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Bureau for Chemical Substance

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Notification of nicotine pouches

Notification of nicotine pouches

In connection with the entry into force of the Act of 21 May 2025 amending the Act on the Protection of Health against Consequences of Consumption of Tobacco and Tobacco Products (Polish Journal of Laws 2025, item 799), we would like to inform you that from 5 July 2025, pursuant to art. 11 ha section 1 of this Act, the manufacturer or importer of nicotine pouches will be obliged to provide the President of the Bureau for Chemical Substances with a list of all ingredients and the quantities used for the manufacture of these products, divided by brand and type (notification of these products).

Nicotine pouch notifications submitted prior to 5 July 2025 will not be accepted.

Notifications of nicotine pouches that have not yet been placed on the market in the territory of the Republic of Poland must be submitted at 6 months prior to the date of placing on the market of those products.

The manufacturer or importer of nicotine pouches that were placed on the market before the date of entry into force of this Act shall submit a notification to the President of the Bureau for Chemical Substances within 6 months from the date of entry into force of this Act, i.e. by 5 January 2026.

In addition, the manufacturer or importer of nicotine pouches shall inform the President of the Bureau in the event of a change in the composition of the product affecting the information provided under Art. 11ha section 1 of the above Act at least 6 months before the date of placing on the market of modified nicotine pouches.

Below you will find general information on the nicotine pouch notification process:

Nicotine pouches should be notified in a similar way to tobacco products.

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 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 received your unique identification number, you can begin submitting information about nicotine pouches.

Below we describe two methods (categories A or B) by which manufactures and importers can submit notifications:

  1. Using a Client/Stand-Alone application (XML submission through web interface - XML Creator, ETRUSTEX) for companies who have basic IT solutions in place. Access is free of charge.
  2. Using System-to-system submissions application (XML submission through AS4 access point) 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):

For tobacco product stakeholders

After selecting one of the above categories (A or B) you will be redirected to a page with the necessary documents and tools. After selecting category A (XML submission through web interface - XML Creator, ETRUSTEX) most often used by applicants, you should download a file called tpd-xml-creator-tool-1.6.1.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 the Protection of Health against Consequences of Consumption of Tobacco and Tobacco Products.

How to create a notification file ready to be sent to the President of the Bureau for Chemical Substances?

When creating notifications in TPD-xml-creator–tool, in the “Submission type” field, please select the “New product” option also for products that are already on the market, but due to the entry into force of the Act of 21 May 2025 amending the Act on health protection against the effects of using tobacco and tobacco products (Journal of Laws 2025, item 799), they are reported for the first time.

In the "Product type" field, please select the "Other" option (due to the inability to select an option indicating nicotine pouches). In the "General Comment" field, please enter the information that the notified product is a nicotine pouch.

In the “Product weight” field, please enter the weight of one pouch in mg. In the “Product tobacco weight” field, enter the value “0” for nicotine pouches (as they do not contain tobacco).

In the "Product Presentation" section, in the "National Market" field, select "Poland" from the drop-down list of countries. Only the "Poland" option will allow you to submit a notification to the database available for the Bureau for Chemical Substances. A correctly created and submitted notification will mean fulfilling the obligations imposed by Article 11ha of the Act of 21 May 2025 amending the Act on the Protection of Health against Consequences of Consumption of Tobacco and Tobacco Products.

In the "Tobacco Ingredients" section, please select "Other" in the drop-down lists and enter "0" in the "Tobacco Quantity" field. This step is necessary for the system to properly verify the submission (even though the product does not contain tobacco).

All product ingredients and their quantities should be entered in the "Other ingredients" section. In the "Ingredient category" field, select the "Other (unburnt)" providing information about the ingredients of the nicotine pouch filling mass, the "Pouch material (unburnt)" option for the pouch itself, and the "Adhesive (unburnt)" option for the glue (if used). The quantities of each ingredient should be given in mg. “Ingredient quantity” is the weight of the ingredient included in one product unit in mg according to recipe. The product unit is one nicotine pouch.

How to send the notification correctly?

Once the notification has been created (in XML file format) it should be submitted using E-trustex. A guide on how to submit your notification correctly is also available on CircaBC in the form of the file EU-CEG_guide.pdf

We encourage you to read the other documents available on CircaBC, remembering that notifications of nicotine pouches are carried out in a similar way to notifications of tobacco products.

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

 

In addition, we would like to inform you that nicotine pouches are subject to the CLP Regulation.

We remind you that in accordance with Article 45 and Annex VIII of the CLP Regulation, importers, downstream users and in some cases distributors shall provide information on mixtures classified as hazardous due to health or physical effects before placing them on the market. The information shall be provided in a harmonised data format throughout the European Economic Area - Poison Centres Notification (PCN). More information can be found on the dedicated Poison Centres website.

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