The traceability system – this applies to tobacco manufacturers and importers
Manufacturers and importers of tobacco products are responsible for several vital parts of the traceability system, such as marking the products with unique identifiers. Manufacturers are also responsible for providing recording equipment to all economic operators involved in the trade of tobacco products.
Applying for identifier codes from the ID issuer
If you are a manufacturer or importer of tobacco products, you must apply for an economic operator identifier code from the competent ID issuer in each Member State where you operate at least one facility. As an importer, you must also apply for an identifier code from the competent ID issuer in each Member State where you release your goods.
If you have facilities in Sweden, you must apply for identifier codes from the national ID issuer in Sweden, All Soft Corp s.r.o.
Application for identifier codes
The application for identifier codes from the ID issuer, is made in two steps. You receive your identifier code as an economic operator by registration using the form available on the ID issuer's website. After this you can log into the ID issuer’s system to apply for identifier codes for facilities and machines.
For your facility where the manufacturing takes place, it is important that the facility type is stated as type "Manufacturing site with warehouse". If you also have storage facilities at another address, these must also have identifier codes, but with the facility type "Standalone warehouse".
If you are operating standalone warehouses that are not based in the EU, where products manufactured in the EU and destined for the Union markets are handled (so called transit through third countries), you may apply for identifier codes (economic operator and facility) from the ID issuer competent for the Member State on whose market most of the products handled are placed.
You must apply for machine identifier codes for the assemblies of machinery that are used for the manufacture of tobacco products and are integral to the manufacturing process. Any identifiable fixed or mobile part of a machine that constitutes a complete module must also be identified by a unique code (machine identifier code). A mobile part may be used for one or more machines simultaneously or interchangeably.
A manufacturing site can have several such assembled machines and machine parts, each machine must have its own identifier code, as must each machine part. See also section on anti-tampering devices.
For information on how to proceed, visit the ID issuer's website.
If there are any changes in the information provided in the application, or if your business ceases, you must report this to the ID issuer without delay.
If your business case to exist, the ID issuer shall de-register the economic operator identifier code. The de-registration of an economic operator identifier code results in an automatic de-registration of related facility identifier codes and machine identifier codes. The de-registration of a facility identifier codes results in an automatic de-registration of related machine identifier codes.
Unique identifiers for tobacco products
For the unit level tobacco products (cigarettes or rolling tobacco) you intend to make available in Sweden, you must apply for unit level UIs and corresponding human-readable codes from the Swedish ID issuer. You are responsible for attaching these UIs to the unit packets and to record and store all events related to your tobacco products in your primary repository.
In order to simplify the registration of the tobacco products, aggregated packages of tobacco products can be marked with unique identifiers on aggregated level. You can choose to create these aggregated identifier codes yourself or request for aggregated level unique identifiers from the competent ID issuers.
Each level of aggregation shall be recorded in the repository.
Only if an aggregated code is to be reused shall message 3.6 Disaggregation of aggregated level UIs, be sent to the repository system.
Traceability marking and security features on tobacco products
Fees for unique identifiers
The ID issuer may only charge fees for electronically delivered unique identifiers. The fee is laid down by the Government in Regulation (2019:224) on fees for unique identifiers on tobacco packages.
Regulation (2019:224) on fees for unique identifiers on tobacco packages (riksdagen.se) (In Swedish)
Anti-tampering devices
Immediately after unit level unique identifiers (UIs) are applied on the unit packets of tobacco product, you must verify that they are correctly applied and are readable. This process must be protected with an anti-tampering device, provided and installed by an independent third party.
If you are a manufacturer or importer of tobacco products other than cigarettes and rolling tobacco, this device must be installed by May 20, 2024 at the latest. For completely manual manufacturing processes, there is no obligation to install anti-tampering devices
The supplier of the anti-tampering device must submit a certificate to the Public Health Agency of Sweden and the European Commission, that states the supplier's independence in relation to the tobacco industry and that the installed device meets the requirements of implementing regulation 2018/574, and from 21 December 2023 the decided changes that follows the amending regulation 2023/448. The template for the certificate is available on the commission's website.
Systems for tobacco traceability and security features (health.ec.europa.eu)
The anti-tampering device must verify that the unit level UIs are applied correctly and are fully readable. The information must be registered either by video or a log file that cannot be changed by any economic operator.
If the device signals that the UI has been applied incorrectly or is not fully readable, you must reapply the UI.
The information registered by the anti-manipulation device must be available for nine (9) months after registration. Full access to the record must be provided to the Public Health Agency of Sweden if the authority so requests.
Primary repository
You, as a manufacturer or importer, are responsible for entering into an agreement with an independent third-party provider to establish a primary repository that exclusively host information related to your tobacco products. The agreement shall be in accordance with the contractual requirements specified in Commission Delegated Regulation (EU) 2018/573.
The selection of an independent third-party supplier shall be made in accordance with the rules of procedure set out in Part A of Annex I, Commission Implementing Regulation (EU) 2018/574 on technical standards for the establishment and operation of a traceability system for tobacco products, and from 21 December 2023 the decided changes that follows the amending regulation 2023/448.
If several legal persons constitute the same manufacturer or importer, the notification shall be submitted jointly by all legal persons.
In cases where the importer concerned cooperates with only one non-EU manufacturer or belongs to the same group of companies as the latter, the data storage contract may be co-signed by both the importer and the non-EU manufacturer. In cases where the importer concerned cooperates with several non-EU manufacturers or is also a Union manufacturer itself, the data storage contract shall be signed solely by the importer.
The agreement and the suitability of the third party shall be approved by the European Commission.
Any amendment to the key elements of the contract shall be subject to approval by the Commission and must be notified in advance.
Manufacturers and importers of tobacco products other than cigarettes and roll-your-own tobacco shall, no later than December 31 2022, notify the Commission of the identity of the proposed independent third-party provider and have the draft data storage agreements approved by the Commission.
Systems for tobacco traceability and security features (health.ec.europa.eu)
Data storage
The data storage facility for the primary repository must be physically located in the territory of the European Union. The agreement and the suitability of the third party shall be approved by the European Commission.
Independent auditor
You must appoint an independent auditor who checks that your data warehouse properly protects the data. The European Commission must approve the selected auditor. At the end of October each year, the auditor shall submit an audit report to the European Commission and the Public Health Agency of Sweden, covering the period from May 20 to May 19.
To support manufacturers in the selection of an independent auditor and for the auditors to fulfill their annual reporting obligations, the European Commission has published guidelines for the annual audit reports on its website.
Providing equipment
You who are a manufacturer of tobacco products must provide all economic operators involved in the trade in tobacco products with the equipment that is necessary for the recording of the tobacco products purchased, sold, stored, transported or otherwise handled. The equipment shall be able to read and transmit the recorded data electronically to the database system.
Those concerned are all economic operators from the manufacturer to the last economic operator before the first retail outlet, including importers, warehouses and transporting companies.
Registration of shipment, trans-loading and arrival
All actions and movements of a tobacco product shall be recorded in the database. This also applies to financial transactions.
It is important that events and transactions are reported in the correct order. The European Commission's website has a brochure that describes the most common errors and how to correct them. The brochure is also available in English.
EU System of Tobacco Traceability: Common reporting mistakes (ec.europa.eu)
If tobacco products are destroyed or stolen
If tobacco products are destroyed or stolen after the unit level UI has been applied to the unit pack, you as the manufacturer or importer must without delay, send a request for deactivation to the relevant primary database.
If tobacco products reported as stolen are recovered, you may transmit a reactivation request (message 2.4).
