REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS on the application of Directive 2014/40/EU concerning the manufacture, presentation and sale of tobacco and related products
Date: 2021-05-20
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: air quality, application of EU law, consumer information, electronic commerce, labelling, packaging, smoking, tobacco, tobacco industry, traceability

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 20.5.2021 COM(2021) 249 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS on the application of Directive 2014/40/EU concerning the manufacture, presentation and sale of tobacco and related products  
 
 
1.  Introduction  
The Tobacco Products  Directive1 ('the Directive' or ‘TPD’),  applicable since May 2016,  aims at 
facilitating the smooth functioning of the internal market, protecting people’s health, particularly 
the  youth,  and  meeting  the  obligations  of  the  World  Health  Organisation  (WHO)  Framework 
Convention on Tobacco Control (FCTC). Under Article 28(1) of the TPD, the Commission must 
submit  a  report  on  the  Directive’s  application2  by  20  May  2021.  The  report  must  discuss, 
specifically, the elements of the Directive that should be reviewed given scientific and technical 
developments,  including  internationally  agreed  rules  and  standards  on  tobacco  and  related 
products. 

The TPD has aimed to reduce tobacco consumption by 2% within five years of its transposition3. 
Based on the latest Eurobarometer4, smoking prevalence among those aged 15+ fell from 26% in 
2014 to 23% in 2020 – a drop5 of 3 percentage points since the TPD came into force, equivalent to 
12.5%. Youth smoking rates fell to 20% in 2020 from 25% in 2014, after peaking at 29% in 2017. 
However,  the  uptake  of  emerging  products,  especially  e-cigarettes,  is  growing  among  young 
people6. This is worrying given the aim to protect the youth.  

Significant developments since the Directive came into force have given new urgency and impetus 
to tobacco control work. At international level, the Sustainable Development Agenda called on all 
countries to implement the FCTC more robustly. At EU level, the  2021 Europe’s Beating Cancer 
Plan places tobacco control at the spotlight of disease prevention efforts to help achieve a tobacco-
free  Europe  by  2040.  The  intermediate  objective  is  to  reach  the  WHO  target  of  a  30%  relative 
reduction  in  tobacco  use  by  2025  as  compared  to  20107,  translating  into  an  EU  smoking 
prevalence  rate  of  around  20%  by  2025  compared  to  29%  in  2010.  To  meet  these  ambitions, 
tobacco control efforts must be stepped up, including strengthening rules on tobacco products.  

2.  Transposition, application and enforcement (Articles 2, 23 and 24)  

2.1. Compliance assessment (transposition and conformity checks)  

Since  the  Directive  entered  into  force,  the  Commission  adopted  10  implementing  acts8,  2 
delegated acts9 and 2 Commission reports10 allowing for all the Directive’s provisions to be fully 

1 Directive 2014/40/EU.  
2 Despite leaving the EU and with the transition period ending on 31 December 2020, the UK is still considered and 
referred to as a Member State for the purposes of this report. This is done so that trends can be appropriately assessed 
given the targets specified in the impact assessment accompanying the TPD’s revision. Moreover, the TPD will 
continue to apply in Northern Ireland after 2020. 
3 TPD impact assessment: 
https://ec.europa.eu/health/sites/health/files/tobacco/docs/com_2012_788_summary_ia_en.pdf  
4 Unless stated otherwise, all prevalence and use data were obtained from Special Eurobarometer 506 – Attitudes of 
Europeans towards tobacco and electronic cigarettes  (Eurobarometer 2020).   
5 Mainly due to the male prevalence rate falling, from 30% to 26%, while for females this rate only fell slightly from 
22% to 21%. 
6 LSE & Open Evidence, Consumer preference and perception of specific categories of tobacco and related products, 
2020 (LSE 2020). 
7 The target was established under the Global action plan for the prevention and control of NCDs 2013-2020. 
8 Commission Implementing Decision (EU) 2015/2186; Commission Implementing Decision (EU) 2016/787;  
Commission Implementing Regulation (EU) 2016/779; Commission Implementing Decision (EU) 2016/786; 
Commission Implementing Decision (EU) 2015/1735; Commission Implementing Decision (EU) 2015/1842; 
Commission Implementing Regulation (EU) 2018/574; Commission Implementing Decision (EU) 2018/576; 
Commission Implementing Decision (EU) 2015/2183; Commission Implementing Decision (EU) 2016/586. 
9 Commission Delegated Directive 2014/109/EU; Commission Delegated Regulation (EU) 2018/573. 

 
 
                                                 
and  timely  implemented.  Member  States  were  required  to  bring  into  force  the  laws,  regulations 
and administrative provisions to transpose the TPD by 20 May 2016, and provide the Commission 
with the text of these provisions. A large number of Member States did not transpose the Directive 
in time and in July 2016, the Commission launched 18 infringement proceedings based on late or 
incomplete  notification  of  national  transposition  measures.  The  Member  States  in  question 
subsequently communicated such measures and the Commission closed all these cases by 2020. 

The Commission has been systematically assessing the conformity of national provisions with the 
Directive  on  the  basis  of  six  priority  areas11.  This  conformity  check  is  ongoing  and  has  been 
completed  for  a  first  group  of  Member  States.  While  scrutinising  these  provisions,  the 
Commission  found deficiencies  and variations  in the Directive’s transposition,  most importantly 
related  to  certain  definitions12,  to  provisions  in  the  areas  of  ingredients  and  emissions,  labelling 
and  packaging,  novel  tobacco  products,  e-cigarettes  and  the  traceability  and  security  features 
systems. The Commission is holding structured bilateral dialogues with Member States to ensure 
conformity.  As  several  of  the  Directive’s  provisions  are  complex,  there  is  still  a  risk  that  their 
interpretation and practical implementation may lead to different outcomes across Member States.  

2.2. Application and enforcement 

In 2014, the Commission established a group of experts on tobacco policy13 (the ‘Expert Group’), 
composed of Member State representatives to provide expertise and help Member States and the 
Commission  cooperate  on  tobacco  control  policies  and  legislation.  Furthermore,  in  line  with 
Article 26 of the Directive, the Commission published a list of competent authorities14 designated 
by  Member  States  to  implement  and  enforce  the  Directive.  Discussions  in  the  Expert  Group 
meetings  and  bilateral  contacts  in  the  context  of  conformity  checks  revealed  that  enforcement 
activities  are  rather  limited  in  several  Member  States.  The  levels  of  enforcement,  control  and 
sanctions vary considerably across the EU. Not all Member States had the capacity or resources to 
ensure  that  only  compliant  products  were  placed  on  the  market15.  Moreover,  despite  Member 
States`  efforts  to  agree  on  a  common  approach,  several  of  the  Directive’s  provisions  are  not 
applied in a harmonised manner.  

The  Directive  has  a  specific  provision  on  cooperation  among  Member  States’  enforcement 
authorities. Feedback from  discussions in the Expert Group meetings shows that Member States 
are  willing  to  have  a  forum,  which  so  far  met  once  in  June  2019,  to  exchange  information  and 
share best practices on enforcing the Directive.   

