# Official Journal L 231/2022

| | ISSN 1977-0677 |
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| Official Journal
  of the European Union | L 231 |
| | |
| English edition | Legislation | Volume 656 September 2022 |

ISSN 1977-0677

Official Journal

of the European Union

L 231

English edition

Legislation

Volume 656 September 2022

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) 2022/1463 of 5 August 2022 setting out technical and operational specifications of the technical system for the cross-border automated exchange of evidence and application of the once-only principle in accordance with Regulation (EU) 2018/1724 of the European Parliament and of the Council (
  1
  ) | 1 |
| | * | Commission Implementing Regulation (EU) 2022/1464 of 2 September 2022 amending Council Regulation (EC) No 1210/2003 concerning certain specific restrictions on economic and financial relations with Iraq | 22 |
| | * | Commission Regulation (EU) 2022/1465 of 5 September 2022 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards certain flavouring substances (
  1
  ) | 24 |
| | * | Commission Regulation (EU) 2022/1466 of 5 September 2022 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the removal of certain flavouring substances from the Union list (
  1
  ) | 32 |
| | * | Commission Implementing Regulation (EU) 2022/1467 of 5 September 2022 amending Implementing Regulation (EU) 2015/2378 as regards the standard forms and computerised formats to be used in relation to Council Directive 2011/16/EU and the list of statistical data to be provided by Member States for the purposes of evaluating that Directive | 36 |
| | * | Commission Implementing Regulation (EU) 2022/1468 of 5 September 2022 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance penflufen and repealing Implementing Regulation (EU) 2018/185 (
  1
  ) | 101 |
| | * | Commission Implementing Regulation (EU) 2022/1469 of 5 September 2022 concerning the authorisation of L-lysine sulphate produced by Escherichia coli CGMCC 7.398 as a feed additive for all animal species (
  1
  ) | 105 |
| | * | Commission Implementing Regulation (EU) 2022/1470 of 5 September 2022 concerning the authorisation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum CBS 139997 and alpha-galactosidase produced by Aspergillus tubingensis ATCC SD 6740 as a feed additive for chickens for fattening, chickens reared for laying, minor poultry species for fattening and reared for laying, and ornamental birds (holder of the authorisation Industrial Técnica Pecuaria S.A.) (
  1
  ) | 109 |
| | * | Commission Implementing Regulation (EU) 2022/1471 of 5 September 2022 concerning the authorisation of lanthanum carbonate octahydrate as a feed additive for cats (holder of authorisation Porus GmbH) (
  1
  ) | 113 |
| | * | Commission Implementing Regulation (EU) 2022/1472 of 5 September 2022 concerning the authorisation of manganese lysinate sulphate as a feed additive for all animal species (
  1
  ) | 116 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Implementing Regulation (EU) 2022/1463 of 5 August 2022 setting out technical and operational specifications of the technical system for the cross-border automated exchange of evidence and application of the once-only principle in accordance with Regulation (EU) 2018/1724 of the European Parliament and of the Council (
  1
  )

1

1

*

Commission Implementing Regulation (EU) 2022/1464 of 2 September 2022 amending Council Regulation (EC) No 1210/2003 concerning certain specific restrictions on economic and financial relations with Iraq

22

*

Commission Regulation (EU) 2022/1465 of 5 September 2022 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards certain flavouring substances (
  1
  )

1

24

*

Commission Regulation (EU) 2022/1466 of 5 September 2022 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the removal of certain flavouring substances from the Union list (
  1
  )

1

32

*

Commission Implementing Regulation (EU) 2022/1467 of 5 September 2022 amending Implementing Regulation (EU) 2015/2378 as regards the standard forms and computerised formats to be used in relation to Council Directive 2011/16/EU and the list of statistical data to be provided by Member States for the purposes of evaluating that Directive

36

*

Commission Implementing Regulation (EU) 2022/1468 of 5 September 2022 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance penflufen and repealing Implementing Regulation (EU) 2018/185 (
  1
  )

1

101

*

Commission Implementing Regulation (EU) 2022/1469 of 5 September 2022 concerning the authorisation of L-lysine sulphate produced by Escherichia coli CGMCC 7.398 as a feed additive for all animal species (
  1
  )

Escherichia coli

1

105

*

Commission Implementing Regulation (EU) 2022/1470 of 5 September 2022 concerning the authorisation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum CBS 139997 and alpha-galactosidase produced by Aspergillus tubingensis ATCC SD 6740 as a feed additive for chickens for fattening, chickens reared for laying, minor poultry species for fattening and reared for laying, and ornamental birds (holder of the authorisation Industrial Técnica Pecuaria S.A.) (
  1
  )

Trichoderma longibrachiatum

Aspergillus tubingensis

1

109

*

Commission Implementing Regulation (EU) 2022/1471 of 5 September 2022 concerning the authorisation of lanthanum carbonate octahydrate as a feed additive for cats (holder of authorisation Porus GmbH) (
  1
  )

1

113

*

Commission Implementing Regulation (EU) 2022/1472 of 5 September 2022 concerning the authorisation of manganese lysinate sulphate as a feed additive for all animal species (
  1
  )

1

116

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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

| 6.9.2022 | EN | Official Journal of the European Union | L 231/1 |
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6.9.2022

EN

Official Journal of the European Union

L 231/1

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COMMISSION IMPLEMENTING REGULATION (EU) 2022/1463

of 5 August 2022

setting out technical and operational specifications of the technical system for the cross-border automated exchange of evidence and application of the ‘once-only’ principle in accordance with Regulation (EU) 2018/1724 of the European Parliament and of the Council

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2018/1724 of the European Parliament and of the Council of 2 October 2018 establishing a single digital gateway to provide access to information, to procedures and to assistance and problem-solving services and amending Regulation (EU) No 1024/2012 (1), and in particular Article 14(9) thereof,

Whereas:

| (1) | Article 14(1) of Regulation (EU) 2018/1724 requires the Commission, in cooperation with Member States, to establish a technical system for the exchange of evidence as required for the online procedures listed in Annex II to that Regulation and the procedures provided for in Directives 2005/36/EC (2), 2006/123/EC (3), 2014/24/EU (4) and 2014/25/EU (5) of the European Parliament and of the Council. |
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(1)

Article 14(1) of Regulation (EU) 2018/1724 requires the Commission, in cooperation with Member States, to establish a technical system for the exchange of evidence as required for the online procedures listed in Annex II to that Regulation and the procedures provided for in Directives 2005/36/EC (2), 2006/123/EC (3), 2014/24/EU (4) and 2014/25/EU (5) of the European Parliament and of the Council.

| (2) | The technical and operational specifications of the ‘once-only’ technical system (OOTS) contained in this Regulation should set out the main components of the architecture of the OOTS, define the technical and operational roles and obligations of the Commission, Member States, evidence requesters, evidence providers and intermediary platforms. Furthermore, these specifications should establish a log system in order to monitor the exchanges and delineate the responsibility for the maintenance, operation and security of the OOTS. |
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(2)

The technical and operational specifications of the ‘once-only’ technical system (OOTS) contained in this Regulation should set out the main components of the architecture of the OOTS, define the technical and operational roles and obligations of the Commission, Member States, evidence requesters, evidence providers and intermediary platforms. Furthermore, these specifications should establish a log system in order to monitor the exchanges and delineate the responsibility for the maintenance, operation and security of the OOTS.

| (3) | In order to enable the establishment of the OOTS by the date set out in Regulation (EU) 2018/1724, it is envisaged to complement this Regulation by more detailed, non-binding technical design documents drawn up in a consensual manner by the Commission in cooperation with the Member States within the gateway coordination group and in accordance with the Commission’s Guidelines for the implementation of the single digital gateway Regulation 2021-2022 work programme. However, where deemed necessary in the light of new technical developments or discussions or differences of opinion within the gateway coordination group, notably on the finalisation of the technical design documents and major design choices, or when the need arises to make certain elements of the technical design documents binding, it will be possible to complement/amend the technical and operational specifications set out in this Regulation in accordance with the examination procedure referred to in Article 37(2) of Regulation (EU) 2018/1724. |
| --- | --- |

(3)

In order to enable the establishment of the OOTS by the date set out in Regulation (EU) 2018/1724, it is envisaged to complement this Regulation by more detailed, non-binding technical design documents drawn up in a consensual manner by the Commission in cooperation with the Member States within the gateway coordination group and in accordance with the Commission’s Guidelines for the implementation of the single digital gateway Regulation 2021-2022 work programme. However, where deemed necessary in the light of new technical developments or discussions or differences of opinion within the gateway coordination group, notably on the finalisation of the technical design documents and major design choices, or when the need arises to make certain elements of the technical design documents binding, it will be possible to complement/amend the technical and operational specifications set out in this Regulation in accordance with the examination procedure referred to in Article 37(2) of Regulation (EU) 2018/1724.

| (4) | In order to reduce the costs of, and the time necessary for, establishing the OOTS, the architecture of the OOTS should, to the extent possible, rely on reusable solutions, be implementation technology neutral and accommodate different national solutions. For example, the OOTS should be able to use the existing national, including central, regional and local level, procedure portals, data services or intermediary platforms, which have been created for national use. The components developed by the Commission should be released under an open software license that promotes reuse and collaboration. |
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(4)

In order to reduce the costs of, and the time necessary for, establishing the OOTS, the architecture of the OOTS should, to the extent possible, rely on reusable solutions, be implementation technology neutral and accommodate different national solutions. For example, the OOTS should be able to use the existing national, including central, regional and local level, procedure portals, data services or intermediary platforms, which have been created for national use. The components developed by the Commission should be released under an open software license that promotes reuse and collaboration.

| (5) | One such reusable solution developed at Union level is the system of eIDAS nodes laid down in Commission Implementing Regulation (EU) 2015/1501 (6), which, by enabling the communication with other nodes of the eIDAS network, can process the request for, and the provision of, cross-border authentication of a user. The eIDAS nodes should enable evidence requesters and, where relevant, evidence providers to identify users requesting evidence to be exchanged through the OOTS so that evidence providers can match the identification data to their existing records. |
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(5)

One such reusable solution developed at Union level is the system of eIDAS nodes laid down in Commission Implementing Regulation (EU) 2015/1501 (6), which, by enabling the communication with other nodes of the eIDAS network, can process the request for, and the provision of, cross-border authentication of a user. The eIDAS nodes should enable evidence requesters and, where relevant, evidence providers to identify users requesting evidence to be exchanged through the OOTS so that evidence providers can match the identification data to their existing records.

| (6) | The OOTS should build on the work already done and exploit synergies with other existing systems for the exchange of evidence or information among authorities relevant for the procedures referred to in Article 14(1) of Regulation (EU) 2018/1724, including systems not covered by Article 14(10) of that Regulation. For example, as far as vehicle and driving license register data is concerned, the OOTS should take into account already developed data models and, where feasible, establish technical bridges to facilitate the connection of competent authorities already using other existing networks (RESPER (7) or EUCARIS (8)) to the OOTS for the provision of evidence in the procedures covered by the OOTS. A similar approach should be taken in relation to other systems such as, but not limited to: the Emrex User Group (EUG) (9) in the education domain, the Electronic Exchange of Social Security Information (EESSI) under Regulation (EC) No 987/2009 of the European Parliament and of the Council (10) in the social security area, the European Criminal Records Information System established by Council Decision 2009/316/JHA (11) for the purpose of judicial cooperation and eCertis (12) used in public procurement procedures. The cooperation between these systems and the OOTS should be defined on a case-by-case basis. |
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(6)

The OOTS should build on the work already done and exploit synergies with other existing systems for the exchange of evidence or information among authorities relevant for the procedures referred to in Article 14(1) of Regulation (EU) 2018/1724, including systems not covered by Article 14(10) of that Regulation. For example, as far as vehicle and driving license register data is concerned, the OOTS should take into account already developed data models and, where feasible, establish technical bridges to facilitate the connection of competent authorities already using other existing networks (RESPER (7) or EUCARIS (8)) to the OOTS for the provision of evidence in the procedures covered by the OOTS. A similar approach should be taken in relation to other systems such as, but not limited to: the Emrex User Group (EUG) (9) in the education domain, the Electronic Exchange of Social Security Information (EESSI) under Regulation (EC) No 987/2009 of the European Parliament and of the Council (10) in the social security area, the European Criminal Records Information System established by Council Decision 2009/316/JHA (11) for the purpose of judicial cooperation and eCertis (12) used in public procurement procedures. The cooperation between these systems and the OOTS should be defined on a case-by-case basis.

| (7) | For the purpose of cross-border authentication of a user, the architecture of the OOTS should be aligned with Regulation (EU) No 910/2014 of the European Parliament and of the Council (13). On 3 June 2021, the Commission adopted a Recommendation on a common Union Toolbox for a coordinated approach towards a European Digital Identity Framework (14). This Recommendation sets up a structured process for cooperation between Member States, the Commission and, where relevant, private sector operators to work on the technical aspects of the European Digital Identity Framework. In order to ensure the necessary alignment between that process and the OOTS, the Commission should ensure appropriate coordination, in particular through the Synergies and Interoperability Contact Group, between the Cooperation Network established by Commission Implementing Decision (EU) 2015/296 (15) and the gateway coordination group. |
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(7)

For the purpose of cross-border authentication of a user, the architecture of the OOTS should be aligned with Regulation (EU) No 910/2014 of the European Parliament and of the Council (13). On 3 June 2021, the Commission adopted a Recommendation on a common Union Toolbox for a coordinated approach towards a European Digital Identity Framework (14). This Recommendation sets up a structured process for cooperation between Member States, the Commission and, where relevant, private sector operators to work on the technical aspects of the European Digital Identity Framework. In order to ensure the necessary alignment between that process and the OOTS, the Commission should ensure appropriate coordination, in particular through the Synergies and Interoperability Contact Group, between the Cooperation Network established by Commission Implementing Decision (EU) 2015/296 (15) and the gateway coordination group.

| (8) | To ensure the security of the cross-border electronic delivery services for the purposes of the OOTS, Member States should ensure that such services comply with the requirements for electronic registered delivery services, laid down in Article 44 of Regulation (EU) No 910/2014. To that effect, it is appropriate that the OOTS uses eDelivery Access Points to create a network of nodes for secure digital data exchange. In addition to enabling secure cross-border delivery, eDelivery provides metadata service functionalities that may support future versions of the OOTS with larger numbers of secure data exchange nodes. Within that framework, Member States should be able to choose the providers of their eDelivery software. |
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(8)

To ensure the security of the cross-border electronic delivery services for the purposes of the OOTS, Member States should ensure that such services comply with the requirements for electronic registered delivery services, laid down in Article 44 of Regulation (EU) No 910/2014. To that effect, it is appropriate that the OOTS uses eDelivery Access Points to create a network of nodes for secure digital data exchange. In addition to enabling secure cross-border delivery, eDelivery provides metadata service functionalities that may support future versions of the OOTS with larger numbers of secure data exchange nodes. Within that framework, Member States should be able to choose the providers of their eDelivery software.

| (9) | To ensure flexibility in the application of this Regulation, Member States should be able to decide to have either one or several eDelivery Access Points, as part of the OOTS. A Member State should therefore be able to deploy a single Access Point managing all OOTS-related eDelivery messaging to the evidence requesters or evidence providers through an intermediary platform, where applicable, or, alternatively, to deploy multiple Access Points at any hierarchical level or for specific domains or sectors or geographic levels of its public administrations. |
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(9)

To ensure flexibility in the application of this Regulation, Member States should be able to decide to have either one or several eDelivery Access Points, as part of the OOTS. A Member State should therefore be able to deploy a single Access Point managing all OOTS-related eDelivery messaging to the evidence requesters or evidence providers through an intermediary platform, where applicable, or, alternatively, to deploy multiple Access Points at any hierarchical level or for specific domains or sectors or geographic levels of its public administrations.

| (10) | According to Union law, including Directives 2005/36/EC, 2006/123/EC, 2014/24/EU, 2014/25/EU and Regulation (EU) 2018/1724, certain administrative procedures are to be made available to users online. As those procedures and the evidence required are not harmonised under Union law, common services should be established to enable the cross-border exchange of evidence required for these procedures through the OOTS. |
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(10)

According to Union law, including Directives 2005/36/EC, 2006/123/EC, 2014/24/EU, 2014/25/EU and Regulation (EU) 2018/1724, certain administrative procedures are to be made available to users online. As those procedures and the evidence required are not harmonised under Union law, common services should be established to enable the cross-border exchange of evidence required for these procedures through the OOTS.

| (11) | Where there is no agreed evidence type that is harmonised across the Union and that all Member States can provide, an evidence broker should help determine which evidence types can be accepted for a particular procedure. |
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(11)

Where there is no agreed evidence type that is harmonised across the Union and that all Member States can provide, an evidence broker should help determine which evidence types can be accepted for a particular procedure.

| (12) | The evidence broker should be based on rule content provided by Member States and should provide an on-line mechanism for Member States to query their information requirements and evidence type sets. The evidence broker should allow Member States to manage and share information about rules relating to types of evidence. |
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(12)

The evidence broker should be based on rule content provided by Member States and should provide an on-line mechanism for Member States to query their information requirements and evidence type sets. The evidence broker should allow Member States to manage and share information about rules relating to types of evidence.

| (13) | In cases where interoperability is needed between the procedure portal and the data services and the common services, this should be supported by technical design documents. |
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(13)

In cases where interoperability is needed between the procedure portal and the data services and the common services, this should be supported by technical design documents.

| (14) | This Regulation should specify when structured and unstructured pieces of evidence that are required for the procedures listed in Article 14(1) of Regulation (EU) 2018/1724 are considered as lawfully issued in electronic format that allows automatic exchange. Unstructured pieces of evidence issued in an electronic format can be exchanged through the OOTS if they are supplemented by the metadata elements of the OOTS generic metadata model contained in the semantic repository referred to in Article 7(1) of this Regulation. Structured pieces of evidence can be exchanged through the OOTS if they are supplemented by the metadata elements of the OOTS generic metadata model referred to in Article 7(1) of this Regulation and are either in compliance with the OOTS data model for the relevant evidence type as referred to in Article 7(2) of this Regulation or accompanied by a human-readable version. |
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(14)

This Regulation should specify when structured and unstructured pieces of evidence that are required for the procedures listed in Article 14(1) of Regulation (EU) 2018/1724 are considered as lawfully issued in electronic format that allows automatic exchange. Unstructured pieces of evidence issued in an electronic format can be exchanged through the OOTS if they are supplemented by the metadata elements of the OOTS generic metadata model contained in the semantic repository referred to in Article 7(1) of this Regulation. Structured pieces of evidence can be exchanged through the OOTS if they are supplemented by the metadata elements of the OOTS generic metadata model referred to in Article 7(1) of this Regulation and are either in compliance with the OOTS data model for the relevant evidence type as referred to in Article 7(2) of this Regulation or accompanied by a human-readable version.

| (15) | Member States should be free to determine when they convert pieces of evidence to an electronic format that allows their automated exchange through the OOTS. However, in order to enhance the usefulness of the OOTS for its users and since the use of data models and metadata schemata for both unstructured and structured formats is generally highly recommended, the Commission should support Member States in their efforts to work towards this goal. |
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(15)

Member States should be free to determine when they convert pieces of evidence to an electronic format that allows their automated exchange through the OOTS. However, in order to enhance the usefulness of the OOTS for its users and since the use of data models and metadata schemata for both unstructured and structured formats is generally highly recommended, the Commission should support Member States in their efforts to work towards this goal.

| (16) | In order to avoid duplication, ensure synergies and provide user choice, the development of OOTS data models for structured evidence types and the standardisation of use cases for the provision of credentials in accordance with the structured process foreseen by Commission Recommendation (EU) 2021/946 of 3 June 2021 on a common Union Toolbox for a coordinated approach towards a European Digital Identity Framework (16) should be done in close cooperation and alignment with each other as far as evidence covered by Article 14 of Regulation (EU) 2018/1724 is concerned, including by identifying common use cases. The alignment of the OOTS data models and the standardised use cases under the aforementioned Commission Recommendation should allow users to rely on alternative means for the provision of evidence covered by Article 14 of Regulation (EU) 2018/1724 either independently of or in combination with the OOTS. When changes are made to the data models and metadata schemata for pieces of evidence contained in the semantic repository, Member States should be given 12 months from the adoption of any update to apply any changes to the pieces of evidence concerned. |
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(16)

In order to avoid duplication, ensure synergies and provide user choice, the development of OOTS data models for structured evidence types and the standardisation of use cases for the provision of credentials in accordance with the structured process foreseen by Commission Recommendation (EU) 2021/946 of 3 June 2021 on a common Union Toolbox for a coordinated approach towards a European Digital Identity Framework (16) should be done in close cooperation and alignment with each other as far as evidence covered by Article 14 of Regulation (EU) 2018/1724 is concerned, including by identifying common use cases. The alignment of the OOTS data models and the standardised use cases under the aforementioned Commission Recommendation should allow users to rely on alternative means for the provision of evidence covered by Article 14 of Regulation (EU) 2018/1724 either independently of or in combination with the OOTS. When changes are made to the data models and metadata schemata for pieces of evidence contained in the semantic repository, Member States should be given 12 months from the adoption of any update to apply any changes to the pieces of evidence concerned.

| (17) | To minimise the amount of data exchanged, in the case of structured evidence, if only a subset of data is requested in the evidence request, the evidence provider or an intermediary platform, where applicable, could enable automated filtering of the data and, where necessary to the transfer, transformation of the data on behalf of the responsible data controller so that only the requested data are exchanged. |
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(17)

To minimise the amount of data exchanged, in the case of structured evidence, if only a subset of data is requested in the evidence request, the evidence provider or an intermediary platform, where applicable, could enable automated filtering of the data and, where necessary to the transfer, transformation of the data on behalf of the responsible data controller so that only the requested data are exchanged.

| (18) | Where Member States manage national registries and services that play the same or an equivalent role as the data service directory or the evidence broker, they should not be required to duplicate their work by contributing to the relevant common services. However, in such a case they should ensure that their national services are connected to the common services in such a way that they can be used by other Member States. Alternatively, those Member States should be able to copy the relevant data from the national registries or services to the data service directory or evidence broker. |
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(18)

Where Member States manage national registries and services that play the same or an equivalent role as the data service directory or the evidence broker, they should not be required to duplicate their work by contributing to the relevant common services. However, in such a case they should ensure that their national services are connected to the common services in such a way that they can be used by other Member States. Alternatively, those Member States should be able to copy the relevant data from the national registries or services to the data service directory or evidence broker.

| (19) | In the 2017 Tallinn Declaration on eGovernment (17), Member States reaffirmed their commitment to progress in linking up their public eServices and implement the once-only principle in order to provide efficient and secure digital public services that will make citizens and businesses lives easier. The 2020 Berlin Declaration on Digital Society and Value-Based Digital Government (18), built on the principles of user centricity and user-friendliness, and set out further key principles on which digital public services should be based, including trust and security in digital government interactions and digital sovereignty and interoperability. This Regulation should implement those commitments by putting users at the centre of the system and requiring that users should be informed about the OOTS, its steps and the consequences of using the system. |
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(19)

In the 2017 Tallinn Declaration on eGovernment (17), Member States reaffirmed their commitment to progress in linking up their public eServices and implement the once-only principle in order to provide efficient and secure digital public services that will make citizens and businesses lives easier. The 2020 Berlin Declaration on Digital Society and Value-Based Digital Government (18), built on the principles of user centricity and user-friendliness, and set out further key principles on which digital public services should be based, including trust and security in digital government interactions and digital sovereignty and interoperability. This Regulation should implement those commitments by putting users at the centre of the system and requiring that users should be informed about the OOTS, its steps and the consequences of using the system.

| (20) | It is important that an appropriate system is in place to allow users to identify themselves for the purposes of the exchange of evidence. The only mutual recognition framework for national electronic identification means at Union level is set out in Regulation (EU) No 910/2014. Electronic identification means issued under electronic identification schemes notified in accordance with that Regulation should therefore be used by evidence requesters to authenticate the identity of a user before the user explicitly requests the use of the OOTS. Where the identification of the relevant evidence provider requires the provision of attributes beyond the mandatory attributes of the minimum data set listed in the Annex to Implementing Regulation (EU) 2015/1501, such additional attributes should also be requested from the user by the evidence requester and provided to the evidence provider or intermediary platform, where applicable, as part of the evidence request. |
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(20)

It is important that an appropriate system is in place to allow users to identify themselves for the purposes of the exchange of evidence. The only mutual recognition framework for national electronic identification means at Union level is set out in Regulation (EU) No 910/2014. Electronic identification means issued under electronic identification schemes notified in accordance with that Regulation should therefore be used by evidence requesters to authenticate the identity of a user before the user explicitly requests the use of the OOTS. Where the identification of the relevant evidence provider requires the provision of attributes beyond the mandatory attributes of the minimum data set listed in the Annex to Implementing Regulation (EU) 2015/1501, such additional attributes should also be requested from the user by the evidence requester and provided to the evidence provider or intermediary platform, where applicable, as part of the evidence request.

| (21) | Some of the procedures listed in Article 14(1) of Regulation (EU) 2018/1724 require that evidence can be requested on behalf of a legal or natural person. For example, certain procedures are relevant for businesses and entrepreneurs should therefore be able to request the exchange of evidence either on their own behalf or through a representative. Regulation (EU) No 910/2014 provides a trusted legal framework for electronic identification means issued for legal persons or for natural persons representing legal persons. The mutual recognition of national electronic identification means under that Regulation applies to these cases of representation. This Regulation should therefore rely on Regulation (EU) No 910/2014, and any implementing acts adopted on its basis, for the identification of users in cases of representation. The gateway coordination group and its subgroups should cooperate closely with the governance structures established under Regulation (EU) No 910/2014 to help develop solutions for powers of representation and mandates. Given the reliance of some of the procedures covered by the OOTS on the framework created by Regulation (EU) No 910/2014, pieces of evidence requested by representatives should also be able to be processed through the OOTS when and to the extent to which these solutions will have been found. |
| --- | --- |

(21)

Some of the procedures listed in Article 14(1) of Regulation (EU) 2018/1724 require that evidence can be requested on behalf of a legal or natural person. For example, certain procedures are relevant for businesses and entrepreneurs should therefore be able to request the exchange of evidence either on their own behalf or through a representative. Regulation (EU) No 910/2014 provides a trusted legal framework for electronic identification means issued for legal persons or for natural persons representing legal persons. The mutual recognition of national electronic identification means under that Regulation applies to these cases of representation. This Regulation should therefore rely on Regulation (EU) No 910/2014, and any implementing acts adopted on its basis, for the identification of users in cases of representation. The gateway coordination group and its subgroups should cooperate closely with the governance structures established under Regulation (EU) No 910/2014 to help develop solutions for powers of representation and mandates. Given the reliance of some of the procedures covered by the OOTS on the framework created by Regulation (EU) No 910/2014, pieces of evidence requested by representatives should also be able to be processed through the OOTS when and to the extent to which these solutions will have been found.

| (22) | In order to reduce the time and cost to implement the OOTS, and to benefit from each other’s implementation experience, the Commission should support Member States and foster collaboration between them on the development of reusable technical solutions and components that can be used to implement national procedure portals, preview spaces and data services. |
| --- | --- |

(22)

In order to reduce the time and cost to implement the OOTS, and to benefit from each other’s implementation experience, the Commission should support Member States and foster collaboration between them on the development of reusable technical solutions and components that can be used to implement national procedure portals, preview spaces and data services.

| (23) | In order to guarantee that users retain control over their personal data at all times while using the OOTS as provided for in Regulation (EU) 2018/1724, the OOTS should allow users to express their decision in relation to these data in two instances. First, it should be ensured that users receive sufficient information to enable them to make an informed and explicit request to process their request for evidence through the OOTS in accordance with Article 14(3), point (a), and Article 14(4), of Regulation (EU) 2018/1724. It should then ensure that they can view the evidence to be exchanged in a secure preview space before deciding whether or not to proceed with the exchange of evidence in accordance with Article 14(3), point (f), of Regulation (EU) 2018/1724, except in the cases referred to in Article 14(5) of that Regulation. |
| --- | --- |

(23)

In order to guarantee that users retain control over their personal data at all times while using the OOTS as provided for in Regulation (EU) 2018/1724, the OOTS should allow users to express their decision in relation to these data in two instances. First, it should be ensured that users receive sufficient information to enable them to make an informed and explicit request to process their request for evidence through the OOTS in accordance with Article 14(3), point (a), and Article 14(4), of Regulation (EU) 2018/1724. It should then ensure that they can view the evidence to be exchanged in a secure preview space before deciding whether or not to proceed with the exchange of evidence in accordance with Article 14(3), point (f), of Regulation (EU) 2018/1724, except in the cases referred to in Article 14(5) of that Regulation.

| (24) | Responsibility for the establishment of the OOTS is shared between Member States and the Commission and the gateway coordination group should therefore play a central role in the governance of the system. In view of the technical nature of its work and in order to facilitate implementation in existing national systems of technical design documents, the work of the gateway coordination group should be supported and prepared by experts coming together in one or several sub-groups created in accordance with its rules of procedure. The functioning of this OOTS governance should be assessed in the report that the Commission is required to submit to the European Parliament and to the Council by 12 December 2022 pursuant to Article 36 of Regulation (EU) 2018/1724. |
| --- | --- |

(24)

Responsibility for the establishment of the OOTS is shared between Member States and the Commission and the gateway coordination group should therefore play a central role in the governance of the system. In view of the technical nature of its work and in order to facilitate implementation in existing national systems of technical design documents, the work of the gateway coordination group should be supported and prepared by experts coming together in one or several sub-groups created in accordance with its rules of procedure. The functioning of this OOTS governance should be assessed in the report that the Commission is required to submit to the European Parliament and to the Council by 12 December 2022 pursuant to Article 36 of Regulation (EU) 2018/1724.

| (25) | To ensure a quick reaction to any possible incidents and downtimes which may affect the functioning of the OOTS, the Member States and the Commission should establish a network of technical support contact points. In order to ensure the proper functioning of the OOTS, those technical support contact points should have the powers and sufficient human and financial resources to enable them to carry out their tasks. |
| --- | --- |

(25)

To ensure a quick reaction to any possible incidents and downtimes which may affect the functioning of the OOTS, the Member States and the Commission should establish a network of technical support contact points. In order to ensure the proper functioning of the OOTS, those technical support contact points should have the powers and sufficient human and financial resources to enable them to carry out their tasks.

| (26) | To ensure an efficient functioning and maintenance of the OOTS, the responsibilities for its different components should be clearly distributed. The Commission, as the owner and operator of the common services, should be responsible for their maintenance, hosting and security. Each Member State should be responsible for ensuring maintenance and the security of those components of the OOTS that they own and for which they are responsible, such as eIDAS nodes, eDelivery Access Points or national registries, in accordance with the relevant Union and national law. |
| --- | --- |

(26)

To ensure an efficient functioning and maintenance of the OOTS, the responsibilities for its different components should be clearly distributed. The Commission, as the owner and operator of the common services, should be responsible for their maintenance, hosting and security. Each Member State should be responsible for ensuring maintenance and the security of those components of the OOTS that they own and for which they are responsible, such as eIDAS nodes, eDelivery Access Points or national registries, in accordance with the relevant Union and national law.

| (27) | In order to ensure appropriate protection of personal data, as required by Regulation (EU) 2016/679 of the European Parliament and of the Council (19), this Regulation should specify the role of Member States, in particular that of the respective competent authorities in their capacity as evidence requester or evidence provider, and of the intermediary platforms, where applicable, in relation to the personal data contained in the evidence that is exchanged through the OOTS. |
| --- | --- |

(27)

In order to ensure appropriate protection of personal data, as required by Regulation (EU) 2016/679 of the European Parliament and of the Council (19), this Regulation should specify the role of Member States, in particular that of the respective competent authorities in their capacity as evidence requester or evidence provider, and of the intermediary platforms, where applicable, in relation to the personal data contained in the evidence that is exchanged through the OOTS.

| (28) | To ensure that the common services are protected against potential threats that harm the confidentiality, integrity or availability of the Commission’s communication and information systems Commission Decision (EU, Euratom) 2017/46 (20) should apply to these services. |
| --- | --- |

(28)

To ensure that the common services are protected against potential threats that harm the confidentiality, integrity or availability of the Commission’s communication and information systems Commission Decision (EU, Euratom) 2017/46 (20) should apply to these services.

| (29) | Article 14(1) to (8) and (10) of Regulation (EU) 2018/1724 apply from 12 December 2023. Therefore, the requirements laid down in this Regulation should also apply from that date. |
| --- | --- |

(29)

Article 14(1) to (8) and (10) of Regulation (EU) 2018/1724 apply from 12 December 2023. Therefore, the requirements laid down in this Regulation should also apply from that date.

| (30) | The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 of the European Parliament and of the Council (21) and delivered Formal Comments on 6 May 2021 (22). |
| --- | --- |

(30)

The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 of the European Parliament and of the Council (21) and delivered Formal Comments on 6 May 2021 (22).

| (31) | The measures provided for in this Regulation are in accordance with the opinion of the Single Digital Gateway Committee, |
| --- | --- |

(31)

The measures provided for in this Regulation are in accordance with the opinion of the Single Digital Gateway Committee,

HAS ADOPTED THIS REGULATION:

SECTION 1

GENERAL PROVISIONS

Article 1

Definitions

For the purposes of this Regulation, the following definitions shall apply:

| (1) | ‘once-only technical system’ (‘OOTS’) means the technical system for the cross-border automated exchange of evidence referred to in Article 14(1) of Regulation (EU) 2018/1724; |
| --- | --- |

(1)

‘once-only technical system’ (‘OOTS’) means the technical system for the cross-border automated exchange of evidence referred to in Article 14(1) of Regulation (EU) 2018/1724;

| (2) | ‘evidence provider’ means a competent authority as referred to in Article 14(2) of Regulation (EU) 2018/1724 that lawfully issues structured or unstructured evidence; |
| --- | --- |

(2)

‘evidence provider’ means a competent authority as referred to in Article 14(2) of Regulation (EU) 2018/1724 that lawfully issues structured or unstructured evidence;

| (3) | ‘evidence requester’ means a competent authority responsible for one or more of the procedures referred to in Article 14(1) of Regulation (EU) 2018/1724; |
| --- | --- |

(3)

‘evidence requester’ means a competent authority responsible for one or more of the procedures referred to in Article 14(1) of Regulation (EU) 2018/1724;

| (4) | ‘eDelivery Access Point’ means a communication component that is part of the eDelivery electronic delivery service based on technical specifications and standards, including the AS4 messaging protocol and ancillary services developed under the Connecting Europe Facility Programme and continued under the Digital Europe Programme, to the extent that these technical specifications and standards overlap with the ISO 15000-2 standard; |
| --- | --- |

