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The EU Regulation of tobacco products
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
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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:
To help member countries transpose the provisions of the Directive, the EU Commission has been tasked with implementing rules, including:
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An additional Implementation Plan provides further details and an indicative timeline for the adoption of implementing legislation under the Tobacco Products Directive (see the document on the side)
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.
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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:
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
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EU Funds available
The EU finances studies, research projects and awards contracts through multi-annual programs funded from the EU budget.
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.
The EU finances studies, research projects and awards contracts through multi-annual programs funded from the EU budget.
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.
TIPS: If you want to be constantly informed on the ongoing legislative process in the European Institutions on Tobacco products and take part to the debate, fill the form below.