10 COM/2016/0269 final; COM/2018/579 final. 
11  Ingredients,  labelling  and  packaging,  novel  tobacco  products,  electronic  cigarettes,  oral  tobacco  (snus)  and 
traceability and security features.  
12  Some  definitions  could  be  improved,  for  instance  novel  tobacco  products,  additive,  flavouring/flavour, 
characterising flavour, nicotine, chewing, nasal and oral tobacco, herbal product for smoking, e-cigarette, cross-border 
distance sales. Furthermore, the following issues are important: eliminating combined categories (smokeless); creating 
new  product  categories  (e.g.  heated  tobacco  products,  nicotine  products);  and  including  devices  used  with  certain 
products (e.g. heated tobacco products). 
13 Commission Decision C(2014) 3509 setting up the group of experts on tobacco policy.  
14 OJ C 136, 12.4.2019, p. 13. 
15 Support Study to the report on the application of the Directive 2014/40/EU (ICF 2021). 

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2.3. Court cases16 

Since entering into force the Directive has endured several legal challenges. In 2016, the European 
Court of Justice upheld its validity and that of several of its provisions, and in 2019, dismissed an 
action to annul delegated and implementing acts on the traceability systems and security features 
for tobacco products. The Court also  rendered judgements on the prohibition of tobacco for oral 
use, the classification of chewing tobacco products and prohibition in stages of flavoured products 
and  the  relevant  labelling  provisions.  Several  court  cases  addressed  unfounded  claims  about  the 
library of pictorial health warnings. The latter have also endured national court procedures where 
such claims were dismissed. About half of Member States reported national court cases related to 
the Directive’s enforcement. 

2.4. Notifications (including under Articles 24(2) and 24(3)) 

Several  Member  States  exercised  their  right  under  Articles  24(2)  and  24(3)  to  maintain  or 
introduce further requirements than those laid down in the Directive. By the time of drafting this 
report,  eight  Member  States  notified  to  the  Commission  national  requirements  on  standardising 
the packaging of tobacco and related products justified on public health grounds, together with the 
grounds for introducing them. The Commission also approved national measures banning a certain 
category of tobacco products notified by three Member States under Article 24(3)17. In addition, 
Member  States  continuously  notify  their  national  laws  on  tobacco  control  to  the  Commission, 
including  those  covering  areas  not  harmonised  by  the  Directive  (e.g.  bans  on  flavours  in  e-
cigarettes,  rules  on  nicotine-free  e-cigarettes,  smoke-free  environments,  age  limits)  under  the 
procedure established by Directive 2015/1535/EU18. Following the assessment, the Commission, 
when needed, acts to ensure the Directive is correctly implemented.  

2.5. Conclusions on transposition, application and enforcement 

The  European  Court  of  Justice  has  upheld  the  Directive’s  validity  and  that  of  several  of  its  key 
provisions  and  addressed  questions  about  its  interpretation.  The  experience  gained  in  the 
compliance  assessments  of  the  national  transposition  measures suggests  that  there  is  some 
variation  in  the  transposition  of  the  Directive’s  provisions  into  national  law.  Therefore,  various 
options to streamline the legislative framework should be explored. A number of definitions may 
also need to be adapted. The level of enforcement varies considerably among Member States and 
the  lack  of  a  legal  basis  for  EU-level  audits  limits  the  Commission’s  ability  to  get  an  accurate 
overview of Member States’ implementation and enforcement activities.   

3.  Ingredients and emissions (Articles 3-7)  

3.1. Emissions and measurement methods (Articles 3 and 4) 

The  TPD  sets  maximum  emission  levels  for  tar,  nicotine  and  carbon  monoxide  (TNCO),  to  be 
measured  using  ISO  methods.  Articles  4(3)  and  4(5)  empower  the  Commission  to  adapt  the 
methods  for  measuring  TNCO  based  on  scientific  and  technical  developments  or  internationally 
agreed standards, and integrate standards agreed by the FCTC or by the WHO into EU law. 

16 https://ec.europa.eu/health/tobacco/key_documents_en#anchor3 
17 See notifications under Article 24(3) of the Directive: https://ec.europa.eu/health/tobacco/products/notifications_en  
18  For  the  description  of  the  process  see:  https://ec.europa.eu/growth/tools-databases/tris/en/about-the-20151535/the-
notification-procedure-in-brief1/  

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Discussions  on  TNCO  measurement  methods  were  held  in  international  fora,  including  the 
FCTC19,  concerning  mostly  ISO  methods  and  the  Canadian  Intense  Smoking  Regime20.  It  was 
agreed that no current smoking regime adequately represents human smoking behaviour21. Since 
then there  have been no new scientific  and technical  developments  that  warrant  a change to  the 
method prescribed.  

In  the  EU,  laboratories  approved  by  Member  States'  competent  authorities  should  monitor  and 
verify TNCO measurements. The Commission published the list of such laboratories22. Except for 
one, no Member State has set any emission limits apart from TNCO for cigarettes, nor mandated 
any additional measurement methods.  

3.2. Reporting of ingredients and emissions (Article 5)  

The  Commission  developed  the  EU  Common  Entry  Gate  (EU-CEG)  system  to  facilitate  the 
reporting  in  electronic  format  of  the  information  on  ingredients  and  emissions  required  under 
Article 5. Overall, the EU-CEG system has operated smoothly and fulfilled its core objectives as a 
data  repository23,  while  reducing  the  administrative  burden  for  manufacturers,  importers  and 
national  regulators.  The  Commission set  up a Joint  Action on Tobacco Control24 to  further help 
Member States analyse and publish EU-CEG data on ingredients and emissions. The Joint Action 
helped  Member  States  to  make  information  publicly  available  online,  as  required  under  Article 
5(4).  The  publication  process  was  difficult,  partly  due  to  some  submitters  misusing  the 
confidentiality tag. 

The EU-CEG system hosts a lot of valuable data and information. However, despite efforts via the 
Joint Action, Member States have so far seldom used it for enforcement and regulatory purposes. 
Moreover,  the  data  are  not  complete  for  certain  mandatory  variables,  e.g.  sales  data.  EU-wide 
analysis,  to  look  at  the  single  market,  is  hindered  by  national  ‘ownership’  of  data,  with  some 
Member States unwilling to share their data. The EU-CEG is costly and resource intensive for the 
Commission.  To  date,  only  about  half  of  the  Member  States  have  charged  fees  for  handling 
information on ingredients under Article 5(8). Reference laboratories, established in several other 