(4)

‘eDelivery Access Point’ means a communication component that is part of the eDelivery electronic delivery service based on technical specifications and standards, including the AS4 messaging protocol and ancillary services developed under the Connecting Europe Facility Programme and continued under the Digital Europe Programme, to the extent that these technical specifications and standards overlap with the ISO 15000-2 standard;

| (5) | ‘eIDAS node’ means a node as defined in Article 2, point (1), of Implementing Regulation (EU) 2015/1501 and complying with the technical and operational requirements laid down in and on the basis of that Regulation; |
| --- | --- |

(5)

‘eIDAS node’ means a node as defined in Article 2, point (1), of Implementing Regulation (EU) 2015/1501 and complying with the technical and operational requirements laid down in and on the basis of that Regulation;

| (6) | ‘intermediary platform’ means a technical solution acting in its own capacity or on behalf of other entities such as evidence providers or evidence requesters, depending on the administrative organisation of Member States in which the intermediary platform operates, and through which evidence providers or evidence requesters connect to the common services referred to in Article 4(1) or to evidence providers or evidence requesters from other Member States; |
| --- | --- |

(6)

‘intermediary platform’ means a technical solution acting in its own capacity or on behalf of other entities such as evidence providers or evidence requesters, depending on the administrative organisation of Member States in which the intermediary platform operates, and through which evidence providers or evidence requesters connect to the common services referred to in Article 4(1) or to evidence providers or evidence requesters from other Member States;

| (7) | ‘data service directory’ means a registry containing the list of evidence providers and the evidence types they issue together with the relevant accompanying information; |
| --- | --- |

(7)

‘data service directory’ means a registry containing the list of evidence providers and the evidence types they issue together with the relevant accompanying information;

| (8) | ‘evidence broker’ means a service allowing an evidence requester to determine which evidence type from another Member State satisfies the evidence requirement for the purposes of a national procedure; |
| --- | --- |

(8)

‘evidence broker’ means a service allowing an evidence requester to determine which evidence type from another Member State satisfies the evidence requirement for the purposes of a national procedure;

| (9) | ‘electronic identification means’ means a material and/or immaterial unit, containing person identification data and which is used for authentication for an online service; |
| --- | --- |

(9)

‘electronic identification means’ means a material and/or immaterial unit, containing person identification data and which is used for authentication for an online service;

| (10) | ‘semantic repository’ means a collection of semantic specifications, linked to the evidence broker and the data service directory, composed of definitions of names, data types and data elements associated with specific evidence types to ensure mutual understanding and cross-lingual interpretation for evidence providers, evidence requesters and users, when exchanging evidence through the OOTS; |
| --- | --- |

(10)

‘semantic repository’ means a collection of semantic specifications, linked to the evidence broker and the data service directory, composed of definitions of names, data types and data elements associated with specific evidence types to ensure mutual understanding and cross-lingual interpretation for evidence providers, evidence requesters and users, when exchanging evidence through the OOTS;

| (11) | ‘technical design documents’ means a set of detailed and non-binding technical documents, drawn up by the Commission in cooperation with Member States in the framework of the gateway coordination group referred to in Article 29 of Regulation (EU) 2018/1724 or any sub-groups referred to in Article 19 of this Regulation, which includes but is not limited to, a high-level architecture, exchange protocols, standards and ancillary services that support the Commission, Member States, evidence providers, evidence requesters, intermediary platforms and other entities concerned in establishing the OOTS in compliance with this Regulation; |
| --- | --- |

(11)

‘technical design documents’ means a set of detailed and non-binding technical documents, drawn up by the Commission in cooperation with Member States in the framework of the gateway coordination group referred to in Article 29 of Regulation (EU) 2018/1724 or any sub-groups referred to in Article 19 of this Regulation, which includes but is not limited to, a high-level architecture, exchange protocols, standards and ancillary services that support the Commission, Member States, evidence providers, evidence requesters, intermediary platforms and other entities concerned in establishing the OOTS in compliance with this Regulation;

| (12) | ‘data service’ means a technical service through which an evidence provider handles the evidence requests and dispatches evidence; |
| --- | --- |

(12)

‘data service’ means a technical service through which an evidence provider handles the evidence requests and dispatches evidence;

| (13) | ‘data model’ means an abstraction that organises elements of data, standardises how they relate to one another and specifies the entities, their attributes and the relationship between such entities; |
| --- | --- |

(13)

‘data model’ means an abstraction that organises elements of data, standardises how they relate to one another and specifies the entities, their attributes and the relationship between such entities;

| (14) | ‘preview space’ means a functionality that enables the user to preview the requested evidence as referred to in Article 15(1), point (b)(ii); |
| --- | --- |

(14)

‘preview space’ means a functionality that enables the user to preview the requested evidence as referred to in Article 15(1), point (b)(ii);

| (15) | ‘structured evidence’ means any evidence in electronic format required for the procedures listed in Article 14(1) of Regulation (EU) 2018/1724 that is organised in predefined elements or fields that have a specific meaning and technical format allowing for processing by software systems, supplemented by the metadata elements of the OOTS generic metadata model referred to in Article 7(1) of this Regulation and either in compliance with the OOTS data model for the relevant evidence type as referred to in Article 7(2) of this Regulation, or accompanied by a human-readable version; |
| --- | --- |

(15)

‘structured evidence’ means any evidence in electronic format required for the procedures listed in Article 14(1) of Regulation (EU) 2018/1724 that is organised in predefined elements or fields that have a specific meaning and technical format allowing for processing by software systems, supplemented by the metadata elements of the OOTS generic metadata model referred to in Article 7(1) of this Regulation and either in compliance with the OOTS data model for the relevant evidence type as referred to in Article 7(2) of this Regulation, or accompanied by a human-readable version;

| (16) | ‘unstructured evidence’ means evidence in electronic format required for the procedures listed in Article 14(1) of Regulation (EU) 2018/1724 that is not organised in predefined elements or fields that have specific meaning and technical format, but is supplemented by the metadata elements of the OOTS generic metadata model referred to in Article 7(1) of this Regulation; |
| --- | --- |

(16)

‘unstructured evidence’ means evidence in electronic format required for the procedures listed in Article 14(1) of Regulation (EU) 2018/1724 that is not organised in predefined elements or fields that have specific meaning and technical format, but is supplemented by the metadata elements of the OOTS generic metadata model referred to in Article 7(1) of this Regulation;

| (17) | ‘evidence type’ means a category of structured or unstructured evidence with a common purpose or content; |
| --- | --- |

(17)

‘evidence type’ means a category of structured or unstructured evidence with a common purpose or content;

| (18) | ‘incident’ means a situation where the OOTS is not performing, fails to transmit the evidence or transmits evidence that has not been requested, or where the evidence has changed or been disclosed during the transmission, as well as any breach of security referred to in Article 29; |
| --- | --- |

(18)

‘incident’ means a situation where the OOTS is not performing, fails to transmit the evidence or transmits evidence that has not been requested, or where the evidence has changed or been disclosed during the transmission, as well as any breach of security referred to in Article 29;

| (19) | ‘procedure portal’ means a webpage or a mobile application where a user can access and complete an online procedure referred to in Article 14(1) of Regulation (EU) 2018/1724. |
| --- | --- |

(19)

‘procedure portal’ means a webpage or a mobile application where a user can access and complete an online procedure referred to in Article 14(1) of Regulation (EU) 2018/1724.

Article 2

Structure of the OOTS

The OOTS shall consist of the following:

| (a) | the procedure portals of evidence requesters and the data services of evidence providers; |
| --- | --- |

(a)

the procedure portals of evidence requesters and the data services of evidence providers;

| (b) | intermediary platforms, where relevant; |
| --- | --- |

(b)

intermediary platforms, where relevant;

| (c) | the preview spaces referred to in Article 15(1), point (b)(ii); |
| --- | --- |

(c)

the preview spaces referred to in Article 15(1), point (b)(ii);

| (d) | the national registries and services referred to in Article 8, where relevant; |
| --- | --- |

(d)

the national registries and services referred to in Article 8, where relevant;

| (e) | eIDAS nodes for user authentication and identity matching; |
| --- | --- |

(e)

eIDAS nodes for user authentication and identity matching;

| (f) | eDelivery Access Points; |
| --- | --- |

(f)

eDelivery Access Points;

| (g) | the common services referred to in Article 4(1); |
| --- | --- |

(g)

the common services referred to in Article 4(1);

| (h) | the integration elements and interfaces required to connect the components referred to in points (a) to (g). |
| --- | --- |

(h)

the integration elements and interfaces required to connect the components referred to in points (a) to (g).

SECTION 2

SERVICES OF THE OOTS

SERVICES OF THE OOTS

Article 3

eIDAS nodes and eDelivery Access Points

1.   Member States shall ensure that evidence requesters are connected to an eIDAS-node to enable user authentication pursuant to Article 11, either directly or through an intermediary platform.

2.   Member States shall ensure that eDelivery Access Points are installed, configured and integrated in the procedure portals of evidence requesters, in the data services of evidence providers and in intermediary platforms.

3.   Member States may choose the number of eDelivery Access Points they use for the OOTS.

Article 4

Common services

1.   The Commission in cooperation with Member States shall establish the following services of the OOTS (‘common services’):

| (a) | the data service directory referred to in Article 5; |
| --- | --- |

(a)

the data service directory referred to in Article 5;

| (b) | the evidence broker referred to in Article 6; |
| --- | --- |

(b)

the evidence broker referred to in Article 6;

| (c) | the semantic repository referred to in Article 7. |
| --- | --- |

(c)

the semantic repository referred to in Article 7.

2.   Member States shall ensure the technical connection between the procedure portals of evidence requesters, directly or through intermediary platforms, with the common services and the proper registration of their data services in the common services. In implementing these connections, Member States shall be guided by the descriptions contained in the technical design documents.

3.   Member States shall ensure that only evidence requesters are connected, directly or through intermediary platforms, to the common services and that only evidence requesters and evidence providers can use the OOTS. Member States shall check the functioning of the connections to the common services at regular intervals.

Article 5

Data service directory

1.   Without prejudice to Article 8 of this Regulation, Member States shall ensure that all evidence providers and evidence types issued by them that are relevant for the online procedures referred to in Article 14(1) of Regulation (EU) 2018/1724 are registered in the data service directory.

2.   The Commission shall be responsible for the development and maintenance of interfaces allowing national coordinators referred to in Article 28 of Regulation (EU) 2018/1724, competent authorities, intermediary platforms where applicable, and the Commission, each within the scope of their responsibilities and the limits of the access rights defined by the Commission, to:

| (a) | register, de-register and carry out any other updates of information contained in the data service directory; |
| --- | --- |

(a)

register, de-register and carry out any other updates of information contained in the data service directory;

| (b) | manage the access rights of persons who are authorised to make registrations and changes to the registered data. |
| --- | --- |

(b)

manage the access rights of persons who are authorised to make registrations and changes to the registered data.

The Commission shall ensure that national coordinators, competent authorities and intermediary platforms can choose between graphical user interfaces for authorised persons and programmatic interfaces for automated uploads.

3.   Member States shall ensure that each type of evidence registered in the data service directory is accompanied by:

| (a) | the level of assurance of the electronic identification means notified by Member States in accordance with Regulation (EU) No 910/2014; and |
| --- | --- |

(a)

the level of assurance of the electronic identification means notified by Member States in accordance with Regulation (EU) No 910/2014; and

| (b) | where applicable, additional attributes, specified in order to facilitate the identification of the relevant evidence provider and that go beyond the mandatory attributes of the minimum data set laid down in accordance with Implementing Regulation (EU) 2015/1501, exchanged using the electronic identification means notified in accordance with Regulation (EU) No 910/2014, required for its exchange through the OOTS. |
| --- | --- |

(b)

where applicable, additional attributes, specified in order to facilitate the identification of the relevant evidence provider and that go beyond the mandatory attributes of the minimum data set laid down in accordance with Implementing Regulation (EU) 2015/1501, exchanged using the electronic identification means notified in accordance with Regulation (EU) No 910/2014, required for its exchange through the OOTS.

4.   The data service directory shall make a clear distinction between the additional attributes referred to in paragraph 3, point (b), of this Article and the attributes exchanged using the electronic identification means notified in accordance with Regulation (EU) No 910/2014 referred to in Article 13(1), point (f), of this Regulation.

5.   The level of assurance referred to in paragraph 3, point (a), required for cross-border users shall not exceed the level of assurance required for non-cross-border users.

6.   Member States shall ensure that the information in the data service directory is kept up to date.

Article 6

Evidence broker

1.   The evidence broker shall allow evidence requesters to determine which evidence types issued in other Member States correspond to the evidence types required in the context of procedures for which that evidence requester is competent.

2.   Member States shall, through the interface referred to in Article 5(2), complement the list of evidence types in the data service directory as referred to in Article 5(1) with the facts or compliance with procedural requirements they prove, possibly jointly with other evidence types, if needed. Member States shall ensure that this information is accurate and kept up to date.

3.   The Commission shall be responsible for the development and maintenance of interfaces that allow national coordinators, competent authorities, intermediary platforms where applicable, and the Commission, each within the scope of their responsibilities and the limits of the access rights defined by the Commission, to:

| (a) | add, change and update the information referred to in paragraph 2; |
| --- | --- |

(a)

add, change and update the information referred to in paragraph 2;

| (b) | manage the access rights of persons who are authorised to make additions and changes to the registered information. |
| --- | --- |

(b)

manage the access rights of persons who are authorised to make additions and changes to the registered information.

The Commission shall ensure that national coordinators, competent authorities and intermediary platforms can choose between graphical user interfaces for authorised persons and programmatic interfaces for automated uploads.

4.   The Commission shall facilitate the mapping of the evidence types issued in one Member State to facts or compliance with procedural requirements that have to be proved in a procedure in another Member State by structuring the discussion and organising the work in the relevant sub-group referred to in Article 19. The sub-group shall set out a formal domain-specific language, whenever possible referencing relevant international standards, and propose that language to the gateway coordination group in accordance with Article 18, point (f).

Article 7

Semantic repository and data models

1.   The semantic repository shall provide access to the OOTS generic metadata model, which is designed to display metadata that uniquely identify the evidence and the evidence provider and which includes additional fields designed to display the metadata referred to in Article 13(1), points (a), (b) and (c).

2.   For the types of structured evidence agreed in the gateway coordination group, the semantic repository shall contain an OOTS data model consisting of at least the following components:

| (a) | a representation of that data model with:






  (i) | a visual data model diagram; and |
| --- | --- | --- |

(a)

a representation of that data model with:

(i)

a visual data model diagram; and

| (ii) | a textual description of all the entities of the data model, consisting of a definition and the list of the attributes of the entity; and, for each attribute, the expected type (e.g. Boolean, Identifier, Date), a definition, the cardinality and the optional usage of a code list; |
| --- | --- |

(ii)

a textual description of all the entities of the data model, consisting of a definition and the list of the attributes of the entity; and, for each attribute, the expected type (e.g. Boolean, Identifier, Date), a definition, the cardinality and the optional usage of a code list;

| (b) | distributions in XML based on XML schema definition (XSD), or an equivalent format, complemented by other widely used serialisation formats, where feasible; |
| --- | --- |

(b)

distributions in XML based on XML schema definition (XSD), or an equivalent format, complemented by other widely used serialisation formats, where feasible;

| (c) | code lists to ensure the automated processing of evidence, available in a structured format; |
| --- | --- |

(c)

code lists to ensure the automated processing of evidence, available in a structured format;

| (d) | a mechanism for conversion into a human-readable format, such as XSLT or equivalent. |
| --- | --- |

(d)

a mechanism for conversion into a human-readable format, such as XSLT or equivalent.

3.   For each type of evidence, the semantic repository shall offer version control and a change log to keep track of different versions.

4.   The semantic repository shall contain a methodology for developing new OOTS data models for evidence types exchanged through the OOTS, consisting of examples and learning materials.

5.   Schedules for updates and adaptations to the OOTS generic metadata models and the OOTS data models shall be regularly discussed by Member States and the Commission in the framework of one of sub-groups of the gateway coordination group referred to in Article 19 and adopted by the gateway coordination group. The evidence providers or intermediary platforms, where applicable, shall apply those updates and adaptations at the latest 12 months after their publication in the semantic repository.

6.   The Commission shall provide Member States with an IT tool which will help them to verify the compliance of the evidence with the OOTS generic metadata model and the OOTS data models.

7.   The Commission shall make the semantic repository publicly available on a dedicated Commission website.

Article 8

National registries and services

1.   Member States that have national registries or services that are equivalent to the data service directory or evidence broker may choose not to register evidence providers, the types of evidence they issue and the facts or compliance with procedural requirements they prove, possibly jointly with other evidence types, and the level of assurance of the electronic identification means required to access each type of evidence as provided for in Articles 5 and 6. In such a case, they shall instead do one of the following:

| (a) | allow other Member States to search their national registries for the information referred to under this paragraph; |
| --- | --- |

(a)

allow other Member States to search their national registries for the information referred to under this paragraph;

| (b) | copy the information referred to under this paragraph from the national registries or services to the data service directory or evidence broker. |
| --- | --- |

(b)

copy the information referred to under this paragraph from the national registries or services to the data service directory or evidence broker.

2.   When implementing paragraph 1, Member States shall be guided by the descriptions contained in the technical design documents.

SECTION 3

EVIDENCE REQUESTERS

EVIDENCE REQUESTERS

Article 9

Explanation to users

1.   Evidence requesters shall ensure that their procedure portals contain an explanation of the OOTS and its features, including the information that:

| (a) | the use of the OOTS is voluntary; |
| --- | --- |

(a)

the use of the OOTS is voluntary;

| (b) | users have the option to preview the evidence in the preview space referred to in Article 15(1), point (b)(ii), and decide whether or not to use it for the procedure; |
| --- | --- |

(b)

users have the option to preview the evidence in the preview space referred to in Article 15(1), point (b)(ii), and decide whether or not to use it for the procedure;

| (c) | users can act on their own behalf or be represented by another legal or natural person, when and to the extent to which solutions for representation, in accordance with Regulation (EU) No 910/2014 and any implementing acts adopted on its basis, have been found. |
| --- | --- |

(c)

users can act on their own behalf or be represented by another legal or natural person, when and to the extent to which solutions for representation, in accordance with Regulation (EU) No 910/2014 and any implementing acts adopted on its basis, have been found.

The information referred to in point (b) of the first subparagraph of this paragraph shall not be required in the case of the procedures referred to in Article 14(5) of Regulation (EU) 2018/1724.

2.   The obligation to provide explanations referred to in paragraph 1 of this Article shall be without prejudice to the obligation to provide the data subjects with the information referred to in Articles 13 and 14 of Regulation (EU) 2016/679.

Article 10

Evidence type selection

1.   Evidence requesters shall give users the possibility to request the types of evidence that correspond, based on the information registered in the evidence broker, to types that would be acceptable under the applicable law in the relevant procedure by direct submission, provided that evidence providers make these types of evidence available through the OOTS in accordance with Article 5(1).

2.   If multiple pieces of evidence can be requested the evidence requester shall ensure that users can select all, a sub-set of, or a specific type of, the evidence.

Article 11

User authentication

1.   Evidence requesters shall rely on electronic identification means that have been issued under an electronic identification scheme that has been notified in accordance with Regulation (EU) No 910/2014 to authenticate the users, acting either on their own behalf or through a representative, when and to the extent to which solutions for representation in accordance with Regulation (EU) No 910/2014 and any implementing acts adopted on its basis, have been found.

2.   Once the user has selected the type of evidence to be exchanged through the OOTS, the evidence requesters shall inform users:

| (a) | where applicable, of any additional attributes referred to in Article 5(3), point (b), of this Regulation that they are to provide; and |
| --- | --- |

(a)

where applicable, of any additional attributes referred to in Article 5(3), point (b), of this Regulation that they are to provide; and

| (b) | that they will be redirected to the relevant evidence provider, evidence providers or, where applicable, intermediary platform or platforms, to preview the selected evidence. |
| --- | --- |

(b)

that they will be redirected to the relevant evidence provider, evidence providers or, where applicable, intermediary platform or platforms, to preview the selected evidence.

3.   Where preview is not required in accordance with Article 14(5) of Regulation (EU) 2018/1724, paragraph 2, point (b), of this Article shall not apply. In that case the evidence provider, evidence providers or, where applicable, intermediary platform or platforms may ask the evidence requester to redirect the user to reidentify and reauthenticate for the purpose of identity and evidence matching. The user may choose not to be redirected. In that case, the evidence requester shall inform the user that the process of identity and evidence matching carried out by the evidence provider might not result in a match as referred to in Article 16 of this Regulation.

Article 12

Explicit request

The evidence requester shall, in addition to the information referred to in Article 9, provide the user with the following:

| (a) | the name(s) of the evidence provider(s); |
| --- | --- |

(a)

the name(s) of the evidence provider(s);

| (b) | the evidence type(s) or data fields to be exchanged. |
| --- | --- |

(b)

the evidence type(s) or data fields to be exchanged.

This Article is without prejudice to the situations where the use of the OOTS is permitted without an explicit request in accordance with Article 14(4) of Regulation (EU) 2018/1724.

Article 13

Evidence request

1.   The evidence requester shall ensure that the evidence request is transmitted to the evidence provider or intermediary platform, where applicable, and contains the following information:

| (a) | the unique identifier of the request; |
| --- | --- |

(a)

the unique identifier of the request;

| (b) | the evidence type that is requested; |
| --- | --- |

(b)

the evidence type that is requested;

| (c) | date and time when the explicit request was made; |
| --- | --- |

(c)

date and time when the explicit request was made;

| (d) | identification of the procedure for which the evidence is required; |
| --- | --- |

(d)

identification of the procedure for which the evidence is required;

| (e) | name and metadata that uniquely identifies the evidence requester and intermediary platform, where applicable; |
| --- | --- |

(e)

name and metadata that uniquely identifies the evidence requester and intermediary platform, where applicable;

| (f) | the attributes of the user, or the user and the representative where applicable, exchanged using the electronic identification means referred to in Article 11(1); |
| --- | --- |

(f)

the attributes of the user, or the user and the representative where applicable, exchanged using the electronic identification means referred to in Article 11(1);

| (g) | the level of assurance, as defined in Regulation (EU) No 910/2014, of the electronic identification means used by the user; |
| --- | --- |

(g)

the level of assurance, as defined in Regulation (EU) No 910/2014, of the electronic identification means used by the user;

| (h) | the additional attributes, referred to in Article 5(3), point (b), provided by the user for the purpose of the request; |
| --- | --- |

(h)

the additional attributes, referred to in Article 5(3), point (b), provided by the user for the purpose of the request;

| (i) | the identification of the evidence provider as registered in the data service directory; |
| --- | --- |

(i)

the identification of the evidence provider as registered in the data service directory;

| (j) | whether the explicit request of the user was required in accordance with Article 14(4) of Regulation (EU) 2018/1724; |
| --- | --- |

(j)

whether the explicit request of the user was required in accordance with Article 14(4) of Regulation (EU) 2018/1724;

| (k) | whether the possibility of previewing the evidence is required in accordance with Article 14(5) of Regulation (EU) 2018/1724. |
| --- | --- |

(k)

whether the possibility of previewing the evidence is required in accordance with Article 14(5) of Regulation (EU) 2018/1724.

2.   The evidence requester shall make a clear distinction between the additional attributes referred to in paragraph 1, point (h), and the attributes referred to in paragraph 1, point (f).

Article 14

User redirection to the evidence provider

1.   Without prejudice to the procedures referred to in Article 14(5) of Regulation (EU) 2018/1724, evidence requesters shall ensure that users, after selecting the evidence to be exchanged through the OOTS in the procedure portal in accordance with Article 10 of this Regulation and stating their explicit request in accordance with Article 12 of this Regulation are redirected to the evidence provider, evidence providers or intermediary platform or platforms, where applicable, to exercise the option to preview the evidence.

2.   For the procedures referred to in Article 14(5) of Regulation (EU) 2018/1724, users can be redirected to the evidence provider, evidence providers or intermediary platform or platforms, where applicable, in accordance with Article 11(3) of this Regulation.

SECTION 4

EVIDENCE PROVIDERS

EVIDENCE PROVIDERS

Article 15

Role in the exchange of evidence

1.   Member States shall ensure that, for the purpose of the evidence exchange through the OOTS, the evidence providers or intermediary platforms, where applicable, shall use application services capable of the following:

| (a) | receiving and interpreting evidence requests delivered by an eDelivery Access Point, which shall be considered as the input to the data services; |
| --- | --- |

(a)

receiving and interpreting evidence requests delivered by an eDelivery Access Point, which shall be considered as the input to the data services;

| (b) | subject to successful identification and authentication in accordance with Article 16 of this Regulation:






  (i) | retrieving any pieces of evidences matching the request; |
| --- | --- | --- |

(b)

subject to successful identification and authentication in accordance with Article 16 of this Regulation:

(i)

retrieving any pieces of evidences matching the request;

| (ii) | except in the case of the procedures referred to in Article 14(5) of Regulation (EU) 2018/1724, allow users to specify which of these pieces of evidence they wish to preview and give them the possibility to preview the pieces thus specified in a preview space; |
| --- | --- |

(ii)

except in the case of the procedures referred to in Article 14(5) of Regulation (EU) 2018/1724, allow users to specify which of these pieces of evidence they wish to preview and give them the possibility to preview the pieces thus specified in a preview space;

| (iii) | allow users to indicate which, if any, of the matching pieces of evidence should be returned to the evidence requester for use in the procedure; |
| --- | --- |

(iii)

allow users to indicate which, if any, of the matching pieces of evidence should be returned to the evidence requester for use in the procedure;

| (c) | returning evidence responses to the evidence requester through an eDelivery Access Point, subject to the user’s decision to use the evidence in the procedure following the possibility to preview it, except in the case of the procedures referred to in Article 14(5) of Regulation (EU) 2018/1724, error reports, including in the situation referred to in Article 16(3), point (a), of this Regulation, or reports concerning evidence in the process of being converted. |
| --- | --- |

(c)

returning evidence responses to the evidence requester through an eDelivery Access Point, subject to the user’s decision to use the evidence in the procedure following the possibility to preview it, except in the case of the procedures referred to in Article 14(5) of Regulation (EU) 2018/1724, error reports, including in the situation referred to in Article 16(3), point (a), of this Regulation, or reports concerning evidence in the process of being converted.

2.   If an evidence response is returned, it shall include the requested evidence and be accompanied by:

| (a) | metadata that uniquely identifies the evidence response; |
| --- | --- |

(a)

metadata that uniquely identifies the evidence response;

| (b) | metadata that uniquely identifies the evidence request; |
| --- | --- |

(b)

metadata that uniquely identifies the evidence request;

| (c) | metadata that indicates the date and time at which the response was generated; |
| --- | --- |

(c)

metadata that indicates the date and time at which the response was generated;

| (d) | metadata that uniquely identifies the evidence and the evidence provider; |
| --- | --- |

(d)

metadata that uniquely identifies the evidence and the evidence provider;

| (e) | where structured evidence does not comply with the OOTS data model relevant for the evidence type concerned, a human-readable version of the evidence. |
| --- | --- |

(e)

where structured evidence does not comply with the OOTS data model relevant for the evidence type concerned, a human-readable version of the evidence.

3.   The evidence response may also include the metadata that uniquely identifies the language or languages of the requested evidence.

4.   If an error report is returned, it shall include metadata that uniquely identifies the evidence request, the date and time at which it was generated and a description of the error that occurred.

5.   Where evidence is not yet available for exchange through the OOTS but in the process of being converted to structured or unstructured evidence as defined in Article 1, points (16) and (17), a report as referred to in paragraph 1, point (c), of this Article shall be returned. That report shall include metadata that uniquely identifies the evidence request, the date and time at which it was generated and a message that the evidence concerned is in the process of being converted to structured or unstructured evidence as defined in Article 1, points (16) and (17), and will be ready for the transmission through the OOTS in the future. The evidence provider shall include in the report the preliminary date and time for when the evidence will be available.

Article 16

Identity and evidence matching

1.   Evidence providers or intermediary platforms, where applicable, may require users to reidentify and reauthenticate for the purpose of identity and evidence matching, including by providing additional attributes.

2.   Evidence providers, or intermediary platforms, where applicable, shall ensure that evidence is only exchanged through the OOTS if the identity attributes of the user, and of the representative where applicable, exchanged using the electronic identification means referred to in Article 11(1) and additional attributes as referred to in Article 11(2), point (a) and provided by the user to facilitate identification by the relevant evidence provider, match the attributes held by them.

3.   Where the process of identity and evidence matching does not result in a match or the identity matching generates two or more results, the user or the representative where applicable shall not be allowed to preview the requested evidence and the evidence shall not be exchanged. In the absence of no such match:

| (a) | an error message shall be sent to the evidence requester; |
| --- | --- |

(a)

an error message shall be sent to the evidence requester;

| (b) | the user shall receive an automated message explaining that the evidence cannot be provided. |
| --- | --- |

(b)

the user shall receive an automated message explaining that the evidence cannot be provided.

SECTION 5

LOG SYSTEM OF THE OOTS

LOG SYSTEM OF THE OOTS

Article 17

Log system

1.   For each evidence request transmitted through the OOTS, the evidence requester, evidence provider(s) or intermediary platform(s), where applicable, shall log the following elements:

| (a) | the evidence request referred to in Article 13(1); |
| --- | --- |

(a)

the evidence request referred to in Article 13(1);

| (b) | the information included in the evidence response, with the exception of the evidence itself, or error report referred to in Article 15(1), point (c), and Article 16(3), point (a); |
| --- | --- |

(b)

the information included in the evidence response, with the exception of the evidence itself, or error report referred to in Article 15(1), point (c), and Article 16(3), point (a);

| (c) | the eDelivery event data related to any of the following:






  (i) | exchange of evidence requests; |
| --- | --- | --- |

(c)

the eDelivery event data related to any of the following:

(i)

exchange of evidence requests;

| (ii) | evidence responses; |
| --- | --- |

(ii)

evidence responses;

| (iii) | error reports. |
| --- | --- |

(iii)

error reports.

2.   For each piece of evidence exchanged through the OOTS, the evidence provider or intermediary platform, where applicable, shall log the decision of the user after previewing the evidence to approve, or not, the use of the piece of evidence for the procedure, or where applicable the fact that the user leaves the preview space or procedure portal without making a specific decision.

3.   The Commission and, in situations referred to in Article 8(1), point (a), the relevant Member States, shall log all interactions with the common services referred to in Article 4(1).

4.   Without prejudice to longer retention periods required under national law for the logs referred to in paragraphs 1, 2 and 3 for the purposes of the OOTS or for other purposes, the Commission and the evidence requesters, evidence providers or intermediary platforms, where applicable, shall keep those logs for a period of 12 months.

5.   In case of suspicion of incidents and for the purposes of audits and random checks of security performed within their respective areas of responsibility referred to in Article 26, the evidence requesters, evidence providers and intermediary platforms, where applicable, shall make available to each other on request the relevant logs referred to in paragraphs 1 and 2 of this Article through the technical support dashboard referred to in Article 22. For those same purposes and in the same manner, Member States and the Commission, where applicable, shall make available to the relevant evidence requesters, evidence providers and intermediary platforms, where applicable, the relevant logs referred to in paragraph 3 of this Article.

SECTION 6

GOVERNANCE OF THE OOTS

GOVERNANCE OF THE OOTS

Article 18

Gateway coordination group

The Commission, in cooperation with Member States in the framework of the gateway coordination group established by Article 29 of Regulation (EU) 2018/1724, shall:

| (a) | oversee the establishment and launch of the OOTS in line with Article 31(3) of this Regulation; |
| --- | --- |

(a)

oversee the establishment and launch of the OOTS in line with Article 31(3) of this Regulation;

| (b) | set priorities for further developments and improvements to the OOTS; |
| --- | --- |

(b)

set priorities for further developments and improvements to the OOTS;

| (c) | determine an indicative schedule for the regular updates to, and maintenance and adaptation of, the technical design documents; |
| --- | --- |

(c)

determine an indicative schedule for the regular updates to, and maintenance and adaptation of, the technical design documents;

| (d) | recommend changes in the technical design documents; |
| --- | --- |

(d)

recommend changes in the technical design documents;

| (e) | organise peer reviews to promote exchanges of experience and good practice between Member States on the application of this Regulation by Member States; |
| --- | --- |

(e)

organise peer reviews to promote exchanges of experience and good practice between Member States on the application of this Regulation by Member States;

| (f) | approve or reject operational modalities submitted by any of the sub-groups established in accordance with the rules of procedure of the gateway coordination group, and, if needed, give specific guidance, and supervise their work. |
| --- | --- |

(f)

approve or reject operational modalities submitted by any of the sub-groups established in accordance with the rules of procedure of the gateway coordination group, and, if needed, give specific guidance, and supervise their work.

Article 19

Sub-groups of the gateway coordination group

1.   To ensure a coordinated development and operation of the OOTS, the sub-groups referred to in Article 18, point (f), shall discuss and where necessary draw up proposals of the operational modalities to be submitted to the gateway coordination group on the following areas, in particular:

| (a) | standardisation of OOTS data models; |
| --- | --- |

(a)

standardisation of OOTS data models;

| (b) | evidence mapping; |
| --- | --- |

(b)

evidence mapping;

| (c) | review, maintenance and interpretation of the technical design documents; |
| --- | --- |

(c)

review, maintenance and interpretation of the technical design documents;

| (d) | operational governance, in particular operational arrangements and service level agreements; |
| --- | --- |

(d)

operational governance, in particular operational arrangements and service level agreements;

| (e) | security of the OOTS, including the drawing up of risk management plans to identify risks, assess their potential impact and plan appropriate technical and organisational responses in case of incidents; |
| --- | --- |

(e)

security of the OOTS, including the drawing up of risk management plans to identify risks, assess their potential impact and plan appropriate technical and organisational responses in case of incidents;

| (f) | testing and deployment of the OOTS components, including interoperability between the national components of the OOTS referred to in Article 2, points (a) to (f) and (h), and the common services referred to in Article 4(1). |
| --- | --- |

(f)

testing and deployment of the OOTS components, including interoperability between the national components of the OOTS referred to in Article 2, points (a) to (f) and (h), and the common services referred to in Article 4(1).

The operational modalities shall include drawing up and proposing standards necessary for interoperability in the respective areas of the sub-groups, following international standards whenever possible. Once approved by the gateway coordination group, these standards shall be included in technical design documents.

2.   The sub-groups shall adopt their proposals for operational modalities by consensus whenever possible. Where it appears that consensus cannot be reached, the chair may decide, if it is supported by the simple majority of the members of the subgroup present at the meeting, that a proposal of the sub-group can be submitted to the gateway coordination group.

