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​The EU Regulation of tobacco products​
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The current EU Directive came into force in May 2016 and is dealing with the rules governing manufacture, presentation and sale of tobacco and related products: cigarettes, rolling tobacco, pipe tobacco, cigars, cigarillos, smokeless tobacco, e-cigarettes, and herbal products for smoking.

With the publication of the European Plan to Fight Cancer in February 2021, the Commission has announced that it intends to present proposals for amendments to this directive, as early as 2021, with the aim of decreasing the number of people who smoke to 5% in 2040 (still in 2020, 25 % of the EU population was smoking).

Current European Directive on tobacco products


On May 20, 2016, the current Tobacco Products Directive entered into force. This Directive replaces the previous one and the provisions that since 1989 have governed the production, presentation and sale of tobacco.

​The Directive:
  • prohibits cigarettes and rolling tobacco with characterizing aromas
  • requires the tobacco industry to report to EU countries on the ingredients used in tobacco products
  • requires health warnings on tobacco and related products: the combined health warnings (image, text and information on how to quit) must cover 65% of the front and back of the packs of cigarettes and roll-your-own tobacco
  • sets minimum sizes for warnings and bans small packaging for certain tobacco products
  • prohibits promotional and misleading elements on tobacco products, e-cigarettes and smoking herbal products
  • introduces the EU-wide tracking and tracing system to combat illicit trade in tobacco products
  • allows EU countries to ban the internet sale of tobacco and related products
  • establishes the safety, quality and notification requirements for e-cigarettes
  • obliges manufacturers and importers to notify EU countries of new tobacco products before placing them on the EU market


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Implementing Acts

To help member states to transpose the provisions of the Directive, the EU Commission has been tasked with implementing rules, including:
  • Commission Implementing Regulation (EU) 2023/448 of 1 March 2023 on technical standards for the establishment and operation of a traceability system for tobacco products
  • Commission Implementing Regulation (EU) 2018/574 of 15 December 2017 on technical standards for the establishment and operation of a traceability system for tobacco products
  • Commission Implementing Decision (EU) 2018/576 of 15 December 2017 on technical standards for security features applied to tobacco products (notified under document C(2017) 8435)
  • Commission Implementing Decision (EU) 2016/786 of 18 May 2016 laying down the procedure for the establishment and operation of an independent advisory panel assisting Member States and the Commission in determining whether tobacco products have a characterising flavour (notified under document C(2016) 2921)
  • Commission Implementing Decision (EU) 2016/787 of 18 May 2016 laying down a priority list of additives contained in cigarettes and roll-your-own tobacco subject to enhanced reporting obligations (notified under document C(2016) 2923)
  • Commission Implementing Regulation (EU) 2016/779 of 18 May 2016 laying down uniform rules as regards the procedures for determining whether a tobacco product has a characterising flavour
  • Commission Implementing Decision (EU) 2016/586 of 14 April 2016 on technical standards for the refill mechanism of electronic cigarettes (notified under document C(2016) 2093)
  • Commission Implementing Decision (EU) 2015/2186 of 25 November 2015 establishing a format for the submission and making available of information on tobacco products (notified under document C(2015) 8162) (Text with EEA relevance)
  • Commission Implementing Decision (EU) 2015/2183 of 24 November 2015 establishing a common format for the notification of electronic cigarettes and refill containers (notified under document C(2015) 8087)
  • Commission Implementing Decision (EU) 2015/1842 of 9 October 2015 on the technical specifications for the layout, design and shape of the combined health warnings for tobacco products for smoking (notified under document C(2015) 6729)
  • Commission Implementing Decision (EU) 2015/1735 of 24 September 2015 on the precise position of the general warning and the information message on roll-your-own tobacco marketed in pouches (notified under document C(2015) 6455) (Text with EEA relevance)
  • COMMISSION IMPLEMENTING REGULATION (EU) …/... amending Implementing Regulation (EU) 2018/574 on technical standards for the establishment and operation of a traceability system for tobacco products
  • COMMISSION IMPLEMENTING DECISION (EU) …/… on technical standards for security features applied to tobacco products
  • COMMISSION IMPLEMENTING REGULATION (EU) …/... on technical standards for the establishment and operation of a traceability system for tobacco products
Degeted Acts:

  • Commission Delegated Directive (EU) 2022/2100 of 29 June 2022 amending Directive 2014/40/EU of the European Parliament and of the Council as regards the withdrawal of certain exemptions in respect of heated tobacco products (Text with EEA relevance)
  • Commission Delegated Regulation (EU) 2018/573 of 15 December 2017 on key elements of data storage contracts to be concluded as part of a traceability system for tobacco products (Text with EEA relevance. )
  • Commission Delegated Directive 2014/109/EU of 10 October 2014 amending Annex II to Directive 2014/40/EU of the European Parliament and of the Council by establishing the library of picture warnings to be used on tobacco products Text with EEA relevance
  • COMMISSION DELEGATED REGULATION (EU) …/... on key elements of data storage contracts to be concluded as part of a traceability system for tobacco products

Electronic cigarettes


Article 20 of the Tobacco Products Directive 2014/40/EU lays down rules for electronic cigarettes sold as consumer products in the EU.

Safety and quality requirements for e-cigarettes

The Directive sets a maximum nicotine concentration and volume for cartridges, tanks and nicotine liquid containers. E-cigarettes should be child-resistant and tamper evident and have a mechanism that allows refilling without spillage to protect consumers. E-cigarette ingredients must be of high purity and e-cigarettes should deliver the same amount of nicotine when puffed at the same strength and duration.

Manufacturers and importers must notify all products they place on the EU market through a standardised electronic format, by accessing the EU Common Entry Gate (EU-CEG).

Packaging and labelling rules for e-cigarettes

Health warnings for e-cigarettes advising consumers that they contain nicotine and should not be used by non-smokers are mandatory. Packaging must also include a list of ingredients contained in the product, information on the product's nicotine content, and a leaflet with instructions for use and information on adverse effects, risk groups, addictiveness and toxicity. Promotional elements are not allowed on e-cigarette packaging, and cross-border advertising and promotion of e-cigarettes is prohibited.

Implementing Legislation

In order to facilitate the implementation of Article 20 of the Directive, the Commission adopted two implementing acts and a Commission report related to e-cigarettes:
  • Commission Implementing Decision (EU) 2015/2183 of 24 November 2015 establishing a common format for the notification of electronic cigarettes and refill containers.
  • Commission Implementing Decision (EU) 2016/586 of 14 April 2016 on technical standards for the refill mechanism of electronic cigarettes.
  • Commission Report COM(2016) 269 final - Report from the Commission to the European Parliament and the Council on the potential risks to public health associated with the use of refillable electronic cigarettes.

In developing the implementing legislation and Commission report, the Commission asked an external contractor to provide it with an overview of potential risks associated with the use of refillable electronic cigarettes and information on technical specifications for refill mechanisms. The final report is available by clicking on the document on the side.



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Registration for new tobacco products


​Click on the banner below to register for new tobacco products.
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Go to the home page of the Public Health Chapter to see the updated Calls list, or request our consulting service with the Form at the bottom of this page.


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