Publication date: December 02, 2024
The Ministry of Health in Poland has proposed a number of draft laws aimed at combating the sale of electronic cigarettes and heated tobacco products. The new regulations will concern the amendment of the Act of 9 November 1995 on the protection of health against the effects of using tobacco and tobacco products (consolidated text: Journal of Laws of 2024, item 1162), hereinafter referred to as the “Tobacco Act”. The Government Legislation Centre website currently presents draft laws prohibiting the sale of nicotine-free electronic cigarettes to persons under 18 years of age and introducing the definition of a heated tobacco product into the Tobacco Act. The Ministry of Health has also announced a draft law on a complete ban on the sale of disposable cigarettes.
Ban on the sale of electronic cigarettes to persons under 18 years of age and other restrictions
The drafters of the amending act aim to limit the use of electronic cigarettes, especially by young people, and to adapt national regulations to EU regulations. The main goal is to introduce a ban on the sale of electronic cigarettes and refill containers (with liquid containing nicotine and without nicotine) to persons under 18 years of age and to limit their availability. Until now, the sale of electronic cigarettes to young people was legal, because the act did not cover e-cigarettes with nicotine-free liquid. The new regulations aim to more effectively protect minors from nicotine addiction and potential introduction to addiction. Under the new regulations, electronic cigarettes and refill containers (i.e. liquids ) will only be sold to adults, and trade in these products on the Internet and in vending machines will also be prohibited.
The amendment assumes a change in the definitions of terms specified in the statutory glossary, i.e. in art. 2 of the Tobacco Act. The following terms have been modified: “smoking electronic cigarettes”, “reserve container” and “electronic cigarette“, specified respectively in points 17, 18 and 20 of the aforementioned article of the Tobacco Act. Thanks to the change in these definitions, their scope of meaning will also include vapor or liquid containing no nicotine. The drafters emphasized that the risk posed by nicotine-free liquids is not at all lower than that resulting from smoking nicotine products. Moreover, it will not be possible to sell a nicotine-free product to a person who is under 18 years of age. In accordance with art. 6 sec. 1 of the Tobacco Act, it is prohibited to make tobacco products, electronic cigarettes or reserve containers available to persons under 18 years of age. The last two terms mentioned in the article will also include nicotine-free products. From the moment the amendment comes into force, the sale of nicotine-free products in vending machines will also be prohibited – in accordance with Art. 6 sec. 3 of the Tobacco Act, and pursuant to Art. 7f item 2 of the Tobacco Act, distance selling, for example via the Internet, will not be legal .
The change will also mean that the use of nicotine-free products will be prohibited where smoking is prohibited. Article 5 of the Tobacco Act contains a list of places where electronic cigarettes and all types of tobacco products may not be used. According to Article 8, Section 1 of the Tobacco Act, advertising and promotion of the described substances will be prohibited. The drafters have equated products containing nicotine with nicotine-free products. It was considered that limiting nicotine-free e-cigarettes on the market and in public spaces will significantly reduce the number of young smokers. This thesis should be considered correct. In the current legal state, there is nothing to prevent selling a nicotine-free cigarette to a child or teenager, which will most likely be the first step towards addiction.
The bill also introduced an obligation to appropriately mark the packaging of nicotine-free products. Article 7a was added to the Tobacco Act, which specifies: on the packaging referred to in paragraph 6, in the case of electronic cigarettes, which may only be used for the consumption of nicotine-free vapor and refill containers containing nicotine-free liquid, the following health warning shall be placed: “Product harmful to health”. The effects of smoking electronic cigarettes (with and without nicotine-containing liquid) have not been fully investigated. The liquids contain, among others, propylene glycol and glycerin, which substances become toxic when heated by a heater. This is the reason why caution should be exercised in their use. Therefore, it was correctly considered that even a product without nicotine should have a health hazard label.