SECTION 7

TECHNICAL SUPPORT

TECHNICAL SUPPORT

Article 20

Commission single point of contact for technical support

1.   The Commission shall designate a single point of contact for technical support ensuring operation and maintenance of the common services referred to in Article 4(1).

2.   The single point of contact for technical support shall liaise with other relevant Commission contact points and coordinate the resolution of problems with eDelivery Access Points or eIDAS nodes.

3.   The Commission shall ensure that its single point of contact for technical support is organised in a way which allows it to perform its tasks in all circumstances and to react at short notice.

Article 21

National single point of contact for technical support

1.   Each Member State shall designate a single point of contact for technical support to ensure operation and maintenance of the relevant components of the OOTS for which they are responsible pursuant to Section 9.

2.   The single points of contact for technical support shall:

| (a) | provide expertise and advice to evidence providers and evidence requesters for all technical problems encountered in relation to the operation of the OOTS and, where necessary, liaise with the Commission technical contact point and with other national technical support contact points; |
| --- | --- |

(a)

provide expertise and advice to evidence providers and evidence requesters for all technical problems encountered in relation to the operation of the OOTS and, where necessary, liaise with the Commission technical contact point and with other national technical support contact points;

| (b) | investigate and solve any possible downtimes of the eDelivery Access Points, possible security breaches and other incidents; |
| --- | --- |

(b)

investigate and solve any possible downtimes of the eDelivery Access Points, possible security breaches and other incidents;

| (c) | inform the technical support contact points of any activities that might result in a breach or a suspected breach of the security of the electronic systems. |
| --- | --- |

(c)

inform the technical support contact points of any activities that might result in a breach or a suspected breach of the security of the electronic systems.

3.   When informed by an evidence provider about doubts as to the lawfulness of one or several evidence requests, the single point of contact for technical support shall:

| (a) | review evidence requests or samples of evidence requests transmitted from the same evidence requester in the past; |
| --- | --- |

(a)

review evidence requests or samples of evidence requests transmitted from the same evidence requester in the past;

| (b) | use the technical support dashboard referred to in Article 22 to ask the single point of contact for technical support designated by the Member State of the evidence requester to transmit logs of selected exchanges referred to in Article 17; |
| --- | --- |

(b)

use the technical support dashboard referred to in Article 22 to ask the single point of contact for technical support designated by the Member State of the evidence requester to transmit logs of selected exchanges referred to in Article 17;

| (c) | bring the issue to the attention of the national coordinator if the problem persists. |
| --- | --- |

(c)

bring the issue to the attention of the national coordinator if the problem persists.

4.   Member States shall ensure that their respective single point of contact for technical support is organised in a way which allows it to perform its tasks in all circumstances and is able to react at short notice.

Article 22

Technical support dashboard

1.   The Commission shall establish a dashboard to facilitate the communication between all technical support contact points.

2.   Member States and the Commission shall record in the dashboard the contact details of the technical support contact points and keep it updated.

3.   The contact points shall, through the dashboard:

| (a) | report any incident considered to be substantial; |
| --- | --- |

(a)

report any incident considered to be substantial;

| (b) | report any temporary or permanent measures undertaken following incidents; |
| --- | --- |

(b)

report any temporary or permanent measures undertaken following incidents;

| (c) | request from the relevant technical support contact points the logs of selected exchanges in the cases referred to in Article 17(5) and, in case of doubt, as to the lawfulness of the evidence request referred to in Article 21(3); |
| --- | --- |

(c)

request from the relevant technical support contact points the logs of selected exchanges in the cases referred to in Article 17(5) and, in case of doubt, as to the lawfulness of the evidence request referred to in Article 21(3);

| (d) | request any other assistance needed in case of incidents. |
| --- | --- |

(d)

request any other assistance needed in case of incidents.

4.   The national coordinators and the chair of the gateway coordination group shall have access to the dashboard.

5.   The Commission and the national coordinators shall use the dashboard to provide information referred to in Article 27 and Article 28(2).

SECTION 8

COOPERATION WITH OTHER GOVERNANCE STRUCTURES

COOPERATION WITH OTHER GOVERNANCE STRUCTURES

Article 23

Scope of the cooperation

The Commission, together with the gateway coordination group and its sub-groups, shall cooperate with relevant governance structures established by Union law or international agreements in areas relevant for the OOTS in order to achieve synergies and to reuse, to the extent possible, the solutions developed in those other fora.

SECTION 9

RESPONSIBILITY FOR MAINTENANCE AND OPERATION OF COMPONENTS OF THE OOTS

RESPONSIBILITY FOR MAINTENANCE AND OPERATION OF COMPONENTS OF THE OOTS

Article 24

Responsibilities of the Commission

The Commission shall be the owner of the common services and the technical support dashboard and responsible for their development, availability, monitoring, updating, maintenance and hosting.

Article 25

Responsibilities of Member States

With respect to the respective national components of the OOTS referred to in Article 2, points (a) to (f) and (h), each Member State shall be considered as the owner and responsible for the establishment, where applicable, and the development, availability, monitoring, updating, maintenance and hosting.

Article 26

Changes and updates

1.   The Commission shall inform Member States of changes and updates to the common services.

2.   Member States shall inform the Commission of changes and updates to the components under their responsibility that may have repercussions on the functioning of the OOTS.

3.   Information on critical updates shall be provided without undue delay. In the case of other, non-critical updates that are likely to affect OOTS components that are owned by other Member States or the common services, the lead time shall be decided by the gateway coordination group on the basis of a proposal from the relevant sub-group.

Article 27

Availability of OOTS

1.   The OOTS operating time frame shall be 24 hours a day/7 days a week, with an availability rate of the eDelivery access points, preview spaces and common services of at least 98 % excluding maintenance scheduled in accordance with paragraph 2 of this Article. The service level targets of the remaining OOTS components shall be specified in the service level agreements referred to in Article 19(1), point (d).

2.   Member States and the Commission shall notify the scheduled maintenance activities related to the relevant components of the OOTS as follows:

| (a) | 5 working days in advance for maintenance operations that may cause an unavailability period of up to 4 hours; |
| --- | --- |

(a)

5 working days in advance for maintenance operations that may cause an unavailability period of up to 4 hours;

| (b) | 10 working days in advance for maintenance operations that may cause an unavailability period of up to 12 hours; |
| --- | --- |

(b)

10 working days in advance for maintenance operations that may cause an unavailability period of up to 12 hours;

| (c) | 30 working days in advance for infrastructure computer room maintenance that may cause up to 6 days unavailability period per year. |
| --- | --- |

(c)

30 working days in advance for infrastructure computer room maintenance that may cause up to 6 days unavailability period per year.

To the extent possible, maintenance operations shall be planned outside working hours.

3.   Where Member States have fixed weekly service windows, they shall inform the Commission of the time and day when such fixed weekly windows are planned. Without prejudice to the obligations set out in paragraph 2, points (a), (b) and (c), if Member States systems become unavailable during such a fixed window, Member States are exempted from the obligation to notify the Commission on each occasion.

4.   In the case of unexpected technical failure of the Member States OOTS components, the relevant Member State shall inform the other Member States and the Commission without delay of their unavailability, and, if known, of the projected resuming of the functioning of the components.

5.   In the case of unexpected failure of the common services, the Commission shall inform Member States without delay of the unavailability of one or more common services, and if known, of the projected resuming of the service.

6.   The notifications referred to in this Article shall be made through the technical support dashboard referred to in Article 22.

SECTION 10

SECURITY

SECURITY

Article 28

Security of common services and national components

1.   The Commission shall ensure the security of the common services referred to in Article 4(1) and the integration elements and interfaces referred to in Article 2, point (h), for which it is responsible.

2.   Member States shall ensure the security of the national components of the OOTS and the integration elements and interfaces referred to in Article 2, point (h), for which they are responsible.

3.   For the purposes referred to in paragraphs 1 and 2, Member States and the Commission shall, at least, and each for the component for which they are responsible, take the necessary measures to:

| (a) | prevent any unauthorised person from having access to components for which they are responsible; |
| --- | --- |

(a)

prevent any unauthorised person from having access to components for which they are responsible;

| (b) | prevent the entry of data and any consultation, modification or deletion of data by unauthorised persons; |
| --- | --- |

(b)

prevent the entry of data and any consultation, modification or deletion of data by unauthorised persons;

| (c) | detect any of the activities referred to in points (a) and (b); and |
| --- | --- |

(c)

detect any of the activities referred to in points (a) and (b); and

| (d) | ensure logging of security events in line with recognised international security standards for information technology. |
| --- | --- |

(d)

ensure logging of security events in line with recognised international security standards for information technology.

4.   Member States shall ensure, in particular:

| (a) | that the connections they operate into and out of the eDelivery Access Points and all internal communication between different national authorities fulfil at least the same level of security requirements as the eDelivery electronic delivery service to protect the security and confidentiality of the exchange and the integrity of evidence exchanged through the OOTS; |
| --- | --- |

(a)

that the connections they operate into and out of the eDelivery Access Points and all internal communication between different national authorities fulfil at least the same level of security requirements as the eDelivery electronic delivery service to protect the security and confidentiality of the exchange and the integrity of evidence exchanged through the OOTS;

| (b) | the non-repudiation of origin of the evidence request transmitted from the access point of the evidence requester, and of the evidence response exchanged or error message transmitted from the access point of the evidence provider. |
| --- | --- |

(b)

the non-repudiation of origin of the evidence request transmitted from the access point of the evidence requester, and of the evidence response exchanged or error message transmitted from the access point of the evidence provider.

5.   In accordance with paragraph 4, the Member State of the evidence provider in any given exchange of evidence shall be responsible for the quality, confidentiality, integrity and availability of the requested evidence until it reaches the eDelivery Access Point of the evidence requester or an intermediary platform, where applicable. The Member State of the evidence requester in any given exchange of evidence shall be responsible for the confidentiality and integrity of the requested evidence from the moment it reaches its eDelivery Access Point.

6.   Member States and the Commission shall ensure the confidentiality, integrity and availability of the logs referred to in Article 17(1), (2) and (3) through appropriate and proportionate security measures, each for the logs that they have recorded.

Article 29

Monitoring of the electronic systems

1.   Member States and the Commission shall conduct regular checks on the components of the OOTS for which they are responsible.

2.   The single points of contact for technical support referred to in Articles 20 and 21 shall use the technical support dashboard referred to in Article 22 to inform each other of problems discovered during the checks that might result in a breach or a suspected breach of the security of the OOTS.

Article 30

Administration management system

The Commission shall set up an administration management system to manage the authentication and authorisation rules for validating the identification data for the purposes of allowing access to the common services and the technical support dashboard.

SECTION 11

FINAL PROVISIONS

FINAL PROVISIONS

Article 31

Testing of the OOTS

1.   Member States and the Commission shall, in the framework of the gateway coordination group, adopt a testing schedule and a set of indicators according to which testing results can be measured and considered as positive.

2.   The Commission shall provide testing services that Member States can use to test the conformity of technical solutions with the indicators referred to in paragraph 1.

3.   Member States and the Commission shall test the functioning of each of the OOTS components and verify that they can function properly according to the indicators referred to in paragraph 1. Only those components of the OOTS for which the tests yield positive results shall be made available for users.

Article 32

Commission assistance

The Commission shall provide a team of experts as part of the Commission technical support contact point to assist national technical support contact points, and national coordinators in all aspects related to the functioning of the OOTS from a technical point of view, in particular:

| (a) | providing guidelines; |
| --- | --- |

(a)

providing guidelines;

| (b) | organising workshops and demonstrations; |
| --- | --- |

(b)

organising workshops and demonstrations;

| (c) | answering individual questions. |
| --- | --- |

(c)

answering individual questions.

Article 33

Processing of personal data

In relation to the processing of personal data present in the evidence subject to exchange through the OOTS and occurring in the components of the OOTS that they own pursuant to Article 25 of this Regulation, the respective competent authorities of Member States, in their capacities as evidence requester or evidence provider, shall act as controllers as defined in Article 4, point 7, of Regulation (EU) 2016/679 and as further specified in Articles 34 and 35 of this Regulation.

Article 34

Responsibilities of evidence requester as data controller

1.   For each evidence exchange through the OOTS, the relevant evidence requester or intermediary platform, where applicable, shall be solely responsible for the completeness and lawfulness of the evidence request. The evidence requester shall ensure, in particular, that the evidence is required for the particular procedure for which it is requested by a user.

2.   Once the evidence exchanged through the OOTS becomes available to the evidence requester or intermediary platform, where applicable, either following the user’s choice to proceed with the exchange of evidence in accordance with Article 14(3), point (f), of Regulation (EU) 2018/1724, or in the case of the procedures referred to in Article 14(5) of Regulation (EU) 2018/1724, the evidence requester or intermediary platform, where applicable, shall ensure the same level of protection of personal data in accordance with Regulation (EU) 2016/679 as in a situation where the user submits or uploads the evidence without having recourse to the OOTS.

Article 35

Responsibilities of evidence provider as data controller

1.   Without prejudice to their obligations set out in Regulation (EU) 2016/679, for each evidence exchange through the OOTS, the relevant evidence provider or intermediary platform, where applicable, shall be solely responsible for verifying:

| (a) | that the requested evidence it holds can be matched to the user in accordance with Article 16; |
| --- | --- |

(a)

that the requested evidence it holds can be matched to the user in accordance with Article 16;

| (b) | that the user is entitled to use the requested evidence. |
| --- | --- |

(b)

that the user is entitled to use the requested evidence.

2.   When an intermediary platform provides the preview space in accordance with Article 15(1), point (b)(ii), of this Regulation it shall be considered as a processor acting on behalf of the evidence provider according to Article 4(8) of Regulation (EU) 2016/679.

Article 36

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.

It shall apply from 12 December 2023.

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

Done at Brussels, 5 August 2022.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 295, 21.11.2018, p. 1.

1

(2)  Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (OJ L 255, 30.9.2005, p. 22).

2

(3)  Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market (OJ L 376, 27.12.2006, p. 36).

3

(4)  Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65).

4

(5)  Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (OJ L 94, 28.3.2014, p. 243).

5

(6)  Commission Implementing Regulation (EU) 2015/1501 of 8 September 2015 on the interoperability framework pursuant to Article 12(8) of Regulation (EU) No 910/2014 of the European Parliament and of the Council on electronic identification and trust services for electronic transactions in the internal market (OJ L 235, 9.9.2015, p. 1).

6

(7)  Driving licence network set up on the basis of Article 15 of Directive 2006/126/EC of the European Parliament and of the Council of 20 December 2006 on driving licences (OJ L 403, 30.12.2006, p. 18).

7

(8)  Treaty concerning a European Vehicle and Driving Licence Information System (EUCARIS), adopted in Luxembourg on 29 June 2000.

8

(9)  Emrex User Group (EUG) is an independent, international network which unites various actors interested in enhancing student data portability; https://emrex.eu/

9

(10)  Regulation (EC) No 987/2009 of the European Parliament and of the Council of 16 September 2009 laying down the procedure for implementing Regulation (EC) No 883/2004 on the coordination of social security systems (OJ L 284, 30.10.2009, p. 1).

10

(11)  Council Decision 2009/316/JHA of 6 April 2009 on the establishment of the European Criminal Records Information System (ECRIS) in application of Article 11 of Framework Decision 2009/315/JHA (OJ L 93, 7.4.2009, p. 33).

11

(12)  https://ec.europa.eu/tools/ecertis/#/homePage

12

(13)  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).

13

(14)  A trusted and secure European e-ID - Recommendation | Shaping Europe’s digital future (europa.eu)

14

(15)  Commission Implementing Decision (EU) 2015/296 of 24 February 2015 establishing procedural arrangements for cooperation between Member States on electronic identification pursuant to Article 12(7) of Regulation (EU) No 910/2014 of the European Parliament and of the Council on electronic identification and trust services for electronic transactions in the internal market (OJ L 53, 25.2.2015, p. 14).

15

(16)  OJ L 210, 14.6.2021, p. 51.

16

(17)  Signed on 6 October 2017, https://digital-strategy.ec.europa.eu/en/news/ministerial-declaration-egovernment-tallinn-declaration

17

(18)  Signed on 8 December 2020; https://digital-strategy.ec.europa.eu/en/news/berlin-declaration-digital-society-and-value-based-digital-government

18

(19)  Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).

19

(20)  Commission Decision (EU, Euratom) 2017/46 of 10 January 2017 on the security of communication and information systems in the European Commission (OJ L 6, 11.1.2017, p. 40).

20

(21)  Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).

21

(22)  https://edps.europa.eu/data-protection/our-work/publications/formal-comments/draft-commission-implementing-regulation-4_en

22

---

| 6.9.2022 | EN | Official Journal of the European Union | L 231/22 |
| --- | --- | --- | --- |

6.9.2022

EN

Official Journal of the European Union

L 231/22

---

COMMISSION IMPLEMENTING REGULATION (EU) 2022/1464

of 2 September 2022

amending Council Regulation (EC) No 1210/2003 concerning certain specific restrictions on economic and financial relations with Iraq

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Regulation (EC) No 1210/2003 of 7 July 2003 concerning certain specific restrictions on economic and financial relations with Iraq and repealing Regulation (EC) No 2465/96 (1), and in particular Article 11(b) thereof,

Whereas:

| (1) | Annex IV to Regulation (EC) No 1210/2003 lists natural and legal persons, bodies or entities associated with the regime of former President Saddam Hussein covered by the freezing of funds and economic resources and by a prohibition to make funds or economic resources available. |
| --- | --- |

(1)

Annex IV to Regulation (EC) No 1210/2003 lists natural and legal persons, bodies or entities associated with the regime of former President Saddam Hussein covered by the freezing of funds and economic resources and by a prohibition to make funds or economic resources available.

| (2) | On 30 August 2022, the Sanctions Committee of the United Nations Security Council decided to remove one natural person from the list of persons and entities to whom the assets freeze should apply. |
| --- | --- |

(2)

On 30 August 2022, the Sanctions Committee of the United Nations Security Council decided to remove one natural person from the list of persons and entities to whom the assets freeze should apply.

| (3) | Annex IV to Regulation (EC) No 1210/2003 should therefore be amended accordingly, |
| --- | --- |

(3)

Annex IV to Regulation (EC) No 1210/2003 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Annex IV to Regulation (EC) No 1210/2003 is amended as set out in Annex I to this Regulation.

Article 2

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

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

Done at Brussels, 2 September 2022.

For the Commission

On behalf of the President

Director-General

Directorate-General for Financial Stability, Financial Services and Capital Markets Union

---

(1)  OJ L 169, 8.7.2003, p. 6.

1

---

ANNEX

In Annex IV to Council Regulation (EC) No 1210/2003, the following entry is deleted:

| ‘74. | Dr. Sahir Berhan (alias (a) Dr. Sahir Barhan, (b) Saher Burhan Al-Deen, (c) Sahir Burhan). Date of birth: 1967. Address: (a) Baghdad, Iraq, (b) United Arab Emirates. Nationality: Iraqi’. |
| --- | --- |

‘74.

---

| 6.9.2022 | EN | Official Journal of the European Union | L 231/24 |
| --- | --- | --- | --- |

6.9.2022

EN

Official Journal of the European Union

L 231/24

---

COMMISSION REGULATION (EU) 2022/1465

of 5 September 2022

amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards certain flavouring substances

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (1), and in particular Article 11(3) thereof,

Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (2), and in particular Article 7(5) thereof,

Whereas:

| (1) | Annex I to Regulation (EC) No 1334/2008 lays down a Union list of flavourings and source materials approved for use in and on foods and their conditions of use. |
| --- | --- |

(1)

Annex I to Regulation (EC) No 1334/2008 lays down a Union list of flavourings and source materials approved for use in and on foods and their conditions of use.

| (2) | Commission Implementing Regulation (EU) No 872/2012 (3) adopted a list of flavouring substances and inserted that list in Annex I, Part A, to Regulation (EC) No 1334/2008. |
| --- | --- |

(2)

Commission Implementing Regulation (EU) No 872/2012 (3) adopted a list of flavouring substances and inserted that list in Annex I, Part A, to Regulation (EC) No 1334/2008.

| (3) | That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application submitted by a Member State or by an interested party. |
| --- | --- |

(3)

That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application submitted by a Member State or by an interested party.

| (4) | The Union list of flavourings and source materials laid down in Annex I to Regulation (EC) No 1334/2008 contains, among others, a number of flavouring substances for which, at the time of adoption of the list by Implementing Regulation (EU) No 872/2012, the European Food Safety Authority (‘the Authority’) had not been able to rule out a safety risk to the health of the consumer on the basis of the data available and had, therefore, considered that additional data was necessary to complete their evaluation. Those substances were included in the Union list of flavouring substances but on the condition that safety data addressing the concerns expressed by the Authority was submitted before the expiry of specific deadlines established in Part A of Annex I to Regulation (EC) No 1334/2008. Among the substances included in the Union list of flavourings and source materials but identified by way of a footnote reference requiring the Authority to complete the evaluation, there were the following five substances of the Flavouring Group Evaluation 208 (FGE.208), namely p-mentha-1,8-dien-7-ol (FL No 02.060), myrtenol (FL No 02.091), myrtenal (FL No 05.106), p-Mentha-1,8-dien-7-yl acetate (FL No 09.278) and myrtenyl acetate (FL No 09.302). The Authority requested additional scientific data that were subsequently submitted by the applicants. |
| --- | --- |

(4)

The Union list of flavourings and source materials laid down in Annex I to Regulation (EC) No 1334/2008 contains, among others, a number of flavouring substances for which, at the time of adoption of the list by Implementing Regulation (EU) No 872/2012, the European Food Safety Authority (‘the Authority’) had not been able to rule out a safety risk to the health of the consumer on the basis of the data available and had, therefore, considered that additional data was necessary to complete their evaluation. Those substances were included in the Union list of flavouring substances but on the condition that safety data addressing the concerns expressed by the Authority was submitted before the expiry of specific deadlines established in Part A of Annex I to Regulation (EC) No 1334/2008. Among the substances included in the Union list of flavourings and source materials but identified by way of a footnote reference requiring the Authority to complete the evaluation, there were the following five substances of the Flavouring Group Evaluation 208 (FGE.208), namely p-mentha-1,8-dien-7-ol (FL No 02.060), myrtenol (FL No 02.091), myrtenal (FL No 05.106), p-Mentha-1,8-dien-7-yl acetate (FL No 09.278) and myrtenyl acetate (FL No 09.302). The Authority requested additional scientific data that were subsequently submitted by the applicants.

| (5) | In its scientific opinion of 24 June 2015 (4), the Authority evaluated the submitted data and concluded that the representative substance of the group, p-mentha-1,8-dien-7-al (FL no 05.117), was genotoxic in vivo and that, therefore, its use as a flavouring substance raised a safety concern. |
| --- | --- |

(5)

In its scientific opinion of 24 June 2015 (4), the Authority evaluated the submitted data and concluded that the representative substance of the group, p-mentha-1,8-dien-7-al (FL no 05.117), was genotoxic in vivo and that, therefore, its use as a flavouring substance raised a safety concern.

| (6) | Following this opinion, the Commission withdrew this substance from the Union list of flavourings by means of Regulation (EU) 2015/1760 (5). |
| --- | --- |

(6)

Following this opinion, the Commission withdrew this substance from the Union list of flavourings by means of Regulation (EU) 2015/1760 (5).

| (7) | As p-mentha-1,8-dien-7-al (FL no 05.117) is representative for four other substances belonging to Flavouring Group Evaluation 208 (FGE.208), the Commission further withdrew those four substances from the Union list by means of Commission Regulation (EU) 2016/637 (6). |
| --- | --- |

(7)

As p-mentha-1,8-dien-7-al (FL no 05.117) is representative for four other substances belonging to Flavouring Group Evaluation 208 (FGE.208), the Commission further withdrew those four substances from the Union list by means of Commission Regulation (EU) 2016/637 (6).

| (8) | As regards p-mentha-1,8-dien-7-ol (FL No 02.060), myrtenol (FL No 02.091), myrtenal (FL No 05.106), p-mentha-1,8-dien-7-yl acetate (FL No 09.278) and myrtenyl acetate (FL No 09.302), the applicants for these substances indicated that they had launched specific individual sets of toxicity studies on them, addressing the concerns expressed by the Authority in its 24 June 2015 opinion. The applicants undertook to submit the requested new data before 30 April 2016. |
| --- | --- |

(8)

As regards p-mentha-1,8-dien-7-ol (FL No 02.060), myrtenol (FL No 02.091), myrtenal (FL No 05.106), p-mentha-1,8-dien-7-yl acetate (FL No 09.278) and myrtenyl acetate (FL No 09.302), the applicants for these substances indicated that they had launched specific individual sets of toxicity studies on them, addressing the concerns expressed by the Authority in its 24 June 2015 opinion. The applicants undertook to submit the requested new data before 30 April 2016.

| (9) | Pending the evaluation, by the Authority, of those substances, their eventual full evaluation under the Authority’s panel procedure and the completion of the subsequent regulatory process, the Commission adopted Regulation (EU) 2016/1244 (7) limiting the uses of these flavouring substances, whilst maintaining their status of substances under evaluation. |
| --- | --- |

(9)

Pending the evaluation, by the Authority, of those substances, their eventual full evaluation under the Authority’s panel procedure and the completion of the subsequent regulatory process, the Commission adopted Regulation (EU) 2016/1244 (7) limiting the uses of these flavouring substances, whilst maintaining their status of substances under evaluation.

| (10) | The applicants submitted scientific studies and other data relevant for the evaluation by 30 April 2016. |
| --- | --- |

(10)

The applicants submitted scientific studies and other data relevant for the evaluation by 30 April 2016.

| (11) | In its opinions of 22 March 2017 (8) and 11 December 2018 (9), the Authority evaluated the submitted data and additional further data, ruled out the concern on genotoxicity for those five substances and decided that they could be evaluated under the procedure of evaluation of existing flavouring substances referred to in Commission Regulation (EC) No 1565/2000 (10). For this purpose, the Authority allocated those five substances to the Flavouring Group Evaluation 73 (FGE.73). In its opinions of 19 September 2017 (11) and 10 December 2020 (12), it updated the evaluations of this group of substances and concluded that those substances do not raise a safety concern. It also provided recommendations to change the name and the specifications of some of those substances. |
| --- | --- |

(11)

In its opinions of 22 March 2017 (8) and 11 December 2018 (9), the Authority evaluated the submitted data and additional further data, ruled out the concern on genotoxicity for those five substances and decided that they could be evaluated under the procedure of evaluation of existing flavouring substances referred to in Commission Regulation (EC) No 1565/2000 (10). For this purpose, the Authority allocated those five substances to the Flavouring Group Evaluation 73 (FGE.73). In its opinions of 19 September 2017 (11) and 10 December 2020 (12), it updated the evaluations of this group of substances and concluded that those substances do not raise a safety concern. It also provided recommendations to change the name and the specifications of some of those substances.

| (12) | Under Regulation (EC) No 1334/2008, the Authority had to complete the evaluation for the following 20 substances of the Flavouring Group Evaluation 203 (FGE.203 rev.1): deca-2,4-dien-1-ol (FL No 02.139); hepta-2,4-dien-1-ol (FL No 02.153); hexa-2,4-dien-1-ol (FL No 02.162); nona-2,4-dien-1-ol (FL No 02.188); hexa-2(trans),4(trans)-dienal (FL No 05.057); trideca-2(trans),4(cis),7(cis)-trienal (Fl No 05.064); nona-2,4-dienal (FL No 05.071); 2,4-decadienal (FL No 05.081); hepta-2,4-dienal (FL No 05.084); penta-2,4-dienal (FL No 05.101); undeca-2,4-dienal (FL No 05.108); dodeca-2,4-dienal (FL No 05.125); octa-2(trans),4(trans)-dienal (FL No 05.127); deca-2(trans),4(trans)-dienal (FL No 05.140); deca-2,4,7-trienal (FL No 05.141); nona-2,4,6-trienal (FL No 05.173); 2,4-octadienal (FL No 05.186); tr-2,tr-4-nonadienal (FL No 05.194); tr-2,tr-4-undecadienal (FL No 05.196), and hexa-2,4-dienyl acetate (FL No 09.573). The Authority has requested additional scientific data that were subsequently submitted by the applicants. |
| --- | --- |

(12)

Under Regulation (EC) No 1334/2008, the Authority had to complete the evaluation for the following 20 substances of the Flavouring Group Evaluation 203 (FGE.203 rev.1): deca-2,4-dien-1-ol (FL No 02.139); hepta-2,4-dien-1-ol (FL No 02.153); hexa-2,4-dien-1-ol (FL No 02.162); nona-2,4-dien-1-ol (FL No 02.188); hexa-2(trans),4(trans)-dienal (FL No 05.057); trideca-2(trans),4(cis),7(cis)-trienal (Fl No 05.064); nona-2,4-dienal (FL No 05.071); 2,4-decadienal (FL No 05.081); hepta-2,4-dienal (FL No 05.084); penta-2,4-dienal (FL No 05.101); undeca-2,4-dienal (FL No 05.108); dodeca-2,4-dienal (FL No 05.125); octa-2(trans),4(trans)-dienal (FL No 05.127); deca-2(trans),4(trans)-dienal (FL No 05.140); deca-2,4,7-trienal (FL No 05.141); nona-2,4,6-trienal (FL No 05.173); 2,4-octadienal (FL No 05.186); tr-2,tr-4-nonadienal (FL No 05.194); tr-2,tr-4-undecadienal (FL No 05.196), and hexa-2,4-dienyl acetate (FL No 09.573). The Authority has requested additional scientific data that were subsequently submitted by the applicants.

| (13) | The substances hexa-2(trans),4(trans)-dienal (FL No 05.057) and deca-2(trans),4(trans)-dienal (FL No 05.140) were used as representative substances for this group of substances, and toxicity data were submitted for them. |
| --- | --- |

(13)

The substances hexa-2(trans),4(trans)-dienal (FL No 05.057) and deca-2(trans),4(trans)-dienal (FL No 05.140) were used as representative substances for this group of substances, and toxicity data were submitted for them.

| (14) | In its scientific opinion of 26 March 2014 (13), the Authority evaluated the submitted data and concluded that it could not rule out safety concerns for both representative substances of the group. Therefore, the Authority could not complete the assessment of the substances belonging to FGE group 203. |
| --- | --- |

(14)

In its scientific opinion of 26 March 2014 (13), the Authority evaluated the submitted data and concluded that it could not rule out safety concerns for both representative substances of the group. Therefore, the Authority could not complete the assessment of the substances belonging to FGE group 203.

| (15) | The applicants for these substances indicated that they had launched a variety of specific toxicity studies on the substances of this group, addressing the concerns the Authority expressed in its 26 March 2014 opinion. |
| --- | --- |

(15)

The applicants for these substances indicated that they had launched a variety of specific toxicity studies on the substances of this group, addressing the concerns the Authority expressed in its 26 March 2014 opinion.

| (16) | The Authority requested further data on identity and characterization, and also poundage and intake data, to allow a proper exposure assessment, in order to fully assess the safety of these substances. |
| --- | --- |

(16)

The Authority requested further data on identity and characterization, and also poundage and intake data, to allow a proper exposure assessment, in order to fully assess the safety of these substances.

| (17) | The applicants undertook to submit the requested new data by 30 September 2016. Pending the submission of the additional data, the evaluation, by the Authority, of the genotoxicity of those substances, their eventual full evaluation under the Authority’s panel procedure and the completion of the subsequent regulatory process, the Commission adopted Regulation (EU) 2017/378 (14) limiting the uses of these flavouring substances, whilst maintaining their status of substances under evaluation. |
| --- | --- |

(17)

The applicants undertook to submit the requested new data by 30 September 2016. Pending the submission of the additional data, the evaluation, by the Authority, of the genotoxicity of those substances, their eventual full evaluation under the Authority’s panel procedure and the completion of the subsequent regulatory process, the Commission adopted Regulation (EU) 2017/378 (14) limiting the uses of these flavouring substances, whilst maintaining their status of substances under evaluation.

| (18) | The applicants submitted scientific studies and data relevant for this evaluation by 30 September 2016. |
| --- | --- |

(18)

The applicants submitted scientific studies and data relevant for this evaluation by 30 September 2016.

| (19) | In its opinion of 5 June 2018 (15), the Authority evaluated the submitted data, ruled out the concern on genotoxicity for those substances and decided that they could be evaluated under the procedure for the evaluation of existing flavouring substances referred to in Regulation (EC) No 1565/2000. For this purpose, the Authority allocated 16 of those substances to Flavouring Group Evaluation 70 (FGE.70) and four of them to Flavouring Group Evaluation 05 (FGE.05). In its opinions adopted on 5 June 2019 (16) and 26 June 2019 (17), it updated the evaluations of the substances in Flavouring Group Evaluation 70, Revision 1 (FGE.70 Rev1) and Flavouring Group Evaluation 05, Revision 3 (FGE.05 Rev3), respectively. As regards the 16 substances in FGE 70 Rev.1, the Authority concluded that they do not raise a safety concern and provided recommendations to change the name and the specifications of some of those substances. As regards the four substances in FGE.05 Rev.3, the Authority also concluded that they do not raise a safety concern and provided recommendations to change the name and the specifications of some of those four substances. |
| --- | --- |

(19)

In its opinion of 5 June 2018 (15), the Authority evaluated the submitted data, ruled out the concern on genotoxicity for those substances and decided that they could be evaluated under the procedure for the evaluation of existing flavouring substances referred to in Regulation (EC) No 1565/2000. For this purpose, the Authority allocated 16 of those substances to Flavouring Group Evaluation 70 (FGE.70) and four of them to Flavouring Group Evaluation 05 (FGE.05). In its opinions adopted on 5 June 2019 (16) and 26 June 2019 (17), it updated the evaluations of the substances in Flavouring Group Evaluation 70, Revision 1 (FGE.70 Rev1) and Flavouring Group Evaluation 05, Revision 3 (FGE.05 Rev3), respectively. As regards the 16 substances in FGE 70 Rev.1, the Authority concluded that they do not raise a safety concern and provided recommendations to change the name and the specifications of some of those substances. As regards the four substances in FGE.05 Rev.3, the Authority also concluded that they do not raise a safety concern and provided recommendations to change the name and the specifications of some of those four substances.

| (20) | Annex I, part A, to Regulation (EC) No 1334/2008 should therefore be amended accordingly. |
| --- | --- |

(20)

Annex I, part A, to Regulation (EC) No 1334/2008 should therefore be amended accordingly.

| (21) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(21)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Annex I, Part A, to Regulation (EC) No 1334/2008 is amended in accordance with the Annex to this Regulation.

Article 2

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

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

Done at Brussels, 5 September 2022.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 354, 31.12.2008, p. 34.

1

(2)  OJ L 354, 31.12.2008, p. 1.

