# Official Journal L 96/2018

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 96 |
| | |
| English edition | Legislation | Volume 6116 April 2018 |

ISSN 1977-0677

Official Journal

of the European Union

L 96

English edition

Legislation

Volume 6116 April 2018

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Delegated Regulation (EU) 2018/573 of 15 December 2017 on key elements of data storage contracts to be concluded as part of a traceability system for tobacco products (
  1
  ) | 1 |
| | * | 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 (
  1
  ) | 7 |
| | | DECISIONS |
| | * | Council Decision (EU) 2018/575 of 12 April 2018 appointing an alternate member, proposed by Malta, of the Committee of the Regions | 56 |
| | * | Commission Implementing Decision (EU) 2018/576 of 15 December 2017 on technical standards for security features applied to tobacco products
  (notified under document C(2017) 8435)

   (
  1
  ) | 57 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Delegated Regulation (EU) 2018/573 of 15 December 2017 on key elements of data storage contracts to be concluded as part of a traceability system for tobacco products (
  1
  )

1

1

*

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 (
  1
  )

1

7

DECISIONS

*

Council Decision (EU) 2018/575 of 12 April 2018 appointing an alternate member, proposed by Malta, of the Committee of the Regions

56

*

Commission Implementing Decision (EU) 2018/576 of 15 December 2017 on technical standards for security features applied to tobacco products
  (notified under document C(2017) 8435)

   (
  1
  )

(notified under document C(2017) 8435)

1

57

| | |
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| | (1)   Text with EEA relevance. |

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(1)   Text with EEA relevance.

1

| EN | Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.
  The titles of all other Acts are printed in bold type and preceded by an asterisk. |
| --- | --- |

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.

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II Non-legislative acts

REGULATIONS

| 16.4.2018 | EN | Official Journal of the European Union | L 96/1 |
| --- | --- | --- | --- |

16.4.2018

EN

Official Journal of the European Union

L 96/1

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COMMISSION DELEGATED REGULATION (EU) 2018/573

of 15 December 2017

on key elements of data storage contracts to be concluded as part of a traceability system for tobacco products

(Text with EEA relevance)

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(12) thereof,

Whereas:

| (1) | Article 15(8) of Directive 2014/40/EU requires each manufacturer and importer, as part of the traceability system for tobacco products, further specified in Commission Implementing Regulation (EU) 2018/574 (2), to conclude a contract with an independent third-party provider for the purpose of hosting information related to its tobacco products. Article 15(12) of Directive 2014/40/EU empowers the Commission to define the key elements of those contracts. |
| --- | --- |

(1)

Article 15(8) of Directive 2014/40/EU requires each manufacturer and importer, as part of the traceability system for tobacco products, further specified in Commission Implementing Regulation (EU) 2018/574 (2), to conclude a contract with an independent third-party provider for the purpose of hosting information related to its tobacco products. Article 15(12) of Directive 2014/40/EU empowers the Commission to define the key elements of those contracts.

| (2) | To ensure the effective functioning of the traceability system for tobacco products in general and the interoperability of the repositories system in particular, it is appropriate to lay down the key elements of the data storage contracts, to include specifications relating to the operability, availability and performance of the services to be provided by data storage providers. The effective and continuous functioning of the traceability system and the data storage system contained therein makes it necessary that clear requirements on data portability are put in place by providers for cases where a manufacturer or importer decides to change its provider. For that reason, the contracts should include provisions requiring the use of technology that is readily available on the market and commonly used in the sector to guarantee an effective and uninterrupted data transfer between current and new providers. |
| --- | --- |

(2)

To ensure the effective functioning of the traceability system for tobacco products in general and the interoperability of the repositories system in particular, it is appropriate to lay down the key elements of the data storage contracts, to include specifications relating to the operability, availability and performance of the services to be provided by data storage providers. The effective and continuous functioning of the traceability system and the data storage system contained therein makes it necessary that clear requirements on data portability are put in place by providers for cases where a manufacturer or importer decides to change its provider. For that reason, the contracts should include provisions requiring the use of technology that is readily available on the market and commonly used in the sector to guarantee an effective and uninterrupted data transfer between current and new providers.

| (3) | In order to ensure the necessary level of flexibility, it should be possible to request the data storage provider to carry out, against a fee, ancillary technical services connected with the operation of the primary repository such as the expansion of the operational functionality of user interfaces, provided that the additional services contribute to the proper functioning of the repositories system and do not violate any of the requirements laid down in Implementing Regulation (EU) 2018/574. Therefore, the contract should provide for such an option. |
| --- | --- |

(3)

In order to ensure the necessary level of flexibility, it should be possible to request the data storage provider to carry out, against a fee, ancillary technical services connected with the operation of the primary repository such as the expansion of the operational functionality of user interfaces, provided that the additional services contribute to the proper functioning of the repositories system and do not violate any of the requirements laid down in Implementing Regulation (EU) 2018/574. Therefore, the contract should provide for such an option.

| (4) | To safeguard the independent operation of the traceability system at all times, the Commission should be able to revoke the approval of an already contracted data storage provider where an assessment or reassessment of the technical capacity or independence of the provider results in an adverse finding as regards its suitability. |
| --- | --- |

(4)

To safeguard the independent operation of the traceability system at all times, the Commission should be able to revoke the approval of an already contracted data storage provider where an assessment or reassessment of the technical capacity or independence of the provider results in an adverse finding as regards its suitability.

| (5) | In order to ensure the effective organisation of the day-to-day functioning of the system, providers of primary repositories should cooperate with one another, as well as with the competent authorities of Member States and the Commission. |
| --- | --- |

(5)

In order to ensure the effective organisation of the day-to-day functioning of the system, providers of primary repositories should cooperate with one another, as well as with the competent authorities of Member States and the Commission.

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter

This Regulation sets out key elements to be included in the data storage contracts referred to in Article 15(8) of Directive 2014/40/EU.

Article 2

Definitions

For the purpose of this Regulation, in addition to the definitions laid down in Directive 2014/40/EU and Implementing Regulation (EU) 2018/574, the following definitions shall apply:

| (1) | ‘contract’ means a contractual agreement between a manufacturer or importer of tobacco products and a provider of data storage systems in accordance with Article 15(8) of Directive 2014/40/EU and Implementing Regulation (EU) 2018/574; |
| --- | --- |

(1)

‘contract’ means a contractual agreement between a manufacturer or importer of tobacco products and a provider of data storage systems in accordance with Article 15(8) of Directive 2014/40/EU and Implementing Regulation (EU) 2018/574;

| (2) | ‘provider’ means any legal person contracted by a manufacturer or importer of tobacco products for the purpose of establishing and operating its primary repository and the related services; |
| --- | --- |

(2)

‘provider’ means any legal person contracted by a manufacturer or importer of tobacco products for the purpose of establishing and operating its primary repository and the related services;

| (3) | ‘data portability’ means the ability to move data among different repositories, by the use of technology that is readily available on the market and commonly used in the sector. |
| --- | --- |

(3)

‘data portability’ means the ability to move data among different repositories, by the use of technology that is readily available on the market and commonly used in the sector.

Article 3

Key responsibilities under the contract

1.   The contract shall specify the key services to be rendered by the provider, which shall include:

| (1) | the establishment and operation of a primary repository in accordance with Article 26 of Implementing Regulation (EU) 2018/574; |
| --- | --- |

(1)

the establishment and operation of a primary repository in accordance with Article 26 of Implementing Regulation (EU) 2018/574;

| (2) | in the case the operator of the primary repository is appointed as provider of the secondary repository, the establishment and operation of the secondary repository and the router, in accordance with Articles 27, 28 and 29 of Implementing Regulation (EU) 2018/574; |
| --- | --- |

(2)

in the case the operator of the primary repository is appointed as provider of the secondary repository, the establishment and operation of the secondary repository and the router, in accordance with Articles 27, 28 and 29 of Implementing Regulation (EU) 2018/574;

| (3) | the provision, upon request, of other ancillary technical services connected with the operation of the primary repository that contribute to the proper functioning of the repositories system. |
| --- | --- |

(3)

the provision, upon request, of other ancillary technical services connected with the operation of the primary repository that contribute to the proper functioning of the repositories system.

2.   In defining the key services referred to in points (1) and (2) of paragraph 1, the contract shall contain specifications relating to the operability, availability and performance of the services meeting the minimum requirements specified in this Regulation and laid down in Chapter V of Implementing Regulation (EU) 2018/574.

Article 4

Technical expertise

The contract shall require providers to issue to the manufacturer or importer a written declaration that they hold, or have at their disposal, the technical and operational expertise necessary to carry out the services referred to in Article 3 and to comply with the requirements laid down in Chapter V of Implementing Regulation (EU) 2018/574.

Article 5

Availability of the primary repository

1.   The contract shall specify a guaranteed monthly uptime and availability of 99,5 % for the primary repository.

2.   The contract shall require that appropriate back-up mechanisms are put in place by the provider to prevent any loss of data that is stored, received or transferred at the time the primary repository becomes unavailable.

Article 6

Access rights

The contract shall specify the requirements for physical and virtual access to be granted, at server and database level, to national administrators of Member States, the Commission, and appointed external auditors to the primary repository, in accordance with Article 25 of Implementing Regulation (EU) 2018/574.

Article 7

Sub-contracting

1.   Where the contract specifies that the provider may subcontract certain obligations under the contract, it shall contain a provision clarifying that the subcontract does not affect the primary responsibility of the provider for the performance of the contract.

2.   The contract shall further require the provider:

| (a) | to ensure that the proposed subcontractor has the necessary technical expertise and meets the requirements of independence laid down in Article 35 of Implementing Regulation (EU) 2018/574. |
| --- | --- |

(a)

to ensure that the proposed subcontractor has the necessary technical expertise and meets the requirements of independence laid down in Article 35 of Implementing Regulation (EU) 2018/574.

| (b) | to submit to the Commission a copy of the declaration referred to in Article 8 of this Regulation signed by the respective sub-contractor(s). |
| --- | --- |

(b)

to submit to the Commission a copy of the declaration referred to in Article 8 of this Regulation signed by the respective sub-contractor(s).

Article 8

Legal and financial independence

The contract shall require providers and, where applicable, their sub-contractors, to issue to the manufacturer or importer, together with the data storage contract, a written declaration that they comply with the requirements for legal and financial independence as laid down in Article 35 of Implementing Regulation (EU) 2018/574.

Article 9

Data protection and confidentiality

1.   The contract shall specify that the provider shall put in place all appropriate measures necessary to ensure the confidentiality, integrity and availability of all data stored in the performance of the contract. Such measures shall include administrative, technical and physical safety and security controls.

2.   The contract shall require that personal data handled under the contract are processed in accordance with Directive 95/46/EC of the European Parliament and of the Council (3).

Article 10

Information security management

The contract shall require providers to declare that the primary repository and, where applicable, the second repository, is managed in accordance with internationally recognised information security management standards. Providers certified to ISO/IEC 27001:2013 shall be presumed to meet those standards.

Article 11

Costs

The contract shall require the costs charged by providers to manufacturers or importers in accordance with Article 30 of Implementing Regulation (EU) 2018/574 to be fair, reasonable, and proportionate to:

| (a) | the services rendered; and |
| --- | --- |

(a)

the services rendered; and

| (b) | the number of unique identifiers requested over a given period of time by the manufacturer or importer concerned. |
| --- | --- |

(b)

the number of unique identifiers requested over a given period of time by the manufacturer or importer concerned.

Article 12

Participation in secondary repository system

1.   The contract shall require the provider to participate in the establishment of the secondary repository system (where the secondary system has not yet been established at the date of the conclusion of the contract) as may be required in accordance with the rules provided for in Chapter V of Implementing Regulation (EU) 2018/574.

2.   The contract shall contain a provision that allows for providers to recover from manufacturers and importers of tobacco products the costs arising in connection with the establishment, operation and maintenance of the secondary repository and the router referred to in Chapter V of Implementing Regulation (EU) 2018/574.

Article 13

Duration

The duration of the contract shall be fixed for a minimum of five years with a possibility of renewal subject to agreement of the Parties and the continuing compliance of the provider with the requirements of Directive 2014/40/EU and Implementing Regulation (EU) 2018/574.

Article 14

Communication with other parties

The contract shall require providers to cooperate with one another, as well as with the competent authorities of Member States, to the extent necessary to ensure the effective organisation of the day-to-day functioning of the repositories system.

Article 15

Audits

1.   The contract shall lay down terms enabling external auditors approved by the Commission, in accordance with Article 15(8) of Directive 2014/40/EU, to carry out announced and unannounced audits in relation to the primary repository, and, where applicable, the secondary repository, including an assessment of whether the provider and, if applicable, its sub-contractors comply with the relevant legislative requirements.

2.   The contract shall specify that external auditors are granted unrestricted physical and virtual access to the primary repository and, where applicable, the secondary repository, and its related services for the duration of the audit.

Article 16

Liability

The contract shall lay down terms detailing the liability of the parties including with respect to direct and indirect damages that may arise under the contract, in accordance with the applicable law. Without prejudice to the applicable law, the contract shall further specify that no limitation of liability exists in case of breach of confidentiality or breach of data protection rules.

Article 17

Termination of contract

1.   The contract shall lay down terms regarding the termination of the contract, in accordance with the applicable law. In the case of termination, the contract shall require the terminating Party to notify the Commission, in accordance with the procedural requirements laid down in Annex I to Implementing Regulation (EU) 2018/574.

2.   The contract shall require parties to provide a minimum notice period of five months for the termination of the contract.

By derogation to the first subparagraph, the contract shall require manufacturers and importers to terminate the contract immediately:

| (a) | in the event of a serious breach by the provider of its obligations under the contract, |
| --- | --- |

(a)

in the event of a serious breach by the provider of its obligations under the contract,

| (b) | where the provider becomes, or is in imminent risk of becoming, insolvent under the applicable law. |
| --- | --- |

(b)

where the provider becomes, or is in imminent risk of becoming, insolvent under the applicable law.

3.   For the purposes of paragraph 2(a) a serious breach shall include:

| (a) | the failure by the provider to carry out obligations or to perform services provided for under the contract that are critical to the effective functioning of the traceability system, including in particular, the failure to comply with requirements laid down in Chapter V of Implementing Regulation (EU) 2018/574, |
| --- | --- |

(a)

the failure by the provider to carry out obligations or to perform services provided for under the contract that are critical to the effective functioning of the traceability system, including in particular, the failure to comply with requirements laid down in Chapter V of Implementing Regulation (EU) 2018/574,

| (b) | where a provider ceases to comply with the requirements for legal and financial independence laid down in Article 35(2) of Implementing Regulation (EU) 2018/574 and where, by the expiry of the time-period referred to in Article 35(6) of Implementing Regulation (EU) 2018/574, compliance with the requirements could not be established. |
| --- | --- |

(b)

where a provider ceases to comply with the requirements for legal and financial independence laid down in Article 35(2) of Implementing Regulation (EU) 2018/574 and where, by the expiry of the time-period referred to in Article 35(6) of Implementing Regulation (EU) 2018/574, compliance with the requirements could not be established.

Article 18

Suspension of services

The contract shall specify that suspension of services in case of late payments by a manufacturer or importer to the provider shall be prohibited, unless the delay exceeds the final payment deadline by thirty days or more.

Article 19

Data portability

1.   The contract shall require providers to ensure full data portability in cases where a manufacturer or importer contracts a new provider to operate its primary repository. The current provider shall deliver to the new provider, prior to the date of termination of the contract, an up-to-date copy of all data stored in the primary repository. Any updates to the data after that delivery shall be migrated to the new provider without undue delay.

2.   In order to ensure business continuity, the contract shall include an applicable exit plan laying down the procedure to be followed in case of the termination of the contract and a new provider is contracted by the manufacturer or importer. The plan shall include a requirement for the current provider to continue providing its services until the new provider becomes operational.

3.   The contract shall contain provisions ensuring that the current provider has no right of retention with respect to any data, information or other necessary material related to the primary repository after they have been delivered to the new provider.

Article 20

Applicable law and jurisdiction

1.   The contract shall be governed by the laws of one of the Member States of the European Union, as agreed by the parties to the contract.

2.   The contract shall be subject to the jurisdiction of one of the Member States of the European Union, as agreed by the parties to the contract.

Article 21

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 December 2017.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  
  OJ L 127, 29.4.2014, p. 1.

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 (see page 7 of this Official Journal).

2

(3)  Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).

3

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| 16.4.2018 | EN | Official Journal of the European Union | L 96/7 |
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16.4.2018

EN

Official Journal of the European Union

L 96/7

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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)

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) | In order to address the issue of illicit trade in tobacco products, Directive 2014/40/EU provides that all unit packets of tobacco products are to be marked with a unique identifier in order for their movements to be recorded. This will enable such products to be tracked and traced throughout the Union. Technical specifications regarding the system's establishment and operation, as well as its compatibility throughout the Union, should be laid down. |
| --- | --- |

(1)

In order to address the issue of illicit trade in tobacco products, Directive 2014/40/EU provides that all unit packets of tobacco products are to be marked with a unique identifier in order for their movements to be recorded. This will enable such products to be tracked and traced throughout the Union. Technical specifications regarding the system's establishment and operation, as well as its compatibility throughout the Union, should be laid down.

| (2) | Rules concerning the marking of packages with a unique identifier, the recording and transmission of data, the processing, storing and accessing of data and the compatibility of components of the traceability system should be set. |
| --- | --- |

(2)

Rules concerning the marking of packages with a unique identifier, the recording and transmission of data, the processing, storing and accessing of data and the compatibility of components of the traceability system should be set.

| (3) | Legislative action at Union level is also necessary in order to implement Article 8 of the Protocol to Eliminate Illicit Trade in Tobacco Products to the World Health Organisation's Framework Convention on Tobacco Control (2) (‘WHO FCTC Protocol’), which has been ratified by the European Union (3) and provides for a global tracking and tracing regime for tobacco products, to be established by the Parties to the WHO FCTC Protocol within five years of its entry into force. |
| --- | --- |

(3)

Legislative action at Union level is also necessary in order to implement Article 8 of the Protocol to Eliminate Illicit Trade in Tobacco Products to the World Health Organisation's Framework Convention on Tobacco Control (2) (‘WHO FCTC Protocol’), which has been ratified by the European Union (3) and provides for a global tracking and tracing regime for tobacco products, to be established by the Parties to the WHO FCTC Protocol within five years of its entry into force.

| (4) | In order to combat multiple existing types of fraudulent activities that result in illicit products being made available to consumers, including practices that entail the false declaration of exports, the traceability system provided for under this Regulation is to apply, in accordance with Article 15 of Directive 2014/40/EU, to all tobacco products manufactured in the Union, as well as to those manufactured outside the Union insofar as they are destined for or placed on the Union market. |
| --- | --- |

(4)

In order to combat multiple existing types of fraudulent activities that result in illicit products being made available to consumers, including practices that entail the false declaration of exports, the traceability system provided for under this Regulation is to apply, in accordance with Article 15 of Directive 2014/40/EU, to all tobacco products manufactured in the Union, as well as to those manufactured outside the Union insofar as they are destined for or placed on the Union market.

| (5) | In order to provide for the independence of the traceability system and guarantee that it is controlled by the Member States, as provided for under Article 8 of the WHO FCTC Protocol, a proper assignment of roles in relation to the marking of packages with a unique identifier is essential. The key task of generation of the unique identifiers at unit packet level should be attributed to an independent third party appointed by each Member State (‘ID issuer’).To avoid the risk that two or more ID issuers, independently of each other, generate the same unique identifier, each ID issuer should be identified by a unique identification code, which should also form part of the unique identifiers issued by them. |
| --- | --- |

(5)

In order to provide for the independence of the traceability system and guarantee that it is controlled by the Member States, as provided for under Article 8 of the WHO FCTC Protocol, a proper assignment of roles in relation to the marking of packages with a unique identifier is essential. The key task of generation of the unique identifiers at unit packet level should be attributed to an independent third party appointed by each Member State (‘ID issuer’).To avoid the risk that two or more ID issuers, independently of each other, generate the same unique identifier, each ID issuer should be identified by a unique identification code, which should also form part of the unique identifiers issued by them.

| (6) | In order to guarantee the uniqueness of the identifier, a serial number generated by the ID issuer should form part of each unique identifier that has a negligible probability of being guessed by falsifiers. |
| --- | --- |

(6)

In order to guarantee the uniqueness of the identifier, a serial number generated by the ID issuer should form part of each unique identifier that has a negligible probability of being guessed by falsifiers.

| (7) | When requesting unit packet unique identifiers from an ID issuer, manufacturers and importers should be required to provide all information necessary for the issuer to be able to generate that identifier, in accordance with Article 15(2), points (a) to (h) of Directive 2014/40/EU, with the exception of date and time of manufacture, which may not be possible to determine in advance and which should be added by economic operators at the moment of production. |
| --- | --- |

(7)

When requesting unit packet unique identifiers from an ID issuer, manufacturers and importers should be required to provide all information necessary for the issuer to be able to generate that identifier, in accordance with Article 15(2), points (a) to (h) of Directive 2014/40/EU, with the exception of date and time of manufacture, which may not be possible to determine in advance and which should be added by economic operators at the moment of production.

| (8) | The length of the unit level unique identifier may impact the speed at which it can be applied to unit packets by tobacco product manufacturers or importers. In order to avoid an excessive impact on this process whilst ensuring sufficient space for all information required at unit packet level, the maximum permitted number of alphanumeric characters for the unit level unique identifier should be laid down. |
| --- | --- |

(8)

The length of the unit level unique identifier may impact the speed at which it can be applied to unit packets by tobacco product manufacturers or importers. In order to avoid an excessive impact on this process whilst ensuring sufficient space for all information required at unit packet level, the maximum permitted number of alphanumeric characters for the unit level unique identifier should be laid down.

| (9) | In order to ensure that unit level unique identifiers are capable of meeting the requirements relating to the maximum permitted number of alphanumeric characters, information required under Article 15(2) points (a) to (h) of Directive 2014/40/EU should be translated into code. |
| --- | --- |

(9)

In order to ensure that unit level unique identifiers are capable of meeting the requirements relating to the maximum permitted number of alphanumeric characters, information required under Article 15(2) points (a) to (h) of Directive 2014/40/EU should be translated into code.

| (10) | For the purpose of enabling the competent authorities of the Member States to decode the unique identifiers without accessing the information stored in the repositories system, flat-files should be established and maintained by the ID issuers. Such flat-files should enable all information codified in the unique identifier codes to be identified. The size of such flat-files should be defined, in order to ensure that they can be downloaded to the devices used by Member States when reading the unique identifiers in offline mode (offline flat-files). |
| --- | --- |

(10)

For the purpose of enabling the competent authorities of the Member States to decode the unique identifiers without accessing the information stored in the repositories system, flat-files should be established and maintained by the ID issuers. Such flat-files should enable all information codified in the unique identifier codes to be identified. The size of such flat-files should be defined, in order to ensure that they can be downloaded to the devices used by Member States when reading the unique identifiers in offline mode (offline flat-files).

| (11) | Directive 2014/40/EU provides that the recording obligations established pursuant to Article 15 may be complied with by the marking and recording of aggregated packaging, such as cartons, mastercases or pallets, provided that the tracking and tracing of all unit packets remains possible. Where economic operators opt to make use of that possibility, they should be required to ensure that such packaging is marked with an aggregated level identifier which is also unique and therefore capable of unequivocally identifying any lower aggregated levels and ultimately the unit packets that it contains. |
| --- | --- |

(11)

Directive 2014/40/EU provides that the recording obligations established pursuant to Article 15 may be complied with by the marking and recording of aggregated packaging, such as cartons, mastercases or pallets, provided that the tracking and tracing of all unit packets remains possible. Where economic operators opt to make use of that possibility, they should be required to ensure that such packaging is marked with an aggregated level identifier which is also unique and therefore capable of unequivocally identifying any lower aggregated levels and ultimately the unit packets that it contains.

