Commission Implementing Regulation (EU) 2023/448 of 1 March 2023 amending Implementing Regulation (EU) 2018/574 on technical standards for the establishment and operation of a traceability system for tobacco products

1. In the event that the operator of the secondary repository gives notice of its intention to cease operating that repository in accordance with the concession contract referred to in paragraph 2 of Part B, it shall immediately inform the Commission thereof and of the date at which the termination is to take effect. The notice period shall not be shorter than nine months. The contract shall provide for the Commission to be able to unilaterally extend it by up to six months if required for establishing and operationalising a replacement operator of the secondary repository. The Commission shall inform the competent authorities of the Member States about the notice period and its potential extension.

1. Where paragraph 1 applies, the contract referred to in paragraph 4 of Part B shall, in turn, be terminated by the parties immediately after the closure of the affected primary repository.

(2) Annex II is amended as follows:

2.1.

The introductory section Key messages to be sent by the economic operators is replaced by the following:

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.

Member States and the Commission may require an extension of the address data to include exact geographic coordinates (latitude and longitude). Both ID issuers and providers of data repositories (including the router) may decide to extend the message content for strictly technical reasons to secure smooth functioning of the traceability system. ID issuers may also decide to extend the message content for non-technical reasons to secure smooth functioning of the tobacco products traceability system with other systems used for regulatory purposes. Before becoming effective, such extensions shall be reflected in the technical specifications updated in accordance with Article 28.

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 traceability system shall contain the identification of the message originator and a timestamp up to the millisecond (see Data Type: Time(L)). This timestamp does not replace the time of the occurrence of a reported event, which shall be reported separately in accordance with the data fields prescribed in this Annex. The identification of the message originator, which may concern a third-party IT service provider, does not replace the identification of the economic operator responsible for the reporting activity (via an EOID to be indicated in the EO_ID field). The means of the identification of the message originator shall be specified in the technical specifications established and updated in accordance with Article 28.

ID issuers and providers of data repositories (including the router) shall timestamp each received message up to the millisecond.

In case of amendments to this Annex, any changes in the key messages listed herein become applicable to the economic operators as of the moment such changes are duly reflected in the technical specifications and the common data dictionary established and updated in accordance with Article 28.

2.2.

Section 1 in Chapter I is amended as follows:

(a) the table row for Data Type Country is replaced by the following:

Country

Country name coded with ISO-3166-1:2013 alpha-2 (or its latest equivalent). For overseas and autonomous regions, the country code of the relevant Member State is applicable.

In case of Northern Ireland, the XI code is applicable.

In case of the international waters, the XZ code is applicable.

DE

(b) the table row for Data Type Text is replaced by the following:

TextSet of characters coded with ISO8859-15:1999Abcde:12345

(c) the table row for Data Type Time(L) is replaced by the following:

Time(L)

UTC (Coordinated Universal Time) in the following format:

YYYY-MM- DDTHH:mm:ss.SSSZ

2019-07-16T19:20:30.205Z

(d) the table row for Data Type upUI(L) is replaced by the following:

upUI(L)Unit packet level unique identifier coded with the invariant set of ISO646:1991 and composed of three blocks: (i) ID issuer’s prefix in accordance with ISO15459-2:2015, (ii) middle block in the format established by the ID issuer and (iii) timestamp following the Data Type: Time(s)

(e) the following table row is inserted after the table row for Data Type upUI(L):

upUI(i)Unit packet level unique identifier coded with the invariant set of ISO646:1991 and composed of two blocks: (i) ID issuer’s prefix in accordance with ISO15459-2:2015 and (ii) middle block in the format established by the ID issuer (i.e. upUI(i) is upUI(L) without the timestamp, a code to be generated by ID issuers in accordance with Article 8(2) of this Regulation)

(f) the table row for Data Type upUI(s) is replaced by the following:

upUI(s)

Unit packet level unique identifier coded with the invariant set of ISO646:1991 and composed of two blocks: (i) ID issuer’s prefix in accordance with ISO15459-2:2015 and (ii) serialisation element in the format established by the ID issuer (i.e. UI made visible in the human readable format on the unit packets in accordance with Article 23 of this Regulation)

Whenever possible ID issuers are requested not to use upper-case letter O (Oscar) and lower-case letter l (lima) as well as upper-case letter I (India) in order to avoid confusions with digits 0 (zero) and 1 (one), respectively.

