Electronic cigarettes, especially disposable ones, have recently been the subject of public debate, primarily due to the announcement of restrictions on their sale by the Ministry of Health. This summary provides an overview of the current legal status and potential legislative changes.
Legal status
The regulatory aspect
The legal framework for the production and marketing of electronic cigarettes with nicotine is set out in Poland by the Tobacco Act[1], the provisions of which implement Directive 2014/40/EU.
As defined in Article 2(20) of the Tobacco Act, it is “product that can be used for consumption of nicotine-containing vapour via a mouth piece, or any component of that product, including a cartridge, a tank and the device without cartridge or tank. Electronic cigarettes can be disposable or refillable by means of a refill container and a tank, or rechargeable with single use cartridges”. The definition adopted in the Tobacco Act is analogous to that contained in Article 2(16) of Directive 2014/40/EU.
The Tobacco Act, following an EU directive, contains numerous regulations relating to electronic cigarettes, including, among others:
- the obligation to notify products to the President of the Bureau for Chemical Substance (“President”) before they are placed on the market;
- composition – toxicological data on the components and substances released in the article, including when heated, with particular reference to the effects of their inhalation on the health of consumers, taking into account in particular their addictive properties, shall be provided as part of the aforementioned notification;
- construction – in the case of disposable e-cigarettes, the capacity of the tank must not exceed 2 ml and the nicotine content of the liquid must not exceed 20 mg/ml;
- labelling – there must be a mandatory health warning on the product label: ”This product contains nicotine which is a highly addictive substance”;
- reports – the submission of annual reports to the President.
The provisions of the Tobacco Act as it currently stands do not cover electronic cigarettes without nicotine.
The tax aspect
Electronic cigarettes are subject to excise duty. The excise duty rate for electronic cigarette liquid is, in principle, PLN 0,55 per millilitre, although nicotine-free liquid is also subject to the tax. According to the Excise Duty Act[2], liquid for electronic cigarettes is “a solution intended for use in electronic cigarettes, whether or not containing nicotine, including a base for this solution containing glycol or glycerol, where the solution is considered to be intended for use in electronic cigarettes, when used or, because of its composition and physico-chemical properties, capable of being used in electronic cigarettes, irrespective of where it is sold or offered for sale”.
Announcement of changes
As announced by the Ministry of Health (“MZ”), the ministry plans to ban the sale of disposable electronic cigarettes with and without nicotine in Poland, justified primarily by the consumption of these products by minors.
Following the mentioned announcement, electronic cigarettes have been the subject of debate in, inter alia, the Sejm and the Senate, including during:
- the meeting of the Parliamentary Group on the Prevention of Addiction of 16 February 2024;
- the meeting of the combined Senate Health Committees and Climate and Environment Committees of 19 March 2024;
- the meeting of the Parliamentary Group on Lung Diseases of 20 March 2024;
- the meeting of the Parliamentary Group on Addiction Prevention of Addiction of 24 April 2024.
According to statements by MZ representatives, various scenarios for the ban were considered, including based on administrative decisions by supervisory authorities. This intention was abandoned, considering an administrative decision to be an inadequate legal measure for the intended purpose (as rightly argued by the vaping industry). The current concept of the Ministry of Health is to introduce the ban by means of a law, and the presentation of draft new legislation is announced in the second half of the year[3].
The Draft Act and what next?
Among other things, the legislator is obliged to publish the draft and conduct a public consultation.
Legislation banning electronic cigarettes (with and without nicotine) should furthermore be notified in advance to the EC for approval; this procedure is provided for in Directive 2014/40/EU (nicotine products) and the Notification Regulation[4] in connection with Directive 2015/1535 (nicotine-free products). The notification procedures in both cases provide for a timeframe of three to six months for the Commission to take a decision.
E-cigarettes with nicotine
In accordance with the procedure provided for in Directive 2014/40/EU, a Member State may prohibit the marketing of a particular category of tobacco or related products a) on account of the specific situation of that Member State, b) and provided that the provisions are justified by the need to protect human health. The Member State shall then be obliged to inform the Commission of the planned ban and state the grounds for it. The Commission shall approve or reject the national provisions considering whether conditions a) and b) are met and whether (i) the notified provisions are justified, necessary and proportionate to their objective and (ii) do not constitute a means of arbitrary discrimination or (iii) a disguised restriction on trade between Member States. The Commission has six months from the submission of the required set of documents to issue its decision.
E-cigarettes without nicotine
The above procedure does not apply to nicotine-free products. For such products, the general obligation to notify acts which prohibit the manufacture, import or placing on the market of products will apply (§4 of the Notification Regulation). The procedure then provides for a three-month deadline for the Commission to analyse the grounds for the notified ban, but this may be extended to six months.
Selected examples of Member States
| Belgium | On 18 March 2024, the Commission considered the notification of a ban on disposable electronic cigarettes (both with and without nicotine) in Belgium.
The EC, in agreeing to the proposed national legislation, considered the ban to be justified by Belgium’s specific situation and the need to protect human health. In the case of Belgium, the ban on the sale of disposable e-cigarettes was justified, inter alia, by the ineffectiveness of the current regulations and the additional restrictions introduced (prior to the sales ban), including: (i) an obligation to notify products, (ii) increased penalties, (iii) stricter composition and labelling requirements, (iv) stricter sales rules, and (v) intensified enforcement of the online sales ban and (vi) the advertising ban[5]. |
| France | The French draft law banning single-use electronic cigarettes was notified to the European Commission in March 2024.
The official deadline for the Commission’s decision is June 2024, but the deadline may be extended if additional information is required. The French legislator has proposed that the ban should cover the manufacture, storage for sale, distribution or free offering, of electronic vaporisation devices that have at least one of the following two characteristics: (i) they are pre-filled with liquid and cannot be refilled; (ii) they have a non-rechargeable battery[6]. |
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[1] Act of 9 November 1995 on health protection against the effects of tobacco and tobacco products.
[2] Act of 6 December 2008 on excise duty.
[3] https://www.msn.com/pl-pl/wiadomosci/other/zdrowie-dzieci-mo%C5%BCe-poczeka%C4%87-ministra-leszczyna-t%C5%82umaczy-si%C4%99-z-op%C3%B3%C5%BAnienia-w-pracach-nad-zakazem-jednorazowych-e-papieros%C3%B3w/ar-BB1m2Lfs (access: 7.06.2024)
[4] Regulation of the Council of Ministers of 23 December 2002 on the functioning of the national system of notification of norms and legal acts.
[5] https://technical-regulation-information-system.ec.europa.eu/en/notification/23601 (access:7.06.2024)
[6] Notification Detail | TRIS – European Commission (europa.eu) (acces: 7.06.2024)
