Report from the Commission to the European Parliament, the Council and the European Economic and Social Committee - Second Report on the Application of the Tobacco Products Directive
Date: 2007-11-27
Institutions: European Commission
Subjects: application of EU law, consumer information, labelling, marketing standard, public health, report, tobacco, tobacco industry

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 27.11.2007 
COM(2007) 754 final 

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE 
COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE 

Second Report on the Application of the Tobacco Products Directive 

EN 

   EN 

 
 
 
  
1. 

2. 

3. 

4. 

4.1. 

4.2. 

4.3. 

5. 

5.1. 

5.2. 

6. 

6.1. 

6.2. 

6.3. 

7. 

8. 

8.1. 

8.2. 

9. 

10. 

11. 

12. 

Introduction .................................................................................................................. 3 

Definitions (Article 2) .................................................................................................. 3 

Maximum tar, nicotine and carbon monoxide yields of cigarettes (Article 3) ............ 4 

Measurement methods (Article 4) and yield labelling................................................. 4 

Measurement of tar, nicotine and carbon monoxide yields ......................................... 4 

Laboratories.................................................................................................................. 5 

GoToLab Network ....................................................................................................... 5 

Labelling (Article 5)..................................................................................................... 5 

Textual warnings.......................................................................................................... 5 

Colour images .............................................................................................................. 6 

Ingredients (Article 6) .................................................................................................. 7 

Reporting on tobacco products ingredients.................................................................. 7 

Administrative agreement with the Joint Research Centre .......................................... 7 

REACH Regulation...................................................................................................... 8 

Product descriptors (Article 7) ..................................................................................... 9 

Tobacco for oral use (Article 8) ................................................................................... 9 

Scientific opinion ......................................................................................................... 9 

Implementation of the ban on oral tobacco.................................................................. 9 

Adaptations (Articles 9 and 10) ................................................................................... 9 

Common list of ingredients (Article 12) .................................................................... 10 

Import, sale and consumption of tobacco products (Article 13)................................ 10 

Emerging Issues ......................................................................................................... 11 

12.1.  Roll-your-own (RYO) cigarettes................................................................................ 11 

12.2.  New tobacco and nicotine products ........................................................................... 11 

12.2.1.  The emerging market ................................................................................................. 11 

12.2.2.  The regulatory challenge............................................................................................ 12 

13. 

Product liability.......................................................................................................... 12 

EN 

2 

   EN 

 
1. 

INTRODUCTION 

Article  11  of  Directive  2001/37/EC  of  5  June  20011  on  the  approximation  of  the 
laws, regulations and administrative provisions of the Member States concerning the 
manufacture,  presentation  and  sale  of  tobacco  products  (hereafter  'the  Directive') 
requires the Commission to regularly report to the European Parliament, the Council 
and the Economic and Social Committee on the application of the Directive. The first 
report on the application of the Directive was adopted on 27 July 2005. 

This  report  contains  the  second  assessment  of  application  of  the  Directive.  It  is 
largely  based  on  the  work  done  and  information  given  by  Member  States  in  the 
Tobacco  Products  Regulatory  Committee,  as  provided  for  under  Article  10  of  the 
Directive, during the last two years. The report incorporates views of stakeholders in 
the  field  of  tobacco  control  as  well  as  of  the  European  Parliament  and  Member 
States. It also outlines potential areas for changes to the Directive in order to allow 
for a proper discussion with Member States and the European Parliament before the 
Commission considers submitting a formal proposal to amend the Directive. 

2. 

DEFINITIONS (ARTICLE 2) 

The  current  definition  of  ingredients  in  Article  2(5)  covers  any  substance  or 
constituent  used  in  the  manufacture  or  preparation  of  a  tobacco  product  and  still 
present  in  the  finished  product  even  if  in  altered  form,  including  paper,  filter,  inks 
and  adhesives.  It  does  not  cover  the  tobacco  leaf  itself  or  other  natural  or 
unprocessed tobacco plant parts. 

