- What is the EU-CEG?
- Which entities are obliged to use the EU-CEG?
- Information on which types of products can be sent to the EU-CEG?
- What does a submitter have to do in order to use the EU-CEG?
- What are technical options for submitting the data to the EU-CEG?
What is the EU-CEG?
EU-CEG stands for the EU common entry gate. It is an IT tool designed to ensure uniform reporting of information on tobacco products and notification of information on electronic cigarettes and refill containers.
The reporting and notification obligations follow from Articles 5(5) and 20(13) the Tobacco Products Directive (2014/40/EU). The specific rules on common electronic formats have been established by Commission Implementing Decision (EU) 2015/2186 for tobacco products and Commission Implementing Decision (EU) 2015/2183 for electronic cigarettes and refill containers.
Member States are also free to make the EU-CEG available for submissions relating to the notification of novel tobacco products, the reporting of herbal products for smoking, nicotine-free electronic cigarettes and other relevant information.
Which entities are obliged to use the EU-CEG?
The Tobacco Products Directive (2014/40/EU) requires manufacturers and importers of tobacco products and related products, including electronic cigarettes and refill containers, to submit key information on their products to the competent authorities of Member States in which they intend to place these products on the market.
The Directive defines:
- 'manufacturer' as any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under their name or trademark; and
- ‘importer of tobacco or related products’ as the owner of, or a person having the right of disposal over, tobacco or related products that have been brought into the territory of the Union.
The Directive also stipulates (in Article 23) that the responsibility shall lie with:
- primarily the manufacturer, if the manufacturer is established in the Union;
- primarily the importer, if the manufacturer is established outside the Union and the importer is established inside the Union;
- jointly the manufacturer and the importer if both are established outside the Union.
Information on which types of products can be sent to the EU-CEG?
The EU-CEG can be used for submitting information on the following types of products:
- Tobacco products [including novel tobacco products];
- Electronic cigarettes/refill containers/related products;
- Herbal products [where applicable].
What does a submitter have to do in order to use the EU-CEG?
The EU-CEG is only accessible for companies with a Submitter ID. Therefore, before any submission can take place, a submitter must obtain a Submitter ID. Submissions also require that at least one of two possible modes of sending the data is put in place.
What are technical options for submitting the data to the EU-CEG?
Product data can be submitted to the EU-CEG system using either the standalone (offered for free by the Commission) or the system-to-system solution.
The standalone option consists of two components. First, a free XML creator that can be installed on a local computer (multiple operating systems are supported). The creator provides a graphical user interface that allows companies to create their notification in the form of one or more XML files. In the second step, the created XML file(s) have to be uploaded via a dedicated online web-interface (GUI) to the EU-CEG. The uploading process requires an ECAS account for authentication purposes.
The system-to-system solution for submitting notifications uses the AS4 protocol for document exchange. The document structure is described in the technical documents available at the European Commission's online library CircaBC. The Commission offers a reference implementation of the AS4 access point called Domibus, which is part of eDelivery in the CEF programme. Domibus is open-source software, but stakeholders are free to choose any other AS4 compliant access point if they wish so.
The EU-CEG reporting tool
- What is the scope and format of data to be provided via the EU-CEG?
- What happens with the data sent to the EU-CEG?
- How is the privacy of data protected?
- How is the confidentiality of data protected?
What is the scope and format of data to be provided via the EU-CEG?
The precise scope and format of data to be provided via the EU-CEG is defined in the Annexes to Commission Implementing Decision (EU) 2015/2186 for tobacco products and Commission Implementing Decision (EU) 2015/2183 for electronic cigarettes and refill containers.
For products that are not covered by the Commission Implementing Decisions, submitters are encouraged to apply the two existing data formats on a "best-fit" basis, e.g. the format provided for in the Annex to Commission Implementing Decision (EU) 2015/2186 for herbal products and the format provided for in the Annex to Commission Implementing Decision (EU) 2015/2183 for products related to electronic cigarettes (such as nicotine-free electronic cigarettes, where applicable).
What happens with the data sent to the EU-CEG?
The EU-CEG performs a technical validation on the submitted data. If the technical validation process is successful, the data are directed to the relevant national data repository. The data then become accessible for the relevant competent national authority. If the technical validation process fails, the EU-CEG will send an error message to the submitter concerned. For more information please consult the EU-CEG technical documentation downloadable from CircaBC.