2.3.

Section 1 in Chapter II is amended as follows:

(a) in point 1.1, the table row for Field EO_Address is replaced by the following:

EO_streetEconomic operator’s street name and house number (or road number and kilometre)TextSM

EO_municipalityEconomic operator’s municipality (city, town or village)TextSMEO_postcodeEconomic operator’s postal codeTextSMn/a is permitted value if no postal code has been assignedEO_A_infoAdditional information on economic operator’s address (e.g. location in the shopping mall or industrial area)TextSO

(b) in point 1.2, the table row for Field EO_Address is replaced by the following:

EO_streetEconomic operator’s street name and house number (or road number and kilometre)TextSMEO_municipalityEconomic operator’s municipality (city, town or village)TextSMEO_postcodeEconomic operator’s postal codeTextSMn/a is permitted value if no postal code has been assignedEO_A_infoAdditional information on economic operator’s address (e.g. location in the shopping mall or industrial area)TextSO

(c) in point 1.4, the table row for Field F_Address is replaced by the following:

F_streetFacility’s street name and house number (or road number and kilometre)TextSMF_municipalityFacility’s municipality (city, town or village)TextSMF_postcodeFacility’s postal codeTextSMn/a is permitted value if no postal code has been assignedF_A_infoAdditional information on facility’s address (e.g. location in the shopping mall or industrial area)TextSO

(d) in point 1.4, the following table rows are inserted after the table row for Field OtherFID_N:

PrevFID_BIndication if the facility was acquired from another operator and had already a facility identifier codeBooleanSM

0 – No (first time registration)

1 – Yes

PrevFID_IDPrevious facility identifier used by the former operator of the facilityFIDSM, if PrevFID_B = 1

(e) in point 1.5, the table row for Field F_Address is replaced by the following:

F_streetFacility’s street name and house number (or road number and kilometre)TextSMF_municipalityFacility’s municipality (city, town or village)TextSMF_postcodeFacility’s postal codeTextSMn/a is permitted value if no postal code has been assignedF_A_infoAdditional information on facility’s address (e.g. location in the shopping mall or industrial area)TextSO

(f) in point 1.5, the following table rows are inserted after the table row for Field OtherFID_N:

PrevFID_BIndication if the facility was acquired from another operator and had already a facility identifier codeBooleanSM

0 – No (first time registration)

1 – Yes

PrevFID_IDPrevious facility identifier used by the former operator of the facilityFIDSM, if PrevFID_B = 1

(g) point 1.7 is replaced by the following:

1.7.

Request for a machine identifier code

Item

FieldCommentsData TypeCardin-alityPriorityValuesMessage_TypeIdentification of message typeTextSM1-7

EO_IDEconomic operator identifier codeEOIDSMEO_CODEEconomic operator’s confirmation code provided in response to the registration of economic operatorTextSMF_IDFacility identifier codeFIDSMPrevMID_BIndication if the object of this request was already registered, e.g. in relation to another facility identifier codeBooleanSM

0 – No (first time registration)

1 – Yes

PrevMID_IDPrevious machine identifier used for the object of this requestMIDSM, if PrevMID_B = 1M_entiretyIndication if this request concerns the machine (v. a part of thereof)BooleanSM

0 – No (machine part)

1 – Yes (machine)

P_ProducerPart’s producerTextSM, if M_entirety = 0P_ModelPart’s modelTextSM, if M_entirety = 0P_NumberPart’s serial numberTextSM, if M_entirety = 0P_MobileIndication if this part is intended to be used with multiple machines (fixed v. mobile part)BooleanSM, if M_entirety = 0

0 – No (fixed part)

1 – Yes (mobile part)

P_ATD1Indication if an anti-tampering device in the sense of Article 2(7) records the functioning of this partBooleanSM, if M_entirety = 0

