Report from 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
Date: 2005-07-27
Institutions: European Commission
Subjects: approximation of laws, consumer information, labelling, marketing standard, public health, report, tobacco, tobacco industry

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 27.7.2005 
COM(2005) 339 final 

REPORT FROM 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 

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REPORT FROM 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 

1. 

2. 

3. 

3.1. 

3.2. 

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

Transposition................................................................................................................ 3 

Application................................................................................................................... 4 

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

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

3.2.1.  Testing laboratories...................................................................................................... 4 

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

3.2.3.  Reporting the yields ..................................................................................................... 5 

3.3. 

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

3.3.1. 

Implementation ............................................................................................................ 5 

3.3.2. 

Impact on smoking....................................................................................................... 5 

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

3.3.4.  Further action ............................................................................................................... 6 

3.4. 

3.5. 

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

Common list of ingredients (Article 12) ...................................................................... 7 

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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 (“the Directive”) requires that the Commission shall 
regularly  report  to  the  European  Parliament,  the  Council  and  the  Economic  and  Social 
Committee on the application of the Directive. 

This report provides the first assessment of the application of the Directive. It is based on the 
feedback  from  Member  States,  largely  in  response  to  a  questionnaire  sent  to  all  of  them 
(EU25) in June 2004. The report takes into account recent developments and new scientific 
knowledge and incorporates views of stakeholders in the area of tobacco control. Given the 
short period of time since the transposition of the Directive, including the delays explained in 
Chapter 2, such experience is limited both at national and EU level.  

However,  the  Report  demonstrates  that  the  positive  effects  of  the  regulation  of  tobacco 
products are already emerging at EU level. This experience will also be useful in the global 
context. The WHO Framework Convention on Tobacco Control2 (FCTC) incorporates many 
of the concepts central to the Directive. 

The  report  does  not  include  separate  sections  on  tobacco  products  for  oral  use  or  roll-your-
own tobacco as the replies from the Member States did not provide any new information and 
as there was not enough new scientific information on ingredients that encourage addiction or 
on tobacco products that may have the potential to reduce harm. However, the Commission 
continues  to  follow  closely  scientific  developments  as  regards  different  aspects  of  tobacco 
products  and  their  health  effects,  including  carcinogenic,  cardiotoxic  and  dependence 
producing effects, and will cover any findings in detail in the next report.  

The report highlights areas that should be developed based on the first experience and in the 
light of new scientific and technical knowledge. 

2. 

TRANSPOSITION 

As of 31 October 2004, the Directive was transposed in all Member States with the exception 
of Estonia3. 

As regards the EU15, there were some delays in the transposition, due by 30 September 2002. 
The  Commission  issued  a  warning  letter  to  those  Member  States  in  November  2002.  Some 
Member States cited the legal uncertainty as a result of challenges before the European Court 
of Justice as a cause for delay. In both two cases4 the Court maintained the Directive. 

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4 

OJ L 194, 18.7.01, p. 26. 
www.who.int/tobacco/framework 
The Estonian Parliament adopted the act that transposes the Directive on 4 May 2005. 
European Court of Justice: cases C210-03 and C434-02. 

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3. 

APPLICATION 

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

All  EU15  countries  respected  the  deadline  in  Article  3  that  by  1  January  2004  cigarettes 
released for free circulation, marketed or manufactured in the Member States should comply 
with  the  maximum  tar,  nicotine  and  carbon  monoxide  (CO)  yields.  In  Greece,  the  tar  yield 
will  apply  from  1  January  2007.  The  EU10  did  not  request  transitional  periods  for  this 
provision. Regarding the yields applied to cigarettes exported to countries outside the EU all 
Member States comply with the deadline of 1 January 2005 set by the Directive. 

3.2.  Measurement methods (Article 4) and yield labelling 

3.2.1.  Testing laboratories  

Thirteen countries have notified the approved  laboratories to the Commission. A number of 
Member  States,  particularly  smaller  ones,  indicated  the  lack  of  an  appropriate  laboratory  in 
the country; their solution is to approve a laboratory in another Member State. 

The Commission will consult Member States on questions related to laboratories, in particular 
on sharing of the laboratory capacity and publish the list of approved laboratories. 