How is the privacy of data protected?
The information received through the EU-CEG will be treated in accordance with Regulation 45/2001 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies (please consult the privacy statement).
Please note that if data relate to non-users (e.g. when a data submission is done by an EU importer and contains information on a third-country manufacturer), the submitter of such data is obliged to forward the privacy statement to the affected non-users as well as to indicate to them the relevant data uploaded in the submission.
How is the confidentiality of data protected?
As part of the submission procedure, submitters have the possibility to indicate the status (confidential / non-confidential) of all submitted data fields. However, it is ultimately left to Member States to decide whether or not such claims are valid, and to ensure national rules for confidential treatment of trade secrets are applied.
In this regard, it should be noted that Recital 10 of Commission Decision (EU) 2015/2186 (laying down the common format for reporting of tobacco products) and Recital 11 of Commission Decision (EU) 2015/2183 (laying down the common format for notification of electronic cigarettes and refill containers) set out that "the legitimate expectation of consumers to have access to adequate information on the content of products they intend to consume should be weighed against manufacturers' interests of protecting recipes of their products. Having regard to those competing interests, data that could reveal ingredients used in small quantities in specific products should, in principle, be kept confidential".
In addition, Articles 6(2) of Commission Decision (EU) 2015/2186 and of Commission Decision (EU) 2015/2183 set out the information that, in principle, will not be considered by the Commission to be confidential or to amount to a trade secret.
Each of the two options has its pros and cons. While the standalone option involves very limited initial investment in terms of the IT effort, it requires the manual entry of data. The system-to-system option represents the opposite trade-off. It makes possible to automate the submission process, but it first requires integrating the AS4 access point into the existing company information system(s) that store the necessary data. It is for each submitter to decide which method is more suitable to their needs and circumstances. Note that it is also technically feasible to use both options interchangeably.
- How can a submitter obtain a Submitter ID?
- What type of entities are required to obtain a Submitter ID?
- Do third parties (enterers, consultancies, etc.) submitting product data on behalf of manufacturers/importers require their own Submitter ID?
- What is an ECAS account? In which cases does a submitter need an ECAS account?
- How will the identity of my company be verified?
- Does a submitter need multiple submitter IDs if its company is active on more than one area of activity covered by the EU-CEG?
- Can a submitter outsource the submission of its data to a third party?
- Can a parent company submit data on behalf of its affiliates?
- My company has appointed a third party to submit data on our behalf. Who is responsible for the data submitted?
- I cannot open the PDF application form which is needed to apply for a Submitter ID.
How can a submitter obtain a Submitter ID?
To obtain a Submitter ID, a submitter must fill in a request form (to download the file, click the right mouse button and select 'save the link as') and send it to the Commission. All necessary instructions can be found in the request form. Upon receipt of a completed request form, the Commission will assign a Submitter ID. It 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.
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.
What type of entities are required to obtain a Submitter ID?
Only manufacturers and/or importers of tobacco and/or e-cigarette products are required to obtain a Submitter ID in order to submit their product data via the EU CEG. Other entities or persons (enterers, consultancies, etc.), including companies whose activities do not relate to the production and/or import of tobacco and/or cigarette products, are not required to register for a Submitter ID.
Do third parties (enterers, consultancies, etc.) submitting product data on behalf of manufacturers/importers require their own Submitter ID?
Third parties, who intend to submit product data on behalf of a manufacturer and/or importer, are not required to have their own Submitter ID in order to do so. In all circumstances, the information provided on the application form should relate to the respective manufacturer or importer.
What is an ECAS account? In which cases does a submitter need an ECAS account?
ECAS refers to the European Commission Authentication Service.
For users opting for the standalone application, an ECAS account is necessary in order to apply for a submitter ID. It will further be used for authentication purposes in the submission procedure.
For more information on how to set up an ECAS account
How will the identity of my company be verified?
The identity of your company will be verified on the basis of the information provided in your request for submitter ID. Please note that, in some cases, it might not be possible to verify the identity of an entity solely based on the information in the mandatory fields of the application form. Therefore, you are encouraged to fill in all the fields in the form, including non-mandatory ones. You are also strongly encouraged to upload any documents (e.g. extracts from relevant registries) which can facilitate verification (page 3 in the request form). Files to be attached should have one of the formats listed here: jpg, jpeg, tiff, tif, xls, xlsx, doc, docx, ppt, pptx, bmp, png, pdf, txt.
