9]               For example, a campaign was organised by a group
representing over 75% of Italian Tobacconists (European Voice, 10 February,
2011). This action was followed by over 30,000 submissions, including 99%
duplicate responses from Italy.

[10]             Special Eurobarometer 385, 2012:
http://ec.europa.eu/health/eurobarometers/index\_en.htm

[11]             European Commission, Health and Consumer
Directorate-General, July 2011, Report on the public consultation on the
possible revision of the Tobacco Products Directive 2001/37/EC. The report and
contributions are published on:         
http://ec.europa.eu/health/tobacco/consultations/tobacco\_cons\_01\_en.htm        
In addition to the contributions received on-line, the contributions received
also through other formats from 20 Member States at the level of Governments or
ministries as well as from two EFTA/EEA countries have also been published on
the same web site.

[12]             Minutes for stakeholder meetings can be found at:      
http://ec.europa.eu/health/tobacco/events/index\_en.htm#anchor4

[13]             Idem.

[14]             The minutes of the meetings can be found at:               
http://ec.europa.eu/health/tobacco/events/index\_en.htm#anchor0

[15]             It is important to underline that the preferred policy
options do not – in the assessment of the Commission – lead to increased
illicit trade. On the other hand, illicit trade accounts already for 8,25% of
the current consumption (Euromonitor data as presented in MATRIX report 2012).

[16]             The suggested summary follows the order of Articles in
the legislative proposal.

[17]             Regulation (EC) No 1907/2006 of the European Parliament
and the Council of 18 December 2006 concerning the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH), establishing a European
Chemicals Agency, amending Directive 1999/45/EC and repealing Council
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as
Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC,
93/105/EC and 2000/21/EC. OJ L 396, 30.12.2006, p. 1.

[18]             For Member States having more than one official
language, the warnings should be increased to 32-35% and 45-50%.

[19]             Hammond D. Health warning messages on tobacco products:
a review. Tob Control 2011; 20:327-3. Sambrook Research International. A Review
of the Science Base to Support the Development of Health Warnings for Tobacco
Packages. Newport: Sambrook Research International; 2009. (Report prepared for
the European Commission).

[20]             75% on both sides in Canada, 30% and 90% in Australia
and New Zealand, 80% of both sides in Uruguay, 60% and 70% in Mauritius, 30%
and 100% in Mexico.

[21]             OJ L 281, 23.11.1995, p. 31.

[22]             OJ C 241, 29.8.1994 (see Article 151 and Annex XV
thereof).

[23]             Case C-434/02 Arnold André GmbH & Co. KG v Landrat des Kreises Herford [2004] ECR I-11825.

[24]             Directive 2001/83 of the European Parliament and of the
Council of 6 November 2001 on the Community code relating to medicinal products
for human use OJ L 311, 28.11.2001, p. 67-128.

[25]             In addition to Article 95 TEC the TPD was also adopted
on the basis of Article 133 TEC.    
In case C-491/01, The Queen v Secretary of State for Health, ex parte British
American Tobacco (Investments) Ltd and Imperial Tobacco Ltd. [2002] ECR I-11453,
the Court found, however, that Article 95 TEC was the only appropriate legal
base, but that the addition of Article 133 TEC as a legal base was not a reason
for declaring the Directive invalid.

[26]             See case C-491/01 The Queen v Secretary of State for
Health, ex parte British American Tobacco (Investments) Ltd and Imperial
Tobacco Ltd.

[27]             Idem, para 77.

[28]             Idem, para 64-75.

[29]             Idem, para 82-83.

[30]             OJ L 194, 18.7.2001, p. 26.

[31]             Reports of the Commission to the European Parliament,
the Council and the European Economic and Social Committee: First Report on the
Application of the Tobacco Products Directive, COM (2005)339 final. Second
Report on the Application of the Tobacco Products Directive, COM (2007)754
final.

