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
Date: 2012-12-19
Institutions: European Commission
Subjects: labelling, market approval, marketing standard, packaging, production standard, smoking, tobacco, tobacco industry

EUROPEAN 
COMMISSION 

Brussels, 19.12.2012  
COM(2012) 788 final 

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) 

{SWD(2012) 452 final} 
{SWD(2012) 453 final} 

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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 20011. 

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  Parliament2.  The  initiative  to 
revise the TPD is included in the Commission's Work Plan 20123. 

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

(cid:121) 

(cid:121) 

(cid:121) 

Update  already  harmonised  areas  to  overcome  Member  States'  obstacles  to 
bring  their  national  legislations  in  line  with  new  market,  scientific  and 
international developments4. 

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 market5. 

Ensure that provisions of the Directive are not circumvented by placing on the 
market of products not compliant with the TPD6.  

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.  

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OJ L 194, 18.7.2001, p. 26–35. 
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.  
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)  
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. 
For  example,  at  this  stage,  eight  Member  States  have  adopted  pictorial  health  warnings  and  the 
regulations of ingredients differ between Member States. 
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). 

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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 years7. 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 

7 

Special Eurobarometer 385, 2012: http://ec.europa.eu/health/eurobarometers/index_en.htm 

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responses8  which  appear  to  be  the  result  of  several  citizen  mobilisation  campaigns 
that took place in some Member States9. 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 online11. 

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 201212. 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  201213.  The  revision  of  TPD 
has also been discussed regularly in the TPD Regulatory Committee from 2009 to 
201214. 

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 

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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. 
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. 
Special Eurobarometer 385, 2012: http://ec.europa.eu/health/eurobarometers/index_en.htm 
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.  
Minutes for stakeholder meetings can be found at: 
http://ec.europa.eu/health/tobacco/events/index_en.htm#anchor4 
Idem.  
The minutes of the meetings can be found at: 
http://ec.europa.eu/health/tobacco/events/index_en.htm#anchor0 

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or  counterfeit  products  non-complying  with  the  requirements  of  the  Directive  is 
already today a significant problem15. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL16 

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 REACH17 are 
applied to tobacco products as appropriate. 

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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). 
The suggested summary follows the order of Articles in the legislative proposal. 
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. 

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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 

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packages18.  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  effective19  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 
experience20  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/EC21.  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.  

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For  Member  States  having  more  than  one  official  language,  the  warnings  should  be  increased  to  32-
35% and 45-50%.  
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). 
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. 
OJ L 281, 23.11.1995, p. 31. 

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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 Treaty22).  

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  product23.  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 

22 
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OJ C 241, 29.8.1994 (see Article 151 and Annex XV thereof). 
Case C-434/02 Arnold André GmbH & Co. KG v Landrat des Kreises Herford [2004] ECR I-11825. 

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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 balance24. 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 

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. 

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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 Union26. 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 features27. Second, approximation of national legislations on tobacco 
products under Article 114 is justified when it is necessary to remove obstacles to the 

25 

26 

27 

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. 
See  case  C-491/01  The  Queen  v  Secretary  of  State  for  Health,  ex  parte  British  American  Tobacco 
(Investments) Ltd and Imperial Tobacco Ltd. 
Idem, para 77. 

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free movement of goods28. 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 circumvented29. 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 

28 
29 

Idem, para 64-75. 
Idem, para 82-83. 

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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:  

(cid:121) 

(cid:121) 

(cid:121) 

(cid:121) 

(cid:121) 

(cid:121) 

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. 

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.  

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

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

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

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

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(cid:121) 

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. 

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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) 

(2) 

30 
31 

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 
products30  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. 

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  useful31.  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 

OJ L 194, 18.7.2001, p. 26. 
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. 

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additives32. In 2010 a broad stakeholder consultation took place33, 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/EC34. 

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.  

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. 

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. 

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. 

(3) 

(4) 

(5) 

(6) 

(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 Parties35. Of relevance are in particular its 

32 

33 

34 

35 

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 
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 
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.  
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. 

