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

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: (1) “unique identifier” means the alphanumeric code enabling the identification of a unit pack or an aggregated packaging of tobacco products; (2) “economic operator” means any natural or legal person who is involved in the trade of tobacco products, including for export, from the manufacturer to the last economic operator before the first retail outlet; (3) “first retail outlet” means the facility where tobacco products are placed on the market for the first time, including vending machines used for the sale of tobacco products; (4) “export” means shipment from the Union to a third country; (5) “aggregated packaging” means any packaging containing more than one unit packet of tobacco products; (5a) “disaggregation of aggregated packaging” means any disassembly of aggregated packaging of tobacco products; (6) “facility” means any location, building, office or vending machine where tobacco products are manufactured, stored, logistically or financially handled or placed on the market; (7) “anti-tampering device” means the device allowing for the recording of the verification process following the application of each unit level unique identifier by means of a video or a log file, which once recorded cannot be further altered by an economic operator; (8) “offline flat-files” means the electronic files established and maintained by each ID issuer that contain data in a plain text format allowing for the extraction of information encoded in the unique identifiers (excluding the time stamp) used at the unit packet and aggregated packaging levels without accessing the repositories system; (9) “registry” means the record established and maintained by each ID issuer of all the identifier codes generated for economic operators, operators of first retail outlets, facilities and machines along with the corresponding information; (10) “data carrier” means a carrier representing data in a form readable with the aid of a device; (11) “machine” means assemblies of machinery that are used for the manufacture of tobacco products and are integral to the manufacturing process; (11a) “machine part” means any identifiable fixed or mobile part of a machine provided that such a part constitutes a complete module. A mobile part may be used for one or more machines simultaneously or interchangeably; (12) “time stamp” means the date and time of occurrence of a particular event recorded in UTC (Coordinated Universal Time) time in a prescribed format; (13) “primary repository” means a repository storing traceability data relating exclusively to the products of a given manufacturer or importer; (14) “secondary repository” means a repository containing a copy of all traceability data stored in the primary repositories; (15) “router” means a device established within the secondary repository that transfers data between different components of the repositories system; (16) “repositories system” means the system consisting of the primary repositories, the secondary repository and the router; (17) “common data dictionary” means a set of information describing the contents, format, and structure of a database and the relationship between its elements, used to control access to and manipulation of the databases common for all primary and secondary repositories; (18) “working day” means every day of work in the Member State for which the ID issuer is competent; (19) “trans-loading” means any transfer of tobacco products from one vehicle to another during which tobacco products do not enter and exit a facility; (20) “vending van” means a vehicle used for the delivery of tobacco products to multiple retail outlets in quantities that have not been predetermined in advance of the delivery; (21) “IT service provider” means a service provider that is tasked by an economic operator with transmitting information on product movements and transactional information to 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: (a) to the services rendered; and (b) to the amount of unit level UIs requested over a given period of time.

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.’.

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.’.

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.