| (12) | In order to ensure that all movements of the unit packets can be recorded and transmitted, manufacturers and importers should verify the unique identifiers so as to ensure their correct application and readability. To control this critical process for the unit level unique identifiers, anti-tampering devices, which are to be supplied by an independent third party, should be installed on the devices used for verification purposes. In laying down rules on the installation of such devices, it is appropriate to take into account differences between undertakings, particularly as regards their size, production output and nature of the production process, so as to ensure that compliance with this requirement does not entail an excessive burden, particularly, on smaller operators, including small and medium-sized enterprises (SMEs). As anti-tampering devices are of particular relevance to the automated production of tobacco products, for the purpose of ensuring that the integrity of unit level unique identifiers is adequately protected, it is appropriate to limit the obligation to install such devices to operators other than those that use fully manual production processes. |
| --- | --- |

(12)

In order to ensure that all movements of the unit packets can be recorded and transmitted, manufacturers and importers should verify the unique identifiers so as to ensure their correct application and readability. To control this critical process for the unit level unique identifiers, anti-tampering devices, which are to be supplied by an independent third party, should be installed on the devices used for verification purposes. In laying down rules on the installation of such devices, it is appropriate to take into account differences between undertakings, particularly as regards their size, production output and nature of the production process, so as to ensure that compliance with this requirement does not entail an excessive burden, particularly, on smaller operators, including small and medium-sized enterprises (SMEs). As anti-tampering devices are of particular relevance to the automated production of tobacco products, for the purpose of ensuring that the integrity of unit level unique identifiers is adequately protected, it is appropriate to limit the obligation to install such devices to operators other than those that use fully manual production processes.

| (13) | In order to minimise the impact of the traceability system on production and distribution schemes, economic operators should be permitted to order batches of the unique identifiers in advance. However, to avoid overstocking of the unique identifiers by economic operators and to control the size of individual orders, a time limit for the application of unique identifiers issued at both unit packet and aggregated levels should be set. These measures should also alleviate potential excessive impacts on the generation and issuing activities performed by the ID issuers. |
| --- | --- |

(13)

In order to minimise the impact of the traceability system on production and distribution schemes, economic operators should be permitted to order batches of the unique identifiers in advance. However, to avoid overstocking of the unique identifiers by economic operators and to control the size of individual orders, a time limit for the application of unique identifiers issued at both unit packet and aggregated levels should be set. These measures should also alleviate potential excessive impacts on the generation and issuing activities performed by the ID issuers.

| (14) | In order to ensure the proper functioning of the traceability system, economic operators and operators of first retail outlets should apply in advance to the relevant ID issuers for an economic operator identifier code and for a facility identifier code for each facility. The assignment of economic operator identifier codes and facility identifier codes permits the efficient identification of all purchasers and of the actual shipment route from manufacturing to the first retail outlet as provided for in Article 15(2) points (i) and (j) of Directive 2014/40/EU. |
| --- | --- |

(14)

In order to ensure the proper functioning of the traceability system, economic operators and operators of first retail outlets should apply in advance to the relevant ID issuers for an economic operator identifier code and for a facility identifier code for each facility. The assignment of economic operator identifier codes and facility identifier codes permits the efficient identification of all purchasers and of the actual shipment route from manufacturing to the first retail outlet as provided for in Article 15(2) points (i) and (j) of Directive 2014/40/EU.

| (15) | Manufacturers or importers should in addition apply for an identifier code for machines used to manufacture tobacco products. The obligation to apply for machine identifier codes permits the efficient identification of the machine used to manufacture the tobacco products in accordance with Article 15(2) point (c) of Directive 2014/40/EU. |
| --- | --- |

(15)

Manufacturers or importers should in addition apply for an identifier code for machines used to manufacture tobacco products. The obligation to apply for machine identifier codes permits the efficient identification of the machine used to manufacture the tobacco products in accordance with Article 15(2) point (c) of Directive 2014/40/EU.

| (16) | In order to ensure that the information contained in the unique identifier is capable of being recorded and transmitted by all relevant economic operators, as well as to guarantee the compatibility of the unique identifier with external components such as scanning devices, the types of permitted data carriers should be specified. |
| --- | --- |

(16)

In order to ensure that the information contained in the unique identifier is capable of being recorded and transmitted by all relevant economic operators, as well as to guarantee the compatibility of the unique identifier with external components such as scanning devices, the types of permitted data carriers should be specified.

| (17) | In order for the traceability system to be able to achieve its objective, it is necessary for it to be capable of enabling easy transmission of all relevant data, providing secure storage of data and ensuring full access to this data for the Commission, the competent authorities of the Member States and the external auditor. The storage architecture should further allow manufacturers and importers to select independent third party data storage providers with which to conclude data storage contracts for the purpose of hosting data related exclusively to their tobacco products (‘primary repositories’), as provided for by Article 15(8) of Directive 2014/40/EU, whilst ensuring authorities are provided with full access to all stored data for the purpose of carrying out their monitoring and enforcement activities. The effectiveness of such monitoring and enforcement activities requires the presence of a single second-level repository system (‘secondary repository’), containing a copy of all the data stored in the primary repositories and providing authorities with a global overview of the functioning of the traceability system. A routing system, operated by the provider of the secondary repository, should be established in order to provide economic operators other than manufacturers and importers with a single entry point to submit the data recorded by them to the traceability system and thereby ease the data transmission. At the same time, the routing service should ensure that data are transmitted to the correct primary repository. |
| --- | --- |

(17)

In order for the traceability system to be able to achieve its objective, it is necessary for it to be capable of enabling easy transmission of all relevant data, providing secure storage of data and ensuring full access to this data for the Commission, the competent authorities of the Member States and the external auditor. The storage architecture should further allow manufacturers and importers to select independent third party data storage providers with which to conclude data storage contracts for the purpose of hosting data related exclusively to their tobacco products (‘primary repositories’), as provided for by Article 15(8) of Directive 2014/40/EU, whilst ensuring authorities are provided with full access to all stored data for the purpose of carrying out their monitoring and enforcement activities. The effectiveness of such monitoring and enforcement activities requires the presence of a single second-level repository system (‘secondary repository’), containing a copy of all the data stored in the primary repositories and providing authorities with a global overview of the functioning of the traceability system. A routing system, operated by the provider of the secondary repository, should be established in order to provide economic operators other than manufacturers and importers with a single entry point to submit the data recorded by them to the traceability system and thereby ease the data transmission. At the same time, the routing service should ensure that data are transmitted to the correct primary repository.

| (18) | In order to guarantee full access for relevant authorities and to contribute to the efficient functioning of the traceability system, the provider of the secondary repository should develop user interfaces enabling the stored data to be viewed and queried. In accessing the repositories system the relevant authorities should be able to rely on the eIDAS (4) based reusable solutions provided as building blocks under the telecommunication part of the Connecting Europe Facility. In addition, to facilitate effective surveillance and enforcement, the user interface should allow for the possibility to define individual automatic alerts based on specific reporting events. |
| --- | --- |

(18)

In order to guarantee full access for relevant authorities and to contribute to the efficient functioning of the traceability system, the provider of the secondary repository should develop user interfaces enabling the stored data to be viewed and queried. In accessing the repositories system the relevant authorities should be able to rely on the eIDAS (4) based reusable solutions provided as building blocks under the telecommunication part of the Connecting Europe Facility. In addition, to facilitate effective surveillance and enforcement, the user interface should allow for the possibility to define individual automatic alerts based on specific reporting events.

| (19) | To ensure interoperability of the components of the repositories system, technical specifications, based on non-proprietary open standards, should be established for the exchange of data between the primary repositories, the secondary repository and the routing system. |
| --- | --- |

(19)

To ensure interoperability of the components of the repositories system, technical specifications, based on non-proprietary open standards, should be established for the exchange of data between the primary repositories, the secondary repository and the routing system.

| (20) | In order to ensure that the required information is recorded and transmitted in a timely and uniform manner by all economic operators, the precise list of supply chain and transactional events that are required to be recorded under Article 15(2), points (i), (j) and (k) of Directive 2014/40/EU, as well as the content of the information messages to be transmitted, should be laid down. |
| --- | --- |

(20)

In order to ensure that the required information is recorded and transmitted in a timely and uniform manner by all economic operators, the precise list of supply chain and transactional events that are required to be recorded under Article 15(2), points (i), (j) and (k) of Directive 2014/40/EU, as well as the content of the information messages to be transmitted, should be laid down.

| (21) | Given that the aim of a traceability system is to provide Member States and the Commission with an effective tool to fight illicit trade of tobacco products, timely availability of supply chain and transactional event data is necessary for investigation and enforcement purposes. The maximum time that may elapse between the occurrence of a relevant supply chain or transactional event and the transmission of the related information to the relevant data storage repository should therefore be established. In laying down such time-limits, it is appropriate to take into account differences between undertakings, particularly as regards their size and production output, so as to ensure that compliance with reporting obligations does not entail an excessive burden, particularly on smaller operators, including small and medium-sized enterprises (SMEs). |
| --- | --- |

(21)

Given that the aim of a traceability system is to provide Member States and the Commission with an effective tool to fight illicit trade of tobacco products, timely availability of supply chain and transactional event data is necessary for investigation and enforcement purposes. The maximum time that may elapse between the occurrence of a relevant supply chain or transactional event and the transmission of the related information to the relevant data storage repository should therefore be established. In laying down such time-limits, it is appropriate to take into account differences between undertakings, particularly as regards their size and production output, so as to ensure that compliance with reporting obligations does not entail an excessive burden, particularly on smaller operators, including small and medium-sized enterprises (SMEs).

| (22) | For investigation and enforcement purposes, it is necessary that competent authorities of Member States and the Commission have access to a record of all economic operators and operators of first retail outlets involved in the trade of tobacco products, as well as the facilities and machines that are used by them to manufacture, store and process their products. Therefore, each ID issuer should establish and maintain a registry that contains the identifier codes for economic operators, operators of first retail outlets, machines and facilities referred to above. An up-to-date copy of these registries, along with the corresponding information, should be transferred electronically via the router to the secondary repository and compiled into an EU-wide register. |
| --- | --- |

(22)

For investigation and enforcement purposes, it is necessary that competent authorities of Member States and the Commission have access to a record of all economic operators and operators of first retail outlets involved in the trade of tobacco products, as well as the facilities and machines that are used by them to manufacture, store and process their products. Therefore, each ID issuer should establish and maintain a registry that contains the identifier codes for economic operators, operators of first retail outlets, machines and facilities referred to above. An up-to-date copy of these registries, along with the corresponding information, should be transferred electronically via the router to the secondary repository and compiled into an EU-wide register.

| (23) | Given the requirement for the traceability system to be independent of manufacturers and importers of tobacco products and to be under the control of the Member States, as provided for under Article 8 of the WHO FCTC Protocol, common criteria for the assessment of independence of all third parties involved in the traceability system (ID issuers, providers of repository services and anti-tampering devices) should be laid down. In order to ensure the continuing respect of the requirement for independence that is critical for ensuring and maintaining the integrity of the traceability system, the procedures governing the appointment of the ID issuers and other independent providers and the monitoring of their compliance with the independence criteria set out in this Regulation should undergo periodic review by the Commission. Conclusions of the review should be published by the Commission and form part of the report on the application of Directive 2014/40/EU provided for under Article 28 of that Directive. |
| --- | --- |

(23)

Given the requirement for the traceability system to be independent of manufacturers and importers of tobacco products and to be under the control of the Member States, as provided for under Article 8 of the WHO FCTC Protocol, common criteria for the assessment of independence of all third parties involved in the traceability system (ID issuers, providers of repository services and anti-tampering devices) should be laid down. In order to ensure the continuing respect of the requirement for independence that is critical for ensuring and maintaining the integrity of the traceability system, the procedures governing the appointment of the ID issuers and other independent providers and the monitoring of their compliance with the independence criteria set out in this Regulation should undergo periodic review by the Commission. Conclusions of the review should be published by the Commission and form part of the report on the application of Directive 2014/40/EU provided for under Article 28 of that Directive.

| (24) | The protection of personal data processed in the context of a traceability system should be ensured in accordance with Directive 95/46/EC of the European Parliament and of the Council (5). |
| --- | --- |

(24)

The protection of personal data processed in the context of a traceability system should be ensured in accordance with Directive 95/46/EC of the European Parliament and of the Council (5).

| (25) | Recourse to international standards should be possible for the purposes of demonstrating fulfilment of certain technical requirements laid down in this Regulation. Where it is not possible to prove compliance with international standards, it should be the responsibility of the persons to whom the obligations are imposed to prove, by verifiable means, that they comply with those requirements. |
| --- | --- |

(25)

Recourse to international standards should be possible for the purposes of demonstrating fulfilment of certain technical requirements laid down in this Regulation. Where it is not possible to prove compliance with international standards, it should be the responsibility of the persons to whom the obligations are imposed to prove, by verifiable means, that they comply with those requirements.

| (26) | 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, |
| --- | --- |

(26)

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:

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; |
| --- | --- |

(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; |
| --- | --- |

(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; |
| --- | --- |

(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; |
| --- | --- |

(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; |
| --- | --- |

(5)

‘aggregated packaging’ means any packaging containing more than one unit packet of tobacco products;

| (6) | ‘facility’ means any location, building or vending machine where tobacco products are manufactured, stored or placed on the market; |
| --- | --- |

(6)

‘facility’ means any location, building or vending machine where tobacco products are manufactured, stored 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; |
| --- | --- |

(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; |
| --- | --- |

(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; |
| --- | --- |

(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; |
| --- | --- |

(10)

‘data carrier’ means a carrier representing data in a form readable with the aid of a device;

| (11) | ‘machine’ means the equipment used for the manufacture of tobacco products which is integral to the manufacturing process; |
| --- | --- |

(11)

‘machine’ means the equipment used for the manufacture of tobacco products which is integral to the manufacturing process;

| (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; |
| --- | --- |

(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; |
| --- | --- |

(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; |
| --- | --- |

(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; |
| --- | --- |

(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; |
| --- | --- |

(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; |
| --- | --- |

(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; |
| --- | --- |

(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; |
| --- | --- |

(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. |
| --- | --- |

(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.

CHAPTER II

TECHNICAL SPECIFICATIONS RELATED TO THE UNIQUE IDENTIFIER

SECTION 1

Common provisions

Article 3

ID issuer

1.   Each Member State shall appoint an entity (the ‘ID issuer’) responsible for generating and issuing unique identifiers, in accordance with Articles 8, 9, 11 and 13, within a maximum period of one year from the date of entry into force of this Implementing Regulation.

2.   Member States shall ensure that an ID issuer that intends to have recourse to subcontractors for the performance of its functions shall only be considered for appointment if the identity of any subcontractors proposed has been communicated to them.

3.   The ID issuer shall be independent and comply with the criteria set out in Article 35.

4.   Each ID issuer shall be equipped with a unique identification code. The code shall be composed of alphanumeric characters and comply with the International Organization for Standardisation/International Electrotechnical Commission standard (‘ISO/IEC’) 15459-2:2015.

5.   Where the same ID issuer is appointed in more than one Member State, it shall be identifiable by the same code.

6.   Member States shall notify the Commission of the appointment of the ID issuer and of its identification code within one month of its appointment.

7.   Member States shall ensure that information related to the identity of the ID issuer appointed and its identification code is made publicly available and accessible online.

8.   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 |
| --- | --- |

(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. |
| --- | --- |

(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.

9.   The ID issuer may establish and charge fees to economic operators solely for generating and issuing unique identifiers. Fees are to be non-discriminatory and proportionate to the number of unique identifiers generated and issued to economic operators taking into account the mode of delivery.

Article 4

Competent ID issuers for generating and issuing unique identifiers

1.   For tobacco products manufactured in the Union, the competent ID issuer shall be the entity appointed for the Member State in which the products are manufactured.

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.

2.   For tobacco products imported into the Union, the competent ID issuer shall be the entity appointed for the Member State on whose market the products are placed.

3.   For tobacco products aggregated in the Union, the competent ID issuer shall be the entity appointed for the Member State in which the products are aggregated.

4.   For tobacco products destined for export, the competent ID issuer shall be the entity appointed for the Member State in which the products are manufactured.

5.   In the event of the temporary absence of the competent ID issuer, the Commission may authorise economic operators to use the services of another ID issuer that has been appointed in accordance with Article 3.

Article 5

Validity of unique identifiers and deactivation

1.   Unique identifiers generated by ID issuers may be used to mark unit packets or aggregated packaging, as provided for by Articles 6 and 10, within a maximum period of six months from the date of receipt of the unique identifiers by the economic operator. After this time period unique identifiers shall become invalid and economic operators shall ensure that they are not used to mark unit packets or aggregated packaging.

2.   The repositories system shall ensure that the unique identifiers that have not been used within the six months period referred to in paragraph 1 shall be automatically deactivated.

3.   At any time, manufacturers and importers may obtain the deactivation of unique identifiers by transmitting a deactivation request to the relevant primary repository. Other economic operators may obtain the deactivation of the unique identifiers by transmitting a deactivation request via the router. The deactivation request shall be introduced electronically, in accordance with Article 36, and shall contain the information listed in point 2.3 of Section 2 of Chapter II of Annex II, in the format indicated therein. The deactivation shall not interfere with the integrity of the information already stored related to the unique identifier.

SECTION 2

Unique identifiers at unit packet level

Article 6

Marking by means of unit level UIs

1.   Manufacturers and importers shall mark each unit packet manufactured or imported in the Union with a unique identifier (‘unit level UI’) compliant with Article 8.

2.   In the case of tobacco products that are manufactured outside the Union, the unit level UI shall be applied on the unit packet before the tobacco product is imported in the Union.

Article 7

Verification of unit level UIs

1.   Manufacturers and importers shall ensure that the application of unit level UIs is directly followed by the verification of those unit level UIs in terms of correct application and readability.

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.

3.   Where the process referred to in paragraph 1 fails to confirm the correct application and full readability of the unit level UI, manufacturers and importers shall re-apply the unit level UI.

4.   Manufacturers and importers shall ensure that the information recorded by the anti-tampering device remains available for a period of nine months from the time of recording.

5.   Manufacturers and importers shall, upon request from Member States, provide full access to the record of the verification process created by the anti-tampering device.

6.   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; |
| --- | --- |

(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 (6); |
| --- | --- |

(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 (6);

| (c) | to fully manual production processes. |
| --- | --- |

(c)

to fully manual production processes.

Article 8

Structure of unit level UIs

1.   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); |
| --- | --- |

(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’); |
| --- | --- |

(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; |
| --- | --- | --- |

(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; |
| --- | --- |

ii.

the manufacturing facility referred to in Article 16;

| iii. | the machine used to manufacture the tobacco products referred to in Article 18; |
| --- | --- |

iii.

the machine used to manufacture the tobacco products referred to in Article 18;

| iv. | the product description; |
| --- | --- |

iv.

the product description;

| v. | the intended market of retail sale; |
| --- | --- |

v.

the intended market of retail sale;

| vi. | the intended shipment route; |
| --- | --- |

vi.

the intended shipment route;

| vii. | where applicable, the importer into the Union; |
| --- | --- |

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. |
| --- | --- |

(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.

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).

3.   Manufacturers or importers shall add the time stamp referred to in paragraph 1, point (d), to the code generated by the ID issuer pursuant to paragraph 2.

4.   Unit level UIs shall not include any data elements other than those listed in paragraph 1.

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

1.   Manufacturers and importers shall send a request to the competent ID issuer for unit level UIs referred to in Article 8. Requests shall be introduced electronically, in accordance with Article 36.

2.   Manufacturers and importers introducing such a request shall supply the information listed in point 2.1. of Section 2 of Chapter II of Annex II, in the format indicated therein.

3.   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); |
| --- | --- |

(a)

generate the codes referred to in Article 8(2);

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

(b)

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

| (c) | electronically transmit the codes to the requesting manufacturer or importer. |
| --- | --- |

(c)

electronically transmit the codes to the requesting manufacturer or importer.

4.   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); |
| --- | --- |

(a)

generate the codes referred to in Article 8(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; |
| --- | --- |

(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;

| (c) | deliver the 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. |
| --- | --- |

(c)

deliver the 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.

5.   Within one working day, manufacturers and importers may cancel a request which was sent pursuant to paragraph 1 by means of a recall message as further defined in Point 5 of Section 5 of Chapter II of Annex II.

SECTION 3

Unique identifiers at aggregated packaging level

Article 10

Marking by means of aggregated level UIs

1.   Where economic operators choose to comply with the recording obligations provided for under Article 15(5) of Directive 2014/40/EU by means of the recording of aggregated packaging, they shall mark aggregated packages containing tobacco products with a unique identifier (‘aggregated level UI’).

2.   Aggregated level UIs shall be generated and issued on the basis of a request to the competent ID issuer or directly by the economic operator.

3.   Where the aggregated level UI is generated on the basis of a request to the competent ID issuer, it shall comply with the structure set out in Article 11(1).

4.   Where the aggregated level UI is generated directly by the economic operator, it shall consist of an individual unit code generated in accordance with ISO/IEC 15459-1:2014 or ISO/IEC 15459-4:2014 or their latest equivalents.

Article 11

Structure of aggregated level UIs generated by ID issuers

1.   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); |
| --- | --- |

(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’); |
| --- | --- |

(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) | the identifier code of the facility (as set out in Article 16) in which the aggregation process took place; |
| --- | --- |

(c)

the identifier code of the facility (as set out in Article 16) in which the aggregation process took place;

| (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. |
| --- | --- |

(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.

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).

3.   Economic operators shall add the time stamp, referred to in paragraph 1, point (d), to the code generated by the ID issuer pursuant to paragraph 2.

4.   The aggregated level UI may be completed by the economic operator with additional information, provided that the maximum character limit set out in paragraph 1 is not exceeded. Any such information may only appear after the data referred to in paragraph 1.

Article 12

Link between UI levels

1.   The aggregated level UI shall be capable of identifying the list of all unique identifiers contained within the aggregated packaging by means of an electronically accessible link to the repositories system.

2.   In order to establish the link referred to in paragraph 1, manufacturers and importers shall transmit to their primary repository the information listed in point 3.2 of Section 2 of Chapter II of Annex II, in the format indicated therein.

3.   In order to establish the link referred to in paragraph 1, economic operators other than manufacturers and importers shall transmit via the router to the secondary repository the information listed in point 3.2 of Section 2 of Chapter II of Annex II, in the format indicated therein.

Article 13

Request and issuing of aggregated level UIs generated by ID issuers

1.   Economic operators requesting aggregated level UIs on the basis of a request to the competent ID issuer shall introduce such requests electronically, in accordance with Article 36.

2.   Economic operators introducing such requests shall supply the information listed in point 2.2. of Section 2 of Chapter II of Annex II, in the format indicated therein.

3.   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); |
| --- | --- |

(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 |
| --- | --- |

(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

| (c) | transmit the codes electronically to the requesting manufacturer or importer. |
| --- | --- |

(c)

transmit the codes electronically to the requesting manufacturer or importer.

4.   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); |
| --- | --- |

(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, as established under Article 26; and |
| --- | --- |

(b)

transmit the codes along with the information referred to in paragraph 2 via the router to the secondary repository, as established under Article 26; and

| (c) | transmit the codes electronically to the requesting economic operators. |
| --- | --- |

(c)

transmit the codes electronically to the requesting economic operators.

5.   Within one working day, economic operators may cancel a request which was sent pursuant to paragraph 1 by means of a recall message as further defined in point 5 of Section 5 of Chapter II of Annex II, in the format indicated therein.