[32]             SCENIHR. Health effects of smokeless tobacco products.
6 February 2008             
http://ec.europa.eu/health/ph\_risk/committees/04\_scenihr/docs/scenihr\_o\_013.pdf            
SCENIHR. Addictiveness and attractiveness of Tobacco Additives. 12 November
2010      
http://ec.europa.eu/health/scientific\_committees/emerging/docs/scenihr\_o\_031.pdf

[33]             European Commission, Health and Consumer
Directorate-General, July 2011, Report on the public consultation on the
possible revision of the Tobacco Products Directive 2001/37/EC. The report and
contributions are published on:         
http://ec.europa.eu/health/tobacco/consultations/tobacco\_cons\_01\_en.htm

[34]             Council Recommendation of 30 November 2009 on smoke
free environments; Council Conclusions of 1-2 December 2011 on prevention,
early diagnosis and treatment of chronic respiratory diseases in children invites the Commission to
consider strengthening the tobacco control legislation; EP Resolution of
15 September 2011 on European Union position and commitment in advance to
the UN high-level meeting on the prevention and control of non-communicable
disesases; EP Resolution of 24 October 2007 on the Green Paper 'Towards a
Europe free from tobacco smoke: policy options at EU level; EP Resolution of 26
November 2009 on smoke free environments.

[35]             Council Decision (2004/513/EC) of 2 June 2004
concerning the conclusion of the WHO Framework Convention on Tobacco Control,
OJ L 213, 15.6.2004, p. 8.

[36]             WTO Appellate Body, AB-2012-1,
United States – Measures Affecting the Production and Sale of Clove Cigarettes
(DS406).

[37]             OJ L 149, 11.6.2005, p. 22-39.

[38]             OJ L 359, 8.12.1989, p. 1.

[39]             OJ C 241, 29.8.1994.

[40]             OJ L 178, 17.7.2000, p. 1-16.

[41]             OJ L 144, 4.6.1997, p. 19-27 and OJ L 304, 22.11.2011,
p. 64-88.

[42]             OJ L 311, 28.11.2001, p. 67, as last amended by Directive
2011/62/EU, OJ L 174, 1.7.2011, p. 74.

[43]             OJ L 55, 28.2.2011, p. 13-18.

[44]             OJ L 204, 21.7.1998, p. 37-48.

[45]             OJ L 281, 23.11.1995, p. 31.

[46]             OJ L 176, 5.7.2011, p. 24.

[47]             OJ L 396, 30.12.2006, p. 1.

[48]             OJ L 353, 31.12.2008, p. 1–1355.

[49]             ABM: Activity-Based Management – ABB: Activity-Based
Budgeting.

[50]             As referred to in Article 49(6)(a) or (b) of the
Financial Regulation.

[51]             Details of management modes and references to the
Financial Regulation may be found on the BudgWeb site: http://www.cc.cec/budg/man/budgmanag/budgmanag\_en.html

[52]             As referred to in Article 185 of the Financial
Regulation.

[53]             Diff. = Differentiated appropriations / Non-diff. =
Non-Differentiated Appropriations.

[54]             EFTA: European Free Trade Association.

[55]             Candidate countries and, where applicable, potential
candidate countries from the Western Balkans.

[56]             Budget line 17.0301 relates to the new nomenclature for
MFF 2014-2020. It corresponds to the same budget line in MFF 2007-2013. This
budget line is indicative and could be changed following the annual procedure.

[57]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions
(former "BA" lines), indirect research, direct research.

[58]             Outputs are products and services to be supplied (e.g.:
number of student exchanges financed, number of km of roads built, etc.).

[59]             As described in Section 1.4.2. "Specific
objective(s)…"

[60]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions
(former "BA" lines), indirect research, direct research.

[61]             CA= Contract Agent; INT= agency staff ("Intérimaire");
JED= "Jeune Expert en Délégation" (Young Experts in
Delegations); LA= Local Agent; SNE= Seconded National Expert.

[62]             Under the ceiling for external personnel from
operational appropriations (former "BA" lines).

[63]             Essentially for Structural Funds, European Agricultural
Fund for Rural Development (EAFRD) and European Fisheries Fund (EFF).

[64]             See points 19 and 24 of the Interinstitutional
Agreement.

[65]             As regards traditional own resources (customs duties,
sugar levies), the amounts indicated must be net amounts, i.e. gross amounts
after deduction of 25% for collection costs.

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