19  Within  the  FCTC,  the  Working  Group  on  Articles  9&10  (Regulation  of  the  contents  and  disclosures  of  tobacco 
products) in which the EU is a key facilitator, looked at the methods. Such methods were also further developed by 
the  WHO  Tobacco  Laboratory  Network  (TobLabNet).  However,  there  has  been  no  consensus  among  the  FCTC 
Parties to approve any of the emission measurement methods for inclusion into the relevant FCTC guidelines. 
20  For  TNCO  measurement,  the  International  Organization  for  Standardization  (ISO  3308)  smoking  regime  (puﬀ  
volume 35 mL, puﬀ  duration 2s, puﬀ  interval 60s) and Health Canada Intense (HCI) smoking regime (puﬀ  volume 
55 mL, puﬀ  duration 2s, puﬀ  interval 30s) are the two approaches usually applied. Due to the different parameters 
used,  higher quantities of tar, nicotine and CO are systematically  measured in the  HCI regime (with 110ml of puff 
volume captured per minute) compared to the ISO method (with 35ml of puff volume captured per minute).   
21  One  of  the  elements  influencing  the  real  individual  exposure  of  smokers  is  filter  ventilation,  a  technical  feature 
designed to dilute the inhaled smoke. This is because smokers, when smoking their cigarette, usually cover some of 
ventilation  holes.  In  order  to  improve  transparency  about  the  characteristics  of  products  on  the  EU-market, 
manufacturers and importers are required to report a set of cigarette-specific parameters which should be considered 
in conjunction  with emission  measurements  when  interpreting  them:  the total ventilation of the filter (0-100%), the 
drop  of  pressure  with  closed  vents  (mmH2O)  and  the  drop  of  pressure  with  open  vents  (mmH2O).  These  data  are 
available to the Member States for such analysis and should provide for unbiased product assessment without a need 
to modify the current TPD reference to the ISO methods. 
22 https://ec.europa.eu/health/sites/health/files/tobacco/docs/approved_laboratories_en.pdf 
23 So far, over 5 500 economic operators applied for a submitter ID. Almost  2400 submitted their products (over 42 
000 tobacco and 300 000 e-cigarettes are active in EU-CEG at the moment).  
24 This Joint Action (http://jaotc.eu/) brought 25 Member States together to help implement the TPD; with a cost of 
EUR 2.5 m (the EU contributed 80%). 

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policy areas, do not exist. The Joint Action improved the situation somewhat. Overall, however, 
most resources were still used for setting up and maintaining the data repository, in detriment of 
data  analysis,  research  and  policy  development,  which  would  allow  the  data  to  be  used  for 
meaningful action.   

The practical  experience of establishing the EU-CEG showed that creating an EU database with 
information  on  ingredients  and  emissions  from  tobacco  products  would  be  technically  possible. 
However,  given  the  constraints  on  Commission  and  Member  States’  resources15  as  well  as  the 
national ownership of data, such a database might be limited in added value without a robust and 
fee-funded  European  system  for  assessing  ingredients  (as  per  Article  28(2)(d)).  Therefore,  the 
required resources of an agency to implement any new tobacco ingredients-related tasks should be 
carefully assessed25.  

3.3. Priority list of additives and enhanced reporting obligations (Article 6) 
Under  Article  6(1),  the  Commission  adopted  a  Decision26,  establishing  a  priority  list  of  15 
additives,  selected  on  the  basis  of  the  SCENIHR  scientific  opinion27.  This  opinion  considered 
available  data  which  suggested  that  an  additive  may  i)  contribute  to  toxic,  addictive  or 
carcinogenic, mutagenic or reprotoxic properties of cigarettes and roll-your-own (RYO) tobacco, 
ii) may result in a characterising flavour, or iii) may facilitate inhalation or nicotine uptake.  

Some 12 major manufacturers worked jointly within an ad hoc industry consortium and submitted 
the reports for 14 priority additives within the legal deadline. For one priority additive – diacetyl – 
the original deadline was not met. Several Member States have taken additional action to ensure 
compliance. The Joint Action peer-reviewed the reports and noted several deficiencies28 which – 
as specifically requested by Member States  – the Commission communicated to industry. While 
industry  provided  certain  clarifications,  Member  States  could  not  confirm  that  any  chemical 
substance  studied  would  not  contribute  to  the  harmful  effect  of  tobacco  use.  Overall,  the 
experience  with  applying  Article  6  shows  that  the  reports  submitted  provided  little  actionable 
information while requiring the Commission and Member States to invest considerable resources 
into reviewing them.  

Based  on  current  experience,  resource  needs  must  be  carefully  considered  when  judging  the 
feasibility  of  establishing,  at  EU  level,  a  positive  list  of  ingredients  and  a  database.  A  more 
structured  and  permanent  mechanism  for  assessing  ingredients  would  be  needed,  taking  into 
account their chemical and physical properties when both burnt and unburnt, including effects of 
the emissions when not burnt.  

3.4. Regulation of ingredients (Article 7) 

From May 2016, the TPD prohibits cigarettes and RYO tobacco with characterising flavours from 
being placed on the market. A four-year phase-out period had been agreed by the co-legislators for 

25 See also Europe's Beating Cancer Plan p.9. 
26 Commission Implementing Decision (EU) 2016/787. 
27 SCENIHR: Additives used in tobacco products. 25 January 2016: 
http://ec.europa.eu/health/scientific_committees/emerging/opinions/index_en.htm  
28  These  deficiencies  related  to  specific  aspects  listed  in  Articles  6(2)  and  6(3),  and  to  the  comprehensiveness, 
methodology and conclusions of the studies conducted (Art.6 (4)). 

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products with characterising flavours with a significant market share (i.e. menthol). So, from May 
2020,  there  are  no  more  exemptions.  While  there  is  no  reported  issue  with  compliance  for 
characterising  candy  or  fruit  flavours,  recent  developments  suggest  less  compliance  with  the 
menthol ban. The exemption for tobacco products other than cigarettes and RYO tobacco must be 
withdrawn if a ‘substantial change of circumstances’ can be established (see section 10). 

The  Commission  invested  substantial  effort  and  resources  into  establishing  and  running  the 
advisory mechanism to help decide whether or not a tobacco product has a characterising flavour. 
This  mechanism  comprises  the  Independent  Advisory  Panel  (IAP)  on  characterising  flavours  in 
tobacco products, which has the format of a Commission expert group, and the Technical Group 
of Sensory and Chemical Assessors, established via public procurement. In practice, implementing 
the  ban  on  characterising  flavours  has  proven  resource-intensive  and  cumbersome,  while  the 
Member  States  and  the  Commission  have  limited  resources.  Several  Member  States  have  also 
banned certain additives in line with Article 7(6).  

3.5. Conclusions on ingredients and emissions 

Overall,  the  Member  States  and  the  Commission  have  put  a  lot  of  effort  and  resources  into 
implementing  Articles  3-7.  However,  the  effective  added  value  for  human  health  and  the 
efficiency of certain provisions is negligible. While the set-ups of the main system – the EU-CEG 
and the Independent Advisory Panel – are fully operational and functional, they are very labour-
intensive  and  neither  the  Commission  nor  Member  States  currently  have  sufficient  resources  to 
use them optimally. It is therefore suggested to study, how the harmonised EU level assessment of 
ingredients and products, including the EU-CEG information, can be improved and organised in a 
more robust and effective way.  

The  work  on  priority  additives  provided  little  actionable  information  so  far  and  its  usefulness 
should  be  reviewed.  The  discussion  around  the  machine  measurement  methods  is  still 
inconclusive.  

4.  Labelling and packaging (Articles 8-14)  

4.1. General  warnings,  information  messages  and  combined  health  warnings 

(Articles 8-12) 

The  Directive  introduces  requirements  for  mandatory  health  warnings  on  tobacco  and  related 
products, including combined health warnings for tobacco products for smoking. The Commission 
adopted two implementing acts to specify where health warnings are to be placed on pouches of 
RYO  tobacco29,  and  to  specify  the  layout,  design  and  shape  of  the  combined  health  warnings30. 
The  Commission  also  developed  the  library  of  picture  warnings  included  in  Annex  II  of  the 
Directive31.  Harmonising  labelling  and  packaging  rules  were  a  key  success  of  the  TPD  as  it 
standardised packaging across the internal market. 