6.   Aggregated level UIs issued by competent ID issuers shall not be reused.

CHAPTER III

IDENTIFIER CODES FOR ECONOMIC OPERATORS, FACILITIES AND MACHINES

Article 14

Request for an economic operator identifier code

1.   Economic operators and operators of first retail outlets shall apply for an economic operator identifier code from the ID issuer competent for each Member State in which they operate at least one facility. Importers shall apply for an identifier code from the ID issuer competent for each Member State on whose market they place their products.

2.   Economic operators and operators of first retail outlets introducing a request pursuant to paragraph 1 shall provide the information listed in point 1.1 of Section 1 of Chapter II of Annex II, in the format indicated therein.

3.   For operators of first retail outlets the obligation to apply for an economic operator identifier code may also be discharged by any other registered economic operator. Such registration by the third party shall be subject to the consent of the operator of the first retail outlet. The third party shall inform the operator of the first retail outlet of the full details of the registration, including the allocated economic operator identifier code.

4.   Economic operators and operators of first retail outlets shall inform the ID issuer of any economic operator identifier codes allocated to them by other ID issuers. If not available at the time of registration, economic operators shall provide that information at the latest within two working days from the receipt of the economic operator identifier codes allocated by another ID issuer.

5.   Any modification of the information submitted in the initial application form and any cessation of the operator activities shall be notified by the relevant operator to the ID issuer without delay, in the formats indicated in points 1.2. and 1.3. of Section 1 of Chapter II of Annex II.

Article 15

Issuing and registration of economic operator identifier codes

1.   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 |
| --- | --- |

(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. |
| --- | --- |

(b)

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

2.   Within two working days, the ID issuer shall transmit the code to the requesting operator.

3.   All the information submitted to the ID issuer in accordance with Article 14(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.

4.   In duly justified cases, Member States may, in accordance with their national laws, require the ID issuer to deactivate an economic operator identifier code. In such cases the Member State shall inform the economic operator or the operator of a first retail outlet of the deactivation, together with the grounds for such deactivation. The deactivation of an economic operator identifier code shall lead to the automatic deactivation of related facility identifier codes and machine identifier codes.

5.   Economic operators and operators of first retail outlets shall exchange information on their respective economic operator identifier codes in order to allow economic operators to record and transmit the transactional information, as provided under Article 33.

Article 16

Request for a facility identifier code

1.   All facilities from manufacturing to the first retail outlet shall be identified by a code (‘facility identifier code’) generated by the ID issuer competent for the territory in which the facility is located.

2.   Economic operators and operators of first retail outlets shall apply for a facility identifier code providing 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.

3.   For first retail outlets, the obligation to apply for a facility identifier code shall lie with the operator of the first retail outlet. This obligation may also be discharged by any other registered economic operator, who may act on behalf of the operator of the first retail outlet. The registration by the third party shall be subject to the consent of the operator of the first retail outlet. The third party shall inform the operator of the first retail outlet about the full details of the registration, including the allocated facility identifier code.

4.   The obligation to apply for a facility identifier code related to manufacturing facilities located outside the Union shall lie with the importer established inside the Union. The importer shall apply to any ID issuer appointed by a Member State on whose market they place their products. The registration by the importer shall be subject to the consent of the entity responsible for the third country manufacturing facility. The importer shall inform the economic operator responsible for the third country manufacturing facility about the full details of registration, including the allocated facility identifier code.

5.   Any modification of the information submitted in the initial application form and any facility closure shall be notified by the economic operator to the ID issuer without delay, in the formats indicated in points 1.5 and 1.6 of Section 1 of Chapter II of Annex II.

Article 17

Issuing and registration of facility identifier codes

1.   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 |
| --- | --- |

(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. |
| --- | --- |

(b)

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

2.   Within two working days from the receipt of the request, the ID issuer shall transmit the code to the requesting operator.

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.

4.   In duly justified cases, Member States may require the ID issuer to deactivate a facility identifier code. In such cases the Member State shall inform the economic operator or the operator of a first retail outlet of the deactivation, together with the grounds for such deactivation. The deactivation of a facility identifier code shall lead to the automatic deactivation of related machine identifier codes.

5.   Economic operators and operators of first retail outlets shall exchange the information on their respective economic operator identifier codes in order to allow economic operators to record and transmit the information on product movements, as provided under Article 32.

Article 18

Request for a machine identifier code

1.   Each machine shall be identified by a code (‘machine identifier code’) generated by the ID issuer competent for the territory in which the machine is located.

2.   Manufacturers and importers shall apply for a machine identifier code by providing to the ID issuer the information listed in point 1.7. of Section 1 of Chapter II of Annex II, in the format indicated therein.

3.   The obligation to apply for a machine identifier code related to machines located in manufacturing facilities outside the Union shall lie with the importer established inside the Union. The importer shall apply to any ID issuer appointed by a Member State on whose market they place their products. The registration by the importer shall be subject to the consent of the entity responsible for the third country manufacturing facility. The importer shall inform the economic operator responsible for the third country manufacturing facility as to the full details of the registration, including the allocated machine identifier code.

4.   Any modification of the information submitted in the initial application form and any decommissioning of the registered machines shall be notified by the manufacturer or the importer to the ID issuer without delay, in the formats indicated in points 1.8 and 1.9 of Section 1 of Chapter II of Annex II.

Article 19

Issuing and registration of machine identifier codes

1.   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 |
| --- | --- |

(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. |
| --- | --- |

(b)

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

2.   Within two working days, the ID issuer shall transmit the code to the requesting operator.

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 relevant ID issuer.

4.   In duly justified cases, Member States may require the ID issuer to deactivate a machine identifier code. In such cases the Member State shall inform the manufacturers and importers of the deactivation, together with the grounds for such deactivation.

Article 20

Transfer of offline flat-files and registries

1.   ID issuers shall establish offline flat-files, as well as registries relating to the information referred to in Articles 14(2), 16(2) and 18(2), along with explanatory notes on the structures thereof.

2.   Offline flat-files shall be no larger than two gigabytes per ID issuer. Each line of the flat-file shall hold one record with fields separated by delimiters such as commas or tabs.

3.   ID issuers shall ensure that an up-to-date copy of all offline flat-files, registries and related explanatory notes are electronically provided via the router to the secondary repository.

4.   Member States may adapt the size limit for offline flat-files referred to in paragraph 2, taking into account both the average size of available memory installed on the verification devices used for offline checks of unique identifiers and the total number of ID issuers.

CHAPTER IV

DATA CARRIERS

Article 21

Data carriers for the Unique Identifiers

1.   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; |
| --- | --- |

(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; |
| --- | --- |

(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. |
| --- | --- |

(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.

2.   In the case of unit level UIs delivered electronically, manufacturers and importers are responsible for encoding unit level UIs in accordance with paragraph 1.

3.   In the case of unit level UIs delivered physically, ID issuers are responsible for encoding the codes generated pursuant to Article 8(2), in accordance with paragraph 1.

4.   By way of derogation from paragraph 1, manufacturers and importers may add the time stamp separately from the data carrier in the format YYMMDDhh as a human readable code.

5.   Aggregated level UIs shall be encoded by economic operators 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; |
| --- | --- |

(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; |
| --- | --- |

(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 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. |
| --- | --- |

(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.

6.   In order to distinguish the data carriers referred to in paragraphs 1 and 5 from any other data carrier placed on unit packets or aggregated packaging, economic operators may add the marking ‘TTT’ next to such data carriers.

Article 22

Quality of the optical data carriers

1.   Economic operators shall ensure high readability of the optical data carriers. A quality of the optical data carriers rated at least 3.5 in accordance with ISO/IEC 15415:2011 for the two-dimensional data carriers, or in accordance with ISO/IEC 15416:2016 for the linear symbols shall be presumed to fulfil the requirements set out in this Article.

2.   Economic operators shall ensure that the optical data carriers are capable of remaining readable for at least five years after their creation.

Article 23

Human-readable code

1.   Economic operators shall ensure that each data carrier includes a human-readable code that enables electronic access to the information related to the unique identifiers stored in the repositories system.

2.   Where the dimensions of the packaging allow, the human-readable code shall be adjacent to the optical data carrier carrying the unique identifier.

CHAPTER V

REPOSITORIES SYSTEM

Article 24

Components of the repositories system

1.   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’); |
| --- | --- |

(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’); |
| --- | --- |

(b)

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

| (c) | a routing service (‘router’) set up and managed by the provider of the secondary repository system. |
| --- | --- |

(c)

a routing service (‘router’) set up and managed by the provider of the secondary repository system.

2.   The sub-systems referred to in paragraph 1 shall be fully interoperable with one another, irrespective of the service provider used.

Article 25

General characteristics of the repositories system

1.   The repositories system shall satisfy the following conditions:

| (a) | it shall allow for functional integration of the repositories system into the traceability system, as well as uninterrupted electronic data exchange between the repositories system and other relevant components of the traceability system; |
| --- | --- |

(a)

it shall allow for functional integration of the repositories system into the traceability system, as well as uninterrupted electronic data exchange between the repositories system and other relevant components of the traceability system;

| (b) | it shall allow for electronic identification and authentication of tobacco products, at unit packet and aggregation level, in accordance with the requirements set out in this Regulation; |
| --- | --- |

(b)

it shall allow for electronic identification and authentication of tobacco products, at unit packet and aggregation level, in accordance with the requirements set out in this Regulation;

| (c) | it shall allow for automatic deactivation of unique identifiers in accordance with the rules set out in Article 5; |
| --- | --- |

(c)

it shall allow for automatic deactivation of unique identifiers in accordance with the rules set out in Article 5;

| (d) | it shall ensure electronic receipt and storing of information recorded and sent to the repositories system by economic operators and ID issuers, in accordance with the requirements of this Regulation; |
| --- | --- |

(d)

it shall ensure electronic receipt and storing of information recorded and sent to the repositories system by economic operators and ID issuers, in accordance with the requirements of this Regulation;

| (e) | it shall ensure storage of data for a minimum period of five years as of the moment the data are uploaded into the repositories system; |
| --- | --- |

(e)

it shall ensure storage of data for a minimum period of five years as of the moment the data are uploaded into the repositories system;

| (f) | it shall allow for automatic status messaging to economic operators, and to Member States and the Commission as requested, such as in the event of success, error or changes related to reporting activities, in accordance with the requirements of this Regulation; |
| --- | --- |

(f)

it shall allow for automatic status messaging to economic operators, and to Member States and the Commission as requested, such as in the event of success, error or changes related to reporting activities, in accordance with the requirements of this Regulation;

| (g) | it shall allow for automatic validation of messages received from economic operators, including refusal of incorrect or incomplete messages, in particular reporting activities related to non-registered or duplicated unique identifiers, whereby the repositories system shall store the information concerning any refused message; |
| --- | --- |

(g)

it shall allow for automatic validation of messages received from economic operators, including refusal of incorrect or incomplete messages, in particular reporting activities related to non-registered or duplicated unique identifiers, whereby the repositories system shall store the information concerning any refused message;

| (h) | it shall ensure messaging between all of its components which shall take place instantaneously, in accordance with the requirements of this Regulation, in particular the overall response time of the repositories system in sending acknowledgment messages, not considering the speed of the internet connection of the end user, which shall be no more than 60 seconds; |
| --- | --- |

(h)

it shall ensure messaging between all of its components which shall take place instantaneously, in accordance with the requirements of this Regulation, in particular the overall response time of the repositories system in sending acknowledgment messages, not considering the speed of the internet connection of the end user, which shall be no more than 60 seconds;

| (i) | it shall ensure continuous availability of all components and services with a monthly uptime of at least 99,5 % and sufficient back-up mechanisms in place; |
| --- | --- |

(i)

it shall ensure continuous availability of all components and services with a monthly uptime of at least 99,5 % and sufficient back-up mechanisms in place;

| (j) | it shall be guarded by security procedures and systems ensuring that access to the repositories and download of the data stored therein is only granted to persons authorised according to this Regulation; |
| --- | --- |

(j)

it shall be guarded by security procedures and systems ensuring that access to the repositories and download of the data stored therein is only granted to persons authorised according to this Regulation;

| (k) | it shall be accessible by the competent authorities of Member States and by the Commission. National administrators designated by the Member States and Commission services shall be granted access rights enabling them to create, manage, and withdraw user access rights for repositories, and related operations stipulated in this Chapter, via a graphical user management interface. The graphical user management interface shall be compatible with Regulation (EU) No 910/2014, in particular the relevant reusable solutions provided as building blocks under the telecommunication part of the Connecting Europe Facility. National administrators designated by the Member States shall be able to grant subsequent access rights to other users under their responsibility; |
| --- | --- |

(k)

it shall be accessible by the competent authorities of Member States and by the Commission. National administrators designated by the Member States and Commission services shall be granted access rights enabling them to create, manage, and withdraw user access rights for repositories, and related operations stipulated in this Chapter, via a graphical user management interface. The graphical user management interface shall be compatible with Regulation (EU) No 910/2014, in particular the relevant reusable solutions provided as building blocks under the telecommunication part of the Connecting Europe Facility. National administrators designated by the Member States shall be able to grant subsequent access rights to other users under their responsibility;

| (l) | it shall enable Member States and the Commission to carry out downloads of full and selected sets of data stored in a repository; |
| --- | --- |

(l)

it shall enable Member States and the Commission to carry out downloads of full and selected sets of data stored in a repository;

| (m) | it shall maintain a complete record (‘audit trail’) of all operations concerning the stored data of the users performing those operations and of the nature of these operations, including the history of users access. The audit trail shall be created when the data is uploaded for the first time and, notwithstanding any additional national requirements, be maintained until at least five years after. |
| --- | --- |

(m)

it shall maintain a complete record (‘audit trail’) of all operations concerning the stored data of the users performing those operations and of the nature of these operations, including the history of users access. The audit trail shall be created when the data is uploaded for the first time and, notwithstanding any additional national requirements, be maintained until at least five years after.

2.   Data stored in the repositories system shall be used only for the purposes referred to in Directive 2014/40/EU and this Regulation.

Article 26

Primary repositories

1.   Each manufacturer and importer shall ensure the establishment of a primary repository. To that end each manufacturer and importer shall contract an independent third party provider, in accordance with the contractual requirements set out in Commission Delegated Regulation (EU) 2018/573 (7). The selection of the independent third party shall take place in accordance with the procedural rules laid down in Annex I, Part A.

2.   Each primary repository shall exclusively host information which relates to the tobacco products of the manufacturer or importer who contracted the repository.

3.   Whenever data are received by the primary repository on the basis of a reporting activity, or for any other permitted reason, it shall be forwarded to the secondary repository instantaneously.

4.   In forwarding all data received to the secondary repository, the primary repositories shall use the data format and data exchange modalities defined by the secondary repository.

5.   Primary repositories shall store the data in accordance with the common data dictionary provided by the secondary repository.

6.   Member States, the Commission, and external auditors approved by the Commission shall be able to carry out basic query requests in relation to all data stored in a primary repository.

Article 27

Secondary repository

1.   A single secondary repository containing a copy of all data stored in primary repositories shall be established. The operator of the secondary repository shall be appointed from among the providers of primary repositories in accordance with the procedure laid down in Annex I, Part B.

2.   The secondary repository shall provide for graphical and non-graphical user interfaces that enable Member States and the Commission to access and query the data stored in the repositories system, using all commonly available database search functions, in particular by remotely carrying out the following operations:

| (a) | retrieval of any information concerning one or multiple unique identifier(s), including the comparison and cross-checking of multiple unique identifiers and the related information, in particular their location in the supply chain; |
| --- | --- |

(a)

retrieval of any information concerning one or multiple unique identifier(s), including the comparison and cross-checking of multiple unique identifiers and the related information, in particular their location in the supply chain;

| (b) | creation of lists and statistics, such as product stocks and inflow/outflow numbers, associated with one or multiple elements of reporting information listed as Data Fields in Annex II; |
| --- | --- |

(b)

creation of lists and statistics, such as product stocks and inflow/outflow numbers, associated with one or multiple elements of reporting information listed as Data Fields in Annex II;

| (c) | identification of all tobacco products that have been reported by an economic operator to the system, including the products reported as recalled, withdrawn, stolen, missing or intended for destruction. |
| --- | --- |

(c)

identification of all tobacco products that have been reported by an economic operator to the system, including the products reported as recalled, withdrawn, stolen, missing or intended for destruction.

3.   The user interfaces referred to in paragraph 2 shall enable each Member State and the Commission to define individual rules for:

| (a) | automatic alerting based on exceptions and specific reporting events, such as abrupt fluctuations or irregularities in trade, attempts to introduce duplicate unique identifiers into the system, deactivation of the identifiers referred to in Articles 15(4), 17(4) and 19(4), or where a product is indicated by economic operators as stolen or missing; |
| --- | --- |

(a)

automatic alerting based on exceptions and specific reporting events, such as abrupt fluctuations or irregularities in trade, attempts to introduce duplicate unique identifiers into the system, deactivation of the identifiers referred to in Articles 15(4), 17(4) and 19(4), or where a product is indicated by economic operators as stolen or missing;

| (b) | the receipt of periodic reports based on any combination of the elements of reporting information listed as Data Field in Annex II. |
| --- | --- |

(b)

the receipt of periodic reports based on any combination of the elements of reporting information listed as Data Field in Annex II.

4.   Automatic alerts and periodic reports referred to in paragraph 3 shall be forwarded to recipient addresses indicated by Member States and the Commission such as individual email addresses and/or internet Protocol (IP) addresses belonging to external systems used and managed by national authorities or the Commission.

5.   The user interfaces referred to in paragraph 2 shall enable Member States and the Commission to connect remotely to the data stored in the repositories system with the analytical software of their choice.

6.   The user interfaces referred to in paragraph 2 shall be provided in the official languages of the Union.

7.   The overall response time of the repository to any given query or alert trigger, not considering the speed of the internet connection of the end user, shall be no more than 5 seconds for the data stored for less than 2 years and no more than 10 seconds for the data stored for 2 years or more, in at least 99 % of all queries and automatic alerts foreseen under paragraphs 2 and 3.

8.   The overall time between the arrival of reporting activity data and its accessibility, via the graphical and non-graphical interfaces, in the primary and secondary repositories shall be no more than 60 seconds in at least 99 % of all data transfer activities.

9.   The repository shall allow for the receipt, storing and making available of offline flat-files for the purpose of updating verification devices used by Member States for offline decoding of unique identifiers.

10.   The provider of the secondary repository shall establish and maintain a register of the information transferred to it in accordance with Article 20(3). A record of the information stored in the register shall be kept for as long as the traceability system is operational.

11.   Member States and the Commission shall retain the right to enter into additional service level agreements with the provider of the secondary repository for the purpose of contracting the latter to carry out additional services not provided for by this Regulation. The provider of the secondary repository may charge proportionate fees for providing such additional services.

12.   The repository services provided to Member States and the Commission under this Article shall be compatible with Regulation (EU) No 910/2014 and in particular allow for the use of reusable solutions provided as building blocks under the telecommunication part of the Connecting Europe Facility.

Article 28

Coordination tasks of the provider of the secondary repository

1.   The provider operating the secondary repository shall communicate to providers operating primary repositories, ID issuers and economic operators, the list of specifications required for the data exchange with the secondary repository and the router. All specifications shall be based on non-proprietary open standards.

The list referred to in the first subparagraph shall be communicated no later than two months following the date when the provider operating the secondary repository was selected.

2.   On the basis of the information listed in Annex II, the provider operating the secondary repository shall establish a common data dictionary. The common data dictionary shall refer to labels of data fields in the human readable format. The common data dictionary shall be communicated to the providers operating primary repositories no later than two months following the date when the provider operating the secondary repository was selected.

3.   Whenever necessary to ensure the effective operation of the repositories system in accordance with the requirements of this Regulation, the provider operating the secondary repository shall update the list referred to in paragraph 1 and the common data dictionary referred to in paragraph 2. Any such update shall be communicated to the providers operating primary repositories at least two months prior to the date of implementing the update into the system.

Article 29

Router

1.   The provider of the secondary repository shall set up and manage a router.

2.   Data exchange between the router and the primary and secondary repositories shall take place using the data format and data exchange modalities defined by the router.

3.   Data exchange between the router and an ID issuer shall take place using the data format and data exchange modalities defined by the router.

4.   Economic operators other than manufacturers and importers shall send the information recorded pursuant to Article 15 of Directive 2014/40/EU and in accordance with this Regulation to the router, which shall transfer it to the primary repository serving the manufacturer or importer whose tobacco products are concerned. A copy of those data shall be transferred instantaneously to the secondary repository system.

Article 30

Costs of the repositories system

1.   All 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 |
| --- | --- |

(a)

to the services rendered; and

| (b) | to the amount of unit level UIs requested over a given period of time. |
| --- | --- |

(b)

to the amount of unit level UIs requested over a given period of time.

2.   The costs, as applicable, of establishing, operating and maintaining the secondary repository and the router shall be transmitted to manufacturers and importers of tobacco products through the costs charged to them by the providers of the primary repositories.

Article 31

Deadline for the establishment of the repositories system

The repositories system shall be established and functional for testing purposes by 20 March 2019.

CHAPTER VI

RECORDING AND TRANSMITTING

Article 32

Recording and transmission of information on product movements

1.   To allow the determination of the actual shipment route of unit packets manufactured in, or imported into the Union, economic operators shall record the following events:

| (a) | application of unit level UIs on unit packets; |
| --- | --- |

(a)

application of unit level UIs on unit packets;

| (b) | application of aggregated level UIs on aggregated packaging; |
| --- | --- |

(b)

application of aggregated level UIs on aggregated packaging;

| (c) | dispatch of tobacco products from a facility; |
| --- | --- |

(c)

dispatch of tobacco products from a facility;

| (d) | arrival of tobacco products at a facility; |
| --- | --- |

(d)

arrival of tobacco products at a facility;

| (e) | trans-loading. |
| --- | --- |

(e)

trans-loading.

2.   Manufacturers and importers shall transmit the information listed in points 3.1 to 3.5 of Section 3 of Chapter II of Annex II, in the format indicated therein, to the primary repository contracted by them. All other economic operators shall transmit the information listed in points 3.1 to 3.5 of Section 3 of Chapter II of Annex II, in the format indicated therein, via the router.

3.   For disaggregation of aggregated packaging marked pursuant to Article 10(4), where an economic operator intends to reuse an aggregated level UI in any future operations, manufacturers and importers shall transmit the information listed in point 3.6 of Section 3 of Chapter II of Annex II, in the format indicated therein, to the primary repository contracted by them. All other economic operators shall transmit the information listed in point 3.6 of Section 3 of Chapter II of Annex II, in the format indicated therein, via the router.

4.   For deliveries to multiple first retail outlets by means of a vending van, manufactures and importers shall transmit the information listed in point 3.7 of Section 3 of Chapter II of Annex II, in the format indicated therein, to the primary repository contracted by them. All other economic operators shall transmit the information listed in point 3.7 of Section 3 of Chapter II of Annex II, in the format indicated therein, via the router.

5.   For dispatch and trans-loading of unit or aggregated packaging of tobacco products with total weight below 10 kg destined outside the Union, Member States in which the dispatch facility is located may allow the recording obligation referred to in paragraph 1 in points (c) to (e) to be discharged by means of providing access to the logistic or postal operator's own track and trace system records.

6.   If following the application of the unique identifier tobacco products are destroyed or stolen, economic operators shall promptly transmit a deactivation request in accordance with the scope and format specified in point 2.3 of Section 2 of Chapter II of Annex II.

7.   The information concerning the event shall be deemed to have been transmitted correctly upon the positive acknowledgement by the primary repository or the router. The acknowledgement shall include a message recall code to be applied by the economic operator if the original message needs to be cancelled.

