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.
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.
Monitoring and reporting of developments related to e-cigarettes
The Directive lays down monitoring and reporting requirements for manufacturers and importers, EU countries and the Commission.
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 can be found here.