2

(3)  Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No 1565/2000 and Commission Decision 1999/217/EC (OJ L 267, 2.10.2012, p. 1).

3

(4)  Scientific Opinion on Flavouring Group Evaluation 208 Revision 1 (FGE.208Rev1): Consideration of genotoxicity data on representatives for 10 alicyclic aldehydes with the α,β-unsaturation in ring/side-chain and precursors from chemical subgroup 2.2 of FGE.19. EFSA Journal 2015;13(7):4173, 28 pp. doi:10.2903/j.efsa.2015.4173. Available online: www.efsa.europa.eu/efsajournal

4

(5)  Commission Regulation (EU) 2015/1760 of 1 October 2015 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of the flavouring substance p-mentha-1,8-dien-7-al (OJ L 257, 2.10.2015, p. 27).

5

(6)  Commission Regulation (EU) 2016/637 of 22 April 2016 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of certain flavouring substances (OJ L 108, 23.4.2016, p. 24).

6

(7)  Commission Regulation (EU) 2016/1244 of 28 July 2016 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards certain flavouring substances from a group related with an alpha beta unsaturation structure (OJ L 204, 29.7.2016, p. 7).

7

(8)  Scientific Opinion on Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2): Consideration of genotoxicity data on alicyclic aldehydes with a,b-unsaturation in ring/side-chain and precursors from chemical subgroup 2.2 of FGE.19. EFSA Journal 2017;15(5):4766. https://doi.org/10.2903/j.efsa.2017.4766

8

(9)  Scientific Opinion on Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3): consideration of genotoxicity data on alicyclic aldehydes with alpha,beta-unsaturation in ring/side-chain and precursors from chemical subgroup 2.2 of FGE.19. EFSA Journal 2019;17(1):5569. https://doi.org/10.2903/j.efsa.2019.5569

9

(10)  Commission Regulation (EC) No 1565/2000 of 18 July 2000 laying down the measures necessary for the adoption of an evaluation programme in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council (OJ L 180, 19.7.2000, p. 8).

10

(11)  Scientific Opinion on Flavouring Group Evaluation 73, Revision 4 (FGE.73Rev4): consideration of alicyclic alcohols, aldehydes, acids and related esters evaluated by JECFA (59th and 63rd meeting) structurally related to primary saturated or unsaturated alicyclic alcohols, aldehydes, acids and esters evaluated by EFSA in FGE.12Rev5. EFSA Journal 2017;15(11):5010. doi: 10.2903/j.efsa.2017.5010. Available at www.efsa.europa.eu/efsajournal

11

(12)  Scientific Opinion on Flavouring Group Evaluation 73, Revision 5 (FGE.73Rev5): consideration of alicyclic alcohols, aldehydes, acids and related esters evaluated by JECFA (59th, 63rd and 86th meeting) and structurally related to substances evaluated in FGE.12Rev5, EFSA Journal 2020;18(1):5970. doi: 10.2903/j.efsa.2020.5970. Available online: www.efsa.europa.eu/efsajournal

12

(13)  Scientific Opinion on Flavouring Group Evaluation 203 Rev 1 (FGE.203 Rev1): EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2014. Scientific Opinion on Flavouring Group Evaluation 203 Revision 1 (FGE.203Rev1): α,β-unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.4 of FGE.19 with two or more conjugated double-bonds and with or without additional non-conjugated double-bonds. EFSA Journal 2014;12(4):3626, 31 pp. doi:10.2903/j.efsa.2014.3626. Available online: www.efsa.europa.eu/efsajournal

13

(14)  Commission Regulation (EU) 2017/378 of 3 March 2017 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards certain flavouring substances (OJ L 58, 4.3.2017, p. 14).

14

(15)  Scientific Opinion on Flavouring Group Evaluation 203, Revision 2 (FGE.203Rev2): alpha,beta-unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.4 of FGE.19 with two or more conjugated double-bonds and with or without additional non-conjugated double-bonds. EFSA Journal 2018;16(7):5322.

15

(16)  Scientific Opinion on Flavouring Group Evaluation 70, Revision 1 (FGE.70Rev1): consideration of aliphatic, linear, α,β-unsaturated, di- and trienals and related alcohols, acids and esters evaluated by JECFA (61st-68th-69th meeting). EFSA Journal 2019;17(7):5749.

16

(17)  Scientific Opinion on Flavouring Group Evaluation 5, Revision 3 (FGE.05Rev3): Branched- and straight-chain unsaturated aldehydes, dienals, unsaturated and saturated carboxylic acids and related esters with saturated and unsaturated aliphatic alcohols and a phenylacetic acid related ester from chemical groups 1, 2, 3, 5 and 15. EFSA Journal 2019;17(8):5761

17

---

ANNEX

Part A, Section 2, Table 1, of Annex I to Regulation (EC) No 1334/2008 is amended as follows:

| (a) | the entry concerning FL No 02.060 is replaced by the following:













  ‘02.060 | p-Mentha-1,8-dien-7-ol | 536-59-4 | 974 | 2024 | | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(a)

the entry concerning FL No 02.060 is replaced by the following:

‘02.060

p-Mentha-1,8-dien-7-ol

536-59-4

974

2024

EFSA’

| (b) | the entry concerning FL No 02.091 is replaced by the following:













  ‘02.091 | Myrtenol | 515-00-4 | 981 | 10285 | | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(b)

the entry concerning FL No 02.091 is replaced by the following:

‘02.091

Myrtenol

515-00-4

981

10285

EFSA’

| (c) | the entry concerning FL No 02.139 is replaced by the following:













  ‘02.139 | Deca-(2E,4E)-dien-1-ol | 18409-21-7 | 1189 | 11748 | | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(c)

the entry concerning FL No 02.139 is replaced by the following:

‘02.139

Deca-(2E,4E)-dien-1-ol

18409-21-7

1189

11748

EFSA’

| (d) | the entry concerning FL No 02.153 is replaced by the following:













  ‘02.153 | Hepta-2,4-dien-1-ol | 33467-79-7 | 1784 | | | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(d)

the entry concerning FL No 02.153 is replaced by the following:

‘02.153

Hepta-2,4-dien-1-ol

33467-79-7

1784

EFSA’

| (e) | the entry concerning FL No 02.162 is replaced by the following:













  ‘02.162 | Hexa-2,4-dien-1-ol | 111-28-4 | 1174 | | | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(e)

the entry concerning FL No 02.162 is replaced by the following:

‘02.162

Hexa-2,4-dien-1-ol

111-28-4

1174

EFSA’

| (f) | the entry concerning FL No 02.188 is replaced by the following:













  ‘02.188 | Nona-2,4-dien-1-ol | 62488-56-6 | 1183 | 11802 | At least 92 %; secondary component 3-4 % 2-nonen-1-ol | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(f)

the entry concerning FL No 02.188 is replaced by the following:

‘02.188

Nona-2,4-dien-1-ol

62488-56-6

1183

11802

At least 92 %; secondary component 3-4 % 2-nonen-1-ol

EFSA’

| (g) | the entry concerning FL No 05.057 is replaced by the following:













  ‘05.057 | Hexa-2(trans),4(trans)-dienal | 142-83-6 | 1175 | 640 | | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(g)

the entry concerning FL No 05.057 is replaced by the following:

‘05.057

Hexa-2(trans),4(trans)-dienal

142-83-6

1175

640

EFSA’

| (h) | the entry concerning FL No 05.064 is replaced by the following:













  ‘05.064 | Trideca-2(trans),4(cis),7(cis)-trienal | 13552-96-0 | 1198 | 685 | At least 71 %; secondary components 14 % 4-cis-7-cis-tridecadienol; 6 % 3-cis-7-cis- tridecadienol; 5 % 2-trans-7-cis-tridecadienal; 3 % 2-trans-4-trans-7-cis-tridecatrienal | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(h)

the entry concerning FL No 05.064 is replaced by the following:

‘05.064

Trideca-2(trans),4(cis),7(cis)-trienal

13552-96-0

1198

685

At least 71 %; secondary components 14 % 4-cis-7-cis-tridecadienol; 6 % 3-cis-7-cis- tridecadienol; 5 % 2-trans-7-cis-tridecadienal; 3 % 2-trans-4-trans-7-cis-tridecatrienal

EFSA’

| (i) | the entry concerning FL No 05.071 is replaced by the following:













  ‘05.071 | Nona-2,4-dienal | 6750-03-4 | 1185 | 732 | At least 89 %; secondary components 5-6 % 2,4-nonadien-1-ol and 1-2 % 2-nonen-1-ol | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(i)

the entry concerning FL No 05.071 is replaced by the following:

‘05.071

Nona-2,4-dienal

6750-03-4

1185

732

At least 89 %; secondary components 5-6 % 2,4-nonadien-1-ol and 1-2 % 2-nonen-1-ol

EFSA’

| (j) | the entry concerning FL No 05.081 is replaced by the following:













  ‘05.081 | 2,4-Decadienal | 2363-88-4 | 3135 | 2120 | At least 89 %; secondary components: mixture of the (cis, cis)-; (cis, trans)- and (trans, cis)-2,4-decadienals (sum of all isomers 95 %); acetone and isopropanol | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(j)

the entry concerning FL No 05.081 is replaced by the following:

‘05.081

2,4-Decadienal

2363-88-4

3135

2120

At least 89 %; secondary components: mixture of the (cis, cis)-; (cis, trans)- and (trans, cis)-2,4-decadienals (sum of all isomers 95 %); acetone and isopropanol

EFSA’

| (k) | the entry concerning FL No 05.084 is replaced by the following:













  ‘05.084 | Hepta-(2E,4E)-dienal | 4313-03-5 | 1179 | 729 | At least 92 %; secondary components 2-4 % (E,Z)-2,4-heptadienal and 2-4 % 2,4-heptadienoic acid | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(k)

the entry concerning FL No 05.084 is replaced by the following:

‘05.084

Hepta-(2E,4E)-dienal

4313-03-5

1179

729

At least 92 %; secondary components 2-4 % (E,Z)-2,4-heptadienal and 2-4 % 2,4-heptadienoic acid

EFSA’

| (l) | the entry concerning FL No 05.101 is replaced by the following:













  ‘05.101 | Penta-2,4-dienal | 764-40-9 | 1173 | 11695 | | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(l)

the entry concerning FL No 05.101 is replaced by the following:

‘05.101

Penta-2,4-dienal

764-40-9

1173

11695

EFSA’

| (m) | the entry concerning FL No 05.106 is replaced by the following:













  ‘05.106 | Myrtenal | 564-94-3 | 980 | 10379 | | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(m)

the entry concerning FL No 05.106 is replaced by the following:

‘05.106

Myrtenal

564-94-3

980

10379

EFSA’

| (n) | the entry concerning FL No 05.108 is replaced by the following:













  ‘05.108 | Undeca-2,4-dienal | 13162-46-4 | 1195 | 10385 | | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(n)

the entry concerning FL No 05.108 is replaced by the following:

‘05.108

Undeca-2,4-dienal

13162-46-4

1195

10385

EFSA’

| (o) | the entry concerning FL No 05.125 is replaced by the following:













  ‘05.125 | Dodeca-(2E,4E)-dienal | 21662-16-8 | 1196 | 11758 | At least 85 %; secondary component 11- 12 % 2-trans-4-cis isomer | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(o)

the entry concerning FL No 05.125 is replaced by the following:

‘05.125

Dodeca-(2E,4E)-dienal

21662-16-8

1196

11758

At least 85 %; secondary component 11- 12 % 2-trans-4-cis isomer

EFSA’

| (p) | the entry concerning FL No 05.127 is replaced by the following:













  ‘05.127 | Octa-2(trans),4(trans)-dienal | 30361-28-5 | 1181 | 11805 | | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(p)

the entry concerning FL No 05.127 is replaced by the following:

‘05.127

Octa-2(trans),4(trans)-dienal

30361-28-5

1181

11805

EFSA’

| (q) | the entry concerning FL No 05.140 is replaced by the following:













  ‘05.140 | Deca-2(trans),4(trans)-dienal | 25152-84-5 | 1190 | 2120 | At least 90 % minimum of the (E, E)-isomer; 95 % (sum of isomers) | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(q)

the entry concerning FL No 05.140 is replaced by the following:

‘05.140

Deca-2(trans),4(trans)-dienal

25152-84-5

1190

2120

At least 90 % minimum of the (E, E)-isomer; 95 % (sum of isomers)

EFSA’

| (r) | the entry concerning FL No 05.141 is replaced by the following:













  ‘05.141 | Deca-2,4,7-trienal | 51325-37-2 | 1786 | | | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(r)

the entry concerning FL No 05.141 is replaced by the following:

‘05.141

Deca-2,4,7-trienal

51325-37-2

1786

EFSA’

| (s) | the entry concerning FL No 05.173 is replaced by the following:













  ‘05.173 | Nona-(2E,4E,6E)-trienal | 57018-53-8 | 1785 | | | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(s)

the entry concerning FL No 05.173 is replaced by the following:

‘05.173

Nona-(2E,4E,6E)-trienal

57018-53-8

1785

EFSA’

| (t) | the entry concerning FL No 05.186 is replaced by the following:













  ‘05.186 | 2,4-Octadienal | 5577-44-6 | | 11805 | At least 85 % E,E with 10 % E, Z | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(t)

the entry concerning FL No 05.186 is replaced by the following:

‘05.186

2,4-Octadienal

5577-44-6

11805

At least 85 % E,E with 10 % E, Z

EFSA’

| (u) | the entry concerning FL No 05.194 is replaced by the following:













  ‘05.194 | (2E, 4E)-nona-2,4-dienal | 5910-87-2 | | 732 | At least 89 %; secondary components at least 5 % 2,4-nonadien-1-ol and 2-nonen-1- ol and other isomers of 2,4-nonadienal | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(u)

the entry concerning FL No 05.194 is replaced by the following:

‘05.194

(2E, 4E)-nona-2,4-dienal

5910-87-2

732

At least 89 %; secondary components at least 5 % 2,4-nonadien-1-ol and 2-nonen-1- ol and other isomers of 2,4-nonadienal

EFSA’

| (v) | the entry concerning FL No 05.196 is replaced by the following:













  ‘05.196 | (2E, 4E)-undeca-2,4-dienal | | | | | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(v)

the entry concerning FL No 05.196 is replaced by the following:

‘05.196

(2E, 4E)-undeca-2,4-dienal

EFSA’

| (w) | the entry concerning FL No 09.278 is replaced by the following:













  ‘09.278 | p-Mentha-1,8-dien-7-yl acetate | 15111-96-3 | 975 | 10742 | | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(w)

the entry concerning FL No 09.278 is replaced by the following:

‘09.278

p-Mentha-1,8-dien-7-yl acetate

15111-96-3

975

10742

EFSA’

| (x) | the entry concerning FL No 09.302 is replaced by the following:













  ‘09.302 | Myrtenyl acetate | 35670-93-0 | 982 | 10887 | | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(x)

the entry concerning FL No 09.302 is replaced by the following:

‘09.302

Myrtenyl acetate

35670-93-0

982

10887

EFSA’

| (y) | the entry concerning FL No 09.573 is replaced by the following:













  ‘09.573 | Hexa-2,4-dienyl acetate | 1516-17-2 | 1780 | 10675 | | | | EFSA’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(y)

the entry concerning FL No 09.573 is replaced by the following:

‘09.573

Hexa-2,4-dienyl acetate

1516-17-2

1780

10675

EFSA’

---

| 6.9.2022 | EN | Official Journal of the European Union | L 231/32 |
| --- | --- | --- | --- |

6.9.2022

EN

Official Journal of the European Union

L 231/32

---

COMMISSION REGULATION (EU) 2022/1466

of 5 September 2022

amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the removal of certain flavouring substances from the Union list

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13 (1), and in particular Article 11(3) thereof,

Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (2), and in particular Article 7(4) thereof,

Whereas:

| (1) | Annex I to Regulation (EC) No 1334/2008 lays down a Union list of flavourings and source materials approved for use in and on foods and their conditions of use. |
| --- | --- |

(1)

Annex I to Regulation (EC) No 1334/2008 lays down a Union list of flavourings and source materials approved for use in and on foods and their conditions of use.

| (2) | By Commission Implementing Regulation (EU) No 872/2012 (3) the list of flavouring substances was adopted and introduced in Part A of Annex I to Regulation (EC) No 1334/2008. |
| --- | --- |

(2)

By Commission Implementing Regulation (EU) No 872/2012 (3) the list of flavouring substances was adopted and introduced in Part A of Annex I to Regulation (EC) No 1334/2008.

| (3) | That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application submitted by a Member State or by an interested party. |
| --- | --- |

(3)

That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application submitted by a Member State or by an interested party.

| (4) | The Union list of flavourings and source materials laid down in Annex I to Regulation (EC) No 1334/2008 contains, among others, a number of flavouring substances for which, at the time of adoption of the list by Regulation (EU) No 872/2012, the European Food Safety Authority (‘the Authority’) had not been able to rule out a safety risk to the health of the consumer on the basis of the data available and had, therefore, considered that additional data was necessary to complete their evaluation. Those substances were included in the Union list of flavouring substances but on the condition that safety data addressing the concerns expressed by the Authority was submitted before the expiry of specific deadlines established in Part A of Annex I to Regulation (EC) No 1334/2008. However, the operators responsible for placing the following substances on the market as flavouring substances did not submit the required data and withdrew their respective applications: 1-(4-Methoxyphenyl)pent-1-en-3-one (FL No 07.030); Vanillylidene acetone (FL No 07.046); 1-(4-Methoxyphenyl)-4-methylpent-1-en-3-one (FL No 07.049); 4-(2,3,6-Trimethylphenyl)but-3-en-2-one (FL No 07.206); 6-Methyl-3-hepten-2-one (FL No 07.258); 5,6-Dihydro-3,6-dimethyl-benzofuran-2(4H)-one (FL No 10.034); 5,6,7,7a-Tetrahydro-3,6-dimethylbenzofuran-2(4H)-one (FL No 10.036); 3,4-Dimethyl-5-pentylidene-furan-2(5H)-one (FL No 10.042); 2,7-Dimethylocta-5(trans),7-dieno-1,4-lactone (FL No 10.043); Hex-2-eno-1,4-lactone (FL No 10.046); Non-2-eno-1,4-lactone (FL No 10.054); 2-Decen-1,4-lactone (FL No 10.060); 5-Pentyl-3H-furan-2-one (FL No 10.170); Allyl 2-furoate (FL No 13.004); 3-(2-furyl)acrylaldehyde (FL No 13.034); Furfurylidene-2-butanal (FL No 13.043); 4-(2-Furyl)but-3-en-2-one (FL No 13.044); 3-(2-Furyl)-2-methylprop-2-enal (FL No 13.046); 3-Acetyl-2,5-dimethylfuran (FL No 13.066); 2-Butylfuran (FL No 13.103), 3-(2-Furyl)-2-phenylprop-2-enal (FL No 13.137) and 3-(5-Methyl-2-furyl)prop-2-enal (FL No 13.150). |
| --- | --- |

(4)

The Union list of flavourings and source materials laid down in Annex I to Regulation (EC) No 1334/2008 contains, among others, a number of flavouring substances for which, at the time of adoption of the list by Regulation (EU) No 872/2012, the European Food Safety Authority (‘the Authority’) had not been able to rule out a safety risk to the health of the consumer on the basis of the data available and had, therefore, considered that additional data was necessary to complete their evaluation. Those substances were included in the Union list of flavouring substances but on the condition that safety data addressing the concerns expressed by the Authority was submitted before the expiry of specific deadlines established in Part A of Annex I to Regulation (EC) No 1334/2008. However, the operators responsible for placing the following substances on the market as flavouring substances did not submit the required data and withdrew their respective applications: 1-(4-Methoxyphenyl)pent-1-en-3-one (FL No 07.030); Vanillylidene acetone (FL No 07.046); 1-(4-Methoxyphenyl)-4-methylpent-1-en-3-one (FL No 07.049); 4-(2,3,6-Trimethylphenyl)but-3-en-2-one (FL No 07.206); 6-Methyl-3-hepten-2-one (FL No 07.258); 5,6-Dihydro-3,6-dimethyl-benzofuran-2(4H)-one (FL No 10.034); 5,6,7,7a-Tetrahydro-3,6-dimethylbenzofuran-2(4H)-one (FL No 10.036); 3,4-Dimethyl-5-pentylidene-furan-2(5H)-one (FL No 10.042); 2,7-Dimethylocta-5(trans),7-dieno-1,4-lactone (FL No 10.043); Hex-2-eno-1,4-lactone (FL No 10.046); Non-2-eno-1,4-lactone (FL No 10.054); 2-Decen-1,4-lactone (FL No 10.060); 5-Pentyl-3H-furan-2-one (FL No 10.170); Allyl 2-furoate (FL No 13.004); 3-(2-furyl)acrylaldehyde (FL No 13.034); Furfurylidene-2-butanal (FL No 13.043); 4-(2-Furyl)but-3-en-2-one (FL No 13.044); 3-(2-Furyl)-2-methylprop-2-enal (FL No 13.046); 3-Acetyl-2,5-dimethylfuran (FL No 13.066); 2-Butylfuran (FL No 13.103), 3-(2-Furyl)-2-phenylprop-2-enal (FL No 13.137) and 3-(5-Methyl-2-furyl)prop-2-enal (FL No 13.150).

| (5) | Those substances should therefore be removed from the Union list of flavouring substances. |
| --- | --- |

(5)

Those substances should therefore be removed from the Union list of flavouring substances.

| (6) | Regulation (EC) No 1334/2008 should therefore be amended accordingly. |
| --- | --- |

(6)

Regulation (EC) No 1334/2008 should therefore be amended accordingly.

| (7) | Foods to which any of the substances concerned have been added and which have been placed on the market in the Union or which have been dispatched from third countries and were in transit to the Union before the entry into force of this Regulation should be allowed to be marketed in the Union until their date of minimum durability or use-by date. This transitional measure should not apply to preparations to which any of the substances concerned has been added and which are not intended to be consumed as such, as the manufacturers of food products that use those preparations as ingredients, know their composition when they use them. |
| --- | --- |

(7)

Foods to which any of the substances concerned have been added and which have been placed on the market in the Union or which have been dispatched from third countries and were in transit to the Union before the entry into force of this Regulation should be allowed to be marketed in the Union until their date of minimum durability or use-by date. This transitional measure should not apply to preparations to which any of the substances concerned has been added and which are not intended to be consumed as such, as the manufacturers of food products that use those preparations as ingredients, know their composition when they use them.

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Amendments to Regulation (EC) No 1334/2008

Annex I to Regulation (EC) No 1334/2008 is amended in accordance with the Annex to this Regulation.

Article 2

Transitional measures

1.   Foods to which any of the flavouring substances listed in the Annex to this Regulation has been added and which were lawfully placed on the market before the entry into force of this Regulation may continue to be marketed until their date of minimum durability or use-by date.

2.   Foods imported into the Union to which any of the flavouring substances listed in the Annex to this Regulation has been added may be marketed until their date of minimum durability or use-by date, if the importer of such food can demonstrate that they were dispatched from the third country concerned and were in transit to the Union before the entry into force of this Regulation.

3.   The transitional measures provided for in paragraphs 1 and 2 shall not apply to preparations, not intended to be consumed as such, to which any of the flavouring substances listed in the Annex to this Regulation has been added.

4.   For the purposes of this Regulation, preparations shall be understood as mixtures of one or more flavourings to which other food ingredients such as food additives, enzymes or carriers may be also incorporated to facilitate their storage, sale, standardisation, dilution or dissolution.

Article 3

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.

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

Done at Brussels, 5 September 2022.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 354, 31.12.2008, p. 34.

1

(2)  OJ L 354, 31.12.2008, p. 1.

2

(3)  Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No 1565/2000 and Commission Decision 1999/217/EC (OJ L 267, 2.10.2012, p. 1).

3

---

ANNEX

In Part A of Annex I to Regulation (EC) No 1334/2008, the following entries are deleted:

| ‘07.030 | 1-(4-Methoxyphenyl)pent-1-en-3-one | 104-27-8 | 826 | 164 | | | 2 | EFSA |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 07.046 | Vanillylidene acetone | 1080-12-2 | 732 | 691 | | | 2 | EFSA |
| 07.049 | 1-(4-Methoxyphenyl)-4-methylpent-1-en-3-one | 103-13-9 | 829 | 719 | | | 2 | EFSA |
| 07.206 | 4-(2,3,6-Trimethylphenyl)but-3-en-2-one | 56681-06-2 | | | | | 2 | EFSA |
| 07.258 | 6-Methyl-3-hepten-2-one | 2009-74-7 | | | | | 1 | EFSA |
| 10.034 | 5,6-Dihydro-3,6-dimethyl-benzofuran-2(4H)-one | 80417-97-6 | 1163 | | | | 2 | EFSA |
| 10.036 | 5,6,7,7a-Tetrahydro-3,6-dimethylbenzofuran-2(4H)-one | 13341-72-5 | 1162 | | | | 2 | EFSA |
| 10.042 | 3,4-Dimethyl-5-pentylidene-furan-2(5H)-one | 774-64-1 | | 11873 | At least 93 %; secondary component 1-2 % 3,4-dimethyl 5-ketobutanoic acid gamma-lactone | | 2 | EFSA |
| 10.043 | 2,7-Dimethylocta-5(trans),7-dieno-1,4-lactone | 78548-56-8 | | | | | 2 | EFSA |
| 10.046 | Hex-2-eno-1,4-lactone | 2407-43-4 | | | | | 2 | EFSA |
| 10.054 | Non-2-eno-1,4-lactone | 21963-26-8 | | | | | 2 | EFSA |
| 10.060 | 2-Decen-1,4-lactone | 2518-53-8 | | | | | 2 | EFSA |
| 10.170 | 5-Pentyl-3H-furan-2-one | 51352-68-2 | 1989 | | Mixture of 3H- and 5H-isomers (2:1) | | 2 | EFSA |
| 13.004 | Allyl 2-furoate | 4208-49-5 | 21 | 360 | | | 2 | EFSA |
| 13.034 | 3-(2-furyl)acrylaldehyde | 623-30-3 | 1497 | | | | 1 | EFSA |
| 13.043 | Furfurylidene-2-butanal | 770-27-4 | 1501 | 11885 | | | 1 | EFSA |
| 13.044 | 4-(2-Furyl)but-3-en-2-one | 623-15-4 | 1511 | 11838 | | | 1 | EFSA |
| 13.046 | 3-(2-Furyl)-2-methylprop-2- enal | 874-66-8 | 1498 | 11878 | | | 1 | EFSA |
| 13.066 | 3-Acetyl-2,5-dimethylfuran | 10599-70-9 | 1506 | 10921 | | | 4 | EFSA |
| 13.103 | 2-Butylfuran | 4466-24-4 | 1490 | 10927 | | | 3 | EFSA |
| 13.137 | 3-(2-F uryl)-2-phenylprop-2- enal | 65545-81-5 | 1502 | 11928 | | | 1 | EFSA |
| 13.150 | 3-(5-Methyl-2-furyl)prop-2-enal | 5555-90-8 | 1499 | | | | 1 | EFSA’ |

‘07.030

1-(4-Methoxyphenyl)pent-1-en-3-one

104-27-8

826

164

2

EFSA

07.046

Vanillylidene acetone

1080-12-2

732

691

2

EFSA

07.049

1-(4-Methoxyphenyl)-4-methylpent-1-en-3-one

103-13-9

829

719

2

EFSA

07.206

4-(2,3,6-Trimethylphenyl)but-3-en-2-one

56681-06-2

2

EFSA

07.258

6-Methyl-3-hepten-2-one

2009-74-7

1

EFSA

10.034

5,6-Dihydro-3,6-dimethyl-benzofuran-2(4H)-one

80417-97-6

1163

2

EFSA

10.036

5,6,7,7a-Tetrahydro-3,6-dimethylbenzofuran-2(4H)-one

13341-72-5

1162

2

EFSA

10.042

3,4-Dimethyl-5-pentylidene-furan-2(5H)-one

774-64-1

11873

At least 93 %; secondary component 1-2 % 3,4-dimethyl 5-ketobutanoic acid gamma-lactone

2

EFSA

10.043

2,7-Dimethylocta-5(trans),7-dieno-1,4-lactone

78548-56-8

2

EFSA

10.046

Hex-2-eno-1,4-lactone

2407-43-4

2

EFSA

10.054

Non-2-eno-1,4-lactone

21963-26-8

2

EFSA

10.060

2-Decen-1,4-lactone

2518-53-8

2

EFSA

10.170

5-Pentyl-3H-furan-2-one

51352-68-2

1989

Mixture of 3H- and 5H-isomers (2:1)

2

EFSA

13.004

Allyl 2-furoate

4208-49-5

21

360

2

EFSA

13.034

3-(2-furyl)acrylaldehyde

623-30-3

1497

1

EFSA

13.043

Furfurylidene-2-butanal

770-27-4

1501

11885

1

EFSA

13.044

4-(2-Furyl)but-3-en-2-one

623-15-4

1511

11838

1

EFSA

13.046

3-(2-Furyl)-2-methylprop-2- enal

874-66-8

1498

11878

1

EFSA

13.066

3-Acetyl-2,5-dimethylfuran

10599-70-9

1506

10921

4

EFSA

13.103

2-Butylfuran

4466-24-4

1490

10927

3

EFSA

13.137

3-(2-F uryl)-2-phenylprop-2- enal

65545-81-5

1502

11928

1

EFSA

13.150

3-(5-Methyl-2-furyl)prop-2-enal

5555-90-8

1499

1

EFSA’

---

| 6.9.2022 | EN | Official Journal of the European Union | L 231/36 |
| --- | --- | --- | --- |

6.9.2022

EN

Official Journal of the European Union

L 231/36

---

COMMISSION IMPLEMENTING REGULATION (EU) 2022/1467

of 5 September 2022

amending Implementing Regulation (EU) 2015/2378 as regards the standard forms and computerised formats to be used in relation to Council Directive 2011/16/EU and the list of statistical data to be provided by Member States for the purposes of evaluating that Directive

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Directive 2011/16/EU of 15 February 2011 on administrative cooperation in the field of taxation and repealing Directive 77/779/EEC (1) and in particular Article 20(4) thereof,

Whereas:

| (1) | Directive 2011/16/EU was amended by Directive (EU) 2021/514 (2) in order to improve the provisions that relate to all forms of exchanges of information and administrative cooperation by providing for a mandatory automatic exchange of information reported by Platform Operators. |
| --- | --- |

(1)

Directive 2011/16/EU was amended by Directive (EU) 2021/514 (2) in order to improve the provisions that relate to all forms of exchanges of information and administrative cooperation by providing for a mandatory automatic exchange of information reported by Platform Operators.

| (2) | Commission Implementing Regulation (EU) 2015/2378 (3) should therefore be adapted to those amendments. The automatic exchange of information pursuant to Article 8ac(2) of Directive 2011/16/EU should be carried out using a standard computerised format. |
| --- | --- |

(2)

Commission Implementing Regulation (EU) 2015/2378 (3) should therefore be adapted to those amendments. The automatic exchange of information pursuant to Article 8ac(2) of Directive 2011/16/EU should be carried out using a standard computerised format.

| (3) | In accordance with Directive 2011/16/EU, it is also necessary to lay down the practical arrangements for the registration and identification of certain Reporting Platform Operators pursuant to Article 8ac(4). |
| --- | --- |

(3)

In accordance with Directive 2011/16/EU, it is also necessary to lay down the practical arrangements for the registration and identification of certain Reporting Platform Operators pursuant to Article 8ac(4).

| (4) | Pursuant to Article 8ac(6) of Directive 2011/16/EU, a central register should be established in order to record information that has to be notified in accordance with Article 8ac(5) and communicated in accordance with subparagraph F(2) and F(4) of Section IV of Annex V. That central register should be made available to the competent authorities of Member States. A standard form should be used for the communication and recording of such information. |
| --- | --- |

(4)

Pursuant to Article 8ac(6) of Directive 2011/16/EU, a central register should be established in order to record information that has to be notified in accordance with Article 8ac(5) and communicated in accordance with subparagraph F(2) and F(4) of Section IV of Annex V. That central register should be made available to the competent authorities of Member States. A standard form should be used for the communication and recording of such information.

| (5) | Article 23(4) of Directive 2011/16/EU provides for a list of statistical data to be provided by Member States for the purposes of its evaluation. For reasons of coherence and legal certainty, the date of application of this Regulation should be aligned with the date of application provided for in Article 2(1), second subparagraph, of Directive (EU) 2021/514. |
| --- | --- |

(5)

Article 23(4) of Directive 2011/16/EU provides for a list of statistical data to be provided by Member States for the purposes of its evaluation. For reasons of coherence and legal certainty, the date of application of this Regulation should be aligned with the date of application provided for in Article 2(1), second subparagraph, of Directive (EU) 2021/514.

| (6) | The European Data Protection Supervisor was consulted on the measures provided for in the Regulation in accordance with Article 42(1) of Regulation (EU) 2018/1725 of the European Parliament and of the Council (4). |
| --- | --- |

(6)

The European Data Protection Supervisor was consulted on the measures provided for in the Regulation in accordance with Article 42(1) of Regulation (EU) 2018/1725 of the European Parliament and of the Council (4).

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Committee on Administrative Cooperation for Taxation, |
| --- | --- |

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Committee on Administrative Cooperation for Taxation,

HAS ADOPTED THIS REGULATION:

Article 1

Implementing Regulation (EU) 2015/2378 is amended as follows:

| (1) | in Article 2, the following paragraph 3 is added:

  ‘3.   The computerised format to be used for the mandatory automatic exchange of information pursuant to Article 8ac(2) of Directive 2011/16/EU shall comply with Annex XIV to this Regulation.’; |
| --- | --- |

(1)

in Article 2, the following paragraph 3 is added:

‘3.   The computerised format to be used for the mandatory automatic exchange of information pursuant to Article 8ac(2) of Directive 2011/16/EU shall comply with Annex XIV to this Regulation.’;

| (2) | in Article 2d(1), the following paragraph is added:
  ‘The list of statistical data required for the mandatory automatic exchange of information pursuant to Article 8ac of Directive 2011/16/EU is set out in Annex XV to this Regulation.’; |
| --- | --- |

(2)

in Article 2d(1), the following paragraph is added:

‘The list of statistical data required for the mandatory automatic exchange of information pursuant to Article 8ac of Directive 2011/16/EU is set out in Annex XV to this Regulation.’;

| (3) | the following Article 2f is added:

  ‘Article 2f
  Standard forms, for the communication of information on Excluded Platform Operators and Foreign Platform Operators to the central register, format of the individual identification number for Foreign Platform Operators and the retention period for information deleted from the central register

  1.   The form to be used for the communication of information on Excluded Platform Operators and Foreign Platform Operators to the central register pursuant to Article 8ac(6) of Directive 2011/16/EU shall comply with Annex XVI to this Regulation.


