Tobacco products and e-cigarettes in Poland – legal status
What are tobacco products and what is e-cigarette?
In accordance with the Polish Act of 22 July 2016 amending the Act on the protection of health against the consequences of tobacco and tobacco products, electronical cigarette is a device that can be used to ingest nicotine-containing vapor via a mouthpiece, or all components of that device, including cartridges, tanks and devices without a cartridge or tank. Electronic cigarettes may be disposable or refillable with a refillable cartridge or tank or rechargeable with a disposable cartridge.
According to the same Act, tobacco product is a product intended for consumption by consumers, consisting even partly of tobacco, including genetically modified tobacco.
The registration of tobacco products
The submission of detailed information on tobacco products to the competent authorities of Member States is done electronically through a common EU-CEG platform administered by the European Commission. Transmission of this information through the EU-CEG, in the appropriate format (Commission Implementing Decision (EU) 2015/2186 of 25 November 2015) is equivalent to compliance with statutory obligations referred to in Article 8a of the Act on Health Protection against the Effects of Tobacco and Tobacco Products.
In the Article 8a of the Act on Health Protection from the Effects of Tobacco and Tobacco Products, the manufacturer or importer of tobacco products is obliged to provide the President of the Bureau of Chemical Substances with one-off information by brand and type.
As for the process of reporting tobacco products, the first step is to create an account on EU login. This is a must for applicants who intend to use the “Client/Stand-Alone” application. EU Login is the European Commission’s authentication system. It allows users to access a number of Commission IT systems using a single username and password.
The next step is to apply for an ID (only the manufacturer and importer can apply for an ID). Once the form has been received by the EC, the process of assigning an ID number to the notifier will start.
Entrepreneurs may register their products to the competent national authorities in two ways:
via a Client/Stand-Alone application
via a System-to-system submissions
The registration of innovative tobacco products
As with “regular” tobacco products, the submission of detailed information on tobacco innovative products to Member States’ competent authorities is done electronically via the EU-CEG platform common to all Member States and administered by the European Commission.
According to Article 11a of the Polish Act on Health Protection against the Effects of Tobacco and Tobacco Products, innovative tobacco products may be made available for the first time for resale or made available for the first time for marketing after obtaining a permit from the President of the Bureau of Chemical Substances issued on the basis of a notification by the manufacturer or importer.
The registration of innovative tobacco products shall be made in electronic form at least 6 months before the date of the intended release referred to above.
The President of the Bureau shall issue a permit or refuse issuing it within 5 months from the date of filing. For issuing the permit, the producer or importer shall pay a fee in the amount of thirty times the average monthly remuneration in the enterprise sector without payments of prizes from profit for the previous year announced, by means of a notice, by the President of the Polish Central Statistical Office.
The license may only be issued for an innovative tobacco product which meets the requirements set out for a smoking tobacco product or a smokeless tobacco product.
Then the registration process is the same as for “standard” tobacco products.
The registration of e-cigarettes and spare containers
The submission of detailed information on electronic cigarettes and spare containers to the competent authorities of the Member States is done electronically through the EU-CEG platform, common to all Member States, administered by the European Commission. The common format for reporting electronic cigarettes and spare containers is set out in Commission Implementing Decision (EU) 2015/2183 of 24 November 2015 establishing a common format for reporting electronic cigarettes and spare containers (OJ EU L 309, 26.11.2015, p. 15).
The transmission of information through the EU-CEG common electronic data transmission system in the format specified in Commission Implementing Decision (EU) 2015/2183 of 24 November 2015 will be equivalent to fulfilling the statutory obligations referred to in Article 11b of the Polish Law on Protection of Health from the Consequences of Tobacco and Tobacco Products. According to Article 11b of the Law on the Protection of Health from the Effects of Tobacco and Tobacco Products, electronic cigarettes and spare containers may be made available for the first time for resale or made available for the first time for marketing after the manufacturer or importer has made a notification and appointed a legal or natural person to contact in the European Union. If the notification has not been made by the manufacturer, any importer shall be obliged to make such notification before the first making available for resale or the first making available for placing on the market.