Article 33

Recording and transmission of transactional information

1.   To allow the determination of the transactional information referred to in Article 15(2), points (j) and (k) of Directive 2014/40/EU, economic operators shall record the following events:

| (a) | issuing of the order number; |
| --- | --- |

(a)

issuing of the order number;

| (b) | issuing of the invoice; |
| --- | --- |

(b)

issuing of the invoice;

| (c) | receipt of the payment. |
| --- | --- |

(c)

receipt of the payment.

2.   Manufacturers and importers shall transmit the information listed in Section 4 of Chapter II of Annex II, in the format indicated therein, to the primary repository contracted by them. All other economic operators shall transmit the information listed in Section 4 of Chapter II of Annex II, in the format indicated therein, via the router.

3.   The responsibility for recording and transmitting the information referred to in paragraph 2 shall lie with the vendor.

4.   The information referred to in paragraph 2 shall be deemed to have been transmitted correctly upon the positive acknowledgement by the primary repositories or the router. The acknowledgement shall include a message recall code to be applied by the economic operator if the original message needs to be cancelled.

Article 34

Time frame for transmission of required information

1.   Economic operators shall transmit the information referred to in Article 32(1) points (a), (b) and (d), Articles 32(3) and (4), and Article 33(1), within 3 hours from the occurrence of the event. The information referred to in Article 32 shall be transmitted in the order of the occurrence of the events.

2.   For the purposes of paragraph 1, the events referred to in Article 33 shall be deemed to occur at the moment when they can be associated with the relevant unit packets for the first time.

3.   Economic operators shall transmit the information concerning the dispatch of tobacco products from a facility and trans-loading referred to in Article 32(1) points (c) and (e), within 24 hours prior to the occurrence of the event.

4.   By way of derogation from paragraph 1, economic operators may transmit the information referred to in Article 32(1) points (a), (b) and (d), Articles 32(3) and (4), and Article 33(1), within 24 hours from the occurrence of the event, if they fulfil any of the following conditions:

| (a) | they, or where applicable, the group of undertakings to which they belong, handled less than 120 million unit level UIs at Union level during the previous calendar year; |
| --- | --- |

(a)

they, or where applicable, the group of undertakings to which they belong, handled less than 120 million unit level UIs at Union level during the previous calendar year;

| (b) | they are small and medium enterprises within the meaning of Commission Recommendation 2003/361/EC. |
| --- | --- |

(b)

they are small and medium enterprises within the meaning of Commission Recommendation 2003/361/EC.

5.   Paragraph 1 shall apply from 20 May 2028. Until that date all economic operators may transmit the information referred to in paragraph 1 within 24 hours from the occurrence of the event.

CHAPTER VII

FINAL PROVISIONS

Article 35

Independence

1.   ID issuers, providers of repository services and anti-tampering devices as well as, where applicable, their subcontractors shall be independent and exercise their functions impartially.

2.   For the purposes of paragraph 1, the following criteria shall be used to assess independence:

| (a) | independence from the tobacco industry in terms of legal form, organisation and decision making. In particular it shall be assessed whether the undertaking or the group of undertakings is not under the direct or indirect control of the tobacco industry, including a minority shareholding; |
| --- | --- |

(a)

independence from the tobacco industry in terms of legal form, organisation and decision making. In particular it shall be assessed whether the undertaking or the group of undertakings is not under the direct or indirect control of the tobacco industry, including a minority shareholding;

| (b) | independence from the tobacco industry in financial terms, which will be presumed if, before assuming their functions the undertaking or the group of undertakings concerned generates less than 10 % of its annual worldwide turnover, excluding VAT and any other indirect taxes, from goods and services supplied to the tobacco sector over the past two calendar years, as may be determined on the basis of the most recent approved accounts. For each subsequent calendar year, the annual worldwide turnover, excluding VAT and any other indirect taxes, from goods and services supplied to the tobacco sector shall not exceed 20 %; |
| --- | --- |

(b)

independence from the tobacco industry in financial terms, which will be presumed if, before assuming their functions the undertaking or the group of undertakings concerned generates less than 10 % of its annual worldwide turnover, excluding VAT and any other indirect taxes, from goods and services supplied to the tobacco sector over the past two calendar years, as may be determined on the basis of the most recent approved accounts. For each subsequent calendar year, the annual worldwide turnover, excluding VAT and any other indirect taxes, from goods and services supplied to the tobacco sector shall not exceed 20 %;

| (c) | absence of conflicts of interests with the tobacco industry of the persons responsible for the management of the undertaking or the group of undertakings, including members of the board of directors or any other form of governing body. In particular, they:






  (1) | shall not have participated in company structures of the tobacco industry for the last five years; |
| --- | --- | --- |

(c)

absence of conflicts of interests with the tobacco industry of the persons responsible for the management of the undertaking or the group of undertakings, including members of the board of directors or any other form of governing body. In particular, they:

(1)

shall not have participated in company structures of the tobacco industry for the last five years;

| (2) | shall act independently from any pecuniary or non-pecuniary interest linked to the tobacco industry, including possession of stocks, participation in private pension programmes or interest held by their partners, spouses or direct relatives in the ascending or descending line. |
| --- | --- |

(2)

shall act independently from any pecuniary or non-pecuniary interest linked to the tobacco industry, including possession of stocks, participation in private pension programmes or interest held by their partners, spouses or direct relatives in the ascending or descending line.

3.   Where ID issuers, providers of repository services and providers of anti-tampering devices have recourse to sub-contractors, they shall remain responsible for ensuring compliance by those subcontractors with the independence criteria set out in paragraph 2.

4.   For the purposes of complying with their obligations under Article 3(8)(a) Member States, as well as the Commission may require ID issuers, providers of repository services and providers of anti-tampering devices, including where applicable their sub-contractors to provide them with documents necessary to assess compliance with the criteria set out in paragraph 2. Such documents may include annual declarations of conformity with the independence criteria set out in paragraph 2. Member States and the Commission may require that the annual declarations include a full list of services provided to the tobacco industry during the last calendar year as well as individual declarations of financial independence from the tobacco industry provided by all management members of the independent provider.

5.   Any change in circumstances related to the criteria referred to in paragraph 2, capable of affecting the independence of ID issuers, providers of repository services and providers of anti-tampering devices (including, where applicable, their subcontractors), that subsist for two consecutive calendar years, shall be communicated without delay to the relevant Member States and to the Commission.

6.   Where, information obtained in accordance with paragraph 4, or the communication referred to in paragraph 5, discloses that providers of repository services and providers of anti-tampering devices (including, where applicable, their subcontractors), no longer meet the requirements laid down in paragraph 2, then within a reasonable time period and at the latest by the end of the calendar year following the calendar year in which the information or communication was received, Member States and, in relation to the provider of secondary repository, the Commission shall take all measures to ensure compliance with the criteria set out in paragraph 2.

7.   ID issuers, providers of repository services and providers of anti-tampering devices shall inform without delay the relevant Member States and the Commission about any occurrences of threats or other attempts at exercising undue influence that may actually or potentially undermine their independence.

8.   Public authorities or undertakings governed by public law along with their subcontractors shall be presumed independent from the tobacco industry.

9.   The procedures governing the appointment of ID issuers, providers of repository services and providers of anti-tampering devices and the monitoring of their compliance with the independence criteria set out in paragraph 2 shall be subject to periodic review by the Commission with a view to assessing their conformity with the requirements of Article 15 of Directive 2014/40/EU and this Regulation. Conclusions of the review shall be published and form part of the report on the application of Directive 2014/40/EU provided for under Article 28 of that Directive.

Article 36

Security and interoperability of communications and data

1.   All electronic communication provided for under this Regulation shall be carried out using secure means. Applicable security protocols and connectivity rules shall be based on non-proprietary open standards. They shall be established by:

| (a) | the ID issuer for communications between the ID issuer and the economic operators registering with the ID issuer or requesting unique identifiers; |
| --- | --- |

(a)

the ID issuer for communications between the ID issuer and the economic operators registering with the ID issuer or requesting unique identifiers;

| (b) | the providers of the primary repositories for communications between the primary repositories and manufactures or importers; |
| --- | --- |

(b)

the providers of the primary repositories for communications between the primary repositories and manufactures or importers;

| (c) | the provider of the secondary repository for communications between the secondary repository and the router and:






  i. | the ID issuers; |
| --- | --- | --- |

(c)

the provider of the secondary repository for communications between the secondary repository and the router and:

i.

the ID issuers;

| ii. | the primary repositories; and |
| --- | --- |

ii.

the primary repositories; and

| iii. | economic operators using the router, i.e. economic operators other than manufacturers and importers. |
| --- | --- |

iii.

economic operators using the router, i.e. economic operators other than manufacturers and importers.

2.   Providers of primary and secondary repositories shall be responsible for the security and integrity of hosted data. Data portability shall be secured in accordance with the common data dictionary set out in Article 28.

3.   For all transfers of data, the sending party is responsible for the completeness of transferred data. In order for the sending party to discharge this obligation, the receiving party shall acknowledge the receipt of transferred data including a checksum value of actual transmitted data or any alternative mechanism allowing for validating the integrity of transmission, in particular its completeness.

Article 37

Transitional provision

1.   Cigarettes and roll-your-own tobacco that were manufactured in the Union or imported into the Union before 20 May 2019 and not marked by means of unit level UIs in accordance with Article 6 may remain in free circulation until 20 May 2020. In relation to these tobacco products which are allowed to remain in free circulation, but not marked with a unit level UIs, the obligations referred to in Chapter VI shall not apply.

2.   Tobacco products other than cigarettes and roll-your-own tobacco that were manufactured in the Union or imported into the Union before 20 May 2024 and not marked by means of unit level UIs in accordance with Article 6 may remain in free circulation until 20 May 2026. In relation to these tobacco products which are allowed to remain in free circulation, but not marked with a unit level UIs, the obligations referred to in Chapter VI shall not apply.

Article 38

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 December 2017.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 127, 29.4.2014, p. 1.

1

(2)  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. 10).

2

(3)  Council Decision (EU) 2016/1749 of 17 June 2016 on the conclusion, on behalf of the European Union, of the Protocol to Eliminate Illicit Trade in Tobacco Products to the World Health Organisation's Framework Convention on Tobacco Control, with the exception of its provisions falling within the scope of Title V of Part Three of the Treaty on the Functioning of the European Union (OJ L 268, 1.10.2016, p. 1). Council Decision (EU) 2016/1750 of 17 June 2016 on the conclusion, on behalf of the European Union, of the Protocol to Eliminate Illicit Trade in Tobacco Products to the World Health Organisation's Framework Convention on Tobacco Control, as regards its provisions on obligations related to judicial cooperation in criminal matters and the definition of criminal offences (OJ L 268, 1.10.2016, p. 6).

3

(4)  Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC (OJ L 257, 28.8.2014, p. 73).

4

(5)  Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).

5

(6)  Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).

6

(7)  Commission Delegated Regulation (EU) 2018/573 of 15 December 2017 on key elements of data storage contracts to be concluded as part of a traceability system for tobacco products (see page 1 of this Official Journal).

7

---

ANNEX I

SELECTION PROCEDURE FOR INDEPENDENT THIRD PARTY PROVIDERS OF REPOSITORY SYSTEMS

PART A

The following procedures shall apply to the selection of an independent third party provider operating a primary repository:

| 1. | Each manufacturer and importer of cigarettes and roll-your-own tobacco shall notify to the Commission, no later than two months following the entry into force of Delegated Regulation (EU) 2018/573:






  (a) | the identity of the third party that it proposes to appoint to operate a primary repository (the ‘proposed provider’), and |
| --- | --- | --- |

1.

Each manufacturer and importer of cigarettes and roll-your-own tobacco shall notify to the Commission, no later than two months following the entry into force of Delegated Regulation (EU) 2018/573:

(a)

the identity of the third party that it proposes to appoint to operate a primary repository (the ‘proposed provider’), and

| (b) | a draft data storage contract containing the key elements laid down in the Delegated Regulation for approval by the Commission. |
| --- | --- |

(b)

a draft data storage contract containing the key elements laid down in the Delegated Regulation for approval by the Commission.

| 2. | The notification shall be accompanied by:






  (a) | the written declaration of technical and operational expertise, referred to in Article 4 of Delegated Regulation (EU) 2018/573, |
| --- | --- | --- |

2.

The notification shall be accompanied by:

(a)

the written declaration of technical and operational expertise, referred to in Article 4 of Delegated Regulation (EU) 2018/573,

| (b) | the written declaration of legal and financial independence, referred to in Article 8 of Delegated Regulation (EU) 2018/573, and |
| --- | --- |

(b)

the written declaration of legal and financial independence, referred to in Article 8 of Delegated Regulation (EU) 2018/573, and

| (c) | a table setting out the correspondence between the contractual clauses and the requirements laid down in Delegated Regulation (EU) 2018/573. |
| --- | --- |

(c)

a table setting out the correspondence between the contractual clauses and the requirements laid down in Delegated Regulation (EU) 2018/573.

| 3. | The Commission shall, within three months of the date of receiving the notification, and on the basis of an examination of the suitability of the proposed provider, in particular, as regards its independence and technical capacities as referred to in Article 15(8) of Directive 2014/40/EU, approve or reject the proposed provider and the draft contract. In the absence of a reply by the Commission within that timeframe, the provider and the draft contract shall be deemed to be approved. |
| --- | --- |

3.

The Commission shall, within three months of the date of receiving the notification, and on the basis of an examination of the suitability of the proposed provider, in particular, as regards its independence and technical capacities as referred to in Article 15(8) of Directive 2014/40/EU, approve or reject the proposed provider and the draft contract. In the absence of a reply by the Commission within that timeframe, the provider and the draft contract shall be deemed to be approved.

| 4. | Where the Commission does not approve the proposed provider or the draft contract, or where it considers that the contract does not incorporate the key elements laid down in Delegated Regulation (EU) 2018/573, the manufacturer or importer concerned shall, within one month of being informed by the Commission, propose an alternative provider and/or make necessary amendments to the draft contract for further consideration by the Commission. |
| --- | --- |

4.

Where the Commission does not approve the proposed provider or the draft contract, or where it considers that the contract does not incorporate the key elements laid down in Delegated Regulation (EU) 2018/573, the manufacturer or importer concerned shall, within one month of being informed by the Commission, propose an alternative provider and/or make necessary amendments to the draft contract for further consideration by the Commission.

| 5. | Once the proposed provider and the draft contract have been approved, the manufacturers and importers shall, within two weeks of such approval, provide in electronic format:






  (a) | a copy of the contract signed by both parties, and |
| --- | --- | --- |

5.

Once the proposed provider and the draft contract have been approved, the manufacturers and importers shall, within two weeks of such approval, provide in electronic format:

(a)

a copy of the contract signed by both parties, and

| (b) | the declarations required to be provided as part of the contract under Articles 4 and 8 of Delegated Regulation (EU) 2018/573. |
| --- | --- |

(b)

the declarations required to be provided as part of the contract under Articles 4 and 8 of Delegated Regulation (EU) 2018/573.

| 6. | Manufacturers and importers of tobacco products other than cigarettes and roll-your-own tobacco shall notify to the Commission, by 31 December 2022, the identity of the proposed provider, a draft data storage contract containing the key elements laid down in Delegated Regulation (EU) 2018/573 for approval by the Commission, and the additional documentation referred to in paragraph 2. |
| --- | --- |

6.

Manufacturers and importers of tobacco products other than cigarettes and roll-your-own tobacco shall notify to the Commission, by 31 December 2022, the identity of the proposed provider, a draft data storage contract containing the key elements laid down in Delegated Regulation (EU) 2018/573 for approval by the Commission, and the additional documentation referred to in paragraph 2.

| 7. | The provider appointed to operate the primary repository shall only integrate its repository into the traceability system following the conclusion of the approved contract. |
| --- | --- |

7.

The provider appointed to operate the primary repository shall only integrate its repository into the traceability system following the conclusion of the approved contract.

| 8. | A list of notified and approved third parties shall be made publicly available by the Commission on a website. |
| --- | --- |

8.

A list of notified and approved third parties shall be made publicly available by the Commission on a website.

| 9. | Any amendment to the key elements of the contract, as defined in Delegated Regulation (EU) 2018/573, shall be subject to approval by the Commission. Any other amendment to the contract shall require prior communication to the Commission. |
| --- | --- |

9.

Any amendment to the key elements of the contract, as defined in Delegated Regulation (EU) 2018/573, shall be subject to approval by the Commission. Any other amendment to the contract shall require prior communication to the Commission.

PART B

The following procedure shall apply to the selection of an independent third party operating the secondary repository system:

| 1. | The Commission shall appoint, from amongst the providers of the primary repositories who have been approved in accordance with Part A within six months following the entry into force of Delegated Regulation (EU) 2018/573, a provider tasked with operating the secondary repository (‘the operator of the secondary repository’) for the purpose of carrying out the services specified in Chapter V of this Regulation. |
| --- | --- |

1.

The Commission shall appoint, from amongst the providers of the primary repositories who have been approved in accordance with Part A within six months following the entry into force of Delegated Regulation (EU) 2018/573, a provider tasked with operating the secondary repository (‘the operator of the secondary repository’) for the purpose of carrying out the services specified in Chapter V of this Regulation.

| 2. | The appointment of the operator of the secondary repository shall be based on an assessment of objective criteria and take place no later than eight months following the entry into force of Delegated Regulation (EU) 2018/573. |
| --- | --- |

2.

The appointment of the operator of the secondary repository shall be based on an assessment of objective criteria and take place no later than eight months following the entry into force of Delegated Regulation (EU) 2018/573.

| 3. | The result of the appointment of the operator of the secondary repository shall be made publicly available by the Commission on a website. |
| --- | --- |

3.

The result of the appointment of the operator of the secondary repository shall be made publicly available by the Commission on a website.

| 4. | Each primary repository provider appointed in accordance with Part A shall enter into an individual contract with the provider appointed to operate the secondary repository for the purpose of carrying out the services specified in Chapter V of this Regulation. |
| --- | --- |

4.

Each primary repository provider appointed in accordance with Part A shall enter into an individual contract with the provider appointed to operate the secondary repository for the purpose of carrying out the services specified in Chapter V of this Regulation.

| 5. | The contracts shall be signed and submitted to the Commission within one month from the date of the appointment. |
| --- | --- |

5.

The contracts shall be signed and submitted to the Commission within one month from the date of the appointment.

PART C

The following requirements shall apply in addition to the selection procedures outlined in Parts A and B:

| 1. | Where the contractual relationship between a manufacturer and importer and the provider of a primary repository is terminated, or expected to be terminated, by any of the parties to the contract, for any reason, including the failure to comply with the criteria for independence laid down in Article 35, the manufacturer or importer shall immediately inform the Commission of such termination, or expected termination, and as soon as it is known, the date of the notification of termination and the date at which the termination is to take effect. The manufacturer or importer shall propose and notify to the Commission a replacement provider as soon as practicable, and at the latest, three months prior to the termination date of the existing contract. The appointment of the replacement provider shall take place in accordance with paragraphs 2 to 7 of Part A. |
| --- | --- |

1.

Where the contractual relationship between a manufacturer and importer and the provider of a primary repository is terminated, or expected to be terminated, by any of the parties to the contract, for any reason, including the failure to comply with the criteria for independence laid down in Article 35, the manufacturer or importer shall immediately inform the Commission of such termination, or expected termination, and as soon as it is known, the date of the notification of termination and the date at which the termination is to take effect. The manufacturer or importer shall propose and notify to the Commission a replacement provider as soon as practicable, and at the latest, three months prior to the termination date of the existing contract. The appointment of the replacement provider shall take place in accordance with paragraphs 2 to 7 of Part A.

| 2. | In the event that the operator of the secondary repository gives notice of its intention to cease operating that repository in accordance with the contracts entered into pursuant to paragraph 4 of Part B, it shall immediately inform the Commission thereof and of the date at which the termination is to take effect. |
| --- | --- |

2.

In the event that the operator of the secondary repository gives notice of its intention to cease operating that repository in accordance with the contracts entered into pursuant to paragraph 4 of Part B, it shall immediately inform the Commission thereof and of the date at which the termination is to take effect.

| 3. | Where the finding referred to in paragraph 1 applies to the provider who has been appointed to operate the secondary repository, the contracts for the operation of the secondary repository entered into pursuant to paragraph 4 of Part B shall, in turn, be terminated by the parties. |
| --- | --- |

3.

Where the finding referred to in paragraph 1 applies to the provider who has been appointed to operate the secondary repository, the contracts for the operation of the secondary repository entered into pursuant to paragraph 4 of Part B shall, in turn, be terminated by the parties.

| 4. | In cases referred to in paragraphs 2 and 3, the Commission shall appoint a replacement operator as soon as practicable, and at the latest, three months prior to the termination date of the existing contract. |
| --- | --- |

4.

In cases referred to in paragraphs 2 and 3, the Commission shall appoint a replacement operator as soon as practicable, and at the latest, three months prior to the termination date of the existing contract.

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ANNEX II

Key messages to be sent by the economic operators

The messages required for regulatory purposes shall contain at least the data fields listed in this Annex. Both ID issuers and providers of data repositories (including the router) may decide to extend the message content for strictly technical purposes to secure smooth functioning of the tobacco products traceability system.

The messages listed in this Annex do not include the messages to be sent back by ID issuers and providers of data repositories (including the router) to the economic operators, such as acknowledgments of receipt.

All the messages generated within the tobacco traceability system shall contain the identification of the originator and a timestamp up to the second (see Data Type: Time(L)). ID issuers and providers of data repositories (including the router) shall timestamp each received message up to the second.

CHAPTER I

FIELD DESCRIPTIONS

SECTION 1

Data Type

| Data Type | Description | Example |
| --- | --- | --- |
| ARC | Administrative Reference Code (ARC) or any successive code adopted under the Excise Movement and Control System (EMCS) | ‘15GB0123456789ABCDEF0’ |
| aUI | Aggregated level unique identifier coded with: | either
  the invariant set of ISO646:1991 and composed of four blocks: (a) ID issuer's prefix in accordance with ISO15459-2:2015, (b) serialisation element in the format established by the ID issuer, (c) tobacco facility identifier code following the Data Type: FID and (d) timestamp following the Data Type: Time(s) |

Data Type

Description

Example

ARC

Administrative Reference Code (ARC) or any successive code adopted under the Excise Movement and Control System (EMCS)

‘15GB0123456789ABCDEF0’

aUI

Aggregated level unique identifier coded with:

either

the invariant set of ISO646:1991 and composed of four blocks: (a) ID issuer's prefix in accordance with ISO15459-2:2015, (b) serialisation element in the format established by the ID issuer, (c) tobacco facility identifier code following the Data Type: FID and (d) timestamp following the Data Type: Time(s)

| | or
  the invariant set of ISO646:1991 forming a code structured in accordance with ISO15459-1:2014 or ISO15459-4:2014 (or their latest equivalent) |
| --- | --- |

or

the invariant set of ISO646:1991 forming a code structured in accordance with ISO15459-1:2014 or ISO15459-4:2014 (or their latest equivalent)

Boolean

Boolean value

| — | ‘0’ (false/disabled) |
| --- | --- |

—

‘0’ (false/disabled)

| — | ‘1’ (true/enabled) |
| --- | --- |

—

‘1’ (true/enabled)

Country

Country name coded with ISO-3166-1:2013 alpha-2 (or its latest equivalent)

‘DE’

Currency

Currency name coded with ISO 4217:2015 (or its latest equivalent)

‘EUR’

Date

UTC (Coordinated Universal Time) date corresponding to the following format: YYYY-MM-DD

‘2019-05-20’

Decimal

Number values, decimal allowed

‘1’ or ‘2,2’ or ‘3,33’

EOID

Economic operator identifier code corresponding to the format established by the ID issuer coded with the invariant set of ISO646:1991

FID

Tobacco facility identifier code corresponding to the format established by the ID issuer coded with the invariant set of ISO646:1991

Integer

Rounded number values, no decimal numbers

‘1’ or ‘22’ or ‘333’

MID

Machine identifier code corresponding to the format established by the ID issuer coded with the invariant set of ISO646:1991

MRN

Movement Reference Number (MRN) is a unique customs registration number. It contains 18 digits and is composed of the following elements: (a) last two digits of the year of formal acceptance of export movement (YY), (b) country name coded with ISO-3166-1:2013 alpha-2 (or its latest equivalent) of the Member State to which the declaration was sent, (c) unique identifier for entry/import per year and country, and (d) check digit.

