# Official Journal L 24/2023

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 24 |
| | |
| English edition | Legislation | Volume 6626 January 2023 |

ISSN 1977-0677

Official Journal

of the European Union

L 24

English edition

Legislation

Volume 6626 January 2023

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Delegated Regulation (EU) 2023/166 of 26 October 2022 correcting the French language version of Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin (
  1
  ) | 1 |
| | * | Commission Delegated Regulation (EU) 2023/167 of 3 November 2022 amending Delegated Regulation (EU) 2020/256 establishing a multiannual rolling planning (
  1
  ) | 3 |
| | * | Commission Implementing Regulation (EU) 2023/168 of 25 January 2023 establishing the template for the annual performance reports on the Instrument for Financial Support for Border Management and Visa Policy for the 2021-2027 programming period, pursuant to Regulation (EU) 2021/1148 of the European Parliament and of the Council | 7 |
| | * | Commission Implementing Regulation (EU) 2023/169 of 25 January 2023 establishing the template for the annual performance reports on the Asylum, Migration and Integration Fund for the 2021-2027 programming period, pursuant to Regulation (EU) 2021/1147 of the European Parliament and of the Council | 16 |
| | * | Commission Implementing Regulation (EU) 2023/170 of 25 January 2023 establishing the template for the annual performance reports on the Internal Security Fund for the 2021-2027 programming period, pursuant to Regulation (EU) 2021/1149 of the European Parliament and of the Council | 24 |
| | | DIRECTIVES |
| | * | Commission Delegated Directive (EU) 2023/171 of 28 October 2022 amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for hexavalent chromium as an anticorrosion agent in gas absorption heat pumps (
  1
  ) | 33 |
| | | DECISIONS |
| | * | Commission Implementing Decision (EU) 2023/172 of 24 January 2023 amending Implementing Decision 2012/715/EU as regards the inclusion of Canada in the list of third countries established by that Decision (
  1
  ) | 37 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Delegated Regulation (EU) 2023/166 of 26 October 2022 correcting the French language version of Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin (
  1
  )

1

1

*

Commission Delegated Regulation (EU) 2023/167 of 3 November 2022 amending Delegated Regulation (EU) 2020/256 establishing a multiannual rolling planning (
  1
  )

1

3

*

Commission Implementing Regulation (EU) 2023/168 of 25 January 2023 establishing the template for the annual performance reports on the Instrument for Financial Support for Border Management and Visa Policy for the 2021-2027 programming period, pursuant to Regulation (EU) 2021/1148 of the European Parliament and of the Council

7

*

Commission Implementing Regulation (EU) 2023/169 of 25 January 2023 establishing the template for the annual performance reports on the Asylum, Migration and Integration Fund for the 2021-2027 programming period, pursuant to Regulation (EU) 2021/1147 of the European Parliament and of the Council

16

*

Commission Implementing Regulation (EU) 2023/170 of 25 January 2023 establishing the template for the annual performance reports on the Internal Security Fund for the 2021-2027 programming period, pursuant to Regulation (EU) 2021/1149 of the European Parliament and of the Council

24

DIRECTIVES

*

Commission Delegated Directive (EU) 2023/171 of 28 October 2022 amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for hexavalent chromium as an anticorrosion agent in gas absorption heat pumps (
  1
  )

1

33

DECISIONS

*

Commission Implementing Decision (EU) 2023/172 of 24 January 2023 amending Implementing Decision 2012/715/EU as regards the inclusion of Canada in the list of third countries established by that Decision (
  1
  )

1

37

| | |
| --- | --- |
| | (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

| 26.1.2023 | EN | Official Journal of the European Union | L 24/1 |
| --- | --- | --- | --- |

26.1.2023

EN

Official Journal of the European Union

L 24/1

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COMMISSION DELEGATED REGULATION (EU) 2023/166

of 26 October 2022

correcting the French language version of Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin

(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 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (1), and in particular Article 10(1) thereof,

Whereas:

| (1) | The French language version of Regulation (EC) No 853/2004 contains an error in section I, chapter IV, point 18(a)(ii) of Annex III as regards the absence of an obligation to empty, scald or bleach stomachs. |
| --- | --- |

(1)

The French language version of Regulation (EC) No 853/2004 contains an error in section I, chapter IV, point 18(a)(ii) of Annex III as regards the absence of an obligation to empty, scald or bleach stomachs.

| (2) | The French language version of Regulation (EC) No 853/2004 should therefore be corrected accordingly. The other language versions are not affected, |
| --- | --- |

(2)

The French language version of Regulation (EC) No 853/2004 should therefore be corrected accordingly. The other language versions are not affected,

HAS ADOPTED THIS REGULATION:

Article 1

(does not concern the English language)

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, 26 October 2022.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 139, 30.4.2004, p. 55.

1

---

| 26.1.2023 | EN | Official Journal of the European Union | L 24/3 |
| --- | --- | --- | --- |

26.1.2023

EN

Official Journal of the European Union

L 24/3

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COMMISSION DELEGATED REGULATION (EU) 2023/167

of 3 November 2022

amending Delegated Regulation (EU) 2020/256 establishing a multiannual rolling planning

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2019/1700 of the European Parliament and of the Council of 10 October 2019 establishing a common framework for European statistics relating to persons and households, based on data at individual level collected from samples, amending Regulations (EC) No 808/2004, (EC) No 452/2008 and (EC) No 1338/2008 of the European Parliament and of the Council, and repealing Regulation (EC) No 1177/2003 of the European Parliament and of the Council and Council Regulation (EC) No 577/98 (1), and in particular Article 4(1) thereof,

Whereas:

| (1) | Commission Delegated Regulation (EU) 2020/256 (2) established a multiannual rolling planning for the collection of data under Regulation (EU) 2019/1700 from 2021 to 2028. |
| --- | --- |

(1)

Commission Delegated Regulation (EU) 2020/256 (2) established a multiannual rolling planning for the collection of data under Regulation (EU) 2019/1700 from 2021 to 2028.

