Notification of herbal products for smoking
Pursuant to Article 11h of the Act on protection of health against the consequences of the consumption of tobacco and tobacco products the manufacturer or importer of herbal products for smoking shall submit to the President a list of all ingredients and the quantities used for the manufacture of these products, divided by brand and type.
The manufacturer or importer of herbal products for smoking shall inform the President if the composition of a product is modified in a way that affects the information.
This information shall be submitted to the President at least 6 months before the placing on the market of a new or modified herbal product for smoking.
The format for the submission and making available of information on herbal products for smoking 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.
Pursuant to Article 4 of the Act of 22 February 2019 on the amendment of the Act on protection of health against the consequences of the consumption of tobacco and tobacco products (Dz.U. of 2019, item 638), the information on herbal products for smoking submitted to the President of the Bureau for Chemical Substances before 19 April 2019 should have been submitted in accordance with the above format by 19 October 2019.
General information on how to submit information on the herbal tobacco products for smoking:
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:
- Download registration form (to download the file right-click and select “save link as”);
- Carefully read the instructions in the form;
- Complete the form;
- 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 during very busy periods 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:
- Using a Client/Stand-Alone application for companies who have basic IT solutions in place. Access is free of charge.
- 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:
- Technical problems should be notified at: SANTE-EUCEG-ITSUPPORT@ec.europa.eu (“print screens” of displayed errors can be attached);
- Information on other problems as well as questions can be sent to: SANTE-EU-CEG@ec.europa.eu.