3.2.2.  Measurement of tar, nicotine and carbon monoxide yields 

Nicotine  is  the  single  most  important  substance  contained  in  cigarettes  and  its  regulation  is 
vital.  Nicotine  is  the  reason  why  people  continue  smoking.  The  nicotine  limit  set  in  the 
Directive  is  an  important  harmonising  measure  and  successfully  brings  nicotine  under 
regulatory  control.  The  WHO5  acknowledges  that  a  broad  and  comprehensive  regulatory 
framework  is  required  to  enable  policy  options  for  controlling  nicotine  to  move  forward  in 
reducing risks.  

The ISO measurement of yields is based on smoking simulated by a machine. New evidence, 
however,  confirms  that  smokers  adjust  inhalation  with  the  yield.  Hence,  despite  lower 
nominal yields from cigarettes, there is only limited evidence that this approach is successful 
in reducing the toxic burden of a smoker. As a result, the health community6 has put the use 
of  the  ISO  standards  into  question.  Although  the  ISO  standards  are  criticised,  there  is  no 
international agreement on alternatives.  

The Commission does not propose to revise the current standards set out the Directive until 
solid  evidence  shows  that  better  methods  exist  to  replace  them.  The  Commission  will 
encourage the scientific and technological development in this area. In particular, the FCTC 
provides  in  Article  9  that  the  Conference  of  the  Parties  shall  propose  guidelines  for  testing, 
measuring  and  regulating  the  contents  and  emissions  of  tobacco  products.  As  soon  as  more 
realistic methodologies are internationally agreed the Commission will consider how to adapt 
the Directive.  

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6 

WHO  Study Group on  Tobacco  Product Regulation  Recommendation  on  tobacco  product  ingredients 
and emissions WHO 2003 http://www.who.int/tobacco/sactob/recommendations/en/ 
“Tobacco or Health in the European Union: past, present and future”. Report prepared by the ASPECT 
consortium, 2004.  

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3.2.3.  Reporting the yields 

Reporting the yields on the packet has led to concerns that consumers may believe that low 
yield products are less harmful, and consequently they smoke more of these. While removal 
of the yield information from packets has been called for, the Commission is of the opinion 
that  the  measured  yields  should  continue  to  be  printed  on  the  packets.  Also  the  FCTC 
provides  that  information  on  relevant  constituents  and  emission  shall  be  placed  on  the 
package in its Article 11(2). 

3.3. 

Labelling (Article 5) 

3.3.1. 

Implementation 

While  the  implementation  of  the  Article  5  overall  is  generally  satisfactory  there  have  been 
some difficulties. In addition, some of the EU10 countries applied a transitional period.  

As  regards  the  black  border  around  the  warnings,  the  Commission  advises  that  the  border 
should not be considered as a part of the warning area. 

Very thin packets pose a special problem: The yield information should be printed parallel to 
the top edge but this leads to poor readability. Printing the information rotated by 90 degrees 
improves readability. Although contrary to the provisions of Article 5(6), the Commission has 
not reacted because this is considered as a temporary solution waiting for the amendment of 
the Directive.  

Member States also reported industry attempts to circumvent the legislation by attempting to 
hide, obscure or reduce the visibility of the warnings by various means, such as a cardboard 
sheath (“etuis en carton”) to cover the warnings and stickers. A year after the new warnings 
were introduced such practices have become limited.  

3.3.2. 

Impact on smoking 

The evidence indicates that these measures influence smoking behaviour despite the fact that 
the  warnings  have  been  in  use  for  a  short  time.  Studies  show  that  smokers  have  been  more 
motivated to stop or to reduce smoking. The warnings have been particularly effective among 
15-24 year olds.  