| (2) | To ensure that the multiannual rolling planning is effective and consistent with users’ needs, it is necessary to adapt it by specifying the ad hoc subject to be covered by the ad hoc module for 2025 of the European Survey on Income and Living Conditions (EU-SILC) as this was not known when Regulation (EU) 2020/256 was adopted. |
| --- | --- |

(2)

To ensure that the multiannual rolling planning is effective and consistent with users’ needs, it is necessary to adapt it by specifying the ad hoc subject to be covered by the ad hoc module for 2025 of the European Survey on Income and Living Conditions (EU-SILC) as this was not known when Regulation (EU) 2020/256 was adopted.

| (3) | The adaptations of the multiannual rolling planning are to enter into force no later than 24 months before the beginning of each data collection period as specified in the planning for annual or infra-annual data collection. |
| --- | --- |

(3)

The adaptations of the multiannual rolling planning are to enter into force no later than 24 months before the beginning of each data collection period as specified in the planning for annual or infra-annual data collection.

| (4) | Delegated Regulation (EU) 2020/256 should therefore be amended accordingly, |
| --- | --- |

(4)

Delegated Regulation (EU) 2020/256 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Delegated Regulation (EU) 2020/256 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on 31 December 2022.

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

Done at Brussels, 3 November 2022.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 261I, 14.10.2019, p. 1.

1

(2)  Commission Delegated Regulation (EU) 2020/256 of 16 December 2019 supplementing Regulation (EU) 2019/1700 of the European Parliament and of the Council by establishing a multiannual rolling planning (OJ L 54, 26.2.2020, p. 1).

2

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ANNEX

In Annex I to Delegated Regulation (EU) 2020/256, part B is replaced by the following:

‘
  Part B: Data collection periods for the domains having several periodicities

| Domains | Groups (acronyms) | Years of data collection |
| --- | --- | --- |
| 2021 | 2022 | 2023 | 2024 | 2025 | 2026 | 2027 | 2028 |
| Labour Force | Quarterly (LFQ) | Every quarter | Every quarter | Every quarter | Every quarter | Every quarter | Every quarter | Every quarter | Every quarter |
| Yearly (LFY) | X | X | X | X | X | X | X | X |
| ‘Reasons for migration’ and ‘working time arrangements’ (LF2YA) | X | | X | | X | | X | |
| ‘Participation in formal and non-formal education and training (12 months)’, ‘disability and other elements of Minimum European Health Module’ and ‘elements of the Minimum European Health Module’ (LF2YB) | | X | | X | | X | | X |
| Labour market situation of migrants and their immediate descendants (LF8YA) | X | | | | | | | |
| Pensions and labour market participation (LF8YB) | | | X | | | | | |
| ‘Young people on the labour market’ and ‘educational attainment – details, including education interrupted or abandoned’ (LF8YC) | | | | X | | | | |
| Reconciliation of work and family life (LF8YD) | | | | | X | | | |
| Work organisation and working time arrangements (LF8YE) | | | | | | | X | |
| Accidents at work and work-related health problems (LF8YF) | | | | | | | | X |
| Ad hoc Subject on job skills | | X | | | | | | |
| Ad hoc Subject (to be defined at a later stage) | | | | | | X | | |
| Income and Living Conditions | Yearly (ILCY) | X | X | X | X | X | X | X | X |
| Children (ILC3YA) | X | | | X | | | X | |
| Health (ILC3YB) | | X | | | X | | | X |
| Labour Market and Housing (ILC3YC) | | | X | | | X | | |
| Quality of life (ILC6YA) | | X | | | | | | X |
| Intergenerational transmission of disadvantages & Housing difficulties (ILC6YB) | | | X | | | | | |
| Access to services (ILC6YC) | | | | X | | | | |
| Over-indebtedness, consumption and wealth (ILC6YD) | | | | | | X | | |
| Ad hoc Subject on Living arrangements and conditions of children within separated or blended families | X | | | | | | | |
| Ad hoc Subject on Households energy efficiency | | | X | | | | | |
| Ad hoc Subject on Energy and the Environment | | | | | X | | | |
| Ad hoc Subject (to be defined at a later stage) | | | | | | | X’ | |

Domains

Groups (acronyms)

Years of data collection

2021

2022

2023

2024

2025

2026

2027

2028

Labour Force

Quarterly (LFQ)

Every quarter

Every quarter

Every quarter

Every quarter

Every quarter

Every quarter

Every quarter

Every quarter

Yearly (LFY)

X

X

X

X

X

X

X

X

‘Reasons for migration’ and ‘working time arrangements’ (LF2YA)

X

X

X

X

‘Participation in formal and non-formal education and training (12 months)’, ‘disability and other elements of Minimum European Health Module’ and ‘elements of the Minimum European Health Module’ (LF2YB)

X

X

X

X

Labour market situation of migrants and their immediate descendants (LF8YA)

X

Pensions and labour market participation (LF8YB)

X

‘Young people on the labour market’ and ‘educational attainment – details, including education interrupted or abandoned’ (LF8YC)

X

Reconciliation of work and family life (LF8YD)

X

Work organisation and working time arrangements (LF8YE)

X

Accidents at work and work-related health problems (LF8YF)

X

Ad hoc Subject on job skills

X

Ad hoc Subject (to be defined at a later stage)

X

Income and Living Conditions

Yearly (ILCY)

X

X

X

X

X

X

X

X

Children (ILC3YA)

X

X

X

Health (ILC3YB)

X

X

X

Labour Market and Housing (ILC3YC)

X

X

Quality of life (ILC6YA)

X

X

Intergenerational transmission of disadvantages & Housing difficulties (ILC6YB)

X

Access to services (ILC6YC)

X

Over-indebtedness, consumption and wealth (ILC6YD)

X

Ad hoc Subject on Living arrangements and conditions of children within separated or blended families

X

Ad hoc Subject on Households energy efficiency

X

Ad hoc Subject on Energy and the Environment

X

Ad hoc Subject (to be defined at a later stage)

X’

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| 26.1.2023 | EN | Official Journal of the European Union | L 24/7 |
| --- | --- | --- | --- |