‘11IT9876AB88901235’

SEED

Excise number composed of: (a) country name coded with ISO-3166-1:2013 alpha-2 (or its latest equivalent) (e.g. ‘LU’) and (b) eleven alphanumeric characters, if needed, padded to the left with zeroes (e.g. ‘00000987ABC’).

‘LU00000987ABC’

ITU

Individual transport unit code (e.g. SSCC) generated in accordance with ISO15459-1:2014 (or its latest equivalent)

‘001234560000000018’

Text

Alphanumeric values coded with ISO8859-15:1999

‘abcde12345’

Time(L)

UTC (Coordinated Universal Time) in the following format: YYYY-MM-DDThh:mm:ssZ

‘2019-07-16T19:20:30Z’

Time(s)

UTC (Coordinated Universal Time) in the following format: YYMMDDhh

‘19071619’

TPID

Tobacco Product Identifier (TP-ID) – numeric identifier used in the EU-CEG system in the format: NNNNN-NN-NNNNN

‘02565-16-00230’

PN

Product number – numeric identifier used in the EU-CEG system to identify product presentations (e.g. GTIN (Global Trade Identification Number) of the product)

‘00012345600012’

upUI(L)

Unit packet level unique identifier coded with the invariant set of ISO646:1991 and composed of three blocks: (a) ID Issuer's prefix in accordance with ISO15459-2:2015, (b) middle block in the format established by the ID issuer and (c) timestamp following the Data Type: Time(s)

upUI(s)

Unit packet level unique identifier coded with the invariant set of ISO646:1991 and composed of two blocks: (a) ID issuer's prefix in accordance with ISO15459-2:2015 and (b) serialisation element in the format established by the ID issuer (i.e. UI made visible in the human readable format on the unit packets)

Year

UTC (Coordinated Universal Time) year in the following format: YYYY

‘2024’

SECTION 2

Cardinality Type

| Type | Description |
| --- | --- |
| Simple (S) | Single value |
| Multiple (M) | Multiple values |

Type

Description

Simple (S)

Single value

Multiple (M)

Multiple values

SECTION 3

Priority Type

| Type | Description |
| --- | --- |
| Mandatory (M) | The variable must be completed to successfully submit the message |
| Optional (O) | The variable relates to supplementary fields which remain optional |

Type

Description

Mandatory (M)

The variable must be completed to successfully submit the message

Optional (O)

The variable relates to supplementary fields which remain optional

CHAPTER II

MESSAGES

SECTION 1

Identifier codes for economic operators, facilities and machines

1.1.   Request for an economic operator identifier code

| Item # | Field | Comments | Data Type | Cardinality | Priority | Values |
| --- | --- | --- | --- | --- | --- | --- |
| | Message_Type | Identification of message type | Text | S | M | 1-1 |
| | EO_Name1 | Economic operator's registered name | Text | S | M | |
| | EO_Name2 | Economic operator's alternative or abridged name | Text | S | O | |
| | EO_Address | Economic operator's address – street name, house number, postal code, city | Text | S | M | |
| | EO_CountryReg | Economic operator's country of registration | Country | S | M | |
| | EO_Email | Economic operator's email address used to inform about registration process, including subsequent changes and other required correspondence | Text | S | M | |
| | VAT_R | Indication of the VAT registration status | Boolean | S | M | 0 – No VAT registration
  1 – VAT number exists |
| | VAT_N | Economic operator's VAT number | Text | S | M, if VAT_R = 1 | |
| | TAX_N | Economic operator's tax registration number | Text | S | M, if VAT_R = 0 | |
| | EO_ExciseNumber1 | Indication if the economic operator has an excise number issued by the competent authority for the purpose of identification of persons/premises | Boolean | S | M | 0 – No SEED number
  1 – SEED number exists |
| | EO_ExciseNumber2 | Economic operator's excise number issued by the competent authority for the purpose of identification of persons/premises | SEED | S | M, if EO_ExciseNumber1 = 1 | |
| | OtherEOID_R | Indication if the economic operator has been allocated an identifier by another ID Issuer | Boolean | S | M | 0 – No
  1 – Yes |
| | OtherEOID_N | Economic operator identifier codes allocated by other ID Issuers | EOID | M | M, if OtherEOID_R = 1 | |
| | Reg_3RD | Indication if the registration is made on behalf of a retail outlet operator not involved otherwise in the tobacco trade | Boolean | S | M | 0 – No
  1 – Yes |
| | Reg_EOID | Identifier of the economic operator that acts on behalf of a retail outlet operator not involved otherwise in the tobacco trade | EOID | S | M, if Reg_3RD = 1 | |

Item #

Field

Comments

Data Type

Cardinality

Priority

Values

Message_Type

Identification of message type

Text

S

M

1-1

EO_Name1

Economic operator's registered name

Text

S

M

EO_Name2

Economic operator's alternative or abridged name

Text

S

O

EO_Address

Economic operator's address – street name, house number, postal code, city

Text

S

M

EO_CountryReg

Economic operator's country of registration

Country

S

M

EO_Email

Economic operator's email address used to inform about registration process, including subsequent changes and other required correspondence

Text

S

M

VAT_R

Indication of the VAT registration status

Boolean

S

M

0 – No VAT registration

1 – VAT number exists

VAT_N

Economic operator's VAT number

Text

S

M, if VAT_R = 1

TAX_N

Economic operator's tax registration number

Text

S

M, if VAT_R = 0

EO_ExciseNumber1

Indication if the economic operator has an excise number issued by the competent authority for the purpose of identification of persons/premises

Boolean

S

M

0 – No SEED number

1 – SEED number exists

EO_ExciseNumber2

Economic operator's excise number issued by the competent authority for the purpose of identification of persons/premises

SEED

S

M, if EO_ExciseNumber1 = 1

OtherEOID_R

Indication if the economic operator has been allocated an identifier by another ID Issuer

Boolean

S

M

0 – No

1 – Yes

OtherEOID_N

Economic operator identifier codes allocated by other ID Issuers

EOID

M

M, if OtherEOID_R = 1

Reg_3RD

Indication if the registration is made on behalf of a retail outlet operator not involved otherwise in the tobacco trade

Boolean

S

M

0 – No

1 – Yes

Reg_EOID

Identifier of the economic operator that acts on behalf of a retail outlet operator not involved otherwise in the tobacco trade

EOID

S

M, if Reg_3RD = 1

1.2.   Correction of information concerning the economic operator identifier code

| Item # | Field | Comments | Data Type | Cardinality | Priority | Values |
| --- | --- | --- | --- | --- | --- | --- |
| | Message_Type | Identification of message type | Text | S | M | 1-2 |
| | EO_ID | Economic operator identifier code | EOID | S | M | |
| | EO_CODE | Economic operator's confirmation code provided in response to the registration of economic operator | Text | S | M | |
| | EO_Name1 | Economic operator's registered name | Text | S | M | |
| | EO_Name2 | Economic operator's alternative or abridged name | Text | S | O | |
| | EO_Address | Economic operator's address – street name, postal code and city | Text | S | M | |
| | EO_CountryReg | Economic operator's country of registration | Country | S | M | |
| | EO_Email | Economic operator's email address used to inform about registration process, including subsequent changes | Text | S | M | |
| | VAT_R | Indication of the VAT registration status | Boolean | S | M | 0 – No VAT registration
  1 – VAT number exists |
| | VAT_N | Economic operator's VAT number | Text | S | M, if VAT_R = 1 | |
| | TAX_N | Economic operator's tax registration number | Text | S | M, if VAT_R = 0 | |
| | EO_ExciseNumber1 | Indication if the economic operator has an excise number issued by the competent authority for the purpose of identification of persons/premises | Boolean | S | M | 0 – No SEED number
  1 – SEED number exists |
| | EO_ExciseNumber2 | Economic operator's excise number issued by the competent authority for the purpose of identification of persons/premises | SEED | S | M, if EO_ExciseNumber1 = 1 | |
| | OtherEOID_R | Indication if the economic operator has been allocated an identifier by another ID Issuer | Boolean | S | M | 0 – No
  1 – Yes |
| | OtherEOID_N | Economic operator identifier codes allocated by other ID Issuers | EOID | M | M, if OtherEOID_R = 1 | |
| | Reg_3RD | Indication if the registration is made on behalf of the retail outlet operator not involved otherwise in the tobacco trade | Boolean | S | M | 0 – No
  1 – Yes |
| | Reg_EOID | Identifier of the economic operator that acts on behalf of the retail outlet operator not involved otherwise in the tobacco trade | EOID | S | M, if Reg_3RD = 1 | |

Item #

Field

Comments

Data Type

Cardinality

Priority

Values

Message_Type

Identification of message type

Text

S

M

1-2

EO_ID

Economic operator identifier code

EOID

S

M

EO_CODE

Economic operator's confirmation code provided in response to the registration of economic operator

Text

S

M

EO_Name1

Economic operator's registered name

Text

S

M

EO_Name2

Economic operator's alternative or abridged name

Text

S

O

EO_Address

Economic operator's address – street name, postal code and city

Text

S

M

EO_CountryReg

Economic operator's country of registration

Country

S

M

EO_Email

Economic operator's email address used to inform about registration process, including subsequent changes

Text

S

M

VAT_R

Indication of the VAT registration status

Boolean

S

M

0 – No VAT registration

1 – VAT number exists

VAT_N

Economic operator's VAT number

Text

S

M, if VAT_R = 1

TAX_N

Economic operator's tax registration number

Text

S

M, if VAT_R = 0

EO_ExciseNumber1

Indication if the economic operator has an excise number issued by the competent authority for the purpose of identification of persons/premises

Boolean

S

M

0 – No SEED number

1 – SEED number exists

EO_ExciseNumber2

Economic operator's excise number issued by the competent authority for the purpose of identification of persons/premises

SEED

S

M, if EO_ExciseNumber1 = 1

OtherEOID_R

Indication if the economic operator has been allocated an identifier by another ID Issuer

Boolean

S

M

0 – No

1 – Yes

OtherEOID_N

Economic operator identifier codes allocated by other ID Issuers

EOID

M

M, if OtherEOID_R = 1

Reg_3RD

Indication if the registration is made on behalf of the retail outlet operator not involved otherwise in the tobacco trade

Boolean

S

M

0 – No

1 – Yes

Reg_EOID

Identifier of the economic operator that acts on behalf of the retail outlet operator not involved otherwise in the tobacco trade

EOID

S

M, if Reg_3RD = 1

1.3.   De-registration of economic operator identifier code

| Item # | Field | Comments | Data Type | Cardinality | Priority | Values |
| --- | --- | --- | --- | --- | --- | --- |
| | Message_Type | Identification of message type | Text | S | M | 1-3 |
| | EO_ID | Economic operator identifier code | EOID | S | M | |
| | EO_CODE | Economic operator's confirmation code provided in response to the registration of economic operator | Text | S | M | |
| | Reg_3RD | Indication if the registration is made on behalf of the retail outlet operator not involved otherwise in the tobacco trade | Boolean | S | M | 0 – No
  1 – Yes |
| | Reg_EOID | Identifier of the economic operator that acts on behalf of the retail outlet operator not involved otherwise in the tobacco trade | EOID | S | M, if Reg_3RD = 1 | |

Item #

Field

Comments

Data Type

Cardinality

Priority

Values

Message_Type

Identification of message type

Text

S

M

1-3

EO_ID

Economic operator identifier code

EOID

S

M

EO_CODE

Economic operator's confirmation code provided in response to the registration of economic operator

Text

S

M

Reg_3RD

Indication if the registration is made on behalf of the retail outlet operator not involved otherwise in the tobacco trade

Boolean

S

M

0 – No

1 – Yes

Reg_EOID

Identifier of the economic operator that acts on behalf of the retail outlet operator not involved otherwise in the tobacco trade

EOID

S

M, if Reg_3RD = 1

1.4.   Request for a facility identifier code

| Item # | Field | Comments | Data Type | Cardinality | Priority | Values |
| --- | --- | --- | --- | --- | --- | --- |
| | Message_Type | Identification of message type | Text | S | M | 1-4 |
| | EO_ID | Economic operator identifier code | EOID | S | M | |
| | EO_CODE | Economic operator's confirmation code provided in response to the registration of economic operator | Text | S | M | |
| | F_Address | Facility's address – street name, house number, postal code and city | Text | S | M | |
| | F_Country | Facility's country | Country | S | M | |
| | F_Type | Type of facility | Integer | S | M | 1 – manufacturing site with warehouse
  2 – standalone warehouse
  3 – retail outlet
  4 – other |
| | F_Type_Other | Description of other facility | Text | S | M, if F_Type = 4 | |
| | F_Status | Indication if a part of the facility has a tax (excise) warehouse status | Boolean | S | M | 0 – No
  1 – Yes |
| | F_ExciseNumber1 | Indication if the facility has an excise number issued by the competent authority for the purpose of identification of persons/premises | Boolean | S | M | 0 – No SEED number
  1 – SEED number exists |
| | F_ExciseNumber2 | Facility's excise number issued by the competent authority for the purpose of identification of persons/premises | SEED | S | M, if F_ExciseNumber1 = 1 | |
| | OtherFID_R | Indication if the facility has been allocated an identifier by another ID Issuer | Boolean | S | M | 0 – No
  1 – Yes (possible only for non-EU facilities) |
| | OtherFID_N | Facility identifier codes allocated by other ID Issuers | FID | M | M, if OtherFID_R = 1 | |
| | Reg_3RD | Indication if the registration is made on behalf of a retail outlet operator not involved otherwise in the tobacco trade | Boolean | S | M | 0 – No
  1 – Yes (possible only if F_Type = 3) |
| | Reg_EOID | Identifier of the economic operator that acts on behalf of the retail outlet operator not involved otherwise in the tobacco trade | EOID | S | M, if Reg_3RD = 1 | |

Item #

Field

Comments

Data Type

Cardinality

Priority

Values

Message_Type

Identification of message type

Text

S

M

1-4

EO_ID

Economic operator identifier code

EOID

S

M

EO_CODE

Economic operator's confirmation code provided in response to the registration of economic operator

Text

S

M

F_Address

Facility's address – street name, house number, postal code and city

Text

S

M

F_Country

Facility's country

Country

S

M

F_Type

Type of facility

Integer

S

M

1 – manufacturing site with warehouse

2 – standalone warehouse

3 – retail outlet

4 – other

F_Type_Other

Description of other facility

Text

S

M, if F_Type = 4

F_Status

Indication if a part of the facility has a tax (excise) warehouse status

Boolean

S

M

0 – No

1 – Yes

F_ExciseNumber1

Indication if the facility has an excise number issued by the competent authority for the purpose of identification of persons/premises

Boolean

S

M

0 – No SEED number

1 – SEED number exists

F_ExciseNumber2

Facility's excise number issued by the competent authority for the purpose of identification of persons/premises

SEED

S

M, if F_ExciseNumber1 = 1

OtherFID_R

Indication if the facility has been allocated an identifier by another ID Issuer

Boolean

S

M

0 – No

1 – Yes (possible only for non-EU facilities)

OtherFID_N

Facility identifier codes allocated by other ID Issuers

FID

M

M, if OtherFID_R = 1

Reg_3RD

Indication if the registration is made on behalf of a retail outlet operator not involved otherwise in the tobacco trade

Boolean

S

M

0 – No

1 – Yes (possible only if F_Type = 3)

Reg_EOID

Identifier of the economic operator that acts on behalf of the retail outlet operator not involved otherwise in the tobacco trade

EOID

S

M, if Reg_3RD = 1

1.5.   Correction of information concerning the facility identifier code

| Item # | Field | Comments | Data Type | Cardinality | Priority | Values |
| --- | --- | --- | --- | --- | --- | --- |
| | Message_Type | Identification of message type | Text | S | M | 1-5 |
| | EO_ID | Economic operator identifier code | EOID | S | M | |
| | EO_CODE | Economic operator's confirmation code provided in response to the registration of economic operator | Text | S | M | |
| | F_ID | Facility identifier code | FID | S | M | |
| | F_Address | Facility's address – street name, postal code and city | Text | S | M | |
| | F_Country | Facility's country | Country | S | M | |
| | F_Type | Type of facility | Integer | S | M | 1 – manufacturing site with warehouse
  2 – standalone warehouse
  3 – retail outlet
  4 – other |
| | F_Type_Other | Description of other facility | Text | S | M, if F_Type = 4 | |
| | F_Status | Indication if a part of the facility has a tax (excise) warehouse status | Boolean | S | M | 0 – No
  1 – Yes |
| | F_ExciseNumber1 | Indication if the facility has an excise number issued by the competent authority for the purpose of identification of persons/premises | Boolean | S | M | 0 – No SEED number
  1 – SEED number exists |
| | F_ExciseNumber2 | Facility's excise number issued by the competent authority for the purpose of identification of persons/premises | SEED | S | M, if F_ExciseNumber1 = 1 | |
| | OtherFID_R | Indication if the facility has been allocated an identifier by another ID Issuer | Boolean | S | M | 0 – No
  1 – Yes (possible only for non-EU facilities) |
| | OtherFID_N | Facility identifier codes allocated by other ID Issuers | FID | M | M, if OtherFID_R = 1 | |
| | Reg_3RD | Indication if the registration is made on behalf of the retail outlet operator not involved otherwise in the tobacco trade | Boolean | S | M | 0 – No
  1 – Yes (possible only if F_Type = 3) |
| | Reg_EOID | Identifier of the economic operator that acts on behalf of the retail outlet operator not involved otherwise in the tobacco trade | EOID | S | M, if Reg_3RD = 1 | |

Item #

Field

Comments

Data Type

Cardinality

Priority

Values

Message_Type

Identification of message type

Text

S

M

1-5

EO_ID

Economic operator identifier code

EOID

S

M

EO_CODE

Economic operator's confirmation code provided in response to the registration of economic operator

Text

S

M

F_ID

Facility identifier code

FID

S

M

F_Address

Facility's address – street name, postal code and city

Text

S

M

F_Country

Facility's country

Country

S

M

F_Type

Type of facility

Integer

S

M

1 – manufacturing site with warehouse

2 – standalone warehouse

3 – retail outlet

4 – other

F_Type_Other

Description of other facility

Text

S

M, if F_Type = 4

F_Status

Indication if a part of the facility has a tax (excise) warehouse status

Boolean

S

M

0 – No

1 – Yes

F_ExciseNumber1

Indication if the facility has an excise number issued by the competent authority for the purpose of identification of persons/premises

Boolean

S

M

0 – No SEED number

1 – SEED number exists

F_ExciseNumber2

Facility's excise number issued by the competent authority for the purpose of identification of persons/premises

SEED

S

M, if F_ExciseNumber1 = 1

OtherFID_R

Indication if the facility has been allocated an identifier by another ID Issuer

Boolean

S

M

0 – No

1 – Yes (possible only for non-EU facilities)

OtherFID_N

Facility identifier codes allocated by other ID Issuers

FID

M

M, if OtherFID_R = 1

Reg_3RD

Indication if the registration is made on behalf of the retail outlet operator not involved otherwise in the tobacco trade

Boolean

S

M

0 – No

1 – Yes (possible only if F_Type = 3)

Reg_EOID

Identifier of the economic operator that acts on behalf of the retail outlet operator not involved otherwise in the tobacco trade

EOID

S

M, if Reg_3RD = 1

1.6.   De-registration of facility identifier code

| Item # | Field | Comments | Data Type | Cardinality | Priority | Values |
| --- | --- | --- | --- | --- | --- | --- |
| | Message_Type | Identification of message type | Text | S | M | 1-6 |
| | EO_ID | Economic operator identifier code | EOID | S | M | |
| | EO_CODE | Economic operator's confirmation code provided in response to the registration of economic operator | Text | S | M | |
| | F_ID | Facility identifier code | FID | S | M | |
| | Reg_3RD | Indication if the de-registration is made on behalf of a retail outlet operator not involved otherwise in the tobacco trade | Boolean | S | M | 0 – No
  1 – Yes |
| | Reg_EOID | Identifier of the economic operator that acts on behalf of the retail outlet operator not involved otherwise in the tobacco trade | EOID | S | M, if Reg_3RD = 1 | |

Item #

Field

Comments

Data Type

Cardinality

Priority

Values

Message_Type

Identification of message type

Text

S

M

1-6

EO_ID

Economic operator identifier code

EOID

S

M

EO_CODE

Economic operator's confirmation code provided in response to the registration of economic operator

Text

S

M

F_ID

Facility identifier code

FID

S

M

Reg_3RD

Indication if the de-registration is made on behalf of a retail outlet operator not involved otherwise in the tobacco trade

Boolean

S

M

0 – No

1 – Yes

Reg_EOID

Identifier of the economic operator that acts on behalf of the retail outlet operator not involved otherwise in the tobacco trade

EOID

S

M, if Reg_3RD = 1

1.7.   Request for a machine identifier code

| Item # | Field | Comments | Data Type | Cardinality | Priority | Values |
| --- | --- | --- | --- | --- | --- | --- |
| | Message_Type | Identification of message type | Text | S | M | 1-7 |
| | EO_ID | Economic operator identifier code | EOID | S | M | |
| | EO_CODE | Economic operator's confirmation code provided in response to the registration of economic operator | Text | S | M | |
| | F_ID | Facility identifier code | FID | S | M | |
| | M_Producer | Machine's producer | Text | S | M | |
| | M_Model | Machine's model | Text | S | M | |
| | M_Number | Machine's serial number | Text | S | M | |
| | M_Capacity | Maximum capacity over 24-hour production cycle expressed in unit packets | Integer | S | M | |

Item #

Field

Comments

Data Type

Cardinality

Priority

Values

Message_Type

Identification of message type

Text

S

M

1-7

EO_ID

Economic operator identifier code

EOID

S

M

EO_CODE

Economic operator's confirmation code provided in response to the registration of economic operator

Text

S

M

F_ID

Facility identifier code

FID

S

M

M_Producer

Machine's producer

Text

S

M

M_Model

Machine's model

Text

S

M

M_Number

Machine's serial number

Text

S

M

M_Capacity

Maximum capacity over 24-hour production cycle expressed in unit packets

Integer

S

M

1.8.   Correction of information concerning the machine identifier code

| Item # | Field | Comments | Data Type | Cardinality | Priority | Values |
| --- | --- | --- | --- | --- | --- | --- |
| | Message_Type | Identification of message type | Text | S | M | 1-8 |
| | EO_ID | Economic operator identifier code | EOID | S | M | |
| | EO_CODE | Economic operator's confirmation code provided in response to the registration of economic operator | Text | S | M | |
| | F_ID | Facility identifier code | FID | S | M | |
| | M_ID | Machine identifier code | MID | S | M | |
| | M_Producer | Machine's producer | Text | S | M | |
| | M_Model | Machine's model | Text | S | M | |
| | M_Number | Machine's serial number | Text | S | M | |
| | M_Capacity | Maximum capacity over 24-hour production cycle expressed in unit packets | Integer | S | M | |

