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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 (Text with EEA relevance. )

Type Implementing Regulation

Publication 2017-12-15

State In force

Department European Commission, SANTE

Source EUR-Lex

Reform history JSON API

CHAPTER I

SUBJECT MATTER AND DEFINITIONS

Article 1

Subject matter

This Regulation lays down the technical standards for the establishment and operation of the traceability system provided for in Article 15 of Directive 2014/40/EU.

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:

(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.

CHAPTER II

TECHNICAL SPECIFICATIONS RELATED TO THE UNIQUE IDENTIFIER

SECTION 1

Common provisions

Article 3

ID issuer

Each Member State shall put in place adequate measures to ensure:

(a) that the ID issuer it has appointed continues to comply with the requirement of independence in accordance with Article 35; and

(b) the continuous operation of the services provided by successive ID issuers, in case a new ID issuer is appointed to take over the services from the previous ID issuer. For this purpose Member States shall require the ID issuer to develop an exit plan laying down the procedure to be followed to guarantee the continuity of the operations until the new ID issuer is appointed.

Article 4

Competent ID issuers for generating and issuing unique identifiers

By derogation to the first subparagraph, the competent ID issuer shall be the entity appointed for the Member State on whose market the products are placed, where such a requirement is imposed by that Member State.

Article 5

Validity of unique identifiers and deactivation

SECTION 2

Unique identifiers at unit packet level

Article 6

Marking by means of unit level UIs

Article 7

Verification of unit level UIs

By way of derogation from paragraphs 2, 4 and 5, the obligation to install an anti-tampering device shall not apply:

(a) until 20 May 2020 to production processes operated by economic operators, or where applicable, the group of undertakings to which they belong, that handled less than 120 million unit level UIs at Union level during the calendar year 2019;

(b) until 20 May 2021 to production processes operated by economic operators falling under the definition of small and medium enterprises set out in Commission Recommendation 2003/361/EC (¹);

Article 8

Structure of unit level UIs

Each unit packet of tobacco products shall be marked with a unit level UI. It shall consist of as short a sequence of alphanumeric characters as possible, not exceeding 50 characters. The sequence shall be unique to a given unit packet and shall be composed of the following data elements:

(a) in the first position, the alphanumeric characters that constitute the ID issuer identification code assigned pursuant to Article 3(4);

(b) an alphanumeric sequence, whose probability to be guessed shall be negligible and in any case lower than one in ten thousand (‘serial number’);

(c) a code (‘product code’) allowing for the determination of the following: i. the place of manufacturing; ii. the manufacturing facility referred to in Article 16; iii. the machine used to manufacture the tobacco products referred to in Article 18; iv. the product description; v. the intended market of retail sale; vi. the intended shipment route; vii. where applicable, the importer into the Union;

(d) in the last position, the time stamp in the form of a numeric sequence of eight characters, in the format YYMMDDhh, indicating the date and time of manufacture.

ID issuers shall prepare and make publicly available instructions for encoding and decoding unit level UIs in accordance with Annex III.

Where ID issuers use encryption or compression for the generation of unit level UIs, they shall inform the competent authorities of the Member States and the Commission of algorithms used for such encryption and compression. Unit level UIs shall not be reused.

Article 9

Request and issuing of unit level UIs

The ID issuer shall, within two working days from the receipt of the request and in the order indicated:

(a) generate the codes referred to in Article 8(2) and the corresponding human-readable codes referred to in Article 23;

(b) transmit both sets of codes along with the information referred to in paragraph 2 via the router to the primary repository of the requesting manufacturer or importer, as established under Article 26; and

However, a Member State may require ID issuers to offer physical delivery of unit level UIs as an alternative to electronic delivery. In cases where physical delivery of unit level UIs is offered, manufacturers and importers shall specify whether physical delivery is requested. In that case, the ID issuer shall within 10 working days from the receipt of the request, and in the following order:

(a) generate the codes referred to in Article 8(2) and the corresponding human-readable codes referred to in Article 23;

(d) deliver both sets of codes to the requesting manufacturer or importer in the form of optical barcodes, compliant with Article 21, placed on physical carriers, such as adhesive labels.

SECTION 3

Unique identifiers at aggregated packaging level

Article 10

Marking by means of aggregated level UIs

Article 11

Structure of aggregated level UIs generated by ID issuers

For aggregated level UI generated on the basis of a request to the competent ID issuer, the structure of the aggregated level UI shall consist of a sequence of a maximum of 100 alphanumeric characters that is unique to a given aggregated package and shall be composed of the following data elements:

(a) in the first position, the alphanumeric characters that constitute the ID issuer identification code assigned under Article 3(4);

(b) an alphanumeric sequence, whose probability to be guessed shall be negligible and in any case lower than one in ten thousand (‘serial number’);

(d) in the last position, the time stamp in the form of a numeric sequence of eight characters, in the format YYMMDDhh, indicating the date and time of aggregation.

ID issuers shall prepare and make publicly available instructions for encoding and decoding aggregated level UIs.