26.1.2023

EN

Official Journal of the European Union

L 24/7

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COMMISSION IMPLEMENTING REGULATION (EU) 2023/168

of 25 January 2023

establishing the template for the annual performance reports on the Instrument for Financial Support for Border Management and Visa Policy for the 2021-2027 programming period, pursuant to Regulation (EU) 2021/1148 of the European Parliament and of the Council

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2021/1148 of the European Parliament and of the Council of 7 July 2021 establishing, as part of the Integrated Border Management Fund, the Instrument for Financial Support for Border Management and Visa Policy (1), and in particular Article 29(5) thereof,

After consulting the Home Affairs Funds Committee,

Whereas:

| (1) | Regulation (EU) 2021/1060 of the European Parliament and of the Council (2), together with the Regulations (EU) 2021/1147 (3), (EU) 2021/1148 and (EU) 2021/1149 of the European Parliament and of the Council (4) (‘Fund-specific Regulations’) establishing respectively the Asylum, Migration and Integration Fund, the Instrument for Financial Support for Border Management and Visa Policy and the Internal Security Fund, constitute a framework for Union funding contributing to the development of the area of freedom, security and justice. |
| --- | --- |

(1)

Regulation (EU) 2021/1060 of the European Parliament and of the Council (2), together with the Regulations (EU) 2021/1147 (3), (EU) 2021/1148 and (EU) 2021/1149 of the European Parliament and of the Council (4) (‘Fund-specific Regulations’) establishing respectively the Asylum, Migration and Integration Fund, the Instrument for Financial Support for Border Management and Visa Policy and the Internal Security Fund, constitute a framework for Union funding contributing to the development of the area of freedom, security and justice.

| (2) | Regulation (EU) 2021/1060, and in particular Article 41(7) thereof, requires Member States to submit an annual performance report to the Commission for each programme in accordance with the Fund-specific Regulations. |
| --- | --- |

(2)

Regulation (EU) 2021/1060, and in particular Article 41(7) thereof, requires Member States to submit an annual performance report to the Commission for each programme in accordance with the Fund-specific Regulations.

| (3) | To ensure uniform conditions in the implementation of annual reporting and that the information provided to the Commission is consistent and comparable, the Regulation (EU) 2021/1148 sets out the need to establish a template for the annual performance reports by means of an implementing act. |
| --- | --- |

(3)

To ensure uniform conditions in the implementation of annual reporting and that the information provided to the Commission is consistent and comparable, the Regulation (EU) 2021/1148 sets out the need to establish a template for the annual performance reports by means of an implementing act.

| (4) | In accordance with Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Ireland does not take part in Regulation (EU) 2021/1148. Therefore, Ireland is not bound by this Regulation. |
| --- | --- |

(4)

In accordance with Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Ireland does not take part in Regulation (EU) 2021/1148. Therefore, Ireland is not bound by this Regulation.

| (5) | In accordance with Article 4 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark implemented Regulation (EU) 2021/1148 in its national law. Therefore, Denmark is bound by this Regulation. |
| --- | --- |

(5)

In accordance with Article 4 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark implemented Regulation (EU) 2021/1148 in its national law. Therefore, Denmark is bound by this Regulation.

| (6) | As regards Iceland and Norway, this Regulation constitutes a development of the provisions of the Schengen acquis (5) within the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the latter’s association with the implementation, application and development of the Schengen acquis which fall within the area referred to in Article 1, Points A and B of Council Decision 1999/437/EC (6). |
| --- | --- |

(6)

As regards Iceland and Norway, this Regulation constitutes a development of the provisions of the Schengen acquis (5) within the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the latter’s association with the implementation, application and development of the Schengen acquis which fall within the area referred to in Article 1, Points A and B of Council Decision 1999/437/EC (6).

| (7) | However, pursuant to Article 7(6) of Regulation (EU) 2021/1148, participation of Iceland and Norway in the Instrument for Financial Support for Border Management and Visa Policy requires arrangements to specify the nature and modes of such participation in accordance with the relevant provisions of their respective association agreements. Therefore this Regulation should apply to Iceland and Norway only once such arrangements are concluded. |
| --- | --- |

(7)

However, pursuant to Article 7(6) of Regulation (EU) 2021/1148, participation of Iceland and Norway in the Instrument for Financial Support for Border Management and Visa Policy requires arrangements to specify the nature and modes of such participation in accordance with the relevant provisions of their respective association agreements. Therefore this Regulation should apply to Iceland and Norway only once such arrangements are concluded.

| (8) | As regards Switzerland, this Regulation constitutes a development of provisions of the Schengen acquis within the meaning of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis (7) which fall within the area referred to in Article 1, points A and B of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2008/146/EC (8). |
| --- | --- |

(8)

As regards Switzerland, this Regulation constitutes a development of provisions of the Schengen acquis within the meaning of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis (7) which fall within the area referred to in Article 1, points A and B of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2008/146/EC (8).

| (9) | However, pursuant to Article 7(6) of Regulation (EU) 2021/1148, participation of Switzerland in the Instrument for Financial Support for Border Management and Visa Policy requires arrangements to specify the nature and modes of such participation in accordance with the relevant provisions of its association agreement. Therefore this Regulation should apply to Switzerland only once such arrangements are concluded. |
| --- | --- |

(9)

However, pursuant to Article 7(6) of Regulation (EU) 2021/1148, participation of Switzerland in the Instrument for Financial Support for Border Management and Visa Policy requires arrangements to specify the nature and modes of such participation in accordance with the relevant provisions of its association agreement. Therefore this Regulation should apply to Switzerland only once such arrangements are concluded.

| (10) | As regards Liechtenstein, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on Liechtenstein’s association with the implementation, application and development of the Schengen acquis (9) which fall within the area referred to in Article 1, points A and B of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2011/350/EU (10). |
| --- | --- |

(10)

As regards Liechtenstein, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on Liechtenstein’s association with the implementation, application and development of the Schengen acquis (9) which fall within the area referred to in Article 1, points A and B of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2011/350/EU (10).