  2.   The key elements to be recorded in the central register, as provided for by Article 8ac(6) of Directive 2011/16/EU shall be the information listed in subparagraph F(2) and F(4) of Section IV of Annex V to that Directive and Annex XVI to this Regulation. The establishment of the central register and the processing of personal data carried out within the central register by the Commission on behalf of the competent authorities of Member States will comply with Regulation (EU) 2016/679 of the European Parliament and of the Council (*1) and Regulation (EU) 2018/1725 of the European Parliament and of the Council (*2). The competent authorities of Member States shall be considered to be data controllers and the Commission shall be considered to be a data processor in accordance with Regulation (EU) 2016/679.


  3.   The format of the individual identification number for Foreign Platform Operators within the meaning of Article 8ac(4) of Directive 2011/16/EU is set out in Annex XVI to this Regulation.


  4.   The retention period for information deleted from the central register, pursuant to Annex V, Section IV, subparagraph F(5), point (d), and Article 8ac(5) of Directive 2011/16/EU are set out in Annex XVI to this Regulation.



  (*1)  Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1)."


  (*2)  Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).’;" |
| --- | --- |

(3)

the following Article 2f is added:

‘Article 2f

Standard forms, for the communication of information on Excluded Platform Operators and Foreign Platform Operators to the central register, format of the individual identification number for Foreign Platform Operators and the retention period for information deleted from the central register

1.   The form to be used for the communication of information on Excluded Platform Operators and Foreign Platform Operators to the central register pursuant to Article 8ac(6) of Directive 2011/16/EU shall comply with Annex XVI to this Regulation.

2.   The key elements to be recorded in the central register, as provided for by Article 8ac(6) of Directive 2011/16/EU shall be the information listed in subparagraph F(2) and F(4) of Section IV of Annex V to that Directive and Annex XVI to this Regulation. The establishment of the central register and the processing of personal data carried out within the central register by the Commission on behalf of the competent authorities of Member States will comply with Regulation (EU) 2016/679 of the European Parliament and of the Council (*1) and Regulation (EU) 2018/1725 of the European Parliament and of the Council (*2). The competent authorities of Member States shall be considered to be data controllers and the Commission shall be considered to be a data processor in accordance with Regulation (EU) 2016/679.

3.   The format of the individual identification number for Foreign Platform Operators within the meaning of Article 8ac(4) of Directive 2011/16/EU is set out in Annex XVI to this Regulation.

4.   The retention period for information deleted from the central register, pursuant to Annex V, Section IV, subparagraph F(5), point (d), and Article 8ac(5) of Directive 2011/16/EU are set out in Annex XVI to this Regulation.

(*1)  Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1)."

*1

(*2)  Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).’;"

*2

| (4) | Annexes I, IX and X are replaced by the text in Annex I to this Regulation; |
| --- | --- |

(4)

Annexes I, IX and X are replaced by the text in Annex I to this Regulation;

| (5) | Annex V is amended in Annex II to this Regulation; |
| --- | --- |

(5)

Annex V is amended in Annex II to this Regulation;

| (6) | Annexes XIV, XV and XVI as set out in Annex III to this Regulation are added. |
| --- | --- |

(6)

Annexes XIV, XV and XVI as set out in Annex III to this Regulation are added.

Article 2

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

It shall apply from 1 January 2023.

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

Done at Brussels, 5 September 2022.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 64, 11.3.2011, p. 1.

1

(2)  Council Directive (EU) 2021/514 of 22 March 2021 amending Directive 2011/16/EU on administrative cooperation in the field of taxation (OJ L 104, 25.3.2021, p. 1).

2

(3)  Commission Implementing Regulation (EU) 2015/2378 of 15 December 2015 laying down detailed rules for implementing certain provisions of Council Directive 2011/16/EU on administrative cooperation in the field of taxation and repealing Implementing Regulation (EU) No 1156/2012 (OJ L 332, 18.12.2015, p. 1).

3

(4)  Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).

4

---

ANNEX I

Annexes I, IX and X are replaced by the following:

‘ANNEX I

Form referred to in Article 1(2)

The form for requests for information and for administrative enquiries, pursuant to Article 5 and Article 5a of Directive 2011/16/EU, and their replies, acknowledgments, requests for additional background information, inability or refusal, pursuant to Article 7 of Directive 2011/16/EU, contains the following fields (1):

| — | Legal basis |
| --- | --- |

—

Legal basis

| — | Reference number |
| --- | --- |

—

Reference number

| — | Date |
| --- | --- |

—

Date

| — | Identity of the requesting and requested authorities |
| --- | --- |

—

Identity of the requesting and requested authorities

| — | Identity of the person under examination or investigation |
| --- | --- |

—

Identity of the person under examination or investigation

| — | General case description and, if appropriate, specific background information likely to allow assessing the foreseeable relevance of the information requested to the administration and enforcement of the domestic laws of Member States concerning the taxes referred to in Article 2 of Directive 2011/16/EU. |
| --- | --- |

—

General case description and, if appropriate, specific background information likely to allow assessing the foreseeable relevance of the information requested to the administration and enforcement of the domestic laws of Member States concerning the taxes referred to in Article 2 of Directive 2011/16/EU.

| — | Tax purpose for which the information is sought |
| --- | --- |

—

Tax purpose for which the information is sought

| — | Period under investigation |
| --- | --- |

—

Period under investigation

| — | Name and address of any person believed to be in possession of the requested information |
| --- | --- |

—

Name and address of any person believed to be in possession of the requested information

| — | Fulfilment of the legal requirement set out in Article 16(1) of Directive 2011/16/EU |
| --- | --- |

—

Fulfilment of the legal requirement set out in Article 16(1) of Directive 2011/16/EU

| — | Fulfilment of the legal requirement set out in Article 17(1) of Directive 2011/16/EU |
| --- | --- |

—

Fulfilment of the legal requirement set out in Article 17(1) of Directive 2011/16/EU

| — | Reasoned request for an administrative enquiry and reasons for refusal to undertake the requested administrative enquiry |
| --- | --- |

—

Reasoned request for an administrative enquiry and reasons for refusal to undertake the requested administrative enquiry

| — | Acknowledgement of the request for information |
| --- | --- |

—

Acknowledgement of the request for information

| — | Request for additional background information |
| --- | --- |

—

Request for additional background information

| — | Reasons for inability or refusal to provide information |
| --- | --- |

—

Reasons for inability or refusal to provide information

| — | Reasons for a failure to respond by the relevant time limit and date by which the requested authority considers it might be able to respond |
| --- | --- |

—

Reasons for a failure to respond by the relevant time limit and date by which the requested authority considers it might be able to respond

| — | A detailed description of the group. |
| --- | --- |

—

A detailed description of the group.

‘ANNEX IX

List referred to in Article 2d

The statistical data required for the forms of administrative cooperation other than the mandatory automatic exchange of information referred to in Article 23(4) of Directive 2011/16/EU covers the following information:

| — | Identification of the Member State |
| --- | --- |

—

Identification of the Member State

| — | Year |
| --- | --- |

—

Year

| — | Part A: Statistics per Member State on exchange of information






  — | on exchange of information on request (Article 5, 6, 7 of Directive 2011/16/EU)






  — | Number of requests sent |
| --- | --- | --- | --- |

—

Part A: Statistics per Member State on exchange of information

—

on exchange of information on request (Article 5, 6, 7 of Directive 2011/16/EU)

—

Number of requests sent

| — | Number of replies received |
| --- | --- |

—

Number of replies received

| — | Number of full replies received within the legal deadline |
| --- | --- |

—

Number of full replies received within the legal deadline

| — | Number of replies for which (part of or the whole) information was received within two months |
| --- | --- |

—

Number of replies for which (part of or the whole) information was received within two months

| — | Number of requests received |
| --- | --- |

—

Number of requests received

| — | Number of replies sent |
| --- | --- |

—

Number of replies sent

| — | Number of refusals on the ground of Article 17 of Directive 2011/16/EU |
| --- | --- |

—

Number of refusals on the ground of Article 17 of Directive 2011/16/EU

| — | on exchange of information on group request (Article 5a of Directive 2011/16/EU)






  — | Number of group requests sent |
| --- | --- | --- |

—

on exchange of information on group request (Article 5a of Directive 2011/16/EU)

—

Number of group requests sent

| — | Number of group replies received |
| --- | --- |

—

Number of group replies received

| — | Number of full group replies received within the legal deadline |
| --- | --- |

—

Number of full group replies received within the legal deadline

| — | Number of group replies for which (part of or the whole) information was received within two months |
| --- | --- |

—

Number of group replies for which (part of or the whole) information was received within two months

| — | Number of group requests received |
| --- | --- |

—

Number of group requests received

| — | Number of group replies sent |
| --- | --- |

—

Number of group replies sent

| — | Number of group refusals on the ground of Article 17 of Directive 2011/16/EU |
| --- | --- |

—

Number of group refusals on the ground of Article 17 of Directive 2011/16/EU

| — | on spontaneous exchange of information (Article 9 and 10 of Directive 2011/16/EU)






  — | Number of spontaneous exchanges sent |
| --- | --- | --- |

—

on spontaneous exchange of information (Article 9 and 10 of Directive 2011/16/EU)

—

Number of spontaneous exchanges sent

| — | Number of spontaneous exchanges received |
| --- | --- |

—

Number of spontaneous exchanges received

| — | Part B: Statistics on other forms of administrative cooperation






  — | on presence in administrative offices and participation in administrative enquiries (Article 11 of Directive 2011/16/EU)






  — | Number of incoming presences in administrative offices and participation in administrative enquiries |
| --- | --- | --- | --- |

—

Part B: Statistics on other forms of administrative cooperation

—

on presence in administrative offices and participation in administrative enquiries (Article 11 of Directive 2011/16/EU)

—

Number of incoming presences in administrative offices and participation in administrative enquiries

| — | Number of outgoing presences in administrative offices and participation in administrative enquiries |
| --- | --- |

—

Number of outgoing presences in administrative offices and participation in administrative enquiries

| — | on simultaneous controls (Article 12 of Directive 2011/16/EU)






  — | Number of simultaneous controls which the Member State has initiated |
| --- | --- | --- |

—

on simultaneous controls (Article 12 of Directive 2011/16/EU)

—

Number of simultaneous controls which the Member State has initiated

| — | Number of simultaneous controls in which the Member State has participated |
| --- | --- |

—

Number of simultaneous controls in which the Member State has participated

| — | on requests for notification (Article 13 of Directive 2011/16/EU)






  — | Number of requests for notification sent |
| --- | --- | --- |

—

on requests for notification (Article 13 of Directive 2011/16/EU)

—

Number of requests for notification sent

| — | Number of requests for notification received |
| --- | --- |

—

Number of requests for notification received

| — | on feedback (Article 14 of Directive 2011/16/EU)






  — | Number of requests for feedback sent |
| --- | --- | --- |

—

on feedback (Article 14 of Directive 2011/16/EU)

—

Number of requests for feedback sent

| — | Number of feedback received |
| --- | --- |

—

Number of feedback received

| — | Number of requests for feedback received |
| --- | --- |

—

Number of requests for feedback received

| — | Number of feedback sent |
| --- | --- |

—

Number of feedback sent

| — | Part C: Statistics on estimated additional revenue or increase in assessed tax due to administrative cooperation. The information under this part is optional






  — | From exchange of information on request |
| --- | --- | --- |

—

Part C: Statistics on estimated additional revenue or increase in assessed tax due to administrative cooperation. The information under this part is optional

—

From exchange of information on request

| — | From spontaneous exchange of information |
| --- | --- |

—

From spontaneous exchange of information

| — | As a result of simultaneous control |
| --- | --- |

—

As a result of simultaneous control

| — | Overall figure and number of cases. |
| --- | --- |

—

Overall figure and number of cases.

‘ANNEX X

List referred to in Article 2d

The statistical data required for the mandatory automatic exchange of information pursuant to Article 23(4) of Directive 2011/16/EU on the categories of income and capital referred to in Article 8(1) of that Directive covers the following information:

| — | For all categories of income and capital referred to in Article 8(1) of Directive 2011/16/EU: statistics on message and taxpayer |
| --- | --- |

—

For all categories of income and capital referred to in Article 8(1) of Directive 2011/16/EU: statistics on message and taxpayer

| — | In the case of income from employment and director's fees: statistics on message and recipient, message and payer, recipient and relationship, payer and relationship, recipient and income |
| --- | --- |

—

In the case of income from employment and director's fees: statistics on message and recipient, message and payer, recipient and relationship, payer and relationship, recipient and income

| — | In the case of pensions: statistics on message and recipient, message and payer, recipient, payer, scheme, income |
| --- | --- |

—

In the case of pensions: statistics on message and recipient, message and payer, recipient, payer, scheme, income

| — | In the case of life insurance products: statistics on message and policy, policy overall, event |
| --- | --- |

—

In the case of life insurance products: statistics on message and policy, policy overall, event

| — | In the case of ownership of and income from immovable property: statistics on message and party, party overall, property quantity and value, transaction quantity and value, loan event quantity and value, right income quantity and value |
| --- | --- |

—

In the case of ownership of and income from immovable property: statistics on message and party, party overall, property quantity and value, transaction quantity and value, loan event quantity and value, right income quantity and value

| — | In the case of income from royalties: statistics on message and recipient, message and payer, recipient and income |
| --- | --- |

—

In the case of income from royalties: statistics on message and recipient, message and payer, recipient and income

| — | In the case of status messages: statistics on status message, status message error |
| --- | --- |

—

In the case of status messages: statistics on status message, status message error

| — | In the case of zero data messages: statistics on zero data message. |
| --- | --- |

—

In the case of zero data messages: statistics on zero data message.

---

(1)  However, only the fields actually filled in a given case need to appear in the form used in that case

1

---

ANNEX II

The title of point (b) to Annex V is replaced by the following:

| ‘(b) | As regards the body for communicating information on income from employment, director's fees or royalties:’ |
| --- | --- |

‘(b)

As regards the body for communicating information on income from employment, director's fees or royalties:’

---

ANNEX III

The following Annexes XIV, XV and XVI are added:

‘ANNEX XIV

Computerised format referred to in Article 2(3)

The computerised format for the mandatory automatic exchange of information pursuant to Article 8ac(2) of Directive 2011/16/EU complies with the following tree structure and contains the following elements and attributes (1)

| <?xml version="1.0" encoding="UTF-8"?>


  <!-- edited with XMLSpy v2021 (x64) (http://www.altova.com) by Romane Dragozis (ARHS Developments S.A.) -->


  <xsd:schema xmlns:dpi="urn:oecd:ties:dpi:v1" xmlns:xsd="http://www.w3.org/2001/XMLSchema" xmlns:stf="urn:oecd:ties:dpistf:v1" xmlns:iso="urn:oecd:ties:isodpitypes:v1" targetNamespace="urn:oecd:ties:dpi:v1" elementFormDefault="qualified" attributeFormDefault="unqualified" version="1.0">


  <xsd:import namespace="urn:oecd:ties:isodpitypes:v1" schemaLocation="isodpitypes_v1.0.xsd"/>


  <xsd:import namespace="urn:oecd:ties:dpistf:v1" schemaLocation="oecddpitypes_v1.0.xsd"/>


  <!--+++++++++++++++++++++++ Reusable Simple types ++++++++++++++++++++++++++++++++++++++ -->


  <!-- Message type definitions -->


  <!-- -->


  <xsd:simpleType name="MessageType_EnumType">


  <xsd:annotation>


  <xsd:documentation xml:lang="en">Message type defines the type of reporting.</xsd:documentation>


  </xsd:annotation>


  <xsd:restriction base="xsd:string">


  <xsd:enumeration value="DPI">


  <xsd:annotation>


  <xsd:documentation>This type defines the messages to be exchanged under the OECD Model Rules and [EU Specific] [EU DIR2021/514].</xsd:documentation>


  </xsd:annotation>


  </xsd:enumeration>


  </xsd:restriction>


  </xsd:simpleType>


  <!-- MessageTypeIndic - 4 -->


  <xsd:simpleType name="DPIMessageTypeIndic_EnumType">


  <xsd:annotation>


  <xsd:documentation xml:lang="en">The MessageTypeIndic defines the type of message sent.</xsd:documentation>


  </xsd:annotation>


  <xsd:restriction base="xsd:string">


  <xsd:enumeration value="DPI401">


  <xsd:annotation>


  <xsd:documentation>The message contains new (including additional) information.</xsd:documentation>


  </xsd:annotation>


  </xsd:enumeration>


  <xsd:enumeration value="DPI402">


  <xsd:annotation>


  <xsd:documentation>The message contains corrections for previously sent information.</xsd:documentation>


  </xsd:annotation>


  </xsd:enumeration>


  <xsd:enumeration value="DPI403">


  <xsd:annotation>


  <xsd:documentation>The message advises that there is no data to report.</xsd:documentation>


  </xsd:annotation>


  </xsd:enumeration>


  </xsd:restriction>


  </xsd:simpleType>


  <!-- -->


  <xsd:simpleType name="INType_EnumType">


  <xsd:annotation>


  <xsd:documentation xml:lang="en">The INType defines the type of identification number being sent.</xsd:documentation>


  </xsd:annotation>


  <xsd:restriction base="xsd:string">


  <xsd:enumeration value="LEI">


  <xsd:annotation>


  <xsd:documentation>Legal Entity Identifier</xsd:documentation>


  </xsd:annotation>


  </xsd:enumeration>


  <xsd:enumeration value="EIN">


  <xsd:annotation>


  <xsd:documentation>Entity Identification Number</xsd:documentation>


  </xsd:annotation>


  </xsd:enumeration>


  <xsd:enumeration value="IIN">


  <xsd:annotation>


  <xsd:documentation>Individual Identification Number</xsd:documentation>


  </xsd:annotation>


  </xsd:enumeration>


  <xsd:enumeration value="BRN">


  <xsd:annotation>


  <xsd:documentation>Business Registration Number</xsd:documentation>


  </xsd:annotation>


  </xsd:enumeration>


  <xsd:enumeration value="Other">


  <xsd:annotation>


  <xsd:documentation>Other</xsd:documentation>


  </xsd:annotation>


  </xsd:enumeration>


  </xsd:restriction>


  </xsd:simpleType>


  <!-- -->


  <!--DPI Property Type -->


  <xsd:simpleType name="DPIPropertyType_EnumType">


  <xsd:annotation>


  <xsd:documentation xml:lang="en">Main business activities


  </xsd:documentation>


  </xsd:annotation>


  <xsd:restriction base="xsd:string">


  <xsd:enumeration value="DPI901">


  <xsd:annotation>


  <xsd:documentation>Office</xsd:documentation>


  </xsd:annotation>


  </xsd:enumeration>


  <xsd:enumeration value="DPI902">


  <xsd:annotation>


  <xsd:documentation>Hotel room</xsd:documentation>


  </xsd:annotation>


  </xsd:enumeration>


  <xsd:enumeration value="DPI903">


  <xsd:annotation>


  <xsd:documentation>Bed and Breakfast room</xsd:documentation>


  </xsd:annotation>


  </xsd:enumeration>


  <xsd:enumeration value="DPI904">


  <xsd:annotation>


  <xsd:documentation>House</xsd:documentation>


  </xsd:annotation>


  </xsd:enumeration>


  <xsd:enumeration value="DPI905">


  <xsd:annotation>


  <xsd:documentation>Apartment</xsd:documentation>


  </xsd:annotation>


  </xsd:enumeration>


  <xsd:enumeration value="DPI906">


  <xsd:annotation>


  <xsd:documentation>Mobile Home</xsd:documentation>


  </xsd:annotation>


  </xsd:enumeration>


  <xsd:enumeration value="DPI907">


  <xsd:annotation>


  <xsd:documentation>Campground</xsd:documentation>


  </xsd:annotation>


  </xsd:enumeration>


  <xsd:enumeration value="DPI908">


  <xsd:annotation>


  <xsd:documentation>Boat</xsd:documentation>


  </xsd:annotation>


  </xsd:enumeration>


  <xsd:enumeration value="DPI909">


  <xsd:annotation>


  <xsd:documentation>Parking Space</xsd:documentation>


  </xsd:annotation>


  </xsd:enumeration>


  <xsd:enumeration value="DPI910">


  <xsd:annotation>


  <xsd:documentation>Other</xsd:documentation>


  </xsd:annotation>


  </xsd:enumeration>


  </xsd:restriction>


  </xsd:simpleType>


  <!-- -->


  <!--DPI Nexus Type -->


  <xsd:simpleType name="Nexus_EnumType">


  <xsd:annotation>


  <xsd:documentation xml:lang="en">The reason for which the information will be filled to the competent authority of the EU Member State.


  </xsd:documentation>


  </xsd:annotation>


  <xsd:restriction base="xsd:string">


  <xsd:enumeration value="RPONEX1">


  <xsd:annotation>


  <xsd:documentation>The Reporting Platform Operator is resident for tax purposes in the EU Member State.</xsd:documentation>


  </xsd:annotation>


  </xsd:enumeration>


  <xsd:enumeration value="RPONEX2">


  <xsd:annotation>


  <xsd:documentation>The Reporting Platform Operator does not have a residence for tax purposes but it is incorporated under the laws of the EU Member State.</xsd:documentation>


  </xsd:annotation>


  </xsd:enumeration>


  <xsd:enumeration value="RPONEX3">


  <xsd:annotation>


  <xsd:documentation>The Reporting Platform Operator does not have a residence for tax purposes but it has its place of management (including effective management) in the EU Member State.</xsd:documentation>


  </xsd:annotation>


  </xsd:enumeration>


  <xsd:enumeration value="RPONEX4">


  <xsd:annotation>


  <xsd:documentation>The Reporting Platform Operator does not have a residence for tax purposes but it has a permanent establishment in the EU Member State and it is not a Qualified Non-Union Platform Operator.</xsd:documentation>


  </xsd:annotation>


  </xsd:enumeration>


  <xsd:enumeration value="RPONEX5">


  <xsd:annotation>


  <xsd:documentation>The Reporting Platform Operator is neither resident for tax purposes, nor incorporated or managed in the EU Member State, nor has a permanent establishment in the EU Member State but it facilitates the carrying out of a Relevant Activity by Reportable Sellers or a Relevant Activity involving the rental of immovable property located in the EU Member State and it is not a Qualified Non-Union Platform Operator.</xsd:documentation>


  </xsd:annotation>


  </xsd:enumeration>


  </xsd:restriction>


  </xsd:simpleType>


  <!-- -->


  <!-- -->


  <!--++++++++++++++++++ Reusable Complex types +++++++++++++++++++++++++++++++++++++ -->


  <!-- -->


  <!--The Name of a Party, given in fixed Form-->


  <xsd:complexType name="NamePerson_Type">


  <xsd:annotation>


  <xsd:documentation xml:lang="en">The user must spread the data about the name of a party over up to six elements. The container element for this will be 'NameFix'. </xsd:documentation>


  </xsd:annotation>


  <xsd:sequence>


  <xsd:element name="PrecedingTitle" type="stf:StringMin1Max200_Type" minOccurs="0">


  <xsd:annotation>


  <xsd:documentation xml:lang="en">His Excellency,Estate of the Late ...</xsd:documentation>


  </xsd:annotation>


  </xsd:element>


  <xsd:element name="Title" type="stf:StringMin1Max200_Type" minOccurs="0" maxOccurs="unbounded">


  <xsd:annotation>


  <xsd:documentation xml:lang="en">Greeting title. Example: Mr, Dr, Ms, Herr, etc. Can have multiple titles.</xsd:documentation>


  </xsd:annotation>


  </xsd:element>


  <xsd:element name="FirstName">


  <xsd:annotation>


  <xsd:documentation xml:lang="en">FirstName of the person</xsd:documentation>


  </xsd:annotation>


  <xsd:complexType>


  <xsd:simpleContent>


  <xsd:extension base="stf:StringMin1Max200_Type">


  <xsd:attribute name="xnlNameType" type="stf:StringMin1Max200_Type">


  <xsd:annotation>


  <xsd:documentation xml:lang="en">Defines the name type of FirstName. Example: Given Name, Forename, First Name, Father's Name, etc. In some countries, FirstName could be a Family Name or a Surname. Use this attribute to define the type for this name.


  </xsd:documentation>


  </xsd:annotation>


  </xsd:attribute>


  </xsd:extension>


  </xsd:simpleContent>


  </xsd:complexType>


  </xsd:element>


  <xsd:element name="MiddleName" minOccurs="0" maxOccurs="unbounded">


  <xsd:annotation>


  <xsd:documentation xml:lang="en">Middle name (essential part of the name for many nationalities). Example: Sakthi in "Nivetha Sakthi Shantha". Can have multiple middle names.</xsd:documentation>


  </xsd:annotation>


  <xsd:complexType>


  <xsd:simpleContent>


  <xsd:extension base="stf:StringMin1Max200_Type">


  <xsd:attribute name="xnlNameType" type="stf:StringMin1Max200_Type">


  <xsd:annotation>


  <xsd:documentation xml:lang="en">Defines the name type of Middle Name. Example: First name, middle name, maiden name, father's name, given name, etc.


  </xsd:documentation>


  </xsd:annotation>


  </xsd:attribute>


  </xsd:extension>


  </xsd:simpleContent>


  </xsd:complexType>


  </xsd:element>


  <xsd:element name="NamePrefix" minOccurs="0">


  <xsd:annotation>


  <xsd:documentation xml:lang="en">de, van, van de, von, etc. Example: Derick de Clarke</xsd:documentation>


  </xsd:annotation>


  <xsd:complexType>


  <xsd:simpleContent>


  <xsd:extension base="stf:StringMin1Max200_Type">


  <xsd:attribute name="xnlNameType" type="stf:StringMin1Max200_Type">


  <xsd:annotation>


  <xsd:documentation xml:lang="en">Defines the type of name associated with the NamePrefix. For example the type of name is LastName and this prefix is the prefix for this last name.


  </xsd:documentation>


  </xsd:annotation>


  </xsd:attribute>


  </xsd:extension>


  </xsd:simpleContent>


  </xsd:complexType>


  </xsd:element>


  <xsd:element name="LastName">


  <xsd:annotation>


  <xsd:documentation xml:lang="en">Represents the position of the name in a name string. Can be Given Name, Forename, Christian Name, Surname, Family Name, etc. Use the attribute "NameType" to define what type this name is.


  In case of a company, this field can be used for the company name.</xsd:documentation>


  </xsd:annotation>


  <xsd:complexType>


  <xsd:simpleContent>


  <xsd:extension base="stf:StringMin1Max200_Type">


  <xsd:attribute name="xnlNameType" type="stf:StringMin1Max200_Type">


  <xsd:annotation>


  <xsd:documentation xml:lang="en">Defines the name type of LastName. Example: Father's name, Family name, Surname, Mother's Name, etc. In some countries, LastName could be the given name or first name.


  </xsd:documentation>


  </xsd:annotation>


  </xsd:attribute>


  </xsd:extension>


  </xsd:simpleContent>


  </xsd:complexType>


  </xsd:element>


  <xsd:element name="GenerationIdentifier" type="stf:StringMin1Max200_Type" minOccurs="0" maxOccurs="unbounded">


  <xsd:annotation>


  <xsd:documentation xml:lang="en">Jnr, Thr Third, III</xsd:documentation>


  </xsd:annotation>


  </xsd:element>


  <xsd:element name="Suffix" type="stf:StringMin1Max200_Type" minOccurs="0" maxOccurs="unbounded">


  <xsd:annotation>


  <xsd:documentation xml:lang="en">Could be compressed initials - PhD, VC, QC</xsd:documentation>


  </xsd:annotation>


  </xsd:element>


  <xsd:element name="GeneralSuffix" type="stf:StringMin1Max200_Type" minOccurs="0">


  <xsd:annotation>


  <xsd:documentation xml:lang="en">Deceased, Retired ...</xsd:documentation>


  </xsd:annotation>


  </xsd:element>


  </xsd:sequence>


  <xsd:attribute name="nameType" type="stf:OECDNameType_EnumType" use="optional">


  <xsd:annotation>


  <xsd:documentation xml:lang="en">It is possible for STF documents to contain several names for the same party. This attribute is a qualifier to indicate the type of a particular name.</xsd:documentation>


  </xsd:annotation>


  </xsd:attribute>


  </xsd:complexType>


  <!-- -->


  <!--Collection of all Data describing a person as a Party -->


  <xsd:complexType name="PersonParty_Type">


  <xsd:annotation>


  <xsd:documentation xml:lang="en">This container brings together all data about a person as a party. Name and address are required components and each can be present more than once to enable as complete a description as possible. Whenever possible one or more identifiers (TIN etc) should be added as well as a residence country code. Additional data that describes and identifies the party can be given. The code for the legal type according to the OECD codelist must be added. The structures of all of the subelements are defined elsewhere in this schema.</xsd:documentation>


  </xsd:annotation>


  <xsd:sequence>


  <xsd:element name="ResCountryCode" type="iso:CountryCode_Type" maxOccurs="unbounded">


  <xsd:annotation>


  <xsd:documentation>This repeatable data element describes the residence country code(s) of the individual Seller and must be present in all data records. This should correspond to the jurisdiction of residence identified on the basis of the due diligence requirements of the OECD Model Rules or [EU Specific] [EU DIR2021/514]. Specifically, under the OECD Model Rules, the residence country code of an individual Seller should correspond to the jurisdiction of the Seller’s primary residence.</xsd:documentation>


  </xsd:annotation>


  </xsd:element>


  <xsd:element name="TIN" type="dpi:TIN_Type" maxOccurs="unbounded">


  <xsd:annotation>


  <xsd:documentation>This repeatable data element provides the tax identification number (TIN) used by the tax administration of the jurisdiction of residence of the individual Seller. In case the individual Seller does not have a TIN, the jurisdiction of residence does not issue a TIN or require the collection of the TIN issued to such Seller, or the TIN is not known to the sending Competent Authority, the Unknown attribute (see below) must be set to “true” and the value “NOTIN” should be entered [OECD Specific]. Furthermore, in case more than one TIN are provided, any provided element cannot be flagged as “unknown”.</xsd:documentation>


  </xsd:annotation>


  </xsd:element>


  <xsd:element name="VAT" type="stf:StringMin1Max200_Type" minOccurs="0">


  <xsd:annotation>


  <xsd:documentation xml:lang="en">This data element must be provided when a VAT Identification number is available.</xsd:documentation>


  </xsd:annotation>


  </xsd:element>


  <xsd:element name="Name" type="dpi:NamePerson_Type" maxOccurs="unbounded">


  <xsd:annotation>


  <xsd:documentation>This element should contain the name of the person.</xsd:documentation>


  </xsd:annotation>


  </xsd:element>


  <xsd:element name="Address" type="dpi:Address_Type" maxOccurs="unbounded">


  <xsd:annotation>


  <xsd:documentation>This data element should contain the address of the person, including the country code of the address as well as the type of the address, indicating the legal character of that address.</xsd:documentation>


  </xsd:annotation>


  </xsd:element>


  <xsd:element name="Nationality" type="iso:CountryCode_Type" minOccurs="0" maxOccurs="unbounded">


  <xsd:annotation>


  <xsd:documentation>The nationality element is not to be provided as part of the DPI schema.</xsd:documentation>


  </xsd:annotation>


  </xsd:element>


  <xsd:element name="BirthInfo">


  <xsd:annotation>


  <xsd:documentation>This data element contains the birth information of an Individual Seller. It is always required to be provided unless such Seller is documented pursuant to a Government Verification Service and is composed of the date and the place of birth.</xsd:documentation>


  </xsd:annotation>


  <xsd:complexType>


  <xsd:sequence>


  <xsd:element name="BirthDate" type="xsd:date">


  <xsd:annotation>


  <xsd:documentation>This element provides the date of birth, complying with the following format: YYYY-MM-DD.</xsd:documentation>


  </xsd:annotation>


  </xsd:element>


  <xsd:element name="BirthPlace" type="dpi:BirthPlace_Type" minOccurs="0">


  <xsd:annotation>


  <xsd:documentation>This element provides information about the place of birth. This element must be filled in at least with the city and the country of birth (either the current jurisdiction identified by 2-characters country code or a former jurisdiction identified by a name).</xsd:documentation>


  </xsd:annotation>


  </xsd:element>


  </xsd:sequence>


  </xsd:complexType>


  </xsd:element>


  </xsd:sequence>


  </xsd:complexType>


  <!-- -->


  <!--Address Fix -->


  <xsd:complexType name="AddressFix_Type">


  <xsd:annotation>


  <xsd:documentation xml:lang="en">Structure of the address for a party broken down into its logical parts, recommended for easy matching. The 'City' element is the only required subelement. All of the subelements are simple text - data type 'string'.


  </xsd:documentation>


  </xsd:annotation>


  <xsd:sequence>


  <xsd:element name="Street" type="stf:StringMin1Max200_Type" minOccurs="0">


  <xsd:annotation>


  <xsd:documentation>The street.</xsd:documentation>


  </xsd:annotation>


  </xsd:element>


  <xsd:element name="BuildingIdentifier" type="stf:StringMin1Max200_Type" minOccurs="0">


  <xsd:annotation>


  <xsd:documentation>The identifier of the building on the street, typically a number.</xsd:documentation>


  </xsd:annotation>


  </xsd:element>


  <xsd:element name="SuiteIdentifier" type="stf:StringMin1Max200_Type" minOccurs="0">


  <xsd:annotation>


  <xsd:documentation>The identifier of an office or similar part of a building.</xsd:documentation>


  </xsd:annotation>


  </xsd:element>


  <xsd:element name="FloorIdentifier" type="stf:StringMin1Max200_Type" minOccurs="0">


  <xsd:annotation>


  <xsd:documentation>The identifier of a floor within a building.</xsd:documentation>


  </xsd:annotation>


  </xsd:element>


  <xsd:element name="DistrictName" type="stf:StringMin1Max200_Type" minOccurs="0">


  <xsd:annotation>


  <xsd:documentation>The name of the district of the address.</xsd:documentation>


  </xsd:annotation>


  </xsd:element>


  <xsd:element name="POB" type="stf:StringMin1Max200_Type" minOccurs="0">


  <xsd:annotation>


  <xsd:documentation>The post office box.</xsd:documentation>


  </xsd:annotation>


  </xsd:element>


  <xsd:element name="PostCode" type="stf:StringMin1Max200_Type" minOccurs="0">


  <xsd:annotation>


  <xsd:documentation>The post code of the address, which must be provided if available.</xsd:documentation>


  </xsd:annotation>


  </xsd:element>


  <xsd:element name="City" type="stf:StringMin1Max200_Type">


  <xsd:annotation>


  <xsd:documentation>The city of the address.</xsd:documentation>


  </xsd:annotation>


  </xsd:element>


  <xsd:element name="CountrySubentity" type="stf:StringMin1Max200_Type" minOccurs="0">


  <xsd:annotation>


  <xsd:documentation>A geographic area of the country larger than district or city, for example a county, a department, a Land, a canton, etc.</xsd:documentation>


  </xsd:annotation>


  </xsd:element>


  </xsd:sequence>


  </xsd:complexType>


  <!-- -->


  <!--The Address of a Party, given in fixed or free Form, possibly in both Forms -->


  <xsd:complexType name="Address_Type">


  <xsd:annotation>


  <xsd:documentation xml:lang="en">The user has the option to enter the data about the address of a party either as one long field or to spread the data over up to eight elements or even to use both formats. If the user chooses the option to enter the data required in separate elements, the container element for this will be 'AddressFix'. If the user chooses the option to enter the data required in a less structured way in 'AddressFree' all available address details shall be presented as one string of bytes, blank or "/" (slash) or carriage return- line feed used as a delimiter between parts of the address. PLEASE NOTE that the address country code is outside both of these elements. The use of the fixed form is recommended as a rule to allow easy matching. However, the use of the free form is recommended if the sending state cannot reliably identify and distinguish the different parts of the address. The user may want to use both formats e.g. if besides separating the logical parts of the address he also wants to indicate a suitable breakdown into print-lines by delimiters in the free text form. In this case 'AddressFix' has to precede 'AddressFree'.