Article 12

Link between UI levels

Article 13

Request and issuing of aggregated level UIs generated by ID issuers

For manufacturers and importers, the ID issuer shall, within two working days from the receipt of the request and in the order indicated:

(a) generate the code referred to in Article 11(2);

(b) transmit the codes along with the information referred to in paragraph 2 via the router to the primary repository of the requesting manufacturer or importer, as established under Article 26; and

For economic operators other than manufacturers and importers, the ID issuer shall, within two working days from the receipt of the request and in the order indicated:

(a) generate the code referred to in Article 11(2);

(b) transmit the codes along with the information referred to in paragraph 2 via the router to the secondary repository established under Article 27; and

CHAPTER III

IDENTIFIER CODES FOR ECONOMIC OPERATORS, FACILITIES AND MACHINES

Article 14

Request for an economic operator identifier code

Economic operators managing standalone warehouses that are not based in the Union and that handle products manufactured in the Union and destined for the Union markets in transit through third countries may apply for an economic operator identifier code from the ID issuer competent for the Member State on whose market most of the products handled by these economic operators are placed.

The de-registration of an economic operator identifier code shall lead to the automatic de-registration of related facility identifier codes and machine identifier codes by the ID issuer.

Article 15

Issuing and registration of economic operator identifier codes

Upon receipt of a request pursuant to Article 14, the ID issuer shall generate an economic operator identifier code, which consists of the following data elements, to be placed in the following order:

(a) in the first position, the alphanumeric characters that constitute the ID issuer identification code assigned under Article 3(4); and

(b) in the second position, an alphanumeric sequence which is unique within the code pool of the ID issuer.

If the requesting operator is a manufacturer or an importer, it shall, within two working days from receiving the code, further transmit the code along with the information on its primary repository established in accordance with Article 26 to the operator of the secondary repository.

Article 16

Request for a facility identifier code

By way of derogation from the first subparagraph, a first retail outlet that is integrated into a non-retail type of facility shall be identified with a separate facility identifier code that corresponds to its function.

Economic operators managing standalone warehouses that are not based in the Union and that handle products manufactured in the Union and destined for the Union markets in transit through third countries may apply for a facility identifier code for a standalone warehouse that is located in a third country from the ID issuer competent for the Member State on whose market most of the products handled by these economic operators are placed. To this end, they shall provide to the ID issuer the information listed in point 1.4 of Section 1 of Chapter II of Annex II, in the format indicated therein.

The de-registration of a facility identifier code shall lead to the automatic de-registration of related machine identifier codes by the ID issuer.

Article 17

Issuing and registration of facility identifier codes

Upon receipt of a request pursuant to Article 16, the ID issuer shall generate a facility identifier code, which consists of the following data elements, to be placed in the following order:

(a) in the first position, the alphanumeric characters that constitute the ID issuer identification code assigned under Article 3(4); and

(b) in the second position, an alphanumeric sequence which is unique within the code pool of the ID issuer.

Article 18

Request for a machine identifier code

Manufacturers and importers shall carry out all necessary modifications of the information submitted in the initial application forms in order to provide the necessary information on machine parts which require a machine identifier code by 20 May 2024. The modifications shall take place in the format indicated in point 1.8 of Section 1 of Chapter II of Annex II. This requirement shall also apply to the information on machines containing no separately identifiable machine parts.

Article 19

Issuing and registration of machine identifier codes

Upon receipt of a request pursuant to Article 18, the ID issuer shall generate a machine identifier code, which consists of the following data elements, to be placed in the indicated position:

(a) in the first position, the alphanumeric characters that constitute the ID issuer identification code assigned under Article 3(4); and

(b) in the second position, an alphanumeric sequence which is unique within the code pool of the ID issuer.

Article 20

Transfer of offline flat-files and registries

CHAPTER IV

DATA CARRIERS

Article 21

Data carriers for the Unique Identifiers

Unit level UIs shall be encoded using at least one of the following types of data carriers:

(a) an optical device-readable Data Matrix with error detection and correction equivalent to or higher than those of the Data Matrix ECC200. Barcodes conforming to ISO/IEC 16022:2006 shall be presumed to fulfil the requirements set out in this point;

(b) an optical device-readable QR Code with a recovery capacity of approximately 30 %. Barcodes conforming to ISO/IEC 18004:2015 with the error correction level H shall be presumed to fulfil the requirements set out in this point;

(c) an optical device-readable DotCode with the error detection and correction equivalent to or higher than those provided with the Reed-Solomon error correction algorithm with the number of check characters (NC) equal to three plus the number of data characters (ND) divided by two (NC = 3 + ND/2). Barcodes conforming to the ISS DotCode Symbology Specification published by the Association for Automatic Identification and Mobility (‘AIM’) (revision 3.0, August 2014) shall be presumed to fulfil the requirements set out in this point.

Aggregated level UIs shall be encoded by economic operators using at least one of the following types of data carriers:

(c) an optical device-readable Code 128 with the error detection equivalent to or higher than the one provided with the algorithm based on the even/odd — bar/space character parity and the check character. Barcodes conforming to ISO/IEC 15417:2007 shall be presumed to fulfil the requirements set out in this point.

In order to distinguish the data carriers referred to in paragraph 5 from any other data carrier placed on aggregated packaging, economic operators shall add the marking ‘EU TTT’ next to such data carriers.

Article 22

Quality of the optical data carriers

Article 23

Human-readable code

CHAPTER V

REPOSITORIES SYSTEM

Article 24

Components of the repositories system

The repositories system shall be composed of the following sub-systems:

(a) repositories which are established for the purpose of storing data relating to tobacco products of individual manufacturers and importers (‘primary repositories’);

(b) a repository which contains a copy of all data stored in the primary repositories system (‘secondary repository’);

Article 25

General characteristics of the repositories system

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