| (11) | However, pursuant to Article 7(6) of Regulation (EU) 2021/1148, participation of Liechtenstein in the Instrument for Financial Support for Border Management and Visa Policy requires arrangements to specify the nature and modes of such participation in accordance with the relevant provisions of its association agreement. Therefore this Regulation should apply to Liechtenstein only once such arrangements are concluded. |
| --- | --- |

(11)

However, pursuant to Article 7(6) of Regulation (EU) 2021/1148, participation of Liechtenstein in the Instrument for Financial Support for Border Management and Visa Policy requires arrangements to specify the nature and modes of such participation in accordance with the relevant provisions of its association agreement. Therefore this Regulation should apply to Liechtenstein only once such arrangements are concluded.

| (12) | To allow for the prompt application of the measures provided for in this Regulation and to ensure that there is no delay in the implementation of the programmes, this Regulation should enter into force on the third day following that of its publication in the Official Journal of the European Union. |
| --- | --- |

(12)

To allow for the prompt application of the measures provided for in this Regulation and to ensure that there is no delay in the implementation of the programmes, this Regulation should enter into force on the third day following that of its publication in the Official Journal of the European Union.

HAS ADOPTED THIS REGULATION:

Article 1

This Regulation establishes the template for the annual performance reports on the Instrument for Financial Support for Border Management and Visa Policy referred to in Article 41(7) of Regulation (EU) 2021/1060 and in Article 29 of Regulation (EU) 2021/1148.

The template is set out in the Annex.

Article 2

This Regulation shall enter into force on the third 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 in accordance with the Treaties.

Done at Brussels, 25 January 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 251, 15.7.2021, p. 48.

1

(2)  Regulation (EU) 2021/1060 of the European Parliament and of the Council of 24 June 2021 laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (OJ L 231, 30.6.2021, p. 159).

2

(3)  Regulation (EU) 2021/1147 of the European Parliament and of the Council of 7 July 2021 establishing the Asylum, Migration and Integration Fund (OJ L 251, 15.7.2021, p. 1).

3

(4)  Regulation (EU) 2021/1149 of the European Parliament and of the Council of 7 July 2021 establishing the Internal Security Fund (OJ L 251, 15.7.2021, p. 94).

4

(5)  
  OJ L 176, 10.7.1999, p. 36.

5

(6)  Council Decision 1999/437/EC of 17 May 1999 on certain arrangements for the application of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengen acquis (OJ L 176, 10.7.1999, p. 31).

6

acquis

(7)  
  OJ L 53, 27.2.2008, p. 52.

7

(8)  Council Decision 2008/146/EC of 28 January 2008 on the conclusion, on behalf of the European Community, of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis (OJ L 53, 27.2.2008, p. 1).

8

acquis

(9)  
  OJ L 160, 18.6.2011, p. 21.

9

(10)  Council Decision 2011/350/EU of 7 March 2011 on the conclusion, on behalf of the European Union, of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis, relating to the abolition of checks at internal borders and movement of persons (OJ L 160, 18.6.2011, p. 19).

10

acquis

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ANNEX

Template for the Annual Performance Reports by the Member States to the Commission on the Instrument for Financial Support for Border Management and Visa Policy, as referred to in Article 29 of Regulation (EU) 2021/1148

IDENTIFICATION

| CCI | |
| --- | --- |
| Title | |
| Version | |
| Accounting year | |
| Date of approval of the report by the monitoring committee | |

CCI

Title

Version

Accounting year

Date of approval of the report by the monitoring committee

1.   Performance

1.1.   Progress in implementation – Article 29(2), point (a), of Regulation (EU) 2021/1148

For each specific objective, report on progress in implementing the programme and in achieving the milestones and targets set out in it, taking into account the most recent data for the accounting year, as required under Article 42 of Regulation (EU) 2021/1060. This refers to the cumulative data provided by 31 July of the year before the year that the report is submitted.

Within each specific objective, the information on progress should preferably be structured around the implementation measures, indicative actions and desired outcomes identified in the programme.

Describe also any steps taken and relevant activities related to the implementation of the partnership as per Article 8(2) of Regulation (EU) 2021/1060.

| Insert text here. Max Length: 7 000 characters |
| --- |

Insert text here. Max Length: 7 000 characters

1.2.   Issues affecting performance – Article 29(2), point (b), of Regulation (EU) 2021/1148

For each specific objective, describe any issues affecting the performance of the programme during the accounting year and any actions taken to address them.

Whenever possible and relevant, you are encouraged to distinguish between issues related to:

| — | underreporting of achievements (1); |
| --- | --- |

—

underreporting of achievements (1);

| — | target setting (2); |
| --- | --- |

—

target setting (2);

| — | procedural delays and administrative capacity (3); |
| --- | --- |

—

procedural delays and administrative capacity (3);

| — | contextual changes (4); |
| --- | --- |

—

contextual changes (4);

| — | the design and/or implementation of the operations; (5) and |
| --- | --- |

—

the design and/or implementation of the operations; (5) and

| — | any other matter. |
| --- | --- |

—

any other matter.

Describe any changes to strategy or national objectives, or any factors that may lead to changes in the future, as well as the modifications that those changes have produced in the targets estimated as per the methodology to establish the performance framework.

Include information on any reasoned opinions delivered by the Commission in respect of infringement proceedings under Article 258 of the Treaty on the Functioning of the European Union (TFEU), and which are linked to the implementation of the Instrument.

| Insert text here. Max Length: 7 000 characters |
| --- |

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1.3.   Specific mitigation measures

If relevant, describe briefly how the programme activities contributed to mitigating the effects of any relevant and sudden changes in the pressure on the management of the external borders resulting from any unforeseen deterioration of the socioeconomic or political situation in third countries, as appropriate. Whenever possible, refer to the volume of resources redeployed for this purpose, and the related outputs and results achieved.

Pay specific attention to activities carried out to mitigate the effects of such sudden changes and whose achievements may not be fully captured by the common output and result indicators.

