Report on the Application of the Directive 2014/40/EU

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The Commission must report on the application of Directive 2014/40/EU no later than 5 years after 20 May 2016. And, after that, whenever necessary, according to Article 28 of the Directive.

The document shall indicate those parts of the Directive that should be reviewed or adapted taking into account new scientific and technical developments as well as internationally agreed rules and standards.

Currently in its preparatory phase, the report is being produced with the assistance of scientific and technical experts, as well as the EU countries, to guarantee that all necessary information is available.

The Commission shall pay special attention to:

  1. the experience gained with respect to the design of package surfaces not governed by this Directive taking into account national, international, legal, economic and scientific developments;
  2. market developments concerning novel tobacco products considering, inter alia, notifications received under Article 19;
  3. market developments which constitute a substantial change of circumstances;
  4. the feasibility, benefits and possible impact of a European system for the regulation of the ingredients used in tobacco products, including the establishment, at Union level, of a list of ingredients that may be used or present in, or added to tobacco products, taking into account, inter alia, the information collected in accordance with Articles 5 and 6;
  5. market developments concerning cigarettes with a diameter of less than 7,5 mm, and consumer perception of their harmfulness as well as the misleading character of such cigarettes;
  6. the feasibility, benefits and possible impact of a Union database containing information on ingredients and emissions from tobacco products collected in accordance with Articles 5 and 6;
  7. market developments concerning electronic cigarettes and refill containers considering, amongst others, information collected in accordance with Article 20, including on the initiation of consumption such products by young people and non-smokers and the impact of such products on cessation efforts as well as measures taken by Member States regarding flavours;
  8. market developments and consumer preferences as regards waterpipe tobacco, with a particular focus on its flavours.

Additionally, the procedures that govern the:

  • appointment of ID issuers
  • providers of repository services
  • providers of anti- tampering devices
  • monitoring of the providers’ compliance with independence criteria

will be reviewed by the European Commission (in line with Article 35(9) of Implementation Regulation 2018/574). Conclusions of this review will also be included in the report.

The report should be followed-up by proposals for adapting the Directive to new developments with a view to support the smooth functioning of the internal market.

The Implementation Report Table provides a preliminary overview of data sources as well as ongoing and planned studies and contracts that will feed into the report.