However,  the  WHO  definition  of  the  contents  of  tobacco  products  as  well  as  the 
legislation of some countries outside the EU (e.g. Canada) include the tobacco leaf 
itself. During recent years, the Commission has received several questions regarding 
radioactive and other substances in tobacco products and their health effects – Radon 
(Rn),  Polonium  (Po-210),  Cadmium  (Cd),  etc.  These  questions  are  all  related  to 
tobacco  leaves.  This  has  led  to  discussion  about  whether  the  tobacco  leaf  and  its 
compounds (natural and/or artificial) should be covered by the definition and thus be 
regulated by the Directive. 

Further action 

The  Commission  will  study  whether  it  is  appropriate  to  include  the  tobacco  leaf  and  other 
natural or unprocessed tobacco plant parts in the definition of ingredients. 

1 

OJ L 194, 18.7.2001, p. 26. 

EN 

3 

   EN 

 
                                                 
3. 

MAXIMUM  TAR,  NICOTINE  AND  CARBON  MONOXIDE  YIELDS  OF  CIGARETTES 
(ARTICLE 3) 

Article  3(1)  of  the  Directive  lays  down  the  maximum  yields  for  tar,  nicotine  and 
carbon monoxide (TNCO) of cigarettes released for free circulation in the EU. The 
limits are now applied in all 27 Member States2. 

Article 3(2) of the Directive makes the same maximum yields applicable to cigarettes 
manufactured  within,  but exported from, the  European  Community, at the latest  by 
1 January  2007.  No  Member  State  has  approached  the  Commission  to  extend  the 
transitional period and the Commission does not envisage modifying the Directive in 
this respect. 

4. 

MEASUREMENT METHODS (ARTICLE 4) AND YIELD LABELLING 

Discussions concerning the first report on application of the Directive revealed that 
Member States wished to have more clarity on questions such as the interpretation of 
thresholds set by the Directive for TNCO testing and on approval of laboratories to 
enable further laboratory cooperation3. 

4.1.  Measurement of tar, nicotine and carbon monoxide yields 

The Tobacco Products Regulatory Committee established under the Directive set up 
a  working  group  consisting  of  experts  from  several  Member  States, 
the 
Commission's Joint Research Centre and the Chairman of the European Network of 
Government Laboratories for Tobacco and Tobacco Products (GoToLab). In the non-
binding  practical  guide  on  "Cigarette  yield  measurement  and  some  basic  steps  for 
laboratory approval"4, published by the Commission's Directorate-General for Health 
and  Consumer  Protection  (DG  SANCO),  the  working  group  proposed  that  the 
maximum  limits  calculated  according  ISO  8243  should  be  regarded  as  maximum 
values around which the confidence interval can fluctuate. 

The  Directive  contains  the  possibility  of  adapting  the  methods  to  scientific  and 
technical  progress  via  the  Tobacco  Products  Regulatory  Committee.  In  April  2007, 
the  Commission  consulted  the  Regulatory  Committee  on  the  pros  and  cons  of 
different  existing  smoking  regimes  (ISO,  Massachusetts,  Canadian 
intense, 
compensatory  method).  No  definitive  conclusion  was  drawn,  although  Member 
States  widely  wished  to  continue  using  the  current  ISO  smoking  regime  on  an 
obligatory basis until solid evidence shows that better methods exist to replace them5. 

2 

3 

4 

5 

Maximum limits for TNCO became applicable in the 14 Member States (EU15 except Greece) as from 
1 January 2004. In the new 10 Member States as from their accession on 1 May 2004 and in Romania 
and Bulgaria as from their accession on 1 January 2007. For Greece the limits also became applicable 
on 1 January 2007 after the temporary derogation expired. 
The list of approved laboratories is available here: 
http://ec.europa.eu/health/ph_determinants/life_style/Tobacco/label_labo_en.htm 
The document is published here: 
http://ec.europa.eu/health/ph_determinants/life_style/Tobacco/Documents/best_practices_en.pdf 
All  presently  used  measurement  methods  are  based  on  machine  testing  which  is  not  suitable  for 
assessing human exposure to smoke. One possibility for human exposure assessment would be to use 
biomarkers, but more research is still needed on this issue. 

EN 

4 

   EN 

 
                                                 
 
4.2. 

Laboratories 

On the basis of the information and best practices gathered from Member States, the 
abovementioned  working  group  suggested  a  number  of  criteria  for  testing  and 
verification  laboratories.  These  were  also  included  in  the  practical  guide  on 
"Cigarette yield measurement and some basic steps for laboratory approval"4. 