Article 11c of the Tobacco Act concerns requirements for electronic cigarettes and refill containers. The provision contains a number of conditions that determine the admission of an electronic cigarette or refill container to circulation. Key regulations include:
The draft amendment also changes this provision. The word “liquid” also refers to a liquid that does not contain nicotine. The quality standards for production and storage of both products will be the same.
Nicotine-free products are also regulated by art. 11f of the Tobacco Act, which specifies the procedure for suspending the production or introduction of electronic cigarettes or refill containers to the market. An order to withdraw a specific product from the market has also been specified. First of all, it is necessary to refer to the concept of the President of the Office, which is defined in the provision in question. According to art. 3a sec. 1 of the Tobacco Act, the President of the Office is the President of the Bureau for Chemical Substances. According to art. 11f sec. 1 of the Tobacco Act, he is authorized to suspend, by way of a decision, the production or introduction of electronic cigarettes or refill containers to the market and may order their withdrawal if they may pose a serious threat to human health. The provision indicates the competence of the Director of the Office resulting from Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (OJ EU. L. of 2014, No. 127, p. 1, as amended ), hereinafter referred to as “Directive 2014/40/EU”. The suspension of production, placing on the market and the order of withdrawal from the market are made for the period of assessment by the European Commission. The action of the European Commission is specified in Article 20 paragraph 11 of Directive 2014/40/EU, according to which after the European Commission is notified by the relevant authority of a Member State of irregularities related to electronic cigarettes, it shall determine without delay whether the interim measures taken are justified. The Commission shall inform the Member State concerned of the results of its assessment so that it can ensure appropriate follow-up.
Since the draft amendment broadens the definitions of electronic cigarettes and refill containers, they should be narrowed in the provision commented on above. In order to maintain compliance with Directive 2014/40/EU, it was added that in this case it will only refer to products containing nicotine. This results from the fact that the definitions of electronic cigarettes and refill containers specified in Directive 2014/40/EU only apply to smoking products containing nicotine. The control of nicotine-free products by the Head of the Office and the European Commission would go beyond the framework specified in EU regulations.
A new Article 11j was also added to the Tobacco Act: control of compliance by entrepreneurs with the provisions of the Act, to the extent not reserved for other bodies, is carried out by the Trade Inspection, acting under the Act of 15 December 2000 on the Trade Inspection (Journal of Laws of 2024, item 312). The drafters indicated that the Trade Inspection has the appropriate competences and resources for effective market supervision. It has specialized personnel with many years of experience in control, as well as a network of branches located throughout the country. Additionally, developed internal control methodologies and experience in the supervision of consumer products constitute a strong basis for exercising supervision over tobacco products, including electronic cigarettes. Its tasks include, among others, controlling compliance of products intended for consumers with the requirements specified in applicable legal acts, including the Tobacco Act. The Trade Inspection also acts as an authority supervising the legality of trade in these products, controlling both entrepreneurs and the market itself.
The draft amendment also contains transitional provisions, according to which the notification of a given nicotine-free product to the President of the Bureau for Chemical Substances must be made within 6 months from the date of entry into force of the amendment. This applies to products introduced to the market before the date of entry into force of the Act. The process of introducing electronic cigarettes and refill containers to the market is described in Article 11b of the Tobacco Act. The provision specifies the formal requirements for notification, the notification fee and the course of the application review by the President of the Bureau. This is another effect of equating nicotine-free products with products containing nicotine. The draft also indicates that if a given nicotine-free product does not meet the requirements specified in the Act, it may remain on the market for a maximum of 6 months from the date of entry into force of the Act. Manufacturers of nicotine-free products will have to meet additional conditions for their product to be released for sale. The new regulations can be expected to increase the costs of production and introduction of new e-cigarettes to the market, which will translate into the retail price of these products.