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Articles 9 (regulation of the contents of tobacco products), 10 (regulation of tobacco 
tobacco  products), 
product  disclosures),  11 
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.  

(packaging  and 

labelling  of 

(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) 

(12) 

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.  

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 

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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 
avoided36. 

(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 

36 

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

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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 market37. 

(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 

37 

OJ L 149, 11.6.2005, p. 22-39. 

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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  use38  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 prohibition39. 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  services40.  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 

38 
39 
40 

OJ L 359, 8.12.1989, p. 1. 
OJ C 241, 29.8.1994. 
OJ L 178, 17.7.2000, p. 1-16. 

EN 

19 

   EN 

                                                 
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 use42 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. 

41 
42 

OJ L 144, 4.6.1997, p. 19-27 and OJ L 304, 22.11.2011, p. 64-88. 
OJ L 311, 28.11.2001, p. 67, as last amended by Directive 2011/62/EU, OJ L 174, 1.7.2011, p. 74. 

EN 

20 

   EN 

                                                 
(37) 

(38) 

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 182/201143. 

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 

43 

OJ L 55, 28.2.2011, p. 13-18. 

EN 

21 

   EN 

                                                 
information  in  the  field  of  technical  standards  and  regulations  and  on  rules  on 
Information Society services44.  

(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 data45. 

(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.  

44 
45 

OJ L 204, 21.7.1998, p. 37-48. 
OJ L 281, 23.11.1995, p. 31. 

EN 

22 

   EN 

                                                 
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) 

(b) 

(c) 

(d) 

(e) 

(f) 

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

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; 

the prohibition to place on the market tobacco for oral use; 

cross-border distance sales of tobacco products;  

the notification obligation for novel tobacco products; 

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) 

(2) 

(3) 

'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; 

'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; 

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

EN 

23 

   EN 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

(10) 

(11) 

'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;  

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

'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 tobacco46; 

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

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

'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; 

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

'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) 

(b) 

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

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) 

(15) 

(16) 

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

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

'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 

46 

OJ L 176, 5.7.2011, p. 24. 

EN 

24 

   EN 

                                                 
placed under a customs suspensive procedure or arrangement, as well as their release 
from a customs suspensive procedure or arrangement; 

(17) 

(18) 

'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; 

'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) 

(23) 

(24) 

(25) 

(26) 

(27) 

(28) 

(29) 

(30) 

'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; 

'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; 

'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; 

'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; 

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

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

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

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

'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 

EN 

25 

   EN 

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) 

(33) 

(34) 

(35) 

'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; 

'tobacco  for  smoking'  means  a  tobacco  product  other  than  a  smokeless  tobacco 
product; 

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

'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. 

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. 

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 

26 

   EN 

2. 

3. 

EN 

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. 

2. 

3. 

4. 

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.  

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.  

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. 

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 

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 

EN 

27 

   EN 

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  mixtures48.  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. 

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.  

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.  

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.  

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 

2. 

3. 

4. 

5. 

47 
48 

OJ L 396, 30.12.2006, p. 1. 
OJ L 353, 31.12.2008, p. 1–1355. 

EN 

28 

   EN 

                                                 
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.  

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. 

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. 

2. 

3. 

4. 

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

(a) 

(b) 

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

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 

EN 

29 

   EN 

6. 

7. 

8. 

9. 

10. 

1. 

2. 

3. 

modification  of  flavour  or  smoke  intensity.  Filters  and  capsules  shall  not  contain 
tobacco. 

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

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. 

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. 

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. 

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 

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. 

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

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.  

EN 

30 

   EN 

4. 

5. 

6. 

7. 

1. 

2. 

3. 

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.  

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.  

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. 

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 

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

Smoking kills – quit now  

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 

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) 

(b) 

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

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

EN 

31 

   EN 

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) 

(c) 

(d) 

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; 

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

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. 

3. 

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.  

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

(a) 

(b) 

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

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. 

