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Tobacco use is one of the largest avoidable causes of morbidity and premature death in the EU. Whilst smoking prevalence in the EU has been declining over the past 30 years, smoking has remained more prevalent among men than women in the EU-27, with some of the new Member States reporting the widest gaps between male and female smokers. For young smokers (13 to 15 years old) this situation is somewhat reversed, with slightly more girls than boys smoking.

Against this background, the European Commission Directorate-General for Health and Consumer Protection (DG SANCO) considered a revision of the Tobacco Products Directive 2001/37/EC across five general areas: scope of the directive, labelling requirements, registration and market control fees, ingredients, and sales arrangements. More specifically, the types of policy options under consideration included (but were not limited to): an increase of warning label sizes on the back of packaging to 100%, a restriction for the display of products at retail outlets and an introduction of additional measurement method for TNCO (the modified ISO method) with maximum limits set accordingly.

DG SANCO commissioned RAND Europe to provide support in assessing the potential health, macroeconomic, and compliance cost and administrative burden impacts of revising the Tobacco Products Directive. In addition to assessing impacts, the study provides an up-to-date overview of the evidence and basis for current tobacco product regulation that may be of interest to a wider audience interested in tobacco control policies.

Table of Contents

  • Chapter One


  • Chapter Two

    Approach and methodology

  • Chapter Three

    Background for tobacco use and its health effects

  • Chapter Four

    Economic and financial description of the tobacco sector

  • Chapter Five

    Administrative burden of the current tobacco directive

  • Chapter Six

    Baseline scenario

  • Chapter Seven

    Scope of regulation

  • Chapter Eight

    Labelling and packaging

  • Chapter Nine

    Registration and market control fees

  • Chapter Ten


  • Chapter Eleven

    Sales arrangements

  • Chapter Twelve

    Comparing the options

  • Chapter Thirteen

    Monitoring and evaluation

  • Chapter Fourteen

    Summary of stakeholder engagement

  • Chapter Fifteen


  • Appendix A

    Template for evidence review

  • Appendix B

    Methodology for estimation of employment share and tax revenue impacts

  • Appendix C

    Methodology for estimation of administrative burden and compliance costs

  • Appendix D

    Environmental impacts

Research conducted by

The research described in this report was prepared for the European Commission Directorate-General for Health and Consumers by RAND Europe.

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