0 – No

1 – Yes

P_ATD2Anti-tampering device’s serial numberTextSM, if M_entirety = 0 and P_ATD1 = 1P_DescriptionPart’s description explaining its technical functionTextSOM_ProducerMachine’s producerTextSM, if M_entirety = 1M_ModelMachine’s modelTextSM, if M_entirety = 1M_NumberMachine’s serial numberTextSM, if M_entirety = 1M_partsIndication if the machine consists of multiple separately identifiable partsBooleanSM, if M_entirety = 1

0 – No

1 – Yes

M_plistList of the identifiable partsMIDMM, if M_entirety = 1 and M_parts = 1M_ATDSerial number of the anti-tampering device in the sense of Article 2(7)TextSM, if M_entirety = 1 and M_parts = 0M_CapacityMaximum capacity over 24-hour production cycle expressed in unit packetsIntegerSM, if M_entirety = 1

(h) point 1.8 is replaced by the following:

1.8.

Correction of information concerning the machine identifier code

Item

FieldCommentsData TypeCardin-alityPriorityValuesMessage_TypeIdentification of message typeTextSM1-8

EO_IDEconomic operator identifier codeEOIDSMEO_CODEEconomic operator’s confirmation code provided in response to the registration of economic operatorTextSMF_IDFacility identifier codeFIDSMM_IDMachine identifier code (subject to the correction of information)MIDSMPrevMID_BIndication if the object of this request was already registered, e.g. in relation to another facility identifier codeBooleanSM

0 – No (first time registration)

1 – Yes

PrevMID_IDPrevious machine identifier code used for the object of this requestMIDSM, if PrevMID_B = 1M_entiretyIndication if this request concerns the machine (v. a part of thereof)BooleanSM

0 – No (machine part)

1 – Yes (machine)

P_ProducerPart’s producerTextSM, if M_entirety = 0P_ModelPart’s modelTextSM, if M_entirety = 0P_NumberPart’s serial numberTextSM, if M_entirety = 0P_MobileIndication if this part is intended to be used with multiple machines (fixed v. mobile part)BooleanSM, if M_entirety = 0

0 – No (fixed part)

1 – Yes (mobile part)

P_ATD1Indication if an anti-tampering device in the sense of Article 2(7) records the functioning of this partBooleanSM, if M_entirety = 0

0 – No

1 – Yes

P_ATD2Anti-tampering device’s serial numberTextSM, if M_entirety = 0 and P_ATD1 = 1P_DescriptionPart’s description explaining its technical functionTextSOM_ProducerMachine’s producerTextSM, if M_entirety = 1M_ModelMachine’s modelTextSM, if M_entirety = 1M_NumberMachine’s serial numberTextSM, if M_entirety = 1M_partsIndication if the machine consists of multiple separately identifiable partsBooleanSM, if M_entirety = 1

0 – No

1 – Yes

M_plistList of the identifiable partsMIDMM, if M_entirety = 1 and M_parts = 1M_ATDSerial number of the anti-tampering device in the sense of Article 2(7)TextSM, if M_entirety = 1 and M_parts = 0M_CapacityMaximum capacity over 24-hour production cycle expressed in unit packetsIntegerSM, if M_entirety = 1

2.4.

Section 2 in Chapter II is amended as follows:

(a) in point 2.1, the table row for Field P_Type is replaced by the following:

P_TypeType of tobacco productIntegerSM

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

11 – Novel tobacco product

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

(b) in point 2.1, the table row for Field P_Brand is replaced by the following:

P_BrandBrand of tobacco product under which the product will be marketed on its intended marketTextSMP_SubType_Exist

Indicates if the product subtype name exists.

Subtype name provides further product identification beyond a product’s brand name.

