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Document 32023R0448
Commission Implementing Regulation (EU) 2023/448 of 1 March 2023 amending Implementing Regulation (EU) 2018/574 on technical standards for the establishment and operation of a traceability system for tobacco products
Commission Implementing Regulation (EU) 2023/448 of 1 March 2023 amending Implementing Regulation (EU) 2018/574 on technical standards for the establishment and operation of a traceability system for tobacco products
Commission Implementing Regulation (EU) 2023/448 of 1 March 2023 amending Implementing Regulation (EU) 2018/574 on technical standards for the establishment and operation of a traceability system for tobacco products
C/2023/1310
OJ L 65, 2.3.2023, p. 28–57
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
2.3.2023 |
EN |
Official Journal of the European Union |
L 65/28 |
COMMISSION IMPLEMENTING REGULATION (EU) 2023/448
of 1 March 2023
amending Implementing Regulation (EU) 2018/574 on technical standards for the establishment and operation of a traceability system for tobacco products
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (1), and in particular Article 15(11) thereof,
Whereas:
(1) |
Commission Implementing Regulation (EU) 2018/574 (2) sets out the rules for the establishment and operation of a traceability system for tobacco products. The traceability system aims to provide Member States and the Commission with an effective tool that enables the tracking and tracing of tobacco products throughout the Union and the identification of fraudulent activities that result in illicit products being available to consumers. |
(2) |
In this regard, the operational rules of the traceability system play an important role in ensuring that the Commission and the Member States receive the data they need in order to ensure the proper functioning of the tobacco traceability system and control of the application of the tobacco traceability legislation as well as enforce this legislation respectively. |
(3) |
The traceability system established in accordance with Implementing Regulation (EU) 2018/574 started collecting data on tobacco products’ movements and transactional data on 20 May 2019. Experience in its implementation has further demonstrated the importance of high quality, accuracy, completeness and comparability of the data that need to be recorded and transmitted to the system in a timely manner. |
(4) |
In its report on the application of Directive 2014/40/EU of 20 May 2021 (3), the Commission stressed that the Member States and the Commission had considerable problems with the quality of traceability data, for example in relation to value added tax numbers, information on production machines or information on last movements of products to retail outlets. In particular, the current definition of machines should be amended to reflect the various machines’ configurations adopted in the sector and address the observed bad quality of information on machines. The report also concluded that data quality remains critical for enforcing the tobacco traceability legislation and for fully attaining the traceability system’s objectives. |
(5) |
The discussions between the Commission and the Member States taking place on a regular basis in the framework of the Expert Subgroup on Traceability and Security Features have further demonstrated that only robust, complete and good-quality data can ensure a fully functional and successful traceability system. For the monitoring and use of these data, the Member States and the Commission need to be equipped with effective analytical tools and technical solutions, in particular necessary interfaces that enable them to access and query the data stored in the repositories system. |
(6) |
Based on the gathered experience and knowledge, there is a need to amend certain technical rules laid down by Implementing Regulation (EU) 2018/574 in order to facilitate the reporting by all actors involved in the trade of tobacco products, reinforce the good practices in terms of data management and analysis, and consequently, improve the functioning of the traceability system for tobacco products. These technical rules concern the operation of the various components of the repositories system, the tasks of and the procedures to be followed by the ID issuers as well as the reporting activities of the economic operators and the technical tools available to the Member States in the context of their enforcement duties, in particular all access interfaces including for mobile inspections. |
(7) |
The amendments address a number of exceptions and special cases that were encountered after the launch of the traceability system, including the presence of economic operators solely involved in non-logistic trading operations, the involvement of non-EU entities in the EU supply chain, the existence of facilities combining non-retail and retail functions, cases of lost identifiers, cases of recovery of stolen goods, IT incidents necessitating data reprocessing, and the presence of atypical non-trade destinations such as laboratories or waste disposal centres. The actual operations of the traceability system also helped obtain a better picture of the size of data sets stored and processed in the repositories system, which in turn necessitates certain changes to the rules concerning the possibilities and characteristics of the repositories system and the tasks of the provider of the secondary repository. |
(8) |
