1. The European
Tobacco Products Directive
Constantine Vardavas
MD, RN, MPH, PHD

2. Declaration
• No conflict of interest to declare.
• Scientific Team Leader (Framework contract: BRFAA-ENSP) responsible for:
– Study on the development of a EU common reporting format for submission
of data on ingredients contained in tobacco and related products, and
disclosure of the collected data to the public
– Study on the identification of potential risks to public health associated with
the use of refillable electronic cigarettes and development of technical
specifications for refill mechanisms
– Report on the identification of assessment of available evidence on toxicity,
addictiveness and attractiveness of ingredients contained in tobacco and
related products on the basis of information submitted by the industry in the
context of reporting obligations introduced by Directive 2001/37/EC
The content/interpretation of these slides are my own; it can in no way be taken to reflect the
views of the European Commission and/or Chafea or any other body of the European Union.

3. The EU and the tobacco epidemic
• 28 EU MS
• 508 million people
• Premature deaths in the EU per year
– 700,000
• Current burden to public health care:
– 25 billion per year
• Productivity losses:
– 8 billion per year.

4. TOBACCO: from Design to Disease

5. Policy priorities
The EU+28 EU MS implement tobacco control measures in the
form of legislation, recommendations and information
campaigns.
These policy measures include:
 the regulation of tobacco products on the EU market (e.g.
packaging, labelling, and ingredients),
 advertising restrictions for tobacco products,
 the creation of smoke-free environments ,
 tax measures and activities against illicit trade ,
 anti-smoking campaigns .
http://ec.europa.eu/health/tobacco/policy_en

6. Policy priorities
The EU+28 EU MS implement tobacco control measures in the
form of legislation, recommendations and information
campaigns.
These policy measures include:
 the regulation of tobacco products on the EU market (e.g.
packaging, labelling, and ingredients),
 advertising restrictions for tobacco products,
 the creation of smoke-free environments ,
 tax measures and activities against illicit trade ,
 anti-smoking campaigns .
http://ec.europa.eu/health/tobacco/policy_en

7. The new EU Directive
The Tobacco Products Directive provides a mandate for
stronger regulation of the manufacture, marketing and
sales of tobacco products, ingredients, additives,
disclosure to the public, oral tobacco and e-cigarettes.
“… will improve the functioning of the internal market for
tobacco and related products, while ensuring a high level
of health protection for European citizens”
The Council of the European Union. Revision of the tobacco products directive.

8. Legislative actions in the EU
Taking into account the significant cross border trade of tobacco products and
diverging national legislation, EU-wide rules are necessary for these products.
The rules ensure that all consumers are equally protected across the EU.
The new Tobacco Products Directive governing the manufacture,
presentation and sale of tobacco and related products was signed on 3 April
2014.
Transposition into national EU legislations
Designing of supportive and implementing acts
http://ec.europa.eu/health/tobacco/policy_en

9. Implementation timeline

10. Products under the Directive (TPD)
• Cigarettes
• Roll Your Own/pipe tobacco
• Smokeless tobacco (Austria, Finland and Sweden)
• Waterpipe tobacco
• E-cigarettes
• Novel tobacco
• Herbal tobacco products

13. Regulation of ingredients (Art 5,6,7)
• TNCO reporting
• Product characteristics reporting
• Ingredient reporting
• Toxicity reporting
• Emissions
• Sales data
• Marketing
Structuring of a reporting format as a tool to collect data
that can be useful to regulators and increase the utility of
the collected data

14. Utility from a public health perspective
• While the main objective of the new common reporting
format is to improve the functioning of the internal
market, it also represents important benefits to public
health.
• Unprecedented opportunity to increase the detail of
information that is available to the regulators and the
general public.
• This increased information will enable regulators to
monitor design & product elements and would provide
crucial information to regulators implementing EU or
national legislations related to tobacco control.

16. Ingredient Regulation
Regulation of ingredients that give a characterizing flavor
Ingredients that:
• vitamins or other additives that create the impression that a tobacco
product has a health benefit or presents reduced health risks;
• caffeine or taurine or other additives and stimulant compounds that are
associated with energy and vitality;
• additives having colouring properties for emissions;
• for tobacco products for smoking, additives that facilitate inhalation or
nicotine uptake; and
• additives that have CMR properties in unburnt form
Priority Additives

17. Misleading cigarette design and packaging
characteristics
• Suggest benefits in terms of weight loss, sex appeal, economic class, social
life or qualities such as femininity, elegance or masculinity.
• Visual elements (color), may be used by the tobacco industry to cue or
amplify the perceived sensory reward from smoking, or to indirectly
communicate a misleading message of reduced harm.
Cigarette design and marketing features are associated with increased smoking
susceptibility and perception of reduced harm among smokers in the EU

18. Design features and youth perceptions of
reduced harm
• Menthol (OR 2.5*)
• Flavours such as spicy, fruity (OR 1.5)
• Shape and size of a cigarette (OR 2*)
• “organic” or “natural” (OR 1.9*)
• Additive free (OR 1.3)

19. Packaging as an industry advertising tool
• Although many factors influence tobacco use behavior,
tobacco industry advertising and promotions stand out as a
prominent factor encouraging tobacco use.
• Using striking colors, distinctive fonts and carefully crafted
materials, cigarette packaging is defined to be highly
attractive, especially among young people.