BooleanSM

0 – No

1 – Yes

P_SubType_NameThe product subtype name (if any) as marketed on its intended marketTextSM, if P_SubType_Exist = 1P_unitsThe number of individual units in the unit packet (number of sticks in the package).IntegerSM, if P_Type = 1 or 2 or 3

(c) in point 2.1, the table row for Field TP_PN is replaced by the following:

TP_PNTobacco product number used in the EU-CEG system (EAN or GTIN or SKU or UPC)PNS

M, if Intended_ Market is a Member State

O, if Intended_ Market is a third country

(d) in point 2.3, the table row for Field Deact_upUI is replaced by the following:

Deact_upUIList of unit packet level UIs to be deactivated

upUI(L)

or

upUI(i)

or

upUI(s)

MM, if Deact_Type = 1

(e) the following point 2.4 is added:

2.4.

Request for reactivation of UIs for products reported as stolen but recovered (only permitted if in preceding message type 2-3, field Deact_Reason1 = 2)

Item

FieldCommentsData TypeCardin-alityPriorityValuesMessage_TypeIdentification of message typeTextSM2-4EO_IDEconomic operator identifier code of the submitting entityEOIDSMF_IDFacility identifier code (facility of recovery)FIDSMReact_TypeReactivation of unit packet or aggregated level UIsIntegerSM

1 – Unit packet level UIs

2 – Aggregated level UIs

React_ReasonDescription of the context of reactivationTextSOReact_upUIList of unit packet level UIs to be reactivated

upUI(L)

or

upUI(i)

or

upUI(s)

MM, if React_Type = 1

React_aUIList of aggregated level UIs to be reactivatedaUIMM, if React_Type = 2

2.5.

Section 3 in Chapter II is amended as follows:

(a) in point 3.3, the table row for Field Destination_ID5 is replaced by the following:

Destination_ID5Destination facility’s street name and house number (or road number and kilometre)TextSM, if Destination_ID1 = 1Destination_ID6Destination facility’s municipality (city, town or village)TextSM, if Destination_ID1 = 1Destination_ID7Destination facility’s postal codeTextSM, if Destination_ID1 = 1n/a is permitted value if no postal code has been assignedDestination_ID8Destination facility’s countryCountrySM, if Destination_ID1 = 1

(b) in point 3.5, the table row for Field Destination_ID3 is replaced by the following:

Destination_ID3Destination facility’s street name and house number (or road number and kilometre)TextSM, if Destination_ID1 = 0Destination_ID4Destination facility’s municipality (city, town or village)TextSM, if Destination_ID1 = 0Destination_ID5Destination facility’s postal codeTextSM, if Destination_ID1 = 0n/a is permitted value if no postal code has been assignedDestination_ID6Destination facility’s countryCountrySM, if Destination_ID1 = 0

(c) the following point 3.8 is added:

3.8.

Dispatch of tobacco products from a facility to laboratories, waste disposal centres, national authorities, international governmental organisations, embassies and military bases

Item

FieldCommentsData TypeCardi-nalityPriorityValuesMessage_TypeIdentification of message typeTextSM3-8EO_IDEconomic operator identifier code of the submitting entityEOIDSMEvent_TimeIntended time of event occurrenceTime(s)SMF_IDDispatch facility identifier codeFIDSMDestination_1Indication of destination typeIntegerSM

1 – Laboratory

2 – Waste disposal centre

3 – National authority

4 – International governmental organisation

5 – Embassy

6 – Military base

Destination_2Destination’s street name and house number (or road number and kilometre)TextSMDestination_3Destination’s municipality (city, town or village)TextSMDestination_4Destination’s postal codeTextSMn/a is permitted value if no postal code has been assignedDestination_5Destination’s countryCountrySM

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

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_vehicleIdentification of the vehicle (i.e. number plates, train number, plane/flight number, ship name or other identification)TextSMn/a is permitted value if Transport_mode = 0 and product movement takes place between adjacent facilities and is delivered manuallyTransport_cont1Indication if the transport is containerised and uses an individual transport unit code (e.g. SSCC)BooleanSM

0 – No

1 – Yes

Transport_cont2Individual transport unit code of the containerITUSM, if Transport_cont1 = 1UI_TypeIdentification of UI types in the dispatch (recorded at the highest level of available aggregation)IntegerSM

1 – only unit packet level UIs

2 – only aggregated level UIs

3 – both unit packet and aggregated level UIs

upUIsList of unit packet level UIs subject to the dispatchupUI(L)MM, if UI_Type = 1 or 3aUIsList of aggregated level UIs subject to the dispatchaUIMM, if UI_Type = 2 or 3S_Dispatch_commentComments by the reporting entityTextSO

2.6.