Compulsory  combined  health  warnings  covering  65%  of  the  front  and  back  surfaces  of  tobacco 
packs  was  an  important  improvement  of  labelling  measures  compared  to  the  Directive 

29 Commission Implementing Decision (EU) 2015/1735. 
30 Commission Implementing Decision (EU) 2015/1842. 
31 Commission Delegated Directive 2014/109/EU. 

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2001/37/EC32. These have been effective in increasing public awareness of the harmful effects of 
tobacco products, and they could be associated with a decrease in tobacco consumption15. 

Complaints  were  received  from  people  claiming  that  they  or  their  relatives  appeared  in  pictures 
without their consent, including hundreds of letters and several court proceedings33. All of these 
claims were proven to be manifestly unfounded.  

Based  on  the  information  of  the  Commission,  Member  States  appear  to  be  largely  applying 
labelling rules properly, with some exceptions as outlined below.  

While harmonised labelling provisions are key example of those TPD provisions that have helped 
improve  the  internal  market’s  functioning,  a  number  of  implementation  challenges  were 
reported15. Article 9(3) provisions on the minimum dimensions of lateral health warnings – which 
translate  into  a  ban34  on  slim  cuboid  packages  less  than  20  mm  deep  –  were  applied  variably. 
There were also questions about the calculation of the surface area for health warnings on bevelled 
or rounded packs in  line with  Recital  2835, and varying degrees  of compliance EU-wide. A  few 
Member  States  made  suggestions15  about  incorporating  provisions  on  bevelled  edges  into  the 
Directive’s text, or banning packs with bevelled edges altogether.  

Article 11(1) allows Member States to exempt tobacco products for smoking other than cigarettes, 
RYO  tobacco  and  waterpipe  tobacco  from  carrying  the  information  message  and  the  combined 
health  warnings.  They  still  need  a  label  with  a  text  warning  and  the  general  warning,  and  a 
reference to cessation services. To date, about half of Member States reported exemptions allowed 
through Article 11. Some criticised the exemption, pointing to industry pressure, and warned that 
consumers may view these exempted products as more attractive or less harmful15. Article 11(6) 
empowers  the  Commission  to  withdraw  the  possibility  of  exemptions  if  there  is  a  substantial 
change of circumstances. However, the set of criteria for the ‘substantial change of circumstances’ 
clause laid down in Article 2(28) (see chapter 10) makes it very difficult to apply.  

The  Article  12  provisions  on  smokeless  tobacco  labelling  were  in  most  cases  applied  properly 
without any major issues reported.  

4.2. Product  presentation,  pack  harmonisation  and  plain  packaging  (Articles  13, 

14, 24(2)) 

Article  13  on  product  presentation  provides  for  a  broad  ban  on  promotional  elements.  Many 
Member States had difficulties in interpreting and implementing Article 13 provisions, especially 
in  clarifying  the  Article’s  scope,  and  in  determining  non-compliance.  Product  presentation  is  an 
area rife with non-compliance and attempts to circumvent the law, with legal challenges occurring 
in several Member States15.  

32 Directive 2001/37/EC. 
33 See the reference under chapter 2.3.  
34 In 2017, the Commission explained to the Expert Group on Tobacco Policy, that it viewed Article 9(3) provisions 
as a ban on slim cuboid packages less than 20 mm deep. 
35 In 2015, DG SANTE presented a non-paper for discussion in the Expert Group on Tobacco Policy, clarifying its 
view of Recital 28 and of how bevelled or rounded edges should be considered in area calculations. 

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Article 14 provisions36 on packaging are generally well understood and implemented.  

Eight  Member States exercised their right  under  Article 24(2) to  go beyond the TPD’s labelling 
provisions  and  introduced  standardised  packaging  for  tobacco  products,  i.e.  plain  packaging. 
These  Member  States  notified  these  measures  to  the  Commission,  along  with  the  grounds  for 
introducing  them,  justified  by  public  health  considerations  and  they  also  proved  that  these 
measures  are  proportionate  and  do  not  constitute  means  of  arbitrary  discrimination.  Based  on 
evidence15 from Member States, plain packaging along with pictorial warnings appear to increase 
awareness  of  tobacco  related-diseases  and  associated  illnesses,  and  the  motivation  to  quit,  and 
help to reduce smoking, including among young people. About half of Europeans are in favour of 
introducing  ‘plain  packaging’  for  cigarettes4.  These  measures  align  with 
international 
developments,  as plain packaging is the  golden standard promoted by the WHO and the  FCTC, 
and  has  been  upheld  as  consistent  with  international  trade  law  in  a  landmark  WTO  ruling37. 
Stricter  regulation  through  plain  packaging  also  helps  with  implementing  product  presentation 
provisions,  namely  a  full  ban  on  promotional  elements.  However,  the  introduction  of  plain 
packaging  requirements  only  in  some  Member  States  can  be  an  obstacle  to  free  movement  of 
goods.  Moreover,  formats  of  standardised  packaging  may  differ  between  Member  States, 
additionally distorting the internal market’s smooth functioning.  

4.3. Conclusions on labelling and packaging 

Overall, labelling and packaging rules are applied properly across the EU. Those rules have led to 
– especially via enlarged combined health warnings – better awareness and understanding of the 
various product categories and health effects of tobacco use. Based on this success, the extent to 
which stronger labelling rules would work for all tobacco product categories should be examined. 
Some  provisions  on  the  packaging/appearance  of  unit  packets  should  be  further  examined, 
particularly the size of warnings, the ban on promotional elements and on ‘slim packages’, and the 
bevelled edges.  

Several  Member  States  went  beyond  the  TPD  provisions  and  have  successfully  rolled  out 
plain/standardised  packaging.  Therefore,  plain  packaging  with  larger  health  warnings  should  be 
also further examined. 

5.  Traceability and security features (Articles 15 and 16)  

Articles 15 and 16 provide for EU-wide systems of traceability and security features for tobacco 
products to address illicit trade. In December 2017, the Commission adopted legislation as regards 
technical  details  to  establish  the  systems  of  traceability  and  security  features  for  tobacco 
products38.  The  systems  began  operating  in  May  2019  within  the  deadline  stipulated  by  the 
Directive. Since then, every newly manufactured or imported unit packet of cigarettes and RYO 
tobacco products have been marked with a unique identifier and bear a security feature. Since the 

36 In particular the requirement on the minimum content of unit packets of cigarettes (20 cigarettes) and roll-your-own 
tobacco (30 g). 
37 In June 2020, a  landmark WTO ruling ended prolonged legal challenges against Australia’s plain packaging law, 
confirming that plain packaging supports the objective of improving public health without restricting trade more than 
necessary, and that trademark restrictions arising from plain packaging are justified as they support the public health 
objective. 
38  Commission  Implementing  Regulation  (EU)  2018/574,  Commission  Delegated  Regulation  (EU)  2018/573, 
Commission Implementing Decision (EU) 2018/576. 

8 

 
 
                                                 
stock exhaustion period ended in May 2020, non-traceable cigarettes and RYO tobacco products 
can no longer be traded. The systems will be expanded to cover all other tobacco products in May 
2024. 