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| --- |

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1.4.   Operating support – Article 16(3) of Regulation (EU) 2021/1148

If operating support was used during the accounting year, describe how it contributed to achieving the objectives of the Instrument (6).

Clarify if operating support was used for the operation and maintenance of large-scale IT systems, including the European Travel Information and Authorisation System (ETIAS).

If the total cumulative eligible cost of operating support for the operations selected for support exceeds 33 % of the total programme allocation at the end of the accounting year, explain the reasons. Additionally, if there is a risk that the threshold is exceeded by the end of the programming period, describe the measures envisaged to mitigate it.

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| --- |

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1.5.   Specific actions (7)

Describe the main achievements of any specific actions carried out during the accounting year, and how they contributed to achieving the objectives of the programme and generating Union added value (8).

Describe how the individual actions have advanced, both procedurally (9) and operationally (10), and highlight any issues affecting their performance, in particular any risk of underspending.

If relevant, break this information down to the project level. If any deviation from the original planning is expected, explain the reasons for this, describe any mitigating actions taken, and provide the revised timetable.

| Insert text here. Max Length: 5 000 characters |
| --- |

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Enter in the Table below the details of all the national specific actions implemented in the programme. The reporting on transnational specific actions should be consistent with the chosen reporting option (11).

| Specific Objective | Name/reference number of the action | Beneficiary | Implementing period | Eligible cost (12) | Eligible expenditure (13) | Progress in the relevant common and/or programme-specific indicators (14) |
| --- | --- | --- | --- | --- | --- | --- |
| Output | Result |
| | | | | | | | |

Specific Objective

Name/reference number of the action

Beneficiary

Implementing period

Eligible cost (12)

Eligible expenditure (13)

Progress in the relevant common and/or programme-specific indicators (14)

Output

Result

1.6.   ETIAS – Article 29(2), point (g), of Regulation (EU) 2021/1148

Provide information on the expenditure in accordance with Article 85(2) and (3) of Regulation (EU) 2018/1240 of the European Parliament and of the Council (15) included in the accounts pursuant to the Article 98 of Regulation (EU) 2021/1060, as per the headings set out in the table below.

| Type of cost | Expenditure in the accounting year |
| --- | --- |
| Large-scale IT systems – European Travel Information and Authorisation System (ETIAS) – Article 85(2) of Regulation (EU) 2018/1240 | |
| Large-scale IT systems – European Travel Information and Authorisation System (ETIAS) – Article 85(3) of Regulation (EU) 2018/1240 | |

Type of cost

Expenditure in the accounting year

Large-scale IT systems – European Travel Information and Authorisation System (ETIAS) – Article 85(2) of Regulation (EU) 2018/1240

Large-scale IT systems – European Travel Information and Authorisation System (ETIAS) – Article 85(3) of Regulation (EU) 2018/1240

1.7.   Only in 2024: continuation of projects – Article 33(4), point (e), of Regulation (EU) 2021/1148

Report on any projects continued after 1 January 2021 that were selected and started under Regulation (EU) No 515/2014 of the European Parliament and of the Council (16), in accordance with Regulation (EU) No 514/2014 of the European Parliament and of the Council (17).

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2.   Complementarity

2.1.   Complementarity with other Union funds – Article 29(2), point (c), of Regulation (EU) 2021/1148

Describe the complementarity and, if relevant, synergies achieved during the accounting year between the actions supported by the Instrument and the support provided by other Union funds, in particular the Instrument for Financial Support for Customs Control Equipment, the Internal Security Fund, the Asylum, Migration and Integration Fund, the Union external financing instruments (18) or in relation to maritime operations of a multipurpose character.

Describe also the complementarity of the activities carried out from the perspective of strengthening inter-agency cooperation (19), including cooperation with the European Border and Coast Guard Agency and the relevant national authorities.

Pay particular attention to:

| — | complementarity with any Union’s external financing instruments for actions taken in or in relation to third countries, underlining the aspects that are consistent with the principles and general objectives of the Union’s external policy; |
| --- | --- |

—

complementarity with any Union’s external financing instruments for actions taken in or in relation to third countries, underlining the aspects that are consistent with the principles and general objectives of the Union’s external policy;

| — | the use of enabling mechanisms, such as existing organisational and procedural arrangements that help achieve synergies and complementarities, and to any actions taken to improve them during the accounting year. |
| --- | --- |

—

the use of enabling mechanisms, such as existing organisational and procedural arrangements that help achieve synergies and complementarities, and to any actions taken to improve them during the accounting year.

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2.2.   Multipurpose equipment and ICT systems – Article 13(14) of Regulation (EU) 2021/1148

Describe briefly the relevant operations involving equipment and ICT systems purchased with the support of the programme during the accounting year and used in complementary areas of customs controls, maritime operations of a multipurpose character or achieving the objectives of the Internal Security Fund and of the Asylum, Migration and Integration Fund. Indicate the place(s) where multipurpose equipment and ICT systems were deployed.

For equipment, also provide information on the period when it was used in the complementary areas.

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| --- |

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For a Union information system funded under the Regulation (EU) 2021/1148 that also serves the objectives of Regulation (EU) 2021/1147 and Regulation (EU) 2021/1149 (multipurpose) or activities required under the Union interoperability legal framework (20), fill in the table below.

| Specific objective | Name of the operation | Beneficiary of the operation | Objective of the operation | Implementation period | Co-financing rate | Eligible costs (21) | Eligible expenditure (22) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | | | | |

Specific objective

Name of the operation

Beneficiary of the operation

Objective of the operation

Implementation period

Co-financing rate

Eligible costs (21)

Eligible expenditure (22)

2.3.   Multiannual planning for the purchase of equipment – Article 13(14), point (d), of Regulation (EU) 2021/1148

Set out the multiannual planning for the expected purchase of equipment under the instrument.

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3.   Implementation of the Union acquis – Article 29(2), point (d), of Regulation (EU) 2021/1148

Describe briefly how, during the accounting year, the programme contributed to implementing the relevant Union acquis (the body of Union law), especially on Schengen, border management and visa policy, and to any relevant action plans.