Item #

Field

Comments

Data Type

Cardinality

Priority

Values

Message_Type

Identification of message type

Text

S

M

1-8

EO_ID

Economic operator identifier code

EOID

S

M

EO_CODE

Economic operator's confirmation code provided in response to the registration of economic operator

Text

S

M

F_ID

Facility identifier code

FID

S

M

M_ID

Machine identifier code

MID

S

M

M_Producer

Machine's producer

Text

S

M

M_Model

Machine's model

Text

S

M

M_Number

Machine's serial number

Text

S

M

M_Capacity

Maximum capacity over 24-hour production cycle expressed in unit packets

Integer

S

M

1.9.   De-registration of machine identifier code

| Item # | Field | Comments | Data Type | Cardinality | Priority | Values |
| --- | --- | --- | --- | --- | --- | --- |
| | Message_Type | Identification of message type | Text | S | M | 1-9 |
| | EO_ID | Economic operator identifier code | EOID | S | M | |
| | EO_CODE | Economic operator's confirmation code provided in response to the registration of economic operator | Text | S | M | |
| | F_ID | Facility identifier code | FID | S | M | |
| | M_ID | Machine identifier code | MID | S | M | |

Item #

Field

Comments

Data Type

Cardinality

Priority

Values

Message_Type

Identification of message type

Text

S

M

1-9

EO_ID

Economic operator identifier code

EOID

S

M

EO_CODE

Economic operator's confirmation code provided in response to the registration of economic operator

Text

S

M

F_ID

Facility identifier code

FID

S

M

M_ID

Machine identifier code

MID

S

M

SECTION 2

Unique identifiers (UIs)

2.1.   Request for unit level UIs

| Item # | Field | Comments | Data Type | Cardinality | Priority | Values |
| --- | --- | --- | --- | --- | --- | --- |
| | Message_Type | Identification of message type | Text | S | M | 2-1 |
| | EO_ID | Economic operator identifier code of the submitting entity (either EU manufacturer or EU importer) | EOID | S | M | |
| | F_ID | Facility identifier code | FID | S | M | |
| | Process_Type | Indication if the production process involves machinery | Boolean | S | M | 0 – No (only for fully hand made products)
  1 – Yes |
| | M_ID | Machine identifier code | MID | S | M, if Process_Type = 1 | |
| | P_Type | Type of tobacco product | Integer | S | M | 1 — Cigarette
  2 — Cigar
  3 — Cigarillo
  4 — Roll your own tobacco
  5 — Pipe tobacco
  6 — Waterpipe tobacco
  7 — Oral tobacco
  8 — Nasal tobacco
  9 — Chewing tobacco
  10 — Novel tobacco product
  11 — Other (product placed on the market before 19 May 2014, not covered by categories 1-9) |
| | P_OtherType | Description of other type of tobacco product | Text | S | M, if P_Type = 11 | |
| | P_CN | Combined Nomenclature (CN) code | Text | S | O | |
| | P_Brand | Brand of tobacco product | Text | S | M | |
| | P_weight | Average gross weight of unit packet, including packaging, in grams with 0,1 gram accuracy | Decimal | S | M | |
| | TP_ID | Tobacco product identifier used in the EU-CEG system | TPID | S | M, if Intended_Market is an EU country | |
| | TP_PN | Tobacco product number used in the EU-CEG system | PN | S | M, if Intended_Market is an EU country | |
| | Intended_Market | Intended country of retail sale | Country | S | M | |
| | Intended_Route1 | Indication if the product is intended to be moved across country boarders with terrestrial/water/air transport | Boolean | S | M | 0 – No
  1 – Yes |
| | Intended_Route2 | The first country of terrestrial/water/air transport after the product leaves the Member State of manufacturing or the Member State of importation established on the basis of a check point on the land border, next seaport or next airport respectively | Country | S | M, if Intended_Route1 = 1 | |
| | Import | Indication if the product is imported into the EU | Boolean | S | M | 0 – No
  1 – Yes |
| | Req_Quantity | Requested quantity of unit packet level UIs | Integer | S | M | |

Item #

Field

Comments

Data Type

Cardinality

Priority

Values

Message_Type

Identification of message type

Text

S

M

2-1

EO_ID

Economic operator identifier code of the submitting entity (either EU manufacturer or EU importer)

EOID

S

M

F_ID

Facility identifier code

FID

S

M

Process_Type

Indication if the production process involves machinery

Boolean

S

M

0 – No (only for fully hand made products)

1 – Yes

M_ID

Machine identifier code

MID

S

M, if Process_Type = 1

P_Type

Type of tobacco product

Integer

S

M

1 — Cigarette

2 — Cigar

3 — Cigarillo

4 — Roll your own tobacco

5 — Pipe tobacco

6 — Waterpipe tobacco

7 — Oral tobacco

8 — Nasal tobacco

9 — Chewing tobacco

10 — Novel tobacco product

11 — Other (product placed on the market before 19 May 2014, not covered by categories 1-9)

P_OtherType

Description of other type of tobacco product

Text

S

M, if P_Type = 11

P_CN

Combined Nomenclature (CN) code

Text

S

O

P_Brand

Brand of tobacco product

Text

S

M

P_weight

Average gross weight of unit packet, including packaging, in grams with 0,1 gram accuracy

Decimal

S

M

TP_ID

Tobacco product identifier used in the EU-CEG system

TPID

S

M, if Intended_Market is an EU country

TP_PN

Tobacco product number used in the EU-CEG system

PN

S

M, if Intended_Market is an EU country

Intended_Market

Intended country of retail sale

Country

S

M

Intended_Route1

Indication if the product is intended to be moved across country boarders with terrestrial/water/air transport

Boolean

S

M

0 – No

1 – Yes

Intended_Route2

The first country of terrestrial/water/air transport after the product leaves the Member State of manufacturing or the Member State of importation established on the basis of a check point on the land border, next seaport or next airport respectively

Country

S

M, if Intended_Route1 = 1

Import

Indication if the product is imported into the EU

Boolean

S

M

0 – No

1 – Yes

Req_Quantity

Requested quantity of unit packet level UIs

Integer

S

M

2.2.   Request for aggregated level UIs

| Item # | Field | Comments | Data Type | Cardinality | Priority | Values |
| --- | --- | --- | --- | --- | --- | --- |
| | Message_Type | Identification of message type | Text | S | M | 2-2 |
| | EO_ID | Economic operator identifier code of the submitting entity | EOID | S | M | |
| | F_ID | Facility identifier code | FID | S | M | |
| | Req_Quantity | Requested quantity of aggregated level UIs | Integer | S | M | |

Item #

Field

Comments

Data Type

Cardinality

Priority

Values

Message_Type

Identification of message type

Text

S

M

2-2

EO_ID

Economic operator identifier code of the submitting entity

EOID

S

M

F_ID

Facility identifier code

FID

S

M

Req_Quantity

Requested quantity of aggregated level UIs

Integer

S

M

2.3.   Request for deactivation of UIs

| Item # | Field | Comments | Data Type | Cardinality | Priority | Values |
| --- | --- | --- | --- | --- | --- | --- |
| | Message_Type | Identification of message type | Text | S | M | 2-3 |
| | EO_ID | Economic operator identifier code of the submitting entity | EOID | S | M | |
| | Deact_Type | Deactivation of unit packet or aggregated level UIs | Integer | S | M | 1 – Unit packet level UIs
  2 – Aggregated level UIs |
| | Deact_Reason1 | Identification of the reason for deactivation | Integer | S | M | 1 – Product destroyed
  2 – Product stolen
  3 – UI destroyed
  4 – UI stolen
  5 – UI unused
  6 – Other |
| | Deact_Reason2 | Description of other reason | Text | S | M, if Deact_Reason1 = 6 | |
| | Deact_Reason3 | Additional description of the reason | Text | S | O | |
| | Deact_upUI | List of unit packet level UIs to be deactivated | upUI(s) | M | M, if Deact_Type = 1 | |
| | Deact_aUI | List of aggregated level UIs to be deactivated | aUI | M | M, if Deact_Type = 2 | |

Item #

Field

Comments

Data Type

Cardinality

Priority

Values

Message_Type

Identification of message type

Text

S

M

2-3

EO_ID

Economic operator identifier code of the submitting entity

EOID

S

M

Deact_Type

Deactivation of unit packet or aggregated level UIs

Integer

S

M

1 – Unit packet level UIs

2 – Aggregated level UIs

Deact_Reason1

Identification of the reason for deactivation

Integer

S

M

1 – Product destroyed

2 – Product stolen

3 – UI destroyed

4 – UI stolen

5 – UI unused

6 – Other

Deact_Reason2

Description of other reason

Text

S

M, if Deact_Reason1 = 6

Deact_Reason3

Additional description of the reason

Text

S

O

Deact_upUI

List of unit packet level UIs to be deactivated

upUI(s)

M

M, if Deact_Type = 1

Deact_aUI

List of aggregated level UIs to be deactivated

aUI

M

M, if Deact_Type = 2

SECTION 3

Recording and transmission of information on product movements

3.1.   Application of unit level UIs on unit packets

| Item # | Field | Comments | Data Type | Cardinality | Priority | Values |
| --- | --- | --- | --- | --- | --- | --- |
| | Message_Type | Identification of message type | Text | S | M | 3-1 |
| | EO_ID | Economic operator identifier code of the submitting entity | EOID | S | M | |
| | F_ID | Facility identifier code | FID | S | M | |
| | upUI_1 | List of unit packet level UIs to be recorded (full length) | upUI(L) | M | M | |
| | upUI_2 | List of corresponding unit packet level UIs to be recorded (as visible in human readable format) indicated in the same order as upUI_1 | upUI(s) | M | M | |
| | upUI_comment | Comments by the reporting entity | Text | S | O | |

Item #

Field

Comments

Data Type

Cardinality

Priority

Values

Message_Type

Identification of message type

Text

S

M

3-1

EO_ID

Economic operator identifier code of the submitting entity

EOID

S

M

F_ID

Facility identifier code

FID

S

M

upUI_1

List of unit packet level UIs to be recorded (full length)

upUI(L)

M

M

upUI_2

List of corresponding unit packet level UIs to be recorded (as visible in human readable format) indicated in the same order as upUI_1

upUI(s)

M

M

upUI_comment

Comments by the reporting entity

Text

S

O

3.2.   Application of aggregated level UIs on aggregated packaging

| Item # | Field | Comments | Data Type | Cardinality | Priority | Values |
| --- | --- | --- | --- | --- | --- | --- |
| | Message_Type | Identification of message type | Text | S | M | 3-2 |
| | EO_ID | Economic operator identifier code of the submitting entity | EOID | S | M | |
| | F_ID | Facility identifier code | FID | S | M | |
| | Event_Time | Time of event occurrence | Time(s) | S | M | |
| | aUI | Aggregated level UI | aUI | S | M | |
| | Aggregation_Type | Identification of aggregation type | Integer | S | M | 1 – aggregation of only unit packet level UIs
  2 – aggregation of only aggregated level UIs
  3 – aggregation of both unit packet and aggregated level UIs |
| | Aggregated_UIs1 | List of unit packet level UIs subject to aggregation | upUI(L) | M | M, if Aggregation_ Type = 1 or 3 | |
| | Aggregated_UIs2 | List of aggregated level UIs subject to further aggregation | aUI | M | M, if Aggregation_ Type = 2 or 3 | |
| | aUI_comment | Comments by the reporting entity | Text | S | O | |

Item #

Field

Comments

Data Type

Cardinality

Priority

Values

Message_Type

Identification of message type

Text

S

M

3-2

EO_ID

Economic operator identifier code of the submitting entity

EOID

S

M

F_ID

Facility identifier code

FID

S

M

Event_Time

Time of event occurrence

Time(s)

S

M

aUI

Aggregated level UI

aUI

S

M

Aggregation_Type

Identification of aggregation type

Integer

S

M

1 – aggregation of only unit packet level UIs

2 – aggregation of only aggregated level UIs

3 – aggregation of both unit packet and aggregated level UIs

Aggregated_UIs1

List of unit packet level UIs subject to aggregation

upUI(L)

M

M, if Aggregation_ Type = 1 or 3

Aggregated_UIs2

List of aggregated level UIs subject to further aggregation

aUI

M

M, if Aggregation_ Type = 2 or 3

aUI_comment

Comments by the reporting entity

Text

S

O

3.3.   Dispatch of tobacco products from a facility

| Item # | Field | Comments | Data Type | Cardinality | Priority | Values |
| --- | --- | --- | --- | --- | --- | --- |
| | Message_Type | Identification of message type | Text | S | M | 3-3 |
| | EO_ID | Economic operator identifier code of the submitting entity | EOID | S | M | |
| | Event_Time | Intended time of event occurrence | Time(s) | S | M | |
| | F_ID | Dispatch facility identifier code | FID | S | M | |
| | Destination_ID1 | Indication of destination type: if the destination facility is located on the EU territory and if it is delivery to a vending machine (VM) or by means of a vending van (VV) delivering to multiple retail outlets in quantities that have not been predetermined in advance of the delivery | Integer | S | M | 1 – Non EU dest.
  2 – EU destination other than VM – fixed quantity delivery
  3 – EU VM(s)
  4 – EU destination other than VM – delivery with VV |
| | Destination_ID2 | Destination facility identifier code | FID | S | M, if Destination_ID1 = 2 | |
| | Destination_ID3 | Destination facility identifier code(s) – possible multiple vending machines | FID | M | M, if Destination_ID1 = 3 | |
| | Destination_ID4 | Destination facility identifier code(s) | FID | M | M, if Destination_ID1 = 4 | |
| | Destination_ID5 | Destination facility's full address: street, house number, postal code, city | Text | S | M, if Destination_ID1 = 1 | |
| | Transport_mode | Mode of transport by which the product leaves the facility, see: Commission Regulation (EC) No 684/2009, Annex II, Code List 7 | Integer | S | M | 0 – Other
  1 – Sea Transport
  2 – Rail transport
  3 – Road transport
  4 – Air transport
  5 – Postal consignment
  6 – Fixed transport installations
  7 – Inland waterway transport |
| | Transport_vehicle | Identification of the vehicle (i.e. number plates, train number, plane/flight number, ship name or other identification) | Text | S | M | ‘n/a’ is permitted value if Transport_mode = 0 and product movement takes place between adjacent facilities and is delivered manually |
| | Transport_cont1 | Indication if the transport is containerised and uses an individual transport unit code (e.g. SSCC) | Boolean | S | M | 0 – No
  1 – Yes |
| | Transport_cont2 | Individual transport unit code of the container | ITU | S | M, if Transport_cont1 = 1 | |
| | Transport_s1 | Indication if the dispatch takes place with the logistic/postal operator who operates its own track and trace system accepted by the Member State of the dispatch facility. Only for small quantities of tobacco products (net weight of the products dispatched below 10 kg) destined for exports to third countries | Boolean | S | M | 0 – No
  1 – Yes |
| | Transport_s2 | The logistic operator's tracking number | Text | S | M, if Transport_s1 = 1 | |
| | EMCS | Dispatch under the Excise Movement and Control System (EMCS) | Boolean | S | M | 0 – No
  1 – Yes |
| | EMCS_ARC | Administrative Reference Code (ARC) | ARC | S | M, if EMCS = 1 | |
| | SAAD | Dispatch with a simplified accompanying document, see: Commission Regulation (EEC) No 3649/92 | Boolean | S | M | 0 – No
  1 – Yes |
| | SAAD_number | Reference number of the declaration and/or authorization which has to be given by the competent authority in the Member State of destination before the movement starts | Text | S | M, if SAAD = 1 | |
| | Exp_Declaration | Indication if the Movement Reference Number (MRN) has been issued by the customs office | Boolean | S | M | 0 – No
  1 – Yes |
| | Exp_ DeclarationNumber | Movement Reference Number (MRN) | MRN | S | M, if Exp_Declaration = 1 | |
| | UI_Type | Identification of UI types in the dispatch (recorded at the highest level of available aggregation) | Integer | S | M | 1 – only unit packet level UIs
  2 – only aggregated level UIs
  3 – both unit packet and aggregated level UIs |
| | upUIs | List of unit packet level UIs subject to the dispatch | upUI(L) | M | M, if UI_Type = 1 or 3 | |
| | aUIs | List of aggregated level UIs subject to the dispatch | aUI | M | M, if UI_Type = 2 or 3 | |
| | Dispatch_comment | Comments by the reporting entity | Text | S | O | |

Item #

Field

Comments

Data Type

Cardinality

Priority

Values

Message_Type

Identification of message type

Text

S

M

3-3

EO_ID

Economic operator identifier code of the submitting entity

EOID

S

M

Event_Time

Intended time of event occurrence

Time(s)

S

M

F_ID

Dispatch facility identifier code

FID

S

M

Destination_ID1

Indication of destination type: if the destination facility is located on the EU territory and if it is delivery to a vending machine (VM) or by means of a vending van (VV) delivering to multiple retail outlets in quantities that have not been predetermined in advance of the delivery

Integer

S

M

1 – Non EU dest.

2 – EU destination other than VM – fixed quantity delivery

3 – EU VM(s)

4 – EU destination other than VM – delivery with VV

Destination_ID2

Destination facility identifier code

FID

S

M, if Destination_ID1 = 2

Destination_ID3

Destination facility identifier code(s) – possible multiple vending machines

FID

M

M, if Destination_ID1 = 3

Destination_ID4

Destination facility identifier code(s)

FID

M

M, if Destination_ID1 = 4

Destination_ID5

Destination facility's full address: street, house number, postal code, city

Text

S

M, if Destination_ID1 = 1

Transport_mode

Mode of transport by which the product leaves the facility, see: Commission Regulation (EC) No 684/2009, Annex II, Code List 7

Integer

S

M

0 – Other

1 – Sea Transport

2 – Rail transport

3 – Road transport

4 – Air transport

5 – Postal consignment

6 – Fixed transport installations

7 – Inland waterway transport

Transport_vehicle

Identification of the vehicle (i.e. number plates, train number, plane/flight number, ship name or other identification)

Text

S

M

‘n/a’ is permitted value if Transport_mode = 0 and product movement takes place between adjacent facilities and is delivered manually

Transport_cont1

Indication if the transport is containerised and uses an individual transport unit code (e.g. SSCC)

Boolean

S

M

0 – No

1 – Yes

Transport_cont2

Individual transport unit code of the container

ITU

S

M, if Transport_cont1 = 1

Transport_s1

Indication if the dispatch takes place with the logistic/postal operator who operates its own track and trace system accepted by the Member State of the dispatch facility. Only for small quantities of tobacco products (net weight of the products dispatched below 10 kg) destined for exports to third countries

Boolean

S

M

0 – No

1 – Yes

Transport_s2

The logistic operator's tracking number

Text

S

M, if Transport_s1 = 1

EMCS

Dispatch under the Excise Movement and Control System (EMCS)

Boolean

S

M

0 – No

1 – Yes

EMCS_ARC

Administrative Reference Code (ARC)

ARC

S

M, if EMCS = 1

SAAD

Dispatch with a simplified accompanying document, see: Commission Regulation (EEC) No 3649/92

Boolean

S

M

0 – No

1 – Yes

SAAD_number

Reference number of the declaration and/or authorization which has to be given by the competent authority in the Member State of destination before the movement starts

Text

S

M, if SAAD = 1

Exp_Declaration

Indication if the Movement Reference Number (MRN) has been issued by the customs office

Boolean

S

M

0 – No

1 – Yes

Exp_ DeclarationNumber

Movement Reference Number (MRN)

MRN

S

M, if Exp_Declaration = 1

UI_Type

Identification of UI types in the dispatch (recorded at the highest level of available aggregation)

Integer

S

M

1 – only unit packet level UIs

2 – only aggregated level UIs

3 – both unit packet and aggregated level UIs

upUIs

List of unit packet level UIs subject to the dispatch

upUI(L)

M

M, if UI_Type = 1 or 3

aUIs

List of aggregated level UIs subject to the dispatch

aUI

M

M, if UI_Type = 2 or 3

Dispatch_comment

Comments by the reporting entity

Text

S

O

3.4.   Arrival of tobacco products at a facility

| Item # | Field | Comments | Data Type | Cardinality | Priority | Values |
| --- | --- | --- | --- | --- | --- | --- |
| | Message_Type | Identification of message type | Text | S | M | 3-4 |
| | EO_ID | Economic operator identifier code of the submitting entity | EOID | S | M | |
| | F_ID | Arrival facility identifier code | FID | S | M | |
| | Event_Time | Time of event occurrence | Time(s) | S | M | |
| | Product_Return | Indication if the arriving products are a return following complete or partial non-delivery | Boolean | S | M | 0 – No
  1 – Yes |
| | UI_Type | Identification of UI types received (recorded at the highest level of available aggregation) | Integer | S | M | 1 – only unit packet level UIs
  2 – only aggregated level UIs
  3 – both unit packet and aggregated level UIs |
| | upUIs | List of unit packet level UIs received | upUI(L) | M | M, if UI_Type = 1 or 3 | |
| | aUIs | List of aggregated level UIs received | aUI | M | M, if UI_Type = 2 or 3 | |
| | Arrival_comment | Comments by the reporting entity | Text | S | O | |

Item #

Field

Comments

Data Type

Cardinality

Priority

Values

Message_Type

Identification of message type

Text

S

M

3-4

EO_ID

Economic operator identifier code of the submitting entity

EOID

S

M

F_ID

Arrival facility identifier code

FID

S

M

Event_Time

Time of event occurrence

Time(s)

S

M

Product_Return

Indication if the arriving products are a return following complete or partial non-delivery

Boolean

S

M

0 – No

1 – Yes

UI_Type

Identification of UI types received (recorded at the highest level of available aggregation)

Integer

S

M

1 – only unit packet level UIs

2 – only aggregated level UIs

3 – both unit packet and aggregated level UIs

upUIs

List of unit packet level UIs received

upUI(L)

M

M, if UI_Type = 1 or 3

aUIs

List of aggregated level UIs received

aUI

M

M, if UI_Type = 2 or 3

Arrival_comment

Comments by the reporting entity

Text

S

O

3.5.   Trans-loading

| Item # | Field | Comments | Data Type | Cardinality | Priority | Values |
| --- | --- | --- | --- | --- | --- | --- |
| | Message_Type | Identification of message type | Text | S | M | 3-5 |
| | EO_ID | Economic operator identifier code of the submitting entity | EOID | S | M | |
| | Event_Time | Intended time of event occurrence | Time(s) | S | M | |
| | Destination_ID1 | Indication if the destination facility is located on the EU territory | Boolean | S | M | 0 – No
  1 – Yes |
| | Destination_ID2 | Destination facility identifier code | FID | S | M, if Destination_ID1 = 1 | |
| | Destination_ID3 | Destination facility's full address | Text | S | M, if Destination_ID1 = 0 | |
| | Transport_mode | Mode of transport to which the product is trans-loaded, see: Commission Regulation (EC) No 684/2009, Annex II, Code List 7 | Integer | S | M | 0 – Other
  1 – Sea Transport
  2 – Rail transport
  3 – Road transport
  4 – Air transport
  5 – Postal consignment
  6 – Fixed transport installations
  7 – Inland waterway transport |
| | Transport_vehicle | Identification of the vehicle (i.e. number plates, train number, plane/flight number, ship name or other identification) | Text | S | M | |
| | Transport_cont1 | Indication if the transport is containerised and uses an individual transport unit code (e.g. SSCC) | Boolean | S | M | 0 – No
  1 – Yes |
| | Transport_cont2 | Individual transport unit code of the container | ITU | S | M, if Transport_cont1 = 1 | |
| | EMCS | Dispatch under the Excise Movement and Control System (EMCS) | Boolean | S | M | 0 – No
  1 – Yes |
| | EMCS_ARC | Administrative Reference Code (ARC) | ARC | S | M, if EMCS = 1 | |
| | UI_Type | Identification of UI types subject to the trans-loading (recorded at the highest level of available aggregation) | Integer | S | M | 1 – only unit packet level UIs
  2 – only aggregated level UIs
  3 – both unit packet and aggregated level UIs |
| | upUIs | List of unit packet level UIs subject to the trans-loading | upUI(L) | M | M, if UI_Type = 1 or 3 | |
| | aUIs | List of aggregated level UIs subject to the trans-loading | aUI | M | M, if UI_Type = 2 or 3 | |
| | Transloading_comment | Comments by the reporting entity | Text | S | O | |