Section 4 in Chapter II is amended as follows:

(a) in point 4.1, the table row for Field Buyer_Address is replaced by the following:

Buyer_Address_1Buyer’s street name and house number (or road number and kilometre)TextSM, if Invoice_Buyer1 = 0Buyer_Address_2Buyer’s municipality (city, town or village)TextSM, if Invoice_Buyer1 = 0Buyer_Address_3Buyer’s postal codeTextSM, if Invoice_Buyer1 = 0n/a is permitted value if no postal code has been assigned

(b) in point 4.3, the table row for Field Payer_Address is replaced by the following:

Payer_Address_1Payer’s street name and house number (or road number and kilometre)TextSM, if Payment_Payer1 = 0Payer _Address_2Payer’s municipality (city, town or village)TextSM, if Payment_Payer1 = 0Payer _Address_3Payer’s postal codeTextSM, if Payment_Payer1 = 0n/a is permitted value if no postal code has been assigned

2.7.

Section 5 in Chapter II is replaced as follows:

Recalls

1. Recalls of requests, operational and transactional messages (possible for message types 2-1, 2-2, 2-3 (only within 24 hours from the original reporting of message 2-3, for Deact_Reason1 other than 2 – Product stolen), 3-1 to 3-8, 4-1, 4-2 and 4-3)

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.

Item #FieldCommentsData TypeCardi-nalityPriorittValuesMessage_TypeIdentification of message typeTextSM5EO_IDEconomic operator identifier code of the submitting entityEOIDSMRecall_CODEMessage recall code provided to the message sender in the acknowledgement of the original message to be recalledTextSMRecall_CODE

Recall_

Reason1

Reason for recalling the original messageIntegerSM

1 – reported event did not materialise (only for message types 3-3, 3-5 and 3-8)

2 – message contained erroneous information

3 – other

Recall_

Reason2

Description of the reason for recalling the original messageTextS

M, if Recall_

Reason1 = 3

Recall_

Reason3

Any additional explanations on the reason for recalling the original messageTextSO

(3) The following Annex III is added:

Annex

ANNEX III

Structure of a unit-level unique identifier

Note:

For the purpose of the above schema, group separators (/FNC1) are considered in the same manner as optional data qualifiers, i.e. their use depends on the ID issuer’s coding structure.

(1)(2)(3)(4)(5)(6)(7)(8)(9)Element:Symbology identifierMandatory data qualifierID issuer’s identification codeOptional data qualifierSerial numberOptional data qualifierProduct codeOptional data qualifierTime stampType:QualifierQualifierString (data element)QualifierString (data element)QualifierString (data element)QualifierString (data element)

Position within the unique identifier:FixedFixedFixedNon-fixedNon-fixedNon-fixedNon-fixedFixedFixedRegulated by:Art. 21(1) and ID issuer’s coding structureArt.3(4), Art.8(1)(a), Art. 21(1) and ID issuer’s coding structureArt.3(4) and Art.8(1)(a)Art. 21(1) and ID issuer’s coding structureArt.8(1)(b)Art. 21(1) and ID issuer’s coding structureArt.8(1)(c)Art. 21(1), Art. 21(4) and ID issuer’s coding structureArt.8(1)(d) and Art.21(4)Applicable international standards:ISO/IEC 16022:2006, or ISO/IEC 18004:2015, or ISS DotCode Symbology Spec.ISO 15459-2:2015 and ISO 15459-3:2014ISO 15459-2:2015 and ISO 15459-3:2014Process:Applied by economic operatorsApplied by economic operatorsGenerated by ID issuersApplied by economic operatorsGenerated by ID issuersApplied by economic operatorsGenerated by ID issuersApplied by economic operatorsApplied by economic operatorsTransmission to the repositories system:NoNoYesNoYesNoYesNoYes