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4.   Communication and visibility – Article 29(2), point (e), of Regulation (EU) 2021/1148

Describe how communication and visibility activities were carried out during the accounting year. In particular, refer to any progress made in relation to the objectives set out in the communication strategy, as measured by the relevant indicators and their targets. If relevant, describe any good practices in reaching out to the target groups and/or disseminating and exploiting the results of the projects.

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| --- |

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Provide a link to the website portal referred to in Article 46, point (b), of Regulation (EU) 2021/1060 and, if different, to the website referred to in Article 49(1) of that Regulation.

| |
| --- |

5.   Enabling conditions and horizontal principles

5.1.   Enabling conditions – Article 29(2), point (f), of Regulation (EU) 2021/1148

Describe how it was ensured that the applicable enabling conditions in Annex III of Regulation (EU) 2021/1060 were fulfilled and applied throughout the accounting year, in particular as regards complying with the Charter of Fundamental Rights of the European Union. If relevant, describe any change that had an impact on how the enabling conditions were fulfilled, as provided for in Article 15(6) of Regulation (EU) 2021/1060.

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5.2.   Compliance with horizontal principles – Article 9 of Regulation (EU) 2021/1060

Describe how you ensured compliance during the accounting year with the horizontal principles laid down in the Common Provision Regulation, in particular equality between men and women and the promotion of gender mainstreaming, as well as avoiding discrimination based on gender, racial or ethnic origin, religion or belief, disability, age or sexual orientation.

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6.   Projects in or in relation to third countries – Article 29(2), point (h), of Regulation (EU) 2021/1148

Describe any actions taking place in or in relation to third countries during the accounting year and how these bring Union added value in achieving the objectives set by the Instrument. Indicate the names of the third countries concerned. Provide a description that clarifies that the actions supported by the Instrument are not development-oriented, serve the interest of internal Union policies and are consistent with activities undertaken within the European Union. If relevant, refer to the consultations with the Commission before the project was approved (Article 13(12) of Regulation (EU) 2021/1148).

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7.   Summary – Article 29(2) of Regulation (EU) 2021/1148

Provide a summary of the Sections 1 to 6, which will be translated and made available to the public.

As a minimum, the summary must cover all the points listed in Article 29(2), and should preferably be structured around them.

The use of bullet points, bold text or informative headings is encouraged, so that interested stakeholders can easily identify the programme’s main achievements and the main issues affecting its performance.

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(1)  This refers to the situation when there is a gap between the nominal target achievement rate measured by the indicators and the actual progress in implementation. For instance, under-reporting of output and results could be due to issues with the development of the IT system, ongoing operations for which output and results are not yet reported, issues with the data collection leading to slow or incomplete reporting, etc.

(2)  This refers to a situation where the low target achievement rate is not due to slow progress but rather to incorrect or unrealistic target setting. It may include lessons learned in connection with the establishment of a the methodology for target setting – such as wrong or incomplete assumptions or issues with the benchmark values selected – and any planned changes to it.

(3)  For instance, issues related to tendering procedures, issues with audit procedures, issues linked to lack of resources at the managing authority level, an unforeseen delay in the adoption of the programme, etc.

(4)  This can include, for instance, socioeconomic or political factors, changes in the regulatory context, etc.

(5)  For instance, issues to do with the scope of the action (e.g. eligibility criteria), low interest from beneficiaries or participants, any deviation in the implementation of the action etc.

(6)  If relevant for this purpose, refer to the information which is in scope of Regulation (EU) 2021/1148 and available as a result of Schengen evaluations, carried out in accordance with Council Regulation (EU) No 1053/2013 of 7 October 2013 establishing an evaluation and monitoring mechanism to verify the application of the Schengen acquis and repealing the Decision of the Executive Committee of 16 September 1998 setting up a Standing Committee on the evaluation and implementation of Schengen (OJ L 295, 6.11.2013, p. 27) and Council Regulation (EU) 2022/922 of 9 June 2022 on the establishment and operation of an evaluation and monitoring mechanism to verify the application of the Schengen acquis, and repealing Regulation (EU) No 1053/2013 (OJ L 160, 15.6.2022, p. 1). Likewise, if relevant, refer to vulnerability assessments carried out in accordance with Regulation (EU) 2019/1896 of the European Parliament and of the Council of 13 November 2019 on the European Border and Coast Guard including recommendations following Schengen evaluations and vulnerability assessments (OJ L 295, 14.11.2019, p. 1) and related recommendations.

(7)  In the case of specific actions with a transnational nature, the scope of this section varies according to the distribution of roles and responsibilities between the lead Member States and the other participating Member States, as well as the choice of the reporting method used. This is described in the Commission’s note of 14 February 2022 – Transnational specific actions under the Asylum, Migration and Integration Fund (AMIF), the Instrument for Financial Support for Border Management and Visa Policy (BMVI),and the Internal Security Fund (ISF) – Arrangements between partners (Ares (2022)1060102).

(8)  Union added value is defined as the generation of results beyond what would have been achieved by Member States acting alone.

(9)  For instance, in connection to procurement activities or any other preparatory steps taken.

(10)  For instance, in terms of deliverables, outputs, results etc.

(11)  As set out in the Commission’s note of 14 February 2022 (Ares (2022)1060102).

(12)  Total eligible cost of selected operations, as reported to the Commission by 31 July of the last accounting year.

(13)  Total amount of eligible expenditure declared by beneficiaries to the managing authority, as reported to the Commission by 31 July of the last accounting year.

(14)  If specific actions represent a top-up of previous operations and there are no dedicated monitoring arrangements, report the output and results pro-rata.

(15)  Regulation (EU) 2018/1240 of the European Parliament and of the Council of 12 September 2018 establishing a European Travel Information and Authorisation System (ETIAS) and amending Regulations (EU) No 1077/2011, (EU) No 515/2014, (EU) 2016/399, (EU) 2016/1624 and (EU) 2017/2226 (OJ L 236, 19.9.2018, p. 1).

