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Bureau for Chemical Substance

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The EU legal acts on tobacco products

On 20 May 2016 the EU member states started to apply 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. Products regulated by this directive include cigarettes, roll-your-own tobacco, pipe tobacco, cigars, cigarillos, smokeless tobacco products, electronic cigarettes and refill containers, herbal products for smoking and novel tobacco products.

This Directive, inter alia:

  • Introduces the prohibition of placing on the market tobacco products with characterising flavours or containing certain additives;
  • Requires manufactures and importers of tobacco products to submit to the competent authorities of the member states detailed information concerning a list of all ingredients, and quantities thereof, used in the manufacture of the tobacco products;
  • Requires that unit packet or outside packaging of tobacco products and of related products shall carry health warnings and sets minimum dimensions of these warnings, as well as appearance and content of unit packets of these products;
  • Prohibits placing any promotional and misleading elements on the tobacco products;
  • Introduces a tracking and tracing system to counteract illicit trade in tobacco products;
  • Allows members states to prohibit cross-border distance sales and internet sales of tobacco products and related products;
  • Introduces safety and quality requirements for electronic cigarettes and refill liquids;
  • Requires manufactures and importers of electronic cigarettes and refill liquids to submit to the competent authorities of the member states detailed information concerning a list of all ingredients contained in, and emissions resulting from the use of, the product;
  • Requires manufactures and importers of novel tobacco products and herbal products for smoking to notify the novel tobacco products and herbal products for smoking before they are placed on the market.

The following list contains all implementing acts to this directive adopted so far by the European Commission:

We would also like to encourage you to visit the European Commission website which contains documents relating to the tobacco directive, e.g. documents which assist in labelling the packaging or document relating to the format of the notification.  

The list below contains legal acts drafted by the Minister of Health in the field of tobacco products and related products:

  • Regulation of the Minister of Health of 1 September 2016 on the list of laboratories verifying the maximum emission levels for tar, nicotine and carbon monoxide in cigarette smoke (Dz. U. of 2016, item 1410);
  • Announcement of the Minister of Health of 2 February 2017 concerning research institutes performing the assessment of reports containing results of priority studies of additives contained in cigarettes and roll-your-own tobacco (Dz. U. of the Minister of Health of 2017, item 12)
  • Announcement of the Minister of Health of 13 March 2020 concerning research institutes performing the assessment of reports containing results of priority studies of additives contained in cigarettes and roll-your-own tobacco (Dz. U. of the Minister of Health of 2020, item 19).

Contact

Contact: tyton@chemikalia.gov.pl

The document below contains a list of all national helpdesks:

National helpdesk in your country

 

Notification of novel tobacco products

The detailed information on tobacco products (including novel tobacco products) shall be submitted to the competent authorities of the member states by means of a common electronic entry gate, EU-CEG, administered by the European Commission.

The format for the submission and making available of information on tobacco products is laid down in the Commission Implementing Decision (EU) 2015/2186 of 25 November 2015 establishing a format for the submission and making available of information on tobacco products (OJ L 312, 27.11.2015, p. 5).

Pursuant to Article 11a of the Act on protection of health against the consequences of the consumption of tobacco and tobacco products, novel tobacco products may be made available for the first time with the purpose of further selling, or made available for the first time with the purpose of placing on the market, after receiving the authorisation from the President, granted on the basis of a notification by the manufacturer or importer.

The notification concerning the novel tobacco products shall be submitted in electronic form at least 6 months before the above mentioned intended placing on the market.

The notification of a novel tobacco product to be placed on the market shall be accompanied by:

  1. detailed description;
  2. instructions for its use;
  3. information on ingredients and emissions, including the information required for all tobacco products pursuant to Article 8a of the Act;
  4. available scientific studies on toxicity, addictiveness and attractiveness of the novel tobacco product, in particular as regards its ingredients and emissions;
  5. available analyses, executive summaries thereof and market surveys on the preferences of various consumer groups, including young people and current smokers;
  6. other available and relevant information, including a risk/benefit analysis of the product, its expected effects on cessation of tobacco consumption, its expected effects on initiation of tobacco consumption and predicted consumer perception;
  7. confirmation of payment.

The manufacturer and importer of novel tobacco products is also required to transmit simultaneously to the President any new or updated information on the studies, research and other information listed above.  

The President shall grant or refuse to grant the authorisation within 5 months of the day of the notification.

For granting the authorisation the manufacturer or importer shall pay into the bank account indicated by the President a fee amounting to 30 times the average monthly remuneration in the enterprise sector without the payment of bonuses from profits for the previous year reported in a notice by the President of the Main Statistical Office.

Notifications without the confirmation of payment of the fee shall not be considered.

The authorisation may only be granted for a novel tobacco product which meets the requirements defined for a tobacco product for smoking or for a smokeless tobacco product.  

General information on how to submit information on the novel tobacco products:

The first step involves creating an account on EU Login. This is mandatory for the submitters intending to use “Client/Stand-Alone” application. EU Login is the European Commission’s Authentication System. It provides access to many IT systems of the Commission using a single user name and password. 

Next you need to apply for an ID number (only manufacturers and importers are eligible to apply for the ID), performing the following steps:

  1. Download registration form (to download the file right-click and select “save link as”);
  2. Carefully read the instructions in the form;
  3. Complete the form;
  4. Submit the completed registration form.

When the EC receives the form, the process of granting the ID number to the submitter will commence. The EC can request that the submitter should provide missing/additional information. The EC will also inform the submitter that it will endeavour to grant the ID number as soon as possible, however it may take up to several days.

Once you have your individual ID number, you can submit the information.

There are 2 methods available for operators to notify their products to the national competent authorities:

  1. Using a Client/Stand-Alone application for companies who have basic IT solutions in place. Access is free of charge.
  2. Using System-to-system submissions application for companies who have advanced IT solutions in place. This application requires access to e-Delivery network, which is compatible with the European Commission network and provides safe data transfer.

More information on  e-Delivery .

More technical documents concerning installation and use of this platform are available on CircaBC (users need to have an account on the EU Login platform)

Upon selecting one of the above categories you will be redirected to CircaBC and asked to select:

  • Latest versions of technical documents, and next
  • XML submission through web interface, and next
  • tpd-xml-creator-tool-1.3.zip. 

TPD-xml-creator–tool is a tool for creating notifications of the tobacco products and related products, which have to be submitted to fulfil the obligations imposed pursuant to the Act on  protection of health against the consequences of the consumption of tobacco and tobacco products.

How to create a notification file ready for submission to the President?

To create the notification in TPD-xml-creator–tool, click on the tab “Product presentation” and select “Poland” in the field “National market”, and the notification will be transferred to the database accessible for the Bureau for Chemical Substances. Appropriately created and sent notification shall mean that the obligations imposed pursuant to the Act on protection of health against the consequences of the consumption of tobacco and tobacco products have been fulfilled.

How to submit the notification correctly?

Once the notification has been created (in XML file format) it should be submitted using E-trustex. CircaBC also provides the information how to submit the notification correctly. Once you are on CircaBC select:

  • Latest versions of technical documents, and next
  • XML submission through web interface, and next
  • ETRUSTEX_tutorial.pdf.

Please refer to other documents on CircaBC.

The following document is also worth knowing:

The Commission has also provided e-mail addresses for contact in case of problems:

This information is available on the EC website

The EC website contains translated versions of manuals instructing how to obtain the ID number and translation of the fields in the file creator both for electronic cigarettes and tobacco products.

Manuals

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