New legislation regulating e-cigarettes in the Czech Republic entered into force on 1 March 2017, introducing specific safety and quality requirements on e-cigarettes in the country for the first time.
Legislative background The new legislation is a result of the national transposition of the so-called Tobacco Products Directive (2014/40/EU) (the "TPD"). Some provisions of the TPD regulating e-cigarettes were already included in the amendment of Act No. 110/1997 Coll., on Foods and Tobacco Products, effective from 7 September 2016. Nevertheless, the capstone of the e-cigarettes regulation, Decree of the Ministry of Health No. 37/2017 Coll., on Electronic Cigarettes, Refills and Herbal Products Intended for Smoking (the "E-cigarettes Decree"), became effective only on 1 March 2017, almost a year after the deadline for harmonisation laid down by the TPD (20 May 2016). This does not mean that e-cigarettes were not regulated at all prior to the effective date. Previously the regulation of e-cigarettes was divided among a number of broad-ranging laws, some regulating product safety in general (e.g. with respect to e-cigarettes as a product) and others regulating chemical substances and chemical mixtures (e.g. with respect to refills – or e-liquids – containing nicotine, which is categorised as a dangerous chemical substance).
What does the E-cigarettes Decree regulate?
- safety and quality requirements for e-cigarettes;
- rules on labelling of e-cigarettes, including prohibited elements and features;
- reporting obligation of manufacturers and importers of e-cigarettes;
- requirements in relation to cross-border distance sale of e-cigarettes.
Safety and quality requirements for e-cigarettes As nicotine is a toxic substance, the new legislation determines maximum nicotine concentrations (20 mg/ml), maximum allowed volume of refills (10 ml) and cartridges of liquid nicotine (2 ml). E-cigarettes must also be secured against undesirable handling, in particular by children. It is important to ensure that e-cigarettes do not break or leak during use and refilling. E-cigarettes must contain only high purity ingredients and must deliver the nicotine doses at consistent levels when inhaled at a similar intensity and duration. E-liquids must not contain (i) vitamins or other additives that create the impression of a health benefit; (ii) caffeine or taurine or other simulant compounds; (iii) additives having colouring properties for emissions; and (iv) additives that have carcinogenic, mutagenic or reprotoxic properties. Basically, the only substance with a risk to human health that e-liquids can contain is nicotine.
Labelling requirements In order to inform consumers that e-cigarettes contain nicotine and should not be used by non-smokers, e-cigarettes must now come with health warnings similar to those found on tobacco products. The health warning must cover at least 30% of the surface of the unit packet and any outside packaging, and must be included on the two largest surfaces of the unit packet and any outside packaging. The packaging must contain a list of all ingredients included in the product, information on the nicotine content, and must include a leaflet with instructions for use and storage, contraindications, warnings for specific risk groups, possible adverse effects and addictiveness, and toxicity. No advertising or promotional features are allowed on the packaging.
Reporting and notification obligations All products that are to be placed on the market, including their ingredients, must be notified to the Ministry of Health of the Czech Republic. Manufacturers and importers are also required to report sales volumes, consumer preferences among various groups, and sales trends. Close cooperation between the respective EU bodies and other EU Member States is required in this regard.
Registration of retailers carrying out cross-border sale of e-cigarettes According to the new regulation, retailers established in another EU Member State who want to engage in cross-border distance sales to consumers in the Czech Republic must be publicly registered with the Ministry of Health of the Czech Republic. Czech retailers wishing to sell in another EU Member State must also register with the Ministry of Health and with the competent authority in the country where their current or potential customers are located.
Regulation of e-cigarettes under the Anti-Smoking Act Coincidentally, as of 31 May 2017 another essential act having an impact on e-cigarettes will enter into force, i.e. the Act on Protection from the Harmful Effects of Addictive Substances (the so-called Anti-Smoking Act). Apart from the strict ban on smoking in public, the Anti-Smoking Act is more liberal with respect to e-cigarettes. However, the Anti-Smoking Act still bans the use of e-cigarettes for example in (i) any publicly accessible interior space, including airports; (ii) public transport, including covered platforms; (iii) health institutions; (iv) schools and educational institutions; and (v) children's playgrounds. The use of e-cigarettes is still possible in restaurants.