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Bureau for Chemical Substance

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Notification of electronic cigarettes and refill containers

Notification of electronic cigarettes and refill containers

The detailed information on electronic cigarettes and refill containers 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 common format for the notification of electronic cigarettes and refill containers is laid down in the Commission Implementing Decision (EU) 2015/2183 of 24 November 2015 establishing a common format for the notification of electronic cigarettes and refill containers    (OJ L 309, 26.11.2015, p. 15).

The submission of the information by means of the 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 11b of the Act on protection of health against the consequences of the consumption of tobacco and tobacco products have been fulfilled.

Pursuant to Article 11b of the Act on protection of health against the consequences of the consumption of tobacco and tobacco products, electronic cigarettes and refill containers may be made available for the first time for further selling or made available for the first time with the purpose of placing on the market after the manufacturer or importer has submitted a notification and indicated a contact legal entity or natural person in the European Union.

If the manufacturer has not submitted the notification, every importer shall submit it prior to making available them for the first time for further selling or making available for the first time with the purpose of placing on the market.

Notifications shall be provided in electronic form to the President, at least 6 months prior to the intended availability.

The notification shall contain:

  1. name (of undertaking) and contact details of the manufacturer, a contact legal or natural person in the European Union and, if applicable, the importer;
  2. a list of all ingredients and emissions resulting from the use of, the product, by brand name and type, including quantities thereof;
  3. toxicological data regarding the product's ingredients and emissions, including when heated, referring in particular to their effects on the health of consumers when inhaled and taking into account, in particular, any addictive effect;
  4. information on the nicotine doses and uptake when consumed under normal or reasonably foreseeable conditions;
  5. a description of the components of the product, including, where applicable, the opening and refill mechanism;
  6. a description of the production process, including whether it involves series production, and the declaration on compliance of the production process of the electronic cigarettes or refill containers with requirements resulting from the act;
  7. a declaration of bearing full responsibility for the quality and safety of the electronic cigarette or refill container placed on the market and used under normal or reasonably foreseeable conditions;
  8. in the case of micro-, small-, and medium-sized enterprises – a declaration on meeting the criteria in accordance with Recommendation 2003/361/EC.

The notification of the electronic cigarettes and refill containers is subject to payment of a fee amounting to 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; 50 % of that fee – for medium-sized enterprises in the meaning of Recommendation 2003/361/EC or 30 % of that fee – for small and micro- enterprises in the meaning of Recommendation 2003/361/EC. The fee shall be paid by the manufacturer or importer into the bank account indicated by the President

Where the contact legal entity or natural person in the European Union has not been appointed or the fee has been unpaid, the President shall request to rectify these deficiencies within 30 days. If the deficiencies are not removed within the prescribed deadline, the notification shall be considered unsubmitted. The fee shall be reimbursed upon request.

Where the information, laid down in 2-5, is modified, the manufacturer or importer shall be obliged to make a new notification.

General information on how to submit information on the electronic cigarettes and refill containers:

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 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.

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 electronic cigarettes and refill containers, 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.

 

Submission of annual reports concerning electronic cigarettes and refill containers

The information concerning annual reports (including sales volumes) should be posted to EU-CEG or sent in an email to: salesvolume@chemikalia.gov.pl

The report should contain the sales volumes (a table) and a text file (information on the preferences of various consumer groups, including young people, non-smokers and the main types of current users, information on the mode of sale of the products, executive summaries of any market surveys carried out within the scope laid down in Article 11(d)(1–3) of the Act of  9 November 1995 on protection of health against the consequences of the consumption of tobacco and tobacco products (Dz. U. of 2019, item 2182), including an English translation thereof).

The following information can be useful for drafting the report:

Table:

Product ID No. – ID number of the product which corresponds with ID number of the notification submitted through EU-CEG.

Brand name – name of the brand which corresponds with brand name of the product notified through EU-EG.

Brand subtype name – name of the brand subtype which corresponds with brand subtype name of the product notified through EU-CEG.

*If several presentations have been added to the ID number, each should be listed in separate lines of the table.   

Product type – type of the product which corresponds with product type notified through EU-CEG.

Product package units – number of the product units sold in a packet e.g. 1, 3, 5

Total volume of e-liquid in one product unit in ml. – quantity of the liquid contained in one unit with the liquid (including the kit – total quantity), if the product does not contain any liquid, write “0”.