Item #

Field

Comments

Data Type

Cardinality

Priority

Values

Message_Type

Identification of message type

Text

S

M

3-5

EO_ID

Economic operator identifier code of the submitting entity

EOID

S

M

Event_Time

Intended time of event occurrence

Time(s)

S

M

Destination_ID1

Indication if the destination facility is located on the EU territory

Boolean

S

M

0 – No

1 – Yes

Destination_ID2

Destination facility identifier code

FID

S

M, if Destination_ID1 = 1

Destination_ID3

Destination facility's full address

Text

S

M, if Destination_ID1 = 0

Transport_mode

Mode of transport to which the product is trans-loaded, see: Commission Regulation (EC) No 684/2009, Annex II, Code List 7

Integer

S

M

0 – Other

1 – Sea Transport

2 – Rail transport

3 – Road transport

4 – Air transport

5 – Postal consignment

6 – Fixed transport installations

7 – Inland waterway transport

Transport_vehicle

Identification of the vehicle (i.e. number plates, train number, plane/flight number, ship name or other identification)

Text

S

M

Transport_cont1

Indication if the transport is containerised and uses an individual transport unit code (e.g. SSCC)

Boolean

S

M

0 – No

1 – Yes

Transport_cont2

Individual transport unit code of the container

ITU

S

M, if Transport_cont1 = 1

EMCS

Dispatch under the Excise Movement and Control System (EMCS)

Boolean

S

M

0 – No

1 – Yes

EMCS_ARC

Administrative Reference Code (ARC)

ARC

S

M, if EMCS = 1

UI_Type

Identification of UI types subject to the trans-loading (recorded at the highest level of available aggregation)

Integer

S

M

1 – only unit packet level UIs

2 – only aggregated level UIs

3 – both unit packet and aggregated level UIs

upUIs

List of unit packet level UIs subject to the trans-loading

upUI(L)

M

M, if UI_Type = 1 or 3

aUIs

List of aggregated level UIs subject to the trans-loading

aUI

M

M, if UI_Type = 2 or 3

Transloading_comment

Comments by the reporting entity

Text

S

O

3.6.   Disaggregation of aggregated level UIs

| Item # | Field | Comments | Data Type | Cardinality | Priority | Values |
| --- | --- | --- | --- | --- | --- | --- |
| | Message_Type | Identification of message type | Text | S | M | 3-6 |
| | EO_ID | Economic operator's identifier | EOID | S | M | |
| | F_ID | Facility's identifier | FID | S | M | |
| | Event_Time | Time of event occurrence | Time(s) | S | M | |
| | aUI | Aggregated level UI subject to disaggregation | aUI | S | M | |
| | disaUI_comment | Comments by the reporting entity | Text | S | O | |

Item #

Field

Comments

Data Type

Cardinality

Priority

Values

Message_Type

Identification of message type

Text

S

M

3-6

EO_ID

Economic operator's identifier

EOID

S

M

F_ID

Facility's identifier

FID

S

M

Event_Time

Time of event occurrence

Time(s)

S

M

aUI

Aggregated level UI subject to disaggregation

aUI

S

M

disaUI_comment

Comments by the reporting entity

Text

S

O

3.7.   Report of delivery carried out with a vending van to retail outlet (required if in message type 3-3, field Destination_ID1 = 4)

| Item # | Field | Comments | Data Type | Cardinality | Priority | Values |
| --- | --- | --- | --- | --- | --- | --- |
| | Message_Type | Identification of message type | Text | S | M | 3-7 |
| | EO_ID | Economic operator identifier code of the submitting entity | EOID | S | M | |
| | F_ID | Facility identifier code of retail outlet | FID | S | M | |
| | Event_Time | Time of event occurrence | Time(s) | S | M | |
| | UI_Type | Identification of UI types delivered (recorded at the highest level of available aggregation) | Integer | S | M | 1 – only unit packet level UIs
  2 – only aggregated level UIs
  3 – both unit packet and aggregated level UIs |
| | upUIs | List of unit packet level UIs delivered | upUI(L) | M | M, if UI_Type = 1 or 3 | |
| | aUIs | List of aggregated level UIs delivered | aUI | M | M, if UI_Type = 2 or 3 | |
| | Delivery_comment | Comments by the reporting entity | Text | S | O | |

Item #

Field

Comments

Data Type

Cardinality

Priority

Values

Message_Type

Identification of message type

Text

S

M

3-7

EO_ID

Economic operator identifier code of the submitting entity

EOID

S

M

F_ID

Facility identifier code of retail outlet

FID

S

M

Event_Time

Time of event occurrence

Time(s)

S

M

UI_Type

Identification of UI types delivered (recorded at the highest level of available aggregation)

Integer

S

M

1 – only unit packet level UIs

2 – only aggregated level UIs

3 – both unit packet and aggregated level UIs

upUIs

List of unit packet level UIs delivered

upUI(L)

M

M, if UI_Type = 1 or 3

aUIs

List of aggregated level UIs delivered

aUI

M

M, if UI_Type = 2 or 3

Delivery_comment

Comments by the reporting entity

Text

S

O

SECTION 4

Transactional events

4.1.   Issuing of the invoice

| Item # | Field | Comments | Data Type | Cardinality | Priority | Values |
| --- | --- | --- | --- | --- | --- | --- |
| | Message_Type | Identification of message type | Text | S | M | 4-1 |
| | EO_ID | Economic operator identifier code of the submitting entity | EOID | S | M | |
| | Event_Time | Time of event occurrence | Time(s) | S | M | |
| | Invoice_Type1 | Type of the invoice | Integer | S | M | 1 – Original
  2 – Correction
  3 – Other |
| | Invoice_Type2 | Description of the other type of the invoice | Text | S | M, if Invoice_Type1 = 3 | |
| | Invoice_Number | Number of the invoice | Text | S | M | |
| | Invoice_Date | Date of the invoice | Date | S | M | |
| | Invoice_Seller | Identity of the seller | EOID | S | M | |
| | Invoice_Buyer1 | Indication if the buyer is located in the EU | Boolean | S | M | 0 – No
  1 – Yes |
| | Invoice_Buyer2 | Identity of the buyer | EOID | S | M, if Invoice_Buyer1 = 1 | |
| | Buyer_Name | Buyer's registered legal name | Text | S | M, if Invoice_Buyer1 = 0 | |
| | Buyer_Address | Buyer's address – street name, house number, postal code, city | Text | S | M, if Invoice_Buyer1 = 0 | |
| | Buyer_CountryReg | Buyer's country of registration | Country | S | M, if Invoice_Buyer1 = 0 | |
| | Buyer_TAX_N | Buyer's tax registration number | Text | S | M, if Invoice_Buyer1 = 0 | |
| | First_Seller_EU | Indication if the invoice is issued by the first seller in the EU, i.e. the EU manufacturer or the importer, and the product is destined for the EU market | Boolean | S | M | 0 – No
  1 – Yes |
| | Product_Items_1 | List of TPIDs corresponding to the product items listed on the invoice | TPID | M | M, if First_Seller_EU = 1 | |
| | Product_Items_2 | List of product numbers corresponding to the product items listed on the invoice (in the same order as Product_Items_1) | PN | M | M, if First_Seller_EU = 1 | |
| | Product_Price | Net unit packet price per each pair of TPID and product number
  (in the same order as Product_ Items_1) | Decimal | M | M, if First_Seller_EU = 1 | |
| | Invoice_Net | Total net amount of the invoice | Decimal | S | M | |
| | Invoice_Currency | Currency of the invoice | Currency | S | M | |
| | UI_Type | Identification of UI types covered by the invoice (recorded at the highest level of available aggregation) | Integer | S | M | 1 – only unit packet level UIs
  2 – only aggregated level UIs
  3 – both unit packet and aggregated level UIs |
| | upUIs | List of unit packet level UIs covered by the invoice | upUI(L) | M | M, if UI_Type = 1 or 3 | |
| | aUIs | List of aggregated level UIs covered by the invoice | aUI | M | M, if UI_Type = 2 or 3 | |
| | Invoice_comment | Comments by the reporting entity | Text | S | O | |

Item #

Field

Comments

Data Type

Cardinality

Priority

Values

Message_Type

Identification of message type

Text

S

M

4-1

EO_ID

Economic operator identifier code of the submitting entity

EOID

S

M

Event_Time

Time of event occurrence

Time(s)

S

M

Invoice_Type1

Type of the invoice

Integer

S

M

1 – Original

2 – Correction

3 – Other

Invoice_Type2

Description of the other type of the invoice

Text

S

M, if Invoice_Type1 = 3

Invoice_Number

Number of the invoice

Text

S

M

Invoice_Date

Date of the invoice

Date

S

M

Invoice_Seller

Identity of the seller

EOID

S

M

Invoice_Buyer1

Indication if the buyer is located in the EU

Boolean

S

M

0 – No

1 – Yes

Invoice_Buyer2

Identity of the buyer

EOID

S

M, if Invoice_Buyer1 = 1

Buyer_Name

Buyer's registered legal name

Text

S

M, if Invoice_Buyer1 = 0

Buyer_Address

Buyer's address – street name, house number, postal code, city

Text

S

M, if Invoice_Buyer1 = 0

Buyer_CountryReg

Buyer's country of registration

Country

S

M, if Invoice_Buyer1 = 0

Buyer_TAX_N

Buyer's tax registration number

Text

S

M, if Invoice_Buyer1 = 0

First_Seller_EU

Indication if the invoice is issued by the first seller in the EU, i.e. the EU manufacturer or the importer, and the product is destined for the EU market

Boolean

S

M

0 – No

1 – Yes

Product_Items_1

List of TPIDs corresponding to the product items listed on the invoice

TPID

M

M, if First_Seller_EU = 1

Product_Items_2

List of product numbers corresponding to the product items listed on the invoice (in the same order as Product_Items_1)

PN

M

M, if First_Seller_EU = 1

Product_Price

Net unit packet price per each pair of TPID and product number

(in the same order as Product_ Items_1)

Decimal

M

M, if First_Seller_EU = 1

Invoice_Net

Total net amount of the invoice

Decimal

S

M

Invoice_Currency

Currency of the invoice

Currency

S

M

UI_Type

Identification of UI types covered by the invoice (recorded at the highest level of available aggregation)

Integer

S

M

1 – only unit packet level UIs

2 – only aggregated level UIs

3 – both unit packet and aggregated level UIs

upUIs

List of unit packet level UIs covered by the invoice

upUI(L)

M

M, if UI_Type = 1 or 3

aUIs

List of aggregated level UIs covered by the invoice

aUI

M

M, if UI_Type = 2 or 3

Invoice_comment

Comments by the reporting entity

Text

S

O

4.2.   Issuing of the order number

| Item # | Field | Comments | Data Type | Cardinality | Priority | Values |
| --- | --- | --- | --- | --- | --- | --- |
| | Message_Type | Identification of message type | Text | S | M | 4-2 |
| | EO_ID | Economic operator identifier code of the submitting entity | EOID | S | M | |
| | Event_Time | Time of event occurrence | Time(s) | S | M | |
| | Order_Number | Number of the purchase order | Text | S | M | |
| | Order_Date | Date of the purchase order | Date | S | M | |
| | UI_Type | Identification of UI types covered by the purchase order (recorded at the highest level of available aggregation) | Integer | S | M | 1 – only unit packet level UIs
  2 – only aggregated level UIs
  3 – both unit packet and aggregated level UIs |
| | upUIs | List of unit packet level UIs covered by the purchase order | upUI(L) | M | M, if UI_Type = 1 or 3 | |
| | aUIs | List of aggregated level UIs covered by the purchase order | aUI | M | M, if UI_Type = 2 or 3 | |
| | Order_comment | Description of the reason for delayed recording of the purchase order | Text | S | O | |

Item #

Field

Comments

Data Type

Cardinality

Priority

Values

Message_Type

Identification of message type

Text

S

M

4-2

EO_ID

Economic operator identifier code of the submitting entity

EOID

S

M

Event_Time

Time of event occurrence

Time(s)

S

M

Order_Number

Number of the purchase order

Text

S

M

Order_Date

Date of the purchase order

Date

S

M

UI_Type

Identification of UI types covered by the purchase order (recorded at the highest level of available aggregation)

Integer

S

M

1 – only unit packet level UIs

2 – only aggregated level UIs

3 – both unit packet and aggregated level UIs

upUIs

List of unit packet level UIs covered by the purchase order

upUI(L)

M

M, if UI_Type = 1 or 3

aUIs

List of aggregated level UIs covered by the purchase order

aUI

M

M, if UI_Type = 2 or 3

Order_comment

Description of the reason for delayed recording of the purchase order

Text

S

O

4.3.   Receipt of the payment

| Item # | Field | Comments | Data Type | Cardinality | Priority | Values |
| --- | --- | --- | --- | --- | --- | --- |
| | Message_Type | Identification of message type | Text | S | M | 4-3 |
| | EO_ID | Economic operator identifier code of the submitting entity | EOID | S | M | |
| | Event_Time | Time of event occurrence | Time(s) | S | M | |
| | Payment_Date | Date of the payment receipt | Date | S | M | |
| | Payment_Type | Type of payment | Integer | S | M | 1 – bank transfer
  2 – bank card
  3 – cash
  4 – other |
| | Payment_Amount | Amount of the payment | Decimal | S | M | |
| | Payment_Currency | Currency of the payment | Currency | S | M | |
| | Payment_Payer1 | Indication if the payer is located in the EU | Boolean | S | M | 0 – No
  1 – Yes |
| | Payment_Payer2 | Identity of the payer | EOID | S | M, if Payment_Payer1 = 1 | |
| | Payer_Name | Payer's registered legal name | Text | S | M, if Payment_Payer1 = 0 | |
| | Payer_Address | Payer's address – street name, house number, postal code and city | Text | S | M, if Payment_Payer1 = 0 | |
| | Payer_CountryReg | Payer's country of registration | Country | S | M, if Payment_Payer1 = 0 | |
| | Payer_TAX_N | Payer's tax registration number | Text | S | M, if Payment_Payer1 = 0 | |
| | Payment_Recipient | Identity of the recipient | EOID | S | M | |
| | Payment_Invoice | Indication if the payment corresponds to the existing invoice | Boolean | S | M | 0 – No
  1 – Yes |
| | Invoice_Paid | Number of the invoice paid with the payment | Text | S | M, if Payment_Invoice = 1 | |
| | UI_Type | Identification of UI types covered by the payment (recorded at the highest level of available aggregation) | Integer | S | M, if Payment_Invoice = 0 | 1 – only unit packet level UIs
  2 – only aggregated level UIs
  3 – both unit packet and aggregated level UIs |
| | upUIs | List of unit packet level UIs covered by the payment | upUI(L) | M | M, if Payment_Invoice = 0 and UI_Type = 1 or 3 | |
| | aUIs | List of aggregated level UIs covered by the payment | aUI | M | M, if Payment_Invoice = 0 and UI_Type = 2 or 3 | |
| | Payment_comment | Comments by the reporting entity | Text | S | O | |

Item #

Field

Comments

Data Type

Cardinality

Priority

Values

Message_Type

Identification of message type

Text

S

M

4-3

EO_ID

Economic operator identifier code of the submitting entity

EOID

S

M

Event_Time

Time of event occurrence

Time(s)

S

M

Payment_Date

Date of the payment receipt

Date

S

M

Payment_Type

Type of payment

Integer

S

M

1 – bank transfer

2 – bank card

3 – cash

4 – other

Payment_Amount

Amount of the payment

Decimal

S

M

Payment_Currency

Currency of the payment

Currency

S

M

Payment_Payer1

Indication if the payer is located in the EU

Boolean

S

M

0 – No

1 – Yes

Payment_Payer2

Identity of the payer

EOID

S

M, if Payment_Payer1 = 1

Payer_Name

Payer's registered legal name

Text

S

M, if Payment_Payer1 = 0

Payer_Address

Payer's address – street name, house number, postal code and city

Text

S

M, if Payment_Payer1 = 0

Payer_CountryReg

Payer's country of registration

Country

S

M, if Payment_Payer1 = 0

Payer_TAX_N

Payer's tax registration number

Text

S

M, if Payment_Payer1 = 0

Payment_Recipient

Identity of the recipient

EOID

S

M

Payment_Invoice

Indication if the payment corresponds to the existing invoice

Boolean

S

M

0 – No

1 – Yes

Invoice_Paid

Number of the invoice paid with the payment

Text

S

M, if Payment_Invoice = 1

UI_Type

Identification of UI types covered by the payment (recorded at the highest level of available aggregation)

Integer

S

M, if Payment_Invoice = 0

1 – only unit packet level UIs

2 – only aggregated level UIs

3 – both unit packet and aggregated level UIs

upUIs

List of unit packet level UIs covered by the payment

upUI(L)

M

M, if Payment_Invoice = 0 and UI_Type = 1 or 3

aUIs

List of aggregated level UIs covered by the payment

aUI

M

M, if Payment_Invoice = 0 and UI_Type = 2 or 3

Payment_comment

Comments by the reporting entity

Text

S

O

SECTION 5

Recalls

5.   Recalls of requests, operational and transactional messages (possible for message types 2-1, 2-2, 3-1 to 3-7, 4-1, 4-2 and 4-3)

| Item # | Field | Comments | Data Type | Cardinality | Priority | Values |
| --- | --- | --- | --- | --- | --- | --- |
| | Message_Type | Identification of message type | Text | S | M | 5 |
| | EO_ID | Economic operator identifier code of the submitting entity | EOID | S | M | |
| | Recall_CODE | Message recall code provided to the message sender in the acknowledgement of the original message to be recalled | Text | S | M | |
| | Recall_Reason1 | Reason for recalling the original message | Integer | S | M | 1 – reported event did not materialise (only for message types 3-3 and 3-5)
  2 – message contained erroneous information
  3 – other |
| | Recall_Reason2 | Description of the reason for recalling the original message | Text | S | M, if Recall_Reason1 = 3 | |
| | Recall_Reason3 | Any additional explanations on the reason for recalling the original message | Text | S | O | |

Item #

Field

Comments

Data Type

Cardinality

Priority

Values

Message_Type

Identification of message type

Text

S

M

5

EO_ID

Economic operator identifier code of the submitting entity

EOID

S

M

Recall_CODE

Message recall code provided to the message sender in the acknowledgement of the original message to be recalled

Text

S

M

Recall_Reason1

Reason for recalling the original message

Integer

S

M

1 – reported event did not materialise (only for message types 3-3 and 3-5)

2 – message contained erroneous information

3 – other

Recall_Reason2

Description of the reason for recalling the original message

Text

S

M, if Recall_Reason1 = 3

Recall_Reason3

Any additional explanations on the reason for recalling the original message

Text

S

O

Notice: A recall with respect to operational and logistic events results in flagging the recalled message as cancelled but does not lead to the deletion of the existing database record.

---

DECISIONS

| 16.4.2018 | EN | Official Journal of the European Union | L 96/56 |
| --- | --- | --- | --- |

16.4.2018

EN

Official Journal of the European Union

L 96/56

---

COUNCIL DECISION (EU) 2018/575

of 12 April 2018

appointing an alternate member, proposed by Malta, of the Committee of the Regions

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 305 thereof,

Having regard to the proposal of the Government of Malta,

Whereas:

| (1) | On 26 January 2015, 5 February 2015 and 23 June 2015, the Council adopted Decisions (EU) 2015/116 (1), (EU) 2015/190 (2) and (EU) 2015/994 (3) appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2015 to 25 January 2020. On 10 November 2015, by Council Decision (EU) 2015/2029 (4), Mr Anthony MIFSUD was replaced by Ms Graziella GALEA as an alternate member. |
| --- | --- |

(1)

On 26 January 2015, 5 February 2015 and 23 June 2015, the Council adopted Decisions (EU) 2015/116 (1), (EU) 2015/190 (2) and (EU) 2015/994 (3) appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2015 to 25 January 2020. On 10 November 2015, by Council Decision (EU) 2015/2029 (4), Mr Anthony MIFSUD was replaced by Ms Graziella GALEA as an alternate member.

| (2) | An alternate member's seat on the Committee of the Regions has become vacant following the end of the mandate on the basis of which Ms Graziella GALEA (Mayor, Saint Paul's Bay Local Council) was proposed, |
| --- | --- |

(2)

An alternate member's seat on the Committee of the Regions has become vacant following the end of the mandate on the basis of which Ms Graziella GALEA (Mayor, Saint Paul's Bay Local Council) was proposed,

HAS ADOPTED THIS DECISION:

Article 1

The following is hereby appointed as an alternate member of the Committee of the Regions for the remainder of the current term of office, which runs until 25 January 2020:

| — | Ms Graziella GALEA, Councillor, Saint Paul's Bay Local Council (change of mandate). |
| --- | --- |

—

Ms Graziella GALEA, Councillor, Saint Paul's Bay Local Council (change of mandate).

Article 2

This Decision shall enter into force on the date of its adoption.

Done at Luxembourg, 12 April 2018.

For the Council

The President

T. DONCHEV

---

(1)  Council Decision (EU) 2015/116 of 26 January 2015 appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2015 to 25 January 2020 (OJ L 20, 27.1.2015, p. 42).

1

(2)  Council Decision (EU) 2015/190 of 5 February 2015 appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2015 to 25 January 2020 (OJ L 31, 7.2.2015, p. 25).

2

(3)  Council Decision (EU) 2015/994 of 23 June 2015 appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2015 to 25 January 2020 (OJ L 159, 25.6.2015, p. 70).

3

(4)  Council Decision (EU) 2015/2029 of 10 November 2015 appointing one Maltese member and two Maltese alternate members of the Committee of the Regions (OJ L 297, 13.11.2015, p. 8).