EN 

32 

   EN 

Article 10 

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

1. 

2. 

3. 

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. 

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.  

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) 

(b) 

(c) 

 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; 

 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; 

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: 

EN 

33 

   EN 

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) 

(b) 

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; 

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 

EN 

34 

   EN 

2. 

3. 

4. 

1. 

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. 

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.  

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. 

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  

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;  

EN 

35 

   EN 

3. 

4. 

5. 

6. 

7. 

8. 

(k) 

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

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.  

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.  

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. 

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. 

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

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.  

EN 

36 

   EN 

9. 

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

(a) 

(b) 

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; 

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) 

(b) 

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

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

EN 

37 

   EN 

2. 

3. 

4. 

5. 

1. 

(c) 

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

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.  

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. 

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. 

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 

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) 

(b) 

(c) 

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

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

other available and relevant information, including a risk/benefit analysis of the 
product,  the  expected  effects  on  cessation  of  tobacco  consumption,  the 

EN 

38 

   EN 

expected  effects  on  initiation  of  tobacco  consumption  and  other  predicted 
consumer perception.  

2. 

3. 

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. 

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. 

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. 

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. 

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; 

2. 

3. 

4. 

EN 

39 

   EN 

5. 

1. 

2. 

3. 

4. 

1. 

(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.  

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 

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

This product can damage your health 

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

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.  

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 

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. 

EN 

40 

   EN 

2. 

3. 

1. 

2. 

3. 

1. 

2. 

3. 

4. 

5. 

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.  

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 

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

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

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 

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

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]. 

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.  

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

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 

EN 

41 

   EN 

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. 

2. 

3. 

1. 

2. 

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. 

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. 

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 

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

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 

EN 

42 

   EN 

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.  

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 

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. 

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. 

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. 

3. 

1. 

2. 

3. 

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) 

(b) 

(c) 

tobacco products; 

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

herbal products for smoking. 

EN 

43 

   EN 

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 
The President 

For the Council 
The President 

EN 

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ANNEX I 

LIST OF TEXT WARNINGS 
(referred to in Article 9 and Article 10(1)) 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

Smoking causes 9 out of 10 lung cancers 

Smoking causes mouth and throat cancer 

Smoking damages your lungs 

Smoking causes heart attacks 

Smoking causes strokes and disability 

Smoking clogs your arteries 

Smoking increases the risk of blindness 

Smoking damages your teeth and gums 

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 

EN 

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ANNEX II 

CORRELATION TABLE  

Directive 2001/37/EC  

This Directive 

Article 1 

Article 2 

Article 3 

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

Article 1 

Article 2 

Article 3 

Article 4 

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

Article 5 

Article 12 

Article 5 

Article 6 

Article 7 

Article 5(1) and (2) 

Article 8 

Article 5(3) and Article 
9(2) 

Article 9 

Article 5 

Article 5(4) 

Article 7 

Article 5(9) 

Article 10 

Article 11 

Article 12 

Article 13 

Article 14 

Article 8 and Article 9(3) 

Article 15 

Article 16 

Article 17 

Article 18 

Article 19 

Article 20 

EN 

46 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Article 10 

Article 11 

Article 13 

Article 14  

Article 15  

Article 16 

Article 17 

Annex I 

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

Article 21 

Article 22 

Article 23 

Article 24 

Articles 25 and 26 

Article 27 

Article 28 

Article 29 

Annex I 

Annex II 

Annex III 

Annex III 

EN 

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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

EN 

48 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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 structure49  

Health for Growth  

1.3. 

Nature of the proposal/initiative  

(cid:133) The proposal/initiative relates to a new action  

(cid:133) The proposal/initiative relates to a new action following a pilot project/preparatory action50  

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

(cid:133) 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. 

49 
50 

ABM: Activity-Based Management – ABB: Activity-Based Budgeting. 
As referred to in Article 49(6)(a) or (b) of the Financial Regulation. 

EN 

49 

   EN 

                                                 
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). 

EN 

50 

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1.6. 