4.3. 

GoToLab Network 

GoToLab  was  established  as  a  network  of  European  governmental  laboratories  for 
tobacco and tobacco products in January 2002 in order to facilitate the exchange of 
experience  of  tobacco  laboratories  in  the  EU6.  The  Commission  consulted  the 
Regulatory Committee in 2006 on how to better link the Regulatory Committee and 
the GoToLab Network. Member States and representatives of the GoToLab Network 
both expressed strong support for enhanced cooperation. 

Further action 

A  functioning  and  appropriately  resourced  laboratory  network  forms  the  basis  for  more 
detailed  joint  work  by  Member  States  and the  Commission  on  tobacco  products  ingredients 
and  emissions.  Therefore,  the  Commission  is  committed  to  promoting  cooperation  among 
independent tobacco laboratories7 within the EU in order to create the operational basis for a 
shared  analysis  and  assessment  of  tobacco  ingredients  and/or  smoke  emissions.  In  order  to 
improve the functioning of the  Directive it would  also be  useful to extend the Commission's 
regulatory powers to cover the development of criteria for approving laboratories and other 
measures to improve laboratory cooperation and mutual recognition in the context of the next 
modification of the Directive. 

Although  the  ISO  standards  are  criticised,  there  is  as  yet  no  international  agreement  on 
alternatives. The Commission, therefore, does not propose to revise the current standards at 
this point in time. The Commission actively follows scientific and technological developments 
in  this  area  and  will  come  back  to  this  question  once  there  is  more  common  international 
understanding  and  agreement  on  the  methods.  The  Commission  considers  it  important  that 
the standards used in the EU are in line with international developments.  

5. 

LABELLING (ARTICLE 5) 

5.1. 

Textual warnings 

The implementation of textual warnings has generally been satisfactory even though 
Member States reported some difficulties in approach with regard to products other 
than  cigarettes  (e.g.  rolling  tobacco  and  novel  tobacco  products).  In  addition,  the 
Commission  received  a  few  complaints  about  implementation  of  Article  5(6)(e), 
which requires warnings to be printed in all official languages of the Member State 

6 

7 

Laboratories  from  5  Member  States  attended  the  first  meeting,  namely  France,  Germany,  United 
Kingdom, the Netherlands and Sweden. The Rules of Procedure are available on the GoToLab website 
along with the list of GoToLab members: http://www.jrc.ec.europa.eu/project/gotolab/index.html 
For independence criteria see the Practical Guide on "Cigarette yield measurement and some basic steps 
for laboratory approval", p.5:  
http://ec.europa.eu/health/ph_determinants/life_style/Tobacco/Documents/best_practices_en.pdf 

EN 

5 

   EN 

 
                                                 
where the product is placed on the market. It is important to note that this is a formal 
requirement  in  all  Member  States  having  more  than  one  official  language,  and  that 
there are no derogations or territorial exceptions (e.g. for airports). The Commission 
is currently looking into these issues in its role as a guardian of the Treaty. 

5.2. 

Colour images 

Article 5(3) of the Directive empowers the Commission to adopt additional warnings 
in the form of colour photographs or other illustrations (pictorials). The decision to 
introduce pictorials is left to Member States. 

The Commission adopted the library of 42 selected source documents8 and technical 
specifications  for  printing  combined  pictorial  and  written  warnings  on  packages  of 
various proportions9. DG SANCO also communicated to Member States its view that 
the place of marketing (country of destination) is what determines application of the 
pictorial  warning  requirements,  not  the  place  of  manufacturing.  It  also  encouraged 
Member  States  on  several  occasions  to  swiftly  introduce  pictorial  warnings  on  all 
tobacco products, and emphasised that Member States may already complement the 
combined  warnings  with  quit-line  telephone  numbers,  Internet  addresses  or  other 
visual  elements  informing  about  the  support  available  to  those  who  want  to  stop 
smoking.  Such  references  should  be  placed  within  the  area  reserved  for  combined 
warnings10. 

