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

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

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

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

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

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

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

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

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

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

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

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

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)

Thank you! http://ec.europa.eu/health/tobacco/products_en