5.1. Traceability 

By the end of 2020, the EU traceability system collected information on 795 000 companies and 
1 520 000 facilities handling tobacco products. The manufacturers and importers of cigarettes and 
RYO  tobacco  products  received  and  applied  45  billion  unique  identifiers,  generated  by  the  ID 
issuers appointed by Member States. The system’s central components, the secondary repository 
and  the  router,  operated  by  Dentsu  Aegis  Network  under  a  concession  contract  with  the 
Commission, handled billions of messages on logistics and transactions in the supply chain.39 

The  EU  traceability  system  was  implemented  with  due  regard  to  the  WHO  FCTC  Protocol  on 
Illicit Trade (ITP), in particular Article 8 thereof. The system’s design fully complies with the ITP 
provisions.  None  of  the  ITP  Party’s  formal  obligations  was  delegated  to  the  tobacco  industry. 
Member States  and the  Commission  control the system through  a series  of mutually  reinforcing 
measures40.  

Altogether,  Member  States  appointed  22  different  entities  to  act  as  ID  issuers,  17  being  state-
controlled  entities,  including  national  printing  houses.  There  are  also  five  private  IT  companies 
contracted by eight Member States. Both public and private entities have been fully integrated into 
the system and their different statuses have not affected its day-to-day operations. 

By the end of 2020, the Commission had approved 46 data storage contracts for providing primary 
repositories,  which  were  concluded  by  the  manufacturers  and  the  importers  of  tobacco  products 
with 10 different providers, although four of them are in the same corporate group. The contracts 
were, among other things, verified against the key contractual elements laid down in Regulation 
(EU)  2018/573,  while  the  providers  were  screened  in  view  of  the  independence  requirements 
under  Article  35  of  Regulation  (EU)  2018/574.  The  Commission  also  rejected  one  data  storage 
contract along with one proposed provider. 

For  the  first  annual  cycle  of  primary-repository  audits,  the  Commission  approved  15  auditors 
proposed  and  paid  by  the  tobacco  manufacturers.  The  Commission  collected  declarations 
concerning anti-tampering devices from the providers who installed them on the production lines 
for which 10 manufacturers and importers of tobacco products were responsible. 

All Member States’ competent authorities and DG OLAF are connected to the interfaces provided 
by the secondary repository operator, and many of them started using the traceability data to help 
with  enforcement.  Those  activities  are  further  facilitated  with  a  mobile  inspection  application 
supplied  by  Dentsu  Aegis  Network  under  a  separate  agreement  with  the  Commission.  Several 

39 If needed, the traceability system’s design and adopted technical solutions can be expanded to other areas requiring 
stricter regulatory controls of supply chain. 
40  These  measures  include:  (a)  the  independent  ID  issuers,  (b)  the  installation  of  anti-tampering  devices  on  the 
production lines, (c) the general exclusion of the industry from consulting the traceability data, (d) the verification of 
the  providers  of  primary  repositories  and  their  auditors  by  the  Commission,  (e)  pre-defined  independence  criteria 
applying to all key third-party providers of IT solutions, (f) a copy of all data stored at the secondary repository and 
(g) real-time data access by the competent authorities. 

9 

 
 
                                                 
Member  States  use  or  intend  to  use  the  EU  system41  to  supply  data  to  their  own  enforcement 
systems.  

Although the system works and represents a major step in the fight against illicit trade, Member 
States and the Commission had considerable problems with the quality of traceability data, e.g. in 
relation to VAT numbers, information on production machines or on last movements of products 
to retail outlets. While data quality has gradually improved, it remains critical for enforcement and 
for fully attaining the system’s objectives. 

5.2. Security features 

To  comply  with  the  security  feature  provisions,  22  Member  States  decided  to  rely  on  and,  if 
necessary, adapt their pre-existing tax stamp and fiscal marking programmes. The remaining five 
Member States introduced new authentication labels. In this sense, the system of security features 
allowed a largely similar security standard to be established EU-wide. 

5.3. Conclusions on traceability and security features 

Despite  the  issues  affecting  data  quality,  the  traceability  system  is  fully  functional  and  well 
established.  The  Commission  will  examine  whether  the  system’s  long-term  performance  can  be 
improved  with  stronger  audits  in  terms  of  their  scope,  operational  impact  and  safeguards 
guaranteeing their impartiality and public trust. 

6.  Cross-border distance sales (Article 18)  

More than half of the Member States banned cross-border distance sales of tobacco and/or related 
products to consumers in their countries. The vast majority of the Member States allowing cross-
border distance sales published lists of the retailers registered in their country on their competent 
authorities’ websites15.  

Monitoring and enforcing cross-border distance sales bans or restrictions have proven challenging. 
Member  States  found  unregistered  retailers  operating  in  their  countries  or  retailers  selling  non-
compliant or banned products. Also, cross-border distance sales occurred in Member States where 
they were banned. Only a few Member States claimed to monitor unregistered retailers’ activity 
and admitted difficulties in closing their websites especially when the servers were located outside 
the  EU.  In  addition,  age  verification  systems  do  not  seem  to  be  effective,  with  Member  States 
calling for improved age verification systems42. 

Member  States  had  difficulties  controlling  cross-border  distance  sales,  with  many  signalling  the 
need  for  strong  enforcement  cooperation.  Some  Member  States  acted  against  non-compliant 
retailers. Moreover, Member States highlighted problems with the TPD definition of ‘cross-border 
distance sales’. 

41 These developments are a big improvement compared to the earlier systems developed by the industry as a part of 
the anti-fraud agreements concluded between the Commission and the major tobacco manufacturers in 2004-2010. 
42 ICF 2021. A mystery shopping exercise showed that many retailers across different Member States use relatively 
weak checks that can be easily circumvented by under-age shoppers: 80% of retailers reviewed use self-reporting as 
age verification, and age is not verified at the point of delivery. 

10 

 
 
                                                 
6.1. Conclusions on cross-border distance sales 

Generally,  there  is  insufficient  monitoring  and  enforcement  of  cross-border  distance  sales 
restrictions or bans under the TPD. Age verification systems seem to be ineffective, vary between 
Member States and are poorly enforced. Not all Member States have published lists of registered 
retailers  as  required.  There  are  difficulties  in  dealing  with  retailers/websites  located  outside  the 
EU. The clarity of certain provisions, especially the definition of ‘cross-border distance sales’ may 
be  improved.  Given  the  persistent  disparities  between  Member  States  and  concerns  over  cross-
border distance sales of non-compliant products, there is scope for developing further the current 
regime,  or  as  an  alternative  consider  banning  cross-border  distance  sales  of  tobacco  and  related 
products, as many Member States have already done. 

7.  Novel tobacco products (Article 19) and other emerging products  

The TPD provisions for ‘novel tobacco products’ were designed to provide a wide regulatory net 
for  new  tobacco  product  categories  rapidly  entering  the  EU  market.  However,  the  date-based 
definition43  means  that  provisions  are  not  specific  to  the  unique  characteristics  of  certain  new 
products. Moreover, the TPD does not fully capture certain new products not containing tobacco, 
such as oral nicotine pouches. These are non-pharmaceutical in nature and are sold as consumer 
products, resembling tobacco for oral use, which the TPD bans under Article 1744. 