Duration and financial impact  

(cid:133) Proposal/initiative of limited duration  

–  (cid:133)  Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY  

–  (cid:133)  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) envisaged51  

X Centralised direct management by the Commission  

(cid:133) Centralised indirect management with the delegation of implementation tasks to: 

–  (cid:133)  executive agencies  

–  (cid:133)  bodies set up by the Communities52  

–  (cid:133)  national public-sector bodies/bodies with public-service mission  

–  (cid:133)  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  

(cid:133) Shared management with the Member States  

(cid:133) Decentralised management with third countries  

(cid:133) 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.  

51 

52 

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 
As referred to in Article 185 of the Financial Regulation. 

EN 

51 

   EN 

                                                 
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; 

EN 

52 

   EN 

– 

– 

– 

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. 

EN 

53 

   EN 

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. 

Budget line 

Type of  
expenditure

Contribution  

Number  
[Description…Health for Growth] 

Diff./non-
diff. 
(53) 

from 
EFTA54 
countries 

from 
candidate 
countries55 

from third 
countries 

within the 
meaning of 
Article 18(1)(aa) 
of the Financial 
Regulation  

Heading of 
multiannual 
financial 
framework 

3 

17.030156 

Diff/non
- 

YES/NO YES/NO 

YES/NO  YES/NO 

•  New budget lines requested  

In order of multiannual financial framework headings and budget lines. 

Budget line 

Type of 
expenditu
re 

Contribution  

Heading of 
multiannual 
financial 
framework  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 

53 
54 
55 
56 

Diff. = Differentiated appropriations / Non-diff. = Non-Differentiated Appropriations. 
EFTA: European Free Trade Association.  
Candidate countries and, where applicable, potential candidate countries from the Western Balkans. 
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.  

EN 

54 

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3.2. 

Estimated impact on expenditure  

3.2.1. 

Summary of estimated impact on expenditure  

Heading of multiannual financial 
framework:  

Number  Health for Growth Programme 

EUR million (to 3 decimal places) 

DG: SANCO 

(cid:121) Operational appropriations  

Number of budget line 17.03.XX 

Number of budget line 

Commitments 

Payments 

Commitments 

Payments 

Appropriations of an administrative nature financed  
 from the envelope for specific programmes57  
Number of budget line  

(1) 

(2) 

(1a) 

(2a) 

(3) 

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Years 2018 and esq 

TOTAL 2014-
2018 

0.900 
0.450 

0.900 
0.900 

0.900 
0.900 

0.900 
0.900 

0.900 
1.350 

TOTAL appropriations 
for DG SANCO 

Commitments 

=1+1a +3 

0.900 

0.900 

0.900 

0.900 

0.900 

Payments 

=2+2a 

+3 

0.450 

0.900 

0.900 

0.900 

1.350 

(cid:121) TOTAL operational appropriations  

Commitments 

Payments 

(4) 

(5) 

0.900 

0.450 

0.900 

0.900 

0.900 

0.900 

0.900 

0.900 

0.900 

1.350 

4.500 
4.500 

4.500 

4.500 

4.500 

4.500 

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. 

EN 

55 

E

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
(cid:121) 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 

Payments 

=5+ 6 

0.450 

0.900 

0.900 

0.900 

1.350 

4.500 

4.500 

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

(cid:121) TOTAL operational appropriations  

Commitments 

Payments 

(cid:121) TOTAL appropriations of an administrative nature 
financed from the envelope for specific programmes  

(4) 

(5) 

(6) 

TOTAL appropriations  
under HEADINGS 1 to 4 
of the multiannual financial framework 
(Reference amount) 

Commitments 

=4+ 6 

Payments 

=5+ 6 

EN 

56 

E

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Heading of multiannual financial 
framework:  

5 

" Administrative expenditure " 

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Years 2018 and esq 

TOTAL 

EUR million (to 3 decimal places) 