  </xsd:documentation>


  </xsd:annotation>


  <xsd:sequence>


  <xsd:element name="CountryCode">


  <xsd:annotation>


  <xsd:documentation>This data element provides the country code associated with the entity’s (or person’s) address.</xsd:documentation>


  </xsd:annotation>


  <xsd:simpleType>


  <xsd:restriction base="iso:CountryCode_Type">


  <xsd:minLength value="1"/>


  <xsd:maxLength value="2"/>


  </xsd:restriction>


  </xsd:simpleType>


  </xsd:element>


  <xsd:choice>


  <xsd:element name="AddressFree" type="stf:StringMin1Max4000_Type">


  <xsd:annotation>


  <xsd:documentation>This data element allows input of address information in free text. It should only be used in exceptional circumstances when it is impossible to provide the address in the fixed format.</xsd:documentation>


  </xsd:annotation>


  </xsd:element>


  <xsd:sequence>


  <xsd:element name="AddressFix" type="dpi:AddressFix_Type"/>


  <xsd:element name="AddressFree" type="stf:StringMin1Max4000_Type" minOccurs="0">


  <xsd:annotation>


  <xsd:documentation>This data element allows input of address information in free text. It should only be used in exceptional circumstances when it is impossible to provide the address in the fixed format.</xsd:documentation>


  </xsd:annotation>


  </xsd:element>


  </xsd:sequence>


  </xsd:choice>


  </xsd:sequence>


  <xsd:attribute name="legalAddressType" type="stf:OECDLegalAddressType_EnumType" use="optional">


  <xsd:annotation>


  <xsd:documentation>This is a datatype for an attribute to an address. It serves to indicate the legal character of that address (residential, business etc.).


  The possible values are:







  — | OECD301= residentialOrBusiness |
| --- | --- |

<?xml version="1.0" encoding="UTF-8"?>

<!-- edited with XMLSpy v2021 (x64) (http://www.altova.com) by Romane Dragozis (ARHS Developments S.A.) -->

<xsd:schema xmlns:dpi="urn:oecd:ties:dpi:v1" xmlns:xsd="http://www.w3.org/2001/XMLSchema" xmlns:stf="urn:oecd:ties:dpistf:v1" xmlns:iso="urn:oecd:ties:isodpitypes:v1" targetNamespace="urn:oecd:ties:dpi:v1" elementFormDefault="qualified" attributeFormDefault="unqualified" version="1.0">

<xsd:import namespace="urn:oecd:ties:isodpitypes:v1" schemaLocation="isodpitypes_v1.0.xsd"/>

<xsd:import namespace="urn:oecd:ties:dpistf:v1" schemaLocation="oecddpitypes_v1.0.xsd"/>

<!--+++++++++++++++++++++++ Reusable Simple types ++++++++++++++++++++++++++++++++++++++ -->

<!-- Message type definitions -->

<!-- -->

<xsd:simpleType name="MessageType_EnumType">

<xsd:annotation>

<xsd:documentation xml:lang="en">Message type defines the type of reporting.</xsd:documentation>

</xsd:annotation>

<xsd:restriction base="xsd:string">

<xsd:enumeration value="DPI">

<xsd:annotation>

<xsd:documentation>This type defines the messages to be exchanged under the OECD Model Rules and [EU Specific] [EU DIR2021/514].</xsd:documentation>

</xsd:annotation>

</xsd:enumeration>

</xsd:restriction>

</xsd:simpleType>

<!-- MessageTypeIndic - 4 -->

<xsd:simpleType name="DPIMessageTypeIndic_EnumType">

<xsd:annotation>

<xsd:documentation xml:lang="en">The MessageTypeIndic defines the type of message sent.</xsd:documentation>

</xsd:annotation>

<xsd:restriction base="xsd:string">

<xsd:enumeration value="DPI401">

<xsd:annotation>

<xsd:documentation>The message contains new (including additional) information.</xsd:documentation>

</xsd:annotation>

</xsd:enumeration>

<xsd:enumeration value="DPI402">

<xsd:annotation>

<xsd:documentation>The message contains corrections for previously sent information.</xsd:documentation>

</xsd:annotation>

</xsd:enumeration>

<xsd:enumeration value="DPI403">

<xsd:annotation>

<xsd:documentation>The message advises that there is no data to report.</xsd:documentation>

</xsd:annotation>

</xsd:enumeration>

</xsd:restriction>

</xsd:simpleType>

<!-- -->

<xsd:simpleType name="INType_EnumType">

<xsd:annotation>

<xsd:documentation xml:lang="en">The INType defines the type of identification number being sent.</xsd:documentation>

</xsd:annotation>

<xsd:restriction base="xsd:string">

<xsd:enumeration value="LEI">

<xsd:annotation>

<xsd:documentation>Legal Entity Identifier</xsd:documentation>

</xsd:annotation>

</xsd:enumeration>

<xsd:enumeration value="EIN">

<xsd:annotation>

<xsd:documentation>Entity Identification Number</xsd:documentation>

</xsd:annotation>

</xsd:enumeration>

<xsd:enumeration value="IIN">

<xsd:annotation>

<xsd:documentation>Individual Identification Number</xsd:documentation>

</xsd:annotation>

</xsd:enumeration>

<xsd:enumeration value="BRN">

<xsd:annotation>

<xsd:documentation>Business Registration Number</xsd:documentation>

</xsd:annotation>

</xsd:enumeration>

<xsd:enumeration value="Other">

<xsd:annotation>

<xsd:documentation>Other</xsd:documentation>

</xsd:annotation>

</xsd:enumeration>

</xsd:restriction>

</xsd:simpleType>

<!-- -->

<!--DPI Property Type -->

<xsd:simpleType name="DPIPropertyType_EnumType">

<xsd:annotation>

<xsd:documentation xml:lang="en">Main business activities

</xsd:documentation>

</xsd:annotation>

<xsd:restriction base="xsd:string">

<xsd:enumeration value="DPI901">

<xsd:annotation>

<xsd:documentation>Office</xsd:documentation>

</xsd:annotation>

</xsd:enumeration>

<xsd:enumeration value="DPI902">

<xsd:annotation>

<xsd:documentation>Hotel room</xsd:documentation>

</xsd:annotation>

</xsd:enumeration>

<xsd:enumeration value="DPI903">

<xsd:annotation>

<xsd:documentation>Bed and Breakfast room</xsd:documentation>

</xsd:annotation>

</xsd:enumeration>

<xsd:enumeration value="DPI904">

<xsd:annotation>

<xsd:documentation>House</xsd:documentation>

</xsd:annotation>

</xsd:enumeration>

<xsd:enumeration value="DPI905">

<xsd:annotation>

<xsd:documentation>Apartment</xsd:documentation>

</xsd:annotation>

</xsd:enumeration>

<xsd:enumeration value="DPI906">

<xsd:annotation>

<xsd:documentation>Mobile Home</xsd:documentation>

</xsd:annotation>

</xsd:enumeration>

<xsd:enumeration value="DPI907">

<xsd:annotation>

<xsd:documentation>Campground</xsd:documentation>

</xsd:annotation>

</xsd:enumeration>

<xsd:enumeration value="DPI908">

<xsd:annotation>

<xsd:documentation>Boat</xsd:documentation>

</xsd:annotation>

</xsd:enumeration>

<xsd:enumeration value="DPI909">

<xsd:annotation>

<xsd:documentation>Parking Space</xsd:documentation>

</xsd:annotation>

</xsd:enumeration>

<xsd:enumeration value="DPI910">

<xsd:annotation>

<xsd:documentation>Other</xsd:documentation>

</xsd:annotation>

</xsd:enumeration>

</xsd:restriction>

</xsd:simpleType>

<!-- -->

<!--DPI Nexus Type -->

<xsd:simpleType name="Nexus_EnumType">

<xsd:annotation>

<xsd:documentation xml:lang="en">The reason for which the information will be filled to the competent authority of the EU Member State.

</xsd:documentation>

</xsd:annotation>

<xsd:restriction base="xsd:string">

<xsd:enumeration value="RPONEX1">

<xsd:annotation>

<xsd:documentation>The Reporting Platform Operator is resident for tax purposes in the EU Member State.</xsd:documentation>

</xsd:annotation>

</xsd:enumeration>

<xsd:enumeration value="RPONEX2">

<xsd:annotation>

<xsd:documentation>The Reporting Platform Operator does not have a residence for tax purposes but it is incorporated under the laws of the EU Member State.</xsd:documentation>

</xsd:annotation>

</xsd:enumeration>

<xsd:enumeration value="RPONEX3">

<xsd:annotation>

<xsd:documentation>The Reporting Platform Operator does not have a residence for tax purposes but it has its place of management (including effective management) in the EU Member State.</xsd:documentation>

</xsd:annotation>

</xsd:enumeration>

<xsd:enumeration value="RPONEX4">

<xsd:annotation>

<xsd:documentation>The Reporting Platform Operator does not have a residence for tax purposes but it has a permanent establishment in the EU Member State and it is not a Qualified Non-Union Platform Operator.</xsd:documentation>

</xsd:annotation>

</xsd:enumeration>

<xsd:enumeration value="RPONEX5">

<xsd:annotation>

<xsd:documentation>The Reporting Platform Operator is neither resident for tax purposes, nor incorporated or managed in the EU Member State, nor has a permanent establishment in the EU Member State but it facilitates the carrying out of a Relevant Activity by Reportable Sellers or a Relevant Activity involving the rental of immovable property located in the EU Member State and it is not a Qualified Non-Union Platform Operator.</xsd:documentation>

</xsd:annotation>

</xsd:enumeration>

</xsd:restriction>

</xsd:simpleType>

<!-- -->

<!-- -->

<!--++++++++++++++++++ Reusable Complex types +++++++++++++++++++++++++++++++++++++ -->

<!-- -->

<!--The Name of a Party, given in fixed Form-->

<xsd:complexType name="NamePerson_Type">

<xsd:annotation>

<xsd:documentation xml:lang="en">The user must spread the data about the name of a party over up to six elements. The container element for this will be 'NameFix'. </xsd:documentation>

</xsd:annotation>

<xsd:sequence>

<xsd:element name="PrecedingTitle" type="stf:StringMin1Max200_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation xml:lang="en">His Excellency,Estate of the Late ...</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="Title" type="stf:StringMin1Max200_Type" minOccurs="0" maxOccurs="unbounded">

<xsd:annotation>

<xsd:documentation xml:lang="en">Greeting title. Example: Mr, Dr, Ms, Herr, etc. Can have multiple titles.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="FirstName">

<xsd:annotation>

<xsd:documentation xml:lang="en">FirstName of the person</xsd:documentation>

</xsd:annotation>

<xsd:complexType>

<xsd:simpleContent>

<xsd:extension base="stf:StringMin1Max200_Type">

<xsd:attribute name="xnlNameType" type="stf:StringMin1Max200_Type">

<xsd:annotation>

<xsd:documentation xml:lang="en">Defines the name type of FirstName. Example: Given Name, Forename, First Name, Father's Name, etc. In some countries, FirstName could be a Family Name or a Surname. Use this attribute to define the type for this name.

</xsd:documentation>

</xsd:annotation>

</xsd:attribute>

</xsd:extension>

</xsd:simpleContent>

</xsd:complexType>

</xsd:element>

<xsd:element name="MiddleName" minOccurs="0" maxOccurs="unbounded">

<xsd:annotation>

<xsd:documentation xml:lang="en">Middle name (essential part of the name for many nationalities). Example: Sakthi in "Nivetha Sakthi Shantha". Can have multiple middle names.</xsd:documentation>

</xsd:annotation>

<xsd:complexType>

<xsd:simpleContent>

<xsd:extension base="stf:StringMin1Max200_Type">

<xsd:attribute name="xnlNameType" type="stf:StringMin1Max200_Type">

<xsd:annotation>

<xsd:documentation xml:lang="en">Defines the name type of Middle Name. Example: First name, middle name, maiden name, father's name, given name, etc.

</xsd:documentation>

</xsd:annotation>

</xsd:attribute>

</xsd:extension>

</xsd:simpleContent>

</xsd:complexType>

</xsd:element>

<xsd:element name="NamePrefix" minOccurs="0">

<xsd:annotation>

<xsd:documentation xml:lang="en">de, van, van de, von, etc. Example: Derick de Clarke</xsd:documentation>

</xsd:annotation>

<xsd:complexType>

<xsd:simpleContent>

<xsd:extension base="stf:StringMin1Max200_Type">

<xsd:attribute name="xnlNameType" type="stf:StringMin1Max200_Type">

<xsd:annotation>

<xsd:documentation xml:lang="en">Defines the type of name associated with the NamePrefix. For example the type of name is LastName and this prefix is the prefix for this last name.

</xsd:documentation>

</xsd:annotation>

</xsd:attribute>

</xsd:extension>

</xsd:simpleContent>

</xsd:complexType>

</xsd:element>

<xsd:element name="LastName">

<xsd:annotation>

<xsd:documentation xml:lang="en">Represents the position of the name in a name string. Can be Given Name, Forename, Christian Name, Surname, Family Name, etc. Use the attribute "NameType" to define what type this name is.

In case of a company, this field can be used for the company name.</xsd:documentation>

</xsd:annotation>

<xsd:complexType>

<xsd:simpleContent>

<xsd:extension base="stf:StringMin1Max200_Type">

<xsd:attribute name="xnlNameType" type="stf:StringMin1Max200_Type">

<xsd:annotation>

<xsd:documentation xml:lang="en">Defines the name type of LastName. Example: Father's name, Family name, Surname, Mother's Name, etc. In some countries, LastName could be the given name or first name.

</xsd:documentation>

</xsd:annotation>

</xsd:attribute>

</xsd:extension>

</xsd:simpleContent>

</xsd:complexType>

</xsd:element>

<xsd:element name="GenerationIdentifier" type="stf:StringMin1Max200_Type" minOccurs="0" maxOccurs="unbounded">

<xsd:annotation>

<xsd:documentation xml:lang="en">Jnr, Thr Third, III</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="Suffix" type="stf:StringMin1Max200_Type" minOccurs="0" maxOccurs="unbounded">

<xsd:annotation>

<xsd:documentation xml:lang="en">Could be compressed initials - PhD, VC, QC</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="GeneralSuffix" type="stf:StringMin1Max200_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation xml:lang="en">Deceased, Retired ...</xsd:documentation>

</xsd:annotation>

</xsd:element>

</xsd:sequence>

<xsd:attribute name="nameType" type="stf:OECDNameType_EnumType" use="optional">

<xsd:annotation>

<xsd:documentation xml:lang="en">It is possible for STF documents to contain several names for the same party. This attribute is a qualifier to indicate the type of a particular name.</xsd:documentation>

</xsd:annotation>

</xsd:attribute>

</xsd:complexType>

<!-- -->

<!--Collection of all Data describing a person as a Party -->

<xsd:complexType name="PersonParty_Type">

<xsd:annotation>

<xsd:documentation xml:lang="en">This container brings together all data about a person as a party. Name and address are required components and each can be present more than once to enable as complete a description as possible. Whenever possible one or more identifiers (TIN etc) should be added as well as a residence country code. Additional data that describes and identifies the party can be given. The code for the legal type according to the OECD codelist must be added. The structures of all of the subelements are defined elsewhere in this schema.</xsd:documentation>

</xsd:annotation>

<xsd:sequence>

<xsd:element name="ResCountryCode" type="iso:CountryCode_Type" maxOccurs="unbounded">

<xsd:annotation>

<xsd:documentation>This repeatable data element describes the residence country code(s) of the individual Seller and must be present in all data records. This should correspond to the jurisdiction of residence identified on the basis of the due diligence requirements of the OECD Model Rules or [EU Specific] [EU DIR2021/514]. Specifically, under the OECD Model Rules, the residence country code of an individual Seller should correspond to the jurisdiction of the Seller’s primary residence.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="TIN" type="dpi:TIN_Type" maxOccurs="unbounded">

<xsd:annotation>

<xsd:documentation>This repeatable data element provides the tax identification number (TIN) used by the tax administration of the jurisdiction of residence of the individual Seller. In case the individual Seller does not have a TIN, the jurisdiction of residence does not issue a TIN or require the collection of the TIN issued to such Seller, or the TIN is not known to the sending Competent Authority, the Unknown attribute (see below) must be set to “true” and the value “NOTIN” should be entered [OECD Specific]. Furthermore, in case more than one TIN are provided, any provided element cannot be flagged as “unknown”.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="VAT" type="stf:StringMin1Max200_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation xml:lang="en">This data element must be provided when a VAT Identification number is available.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="Name" type="dpi:NamePerson_Type" maxOccurs="unbounded">

<xsd:annotation>

<xsd:documentation>This element should contain the name of the person.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="Address" type="dpi:Address_Type" maxOccurs="unbounded">

<xsd:annotation>

<xsd:documentation>This data element should contain the address of the person, including the country code of the address as well as the type of the address, indicating the legal character of that address.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="Nationality" type="iso:CountryCode_Type" minOccurs="0" maxOccurs="unbounded">

<xsd:annotation>

<xsd:documentation>The nationality element is not to be provided as part of the DPI schema.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="BirthInfo">

<xsd:annotation>

<xsd:documentation>This data element contains the birth information of an Individual Seller. It is always required to be provided unless such Seller is documented pursuant to a Government Verification Service and is composed of the date and the place of birth.</xsd:documentation>

</xsd:annotation>

<xsd:complexType>

<xsd:sequence>

<xsd:element name="BirthDate" type="xsd:date">

<xsd:annotation>

<xsd:documentation>This element provides the date of birth, complying with the following format: YYYY-MM-DD.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="BirthPlace" type="dpi:BirthPlace_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation>This element provides information about the place of birth. This element must be filled in at least with the city and the country of birth (either the current jurisdiction identified by 2-characters country code or a former jurisdiction identified by a name).</xsd:documentation>

</xsd:annotation>

</xsd:element>

</xsd:sequence>

</xsd:complexType>

</xsd:element>

</xsd:sequence>

</xsd:complexType>

<!-- -->

<!--Address Fix -->

<xsd:complexType name="AddressFix_Type">

<xsd:annotation>

<xsd:documentation xml:lang="en">Structure of the address for a party broken down into its logical parts, recommended for easy matching. The 'City' element is the only required subelement. All of the subelements are simple text - data type 'string'.

</xsd:documentation>

</xsd:annotation>

<xsd:sequence>

<xsd:element name="Street" type="stf:StringMin1Max200_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation>The street.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="BuildingIdentifier" type="stf:StringMin1Max200_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation>The identifier of the building on the street, typically a number.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="SuiteIdentifier" type="stf:StringMin1Max200_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation>The identifier of an office or similar part of a building.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="FloorIdentifier" type="stf:StringMin1Max200_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation>The identifier of a floor within a building.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="DistrictName" type="stf:StringMin1Max200_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation>The name of the district of the address.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="POB" type="stf:StringMin1Max200_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation>The post office box.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="PostCode" type="stf:StringMin1Max200_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation>The post code of the address, which must be provided if available.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="City" type="stf:StringMin1Max200_Type">

<xsd:annotation>

<xsd:documentation>The city of the address.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="CountrySubentity" type="stf:StringMin1Max200_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation>A geographic area of the country larger than district or city, for example a county, a department, a Land, a canton, etc.</xsd:documentation>

</xsd:annotation>

</xsd:element>

</xsd:sequence>

</xsd:complexType>

<!-- -->

<!--The Address of a Party, given in fixed or free Form, possibly in both Forms -->

<xsd:complexType name="Address_Type">

<xsd:annotation>

<xsd:documentation xml:lang="en">The user has the option to enter the data about the address of a party either as one long field or to spread the data over up to eight elements or even to use both formats. If the user chooses the option to enter the data required in separate elements, the container element for this will be 'AddressFix'. If the user chooses the option to enter the data required in a less structured way in 'AddressFree' all available address details shall be presented as one string of bytes, blank or "/" (slash) or carriage return- line feed used as a delimiter between parts of the address. PLEASE NOTE that the address country code is outside both of these elements. The use of the fixed form is recommended as a rule to allow easy matching. However, the use of the free form is recommended if the sending state cannot reliably identify and distinguish the different parts of the address. The user may want to use both formats e.g. if besides separating the logical parts of the address he also wants to indicate a suitable breakdown into print-lines by delimiters in the free text form. In this case 'AddressFix' has to precede 'AddressFree'.

</xsd:documentation>

</xsd:annotation>

<xsd:sequence>

<xsd:element name="CountryCode">

<xsd:annotation>

<xsd:documentation>This data element provides the country code associated with the entity’s (or person’s) address.</xsd:documentation>

</xsd:annotation>

<xsd:simpleType>

<xsd:restriction base="iso:CountryCode_Type">

<xsd:minLength value="1"/>

<xsd:maxLength value="2"/>

</xsd:restriction>

</xsd:simpleType>

</xsd:element>

<xsd:choice>

<xsd:element name="AddressFree" type="stf:StringMin1Max4000_Type">

<xsd:annotation>

<xsd:documentation>This data element allows input of address information in free text. It should only be used in exceptional circumstances when it is impossible to provide the address in the fixed format.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:sequence>

<xsd:element name="AddressFix" type="dpi:AddressFix_Type"/>

<xsd:element name="AddressFree" type="stf:StringMin1Max4000_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation>This data element allows input of address information in free text. It should only be used in exceptional circumstances when it is impossible to provide the address in the fixed format.</xsd:documentation>

</xsd:annotation>

</xsd:element>

</xsd:sequence>

</xsd:choice>

</xsd:sequence>

<xsd:attribute name="legalAddressType" type="stf:OECDLegalAddressType_EnumType" use="optional">

<xsd:annotation>

<xsd:documentation>This is a datatype for an attribute to an address. It serves to indicate the legal character of that address (residential, business etc.).

The possible values are:

—

OECD301= residentialOrBusiness

| — | OECD302= residential |
| --- | --- |

—

OECD302= residential

| — | OECD303= business |
| --- | --- |

—

OECD303= business

| — | OECD304= registeredOffice |
| --- | --- |

—

OECD304= registeredOffice

| — | OECD305= unspecified |
| --- | --- |

—

OECD305= unspecified

The address of the Reportable Platform Operator must represent the “Registered Office Address” (OECD304).</xsd:documentation>

</xsd:annotation>

</xsd:attribute>

</xsd:complexType>

<!-- -->

<!--The place of birth -->

<xsd:complexType name="BirthPlace_Type">

<xsd:annotation>

<xsd:documentation>This element provides information about the place of birth. This element must be filled in at least with the city and the country of birth (either the current jurisdiction identified by 2-characters country code or a former jurisdiction identified by a name).</xsd:documentation>

</xsd:annotation>

<xsd:sequence>

<xsd:element name="City" type="stf:StringMin1Max200_Type">

<xsd:annotation>

<xsd:documentation>The city of birth.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="CitySubentity" type="stf:StringMin1Max200_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation>The city subentity of birth.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="CountryInfo">

<xsd:complexType>

<xsd:choice>

<xsd:element name="CountryCode" type="iso:CountryCode_Type">

<xsd:annotation>

<xsd:documentation>The current jurisdiction of birth.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="FormerCountryName" type="stf:StringMin1Max200_Type">

<xsd:annotation>

<xsd:documentation>The former jurisdiction of birth. The Former Country Name element should be used in case the person was born in a country that has since ceased to exist.</xsd:documentation>

</xsd:annotation>

</xsd:element>

</xsd:choice>

</xsd:complexType>

</xsd:element>

</xsd:sequence>

</xsd:complexType>

<!-- -->

<!--General Type for Monetary Amounts -->

<xsd:complexType name="MonAmnt_Type">

<xsd:annotation>

<xsd:documentation xml:lang="en">This data type is to be used whenever monetary amounts are to be communicated. Such amounts shall be given in full units, i.e. without decimals. The code for the currency in which the value is expressed has to be taken from the ISO codelist 4217 and added in attribute currCode.

</xsd:documentation>

</xsd:annotation>

<xsd:simpleContent>

<xsd:extension base="xsd:integer">

<xsd:attribute name="currCode" type="iso:currCode_Type" use="required"/>

</xsd:extension>

</xsd:simpleContent>

</xsd:complexType>

<!-- -->

<!--Organisation name -->

<xsd:complexType name="NameOrganisation_Type">

<xsd:annotation>

<xsd:documentation xml:lang="en">Name of organisation</xsd:documentation>

</xsd:annotation>

<xsd:simpleContent>

<xsd:extension base="stf:StringMin1Max200_Type"/>

</xsd:simpleContent>

</xsd:complexType>

<!-- -->

<!--Organisation name (Reportable Seller)-->

<xsd:complexType name="NameReportableSeller_Type">

<xsd:annotation>

<xsd:documentation xml:lang="en">Name of Seller</xsd:documentation>

</xsd:annotation>

<xsd:simpleContent>

<xsd:extension base="stf:StringMin1Max200_Type"/>

</xsd:simpleContent>

</xsd:complexType>

<!-- -->

<!--TIN -->

<xsd:complexType name="TIN_Type">

<xsd:annotation>

<xsd:documentation xml:lang="en">This is the identification number/identification code for the party in question. As the identifier may be not strictly numeric, it is just defined as a string of characters. Attribute 'issuedBy' is required to designate the issuer of the identifier. </xsd:documentation>

</xsd:annotation>

<xsd:simpleContent>

<xsd:extension base="stf:StringMin0Max200_Type">

<xsd:attribute name="issuedBy" type="iso:CountryCode_Type" use="optional">

<xsd:annotation>

<xsd:documentation xml:lang="en">Country code of issuing country, indicating country of Residence (to taxes and other).

It should always be provided, unless the TIN element is flagged as “unknown”.</xsd:documentation>

</xsd:annotation>

</xsd:attribute>

<xsd:attribute name="unknown" type="xsd:boolean" use="optional">

<xsd:annotation>

<xsd:documentation xml:lang="en">This attribute must be provided if the TIN is not available or inexistent. Any value provided for a TIN flagged as unknown will be discarded.</xsd:documentation>

</xsd:annotation>

</xsd:attribute>

</xsd:extension>

</xsd:simpleContent>

</xsd:complexType>

<!-- -->

<!--Message specification: Data identifying and describing the message as a whole-->

<xsd:complexType name="MessageSpec_Type">

<xsd:annotation>

<xsd:documentation xml:lang="en">Information in the message header identifies the Tax Administration that is sending the message. It specifies when the message was created, what period (normally a year) the report is for, and the nature of the report (original, corrected, supplemental, etc).</xsd:documentation>

</xsd:annotation>

<xsd:sequence>

<xsd:element name="SendingEntityIN" type="stf:StringMin1Max200_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation>Although not used for exchanges between Competent Authorities under the DPI MCAA and [EU DIR2021/514], for domestic reporting, this data element can be used in case the schema is mandated for domestic reporting by Reporting Platform Operators to their tax administration. In such instances, it identifies the Reporting Platform Operator sending the message through a domestically-defined identification number.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="TransmittingCountry" type="iso:CountryCode_Type">

<xsd:annotation>

<xsd:documentation>This data element identifies the jurisdiction of the Competent Authority transmitting the DPI message.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="ReceivingCountry" type="iso:CountryCode_Type">

<xsd:annotation>

<xsd:documentation>This data element identifies the jurisdiction of the Competent Authority receiving the DPI message.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="MessageType" type="dpi:MessageType_EnumType">

<xsd:annotation>

<xsd:documentation>This data element specifies the type of message being sent. The only allowable entry for messages exchanged under the OECD Model Rules and [EU Specific] [EU DIR2021/514] in this field is “DPI”.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="Warning" type="stf:StringMin1Max4000_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation xml:lang="en">Free text expressing the restrictions for use of the information this message contains and the legal framework under which it is given.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="Contact" type="stf:StringMin1Max4000_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation xml:lang="en">All necessary contact information about persons responsible for and involved in the processing of the data transmitted in this message, both legally and technically. Free text as this is not intended for automatic processing.

In international exchanges, this data element contains the contact details of the sending competent authority.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="MessageRefId" type="stf:StringMin1Max170_Type">

<xsd:annotation>

<xsd:documentation xml:lang="en">Sender's unique identifier for this message.

The Message RefID must start with the country code of the sending jurisdiction, then the year of the reportable period, then the receiving country code before a unique identifier.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="MessageTypeIndic" type="dpi:DPIMessageTypeIndic_EnumType">

<xsd:annotation>

<xsd:documentation>This data element specifies the type of information that is sent, i.e. whether it is new information or whether the message seeks to correct or delete previously sent information.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="ReportingPeriod" type="xsd:date">

<xsd:annotation>

<xsd:documentation xml:lang="en">The reporting year for which information is transmitted in documents of the current message. This is in yyyy-MM-DD format, on the basis of the calendar year in which the relevant Reportable Period under the OECD Model Rules or [EU Specific] [EU DIR2021/514] ended.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="Timestamp" type="xsd:dateTime">

<xsd:annotation>

<xsd:documentation>This data element identifies the date and time when the message was compiled. It is anticipated that this element will be automatically populated by the host system. The format for use is yyyy-MM-DD’T’hh:mm:ss.nnn. Fractions of seconds may be used (in such a case the milli-seconds will be provided on 3 digits, see “.nnn” in the format above). </xsd:documentation>

</xsd:annotation>

</xsd:element>

</xsd:sequence>

</xsd:complexType>

<!-- -->

<!--Organisation Identification Number -->

<xsd:complexType name="OrganisationIN_Type">

<xsd:annotation>

<xsd:documentation xml:lang="en">This is the identification number/identification code for the Entity in question. As the identifier may be not strictly numeric, it is just defined as a string of characters. Attribute 'issuedBy' is required to designate the issuer of the identifier. Attribute 'INType' defines the type of identification number. </xsd:documentation>

</xsd:annotation>

<xsd:simpleContent>

<xsd:extension base="stf:StringMin1Max200_Type">

<xsd:attribute name="issuedBy" type="iso:CountryCode_Type" use="optional">

<xsd:annotation>

<xsd:documentation xml:lang="en">Country code of issuing country, indicating country of Residence (to taxes and other)</xsd:documentation>

</xsd:annotation>

</xsd:attribute>

<xsd:attribute name="INType" type="dpi:INType_EnumType" use="required">

<xsd:annotation>

<xsd:documentation xml:lang="en">This attribute defines the type of identification number being sent among the following:

| — | [EU Specific]: IIN for the reporting of an individual identification number; |
| --- | --- |

—

[EU Specific]: IIN for the reporting of an individual identification number;

| — | LEI for the reporting of a legal entity identifier; |
| --- | --- |

—

LEI for the reporting of a legal entity identifier;

| — | EIN for the reporting of an entity identification number; |
| --- | --- |

—

EIN for the reporting of an entity identification number;

| — | BRN for the reporting of a business registration number; or |
| --- | --- |

—

BRN for the reporting of a business registration number; or

| — | Other. |
| --- | --- |

—

Other.

</xsd:documentation>

</xsd:annotation>

</xsd:attribute>

</xsd:extension>

</xsd:simpleContent>

</xsd:complexType>

<!-- -->

<!--Collection of all Data describing an organisationy as party-->

<xsd:complexType name="OrganisationParty_Type">

<xsd:annotation>

<xsd:documentation xml:lang="en">

This container brings together all data about an organisation as a party. Name and address are required components and each can be present more than once to enable as complete a description as possible. Whenever possible one or more identifiers (TIN etc) should be added as well as a residence country code. Additional data that describes and identifies the party can be given . The code for the legal type according to the OECD codelist must be added. The structures of all of the subelements are defined elsewhere in this schema.</xsd:documentation>

</xsd:annotation>

<xsd:sequence>

<xsd:element name="ResCountryCode" minOccurs="0" maxOccurs="unbounded">

<xsd:annotation>

<xsd:documentation>This repeatable data element describes the residence country code(s) of the entity.

In case of an Entity Seller this should always be present and should correspond to the jurisdiction of residence identified on the basis of the due diligence requirements of the OECD Model Rules or [EU Specific] [EU DIR2021/514]. Specifically, under the OECD Model Rules, the residence country code of an Entity Seller should correspond to the jurisdiction in which its registered office is located.

In case of a Reporting Platform Operator, the residence country code should correspond to the jurisdiction where the Reporting Platform Operator is resident for tax purposes or, where it does not have a residence for tax purposes, either the jurisdiction it is incorporated under or the jurisdiction that it has its place of management (including effective management) in, [EU Specific] or the Member State where it has a permanent establishment in.

[EU Specific]: Reporting Platform Operator: This element is optional.</xsd:documentation>

</xsd:annotation>

<xsd:simpleType>

<xsd:restriction base="iso:CountryCode_Type"/>

</xsd:simpleType>

</xsd:element>

<xsd:element name="TIN" type="dpi:TIN_Type" maxOccurs="unbounded">

<xsd:annotation>

<xsd:documentation>This repeatable data element provides the tax identification number (TIN) used by the tax administration of the jurisdiction of residence of the entity. In case the entity does not have a TIN, or the TIN is not known to the sending Competent Authority, the value “NOTIN” should be entered [OECD Specific] and the Unknown attribute (see below) must be set to “true”. Furthermore, in case more than one TIN are provided, any provided element cannot be flagged as “unknown”.

[EU Specific]: This element must be present for both Reporting Platform Operator and Entity Seller.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="IN" type="dpi:OrganisationIN_Type" minOccurs="0" maxOccurs="unbounded">

<xsd:annotation>

<xsd:documentation xml:lang="en">This data element can be provided (and repeated) if there are other INs available, such as a company registration number or an Entity Identification Number (EIN).