Does a submitter need multiple submitter IDs if its company is active on more than one area of activity covered by the EU-CEG?
No, a submitter only has to apply one time for a submitter ID and may use its ID for any future submission of data related to any type of product. This being said, a submitter should indicate all its areas of activity in its request for submitter ID.
Can a submitter outsource the submission of its data to a third party?
Yes, it is possible for third parties to submit the data on your behalf. In the EU-CEG system, such a third party is called "enterer". It is for a submitter to manage the access rights to the EU-CEG for its enterer(s).
If an enterer wants to use the standalone application, it is required to sign-up for a separate ECAS account. Subsequently, a submitter has to authorise such an enterer using its own (i.e. the submitter's) ECAS account, i.e. grant a given enterer rights to upload notifications on submitter's behalf.
If an enterer wants to use the system-to-system solution, a submitter has to give its authentication certificate to such an enterer.
Finally, please note that the format of electronic submission includes a field titled "Submitter_Appoints_Enterer" that has to be ticked in case a submitter decides to appoint a third party ("enterer") to submit data on its behalf.
Can a parent company submit data on behalf of its affiliates?
Yes. In the case of parent and affiliate companies, the EU-CEG system has been designed in such a way as to allow for the possibility of a parent company to take the lead in submitting information on all the products it places on the market (including those of its affiliates) using its own Submitter ID, and to indicate in the relevant fields the details of its affiliate companies and of the various formats/presentations that the product is marketed in.
The parent company (or a single entity within the group of undertakings) is also strongly recommended, to take the lead in submitting information on all the products it places on the market (including those of its affiliates), using its own Submitter ID, and indicating in the relevant fields the details of the affiliate companies and of the various formats/presentations that the product in question is marketed in.
Should this not be the method chosen amongst parent/affiliate companies to submit data, the implementing decisions require that, for each product, submitters should indicate the TP-IDs/EC-IDs of all products with same design and composition known to the submitter.
My company has appointed a third party to submit data on our behalf. Who is responsible for the data submitted?
In cases where a submitter appoints a third party to submit data on its behalf, a submitter nevertheless remains responsible both for the general obligation to submit notifications as well as the accuracy of the data contained therein (see Art. 23(1) of Directive 2014/40/EU).
I cannot open the PDF application form which is needed to apply for a Submitter ID.
PDF files often cannot be opened from within the internet browser window (e.g. Chrome, Firefox, Internet Explorer). Therefore, please make sure that you download the PDF application form onto your computer first. Then open the form on your computer locally (e.g. Windows Explorer). Should you continue to face problems in opening the file, please consult the EU-CEG IT Support Team (SANTE-EUCEG-ITSUPPORT@ec.europa.eu).
Submission procedure (general)
- What is the link between a Submitter ID and a Product ID?
- Is it possible with a single access point (under the system-to-system solution) to submit data on behalf of multiple submitter IDs?
- Is it possible to make test submissions before an actual notification is sent to the EU-CEG?
- How can I tell that my submission has been successful?
- I intend to submit products that have very similar characteristics (e.g. ingredients). Is there are possibility to copy product data from one XML submission file into another file so that I do not again have to fill in all data?
What is the link between a Submitter ID and a Product ID?
A Submitter ID forms the basis for Product IDs to be assigned by a given submitter to each of its products.
The format of a Product ID is 'submitter ID-year-product number' (NNNNN-NN-NNNNN), where 'year' is a year within which data on a given product were submitted for the first time (2 digits), and 'product number' is a number attributed by a submitter to that product when submitting data for the first time.
Is it possible with a single access point (under the system-to-system solution) to submit data on behalf of multiple submitter IDs?
eDelivery provides a reference implementation for the AS4 access point called Domibus. The current version of Domibus (version 3.1) only supports one authentication certificate at a time. Since a submitter ID can be only linked to one certificate, it also means that in the Domibus implementation one access point is effectively restricted to one submitter ID.
In order to submit for multiple submitter IDs either multiple Domibus instances or reconfiguring of Domibus with another certificate before submitting is required. Note, however, that apart from Domibus there are other AS4 implementations which might support multiple certificates. Also, the next Domibus version is likely to support multiple certificates (the release date has not been confirmed yet).
Is it possible to make test submissions before an actual notification is sent to the EU-CEG?