4

---

| 16.4.2018 | EN | Official Journal of the European Union | L 96/57 |
| --- | --- | --- | --- |

16.4.2018

EN

Official Journal of the European Union

L 96/57

---

COMMISSION IMPLEMENTING DECISION (EU) 2018/576

of 15 December 2017

on technical standards for security features applied to tobacco products

(notified under document C(2017) 8435)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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 16(2) thereof,

Whereas:

| (1) | Directive 2014/40/EU provides that all unit packets of tobacco products placed on the market are to carry a tamper proof security feature, composed of visible and invisible elements, for the purpose of facilitating the verification of whether or not tobacco products are authentic. Technical standards for a system of security features should be laid down. |
| --- | --- |

(1)

Directive 2014/40/EU provides that all unit packets of tobacco products placed on the market are to carry a tamper proof security feature, composed of visible and invisible elements, for the purpose of facilitating the verification of whether or not tobacco products are authentic. Technical standards for a system of security features should be laid down.

| (2) | The security features along with the system for ensuring the traceability of tobacco products, provided for in Article 15 of Directive 2014/40/EU and established in Commission Implementing Regulation (EU) 2018/574 (2), should allow for monitoring and more effective enforcement of the compliance of tobacco products with Directive 2014/40/EU. |
| --- | --- |

(2)

The security features along with the system for ensuring the traceability of tobacco products, provided for in Article 15 of Directive 2014/40/EU and established in Commission Implementing Regulation (EU) 2018/574 (2), should allow for monitoring and more effective enforcement of the compliance of tobacco products with Directive 2014/40/EU.

| (3) | Common rules on security feature standards in the Union are essential as divergent and insufficiently precise national requirements are likely to undermine efforts to improve compliance of tobacco products with Union tobacco products regulation. A more harmonised framework for security features across Member States should also facilitate the functioning of the internal market of legal tobacco products. |
| --- | --- |

(3)

Common rules on security feature standards in the Union are essential as divergent and insufficiently precise national requirements are likely to undermine efforts to improve compliance of tobacco products with Union tobacco products regulation. A more harmonised framework for security features across Member States should also facilitate the functioning of the internal market of legal tobacco products.

| (4) | The technical standards for security features should give due regard to the high degree of innovation that exists in this area, while enabling competent authorities of Member States to verify the authenticity of tobacco products in an effective manner. Each Member State should be able to define the combination or combinations of authentication elements that are to be used to develop security features that are applied to tobacco products manufactured on or imported into its territory. The combination or combinations used should include visible and invisible elements. According to international standards, invisible elements, which are not directly perceptible by human senses, may further be defined by reference to the sophistication of equipment necessary for the verification of their authenticity. In order to maximise the robustness of the features, it is appropriate to require the use of at least one invisible element the verification of which requires the use of purpose built tools or professional laboratory equipment. The inclusion of a variety of different types of authentication elements into a security feature should ensure the necessary balance between flexibility and a high level of security. This should also enable Member States to take into account new innovative solutions, capable of further bolstering the effectiveness of security features. |
| --- | --- |

(4)

The technical standards for security features should give due regard to the high degree of innovation that exists in this area, while enabling competent authorities of Member States to verify the authenticity of tobacco products in an effective manner. Each Member State should be able to define the combination or combinations of authentication elements that are to be used to develop security features that are applied to tobacco products manufactured on or imported into its territory. The combination or combinations used should include visible and invisible elements. According to international standards, invisible elements, which are not directly perceptible by human senses, may further be defined by reference to the sophistication of equipment necessary for the verification of their authenticity. In order to maximise the robustness of the features, it is appropriate to require the use of at least one invisible element the verification of which requires the use of purpose built tools or professional laboratory equipment. The inclusion of a variety of different types of authentication elements into a security feature should ensure the necessary balance between flexibility and a high level of security. This should also enable Member States to take into account new innovative solutions, capable of further bolstering the effectiveness of security features.

| (5) | The combination of different authentication elements should be required as an important step in guaranteeing that the integrity of the final security feature applied to a tobacco product is well protected. |
| --- | --- |

(5)

The combination of different authentication elements should be required as an important step in guaranteeing that the integrity of the final security feature applied to a tobacco product is well protected.

| (6) | The importance of ensuring the robustness of a system for security features is recognised by internationally recognised standards (3). To this end, additional safeguards should be put in place, which shield security features and their different authentication elements from internal and external threats to the greatest extent possible. It should therefore be required that at least one authentication element in a security feature is provided by an independent third party solution provider, thereby reducing the potential for attacks perpetrated by persons or entities that are directly or indirectly connected with the producer or originator of authentication elements used to develop the security feature. In addition, in order to ensure the continuing respect of the requirement for independence that is critical for ensuring and maintaining the integrity of security features across the Union, the procedures for monitoring compliance with the independence criteria set out in this Decision should undergo periodic review by the Commission. Conclusions of the review should be published by the Commission and form part of the report on the application of Directive 2014/40/EU provided for under Article 28 of that Directive. |
| --- | --- |

(6)

The importance of ensuring the robustness of a system for security features is recognised by internationally recognised standards (3). To this end, additional safeguards should be put in place, which shield security features and their different authentication elements from internal and external threats to the greatest extent possible. It should therefore be required that at least one authentication element in a security feature is provided by an independent third party solution provider, thereby reducing the potential for attacks perpetrated by persons or entities that are directly or indirectly connected with the producer or originator of authentication elements used to develop the security feature. In addition, in order to ensure the continuing respect of the requirement for independence that is critical for ensuring and maintaining the integrity of security features across the Union, the procedures for monitoring compliance with the independence criteria set out in this Decision should undergo periodic review by the Commission. Conclusions of the review should be published by the Commission and form part of the report on the application of Directive 2014/40/EU provided for under Article 28 of that Directive.

| (7) | Several Member States require tax stamps or national identification marks for fiscal purposes. Those Member States should be free to allow that their stamps or marks are used as the security feature subject to the requirements of Article 16 of Directive 2014/40/EU and of this Decision. In order to alleviate any unnecessary economic burden, Member States whose tax stamps or national identification marks do not comply with one or more of the requirements of Article 16 of Directive 2014/40/EU and of this Decision should be allowed to use their tax stamps or national identification marks as a part of the security feature. In such cases, Member States should ensure that manufacturers and importers of tobacco products are informed of the additional authentication elements necessary to develop a security feature that is compliant with all legislative requirements. |
| --- | --- |

(7)

Several Member States require tax stamps or national identification marks for fiscal purposes. Those Member States should be free to allow that their stamps or marks are used as the security feature subject to the requirements of Article 16 of Directive 2014/40/EU and of this Decision. In order to alleviate any unnecessary economic burden, Member States whose tax stamps or national identification marks do not comply with one or more of the requirements of Article 16 of Directive 2014/40/EU and of this Decision should be allowed to use their tax stamps or national identification marks as a part of the security feature. In such cases, Member States should ensure that manufacturers and importers of tobacco products are informed of the additional authentication elements necessary to develop a security feature that is compliant with all legislative requirements.

| (8) | In order to ensure the integrity of security features and to protect it from external attack, they should be applied either by affixing, printing or a combination of both, in a manner that protects them from being replaced, reused or modified in any way. In addition, security features should allow for the identification and verification of the authenticity of an individual unit packet of tobacco product for the entire time the tobacco product is placed on the market. |
| --- | --- |

(8)

In order to ensure the integrity of security features and to protect it from external attack, they should be applied either by affixing, printing or a combination of both, in a manner that protects them from being replaced, reused or modified in any way. In addition, security features should allow for the identification and verification of the authenticity of an individual unit packet of tobacco product for the entire time the tobacco product is placed on the market.

| (9) | In order to allow for the verification of the authenticity of a tobacco product and thereby stepping up the fight against illicit trade of tobacco products in the Union, Member States and the Commission should, upon request, be provided with sample products that may be used as a reference for the purposes of laboratory analysis. Additionally, in order to enable competent authorities of one Member State to verify the authenticity of a tobacco product destined for the national market of another Member State, Member States should assist each other in sharing the reference products obtained, as well as providing knowledge and expertise available insofar as this is possible. |
| --- | --- |

(9)

In order to allow for the verification of the authenticity of a tobacco product and thereby stepping up the fight against illicit trade of tobacco products in the Union, Member States and the Commission should, upon request, be provided with sample products that may be used as a reference for the purposes of laboratory analysis. Additionally, in order to enable competent authorities of one Member State to verify the authenticity of a tobacco product destined for the national market of another Member State, Member States should assist each other in sharing the reference products obtained, as well as providing knowledge and expertise available insofar as this is possible.

| (10) | The measures provided for in this Decision are in accordance with the opinion of the Committee referred to in Article 25 of Directive 2014/40/EU, |
| --- | --- |

(10)

The measures provided for in this Decision are in accordance with the opinion of the Committee referred to in Article 25 of Directive 2014/40/EU,

HAS ADOPTED THIS DECISION:

Article 1

Subject matter

This Decision lays down technical standards for security features applied to unit packets of tobacco products placed on the Union market.

Article 2

Definitions

For the purposes of this Decision, in addition to the definitions laid down in Article 2 of Directive 2014/40/EU, the following definitions shall apply:

| (a) | ‘authentication element’ means an element of a security feature; |
| --- | --- |

(a)

‘authentication element’ means an element of a security feature;

| (b) | ‘overt’ means directly perceptible by one or more of the human senses without recourse to external devices. The ‘overt’ category of authentication solutions referred to in ISO 12931:2012 shall be presumed to meet this definition; |
| --- | --- |

(b)

‘overt’ means directly perceptible by one or more of the human senses without recourse to external devices. The ‘overt’ category of authentication solutions referred to in ISO 12931:2012 shall be presumed to meet this definition;

| (c) | ‘semi-covert’ means not directly perceptible by the human senses but detectable by those senses through the use of external devices, such as a UV torch or a special pen or marker, which do not require expert knowledge or specialist training. The ‘covert’ category of authentication solutions authenticated with off-the-shelf tools referred to in ISO 12931:2012 shall be presumed to meet this definition; |
| --- | --- |

(c)

‘semi-covert’ means not directly perceptible by the human senses but detectable by those senses through the use of external devices, such as a UV torch or a special pen or marker, which do not require expert knowledge or specialist training. The ‘covert’ category of authentication solutions authenticated with off-the-shelf tools referred to in ISO 12931:2012 shall be presumed to meet this definition;

| (d) | ‘covert’ means not directly perceptible by the human senses and detectable only through the use of purpose built tools or professional laboratory equipment. The ‘covert’ categories of authentication solutions requiring purpose built tools and forensic analysis referred to in ISO 12931:2012 shall be presumed to meet this definition. |
| --- | --- |

(d)

‘covert’ means not directly perceptible by the human senses and detectable only through the use of purpose built tools or professional laboratory equipment. The ‘covert’ categories of authentication solutions requiring purpose built tools and forensic analysis referred to in ISO 12931:2012 shall be presumed to meet this definition.

Article 3

Security feature

1.   Member States shall require security features to be composed of no less than five types of authentication elements, of which at least:

| (a) | one is overt; |
| --- | --- |

(a)

one is overt;

| (b) | one is semi-covert; |
| --- | --- |

(b)

one is semi-covert;

| (c) | one is covert. |
| --- | --- |

(c)

one is covert.

2.   Member States shall require at least one of the authentication elements, referred to in paragraph 1, to be provided by an independent third-party provider meeting the requirements laid down in Article 8.

3.   Each Member State shall communicate to manufacturers and importers of tobacco products the combination or combinations of authentication elements that are to be used in security features applied to unit packets of tobacco products placed on its market.

The authentication elements referred to in the first subparagraph may include any of the overt, semi-covert and covert types of authentication elements set out in the Annex.

4.   The communication referred to in paragraph 3 shall take place by 20 September 2018 at the latest. Any subsequent changes to the combination or combinations of authentication elements shall be communicated by Member States to manufacturers and importers of tobacco products at least 6 months prior to the date when the changes are intended to take effect.

Article 4

Use of tax stamps as security feature

1.   Member States allowing tax stamps or national identification marks for fiscal purposes to be used to develop security features shall ensure that the final security features comply with the requirements of Article 3 of this Decision and Article 16 of Directive 2014/40/EU.

2.   Where a tax stamp or national identification mark for fiscal purposes intended for use as a security feature does not comply with one or more of the requirements referred to in paragraph 1, it shall only be used as a part of the security feature. In such cases, Member States shall ensure that manufacturers and importers of tobacco products are informed of the additional types of authentication elements required to develop a compliant security feature.

3.   The information referred to in paragraph 2 shall be made available to manufacturers and importers of tobacco products by 20 September 2018 at the latest. Any subsequent information related to changes to the tax stamp or national identification mark for fiscal purposes intended for use as a security feature shall be communicated to manufacturers and importers of tobacco products at least 6 months prior to the date when the changes are intended to take effect, provided this information is necessary for them to develop a compliant security feature.

Article 5

Applying security features to unit packets

1.   Member States shall require security features to be applied to unit packets of tobacco products using any of the following methods:

| (a) | affixing; |
| --- | --- |

(a)

affixing;

| (b) | printing; |
| --- | --- |

(b)

printing;

| (c) | combination of affixing and printing. |
| --- | --- |

(c)

combination of affixing and printing.

2.   Security features shall be applied to unit packets of tobacco products in a manner that:

| (a) | allows for the identification and verification of the authenticity of an individual unit packet of tobacco product for the entire time the tobacco product is placed on the market; and |
| --- | --- |

(a)

allows for the identification and verification of the authenticity of an individual unit packet of tobacco product for the entire time the tobacco product is placed on the market; and

| (b) | protects them from being replaced, reused or modified in any way. |
| --- | --- |

(b)

protects them from being replaced, reused or modified in any way.

Article 6

Integrity of security features

1.   Member States may decide, at any moment, to implement or withdraw schemes for the rotation of security features.

2.   If a Member State has reasons to believe that the integrity of any authentication element of a security feature currently in use on their market is compromised, they shall require that the security feature concerned be replaced or modified. If a Member State detects a compromised security feature, it shall inform the manufacturers and importers and security feature providers concerned within 5 working days thereof.

3.   Member States may lay down formal guidelines or requirements on the security of production and distribution procedures, such as those relating to the use of secure equipment and other components, audits, monitoring tools for production quantities, and secure shipping, in order to avert, deter, identify and mitigate the unlawful production, distribution or theft of security features and the authentication elements of which they are composed.

Article 7

Verification of authenticity of tobacco products

1.   Member States shall ensure that they possess the means necessary to analyse each combination of authentication elements that they permit to be used to develop security features, in accordance with Articles 3 and 4 of this Decision, for the purposes of determining whether or not a unit packet of a tobacco product is authentic. The analysis should be carried out in line with internationally recognised performance criteria and evaluation methodology, such as those laid down in ISO 12931:2012.

2.   Member States shall require manufacturers and importers of tobacco products located on their territory to provide, upon written request, samples of tobacco products currently placed on the market. The samples shall be provided in unit packet format and include the applied security feature. Member States shall, upon request, make available to the Commission the samples of tobacco products received.

3.   Member States shall, upon request, assist each other in the verification of the authenticity of a tobacco product destined for the national market of another Member State, including by sharing any samples obtained pursuant to paragraph 2.

Article 8

Independence of authentication element providers

1.   For the purpose of Article 3(2), a provider of authentication elements, as well as, where applicable, its subcontractors, shall be considered independent, if the following criteria are met:

| (a) | independence from the tobacco industry in terms of legal form, organisation and decision making. In particular it shall be assessed whether the undertaking or the group of undertakings is not under the direct or indirect control of the tobacco industry, including a minority shareholding; |
| --- | --- |

(a)

independence from the tobacco industry in terms of legal form, organisation and decision making. In particular it shall be assessed whether the undertaking or the group of undertakings is not under the direct or indirect control of the tobacco industry, including a minority shareholding;

| (b) | independence from the tobacco industry in financial terms, which will be presumed if, before assuming its functions, the undertaking or the group of undertakings generates less than 10 % of its annual worldwide turnover, excluding VAT and any other indirect taxes, from goods and services supplied to the tobacco sector over the past 2 calendar years, as may be determined on the basis of the most recent approved accounts. For each subsequent calendar year, the annual worldwide turnover, excluding VAT and any other indirect taxes, from goods and services supplied to the tobacco sector shall not exceed 20 %; |
| --- | --- |

(b)

independence from the tobacco industry in financial terms, which will be presumed if, before assuming its functions, the undertaking or the group of undertakings generates less than 10 % of its annual worldwide turnover, excluding VAT and any other indirect taxes, from goods and services supplied to the tobacco sector over the past 2 calendar years, as may be determined on the basis of the most recent approved accounts. For each subsequent calendar year, the annual worldwide turnover, excluding VAT and any other indirect taxes, from goods and services supplied to the tobacco sector shall not exceed 20 %;

| (c) | absence of conflicts of interests with the tobacco industry of the persons responsible for the management of the undertaking or the group of undertakings, including members of the board of directors or any other form of governing body. In particular, they:






  (i) | shall not have participated in company structures of the tobacco industry for the last 5 years; |
| --- | --- | --- |

(c)

absence of conflicts of interests with the tobacco industry of the persons responsible for the management of the undertaking or the group of undertakings, including members of the board of directors or any other form of governing body. In particular, they:

(i)

shall not have participated in company structures of the tobacco industry for the last 5 years;

| (ii) | shall act independently from any pecuniary or non-pecuniary interest linked to the tobacco industry, including possession of stocks, participation in private pension programmes or interest held by their partners, spouses or direct relatives in the ascending or descending line. |
| --- | --- |

(ii)

shall act independently from any pecuniary or non-pecuniary interest linked to the tobacco industry, including possession of stocks, participation in private pension programmes or interest held by their partners, spouses or direct relatives in the ascending or descending line.

2.   Where a provider of authentication elements has recourse to sub-contractors, it shall remain responsible for ensuring compliance by those subcontractors with the independence criteria set out in paragraph 1.

3.   Member States, as well as the Commission, may require providers of authentication elements, including where applicable their sub-contractors, to provide them with documents necessary to assess compliance with the criteria set out in paragraph 1. Such documents may include annual declarations of conformity with the independence criteria set out in paragraph 1. Member States and the Commission may require that the annual declarations include a full list of services provided to the tobacco industry during the last calendar year as well as individual declarations of financial independence from the tobacco industry provided by all management members of the independent provider.

4.   Any change in circumstances related to the criteria referred to in paragraph 1, capable of affecting the independence of a provider of authentication elements (including, where applicable, its subcontractors), that subsist for 2 consecutive calendar years, shall be communicated without delay to the relevant Member States and to the Commission.

5.   Where, information obtained in accordance with paragraph 3, or the communication referred to in paragraph 4, discloses that a provider of authentication elements (including, where applicable, its subcontractors) no longer meets the requirements laid down in paragraph 1, then within a reasonable time period and at the latest by the end of the calendar year following the calendar year in which the information or communication was received, Member States shall take all measures necessary to ensure compliance with the criteria set out in paragraph 1.

6.   Providers of authentication elements shall inform without delay the relevant Member States and the Commission about any occurrences of threats or other attempts at exercising undue influence that may actually or potentially undermine their independence.

7.   Public authorities or undertakings governed by public law along with their subcontractors shall be presumed independent from the tobacco industry.

8.   The procedures governing the monitoring of compliance with the independence criteria set out in paragraph 1 shall be subject to periodic review by the Commission with a view to assessing their conformity with the requirements of this Decision. Conclusions of the review shall be published and form part of the report on the application of Directive 2014/40/EU provided for under Article 28 of that Directive.

Article 9

Transitional provision

1.   Cigarettes and roll-your-own tobacco that were manufactured in the Union or imported into the Union before 20 May 2019 and do not carry a security feature in accordance with this Decision may remain in free circulation until 20 May 2020.

2.   Tobacco products other than cigarettes and roll-your-own tobacco that were manufactured in the Union or imported into the Union before 20 May 2024 and do not carry a security feature in accordance with this Decision may remain in free circulation until 20 May 2026.

Article 10

Addressees

This Decision is addressed to the Member States.

Done at Brussels, 15 December 2017.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission

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(1)  
  OJ L 127, 29.4.2014, p. 1.

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 (see page 7 of this Official Journal).

2

(3)  ISO 12931:2012 (Performance criteria for authentication solutions used to combat counterfeiting of material goods).

3

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ANNEX

TYPES OF AUTHENTICATION ELEMENTS

| Overt | Semi-covert | Covert |
| --- | --- | --- |
| Guilloche

  Ornamental pattern of two or more interlaced bands that are printed in multiple non-standard colours. | Laser images

  Image becomes visible to the human eye only when emblazed with a light of a specific wavelength, such as a laser pointer. | DNA taggants

  Forensic marker which uses combinatorical mathematical principles to define nucleotide sequences. |
| Rainbow printing

  Combination of two or more colours and subtly merging of colours into each other, which leads to the formation of intervening tints (taking on rainbow colours). | Polarised image

  Image becomes visible to the human eye only when a specific polarising filter is placed over it. | Molecular taggants

  Chemical marker which, often formulated in the base materials of the object tagged to, allows for the detection of dilution and mix ratios in materials. Uniquely encoded and incorporated at trace levels. |
| Latent image

  A line pattern printed by intaglio that reveals a different image when tilting the object on which it is printed. May be combined with colour-changing ink. | UV dull paper

  Special paper that will not reflect ultraviolet light. Suitable for printing with ultraviolet (UV) inks that will show up under special UV lamps. | Security fibres (covert)

  Invisible fluorescent fibres that are randomly placed on suitable paper. Cannot be scanned or photocopied and will only become visible under special UV lamps. |
| Colour-changing ink

  Reveals changing colours when viewed under different angles. | Security fibres (semi-covert)

  Visible fluorescent fibres fully or partially embedded in a random pattern that is non-reproducible. May come in a range of colours and shapes. Change their colour under UV light. | Magnetic elements

  Pattern of magnetic elements that generate a signal or a series of signals, which can be detected remotely by special identification devices. |
| Tactile patterns

  Intaglio printing producing a raised tactile relief, which can be authenticated under oblique light. May be combined with latent image. | Microprint

  Print using extremely small text that requires magnification to become readable with the naked eye. | Anti-Stokes inks

  Inks with Anti-Stokes properties that can be examined using a video spectral comparator (VSC instruments). |
| Hologram

  Display of a fully three-dimensional photographic recording of a light field with angle of observation. | Thermochromic ink

  Heat reactive ink that is sensitive to temperature change. Ink will change colour or disappear when exposed to temperature changes. | Reactive inks (covert)

  Colourless or transparent inks that become visible upon reaction with a specific solvent that is applied by means of purpose built tools under laboratory conditions. |
| | Reactive inks (semi-covert)

  Colourless or transparent inks that become visible upon reaction with a specific solvent that is applied by means of a special pen or marker. | |

Overt

Semi-covert

Covert

Guilloche

Ornamental pattern of two or more interlaced bands that are printed in multiple non-standard colours.

Laser images

Image becomes visible to the human eye only when emblazed with a light of a specific wavelength, such as a laser pointer.

DNA taggants

Forensic marker which uses combinatorical mathematical principles to define nucleotide sequences.

Rainbow printing

Combination of two or more colours and subtly merging of colours into each other, which leads to the formation of intervening tints (taking on rainbow colours).

Polarised image

Image becomes visible to the human eye only when a specific polarising filter is placed over it.

Molecular taggants

Chemical marker which, often formulated in the base materials of the object tagged to, allows for the detection of dilution and mix ratios in materials. Uniquely encoded and incorporated at trace levels.

Latent image

A line pattern printed by intaglio that reveals a different image when tilting the object on which it is printed. May be combined with colour-changing ink.

UV dull paper

Special paper that will not reflect ultraviolet light. Suitable for printing with ultraviolet (UV) inks that will show up under special UV lamps.

Security fibres (covert)

Invisible fluorescent fibres that are randomly placed on suitable paper. Cannot be scanned or photocopied and will only become visible under special UV lamps.

Colour-changing ink

Reveals changing colours when viewed under different angles.

Security fibres (semi-covert)

Visible fluorescent fibres fully or partially embedded in a random pattern that is non-reproducible. May come in a range of colours and shapes. Change their colour under UV light.

Magnetic elements

Pattern of magnetic elements that generate a signal or a series of signals, which can be detected remotely by special identification devices.

Tactile patterns

Intaglio printing producing a raised tactile relief, which can be authenticated under oblique light. May be combined with latent image.

Microprint

Print using extremely small text that requires magnification to become readable with the naked eye.

Anti-Stokes inks

Inks with Anti-Stokes properties that can be examined using a video spectral comparator (VSC instruments).

Hologram

Display of a fully three-dimensional photographic recording of a light field with angle of observation.

Thermochromic ink

Heat reactive ink that is sensitive to temperature change. Ink will change colour or disappear when exposed to temperature changes.

Reactive inks (covert)

Colourless or transparent inks that become visible upon reaction with a specific solvent that is applied by means of purpose built tools under laboratory conditions.

Reactive inks (semi-covert)

Colourless or transparent inks that become visible upon reaction with a specific solvent that is applied by means of a special pen or marker.

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