(16)  Regulation (EU) No 515/2014 of the European Parliament and of the Council of 16 April 2014 establishing, as part of the Internal Security Fund, the instrument for financial support for external borders and visa and repealing Decision No 574/2007/EC (OJ L 150, 20.5.2014, p. 143).

(17)  Regulation (EU) No 514/2014 of the European Parliament and of the Council of 16 April 2014 laying down general provisions on the Asylum, Migration and Integration Fund and on the instrument for financial support for police cooperation, preventing and combating crime, and crisis management (OJ L 150, 20.5.2014, p. 112).

(18)  In particular, e.g. the Neighbourhood, Development and International Cooperation Instrument (NDICI) – Global Europe and the Instrument for Pre-accession assistance (IPA).

(19)  Such as cooperation at Union level between the Member States, and between Member States and relevant Union bodies, offices and agencies, as well as cooperation at national level among the competent authorities within each Member State.

(20)  Regulation (EU) 2019/817 of the European Parliament and of the Council of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of borders and visa and amending Regulations (EC) No 767/2008, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1726 and (EU) 2018/1861 of the European Parliament and of the Council and Council Decisions 2004/512/EC and 2008/633/JHA (OJ L 135, 22.5.2019, p. 27).

Regulation (EU) 2019/818 of the European Parliament and of the Council of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of police and judicial cooperation, asylum and migration and amending Regulations (EU) 2018/1726, (EU) 2018/1862 and (EU) 2019/816 (OJ L 135, 22.5.2019, p. 85).

(21)  Total eligible cost of selected operations, as reported to the Commission by 31 July of the last accounting year.

(22)  Total amount of eligible expenditure declared by the beneficiaries to the managing authority, as reported to the Commission by 31 July of the last accounting year.

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| 26.1.2023 | EN | Official Journal of the European Union | L 24/16 |
| --- | --- | --- | --- |

26.1.2023

EN

Official Journal of the European Union

L 24/16

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COMMISSION IMPLEMENTING REGULATION (EU) 2023/169

of 25 January 2023

establishing the template for the annual performance reports on the Asylum, Migration and Integration Fund for the 2021-2027 programming period, pursuant to Regulation (EU) 2021/1147 of the European Parliament and of the Council

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2021/1147 of the European Parliament and of the Council of 7 July 2021 establishing the Asylum, Migration and Integration Fund (1), and in particular Article 35(5) thereof,

After consulting the Home Affairs Funds Committee,

Whereas:

| (1) | Regulation (EU) 2021/1060 of the European Parliament and of the Council (2), together with the Regulations (EU) 2021/1147, (EU) 2021/1148 (3) and (EU) 2021/1149 of the European Parliament and of the Council (4) (‘Fund-specific Regulations’) establishing respectively the Asylum, Migration and Integration Fund, the Instrument for Financial Support for Border Management and Visa Policy and the Internal Security Fund constitute a framework for Union funding contributing to the development of the area of freedom, security and justice. |
| --- | --- |

(1)

Regulation (EU) 2021/1060 of the European Parliament and of the Council (2), together with the Regulations (EU) 2021/1147, (EU) 2021/1148 (3) and (EU) 2021/1149 of the European Parliament and of the Council (4) (‘Fund-specific Regulations’) establishing respectively the Asylum, Migration and Integration Fund, the Instrument for Financial Support for Border Management and Visa Policy and the Internal Security Fund constitute a framework for Union funding contributing to the development of the area of freedom, security and justice.

| (2) | Regulation (EU) 2021/1060, and in particular Article 41(7) thereof, requires Member States to submit an annual performance report to the Commission for each programme in accordance with the Fund-specific Regulations. |
| --- | --- |

(2)

Regulation (EU) 2021/1060, and in particular Article 41(7) thereof, requires Member States to submit an annual performance report to the Commission for each programme in accordance with the Fund-specific Regulations.

| (3) | To ensure uniform conditions in the implementation of annual reporting and that the information provided to the Commission is consistent and comparable, Regulation (EU) 2021/1147 sets out the need to establish a template for the annual performance reports by means of an implementing act. |
| --- | --- |

(3)

To ensure uniform conditions in the implementation of annual reporting and that the information provided to the Commission is consistent and comparable, Regulation (EU) 2021/1147 sets out the need to establish a template for the annual performance reports by means of an implementing act.

| (4) | In accordance with Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Ireland takes part in Regulation (EU) 2021/1147. Therefore, Ireland is bound by this Regulation. |
| --- | --- |

(4)

In accordance with Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Ireland takes part in Regulation (EU) 2021/1147. Therefore, Ireland is bound by this Regulation.

| (5) | In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark does not take part in and is not bound by Regulation (EU) 2021/1147. Therefore, Denmark is not bound by this Regulation. |
| --- | --- |

(5)

In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark does not take part in and is not bound by Regulation (EU) 2021/1147. Therefore, Denmark is not bound by this Regulation.

| (6) | To allow for the prompt application of the measures provided for in this Regulation and to ensure that there is no delay in the implementation of the programmes, this Regulation should enter into force on the third day following that of its publication in the Official Journal of the European Union, |
| --- | --- |

(6)

To allow for the prompt application of the measures provided for in this Regulation and to ensure that there is no delay in the implementation of the programmes, this Regulation should enter into force on the third day following that of its publication in the Official Journal of the European Union,

HAS ADOPTED THIS REGULATION:

Article 1

This Regulation establishes the template for the annual performance reports on the Asylum, Migration and Integration Fund referred to in Article 41(7) of Regulation (EU) 2021/1060 and in Article 35 of Regulation (EU) 2021/1147.

The template is set out in the Annex.

Article 2

This Regulation shall enter into force on the third 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 in accordance with the Treaties.

Done at Brussels, 25 January 2023.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 251, 15.7.2021, p. 1.

1

(2)  Regulation (EU) 2021/1060 of the European Parliament and of the Council of 24 June 2021 laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (OJ L 231, 30.6.2021, p. 159).