The number of devices in a kit  – e.g.:

• one kit with 1 device and 3 refill containers makes the value of 1
•   one kit with 2 devices makes the value of 2

The number of tanks with e-liquid in a kit  – e.g.

• one kit with 1 device and 3 refill containers makes the value of 3
• one kit with 2 devices with no tanks makes the value of 0

Sales volume (quantity of products sold) – number of products sold (if the products are sold individually – in pieces) or in kits (if a pack contains e.g. 3 e-liquids)

Year – sales year

(Example of the table is presented in the section materials at the end of the page)

Text document

Should contain:

– information on the preferences of various consumer groups, including young people, non-smokers and the main types of current users;

– information on the mode of sale of the products, e.g. retail, wholesale

Notes: regardless of the form of sale, the annual report shall contain information on the preferences of various consumer groups, including young people, non-smokers and the main types of current users.

– executive summaries of any market surveys carried out within the scope laid down in Article 11(d)(1–3) of the Act of  9 November 1995 on protection of health against the consequences of the consumption of tobacco and tobacco products (Dz. U. of 2019, item 2182), including an English translation thereof.

Information concerning nicotine (CAS 54-11-5, EC 200-193-3)

Nicotine is subject to the provisions of Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals. Nicotine is listed in Annex I, Part 2 of this regulation, in connection with the ban on its use in pesticides in the Union. Pursuant to the provisions of Regulation No 649/2012 export of chemicals listed in Annex I outside the Union is subject to prior submission of the export notification to the designated authority in the exporting country. Where these chemicals are imported there is no obligation to notify the import into the Union, however Regulation 649/2012 requires importers to submit to the national designated authority annual reports on the quantities of the chemicals imported into the Union. This obligation is binding irrespective of intended category of their use. More information: Export/Import – Reporting in accordance with Article 10 of Regulation No 649/2012 (see materials below)

Irrespective of the provisions of Regulation No 649/2012, placing nicotine on the market is subject to provisions of the Act of 25 February 2011 on the chemical substances and their mixtures (Dz. U. No 63(322), provisions of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (REACH), including, in particular, Article 6 concerning the obligation of registration, and provisions of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 (CLP) on classification, labelling and packaging. Pursuant to the provisions of CLP regulation, labelling of nicotine placed on the market in Poland shall be in Polish.

Moreover, if liquids containing nicotine are classified as hazardous, pursuant to Article 15 of the Act of 25 February 2011 on the chemical substances and their mixtures (63(322)), the President of the Bureau for Chemical Substances shall be informed of the import (or manufacture) of such mixtures through submission of safety data sheet thereof. More information on how to complete this notification is available on the website of the Bureau for Chemical Substances.

Changes to classification and labelling of nicotine should also be emphasised. Since 1 December 2018 a new harmonised classification of nicotine has been binding pursuant to the amendment implemented through Regulation of the Commission (UE) 2017/776 of 4 May 2017. In order to facilitate classification of mixtures under acute toxicity class, acute toxicity estimate values (ATE) have been introduced in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for three routes of exposure respectively.

Harmonised classification of nicotine until 30 November 2018:

  Classification  

Labelling

Acute Tox. 1; H310

H310

Acute Tox. 3 (*); H301

H301

Aquatic Chronic 2; H411

H411

 

GHS06; GHS09, Dgr

Harmonised classification of nicotine mandatory from 1 December 2018 (substances and mixtures can be classified from May 2017):

  Classification

Labelling

ATE Values

Acute Tox. 2; H330

H330

inhalation: ATE = 0,19 mg/L (dusts or mists)

Acute Tox. 2; H310

H310

dermal: ATE = 70 mg/kg

Acute Tox. 2; H300

H300

oral: ATE = 5 mg/kg

Aquatic Chronic 2; H411

H411

 

 

GHS06, GHS09, Dgr

 

Materials

OBLIGATION TO SUBMIT INFORMATION ON THE QUANTITY OF NICOTINE IMPORTS OR EXPORTS

 

Withdrawal from the market

If you are intending to withdraw a product from the market, you are kindly requested to update the notification in EU-CEG in the tab Product presentation in Withdrawal date. It is especially important in case of tobacco products since this information, inter alia, provides a basis for issuing the annual request for payment.

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