Annex I to Implementing Regulation (EU) 2018/574 sets out the procedures for selecting the primary and secondary repositories’ operators. To ensure consistency in the manner in which notifications of the identity of the proposed provider are submitted to the Commission by group of undertakings, and by importers and non-Union manufacturers, and the relevant data storage contracts are signed, it is appropriate to further clarify certain rules on the submission of notifications and the signature of data storage contracts. In addition, given the fact that the extension of the tobacco traceability system to all tobacco products that is foreseen by Article 15(13) of Directive 2014/40/EU, may increase the number of these notifications and data storage contracts, it is also necessary to lay down further details of the procedure for the approval of amendments to the key elements of data storage contracts, including the explicit possibility for the Commission to tacitly approve such amendments. |
(9) |
It is also appropriate to amend the period within which the contracts between each primary repository provider and the provider of the secondary repository shall be signed and submitted to the Commission to ensure that these entities have sufficient time to comply with their obligations. With regard to the requirements that apply to the procedure concerning the termination of the contractual relationship between the Commission and the provider of the secondary repository, it is necessary to lay down further details on the notice period that needs to be respected by the provider of the secondary repository, so that business continuity and an uninterrupted flow of data are fully ensured in the system. |
(10) |
The Protocol to Eliminate Illicit Trade in Tobacco Products to the World Health Organisation’s Framework Convention on Tobacco Control (4), which provides for a package of measures to be taken by its Parties to eliminate the illicit trade in tobacco products entered into force on 25 September 2018. It is appropriate for the traceability system established in the EU to be up to date with the technical developments concerning the establishment of a global tracking and tracing regime. |
(11) |
Implementing Regulation (EU) 2018/574 should therefore be amended accordingly. |
(12) |
Some provisions of this Regulation should start to apply at a later date than its entry into force, in order to allow ID issuers as well as providers of repository services and of anti-tampering devices and other economic operators to prepare for the requirements introduced by these provisions. |
(13) |
The measures provided for in this Regulation are in accordance with the opinion of the Committee referred to in Article 25 of Directive 2014/40/EU, |
HAS ADOPTED THIS REGULATION:
Article 1
Implementing Regulation (EU) 2018/574 is amended as follows:
(1) |
Article 2 is replaced by the following: ‘Article 2 Definitions For the purposes of this Regulation, in addition to the definitions laid down in Article 2 of Directive 2014/40/EU, the following definitions shall apply:
|
(2) |
in Article 3, paragraph 9 is replaced by the following: ‘9. The ID issuer may establish and charge fees to economic operators for generating and issuing unique identifiers. Fees are to be non-discriminatory, cost-based and proportionate to the number of unique identifiers generated and issued to economic operators taking into account the mode of delivery. Fees may reflect all fixed and variable costs incurred by the ID issuer in meeting its requirements under this Regulation.’ |
(3) |
in Article 7, paragraph 2 is replaced by the following: ‘2. The process referred to in paragraph 1 shall be protected with an anti-tampering device supplied and installed by an independent third party who shall provide a declaration to the relevant Member States and the Commission that the installed device meets the requirements of this Regulation. The record generated by the device shall provide proof of correct application and readability of each unit level unique identifier. The device shall ensure that any omission in the marking process referred to in Article 6 is recorded.’ |
(4) |
in Article 8, paragraph 2 is replaced by the following: ‘2. ID issuers shall be responsible for the generation of a code consisting of the elements listed in paragraph 1, points (a), (b), and (c). ID issuers shall prepare and make publicly available instructions for encoding and decoding unit level UIs in accordance with Annex III.’ |
(5) |
Article 9 is amended as follows:
|
(6) |
in Article 11, paragraph 2 is replaced by the following: ‘2. ID issuers shall be responsible for the generation of a code consisting of the elements listed in paragraph 1, points (a), (b), and (c). ID issuers shall prepare and make publicly available instructions for encoding and decoding aggregated level UIs.’ |
(7) |
Article 14 is amended as follows:
|
(8) |
Article 15 is amended as follows:
|
(9) |
Article 16 is amended as follows:
|
(10) |
in Article 17, paragraph 3 is replaced by the following: ‘3. All the information submitted to the ID issuer in accordance with Article 16(2), and the corresponding identifier codes shall form part of a registry to be established, managed and kept up to date by the competent ID issuer. The competent ID issuer shall keep a record of the information stored in the register for as long as the traceability system is operational.’ |
(11) |
Article 18 is amended as follows:
|
(12) |