There are many arguments that the number of young smokers may decrease after the introduction of new regulations. The introduction of a ban on the sale of nicotine-free e-cigarettes to persons under 18 deserves special attention. Apart from one case described in these considerations, nicotine products have been equated with nicotine-free products. Of course, the administration authorities will have to enforce the new regulations (if they come into force) to effectively combat the smoking of electronic cigarettes by children and young people.
An alternative to regular cigarettes can also be heated tobacco. There are many myths about this product. It is emphasized that it is a safer product than traditional cigarettes. However, experts warn that using this stimulant can be just as harmful to health. The smoke created as a result of heating tobacco contains substances that are very harmful to health, and above all nicotine . As in the case of electronic cigarettes, researchers do not yet know what the long-term effects of smoking heated tobacco are – checking the health effects of this type of stimulant requires long-term observations.
The Ministry of Health has proposed an amendment to the Tobacco Act, which will include a definition of a heated tobacco product in the regulations. Article 20a of the Tobacco Act will be introduced, which provides that a heated tobacco product means an innovative tobacco product in which, as a result of heating, nicotine and other substances are released, which are then inhaled by the consumer, and which, depending on its characteristics, is a smokeless tobacco product or a tobacco product for smoking. The amendment was dictated by the implementation of Commission Delegated Directive (EU) 2022/2100 of 29 June 2022 amending Directive 2014/40/EU of the European Parliament and of the Council as regards the abolition of certain exemptions for heated tobacco products (OJ EU L 283, 2022, p. 4), hereinafter referred to as Directive 2022/2100. In short, the amendment to Directive 2014/40/EU concerns:
In accordance with Directive 2022/2100, the drafters have amended Article 7e of the Tobacco Act, which clearly states that heated tobacco products may not be flavored in any way. In addition, the provisions regarding the introduction of heated tobacco to the market have been amended. This process is described in Article 11a of the Tobacco Act. If the Act enters into force, the provisions introduced by the amendment will be applied to ongoing proceedings aimed at obtaining consent for the distribution of heated tobacco products from the President of the Office. Due to the fact that Poland is late in transposing Directive 2022/2100, this was the only solution. Moreover, it will allow administrative bodies to act more effectively in the control of the tobacco market throughout the country.
The draft amendment also assumes the removal from the market of heated tobacco products previously approved by the President of the Office if they:
1) they have a characteristic aroma;
2) contain flavourings in any of their components, such as filters, paper, packaging and capsules;
3) they have been given technical properties that make it possible to change the smell or taste of given tobacco products or the intensity of their smoke;
4) contain tobacco or nicotine in filters, paper or capsules.
The calculation complies with the regulations resulting from Directive 2022/2100. The withdrawal of the permit will be the responsibility of the President of the Office, who will determine the expiry of the decision issued by him after prior appropriate assessment. The drafters proposed a 9-month deadline for the withdrawal from sale of all heated tobacco products that do not meet the conditions. The deadline is counted from the date of entry into force of the Act.
The Ministry of Health has announced that it will submit a bill for consideration that will completely abolish the possibility of selling disposable electronic cigarettes. The drafters emphasize that the use of these stimulants is a common phenomenon among young people. The considerations on the harmfulness of electronic cigarettes have already been described in this argument. It has been pointed out that the colorful packaging and the way these stimulants are presented in stores are mainly aimed at young people. The bill is not currently available on the Government Legislation Center website, so the details are not yet known. The ban on disposable cigarettes was recently introduced in Great Britain and will be in force from June 2025 – for now only in England. Statistical data indicate that as many as 9% of British people use e-cigarettes. The government, in addition to the argument regarding public health, has pointed out that disposable e-cigarettes are very harmful to the environment – used ones are stored in landfills in huge quantities, and toxic chemicals contained in batteries are released into the soil.
The effects of introducing these restrictions should be closely monitored to avoid potential errors when introducing a similar regulation into the Polish legal system. The idea is right, but it will be possible to transfer the disposable electronic cigarette market to the grey zone.