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Notification of tobacco products

Notification of tobacco products (cigarettes, roll-your-own tobacco, pipe tobacco, cigars, cigarillos, smokeless tobacco products)

The detailed information on tobacco products shall be submitted to the member states competent authorities electronically using an EU-CEG platform which is common for all member states and 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).

The submission of the information by means of a common electronic entry gate EU-CEG, in the format laid down in the Commission Implementing Decision (EU) 2015/2186 of 25 November 2015, will mean that the statutory obligations laid down in Article 8a of the Act on protection of health against the consequences of the consumption of tobacco and tobacco products have been fulfilled.

Which information should be submitted through EU-CEG?

Pursuant to Article 8a of the Act on protection of health against the consequences of the consumption of tobacco and tobacco products, manufacturers or importers of tobacco products are obliged to submit to the President of the Bureau for Chemical Substances one-time information by brand names and types concerning:

  1. a list of all ingredients, and quantities thereof, used in the manufacture of the tobacco products, in descending order of the weight of each ingredient included in a given tobacco product;
  2. the emission levels referred to in Article 10(1) of the Act, and other emission levels laid down in the provisions laid down in Article 10(10) of the Act;
  3. if available, information on other emissions of the tobacco products.

The above list of ingredients shall be accompanied by:

  1. a statement setting out the reasons for the inclusion of such ingredients in the tobacco products including the information whether the ingredients have been registered under Regulation No 1907/2006, as well as their classification under Regulation No 1272/2008 of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1, as amended).
  2. the relevant toxicological data regarding the ingredients in burnt or unburnt form, as appropriate, referring in particular to their effects on the health of consumers and taking into account, inter alia, any addictive effects;
  3. for cigarettes and roll-your-own tobacco, a technical document setting out a general description of the additives used and their properties.

For new or modified tobacco products the information shall be submitted to the President 6 months prior to the placing on the market of those products.

The manufacturer or importer shall also immediately inform the President, if the composition of a product is modified in a way that affects the information provided.

General information on how to submit information on the 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 network.

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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