Also challenging is the use of flavours, which particularly appeal to young people. Novel tobacco 
products  are  exempted  from  the  ban  on  characterising  flavours  (Article  7  (12)).  The  TPD  gives 
scope  for  withdrawing  this  exemption,  but  there  is  a  significant  regulatory  barrier  –  the 
Commission has to demonstrate a ‘substantial change of circumstances’ (see chapter 10).  

Heated  tobacco  products  (HTPs),  the  prominent  type  of  novel  tobacco  products,  have  increased 
their  presence  in  the  EU  market45,  with  EUR  2.92  billion in  sales  in  201946  (2%  of  the  tobacco 
market).  In  2020,  7%  of  Europeans  aged  15-24  had  (at  least)  tried  HTPs  and  2%  were  current 
users. 

Views differ over the extent to which novel tobacco products, especially HTPs, negatively affect 
the  individual  user’s  health.  While  the  industry  often  presents  HTPs  as  reduced-risk  products 
compared to conventional tobacco products, claiming they help smokers quit, worrying trends of 
popularity  exist  among  youths47.  Evidence  also  shows  that  many  users48  become  ‘dual  users’49 

43 The TPD defines this category as products placed on the market after 19 May 2014, which do not fall into any other 
product category (i.e. cigarettes, RYO tobacco, pipe tobacco, waterpipe tobacco, cigars, cigarillos, chewing tobacco, 
nasal tobacco or tobacco for oral use) under the Directive. 
44 Article 151 of the Act of Accession of Austria, Finland and Sweden grants Sweden a derogation from the ban. 
45 EU-CEG Data. Cumulatively, by September 2020 almost 1 000 active unique TP-IDs were registered in EU-CEG. 
Data also shows a steady EU-wide increase in product launches being registered in EU-CEG, peaking at almost 500 
new  launches  in  2020  only.  These  numbers  include  unique-IDs  launched  in  EU  countries.  If  the  same  product  is 
launched in several countries, it is only counted once. 
46 Euromonitor Passport.  
47  LSE  2020.  Research  within  a  specific  sample  across  12  Member  States  showed  that  31%  of  young  respondents 
(aged  18-25)  had  some  experience  with  HTPs,  among  which  8%  were  current  users.  Interestingly,  this  figure  was 
lower for people over 26, with only 27% having tried HTPs. Among current HTP users, almost 60% were daily users 
in both age groups.  
48 LSE 2020. In terms of product perception, 44% of respondents among both age groups felt HTPs were ‘unhealthy’ 
and a further 77% felt that young people underestimated the risks of using them. 
49 LSE 2020. 85% of respondents in the product perception study claimed to use other products in addition to HTPs. 

11 

 
 
                                                 
despite intending to reduce consumption of another tobacco product.  As other tobacco products, 
HTPs  contain  nicotine,  an  addictive  substance,  and  evidence  shows  that  HTPs  emit  chemical 
substances, including several toxicants50.  

The application of TPD provisions to novel tobacco products depends on whether these products 
are defined as a smokeless tobacco product or a tobacco product for smoking (Article 19(4)). A 
smokeless  tobacco  product  is  defined  as  lacking  a  combustion  process.  This  is  a  challenge  for 
regulators  as  the  principle  of  combustion  is  ambiguous,  leading  to  Member  States  classifying 
certain products in a divergent manner, as also addressed at international (WCO) level51. 

Moreover,  without  flexibility  to  define  new  product  categories,  it  is  challenging  to  apply  rules 
developed for existing categories to novel tobacco products, as they do not necessarily respond to 
the distinct properties of the new products.  

These novel tobacco products also pose challenges for applying tobacco control measures overall, 
including  on  advertising  and  smoke-free  environments.  The  device  specifically  designed  for 
consuming  such  products  is  widely  promoted  in  some  Member  States,  thus  circumventing  the 
tobacco  advertising  bans.  Classifying  a  product  as  smokeless  may  also  lead  to  smoke-free 
environment laws, historically focused on tobacco products for smoking, being circumvented. To 
clarify  the  issues  above  and  address  the  regulatory  challenges  posed  by  these  products,  the  EU 
initiated and supported a mandate at the WHO FCTC COP852.  

7.1. Conclusions on novel tobacco and emerging products 

The  EU  regulatory  framework  does  not  currently  address  all  novel  tobacco  and  emerging 
products,  nor  provide  flexibility  to  address  rapid  product  developments.  HTPs  should  be 
monitored closely as they  pose specific  regulatory  challenges, including  health warnings, use of 
flavours  and  interaction  with  devices.  There  are  also  legal  loopholes  with  respect  to  emerging 
nicotine or similar products (excluding those authorised for medical purposes and/or for smoking 
cessation under medical authorisation). 

8.  Electronic cigarettes and refill containers (Article 20)  

E-cigarettes,  containing  nicotine  but  no  tobacco,  are  a  specific  diverse  product  category, 
accounting  for  up  to  7%  of  the  national  EU  markets,  in  terms  of  value,  for  tobacco  and  related 
products53.  The  EU-CEG  contains  over  300 000  active  e-cigarettes,  compared  to  over  42 000 
active tobacco products54. In recent years, big tobacco companies have increased investments in e-
cigarettes.  

The  EU  was  the  first  regional  jurisdiction  to  regulate  them,  including  advertising.  To  capture  a 
wide net of diverse products, the TPD broadly defines this category to encompass both the device, 

50 WHO 2020. Heated tobacco products: a brief.  
51  Customs  Co-operation Council International Convention  on the  Harmonized Commodity Description and Coding 
System. 
52 Conference of the Parties to the FCTC, Eighth session, 1-6 October 2018.  
53 Euromonitor Passport. E-cigarettes’ market presence is substantial,  with 2019 data showing the UK as the largest 
market (EUR 2 417 m), followed by France (EUR 847 m), and Germany (EUR 673 m) and Poland. 
54  Open  systems  with  refillable  tanks  are  the  most  popular,  followed  by  rechargeable  devices  with  replaceable 
cartridges.  While  closed  systems  restrict  device  manipulation  and  reduce  malpractice,  open  systems  allow 
independent dosing and tailored interoperability, which can act as a gateway for user negligence. 

12 

 
 
                                                 
including its parts, and refill containers with nicotine containing e-liquid. This has provided legal 
clarity, particularly when compared to provisions on novel tobacco products, where the device is 
not specifically captured. The Commission adopted two implementing acts and a report on risks 
associated with refillable e-cigarettes55. 

Overall, Member States had a fairly good experience with implementing certain provisions on e-
cigarettes, with scope for improvement in other specific areas. While manufacturers and importers 
submit notifications to the competent authorities, in line with Article 20(2), more could be done to 
provide higher quality information, particularly on toxicological data and consistent nicotine doses 
upon  consumption,  e.g.  by  standardising  assessment  methods.  Certain  provisions  have  proven 
challenging  to  implement  in  practice,  e.g.  health  warnings  under  Article  20(4)(b)(iii)  not  only 
apply  to  refill  containers  or  pre-filled  devices  but  also  to  the  e-cigarette  device  itself.  Further 
specification  and  more  differentiated  warnings  would  help,  in  particular  when  a  product  is 
marketed without a nicotine-containing liquid. Also, questions over interpretation were raised over 
i) labelling requirements for unit packets and outside packaging, ii) the information allowed under 
the  exemption  from  the  bans  of  promotional  elements  (e.g.  nicotine  content  and  information  on 
flavourings), and iii) the limits for the tank size.  