20. Packaging and Labelling
• PRE TPD

21. Packaging and Labelling

22. Packaging and Labelling

23. Tobacco Packaging
Characteristics Cognitive only
response1
aOR (95%CI)
Behavioral
response 2
aOR (95%CI)
Gender
EU Region
Western Europe (Referent) Ref. Ref.
Southern Europe 2.97 (2.06-4.26)* 1.29 (1-1.66)*
Northern Europe 2.26 (1.57-3.25)* 1.46 (1.13-1.89)*
Eastern Europe 1.71 (1.18-2.49)* 1.54 (1.2-1.96)*
Age
15-24 (Referent) Ref. Ref.
25-39 1.08 (0.74-1.58) 1.13 (0.85-1.51)
40-54 1.13 (0.76-1.66) 1.05 (0.78-1.41)
55+ 1.31 (0.87-1.95) 1.02 (0.75-1.39)
Presence of pictorial warnings on
cigarettes4
Countries with text warnings Ref. Ref.
Countries with pictorial warnings 1.11 (0.87-1.4) 1.31 (1.1-1.56)*
Effectiveness of Text versus Pictorial Health Warning Labels and Predictors of Support for Plain
Packaging of Tobacco Products within the European Union. Eur Add Res 2015

24. E-CIGARETTES & NOVEL PRODUCTS

25. 4 “Classical” stages of the tobacco epidemic:
Prevalence-death “categorization”

26. Evolution of the global tobacco epidemic
Type 1
Oral tobacco and
Cigarettes
Type 2
Dual use Type 3
Non combustible
products
Vardavas & Agaku in “The Tobacco Epidemic-2nd edition” 2015 Karger. Editor(s): Loddenkemper R, Kreuter M

27. Hypothesis of 3 epidemic phenotypes
Type 1
Smokeless and
Cigarettes
Still increasing prevalence
Regional production/use
Traditional TC initiatives
S+E Asia, Middle East, African
Region
Type 2
Dual Infectivity
Located in countries with
developing TC initiatives
An environment potentially
interested in other products but still
at the apex of the epidemic
Steady cigarette sales/consumption
Growing awareness of the harm
caused by tobacco
Eastern and Southern Europe*,
Type 3
Modified Risk
Tobacco Products
Advanced TC
Steady reductions in cigarette
sales/consumption
Greater awareness
Multiple product use
Consumer pressure
Examples: USA, Canada,
Northwestern Europe,
Vardavas & Agaku in “The Tobacco Epidemic-2nd edition” 2015 Karger. Editor(s): Loddenkemper R, Kreuter M

28. Warning labels for e-cigarettes
‘This product contains nicotine which is a
highly addictive substance. It is not
recommended for use by nonsmokers’.
Or
‘This product contains nicotine which is a
highly addictive substance.’
Appear on the two largest surfaces of the
unit packet and any outside packaging and
cover 30 % of the surfaces of the unit packet
and any outside packaging (Art20.4)
Optional
each unit packet and any outside packaging of such
products shall carry an additional text warnings

29. Safety/ Special mandates
• Toxicological/addiction data regarding the product's ingredients and
emissions, including when heated
• Information on the nicotine doses and uptake;
• Only ingredients of high purity are used in the manufacture.
• Electronic cigarettes deliver the nicotine doses at consistent levels;
• Except for nicotine, only ingredients are used in the nicotine-containing liquid
that do not pose a risk to human health in heated or unheated form”

30. Other aspects of Article 20
Regulating promoting and advertising
 Audiovisual (TV) ads; Radio ads; Radio programme sponsorship
 Any form of public or private contribution to any event, activity or
individual person
 Cross border advertising
Additional Reporting requirements
• Comprehensive data on sales volumes,
• Information on the preferences of various consumer groups, including
young people, non-smokers and the main types of current users;
• The mode of sale of the products; (i.e. online vs in shop)
• Executive summaries of any market surveys carried out in respect of the
above
Unit packets of electronic cigarettes and refill containers include a leaflet with
information

31. TACKling SecondHand Smoke and electronic
cigarettes aerosols – TACK SHS

32. Novel Tobacco Products
• Information on ingredients and emissions
• Available scientific studies on toxicity, addictiveness and
attractiveness
• Available studies, executive summaries thereof and
market research on the preferences of various consumer
groups, including young people and current smokers;
• Risk/benefit analysis of the product:
– its expected effects on cessation of tobacco consumption,
– its expected effects on initiation of tobacco consumption
– predicted consumer perception.

33. Tracking and tracing
• Illicit trade is a threat to tobacco control.
• Continuum of monitoring through all stages in
handling from production to the consumer.
• A tamper proof security feature, composed of
visible and invisible elements.

34. Monitoring the TPD
• Maximise the wealth of data that will be collected
5 year
follow up
Monitoring
Data
Collection
Re-
evaluation
Alteration
of the
legislation

35. • To monitor and evaluate the impact of the TPD within the context of FCTC
ratification at a European level.
• To evaluate the psychosocial and behavioral impact of TPD implementation
and FCTC implementation,
• Collection of information from 28 EU MS.

36. WP2/3/4 - Through the creation of a cohort of
adult smokers in 6 EU MS (n=6000) in a pre- vs.
post-TPD study design (WP2-WP3)- part of the
ITC study
• Greece (University of Athens)
• Germany (German Cancer Research Center)
• Hungary (Smoking or Health Hungarian foundation)
• Poland (Health Promotion Foundation)
• Romania (Aer Pur Romania)
• Spain (Institut Catala d’Oncologia)

37. • WP5- Repeated cross sectional
Eurobarometer Survey’s - 100,000
adults in 2009-2017
• WP6 – Evolution of the e-cigarettes

39. Evidence based decisions
Tobacco control regulatory
science,
Evidence based decisions
lead to the implementation of
tobacco control legislations

40. Thank you