A Dutch study indicated that some adults smoked less and were more motivated to quit as a 
result  of  the  warnings.  Among  13-18  year  olds  the  effect  was  strong:  28%  said  that  they 
smoked  less  because  of  the  warnings7.  Another  Dutch  study  found  that  the  inclusion  of  the 
quit line number increased calls to the service, in particular from lower income groups8 that 
are  usually  less  active.  A  Belgian  study  found  that  bigger,  clearer  warnings  motivated 
smokers  to  stop  smoking  and  made  cigarette  packs  less  attractive  to  youngsters9.  Of  Polish 
male  smokers,  3%  said  they  had  quit  because  of  the  large  health  warnings,  16%  had  tried 

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Persbericht Defacto (2002) 28% van jonge rokers rookt minder door de nieuwe waarschuwingen op. 
Willemsen M, Simons C, Zeeman G(2002). Impact of the new EU health warnings on the Dutch quit 
line, Tobacco Control, 11:381-2. 
Joossens L, Onderzoek naar het effect van gezondheidswaarschuwingen op sigarettenpakjes in België, 
Vlaams Instituut voor Gezondheidspromotie, Brussel, 2004. 

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quitting,  and  14%  claimed  to  understand  health  effects  of  smoking  better10.  In  Malta,  the 
demand for smoking cessation enquiries increased threefold following the introduction of the 
warnings. 

3.3.3.  Colour images 

In  line  with  Article  5  (3)  of  the  Directive,  the  Commission  adopted  in  September  2003 
Decision  2003/641/EC11,  which  establishes  rules  for  the  use  of  photographs  or  other 
illustrations as health warnings and conditions under which they may be used. In accordance 
with Article 3 of the Decision, the Commission created a library of images12 in May 2005.  

According to a EuroBarometer survey in the autumn of 2002, 38% of the citizens believe that 
the  addition  of  colour  images  to  cigarette  packages  would  be  useful  in  persuading  people 
either not to smoke, to smoke less, or to quit13. This is also what the Member States in general 
believe according to the questionnaire. The majority of the Member States intends to study the 
use  the  images.  The  Commission  encourages  the  Member  State  to  use  the  new  pictorial 
warnings. 

3.3.4.  Further action 

The  Commission  will  consider  further  development  of  labelling,  such  as  a  wider  use  of  the 
quit line telephone numbers, once more information is available on the use of new textual and 
pictorial warnings.  

3.4. 

Ingredients (Article 6) 

There  have  been  some  difficulties  associated  to  the  submission  of  ingredient  information  to 
Member States by the industry. Only 13 Member States have submitted Article 6 information 
to the Commission. 

The format of the information transmitted from the industry to the Member States and further 
to the Commission varies greatly. National authorities have received information that is either 
too detailed or too sparse.  

In general the data sent to the Member States does not comply fully with the Directive. Article 
6 requires the  disclosure of all ingredients and their quantities used in the manufacturing of 
tobacco products. The industry has put forward  a template known as the “three model list”, 
providing information according to a “quantity not exceeded” model. This conflicts with the 
Directive because it does not give a precise quantity and the exact information is not provided 
by brand.  

The  Netherlands  and  Belgium  are  attempting  to  establish  specific  implementing  regulations 
for  the  submission  of  tobacco  ingredients.  The  industry  has  legally  challenged  the  Dutch 

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13 

World  Bank  Report,  Curbing  the  epidemic.  Governments  and  the  economics  of  tobacco  control, 
Washington DC, 1999. 
OJ L 226, 10/09/2003 p.24. 
C(2005) 1452 to be published in the OJ. 
European  Commission,  Health  &  Consumer  protection,  Smoking  and  the  environment:  actions  and 
attitudes, Special Eurobarometer 183/Wave 58.2, November 2003. 

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regulation concerning the proposed model14. It seems that this legal action is inhibiting similar 
initiatives in other Member States. 

A further important barrier to the full implementation of this article is the lack of capacity to 
analyse the data received at Member State and EU level. 

The  Directive  has  succeeded  in  generating  considerable  debate  on  the  disclosure  of 
ingredients and placed the issue high on the European tobacco control agenda A harmonised 
reporting  system  and  the  definition  of  ingredients  need  further  discussion  to  facilitate  full 
compliance. 

The  current  reporting  system  needs  to  be  improved  to  facilitate  processing,  assessment  and 
wide  dissemination.  The  core  element  of  ingredient  regulation  is  the  full  disclosure  of 
information  by  the  tobacco  manufacturers.  All  ingredients  and  constituents  used  in  the 
manufacturing of a tobacco product and still present in the finished product must be included. 
The development of a reporting system should consider existing initiatives, such as the Dutch 
and Belgian models, and the European Chemicals Bureau’s system.  