Based on this preparatory work, Belgium was the first EU Member State to introduce 
combined warnings in November 2006 and, as of 10 June 2007, they feature on all 
cigarette packets sold in Belgium. Implementation has been quite smooth so far. The 
next country to follow suit will be Romania, where pictorials will become mandatory 
in  July  2008.  In  the  UK,  the  warnings  are  planned  to  appear  on  cigarette  packets 
from autumn 2008 and on other tobacco products the following year. According to 
the  information  available  to  the  Commission, Finland and  Latvia  have  also  taken  a 
decision  to  require  the  use  of  pictorial  warnings,  while  further  Member  States  are 
considering  introducing  the  warnings  in  the  near  future.  The  Commission  has  also 
concluded copyright agreements with New Zealand and Switzerland, to allow them 
to use the EC pictorial library. 

The Dutch government commissioned a study to review the published evidence from 
Canada, Brazil, Australia and New Zealand as regards the effectiveness of pictorial 
warnings. The study concludes that pictorials are more effective than text warnings 
alone  when  it  comes  to  improving  knowledge  about  the  health  effects  of  smoking 
and increasing the intention to quit smoking11. 

8 

9 

10 
11 

Commission  Decision  2003/641/EC  of  5  September  2003  on  the  use  of  colour  photographs  or  other 
illustrations as health warnings on tobacco packages, OJ L 226, 10.9.2003, p. 24. 
These additional specifications were established by Annex III to Commission Decision C(2006) 1502 
final of 12 April 2006 amending the Commission Decision of May 2005.The new rules are illustrated 
by  an  informal  guidance  document  containing  demonstrative  adaptations  of  the  warnings  for  one-
language and three-language countries. 
Article 4(5) of Commission Decision 2003/641/EC. 
Research  voor  Beleid.  Kleurenfoto's  op  tabaksverpakkingen  -  Ervaringen  in  andere  landen.  Een 
onderzoek 
januari  2007. 
http://www.research.nl/index.cfm/28,4072,c,html/VGP-2745670B.pdf 

in  opdracht  van  het  ministerie  van  VWS,  Leiden,  22 

EN 

6 

   EN 

 
                                                 
There are strong voices in Member States and the European Parliament that say the 
labelling on TNCO yields is misleading for consumers and should be taken off  the 
packs. A number of Member States also pleaded for combined warnings to be made 
mandatory on all tobacco packets, which would facilitate their introduction in all EU 
countries.  There  were  also  strong  voices  in  Member  States  and  the  European 
Parliament for making the cessation information mandatory as well as for increasing 
the size of the warnings and placing pictorials on both sides of the package. 

Further action 

The  Commission  considers  all  these  proposals  to  be  promising  and  will  explore  them  in 
more detail for future changes to the Directive. The upcoming guidelines on packaging and 
labelling  under  the  WHO's  Framework  Convention  on  Tobacco  Control  will  be  a 
supplementary source of information. 

The  Commission  is  currently  examining  the  possibilities  with  regard  to  an  increased  size 
for  the  warnings,  mandatory  pictorial  warnings  on  both  sides  of  the  package  and  the 
replacement  of  the  maximum  limits  of  TNCO  by  information  on  help-lines  and/or  other 
substances in tobacco products (e.g. labelling of the use of GMOs). 

6. 

INGREDIENTS (ARTICLE 6) 

6.1. 

Reporting on tobacco product ingredients 

The Regulatory Committee set up a working group consisting of several experts from 
the  Member  States,  chaired  by  the  Commission,  to  develop  harmonised  reporting 
formats  for  tobacco  product  ingredients  which  would  enable  a  better  analysis  and 
comparison  of  the  information  delivered  by  tobacco  manufacturers.  Two  sets  of 
formats were developed: one requiring all the ingredient information manufacturers 
have to make available to national regulators and one requiring the information that 
has  to  be  given  to  the  public12.  Although  not  legally  binding  under  the  current 
framework, the Member States, manufacturers and importers are expected to use the 
formats.  Electronic  submission  of  data  would  be  the  desirable  form.  Currently,  a 
group  of  Member  States  is  developing  an  electronic  databank  of  tobacco  product 
ingredients.  This  project  was  recommended  for  co-funding  from  the  Community's 
Public Health Programme 2007. 

6.2. 

Administrative agreement with the Joint Research Centre 

To assist the Commission and the Member States with the work on tobacco product 
ingredients,  DG  SANCO  signed  an  administrative  arrangement  with 
the 
Commission's  Joint  Research  Centre  (JRC)  in  2006.  This  arrangement,  involving  a 
financial  amount  of  €558 502,  will  run  for  one  year13.  A  prolongation  with  similar 
amounts for a total of three years is foreseen. 

