The EU 28 countries are bound by the EU Tobacco Products Directive (TPD) 2014. Article 20 relates to electronic cigarettes and refills specifically.
The directive harmonises many, but not all, regulations around tobacco products. E-cigarettes and nicotine refills are categorised as tobacco products.
Member states are free to apply their own regulations in regard to flavours, smoke-free environments, domestic sales arrangements, domestic advertising, brand-stretching, or minimum age limits.
Manufacturers and importers of electronic cigarettes and refill containers shall submit a notification to the competent authorities of the Member States of any such products which they intend to place on the market.
Member States shall ensure that:
- nicotine-containing liquid is only placed on the market in dedicated refill containers not exceeding a volume of 10 ml, in disposable electronic cigarettes or in single use cartridges and that the cartridges or tanks do not exceed a volume of 2 ml.
- the nicotine-containing liquid does not contain nicotine in excess of 20 mg/ml.
- the nicotine-containing liquid does not contain additives listed in Article 7(6) EU TPD 2014.
- only ingredients of high purity are used in the manufacture of the nicotine-containing liquid. The ingredients other than nicotine must not pose a risk to health.
- electronic cigarettes deliver the nicotine doses at consistent levels under normal conditions of use.
- electronic cigarettes and refill containers are child- and tamper-proof, are protected against breakage and leakage and have a mechanism that ensures refilling without leakage.
- unit packets of electronic cigarettes and refill containers include a leaflet with information on:
- instructions for use and storage of the product, including a reference that the product is not recommended for use by young people and non-smokers;
- warnings for specific risk groups;
- possible adverse effects;
- addictiveness and toxicity; and
- contact details of the manufacturer or importer and a legal or natural contact person within the Union;
- Unit packets and any outside packaging of electronic cigarettes and refill containers:
- include a list of all ingredients contained in the product and an indication of the nicotine content of the product, the batch number and a recommendation to keep the product out of reach of children.
- carry one of the two prescribed health warnings.
- Advertising in Information Society services, TV, radio, in the press and other printed publications, with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers are prohibited, except for publications that are intended exclusively for professionals
- any form of public or private contribution to any event, activity or individual person with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers is prohibited;
- Conditions on cross-border sales apply where individual member states have not banned them.
- Monitoring of e-cigarettes use and adverse effects
- Mutual warnings between states of e-cigarettes and products which are not safe.
- As e-cigarettes are a relatively new product for which evidence is only starting to emerge, the Directive lays down monitoring and reporting requirements for manufacturers and importers,
- E-cigarette manufacturers must notify Member States of all products they place on the market and report annually to them on sales volumes, consumer preferences and trends.
- Member State authorities will monitor the market for any evidence that e-cigarettes lead to nicotine addiction or to tobacco consumption, especially in young people and non-smokers.