1. EU tobacco and nicotine regulations - general aspects
Anna-Eva Ampelas Head of Unit Health in all policies, global health, tobacco control Directorate General for Health and Food Safety (DG SANTE) European Commission SRNT-EUROPE SATELLITE SYMPOSIUM, 8 March 2017

2. Smoking prevalence E-cigarette consumption 11 December 2014, Brussels
12% have tried e-cigarettes (7% in 2012). 67% of these to reduce or quit smoking.
14% of e-cigarette users were able to stop smoking.
11 December 2014, Brussels

3. Tobacco Products Directive 2014/40/EU
objective - to guarantee the proper functioning of the EU internal market, while ensuring a high level of health protection
health focus - initiation of tobacco consumption, in particular by young people
Adopted in April 2014, complemented by implementing and delegated acts, applied by Member States since 20 May 2016
Expected outcome: 2% drop in consumption of tobacco over a period of 5 years

4. Main elements of TPD (1/2)
Packaging and labelling
Mandatory combined (picture, text and cessation info) warnings (65%) on both sides of the packet
Ban on promotional and misleading elements
Ingredients
Ban of tobacco products with characterising flavours
Reporting obligations for all ingredients and enhanced reporting for additives on a priority list

5. Main elements of TPD (2/2)
Illicit trade
EU-wide tracking and tracing at unit pack level (implementation on-going)
Security features on all packs
Smokeless and novel tobacco
Continued ban of oral tobacco (snus)
Stricter labelling rules for other smokeless tobacco products
Prior notification and enhanced reporting for novel tobacco products

6. Why EU action on e-cigarettes?
Differing or non-existent rules across EU MS
EU Member States regulated ENDS/e-cigarettes very
differently (as pharmaceuticals, consumer products,
tobacco products)
Growth of EU market
the EU market was experiencing rapid growth
Public health concerns
Misleading/inconsistent product information, vivid and innovative marketing
Differing qualities of e-cigarettes
Lack of information on long-term health effects
No conclusive evidence as regards the impact on initiation, cessation

7. TPD Electronic cigarettes (Art.20)
Nicotine containing (or potentially containing) e-cigarettes
disposable
rechargeable
refillable
Refill containers: with nicotine-containing liquid, which can be used to refill an e-cigarette

8. TPD Electronic cigarettes (Art.20)
Main provisions in the TPD
Safety and quality e.g. nicotine threshold, market surveillance
Packaging and labelling, including health warning and info leaflet
6 months prior notification, extensive reporting obligations
Advertising restrictions
Special rules for "refillables"
National competence: flavours, age limits, points of sales, nicotine free ecigs

9. Commission Decision on common notification format
Adopted in November 2015
Information to be sent to MS through the EU-Common Entry Gate (EU-CEG)
Type of information: product information (brand, launch date, withdrawal date etc.), description of ingredients, emissions

10. Commission Decision on technical standards for refillables
Adopted in April 2016
Technical specifications for a mechanism ensuring refilling without leakage
Appropriate instructions for refilling

11. Commission Report on Health risks
Published on 20 May 2016
Use of refillables and the potential exposure to e-liquids containing nicotine in high concentrations, may pose risks to public health (mitigated by TPD and national regulation)
Further study needed
Need for raised awareness of the toxicity of the nicotine in e-liquids

12. New products emerging Products such as heated tobacco products
The European Commission:
closely monitors developments related to these products
favours a cautious approach given the lack of evidence on their health effects and use patterns
reminds that the relevant provisions of the Tobacco Products Directive apply and should be enforced

13. What ‘s next? Gathering more data on e-cigarettes
Regular discussions with Member States (Expert Group, Joint Action etc.)
Eurobarometer surveys, data from MS
Scientific monitoring
Discussions in international fora, eg WHO FCTC context
Commission 5 year report (Art 28 TPD)

14. Thank you!