Applying  Article  20(5)  –  banning  commercial  communications  and  sponsorship  activities  to 
promote e-cigarettes - continues to be challenging, especially in information society services and 
on social media where young people are particularly exposed/targeted.  

Regarding  reporting  market  surveillance  activities,  Member  States  have  a  legal  obligation  to 
report  dangerous  e-cigarettes,  chargers  supplied  with  them  and  refill  containers  in  the  Safety 
Gate/RAPEX,  as  well  as,  measures  taken  against  them.  The  Information  and  Communication 
System for Market Surveillance (ICSMS) is also available to authorities to exchange information 
on non-compliant products. However, the use of these tools by Member States is uneven.  

Safety concerns related to e-cigarettes spiralled worldwide in 2019 with ‘EVALI’ (E-cigarette or 
Vaping Associated Lung Injury) cases rising sharply in the USA56. These cases have since been 
linked  to  cannabis  extract  and/or  vitamin  E  acetate  containing  e-liquids.  EU  countries  have  not 
observed  this  trend,  possibly  due  in  part  to  the  specificities  of  e-cigarette  regulation  under  the 
TPD,  notably  additive  restrictions,  e.g.  a  ban  of  vitamins  in  nicotine-containing  liquids.  These 
events show that the toxicological effects of the heated and inhaled forms of ingredients of both 
nicotine-containing  and  (thus  far  unregulated)  nicotine-free  e-cigarettes  should  be  highlighted. 
The  TPD  also  sets  a  maximum  nicotine  concentration  of  20  mg/ml  and  overall  this  has  been 
implemented, although industry use of technical features can increase nicotine uptake per puff.  

The industry presents e-cigarettes as reduced-risk products  and claims that they help smokers to 
quit. However, worrying trends of popularity57 exist among youths. There is strong evidence that 
flavours  in  e-liquids  are  attractive  to  youths  and  adults.  Significantly,  young  people  use  non-

55  Commission  Implementing  Decision  (EU)  2015/2183,  Commission  Implementing  Decision  (EU)  2016/586, 
COM/2016/0269 final. 
56  CDC.  Outbreak  of  Lung 
https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html  
57 LSE 2020. The two main reasons for using e-cigarettes were ‘enjoyment’ and ‘trying to quit or reduce consumption 
of  a  tobacco  product’.  Yet  quitting  or  reducing  consumption  was  more  pronounced  for  those  aged  over  26  (54%), 
compared to young people aged 18-25 (33%). 

Injury  Associated  with  E-cigarette  Use,  or  Vaping.  Feb  2020 

13 

 
 
                                                 
traditional  flavours  in  particular,  such  as  candy  and  fruit4
58.  These  flavours  strongly  influence 
young people by decreasing harm perception and increasing the will to try59. Member States are 
increasingly banning flavours for e-cigarettes. 

Views  on  the  actual  health  effects  of  e-cigarettes  are  divided,  ranging  from  harmful  to  harm-
reducing for the individual, compared to conventional tobacco products for smoking. As scientific 
consensus has yet to be reached, the precautionary principle prevails and the TPD takes a careful 
approach in regulating these products60. The WHO further concluded that no firm evidence exists 
on the safety of e-cigarettes, but there is increasing evidence of harm61. Also, there is concern over 
increased indoor use62 and potential related harm. 

To  better  understand  the  health  effects  and  the  public  health  dimension  of  e-cigarettes,  the 
Commission has tasked the Scientific Committee on Health and Environmental Risks (SCHEER) 
to study the health effects of e-cigarette use, and their role in encouraging people to start or quit 
smoking. For users of electronic cigarettes, they found moderate weight  of evidence for risks of 
local irritative damage to the respiratory tract and moderate, but a growing level of evidence from 
human  data  suggesting  that  electronic  cigarettes  have  harmful  health  effects,  especially  but  not 
limited to the cardiovascular system. More so, they found weak to moderate weight of evidence 
for  risks  of  carcinogenicity  of  the  respiratory  tract  due  to  long-term,  cumulative  exposure  to 
nitrosamines and due to exposure to acetaldehyde and formaldehyde and concluded that weight of 
evidence for risk of poisoning and injuries due to burns and explosion is strong. They also found 
weak to moderate weight of evidence for several risks related to second-hand exposure. Overall, 
there is moderate evidence that electronic cigarettes are a gateway to smoking for  young people 
and  strong  evidence  that  flavours  have  a  relevant  contribution  for  attractiveness  of  use  of 
electronic  cigarette  and  initiation.  On  the  other  hand,  there  is  weak  evidence  for  the  support  of 
electronic  cigarettes'  effectiveness  in  helping  smokers  to  quit  while  the  evidence  on  smoking 
reduction is assessed as weak to moderate59.  

8.1. Conclusions on e-cigarettes and refill containers 

E-cigarettes  contain  nicotine,  a  toxic  substance.  The  Commission  will  base  its  risk  management 
decisions  on  e-cigarettes  on  the  SCHEER  scientific  opinion.  The  SCHEER  opinion  underlined 
their  health  consequences  and  the  important  role  they  play  in  smoking  initiation.  This  opinion 
supports the careful and precautionary approach taken so far.  

However, it should be explored whether some provisions could be further developed or clarified, 
such  as  tank  size  or  labelling  requirements;  use  of  flavours;  use  of  nicotine-free  liquids;  and 
advertising provisions.  

Insofar  as  e-cigarettes  are  smoking  cessation  aids,  their  regulation  should  follow  the 
pharmaceutical legislation. 

58 75% of 15-24 year olds are using fruit flavoured and 30% candy flavoured e-liquids. 
59 SCHEER 2021. Opinion on electronic cigarettes. 
60 This approach was validated in the ECJ Case 477/14.  
61 WHO 2015. A systematic review of health effects of electronic cigarettes. 
62 19-28% of Europeans report exposure to e-cigarettes or HTPs in public spaces where people do not usually smoke 
(e.g. shopping malls, airports), and in drinking or eating establishments. 

14 

 
 
 
                                                 
9.  Herbal products for smoking (Articles 21 and 22)  

Herbal  products  for  smoking  were  newly  added  to  the  TPD.  These  include  products  based  on 
plants,  fruits  or  flowers,  which  can  be  consumed  via  combustion  without  tobacco.  The  TPD 
provisions complement other relevant legislative frameworks and do not regulate as such the types 
of  plants,  herbs  or  fruits  contained  in  herbal  products  for  smoking.  Over  1 600  product 
presentations  are  active  in  EU-CEG,  most  of  which  could  be  linked  to  cannabis  products  for 
smoking.  There  are  concerns  over  the  finding  that  some  cannabidiol  (CBD)  products  may  also 
contain  tetrahydrocannabinol  (THC)63,  which  is  controlled  under  the  1971  UN  Convention  on 
Psychotropic  Substances,  of  which  all  Member  States  are  Parties  to64.  The  2020  Eurobarometer 
survey  identified  that  8%  of  Europeans  have  used  products  containing  cannabis  in  the  last  12 
months,  most  frequently  by  smoking  it  with  tobacco4.  With  certain  types  of  cannabis  being 
decriminalised  in  a  few  EU  countries  and  some  other  countries  worldwide,  interest  in  these 
products has increased.  