[EU Specific]:

| — | Reporting Platform Operator: Where relevant, the individual identification number (IIN) shall be provided |
| --- | --- |

—

Reporting Platform Operator: Where relevant, the individual identification number (IIN) shall be provided

| — | Entity Seller: The business registration number (BRN) must be provided</xsd:documentation> |
| --- | --- |

—

Entity Seller: The business registration number (BRN) must be provided</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="VAT" type="stf:StringMin1Max200_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation xml:lang="en">This data element can be provided when a VAT Identification number is available.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="Name" type="dpi:NameOrganisation_Type" maxOccurs="unbounded">

<xsd:annotation>

<xsd:documentation>This element should contain the legal name of the entity, including the domestic designation for the legal form, as indicated in its articles of incorporation or any similar document.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="PlatformBusinessName" type="stf:StringMin1Max200_Type" minOccurs="0" maxOccurs="unbounded">

<xsd:annotation>

<xsd:documentation>The repeatable Platform Business Name element identifies the business name(s) of the other Reporting Platform(s) in respect of which the Reporting Platform Operator is reporting.

This element must not be used for the Entity Sellers.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="Address" type="dpi:Address_Type" maxOccurs="unbounded">

<xsd:annotation>

<xsd:documentation>This data element should contain the address of the entity, including the country code of the address as well as the type of the address, indicating the legal character of that address.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="Nexus" type="dpi:Nexus_EnumType" minOccurs="0">

<xsd:annotation>

<xsd:documentation>[EU Specific] This data element provides the reason for which the information will be reported to the competent authority of the EU Member State.

This data element must not be used for Entity Seller.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="AssumedReporting" type="xsd:boolean" minOccurs="0">

<xsd:annotation>

<xsd:documentation>The Assumed Reporting element identifies whether the Reporting Platform Operator is not reporting information on Reportable Sellers, because another Reporting Platform Operator has assumed the reporting.

When “AssumedReporting” is set to “true”, it means that another Reporting Platform Operator reported for the Reporting Platform Operator. Otherwise, this element must be set to “false”.

This element is mandatory for Reporting Platform Operator and must not be provided for an Entity Seller.

By way of an example, Platform Z is operated by two Platform Operators: Platform Operator 1 (resident in jurisdiction 1) and Platform Operator 2 (resident in jurisdiction 2). In satisfying the reporting requirements, Platform Operator 1 has obtained assurances from Platform Operator 2 that it will fulfil the reporting obligations with respect to all of the Reportable Sellers of Platform Operator 1 in jurisdiction 2.

Platform Operator 1 will therefore provide its identification information and set the AssumedReporting element to “true” to notify its jurisdiction residence (jurisdiction 1) that it has relied on another Platform Operator to fulfil the reporting requirements. Platform Operator 1 will also use the AssumingPlatformOperator element (discussed further below) to report to its jurisdiction (jurisdiction 1) identification information on Platform Operator 2, assuming the reporting obligation in the name of Platform Operator 1. Platform Operator 1 will not provide ReportableSeller element.

At the same time, Platform Operator 2 will use the AssumedPlatformOperator element (discussed further below) to report to its jurisdiction of residence (jurisdiction 2) identification information on Platform Operator 1, for which it has assumed reporting obligations, and complete the Platform Operator element for itself.

[EU Specific] This element is optional for the purposes of [EU DIR2021/514].

</xsd:documentation>

</xsd:annotation>

</xsd:element>

</xsd:sequence>

</xsd:complexType>

<!-- -->

<!--Correctable Platform Operator_Type-->

<xsd:complexType name="CorrectablePlatformOperator_Type">

<xsd:annotation>

<xsd:documentation>This correctable extends the information about the Reporting Platform Operator by considering the DocSpec element used to identify the particular report within the DPI message being transmitted.</xsd:documentation>

</xsd:annotation>

<xsd:complexContent>

<xsd:extension base="dpi:OrganisationParty_Type">

<xsd:sequence>

<xsd:element name="DocSpec" type="stf:DocSpec_Type">

<xsd:annotation>

<xsd:documentation>DocSpec identifies the particular report within the DPI message being transmitted. It permits the identification of reports requiring correction.</xsd:documentation>

</xsd:annotation>

</xsd:element>

</xsd:sequence>

</xsd:extension>

</xsd:complexContent>

</xsd:complexType>

<!-- -->

<!--Correctable Reportable Seller-->

<xsd:complexType name="CorrectableReportableSeller_Type">

<xsd:annotation>

<xsd:documentation>This correctable extends the information about the Reportable Seller by considering the DocSpec element used to identify the particular report within the DPI message being transmitted.</xsd:documentation>

</xsd:annotation>

<xsd:complexContent>

<xsd:extension base="dpi:ReportableSeller_Type">

<xsd:sequence>

<xsd:element name="DocSpec" type="stf:DocSpec_Type">

<xsd:annotation>

<xsd:documentation>DocSpec identifies the particular report within the DPI message being transmitted. It permits the identification of reports requiring correction.</xsd:documentation>

</xsd:annotation>

</xsd:element>

</xsd:sequence>

</xsd:extension>

</xsd:complexContent>

</xsd:complexType>

<!-- -->

<!--Additional Info -->

<xsd:complexType name="CorrectableAdditionalInfo_Type">

<xsd:sequence>

<xsd:element name="DocSpec" type="stf:DocSpec_Type"/>

<xsd:element name="OtherInfo" type="stf:StringMin1Max4000WithLang_Type" maxOccurs="unbounded">

<xsd:annotation>

<xsd:documentation>Please include any further brief information or explanation you consider necessary or that would facilitate the understanding of the compulsory information provided in the country-by-country report. </xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="ResCountryCode" type="iso:CountryCode_Type" minOccurs="0" maxOccurs="unbounded"/>

<!-- <xsd:element name="SummaryRef" type="dpi:DPISummaryListElementsType_EnumType" minOccurs="0" maxOccurs="unbounded"/> -->

</xsd:sequence>

</xsd:complexType>

<!-- -->

<!--Duplicate of Account Holder Type (from CRS)-->

<xsd:complexType name="AccountHolder_Type">

<xsd:sequence>

<xsd:choice>

<xsd:element name="Individual" type="dpi:NameReportableSeller_Type"/>

<xsd:sequence>

<xsd:element name="Organisation" type="dpi:OrganisationParty_Type"/>

<xsd:element name="AcctHolderType"/>

</xsd:sequence>

</xsd:choice>

</xsd:sequence>

</xsd:complexType>

<!-- -->

<!--Financial Identifer for Identity-->

<xsd:complexType name="FinancialIdentifier_Type">

<xsd:annotation>

<xsd:documentation xml:lang="en">The Financial Identifier is an optional (mandatory) element that reflects the Financial Account Identifier which, under the OECD Model Rules or [EU Specific] [EU DIR2021/514], is the unique identifying number or reference available to the Reporting Platform Operator of the bank account or other payment account to which the Consideration is paid or credited. Under subparagraphs B(2)(c) and B(3)(c) of Section III of the OECD Model Rules or [EU Specific] subparagraphs B(2)(b) and B(3)(b) of Section III of [EU DIR2021/514], the Financial Identifier must be reported and exchanged provided that it is available to the Reporting Platform Operator and that the jurisdiction of the Reportable Seller’s residence has indicated that it wishes to receive such Financial Identifiers for taxpayer matching purposes.</xsd:documentation>

</xsd:annotation>

<xsd:sequence>

<xsd:element name="Identifier" type="dpi:Identifier_Type">

<xsd:annotation>

<xsd:documentation xml:lang="en">Entity Identification Number, which contains the Financial Account Identifier pertaining to the Reportable Seller should be reflected. Financial Account Identifiers can include the IBAN number, sort code and account number and any other payment account identifier that the Reporting Platform Operator used for transferring the Consideration in respect to a Reportable Seller.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="AccountHolderName" type="stf:StringMin1Max200_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation>The Account Holder Name field is an optional (mandatory) element which, reflecting subparagraphs B(2)(d) and B(3)(d) of Section III of the OECD Model Rules or [EU Specific] subparagraphs B(2)(c) and B(3)(c) of Section III of [EU DIR2021/514], contains the name of the holder of the financial account to which the Consideration is paid or credited, where different from the name of the Reportable Seller and to the extent available to the Reporting Platform Operator.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="OtherInfo" type="stf:StringMin1Max400_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation>Reflecting subparagraphs B(2)(d) and B(3)(d) of Section III of the OECD Model Rules or [EU Specific] subparagraphs B(2)(c) and B(3)(c) of Section III of [EU DIR2021/514], the OtherInfo field contains any other identifying information available to the Reporting Platform Operator with respect to that account holder.</xsd:documentation>

</xsd:annotation>

</xsd:element>

</xsd:sequence>

</xsd:complexType>

<!-- -->

<!--Identifer for Financial Identifier-->

<xsd:complexType name="Identifier_Type">

<xsd:annotation>

<xsd:documentation xml:lang="en">The Identifier field is a required element which contains the Financial Account Identifier pertaining to the Reportable Seller should be reflected. Financial Account Identifiers can include the IBAN number, sort code and account number and any other payment account identifier that the Reporting Platform Operator used for transferring the Consideration in respect to a Reportable Seller.</xsd:documentation>

</xsd:annotation>

<xsd:simpleContent>

<xsd:extension base="stf:StringMin1Max200_Type">

<xsd:attribute name="AccountNumberType" type="stf:StringMin1Max200_Type">

<xsd:annotation>

<xsd:documentation xml:lang="en">This attribute describes the type of account number being sent.</xsd:documentation>

</xsd:annotation>

</xsd:attribute>

</xsd:extension>

</xsd:simpleContent>

</xsd:complexType>

<!-- -->

<!--OtherActivities (Complex)-->

<xsd:complexType name="OtherActivities_Type">

<xsd:sequence>

<xsd:element name="Consideration" type="dpi:ConsiderationType">

<xsd:annotation>

<xsd:documentation>The Consideration element contains information on the Consideration received by a Reportable Seller in relation to the Relevant Activities provided. It is further split into four elements, representing the quarters during which the Consideration was paid or credited to a Reportable Seller. In this respect, Consideration is considered to be paid or credited to a Reportable Seller when it is paid or credited to an account specified by the Reportable Seller (as stated in paragraph 32 of the Commentary to Section I of the OECD Model Rules).</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="NumberOfActivities" type="dpi:NumberOfActivities_Type">

<xsd:annotation>

<xsd:documentation>The Number of Activities element specified the number of Relevant Activities that a Reportable Seller has provided. It is further split into four elements. These elements represent the four quarters in respect of which reporting of the number of Relevant Activities in respect of which Consideration was paid or credited to the Reportable Seller is required. As such, that the numbers of activities are reported on the basis of the date of payment or credit of the Consideration.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="Fees" type="dpi:FeesType">

<xsd:annotation>

<xsd:documentation>The Fees element is further split into four elements, representing the quarters in respect of which reporting takes place. </xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="Taxes" type="dpi:TaxesType">

<xsd:annotation>

<xsd:documentation>The Taxes element is further split into four elements, representing the quarters in respect of which reporting takes place. </xsd:documentation>

</xsd:annotation>

</xsd:element>

</xsd:sequence>

</xsd:complexType>

<!-- -->

<!--Number of Activities (Complex)-->

<xsd:complexType name="NumberOfActivities_Type">

<xsd:annotation>

<xsd:documentation>The Number of Services element is further split into four elements, representing the quarters in respect of which reporting takes place. </xsd:documentation>

</xsd:annotation>

<xsd:sequence>

<xsd:element name="NumbQ1" type="xsd:integer"/>

<xsd:element name="NumbQ2" type="xsd:integer"/>

<xsd:element name="NumbQ3" type="xsd:integer"/>

<xsd:element name="NumbQ4" type="xsd:integer"/>

</xsd:sequence>

</xsd:complexType>

<!-- -->

<!--Taxes Type (Complex)-->

<xsd:complexType name="TaxesType">

<xsd:annotation>

<xsd:documentation>The Taxes element is further split into four elements, representing the quarters in respect of which reporting takes place.

Each quarter element is further comprised of the MonAmnt_Type, used to communicate taxes withheld in respect of Sellers. Such amounts shall be given in full units, i.e. without decimals. The code for the currency, in which the value is expressed has to be taken from the ISO code list 4217 and added in attribute currCode.</xsd:documentation>

</xsd:annotation>

<xsd:sequence>

<xsd:element name="TaxQ1" type="dpi:MonAmnt_Type"/>

<xsd:element name="TaxQ2" type="dpi:MonAmnt_Type"/>

<xsd:element name="TaxQ3" type="dpi:MonAmnt_Type"/>

<xsd:element name="TaxQ4" type="dpi:MonAmnt_Type"/>

</xsd:sequence>

</xsd:complexType>

<!-- -->

<!--Fees Type (Complex) -->

<xsd:complexType name="FeesType">

<xsd:sequence>

<xsd:annotation>

<xsd:documentation>The Fees element is further split into four elements, representing the quarters in respect of which reporting takes place.

Each quarter element is further comprised of the MonAmnt_Type, used to communicate the fees withheld in respect of Sellers. Such amounts shall be given in full units, i.e. without decimals. The code for the currency, in which the value is expressed has to be taken from the ISO code list 4217 and added in attribute currCode.</xsd:documentation>

</xsd:annotation>

<xsd:element name="FeesQ1" type="dpi:MonAmnt_Type"/>

<xsd:element name="FeesQ2" type="dpi:MonAmnt_Type"/>

<xsd:element name="FeesQ3" type="dpi:MonAmnt_Type"/>

<xsd:element name="FeesQ4" type="dpi:MonAmnt_Type"/>

</xsd:sequence>

</xsd:complexType>

<!-- -->

<!--Consideration Type (Complex) -->

<xsd:complexType name="ConsiderationType">

<xsd:sequence>

<xsd:annotation>

<xsd:documentation>The Consideration element is further split into four elements, representing the quarters in respect of which reporting takes place.

Each quarter element is further comprised of the MonAmnt_Type, used to communicate the monetary amounts earned by Sellers. Such amounts shall be given in full units, i.e. without decimals. The code for the currency, in which the value is expressed has to be taken from the ISO code list 4217 and added in attribute currCode.</xsd:documentation>

</xsd:annotation>

<xsd:element name="ConsQ1" type="dpi:MonAmnt_Type"/>

<xsd:element name="ConsQ2" type="dpi:MonAmnt_Type"/>

<xsd:element name="ConsQ3" type="dpi:MonAmnt_Type"/>

<xsd:element name="ConsQ4" type="dpi:MonAmnt_Type"/>

</xsd:sequence>

</xsd:complexType>

<!-- -->

<!--Property Listing Type (Complex) -->

<xsd:complexType name="PropertyListingType">

<xsd:sequence>

<xsd:element name="Address" type="dpi:Address_Type">

<xsd:annotation>

<xsd:documentation>The Address element is further comprised of the elements as described above under the Address Type.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="LandRegistrationNumber" type="stf:StringMin1Max200_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation>The Land Registration Number element contains the land registration number, which under subparagraph B(3)(f) of Section III of the OECD Model Rules or [EU Specific] subparagraph B(3)(e) of Section III of [EU DIR2021/514], is reportable if available to the Reporting Platform Operator. For these purposes, the land registration number includes functional equivalents, such as a cadastral number.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="Consideration" type="dpi:ConsiderationType">

<xsd:annotation>

<xsd:documentation>The Consideration element contains information on the Consideration received by a Reportable Seller in relation to the Relevant Activities provided. It is further split into four elements, representing the quarters during which the Consideration was paid or credited to a Reportable Seller. In this respect, Consideration is considered to be paid or credited to a Reportable Seller when it is paid or credited to an account specified by the Reportable Seller (as stated in paragraph 32 of the Commentary to Section I of the OECD Model Rules).

For Relevant Activities involving the rental of immovable property, the Consideration information must be provided separately with respect to each Property Listing.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="NumberOfActivities" type="dpi:NumberOfActivities_Type">

<xsd:annotation>

<xsd:documentation>The Number of Activities element specified the number of Relevant Activities that a Reportable Seller has provided. It is further split into four elements. These elements represent the four quarters in respect of which reporting of the number of Relevant Activities in respect of which Consideration was paid or credited to the Reportable Seller is required.

For Relevant Activities involving the rental of immovable property, the number of activities must be provided separately with respect to each Property Listing.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="Fees" type="dpi:FeesType">

<xsd:annotation>

<xsd:documentation>The Fees element specified the fees and commissions that a Reporting Platform Operator has withheld in respect of a Reportable Seller. It is split into four elements, representing the quarters in respect of which the reporting of fees or commissions withheld or charged by the Reporting Platform Operator is required under subparagraphs B(2)(g) and B(3)(h) of Section III of the OECD Model Rules or [EU Specific] subparagraphs B(2)(f) and B(3)(g) of Section III of [EU DIR2021/514]. </xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="Taxes" type="dpi:TaxesType">

<xsd:annotation>

<xsd:documentation>The Taxes element specifies the taxes that a Reporting Platform Operator has withheld in respect of a Reportable Seller. It is further split into four elements, representing the quarters in respect of which reporting of taxes withheld by the Reporting Platform Operator is required under subparagraphs B(2)(g) and B(3)(h) of Section III of the OECD Model Rules or [EU Specific] subparagraphs B(2)(f) and B(3)(g) of Section III of [EU DIR2021/514].</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="PropertyType" type="dpi:DPIPropertyType_EnumType" minOccurs="0">

<xsd:annotation>

<xsd:documentation>The Property Type element specifies the type of property rented. DPI901 to DPI910.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="OtherPropertyType" type="stf:StringMin1Max200_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation>This element describes the type of property in case “DPI910” is selected as Property Type. This element cannot be used in case another Property Type is selected.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="RentedDays" minOccurs="0">

<xsd:annotation>

<xsd:documentation>The Rented Days element contains the number of days that the Property Listing was rented during the Reportable Period.

4 numbers max. Set the type as simple</xsd:documentation>

</xsd:annotation>

<xsd:simpleType>

<xsd:restriction base="xsd:integer">

<xsd:totalDigits value="4"/>

<xsd:minInclusive value="1"/>

</xsd:restriction>

</xsd:simpleType>

</xsd:element>

</xsd:sequence>

</xsd:complexType>

<!-- -->

<!--GVS Type (Complex) -->

<xsd:complexType name="GVSType">

<xsd:annotation>

<xsd:documentation>The GVS element reflects the Government Verification Service (GVS) due diligence procedures and is composed of the Name GVS, Jurisdiction GVS, Reference GVS and Other TIN GVS elements, which contain the information items subject to reporting (and exchange) in respect of a Reportable Seller that has been identified on the basis of a Government Verification Service, as well as the Financial Identifier element.

[EU Specific] At the time of publication, the collection and exchange of GVS information is not a legal requirement under [EU DIR2021/514].</xsd:documentation>

</xsd:annotation>

<xsd:sequence>

<xsd:element name="NameGVS" type="stf:StringMin1Max200_Type">

<xsd:annotation>

<xsd:documentation>The Name GVS element contains the legal name of the Reportable Seller.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="JurisdictionGVS">

<xsd:annotation>

<xsd:documentation>The Jurisdiction GVS element identifies the jurisdiction whose Government Verification Service was relied upon by the Reporting Platform Operator in respect of the Reportable Seller.

It uses the 2-character alphabetic country code and country name list based on the ISO 3166-1 Alpha 2 standard.</xsd:documentation>

</xsd:annotation>

<xsd:simpleType>

<xsd:restriction base="iso:CountryCode_Type"/>

</xsd:simpleType>

</xsd:element>

<xsd:element name="ReferenceGVS" type="stf:StringMin1Max200_Type">

<xsd:annotation>

<xsd:documentation>The Reference GVS element contains the unique reference number or code provided by the jurisdiction whose GVS was used, allowing that jurisdiction to match the Reportable Seller to a taxpayer within its database.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="OtherTINGVS" type="stf:StringMin1Max200_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation>Reflecting subparagraph B(2)(b) and B(3)(b) of Section III of the OECD Model Rules, the Other TIN GVS element contains any TIN available to the Reporting Platform Operator, including the jurisdiction of issuance.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="FinancialIdentifier" type="dpi:FinancialIdentifier_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation>The Financial Identifier is an optional (mandatory) element that reflects the Financial Account Identifier which is the unique identifying number or reference available to the Reporting Platform Operator of the bank account or other payment account to which the Consideration is paid or credited.</xsd:documentation>

</xsd:annotation>

</xsd:element>

</xsd:sequence>

</xsd:complexType>

<!-- -->

<!-- Reportable Seller (Complex)-->

<xsd:complexType name="ReportableSeller_Type">

<xsd:sequence>

<xsd:element name="Identity">

<xsd:annotation>

<xsd:documentation>The Identity element is further comprised of the EntitySeller and IndividualSeller elements.</xsd:documentation>

</xsd:annotation>

<xsd:complexType>

<xsd:choice>

<xsd:element name="EntitySeller">

<xsd:annotation>

<xsd:documentation>The Entity Seller element is further comprised of the Standard and GVS elements.</xsd:documentation>

</xsd:annotation>

<xsd:complexType>

<xsd:choice>

<xsd:element name="Standard">

<xsd:annotation>

<xsd:documentation>The Standard element reflects the standard due diligence procedures and is further comprised of the EntSellerID (that follows the OrganisationParty Type) and FinancialIdentifier elements. Platform Operators by default would use the standard due diligence procedures, but can also rely on the GVS procedure where it has been made available by the Reportable Jurisdiction .

The Standard element should be completed in case the Reporting Platform Operator has relied on the standard due diligence procedures of the OECD Model Rules or [EU Specific] [EU DIR2021/514] to identify and document the Entity Seller.</xsd:documentation>

</xsd:annotation>

<xsd:complexType>

<xsd:sequence>

<xsd:element name="EntSellerID" type="dpi:OrganisationParty_Type">

<xsd:annotation>

<xsd:documentation>The EntSellerID element identifies the Entity Seller and follows the OrganisationParty_Type.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="FinancialIdentifier" type="dpi:FinancialIdentifier_Type" minOccurs="0" maxOccurs="unbounded">

<xsd:annotation>

<xsd:documentation>The Financial Identifier is an optional (mandatory) element that reflects the Financial Account Identifier which, under the OECD Model Rules or [EU Specific] [EU DIR2021/514], is the unique identifying number or reference available to the Reporting Platform Operator of the bank account or other payment account to which the Consideration is paid or credited. Under subparagraphs B(2)(c) and B(3)(c) of Section III of the OECD Model Rules or [EU Specific] subparagraphs B(2)(b) and B(3)(b) of Section III of [EU DIR2021/514], the Financial Identifier must be reported and exchanged provided that it is available to the Reporting Platform Operator and that the jurisdiction of the Reportable Seller’s residence has indicated that it wishes to receive such Financial Identifiers for taxpayer matching purposes.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="PermanentEstablishments" type="dpi:PermanentEstablishments_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation>[EU Specific] This data element provides information on any permanent establishment through which Relevant Activities are carried out by the Entity Seller in the Union, indicating each respective EU Member State where such a permanent establishment is located.</xsd:documentation>

</xsd:annotation>

</xsd:element>

</xsd:sequence>

</xsd:complexType>

</xsd:element>

<xsd:element name="GVS" type="dpi:GVSType">

<xsd:annotation>

<xsd:documentation>The GVS element should be completed in case the Reporting Platform Operator has relied on an approved Government Verification Service in order to identify and document the Entity Seller.</xsd:documentation>

</xsd:annotation>

</xsd:element>

</xsd:choice>

</xsd:complexType>

</xsd:element>

<xsd:element name="IndividualSeller">

<xsd:complexType>

<xsd:choice>

<xsd:element name="Standard">

<xsd:annotation>

<xsd:documentation>The Standard element reflects the standard due diligence procedures and is further comprised of the IndSellerID element (which follows the PersonParty Type) and the Financial Identifier element. Platform Operators by default would use the standard due diligence procedures, but can also rely on the GVS procedure where it has been made available by the Reportable Jurisdiction .

The PersonParty_Type, as enumerated in Section III of the OECD Model Rules or [EU Specific] [EU DIR2021/514], defines the information to be included in relation to an individual where the standard due diligence procedures are followed.</xsd:documentation>

</xsd:annotation>

<xsd:complexType>

<xsd:sequence>

<xsd:element name="IndSellerID" type="dpi:PersonParty_Type">

<xsd:annotation>

<xsd:documentation>The IndSellerID element identifies the individual Seller and follows the PersonParty_Type</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="FinancialIdentifier" type="dpi:FinancialIdentifier_Type" minOccurs="0" maxOccurs="unbounded">

<xsd:annotation>

<xsd:documentation>The Financial Identifier is an optional (mandatory) and repeatable element that reflects the Financial Account Identifier which, under the OECD Model Rules or [EU Specific] [EU DIR2021/514], is the unique identifying number or reference available to the Reporting Platform Operator of the bank account or other payment account to which the Consideration is paid or credited. Under subparagraphs B(2)(c) and B(3)(c) of Section III of the OECD Model Rules or [EU Specific] subparagraphs B(2)(b) and B(3)(b) of Section III of [EU DIR2021/514], the Financial Identifier must be reported and exchanged provided that it is available to the Reporting Platform Operator and that the jurisdiction of the Reportable Seller’s residence has indicated that it wishes to receive such Financial Identifiers for taxpayer matching purposes.</xsd:documentation>

</xsd:annotation>

</xsd:element>

</xsd:sequence>

</xsd:complexType>

</xsd:element>

<xsd:element name="GVS" type="dpi:GVSType">

<xsd:annotation>

<xsd:documentation>The GVS element should be completed in case the Reporting Platform Operator has relied on an approved Government Verification Service in order to identify and document the Individual Seller.</xsd:documentation>

</xsd:annotation>

</xsd:element>

</xsd:choice>

</xsd:complexType>

</xsd:element>

</xsd:choice>

</xsd:complexType>

</xsd:element>

<xsd:element name="RelevantActivities">

<xsd:annotation>

<xsd:documentation>The Relevant Activities element includes information on the Relevant Activities provided by Reportable Sellers and the Consideration derived therefrom. The element is comprised of the Immovable Property, Personal Services, sale of Goods and Transportation Rental elements, reflecting the nature of the activities provided by the Reportable Seller. Under the OECD Model Rules and [EU DIR2021/514], information in respect of the Immovable Property and Personal Services elements must be provided. Under the OECD Extended Scope and [EU DIR2021/514], information in respect of the sale of Goods and Transportation Rental elements must also be provided.</xsd:documentation>

</xsd:annotation>

<xsd:complexType>

<xsd:sequence>

<xsd:element name="ImmovableProperty" minOccurs="0">

<xsd:annotation>

<xsd:documentation>The Immovable Property element contains information on Relevant Activities provided by a Reportable Seller in relation to the rental of immovable property. It comprises the repeatable Property Listing element.</xsd:documentation>

</xsd:annotation>

<xsd:complexType>

<xsd:sequence>

<xsd:element name="PropertyListing" type="dpi:PropertyListingType" maxOccurs="unbounded">

<xsd:annotation>

<xsd:documentation>The Property Listing element is comprised of the Address, Land Registration Number, Consideration, Number of Activities, Fees, Taxes, Property Type and Rented days elements.</xsd:documentation>

</xsd:annotation>

</xsd:element>

</xsd:sequence>

</xsd:complexType>

</xsd:element>

<xsd:element name="PersonalServices" type="dpi:OtherActivities_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation>The Personal Services element contains information on Relevant Activities involving time- or task-based work performed by one or more individuals, acting either independently or on behalf of an Entity, and which is carried out at the request of a user, either online or physically offline after having been facilitated via Platform.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="SaleOfGoods" type="dpi:OtherActivities_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation>The sale of Goods element specifies the Relevant Activities provided by a Reportable Seller with respect to sale of goods.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="TransportationRental" type="dpi:OtherActivities_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation>The Transportation Rental element specifies the Relevant Activities provided by a Reportable Seller with respect to the rental of any mode of transport.</xsd:documentation>

</xsd:annotation>

</xsd:element>

</xsd:sequence>

</xsd:complexType>

</xsd:element>

</xsd:sequence>

</xsd:complexType>

<!-- -->

<!-- Permanent Establishments (Complex)-->

<xsd:complexType name="PermanentEstablishments_Type">

<xsd:sequence>

<xsd:annotation>

<xsd:documentation>The repeatable Permanent Establishment element identifies an EU Member State where a permanent establishment through which Relevant Activities are carried out by the Entity Seller in the Union is located.</xsd:documentation>

</xsd:annotation>

<xsd:element name="PermanentEstablishment" type="iso:MSCountryCode_Type" maxOccurs="unbounded"/>

</xsd:sequence>

</xsd:complexType>

<!-- -->

<!-- Other Platform Operators (Complex)-->

<xsd:complexType name="OtherPlatformOperators_Type">

<xsd:choice>

<xsd:sequence>

<xsd:element name="AssumingPlatformOperator" type="dpi:CorrectableOtherRPO_Type">

<xsd:annotation>

<xsd:documentation>This element provides information about the Platform Operator assuming the reporting in the name of the Reporting Platform Operator, as identified in the Platform Operator element.</xsd:documentation>

</xsd:annotation>

</xsd:element>

</xsd:sequence>

<xsd:sequence>

<xsd:element name="AssumedPlatformOperator" type="dpi:CorrectableOtherRPO_Type" maxOccurs="unbounded">

<xsd:annotation>

<xsd:documentation>This repeatable element provides information about each Platform Operator for which the Reporting Platform Operator, as identified in the Platform Operator element, assumes the reporting.</xsd:documentation>

</xsd:annotation>

</xsd:element>

</xsd:sequence>

</xsd:choice>

</xsd:complexType>

<xsd:complexType name="OtherRPO_Type">

<xsd:sequence>

<xsd:annotation>

<xsd:documentation>This element provides information about the assuming or assumed Platform Operator.</xsd:documentation>

</xsd:annotation>

<xsd:element name="ResCountryCode" type="iso:CountryCode_Type" minOccurs="0" maxOccurs="unbounded">

<xsd:annotation>

<xsd:documentation>This repeatable data element describes the residence country code(s) of the Platform Operator assuming the reporting or the residence country code(s) of each Platform Operator for which the Reporting Platform Operator assumes the reporting. As with the residence country code(s) of the Reporting Platform Operator, the residence country code of this Platform Operator should correspond to the jurisdiction where the Platform Operator is resident for tax purposes or, where it does not have a residence for tax purposes, either the jurisdiction it is incorporated under or the jurisdiction that it has its place of management (including effective management) in, [EU Specific] or the Member State where it has a permanent establishment in.

[EU Specific] This element is optional for the purposes of [EU DIR2021/514].

</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="TIN" type="dpi:TIN_Type" maxOccurs="unbounded">

<xsd:annotation>

<xsd:documentation>This data element provides the tax identification number (TIN) used by the tax administration of the jurisdiction of residence of the entity. In case the entity does not have a TIN, or the TIN is not known to the sending Competent Authority, the Unknown attribute (see below) must be set to “true”. Furthermore, in case more than one TIN are provided, any provided element cannot be flagged as “unknown”.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="Name" type="dpi:NameOrganisation_Type">

<xsd:annotation>

<xsd:documentation>This element should contain the legal name of the entity, including the domestic designation for the legal form, as indicated in its articles of incorporation or any similar document.</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="Address" type="dpi:Address_Type">

<xsd:annotation>

<xsd:documentation>This data element should contain the address of the entity, including the country code of the address as well as the type of the address, indicating the legal character of that address.</xsd:documentation>

</xsd:annotation>

</xsd:element>

</xsd:sequence>

</xsd:complexType>

<!-- -->

<!-- Correctable Other Platform Operator (Complex)-->

<xsd:complexType name="CorrectableOtherRPO_Type">

<xsd:complexContent>

<xsd:extension base="dpi:OtherRPO_Type">

<xsd:sequence>

<xsd:element name="DocSpec" type="stf:DocSpec_Type">

<xsd:annotation>

<xsd:documentation>DocSpec identifies the particular report within the DPI message being transmitted. It permits the identification of reports requiring correction (for further guidance see the Corrections section below).</xsd:documentation>

</xsd:annotation>

</xsd:element>

</xsd:sequence>

</xsd:extension>

</xsd:complexContent>

</xsd:complexType>

<!--DPI Body Type - DPI Reporting -->

<xsd:complexType name="DPIBody_Type">

<xsd:sequence>

<xsd:annotation>

<xsd:documentation>The DPI Body element contains the information on the Reporting Platform Operator, as well as on the Relevant Services performed by Reportable Sellers that give rise to the exchange.</xsd:documentation>

</xsd:annotation>

<xsd:element name="PlatformOperator" type="dpi:CorrectablePlatformOperator_Type">

<xsd:annotation>

<xsd:documentation>The Platform Operator element identifies the Reporting Platform Operator and follows the Organisation Party type (see OrganisationParty_Type).</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="OtherPlatformOperators" type="dpi:OtherPlatformOperators_Type" minOccurs="0">

<xsd:annotation>

<xsd:documentation>This other Platform Operators element identifies either:

| — | The Platform Operator assuming the reporting in the name of the Reporting Platform Operator, as identified in the Platform Operator element; |
| --- | --- |

—

The Platform Operator assuming the reporting in the name of the Reporting Platform Operator, as identified in the Platform Operator element;

| — | Each Platform Operator for which the Reporting Platform Operator, as identified in the Platform Operator element, assumes the reporting. |
| --- | --- |

—

Each Platform Operator for which the Reporting Platform Operator, as identified in the Platform Operator element, assumes the reporting.

[OECD Specific] This element must be provided, if available.

[EU Specific] This element is optional for the purposes of [EU DIR2021/514].

</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="ReportableSeller" type="dpi:CorrectableReportableSeller_Type" minOccurs="0" maxOccurs="unbounded">

<xsd:annotation>

<xsd:documentation>This element contains the identification information on each Reportable Seller, as well as information on the Relevant Services provided by such Reportable Seller and the Consideration derived therefrom.

