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Tobacco e-cigarettes

Procedures of notifications

Submission of detailed information on tobacco and related products to competent authorities must be done electronically through the entry gate administered by the European Commission, common for all Member States.
 
ATTENTION!!!
 
For tobacco products
 
Submitting information via a common format established by Decision (EU) 2015/2186 of 25 November 2015, will be considered as an fulfillment of obligations under article 8a of the Act on Protection of Health against the Consequences of the Consumption of Tobacco and Tobacco Products (Journal of Laws 2016, item 1331). 
 
For electronic cigarettes and refill containers
 
Submitting information via a common format established by Decision (EU) 2015/2183 of 24 November 2015, will be considered as an fulfillment of obligations under article 11b of the Act on Protection of Health against the Consequences of the Consumption of Tobacco and Tobacco Products (Journal of Laws 2016, item 1331).
 
Below you can find general information about procedure of notification:
 
Firstly, you should create an ECAS account . This step is mandatory for submitters who intend to use the standalone application. ECAS is the European Commission Authentication Service. It allows users to access a wide range of Commission information systems, using a single username and password. 
 
Then in order to apply for a Submitter ID (only manufactures and/or importers are required to obtain a Submitter ID in order to submit product data through the EU-CEG), please follow the following steps:
  1. download the registration form (use Internet Explorer web browser);
  2. read carefully the instructions contained in the registration form;
  3. complete the registration form;
  4. submit the registration form.
Upon receipt of a completed request form, the Commission will begin the process of assigning a Submitter ID. The Commission reserves the right to revert to applicants should additional information be required, to withhold Submitter IDs pending further verification and to withdraw previously assigned Submitter IDs, should it deem necessary. What is more, the Commission will endeavour to complete the assignment process within as short a timeframe as possible. Please note, however, that the assignment of a Submitter ID does not take place instantaneously upon receipt of the form and that during peak requesting periods, additional processing time up to several days may be required. Please bear this in mind when submitting your request forms.
 
When you have got an individual Submitter ID, you can make a notification.
 
Below there is detailed information about Polish requirements in relation to notification procedure of each products:
 
Once a Submitter ID has been acquired, there will be two possible means of submitting reporting information to Member States via the EU-CEG:
  1. via a Client/Stand-Alone application (suitable for companies with smaller IT infrastructures). This is free of charge.
  2. system-to-system submissions (suitable for companies with larger IT infrastructures). Companies making system-to-system submissions will need to ensure access to the e-Delivery network, which is a network operated by the Commission and ensuring secure and reliable information transfer. More information you can find below:

https://joinup.ec.europa.eu/software/cipaedelivery/description

Technical documents of relevance for companies' IT preparations for EU-CEG submissions are regularly shared via CircaBC, a European Commission-led web-based application enabling groups to share information and resources. Please note you will need to obtain an ECAS in order to connect to CircaBC. Once you have established connection, you will find the documents at the following links:
 
After choosing one of the above categories, you will be directed in CircaBC. Then you should click:
 
  • Latest versions of technical documents, next click
  • XML submission through web interface and click
  • tpd-xml-creator-tool-1.2.3.zip
TPD-xml-creator–tool is a tool, which is used to create notifications of tobacco products and related products, that should be done to carry out obligations resulting from the Act
of 22 July 2016 on the Amendment of the Act on Protection of Health against the Consequences of the Consumption of Tobacco and Tobacco Products (Journal of Laws 2016, item 1331). 
 
For your information the creator „TPD-xml-creator–tool”, the EUCEG XML submission System (ETRUSTEX) and all guidebooks are available only in English language.
 
How to create a file of notification that should be submitted to the Inspector?
During the process of creation of the notification in TPD-xml-creator–tool in the folder „Product presentation” in the field „National market” after choosing „Poland”, the notification will be directed to the data base, which is available to Bureau for Chemical Substances. Correctly created and submitted notification will be considered as an fulfillment of obligations under the Act of 22 July 2016 on the Amendment of the Act on Protection of Health against the Consequences of the Consumption of Tobacco and Tobacco Products (Journal of Laws 2016, item 1331). 
How correctly submit a notification?
After creating notifications (in XML form) you should submit them using E-trustex system. A guidance on this procedure is in CircaBC. In CircaBC you should choose:
  • Latest versions of technical documents, next click
  • XML submission through web interface and click
  • ETRUSTEX_tutorial.pdf.
We also encourage all the producers and importers to read other documents, which are available in CircaBC.
 
We also remind about following decisions:
 
Commission’s Contacts 
  • Should you encounter technical difficulties when requesting a Submitter ID, please contact SANTE-EUCEG-ITSUPPORT@ec.europa.eu (including in your message a 'print screen' of the window where the problem appears and a copy of your registration form).
  • For other general matters related to the functioning of the EU-CEG, but not to your request, please contact SANTE-EU-CEG@ec.europa.eu.
All information above you can also find:
 
http://ec.europa.eu/health/euceg/#fragment0
 
http://ec.europa.eu/health/euceg/#fragment1
 

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