12 

13 

The practical guide "Reporting on tobacco ingredients" is available here: 
http://ec.europa.eu/health/ph_determinants/life_style/Tobacco/Documents/practical_guidance_en.pdf  
DG JRC will mainly focus on analysing the tobacco ingredient data sets, and coordinate the work of the 
GoToLab  Network,  provide  scientific  assistance  for  the  regulatory  process,  assist  DG  SANCO  in  its 
work  as  a  key  facilitator  for  the  FCTC  working  group  on  tobacco  product  regulation,  check  and 

EN 

7 

   EN 

 
                                                 
 
The JRC set up an expert group to develop guiding questions for the data analyses of 
tobacco product ingredients and to establish, in line with international developments 
in this area, an initial priority list of ingredients for further analysis. The group will 
also discuss issues relating to addictiveness and attractiveness. 

6.3. 

REACH Regulation 

The work on ingredients under the Directive is closely linked to developments under 
the REACH Regulation14 which covers the chemical ingredients of tobacco products 
just like any other chemical substance. It will be necessary to summarise and to take 
into account the information on tobacco ingredients made available under REACH in 
order to avoid overlaps with the on-going work in the context of the Directive15. 

Further action 

The  Commission  is  committed  to  putting  into  practice  all  the  activities  listed  in  the 
Commission statement on REACH16. 

A  number  of  Member  States  as  well  as  the  industry  wish  to  make  the  reporting  formats  on 
ingredients  compulsory.  In  this  respect  extending  the  Commission's  regulatory  powers  by 
amending Article 9 of the Directive should be considered. 

The introduction of fines By Member State for non-delivery of information by the industry as 
well as a possible extension of reporting requirements, e.g. the inclusion of the Hoffmann list 
of analytes, could be considered. 

The European Parliament asked the Commission for further amendments to the Directive in 
its  resolution  on  the  Green  Paper  "Towards  a  Europe  free  from  tobacco  smoke:  policy 
options  at  EU  level"  (adopted  by  the  European  Parliament  on  24  October),  such  as  the 
development of a full compendium of tobacco additives and substances in tobacco smoke, and 
making publicly available all existing toxicological data on the additives and ingredients in 
tobacco  smoke.  These  proposals  will  be  positively  and  thoroughly  studied.  An  even  more 
stringent  approach  would  be  to  not  allow  any  additives  in  tobacco  products  unless 
manufacturers proved their safety. 

14 

15 
16 

summarise  information  on  tobacco  product  ingredients  covered  by  REACH  and  review  the  scientific 
data on addictiveness. 
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), 
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. 
On the information to be submitted see in particular Articles 10–13 of the REACH Regulation. 
See 
the  Council  website: 
tobacco 
http://register.consilium.europa.eu/pdf/en/06/st16/st16908-ad01.en06.pdf  (REACH  is  item  30,  the 
tobacco  declaration  starts  on  p.  16).  Together  with  the  other  declarations  made  on  the  REACH 
Regulation,  it is  included  in the  minutes  of  the  meeting  of  the  Environment  Council of 18 December 
2006 at which REACH was adopted (reference 16908/06 Add 1). 

the  Commission's 

ingredients  on 

statement  on 

EN 

8 

   EN 

 
                                                                                                                                                         
7. 

PRODUCT DESCRIPTORS (ARTICLE 7) 

Until  now,  the  Commission  has  not  received  any  formal  complaints  about 
implementation  of  this  Article.  It  will  continue  monitoring  the  developments  under 
this provision and make appropriate proposals if necessary. 

8. 

TOBACCO FOR ORAL USE (ARTICLE 8) 

Article 8 of the Directive prohibits the marketing of oral tobacco, without prejudice 
to Article 151 of the Act of Accession of Austria, Finland and Sweden. 

8.1. 

Scientific opinion 

In  order  to  obtain  a  better  understanding  of  the  health  effects  of  various  smokeless 
tobacco  products  and  their  role  in  smoking  cessation  and  initiation,  DG  SANCO 
requested  an  opinion  from  its  Scientific  Committee  on  Emerging  and  Newly 
Identified Health Risks (SCENIHR)17. 