in Article 19, paragraph 3 is replaced by the following: ‘3. All the information submitted to the ID issuer in accordance with Article 18(2), and the corresponding identifier codes shall form part of a registry to be established, managed and kept up to date by the competent ID issuer. The competent ID issuer shall keep a record of the information stored in the register for as long as the traceability system is operational.’ |
(13) |
in Article 20, the following paragraph 5 is added: ‘5. ID issuers shall provide a secure online service for economic operators and operators of first retail outlets allowing them to consult the registries referred to in paragraph 1 as far as their own economic operator, facility and machine identifier codes are concerned. This service shall include a secure procedure for economic operators and operators of first retail outlets to reclaim their own economic operator identifier codes.’ |
(14) |
Article 21 is amended as follows:
|
(15) |
Article 25(1), point (g), is replaced by the following:
|
(16) |
Article 27 is amended as follows:
|
(17) |
Article 28 is amended as follows:
|
(18) |
In Article 29, the following paragraphs 5 and 6 are added: ‘5. Manufacturers and importers who doubt the correct functioning of their primary repositories shall have the possibility to verify against the router, by consulting the operator of the router, whether messages concerning the final dispatch of products out of their physical possession that are sent to the primary repositories, have been transmitted correctly. The operator of the router may set a daily limit on the use of this functionality. 6. The provider of the secondary repository shall establish and communicate to economic operators and IT service providers the terms and conditions, including the fair use policy, applicable to the use of the secondary repository and the router. The terms and conditions shall guarantee the right of economic operators to use the secondary repository and the router in line with their business needs and shall prevent repeated cases of negligent use.’. |
(19) |
Article 30 is replaced by the following: ‘Article 30 Costs of the repositories system 1. All ordinary costs related to the repositories system referred to in Article 24(1), including those that arise from its establishment, operation and maintenance, shall be borne by manufacturers and importers of tobacco products. Those costs shall be fair, reasonable, and proportionate:
2. The ordinary costs, as applicable, of establishing, operating and maintaining the secondary repository and the router shall be passed onto the manufacturers and importers of tobacco products through the costs charged to them by the providers of the primary repositories. 3. All extraordinary costs related to the reprocessing operations referred to in Article 28(4) charged by the provider of the secondary repository to the provider of the primary repository that made the request shall be fair, reasonable and proportionate to the services rendered. The provider of the secondary repository shall however itself bear any extraordinary costs of the reprocessing operations referred to in Article 28(4) to the extent that it is responsible for the causes leading to the reprocessing operations.’. |
(20) |
Article 32 is amended as follows:
|
(21) |
In Article 33, paragraph 3 is replaced by the following: ‘3. The responsibility for recording and transmitting the information referred to in paragraph 2 shall lie with the economic operator who is the vendor. To this end, all the reporting activities shall use the identifier code of this economic operator. IT service providers may also transmit this information on behalf of the economic operator who is the vendor of the tobacco products.’. |
(22) |
Article 34 is amended as follows:
|
(23) |
Article 36(1), point (a), is replaced by the following:
|
(24) |
The following Article 36a is inserted: ‘Article 36a Quality of data 1. The Member States may, issue reports on the inadequate quality of data reported by economic operators to the repositories system. These reports shall be addressed to the concerned economic operators and include examples of misreporting. 2. Member States shall require ID issuers to perform checks of addresses and other electronically verifiable data that are provided to the system by economic operators and operators of first retail outlets through ID issuers.’. |
(25) |
Annexes I and II are amended in accordance with the Annex to this Regulation. |
(26) |
Annex III is added in accordance with the Annex to this Regulation. |
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 1 shall apply from 21 December 2023.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 1 March 2023.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 127, 29.4.2014, p. 1.
(2) Commission Implementing Regulation (EU) 2018/574 of 15 December 2017 on technical standards for the establishment and operation of a traceability system for tobacco products (OJ L 96, 16.4.2018, p. 7).
(3) Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the application of Directive 2014/40/EU concerning the manufacture, presentation and sale of tobacco and related products, COM(2021) 249 final.
(4) Protocol to Eliminate Illicit Trade in Tobacco Products to the World Health Organisation’s Framework Convention on Tobacco Control (OJ L 268, 1.10.2016, p. 1).
ANNEX
Implementing Regulation (EU) 2018/574 is amended as follows:
(1) |
Annex I is amended as follows:
|
(2) |
Annex II is amended as follows:
|
(3) |
The following Annex III is added: ‘ANNEX III Structure of a unit-level unique identifier
|