Experts  have  expressed  concerns  that  the  current  definition  of  ingredients  is  too  limited.  A 
way  forward  could  therefore  be  to  adopt  the  WHO  working  group  definition15  that 
“ingredients  include  all  product  components,  materials  used  to  manufacture  those 
components,  residual  substances  from  agricultural  practices,  storage  and  processing,  and 
substances that can migrate from packaging into the product.”  

It seems clear that Article 6 needs to be developed. The Commission will carry out an analysis 
of the information collected so far in order to create a basis for any amendments needed and 
consult the Regulatory Committee established under Article 10. 

In  response  to  requests  by  Member  States  and  the  industry,  the  Commission  will  develop 
harmonised  data  collection  methods  that  are  based  on  a  common  EU  format  and  improved 
definitions.  The  Commission  intends  to  launch  a  consultation  involving  Member  States  and 
stakeholders on this matter. 

3.5. 

Common list of ingredients (Article 12) 

Given the limited progress on Article 6, and in particular due to the lack of full submission of 
information,  the  Commission  has  been  unable  to  develop  a  proposal  for  a  common  list  of 
ingredients.  However,  the  Commission  has  carried  out  an  in-depth  exploration  on  the 
feasibility and relevance of a common list of ingredients16. 

This consultation raised issues beyond the availability of data that may put into question the 
approach  as  set  out  in  Article  12.  The  Commission  has  drawn  a  number  of  important 
conclusions relating to the relevance and utility of a list of ingredients. 

A  rationale  behind  an  authorised  list  of  ingredients  is  –  inter  alia  -  to  be  able  to  regulate 
additives that are known not to increase the toxicity or addictiveness, or to ban those that are 

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16 

The Dutch State is summoned by seven tobacco companies. 
WHO Scientific Advisory Committee on Tobacco Product Regulation. 
www.who.int/tobacco/sactob/recommendations/en 
This  includes  expert  meetings  on  29  September  2003  and  18  February  2004.  Commission  supported 
workshops in March 2004 and in June 2004 in Limerick. In addition, the writing of the report “Tobacco 
or Health in the European Union: past, present and future” was a consultative process in itself.  

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only used to attract children. A rationale for a common list in the EU is to avoid a situation 
where tobacco companies could seek approval in a country with the weakest system.  

The  successful  establishment  of  a  common  list  depends  firstly  on  ingredient  information 
received  from  the  industry  in  a  relevant  and  timely  way.  Following  the  provision  of 
information,  it  is  necessary  to  determine  those  ingredients  that  increase  toxicity  or 
addictiveness of the product. Moreover, scientifically sound criteria are needed for approval 
or prohibition of ingredients. 

Such  information  will  need  to  be  based  on  accepted  tests  that  measure  toxicity  and 
addictiveness of ingredients. However, the Commission was advised that no clear criteria for 
measuring  toxicity  and  addictiveness  currently  exist.  Methodologies  should  be  validated  for 
their sensitivity, specificity and comparability. This is a demanding task requiring skills and 
expertise  currently  not  widely  available.  In  particular,  methodologies  for  assessing 
addictiveness are not well developed and not applicable to routine, large-scale monitoring, the 
development will take several years. 

The Directive requires that industry provides only the available toxicological data. However, 
this is not adequate to meet the needs of developing ingredient regulation. 

Questions  arise  as  to  who  should  be  responsible  for  the  burden  of  proof  in  general,  and 
specifically who should develop and carry out the testing, and at what level. The Commission 
is convinced that leading the development such tests would be best left in the public sphere. 

There  have  been  calls  in  many  countries,  and  at  European  level,  for  a  regulatory  body  for 
tobacco products. Given the global  nature of  tobacco  products, the WHO should  coordinate 
regulatory  efforts  through  the  FCTC.  Article  9  of  the  FCTC  calls  for  the  development  of 
internationally  accepted  guidelines  for  testing,  measuring  and  regulating  the  contents  and 
emissions. 

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