On  21  June  2007,  the  SCENIHR  approved  a  preliminary  report  for  public 
consultation on the health effects of smokeless tobacco products18. Interested parties 
and  stakeholders  were  invited  to  comment  through  online  consultation.  The  final 
report is expected at the beginning of 2008. 

8.2. 

Implementation of the ban on oral tobacco 

The  ban  on  tobacco  for  oral  use  in  Article  8  has,  in  general,  been  transposed  in 
Member  States.  However,  controlling  smuggling  and  illegal  sale,  particularly 
through the Internet, is difficult19. 

Further action 

The final scientific opinion on the health effects of smokeless tobacco products will form the 
scientific basis for any future risk management decision of the Commission on this issue. 

9. 

ADAPTATIONS (ARTICLES 9 AND 10) 

The  Directive  gives  the  Commission  regulatory  powers  to  adapt  the  measurement 
methods  for  TNCO  yields,  to  adapt  health  warnings  and  to  introduce  markings  for 
identification and tracing purposes. It does not enable the Commission to make the 
reporting  formats  mandatory,  to  adopt  a  list  of  criteria  for  the  authorisation  of 
laboratories,  to  adopt  measures  to  improve  laboratory  cooperation  or  to  amend  the 

17 

18 

19 

The mandate is available at: 
http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_q_004.pdf  
The preliminary opinion is currently available at: 
http://ec.europa.eu/health/ph_risk/committees/04_scenihr/scenihr_cons_06_en.htm  
In its judgment of 18 May 2006 in case C-343/05 (Commission v Finland) the Court of Justice found 
that Finland had, as regards the Province of Åland, failed to transpose the prohibition on placing on the 
market  of  snus  and  its  observance on vessels  registered  in  Finland. In  October  2007  the  Commission 
decided to bring Finland in the Court of Justice for non-compliance of the above judgment.  

EN 

9 

   EN 

 
                                                 
 
 
common  list  of  ingredients  provided  under  Article  12  of  the  Directive,  once 
established. The effective implementation of the Directive could be better ensured if 
the Commission could adopt such measures. 

Further action 

In  order  to  improve  the  functioning  of  the  Directive  it  would  be  useful  to  extend  the 
Commission's  regulatory  powers  to  cover  the  development  of  criteria  for  the  approval  of 
laboratories20, mutual recognition and measures intended to facilitate cooperation among the 
tobacco  testing  and  verification  laboratories,  the  introduction  and  amendment  of  the 
reporting  formats  for  ingredients  and,  in  future,  the  establishment  and  amendment  of  a 
common list of ingredients. 

10. 

COMMON LIST OF INGREDIENTS (ARTICLE 12) 

Given the still limited progress on Article 6 the Commission was not in a position to 
develop  a  proposal  for  a  common  list  of  ingredients.  Any  meaningful  work  on 
specific ingredients requires human and financial resources that are currently not yet 
available. 

Further action 

Development  in  this  area  depends  on  the  progress  of  work  outlined  under  Article  6.  In  the 
abovementioned  resolution  the  European  Parliament  asked  the  Commission  for  further 
amendments to the Directive as regards ingredients, such as a ban on all additives for which 
manufacturers  and  importers  do  not  deliver  complete  data  sets,  an  immediate  ban  on  all 
addiction-enhancing additives and on all additives shown by existing toxicological data to be 
carcinogenic, mutagenic or toxic to reproduction as such or upon pyrolysis. 

The Commission will study these suggestions. It will also consider co-financing research on 
the  toxicity  and  in  particular  addictiveness  of  tobacco  ingredients  and/or  smoke  emissions 
under the Research Framework Programme. Other steps might follow. 

11. 

IMPORT, SALE AND CONSUMPTION OF TOBACCO PRODUCTS (ARTICLE 13) 

Several Member States have drawn the Commission's attention to the increasing and 
expanding  marketing  of  cigarettes  with  candy  flavourings.  The  sweet-flavoured 
cigarettes  appeal  specifically  to  young  people,  and  thus  might  increase  smoking 
initiation.  These  types  of  products  are  usually  accompanied  by  attractive,  modern 
packages and trendy brand names attractive to young people. 