DG: SANCO 

(cid:121) Human resources  

0.571 

0.571 

0.571 

0.508 

0.508 

(cid:121) Other administrative expenditure  

0.018 

0.165 

0.168 

0.172 

0.136 

TOTAL DG SANCO 

Appropriations  

0.589 

0.736 

0.739 

0.68 

0.644 

TOTAL appropriations 
under HEADING 5 
of the multiannual financial framework  

(Total 
= Total payments) 

commitments 

0.589 

0.736 

0.739 

0.68 

0.644 

2.729 

0.659 

3.388 

3.388 

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Years 2018 and esq 

TOTAL 

EUR million (to 3 decimal places) 

TOTAL appropriations  
under HEADINGS 1 to 5 
of the multiannual financial framework  

Commitments 

1.489

1.636

1.639 

1.58

1.544

Payments 

1.039

1.636

1.639 

1.58

1.994

7.888

7.888

EN 

57 

E

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.2.  Estimated impact on operational appropriations  

–  (cid:133)  The proposal/initiative does not require the use of operational appropriations  

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

Year 2014 

Year 2015 

Year 2016 

Year 2017 

Year 2018 and sq years 

TOTAL 

Commitment appropriations in EUR million (to 3 decimal places) 

Indicate 
objectives and 
outputs  

Type of 
output58 

(cid:216) 

Ave-
rage 
cost  
of the 
out-
put 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

OUTPUTS 

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

Total 
numbe
r of 
output
s 

Total  
cost 

SPECIFIC OBJECTIVE No 159… 

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) 

0.233 

3 

0.800 

3 

0.800 

3 

0.800 

3 

0.800 

3 

0.800 

- Output 

Techni-
cal, 
market 
and 
scienti-
fic 
reports 

58 
59 

Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.). 
As described in Section 1.4.2. "Specific objective(s)…" 

EN 

58 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
0.100 

1 

0.100 

1 

0.100 

1 

0.100 

1 

0.100 

1 

0.100 

- Output 

Up-to 
date IT 
tool for 
analysis 
of ingre-
dients 
data 

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 

EN 

59 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.3.  Estimated impact on appropriations of an administrative nature 

3.2.3.1.  Summary  

–  (cid:133)  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 

0.571 

0.571 

0.571 

0.508 

0.508 

0.018 

0.165 

0.168 

0.172 

0.136 

0.589 

0.736 

0.739 

0.68 

0.644 

2.729 

0.659 

3.388 

HEADING 5 
of the multiannual 
financial framework 

Human resources  

Other administrative 
expenditure  

Subtotal HEADING 5 
of the multiannual 
financial framework  

Outside HEADING 560 
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

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. 

EN 

60 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.2.3.2.   Estimated requirements of human resources  

–  (cid:133)  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 

(cid:121) 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) 

(cid:121) 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 Headquarters63 

- 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 

61 

62 
63 

CA= Contract Agent; INT= agency staff ("Intérimaire"); JED= "Jeune Expert en Délégation" (Young 
Experts in Delegations); LA= Local Agent; SNE= Seconded National Expert. 
Under the ceiling for external personnel from operational appropriations (former "BA" lines). 
Essentially  for  Structural  Funds,  European  Agricultural  Fund  for  Rural  Development  (EAFRD)  and 
European Fisheries Fund (EFF). 

EN 

61 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
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. 

–  (cid:133)  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. 

… 

–  (cid:133)  Proposal/initiative requires application of the flexibility instrument or revision 

of the multiannual financial framework64. 

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  

64 

See points 19 and 24 of the Interinstitutional Agreement. 

EN 

62 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.3. 

Estimated impact on revenue  

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

–  (cid:133)  Proposal/initiative has the following financial impact: 

(cid:133) 

(cid:133) 

on own resources  

on miscellaneous revenue  

Appropriation
s available for 
the ongoing 
budget year 

Budget revenue line: 

Article …………. 

EUR million (to 3 decimal places) 

Impact of the proposal/initiative65 

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) 

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

… 

Specify the method for calculating the impact on revenue. 

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. 

EN 

63 

   EN