In case of Nil Reporting, i.e. when MessageTypeIndic is set to “DPI403”, no Reportable Seller must be provided.</xsd:documentation>

</xsd:annotation>

</xsd:element>

</xsd:sequence>

</xsd:complexType>

<!-- -->

<!--+++++++++++++++++++++++++++++++++++++++++++++++++++++++++ Schema element ++++++++++++++++++++++++++++++++++++++++++++ -->

<!-- DPI OECD File Message structure -->

<!-- -->

<!--DPI Message structure -->

<xsd:element name="DPI_OECD">

<xsd:complexType>

<xsd:sequence>

<xsd:element name="MessageSpec" type="dpi:MessageSpec_Type">

<xsd:annotation>

<xsd:documentation>The information in the message header identifies the tax administration that is sending the DPI message. It specifies when the message was created, what reporting period the report is for, and the nature of the report (original, supplemental, etc.).</xsd:documentation>

</xsd:annotation>

</xsd:element>

<xsd:element name="DPIBody" type="dpi:DPIBody_Type" minOccurs="0" maxOccurs="unbounded">

<xsd:annotation>

<xsd:documentation>The DPI Body element contains the information on the Reporting Platform Operator, as well as on the Relevant Services performed by Reportable Sellers that give rise to the exchange.</xsd:documentation>

</xsd:annotation>

</xsd:element>

</xsd:sequence>

<xsd:attribute name="version" type="stf:StringMin1Max10_Type">

<xsd:annotation>

<xsd:documentation xml:lang="en">The DPI Version.</xsd:documentation>

</xsd:annotation>

</xsd:attribute>

</xsd:complexType>

</xsd:element>

<!-- -->

</xsd:schema>

‘ANNEX XV

List referred to in Article 2d

The statistical data required for the mandatory exchange of information in accordance with Article 8ac(2) of Directive 2011/16/EU, pursuant to Article 23(4) of that Directive covers the following information:

| — | Per message, statistics on the total number of reports received from reporting platform operators for the mandatory automatic exchange of information |
| --- | --- |

—

Per message, statistics on the total number of reports received from reporting platform operators for the mandatory automatic exchange of information

| — | Per message, statistics on the total number of reports received from each other Member State |
| --- | --- |

—

Per message, statistics on the total number of reports received from each other Member State

| — | Per reportable seller, statistics on reportable seller type, taxpayer identification number or functional equivalent, Member State of residence of reportable seller and reason for exchange; Member State of residence of reportable seller and/or Member State in which the immovable property is located |
| --- | --- |

—

Per reportable seller, statistics on reportable seller type, taxpayer identification number or functional equivalent, Member State of residence of reportable seller and reason for exchange; Member State of residence of reportable seller and/or Member State in which the immovable property is located

| — | Per reporting platform operator, statistics on relevant activity type and consideration and type of property listing. |
| --- | --- |

—

Per reporting platform operator, statistics on relevant activity type and consideration and type of property listing.

‘ANNEX XVI

Form referred to in Article 2f(1)

The form to be used for the communication of information on Excluded Platform Operators pursuant to Article 8ac(6) of Directive 2011/16/EU and for the communication of information on Foreign Platform Operators pursuant to subparagraph F(2) and F(4) of Section IV of Annex V to Directive 2011/16/EU contains the following fields:

| (a) | Name of Excluded Platform Operator |
| --- | --- |

(a)

Name of Excluded Platform Operator

| (b) | postal address of Excluded Platform Operator |
| --- | --- |

(b)

postal address of Excluded Platform Operator

| (c) | electronic address, including websites of Excluded Platform Operator |
| --- | --- |

(c)

electronic address, including websites of Excluded Platform Operator

| (d) | any TIN issued to the Excluded Platform Operator, if available |
| --- | --- |

(d)

any TIN issued to the Excluded Platform Operator, if available

| (e) | Member State where the demonstration in accordance with subparagraph A(3) of Section I of Annex V to Directive 2011/16/EU was provided to,; and |
| --- | --- |

(e)

Member State where the demonstration in accordance with subparagraph A(3) of Section I of Annex V to Directive 2011/16/EU was provided to,; and

| (f) | fiscal year from which the status of Excluded Platform Operator was granted. |
| --- | --- |

(f)

fiscal year from which the status of Excluded Platform Operator was granted.

Format of the individual identification number for Foreign Platform Operators

The individual identification number shall be composed of the following 12-digit format, CCYYYYXXXXXX where: CC is the ISO Country Code of the Member State issuing the individual identification number; YYYY is the year where the Foreign Platform Operator registers with the Member State of single registration; and XXXXXX is a unique string of characters composed of letters and/or numbers.

Retention period for certain information deleted or removed from the central register

| 1. | Where the registration of a Reporting Platform Operator within the meaning of point (b) of subparagraph A(4) of Section I of Annex V to Directive 2011/16/EU, as amended by Directive (EU) 2021/514 is revoked in accordance with subparagraph F(7) of Section IV of Annex V to Directive 2011/16/EU, the Member State of single registration shall delete the Reporting Platform Operator from the central register. The central register shall retain the deleted information referred to in subparagraph F(2) and F(4) of Section IV of Annex V to Directive 2011/16/EU for no longer than 12 months from the date of deletion. |
| --- | --- |

1.

| 2. | Information recorded in the central register for Excluded Platform Operators will be removed where an Excluded Platform Operator within the meaning of subparagraph A(3) of Section I of Annex V to Directive 2011/16/EU as amended by Directive (EU) 2021/514 does not demonstrate, upfront and on an annual basis, to the satisfaction of the competent authority of the Member State to which, in accordance with the rules laid down in subparagraphs A(1) to A(3) of Section III of Annex V to Directive 2011/16/EU, the Platform Operator otherwise would have had to report that Platform’s entire business model is such that it does not have Reportable Sellers. The central register shall retain the removed information referred to in Annex XVI, points (a) to (f) of this Regulation for no longer than 12 months from the date of the removal of the recorded information. |
| --- | --- |

2.

---

(1)  However, only the elements and attributes actually applicable in a given case further to the performance of the due diligence and reporting rules included in Section II and Section III of Annex V of Council Directive 2011/16/EU, as amended by Council Directive (EU) 2021/514 need to appear in the computerised format used in that case.

1

---

| 6.9.2022 | EN | Official Journal of the European Union | L 231/101 |
| --- | --- | --- | --- |

6.9.2022

EN

Official Journal of the European Union

L 231/101

---

COMMISSION IMPLEMENTING REGULATION (EU) 2022/1468

of 5 September 2022

amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance penflufen and repealing Implementing Regulation (EU) 2018/185

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 21(3), second alternative in conjunction with Article 6 thereof, and Article 78(2) thereof,

Whereas:

| (1) | Commission Implementing Regulation (EU) No 1031/2013 (2) approved the active substance penflufen and added it to Part B of the Annex to Commission Implementing Regulation (EU) No 540/2011 (3), subject to certain conditions, requiring, in particular, the submission of confirmatory information in accordance with Article 6 of Regulation (EC) No 1107/2009. |
| --- | --- |

(1)

Commission Implementing Regulation (EU) No 1031/2013 (2) approved the active substance penflufen and added it to Part B of the Annex to Commission Implementing Regulation (EU) No 540/2011 (3), subject to certain conditions, requiring, in particular, the submission of confirmatory information in accordance with Article 6 of Regulation (EC) No 1107/2009.

| (2) | Commission Implementing Regulation (EU) 2018/185 (4) amended the conditions of approval of the active substance penflufen and addressed part of the confirmatory information required by Implementing Regulation (EU) No 1031/2013. |
| --- | --- |

(2)

Commission Implementing Regulation (EU) 2018/185 (4) amended the conditions of approval of the active substance penflufen and addressed part of the confirmatory information required by Implementing Regulation (EU) No 1031/2013.

| (3) | Implementing Regulation (EU) No 1031/2013 also provides for the submission of further confirmatory information as regards the relevance of the metabolite M01 (penflufen-3-hydroxy-butyl) for groundwater if penflufen is classified, under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (5), as ‘carcinogen category 2’ within 6 months from the notification of the classification decision concerning that substance. |
| --- | --- |

(3)

Implementing Regulation (EU) No 1031/2013 also provides for the submission of further confirmatory information as regards the relevance of the metabolite M01 (penflufen-3-hydroxy-butyl) for groundwater if penflufen is classified, under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (5), as ‘carcinogen category 2’ within 6 months from the notification of the classification decision concerning that substance.

| (4) | On 15 October 2018, the European Chemical Agency’s Committee for Risk Assessment adopted an opinion (6)in which it concludedthat penflufen should be classified as ‘carcinogen category 2’. Following that opinion, and since Member States agreed with such a classification, penflufen was included in the list of harmonised classification and labelling of hazardous substances provided for in Annex VI to Regulation (EC) No 1272/2008 (7). |
| --- | --- |

(4)

On 15 October 2018, the European Chemical Agency’s Committee for Risk Assessment adopted an opinion (6)in which it concludedthat penflufen should be classified as ‘carcinogen category 2’. Following that opinion, and since Member States agreed with such a classification, penflufen was included in the list of harmonised classification and labelling of hazardous substances provided for in Annex VI to Regulation (EC) No 1272/2008 (7).

| (5) | On 15 March 2019, the applicant informed Poland, the rapporteur Member State, that it would not submit the required confirmatory information, which was only relevant for the representative use to treat seed potato tubers before or during planting. |
| --- | --- |

(5)

On 15 March 2019, the applicant informed Poland, the rapporteur Member State, that it would not submit the required confirmatory information, which was only relevant for the representative use to treat seed potato tubers before or during planting.

| (6) | Since the information required in accordance with Article 6(f) of Regulation (EC) No 1107/2009 has not been provided, the Commission informed the Member States, the Authority and the producer of the active substance penflufen that a Regulation will be proposed to withdraw the approval or to amend the conditions of approval of penflufen. |
| --- | --- |

(6)

Since the information required in accordance with Article 6(f) of Regulation (EC) No 1107/2009 has not been provided, the Commission informed the Member States, the Authority and the producer of the active substance penflufen that a Regulation will be proposed to withdraw the approval or to amend the conditions of approval of penflufen.

| (7) | On 19 February 2021 the applicant was given the possibility to submit comments and any relevant information to the Commission. The applicant submitted its comments confirming that it would not submit the confirmatory information requested. |
| --- | --- |

(7)

On 19 February 2021 the applicant was given the possibility to submit comments and any relevant information to the Commission. The applicant submitted its comments confirming that it would not submit the confirmatory information requested.

| (8) | The Commission has concluded that the available data is not sufficient to determine the relevance of the metabolite M01 (penflufen-3-hydroxy-butyl), which is predicted to occur above 0,1 μg/L in all relevant groundwater scenarios when seed potato tubers treated with penflufen are planted, as the information required in Implementing Regulation (EU) No 1031/2013 has not been provided. |
| --- | --- |

(8)

The Commission has concluded that the available data is not sufficient to determine the relevance of the metabolite M01 (penflufen-3-hydroxy-butyl), which is predicted to occur above 0,1 μg/L in all relevant groundwater scenarios when seed potato tubers treated with penflufen are planted, as the information required in Implementing Regulation (EU) No 1031/2013 has not been provided.

| (9) | Therefore, it is necessary and appropriate to restrict the approval of penflufen and prohibit the treatment of seed potato tubers before or during planting, while it is possible to maintain the use of penflufen to treat cereal seeds, since safe uses have been demonstrated. |
| --- | --- |

(9)

Therefore, it is necessary and appropriate to restrict the approval of penflufen and prohibit the treatment of seed potato tubers before or during planting, while it is possible to maintain the use of penflufen to treat cereal seeds, since safe uses have been demonstrated.

| (10) | The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
| --- | --- |

(10)

The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

| (11) | For the sake of clarity, and since the amendments made by this Regulation make Implementing Regulation (EU) 2018/185 redundant, it is also appropriate to repeal Implementing Regulation (EU) 2018/185. |
| --- | --- |

(11)

For the sake of clarity, and since the amendments made by this Regulation make Implementing Regulation (EU) 2018/185 redundant, it is also appropriate to repeal Implementing Regulation (EU) 2018/185.

| (12) | Member States should be provided with sufficient time to amend or withdraw authorisations for plant protection products containing penflufen which are not complying with the restricted conditions of approval. |
| --- | --- |

(12)

Member States should be provided with sufficient time to amend or withdraw authorisations for plant protection products containing penflufen which are not complying with the restricted conditions of approval.

| (13) | For plant protection products containing penflufen, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, this period should expire at the latest 12 months after the entry into force of this Regulation. |
| --- | --- |

(13)

For plant protection products containing penflufen, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, this period should expire at the latest 12 months after the entry into force of this Regulation.

| (14) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(14)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Amendmentto Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.

Article 2

Repeal of Implementing Regulation (EU) 2018/185

Implementing Regulation (EU) 2018/185 is repealed.

Article 3

Transitional measures

Member States shall, where necessary, amend or withdraw existing authorisations for plant protection products containing penflufen as active substance by 26 March 2023.

Article 4

Grace period

Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire on 26 September 2023 at the latest.

Article 5

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.

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

Done at Brussels, 5 September 2022.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 309, 24.11.2009, p. 1.

1

(2)  Commission Implementing Regulation (EU) No 1031/2013 of 24 October 2013 approving the active substance penflufen, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 283, 25.10.2013, p. 17).

2

(3)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

3

(4)  Commission Implementing Regulation (EU) 2018/185 of 7 February 2018 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance penflufen (OJ L 34, 8.2.2018, p. 13).

4

(5)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

5

(6)  Opinion of 15 October 2018 concerning 5-fluoro-1,3-dimethyl-N-[2-(4-methylpentan-2-yl)phenyl]-1Hpyrazole-4-carboxamide;2'-[(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide; penflufen (CLH-O-0000001412-86-233/F).

6

(7)  See Commission Delegated Regulation (EU) 2020/1182 of 19 May 2020 amending, for the purposes of its adaptation to technical and scientific progress, Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ L 261, 11.8.2020, p. 2).

7

---

ANNEX

In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the column ‘Specific provisions’ of entry 55, on penflufen, is replaced by the following:

‘PART A

Only uses to treat cereal seeds before or during sowing may be authorised, limited to one application every third year on the same field.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on penflufen, and in particular Appendices I and II thereof, shall be taken into account.

In this overall assessment, Member States shall pay particular attention to:

| (a) | the protection of operators; |
| --- | --- |

(a)

the protection of operators;

| (b) | the protection of birds; |
| --- | --- |

(b)

the protection of birds;

| (c) | the protection of groundwater, when the substance is applied to regions with vulnerable soil and/or climatic conditions; |
| --- | --- |

(c)

the protection of groundwater, when the substance is applied to regions with vulnerable soil and/or climatic conditions;

| (d) | to the residues in surface water abducted for drinking water purposes, in or from areas where products containing penflufen are used. |
| --- | --- |

(d)

to the residues in surface water abducted for drinking water purposes, in or from areas where products containing penflufen are used.

Conditions of use shall include risk mitigation measures, where appropriate.’

---

| 6.9.2022 | EN | Official Journal of the European Union | L 231/105 |
| --- | --- | --- | --- |

6.9.2022

EN

Official Journal of the European Union

L 231/105

---

COMMISSION IMPLEMENTING REGULATION (EU) 2022/1469

of 5 September 2022

concerning the authorisation of L-lysine sulphate produced by Escherichia coli CGMCC 7.398 as a feed additive for all animal species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation. |
| --- | --- |

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation.

| (2) | In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-lysine sulphate produced by Escherichia coli CGMCC 7.398. The application was accompanied by the particulars and documents required under Article 7(3) of that Regulation. |
| --- | --- |

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-lysine sulphate produced by Escherichia coli CGMCC 7.398. The application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.

| (3) | The application concerns the authorisation of L-lysine sulphate produced by Escherichia coli CGMCC 7.398 as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’. |
| --- | --- |

(3)

The application concerns the authorisation of L-lysine sulphate produced by Escherichia coli CGMCC 7.398 as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 23 March 2022 (2) that, under the proposed conditions of use L-lysine sulphate produced by Escherichia coli CGMCC 7.398, when supplemented to diets in appropriate amounts, does not have an adverse effect on animal health, consumer safety or the environment. With respect to the safety of the user of that additive, the Authority could not conclude on the potential of L-lysine sulphate to be irritant to skin or eyes, or on its potential to be a dermal sensitiser. The endotoxin activity of the additive represents a risk of exposure by inhalation to endotoxins for persons handling the additive. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. Further, the Authority concluded that the additive is considered an efficacious source of the essential amino acid L-lysine for animal nutrition and that in order to be efficacious in ruminants, it should be protected against degradation in the rumen. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 23 March 2022 (2) that, under the proposed conditions of use L-lysine sulphate produced by Escherichia coli CGMCC 7.398, when supplemented to diets in appropriate amounts, does not have an adverse effect on animal health, consumer safety or the environment. With respect to the safety of the user of that additive, the Authority could not conclude on the potential of L-lysine sulphate to be irritant to skin or eyes, or on its potential to be a dermal sensitiser. The endotoxin activity of the additive represents a risk of exposure by inhalation to endotoxins for persons handling the additive. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. Further, the Authority concluded that the additive is considered an efficacious source of the essential amino acid L-lysine for animal nutrition and that in order to be efficacious in ruminants, it should be protected against degradation in the rumen. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | The assessment of L-lysine sulphate produced by Escherichia coli CGMCC 7.398 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this substance should be authorised as specified in the Annex to this Regulation. |
| --- | --- |

(5)

The assessment of L-lysine sulphate produced by Escherichia coli CGMCC 7.398 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this substance should be authorised as specified in the Annex to this Regulation.

| (6) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(6)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, is authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2

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

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

Done at Brussels, 5 September 2022.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 268, 18.10.2003, p. 29.

1

(2)  EFSA Journal 2022;20(4):7246.

2

EFSA Journal

---

ANNEX

| Identification number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method. | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg additive/kg of complete feed with a moisture content of 12 % |
| Category: nutritional additives. Functional group: amino acids, their salts and analogues. |
| 3c323i | | L-lysine sulphate | Additive composition

  Preparation of L-lysine with a content of:






  — | lysine ≥ 55,0 % |

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method.

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg additive/kg of complete feed with a moisture content of 12 %

Category: nutritional additives. Functional group: amino acids, their salts and analogues.

3c323i

L-lysine sulphate

Additive composition

Preparation of L-lysine with a content of:

—

lysine ≥ 55,0 %

| — | sulphate ≥ 18,0 % |
| --- | --- |

—

sulphate ≥ 18,0 %

Solid form

All species

-

-

10 000

| 1. | The L-lysine content shall be indicated on the labelling of the additive. |
| --- | --- |

1.

The L-lysine content shall be indicated on the labelling of the additive.

| 2. | Declarations to be made on the labelling of the additive and premixtures: ‘The supplementation with L-lysine should take into account all essential and conditional essential amino acids in order to avoid imbalances.’ |
| --- | --- |

2.

Declarations to be made on the labelling of the additive and premixtures: ‘The supplementation with L-lysine should take into account all essential and conditional essential amino acids in order to avoid imbalances.’

| 3. | The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1 600 IU endotoxins/m3 air (2). |
| --- | --- |

3.

The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1 600 IU endotoxins/m3 air (2).

| 4. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation. Where those risks cannot be eliminated or reduced to a minimum level by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eyes and breathing protection. |
| --- | --- |

4.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation. Where those risks cannot be eliminated or reduced to a minimum level by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eyes and breathing protection.

26.9.2032

Characterisation of the active substance

L-lysine sulphate produced by fermentation with Escherichia coli CGMCC 7.398

Chemical formula: C12H28N4O4-O4S

CAS number: 60343-69-3

Analytical methods
   (1)

For the quantification of lysine in the feed additive and premixtures containing more than 10 % lysine:

| — | ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) – EN ISO 17180 |
| --- | --- |

—

ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) – EN ISO 17180

For the identification of sulphate in the feed additive:

| — | European Pharmacopoeia Monograph 20301 |
| --- | --- |

—

European Pharmacopoeia Monograph 20301

For the quantification of lysine in premixtures, compound feed and feed materials:

| — | ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) – Commission Regulation (EC) No 152/2009 (Annex III, F). |
| --- | --- |

—

ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) – Commission Regulation (EC) No 152/2009 (Annex III, F).

---

(1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(2)  Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA (EFSA Journal 2018;16(10):5458); analytical method: European Pharmacopoeia 2.6.14. (bacterial endotoxins).

---

| 6.9.2022 | EN | Official Journal of the European Union | L 231/109 |
| --- | --- | --- | --- |

6.9.2022

EN

Official Journal of the European Union

L 231/109

---

COMMISSION IMPLEMENTING REGULATION (EU) 2022/1470

of 5 September 2022

concerning the authorisation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum CBS 139997 and alpha-galactosidase produced by Aspergillus tubingensis ATCC SD 6740 as a feed additive for chickens for fattening, chickens reared for laying, minor poultry species for fattening and reared for laying, and ornamental birds (holder of the authorisation Industrial Técnica Pecuaria S.A.)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. |
| --- | --- |

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

| (2) | In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum CBS 139997 and alpha-galactosidase produced by Aspergillus tubingensis ATCC SD 6740. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum CBS 139997 and alpha-galactosidase produced by Aspergillus tubingensis ATCC SD 6740. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | The application concerns the authorisation of the preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum CBS 139997 and alpha-galactosidase produced by Aspergillus tubingensis ATCC SD 6740 as feed additive for chickens for fattening, chickens reared for laying, minor poultry species for fattening and reared for laying, and ornamental birds, to be classified in the additive category ‘zootechnical additives’ and the functional group ‘digestibility enhancers’. |
| --- | --- |

(3)

The application concerns the authorisation of the preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum CBS 139997 and alpha-galactosidase produced by Aspergillus tubingensis ATCC SD 6740 as feed additive for chickens for fattening, chickens reared for laying, minor poultry species for fattening and reared for laying, and ornamental birds, to be classified in the additive category ‘zootechnical additives’ and the functional group ‘digestibility enhancers’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinions of 19 March 2020 (2) and 10 November 2021 (3) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum CBS 139997 and alpha-galactosidase produced by Aspergillus tubingensis ATCC SD 6740 does not have an adverse effect on animal health, consumer safety or the environment. Due to the lack of data, the Authority couldn’t conclude on the skin or eye irritation potential of the preparation nor on its skin sensitisation potential. Owing to the proteinaceous nature of the preparation, it should be regarded as a potential respiratory sensitiser, but the exposure is presumed to be limited due to the low dusting potential. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 19 March 2020 (2) and 10 November 2021 (3) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum CBS 139997 and alpha-galactosidase produced by Aspergillus tubingensis ATCC SD 6740 does not have an adverse effect on animal health, consumer safety or the environment. Due to the lack of data, the Authority couldn’t conclude on the skin or eye irritation potential of the preparation nor on its skin sensitisation potential. Owing to the proteinaceous nature of the preparation, it should be regarded as a potential respiratory sensitiser, but the exposure is presumed to be limited due to the low dusting potential. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive.

| (5) | The Authority further concluded that the preparation has a potential to be efficacious as a zootechnical additive for the requested target species. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| --- | --- |

(5)

The Authority further concluded that the preparation has a potential to be efficacious as a zootechnical additive for the requested target species. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (6) | The assessment of the preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum CBS 139997 and alpha-galactosidase produced by Aspergillus tubingensis ATCC SD 6740 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation. |
| --- | --- |

(6)

The assessment of the preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum CBS 139997 and alpha-galactosidase produced by Aspergillus tubingensis ATCC SD 6740 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

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

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

Done at Brussels, 5 September 2022.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 268, 18.10.2003, p. 29.

1

(2)  EFSA Journal 2020;18(4):6086.

2

EFSA Journal

(3)  EFSA Journal 2021;19(12):6981.

3

EFSA Journal

---

ANNEX

| Identification number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Units of activity/kg of complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: digestibility enhancers |
| 4a33 | Industrial Técnica Pecuaria S.A | Endo-1,4-beta- xylanase and alpha-galactosidase | Additive composition

  Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma longibrachiatum CBS 139997 and alpha-galactosidase (EC, 3.2.1.22) produced by Aspergillus tubingensis ATCC SD 6740 having a minimum enzyme activity of:
  50 AXC (1)/g of additive and 40 GALU/g (2) of additive
  Solid form | Chickens for fattening,
  Chickens reared for laying
  Minor poultry species for fattening and reared for laying
  Ornamental birds | - | 18 AXC
  14 GALU | - | 1. | In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. |

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Units of activity/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers

4a33

Industrial Técnica Pecuaria S.A

Endo-1,4-beta- xylanase and alpha-galactosidase

Additive composition

Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma longibrachiatum CBS 139997 and alpha-galactosidase (EC, 3.2.1.22) produced by Aspergillus tubingensis ATCC SD 6740 having a minimum enzyme activity of:

50 AXC (1)/g of additive and 40 GALU/g (2) of additive

Solid form

Chickens for fattening,

Chickens reared for laying

Minor poultry species for fattening and reared for laying

Ornamental birds

-

18 AXC

14 GALU

-

1.

In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.

| 2. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eyes and breathing protection. |
| --- | --- |

2.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eyes and breathing protection.

26.9.2032

Characterisation of active substance

Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma longibrachiatum CBS 139997 and a-galactosidase (EC 3.2.1.22) produced by Aspergillus tubingensis ATCC SD 6740

Analytical method
   (3)

For the quantification of endo-1,4-beta-xylanase in the feed additive, premixtures and feedingstuffs:

| — | colorimetric method based enzymatic reaction of endo-1,4-beta-xylanase i) on a wheat arabinoxylan substrate (for the feed additive and premixtures) and ii) on an azo-xylan substrate (for feedingstuffs). |
| --- | --- |

—

colorimetric method based enzymatic reaction of endo-1,4-beta-xylanase i) on a wheat arabinoxylan substrate (for the feed additive and premixtures) and ii) on an azo-xylan substrate (for feedingstuffs).

For the quantification of alpha-galactosidase in the feed additive, premixtures and feedingstuffs:

| — | colorimetric method based on the enzymatic reaction of alpha-galactosidase on the para-nitrophenyl-alpha-D-galactopyranoside substrate |
| --- | --- |

—

colorimetric method based on the enzymatic reaction of alpha-galactosidase on the para-nitrophenyl-alpha-D-galactopyranoside substrate

---

(1)  1Unit of endo-1,4-beta-xylanase activity (AXC) is the amount of enzyme, which liberates 0,058 micromoles per minute of reducing sugars, expressed as xylose equivalents, from a wheat arabinoxylan substrate at pH 4,7 and 30 °C.

(2)  1Unit of alpha-galactosidase activity (GALU) is defined as the amount of enzyme which degrades one micromole per minute of para-nitrophenyl-alpha-D-galactopyranoside at pH 5,5 and 37 °C.

(3)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

---

| 6.9.2022 | EN | Official Journal of the European Union | L 231/113 |
| --- | --- | --- | --- |

6.9.2022

EN

Official Journal of the European Union

L 231/113

---

COMMISSION IMPLEMENTING REGULATION (EU) 2022/1471

of 5 September 2022

concerning the authorisation of lanthanum carbonate octahydrate as a feed additive for cats (holder of authorisation Porus GmbH)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation. |
| --- | --- |

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation.

| (2) | In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of lanthanum carbonate octahydrate. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of lanthanum carbonate octahydrate. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | That application concerns the authorisation of lanthanum carbonate octahydrate as a feed additive for cats to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘other zootechnical additives’. |
| --- | --- |

(3)

That application concerns the authorisation of lanthanum carbonate octahydrate as a feed additive for cats to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘other zootechnical additives’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 January 2022 (2) that, under the proposed conditions of use, lanthanum carbonate octahydrate does not have an adverse effect on animal health. The Authority concluded that the additive has a potential to be efficacious as a zootechnical additive in cats. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 January 2022 (2) that, under the proposed conditions of use, lanthanum carbonate octahydrate does not have an adverse effect on animal health. The Authority concluded that the additive has a potential to be efficacious as a zootechnical additive in cats. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | The assessment of the lanthanum carbonate octahydrate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. |
| --- | --- |

(5)

The assessment of the lanthanum carbonate octahydrate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.

| (6) | The use of that preparation should therefore be authorised as specified in the Annex to this Regulation. |
| --- | --- |

(6)

The use of that preparation should therefore be authorised as specified in the Annex to this Regulation.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

The additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

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

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

Done at Brussels, 5 September 2022.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 268, 18.10.2003, p. 29.

1

(2)  EFSA Journal 2022;20(2):7168.

2

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ANNEX

| Identification number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: other zootechnical additives (decrease in phosphorous excretion via urine) |
| 4d23 | Porus GmbH | Lanthanum carbonate octahydrate | Additive composition

  Preparation of lanthanum carbonate octahydrate having at least 85 % lanthanum carbonate octahydrate as active substance.
  Solid form

  Characterisation of the active substance

  Lanthanum carbonate octahydrate
  La2(CO3)3*8H2O
  CAS number 6487-39-4

  Analytical method
   (1)

  For the quantification of carbonate in the feed additive:
  EU method Commission Regulation (EC) No 152/2009 (Annex III, O)
  For the quantification of lanthanum in the feed additive and feedingstuffs:
  Inductively coupled plasma-atomic emission spectrometry (ICP-AES) | Cats | - | 1 500 | 7 500 | 1. | In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. |

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: other zootechnical additives (decrease in phosphorous excretion via urine)

4d23

Porus GmbH

Lanthanum carbonate octahydrate

Additive composition

Preparation of lanthanum carbonate octahydrate having at least 85 % lanthanum carbonate octahydrate as active substance.

Solid form

Characterisation of the active substance

Lanthanum carbonate octahydrate

La2(CO3)3*8H2O

CAS number 6487-39-4

Analytical method
   (1)

For the quantification of carbonate in the feed additive:

EU method Commission Regulation (EC) No 152/2009 (Annex III, O)

For the quantification of lanthanum in the feed additive and feedingstuffs:

Inductively coupled plasma-atomic emission spectrometry (ICP-AES)

Cats

-

1 500

7 500

1.

In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.

| 2. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. |
| --- | --- |

2.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

| 3. | In the directions for use of the additive, the following shall be indicated:
  ‘Avoid simultaneous use of feeds with high level of phosphorus.’ |
| --- | --- |

3.

In the directions for use of the additive, the following shall be indicated:

‘Avoid simultaneous use of feeds with high level of phosphorus.’

26 September 2032

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(1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

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| 6.9.2022 | EN | Official Journal of the European Union | L 231/116 |
| --- | --- | --- | --- |

6.9.2022

EN

Official Journal of the European Union

L 231/116

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COMMISSION IMPLEMENTING REGULATION (EU) 2022/1472

of 5 September 2022

concerning the authorisation of manganese lysinate sulphate as a feed additive for all animal species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation. |
| --- | --- |

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation.

| (2) | In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of manganese lysinate sulphate. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of manganese lysinate sulphate. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | The application concerns the authorisation of manganese lysinate sulphate as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’ and the functional group ‘compounds of trace elements’. |
| --- | --- |

(3)

The application concerns the authorisation of manganese lysinate sulphate as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’ and the functional group ‘compounds of trace elements’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 January 2022 (2) that, under the proposed conditions of use, manganese lysinate sulphate does not have an adverse effect on animal health, consumer safety or the environment. The Authority further concluded that the handling of the substance poses a risk to users by inhalation and that it is irritant to eyes and skin and should be considered a dermal sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the substance is efficacious in chickens for fattening; this conclusion can be extended to all other animal species. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 January 2022 (2) that, under the proposed conditions of use, manganese lysinate sulphate does not have an adverse effect on animal health, consumer safety or the environment. The Authority further concluded that the handling of the substance poses a risk to users by inhalation and that it is irritant to eyes and skin and should be considered a dermal sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the substance is efficacious in chickens for fattening; this conclusion can be extended to all other animal species. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | The assessment of manganese lysinate sulphate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation. |
| --- | --- |

(5)

The assessment of manganese lysinate sulphate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation.

| (6) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(6)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

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

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

Done at Brussels, 5 September 2022.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  OJ L 268, 18.10.2003, p. 29.

1

(2)  EFSA Journal 2022;20(3):7165.

2

EFSA Journal

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ANNEX

| Identification number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Content of element (Mn) in mg/kg of complete feed with a moisture content of 12 % |
| Category of nutritional additives. Functional group: compounds of trace elements. |
| 3b511 | - | Manganese lysinate sulphate | Additive composition

  Manganese and amino acid L-lysine: ratio of 1:1
  (monohydrate) having a content of:






  — | manganese 16 % – 18 %; |

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Content of element (Mn) in mg/kg of complete feed with a moisture content of 12 %

Category of nutritional additives. Functional group: compounds of trace elements.

3b511

-

Manganese lysinate sulphate

Additive composition

Manganese and amino acid L-lysine: ratio of 1:1

(monohydrate) having a content of:

—

manganese 16 % – 18 %;

| — | lysine 44 % – 47 %; |
| --- | --- |

—

lysine 44 % – 47 %;

| — | sulphate 27 % – 31 % (calculated from sulphur), |
| --- | --- |

—

sulphate 27 % – 31 % (calculated from sulphur),

Solid form (≤ 10 % moisture)

All animal species other than fish

-

-

150 (total)

| 1. | The additive shall be incorporated into feed in the form of a premixture. |
| --- | --- |

1.

The additive shall be incorporated into feed in the form of a premixture.

| 2. | For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including breathing, skin and eye protection. |
| --- | --- |

2.

For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including breathing, skin and eye protection.

26.9.2032

Characterisation of the active substances

Chemical formulas:

C6H16MnN2O7S

IUPAC: monoaquamonolysinatomanganese (II) sulphate

Fish

100 (total)

Analytical methods
   (1)

For the quantification of total manganese in the feed additive, premixtures and feedingstuffs:

| — | Atomic Absorption Spectrometry (AAS) – ISO 6869; or |
| --- | --- |

—

Atomic Absorption Spectrometry (AAS) – ISO 6869; or

| — | Inductively Coupled Plasma-Atomic Emission Spectrometry after pressure digestion (ICP-AES) – EN 15621; or |
| --- | --- |

—

Inductively Coupled Plasma-Atomic Emission Spectrometry after pressure digestion (ICP-AES) – EN 15621; or

| — | Inductively Coupled Plasma-Atomic Emission Spectrometry (ICP-AES) – EN 15510; or |
| --- | --- |

—

Inductively Coupled Plasma-Atomic Emission Spectrometry (ICP-AES) – EN 15510; or

| — | Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) – EN 17053 (for premixtures and feedingstuffs only); or |
| --- | --- |

—

Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) – EN 17053 (for premixtures and feedingstuffs only); or

| — | Atomic Absorption Spectrometry (AAS) – Commission Regulation (EC) No 152/2009 (for feedingstuffs only) |
| --- | --- |

—

Atomic Absorption Spectrometry (AAS) – Commission Regulation (EC) No 152/2009 (for feedingstuffs only)

For the quantification of lysine in the feed additive:

| — | ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS/FLD) – EN ISO 17180 |
| --- | --- |

—

ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS/FLD) – EN ISO 17180

For the identification of sulphate in the feed additive:

| — | European Pharmacopoeia monograph 20301 |
| --- | --- |

—

European Pharmacopoeia monograph 20301

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(1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

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