According to Article 13 of the Directive, Members States can keep or introduce more 
stringent rules concerning the manufacture, import, sale and consumption of tobacco 
products which they deem necessary in order to protect public health. However, the 
rules must comply with the EC Treaty. 

20 

The  review  of  the  Directive  will  need  to  take  into  account  any  possible  change  which  follows  the 
outcome of the negotiations on the "Regulation of the European Parliament and of the Council setting 
out the requirements for accreditation and market surveillance relating to the marketing of products". 

EN 

10 

   EN 

 
                                                 
Further action 

The  Commission  will  encourage  MS  to  monitor  any  development  in  the  import,  sale  and 
consumption of tobacco products and to take appropriate measures to protect their citizens in 
accordance with Article 13. The Commission will assess the measures under Directive 98/34 
following the notification by Member State. 

In order to decrease the smoking initiation and to protect EU consumers on equal basis in all 
Member  States  the  introduction  of  generic  (black  &  white)  standardised  packaging  for  all 
tobacco products could be explored as a possibility to reduce the attractiveness. 

The Commission will take into account any possible change which follows the outcome of the 
negotiations on the "Regulation of the European Parliament and of the Council setting out the 
requirements  for  accreditation  and  market  surveillance  relating  to  the  marketing  of 
products". 

12. 

EMERGING ISSUES 

12.1.  Roll-your-own (RYO) cigarettes 

Several  Member  States  have  underlined  that  the  sales,  and  accordingly the 
consumption,  of  roll-your-own  cigarettes are  dramatically  increasing,  especially 
among  young  people.  The  main  reason  for  this  development  is  seen  in  the  lower 
taxes on RYOs than on cigarettes, which results in lower retail prices. 

Some  Member  States apply  the  maximum  limits  of  the  TNCO  yields  for  cigarettes 
(10:1:10) also to RYOs; in other Member States no such requirement is established, 
as until now no internationally accepted measurement method existed. 

Recently an ISO method 15592 part 3 was validated for RYO cigarettes. 

Further action 

Validated and internationally recognised measurement methods for RYO could be adopted by 
using the comitology procedure. 

The  Commission  intends  to  look  at  the  taxation  of  RYO  tobacco  at  the  next  revision  of  the 
Tobacco Taxation Legal Framework. 

12.2.  New tobacco and nicotine products 

12.2.1.  The emerging market 

When it was adopted in 2001, the Directive intended to cover tobacco products that 
were  on  the  market.  Since  then,  the  tobacco  products  market  has  increasingly 
diversified.  In  addition  to  the  development  of  new  types  of  tobacco  and  nicotine 
products, some traditional tobacco products and patterns of use are becoming more 
popular. 

EN 

11 

   EN 

 
12.2.2.  The regulatory challenge 

The emergence of new types of tobacco and nicotine-related products raises the issue 
of  whether  the  present  regulatory  framework  for  tobacco  products  and  the  existing 
pharmaceutical  and  general  food  legislation21  make  it  possible  to  tackle  effectively 
all these kind of products. 

Further action 

The Commission will study the regulatory challenges outlined above with a view to at least 
ensuring that  new tobacco and/or nicotine products marketed are regulated properly at EC 
level to serve the public health and internal market objectives. The Commission will also look 
at  the  relationship  of  the  tobacco  products  regulatory  framework  with  the  novel  foods  and 
pharmaceutical legislation. 

13. 

PRODUCT LIABILITY 

The European Parliament asked the Commission to apply product liability in respect 
of  manufacturers  and  to  introduce  manufacturer  liability  for  the  financing  of  all 
health costs arising from tobacco consumption. In its Article 19 on product liability, 
the Framework Convention on Tobacco Control, to which the Community is a Party, 
asks all Parties to consider taking legislative action or promoting their existing laws 
to deal with criminal and civil liability, including compensation where appropriate. 

Further action 

The  Commission  will  commission  a  study  on  the  best  ways  forward  to  strengthen  product 
liability  of  tobacco  manufacturers  and  importers  in  the  EU  as  well  as  their  liability  for 
financing  the health costs arising from  tobacco consumption. This study  will  form the basis 
for further action. 

21 

Directive 2001/83/EC, OJ L 311, 28.11.2001; Regulation (EC) No 178/2002, OJ L 31, 1.2.2002, pp. 1–
24. 

EN 

12 

   EN