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EU tobacco and nicotine regulations - general aspects

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.

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EU tobacco and nicotine regulations - general aspects

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  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 • 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 reportingobligations • 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! http://ec.europa.eu/health/tobacco/products_en

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