The application for registration of electronic cigarettes and spare containers is subject to a charge equal to the average monthly remuneration in the enterprise sector without payments of rewards from profit for the previous year announced, by means of a notice, by the President of the Polish Central Statistical Office, 50% of this charge – in case of medium enterprises within the meaning of Recommendation 2003/361/EC or 30% of this fee – in case of small and micro enterprises within the meaning of Recommendation 2003/361/EC. The fee shall be paid by the producer or importer to the bank account indicated by the President of the Office.
Then the registration process is the same as for “standard” tobacco products.
The registration of herbal products for smoking
In accordance with Article 11h of the Polish Act on health protection against the effects of tobacco and tobacco products, the manufacturer or importer of smoking herbal products provides the President of the Bureau of Chemical Substances with a list of all ingredients, with their quantity, used in the manufacture of these products, broken down by brands and types.
The manufacturer or importer of herbal smoking products shall inform the President of the Bureau in the event of a change in the composition of the product affecting the information provided.
The aforementioned information should be provided to the President of the Office at least 6 months prior to the date of placing a new or modified herbal smoking product on the market.
Then the registration process is the same as for “standard” tobacco products.
Nicotine-related information (CAS 54-11-5, EC 200-193-3)
Nicotine is regulated by Regulation (EC) No 649/2012 of the European Parliament and of the Council of 4 July 2012 on the export and import of dangerous chemicals. Under the provisions of Regulation 649/2012, the export of an Annex I chemical outside the EU must be preceded by the submission of an export notification to the designated authority of the exporting country.
There is no obligation to notify imports of these chemicals into the EU, but Regulation 649/2012 requires importers to submit annual reports to the designated national authority on the quantities of chemicals imported.
In accordance with the CLP Regulation, the labelling of nicotine marketed in Poland should be in Polish.
From 1 December 2018, a new harmonized classification of nicotine as amended by Commission Regulation (EU) 2017/776 of 4 May 2017 is in force. In order to facilitate the classification of mixtures in the acute toxicity class, estimated acute toxicity (ATE) values for the three exposure routes have been introduced into Part 3 of Annex VI to Regulation (EC) No 1272/2008, respectively.
E-cigarette market monitoring
In accordance with the provisions of Article 11d (4) of the Act on Health Protection from the Effects of Tobacco and Tobacco Products, the President of the Bureau of Chemical Substances shall monitor the development of the market for electronic cigarettes and the development of the market for replacement containers, taking into account all evidence indicating that the use of electronic cigarettes and replacement containers leads to nicotine addiction and ultimately to the consumption of tobacco products.
Withdrawal from the market
In order to withdraw a product from the market, it is necessary to update the notification in the EU-CEG system under Product presentation under Withdrawal date. This is particularly important in the case of tobacco products, as this will be the basis for issuing the annual call for payment.
Polish legal acts
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 on the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC was transposed into the Polish legal order by the Act of 22 July 2016 amending the Act on the protection of health against the consequences of tobacco and tobacco products (Journal of Laws 2016, item 1331).
The current consolidated text of the Act on Protection of Health Against the Consequences of Use of Tobacco and Tobacco Products (Journal of Laws of 2021, item 276).
Additional legal basis under Polish law:
Regulation of the Minister of Health of 1 September 2016 on the list of laboratories carrying out verification of the maximum level of emitted tar, nicotine and carbon monoxide in cigarette smoke (Journal of Laws 2016, item 1410).
Announcement of the Minister of Health of March 13, 2020 on research institutes evaluating reports containing results of tests of priority additives contained in cigarettes and roll-your-own tobacco.
EU legal acts – tobacco products
Since 20 May 2016, Member States of the European Union have applied 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 on the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC. The products regulated by the Directive include cigarettes, roll-your-own tobacco, pipe tobacco, cigars, cigarillos, smokeless tobacco products, electronic cigarettes and spare containers, and herbal smoking products and novelty tobacco products.
In addition EC has enacted a number of implementing acts for this Directive.
Fees
The application for registration of electronic cigarettes and spare containers is subject to a fee equal to the average monthly remuneration in the enterprise sector without payments of rewards from profit for the previous year announced, by means of a notice, by the President of the Central Statistical Office, 50% of this charge – in case of medium enterprises within the meaning of Recommendation 2003/361/EC or 30% of this charge – in case of small and micro enterprises within the meaning of Recommendation 2003/361/EC. The fee shall be paid by the producer or importer to the bank account indicated by the President of the Office.