The EU-CEG is available in two environments: acceptance and production. The acceptance environment provides for a possibility of carrying out necessary technical tests before sending an actual notification to the EU-CEG's production environment. Please note that any submissions made in the acceptance environment are considered to have been carried out for test purposes and cannot be regarded as formal notifications.
Further information on the two environments can be found in the technical documentation made available in CircaBC.
How can I tell that my submission has been successful?
The EU-CEG generates success/error messages as a part of the data validation process. Specific error codes are provided in the technical documentation made available in CircaBC.
I intend to submit products that have very similar characteristics (e.g. ingredients). Is there are possibility to copy product data from one XML submission file into another file so that I do not again have to fill in all data?
There exists a technical workaround that allows submitters to copy product information from one XML file to another XML file. For a detailed description, please view this manual.
(Note: This is not an official function of the XML creator and therefore the European Commission does not take any responsibility should data be lost or alternated in any way in the process)
Submission procedure (technical)
- Where can the technical documentation be found?
- What is eDelivery? What is required to use eDelivery?
- Is it possible to use the standalone application for the purpose of submitting updated product information (in the form of XML information files and other attachments) via the eDelivery mechanism?
- Can a submitter install the standalone client on several computers?
- Where / how can I upload my product information if I use the standalone application (XML Creator Tool) ?
Where can the technical documentation be found?
The technical documentation, along with any subsequent updates, is published in CircaBC. You can download the documents from the following links:
Please note that you will need to obtain an ECAS [European Commission Authentication Service] username and password in order to connect to CircaBC.
What is eDelivery? What is required to use eDelivery?
eDelivery is a document exchange network. Users gain access to this secure network through access points, which communicate with each other using a standard protocol, AS4, for message exchanges. eDelivery provides a reference implementation for the AS4 access point called Domibus.
The relevant technical documentation can be downloaded from CircaBC.
Is it possible to use the standalone application for the purpose of submitting updated product information (in the form of XML information files and other attachments) via the eDelivery mechanism?
The standalone client contains the option to create XML files. If a submitter has an eDelivery access point at its disposal, this may also be used to submit the XML files created with the standalone client.
Can a submitter install the standalone client on several computers?
Yes, installation on several computers is possible. Note, however, that the information is only saved locally (unless a network drive is used) and information saved in the standalone client on one computer will not be automatically accessible from other computers.
Where / how can I upload my product information if I use the standalone application (XML Creator Tool) ?
All product information must be uploaded in the form of XML files through the eTrustEx platform for DG SANTE.
What type of ID should be used for 'herbal products for smoking' and for 'nicotine-free' products?
The acquisition of a submitter ID by importers/manufactures follows a unified procedure which is independent of the type of product concerned. Accordingly, manufactures/importers of tobacco products, e-cigarettes or other products (herbal products, nicotine-free products) need to apply for a submitter ID in the same manner. Please note that a submitter only has to apply one time for a submitter ID and may use its ID for any future submission of data related to any type of product.
The submitter ID will form the basis for the product IDs to be assigned by the submitter to each of its products. For tobacco products this product ID is known as a "TP-ID", while for e-cigarettes it is known as an "EC-ID". Both herbal and nicotine-free products will be allocated an "other products ID".
The format of the product ID should be ‘submitter ID-year-product number’ (NNNNN-NN- NNNNN), where ‘year’ is the year within which data on the product were submitted for the first time (2 digits), and ‘product number’ is the number attributed by the submitter to the product when submitting data for the first time.
- Are there registration fees or any other fees applicable to companies that use the EU-CEG?
- I do not find the response to my question on this list. Whom should I contact to obtain the response?
Are there registration fees or any other fees applicable to companies that use the EU-CEG?
The Commission does not apply any fees to companies for the use of the EU-CEG. The TPD sets out, however, that Member States may charge proportionate fees for receiving, storing, handling and analysing the information submitted.
I do not find the response to my question on this list. Whom should I contact to obtain the response?
In case of additional questions, please contact one of the following functional mailboxes:
SANTE-SUBID-EUCEG@ec.europa.eu – for issues relating to your request for a Submitter ID;
SANTE-EUCEG-ITSUPPORT@ec.europa.eu – for IT support to assist with technical questions related to fulfilling any legal obligations under the TPD;
SANTE-EU-CEG@ec.europa.eu – for non-technical matters related to the functioning of the EU-CEG.