The  current  definition  of  herbal  products  for  smoking  does  not  capture  certain  new  products 
entering  the  market,  such  as  CBD  containing  cannabis  extracts  and  oils,  used  particularly  in  e-
cigarettes  (with  or  without  nicotine).  In  the  context  of  the  TPD,  there  is  lack  of  clarity  of  the 
regulation of cannabis extracts or synthetic CBD in e-liquids.  

9.1. Conclusions on herbal products for smoking 

Overall,  Articles  21  and  22  of  the  TPD  have  been  implemented  EU-wide,  with  Member  States 
reporting some issues around labelling requirements15. They also reported good compliance with 
reporting obligations on ingredients. However, a significant challenge lies in competent authorities 
ensuring that all relevant products  are submitted to the EU-CEG. Nonetheless, cannabis  extracts 
are currently regulated at national level. 

10.  Specific  consideration  for  other  product  types  and  categories,  including 

market developments and substantial change of circumstances   

10.1. Waterpipe tobacco, slim cigarettes and other product categories  

Article 28 of the TPD tasked the Commission to also specifically look at waterpipe tobacco and 
slim  cigarettes,  for  which  it  mandated  a  specific  study6.  On  implementing  provisions  on  slim 
cigarettes,  waterpipe  tobacco,  and  cigarillos,  different  experiences  have  been  reported.  Most 
Member States  do not  mandate pictorial warnings for cigarillos,  often targeted at  cigarette users 
with  their  lower  price  or  features  banned  in  cigarettes,  e.g.  flavour  capsules.  Waterpipe  tobacco 
use frequently takes place in specific premises, e.g. shisha lounges, where consumers do not see 
health warning labels and pictorials. Another concern over waterpipe tobacco, as for cigarillos, is 
the use of flavours and their attractiveness to youths.  

63 EMCDDA 2019. Developments in the European cannabis market, EMCDDA Papers.  
64 https://treaties.un.org/pages/ViewDetails.aspx?src=TREATY&mtdsg_no=VI-16&chapter=6#3  

15 

 
 
                                                 
The  EU  waterpipe  market  is  significant65,  and  some  EU  countries  have  one  of  the  highest 
prevalence of waterpipe tobacco use among youths66. The slim cigarette market has been declining 
since  2000,  but  retail  volume  has  increased  in  several  Eastern  European  Member  States6.  More 
women smoke slim cigarettes (10%) than men (2%).   

Evidence shows that the risks associated with waterpipe tobacco are underestimated67. Flavour use 
is  strongly  linked  to  waterpipe  tobacco,  and  ‘nice  flavours’  was  the  term  most  frequently 
associated  with  these  products6.  Some  people  may  also  underestimate  the  risks  associated  with 
slim cigarette use68. Eurobarometer 2017 stated that 18% of respondents identified slim cigarettes 
as attractive. However, connotations of femininity are less deep-rooted6.  

During the reporting period, the snus ban was clearly circumvented as, outside of Sweden, many 
snus-like  products  were  presented  as  chewing  tobacco  to  gain  a  legal  status.  Legal  loopholes 
related to chewing bags and emerging nicotine pouches became apparent.  

10.2. Substantial change of circumstance clause (Articles 2(28), 7(12), 11(6)) 
The  TPD  sets  out  criteria  for  a  ‘substantial  change  of  circumstances’69  and  calls  for  the 
Commission to withdraw certain regulatory exemptions once those conditions are met (a flavour 
ban  for  product  categories  other  than  cigarettes  and  RYO  tobacco,  labelling  exemptions).  The 
Commission  followed  the  market  shares  closely  and  no  product  category  reached  the  threshold 
that would mandate the Commission to trigger this clause in the reporting period. The closest to 
the threshold are HTPs70. Therefore, assessing the current criteria should be considered. 

10.3. Other considerations 

The TPD enabled some tobacco control actions to be financed by fees, and some Member States 
started  to  use  such  options.  Further  exploration  of  how  to  fully  finance  tobacco  control  actions 
through  fees  is  merited.  The  Directive  does  not  contain  provisions  on  the  tobacco  industry’s 
liability for the health effects and health costs of tobacco and related product use. However, in line 
with  Article  19  of  the  FCTC71,  the  EU  could,  for  the  next  TPD  review,  examine  options  to 
increasing tobacco manufacturers’ liability. 

11.  Conclusions  

The TPD has enhanced tobacco control and its validity was upheld in courts. It strengthened rules, 
e.g.  enlarged  combined  health  warnings,  the  track  and  trace  system,  banning  characterising 
flavours,  the  ingredients  database,  the  regulation  of  electronic  cigarettes,  all  of  which  have 
established  their  position  as  part  of  a  comprehensive  EU  tobacco  control  policy.  The  TPD 

65 LSE 2020. Germany alone accounts over half of the EU pipe tobacco market, with a retail volume worth EUR 368 
m for waterpipe and pipe tobacco in 2017. 
66  Jawad et. al., The prevalence and trends of waterpipe tobacco smoking : A systematic review, PLoS One, 2018.  
67  LSE  2020.  Despite  users  being  exposed  to  both  tobacco  and  charcoal,  waterpipe  tobacco  was  perceived  as  less 
harmful than cigarettes and HTPs. 
68 7% of Eurobarometer 458 (2017) respondents identified slim cigarettes as less harmful than normal cigarettes. 
69 Article 2(28) provides for a set of objective criteria defining ‘substantial change of circumstances’. 
70 Euromonitor Passport. HTPs’ market share was approaching 2% in 2019. 
71 Article 19(1) FCTC stipulates that ‘for the purpose of tobacco control, the Parties shall consider taking legislative 
action  or  promoting  their  existing  laws,  where  necessary,  to  deal  with  criminal  and  civil  liability,  including 
compensation where appropriate.’  

16 

 
 
                                                 
achieved  the  2%  reduction  target  of  the  impact  assessment  with  decreased  smoking  prevalence 
among youths. The Directive also implemented relevant WHO FCTC provisions.  

The  study  that  gathered  evidence  for  this  report  concluded  that  the  TPD  has  contributed  to  the 
improvement of public health. The TPD provides added value and Member States could not have 
accomplished  the  same  objectives  alone.  In  general,  the  TPD  was  considered  to  be  consistent 
internally,  but  due  to  market  developments  there  is  scope  for  improvement  in  certain  essential 
areas. Compliance of national laws with the TPD and their harmonised application varies. Many 
Member States lack adequate enforcement resources. The new functional systems (EU-CEG, IAP, 
traceability) are relatively resource-intensive. 

Persistently high smoking rates, high numbers of youths taking up smoking, the WHO target of a 
30%  relative  reduction  in  tobacco  use  by  2025  as  compared  to  20107,  as  well  as  the  Europe’s 
Beating  Cancer  Plan’s  objective  to  achieve  a  tobacco-free  generation  by  2040,  should  be  duly 
taken into consideration when assessing the EU framework on tobacco and related products.  

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