2

(3)  Regulation (EU) 2021/1148 of the European Parliament and of the Council of 7 July 2021 establishing, as part of the Integrated Border Management Fund, the Instrument for Financial Support for Border Management and Visa Policy (OJ L 251, 15.7.2021, p. 48).

3

(4)  Regulation (EU) 2021/1149 of the European Parliament and of the Council of 7 July 2021 establishing the Internal Security Fund (OJ L 251, 15.7.2021, p. 94).

4

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ANNEX

Template for the annual performance report on the Asylum, Migration and Integration Fund by the Member States to the Commission, as referred to in Article 35 of Regulation (EU) 2021/1147

IDENTIFICATION

| CCI | |
| --- | --- |
| Title | |
| Version | |
| Accounting year | |
| Date of approval of the report by the monitoring committee | |

CCI

Title

Version

Accounting year

Date of approval of the report by the monitoring committee

1.   Performance

1.1.   Progress in implementation – Article 35(2), point (a), of Regulation (EU) 2021/1147

For each specific objective, report on progress in implementing the programme and in achieving the milestones and targets set out in it, taking into account the most recent data for the accounting year, as required under Article 42 of Regulation (EU) 2021/1060. This refers to the cumulative data provided by 31 July of the year before the year that the report is submitted.

Within each specific objective, the information on progress should preferably be structured around the implementation measures, indicative actions and desired outcomes identified in the programme.

Describe also any steps taken and relevant activities related to the implementation of the partnership as per Article 8(2) of Regulation (EU) 2021/1060.

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1.2.   Issues affecting performance – Article 35(2), point (b), of Regulation (EU) 2021/1147

For each specific objective, describe any issues affecting the performance of the programme during the accounting year and any actions taken to address them.

Whenever possible and relevant, you are encouraged to distinguish between issues related to:

| — | underreporting of achievements (1); |
| --- | --- |

—

underreporting of achievements (1);

| — | target setting (2); |
| --- | --- |

—

target setting (2);

| — | procedural delays and administrative capacity (3); |
| --- | --- |

—

procedural delays and administrative capacity (3);

| — | contextual changes (4); |
| --- | --- |

—

contextual changes (4);

| — | the design and/or implementation of the operations (5); |
| --- | --- |

—

the design and/or implementation of the operations (5);

| — | any other matter. |
| --- | --- |

—

any other matter.

Describe any changes to strategy or national objectives, or any factors that may lead to changes in the future, as well as the modifications that those changes have produced in the targets estimated as per the methodology to establish the performance framework.

Include information on any reasoned opinions delivered by the Commission in respect of infringement proceedings under Article 258 of the Treaty on the Functioning of the European Union (TFEU), and which are linked to the implementation of the fund.

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1.3.   Specific mitigation measures

If relevant, describe briefly how the programme activities contributed to mitigating the effects of any sudden changes in the migratory pressure resulting from any unforeseen deterioration of the socioeconomic or political situation in relevant third countries. Whenever possible, refer to the volume of resources redeployed for this purpose, and the related outputs and results achieved.

Pay specific attention to activities carried out to mitigate the effects of such sudden changes and whose achievements may not be fully captured by the common output and result indicators.

| Insert text here. Max Length: 4 000 characters |
| --- |

Insert text here. Max Length: 4 000 characters

1.4.   Operating support – Article 21(3) of Regulation (EU) 2021/1147

If operating support was used during the accounting year, describe how it contributed to achieving the objectives of the fund (6).

If the total cumulative eligible cost of operating support for the operations selected for support exceeds 15 % of the total programme allocation at the end of the accounting year, explain the reasons. Additionally, if there is a risk that the threshold is exceeded by the end of the programming period, describe the measures envisaged to mitigate it.

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| --- |

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1.5.   Specific actions (7)

Describe the main achievements of any specific actions carried out during the accounting year, and how they contributed to achieving the objectives of the programme and to generating Union added value (8).

Describe how the individual actions have advanced, both procedurally (9) and operationally (10) and highlight any issues affecting their performance, in particular any risk of underspending.

If relevant, break this information down to the project level. If any deviation from the original planning is expected, explain the reasons for this, describe any mitigating actions taken, and provide the revised timetable.

| Insert text here. Max Length: 5 000 characters |
| --- |

Insert text here. Max Length: 5 000 characters

Enter in the Table below the details of all the national specific actions implemented in the programme. The reporting on transnational specific actions should be consistent with the chosen reporting option (11).

| Specific Objective | Name/reference number of the action | Beneficiary | Implementing period | Eligible cost  (12) | Eligible expenditure  (13) | Progress in the relevant common and/or programme-specific indicators (14) |
| --- | --- | --- | --- | --- | --- | --- |
| Output | Result |
| | | | | | | | |

Specific Objective

Name/reference number of the action

Beneficiary

Implementing period

Eligible cost  (12)

Eligible expenditure  (13)

Progress in the relevant common and/or programme-specific indicators (14)

Output

Result

1.6.   Resettlement and relocation – Article 35(2), points (g) and (h), of Regulation (EU) 2021/1147

Report on the consolidated figures for the accounting year in the table below.

| Number of persons admitted through resettlement | |
| --- | --- |
| Number of persons admitted through humanitarian admission in line with Article 19(2) of the Regulation (EU) 2021/1147 | |
| Number of vulnerable persons admitted through humanitarian admission in line with Article 19(3) of the Regulation (EU) 2021/1147 | |
| Number of applicants for or beneficiaries of international protection transferred in | |
| Number of applicants for or beneficiaries of international protection transferred out | |

Number of persons admitted through resettlement

Number of persons admitted through humanitarian admission in line with Article 19(2) of the Regulation (EU) 2021/1147

Number of vulnerable persons admitted through humanitarian admission in line with Article 19(3) of the Regulation (EU) 2021/1147

Number of applicants for or beneficiaries of international protection transferred in

Number of applicants for or beneficiaries of international protection transferred out

If relevant, describe any corrections or changes made to the values sent bi-annually via the data transmission module in the System for Fund Management in the European Union (SFC), and which are reflected in the table above in the consolidated figures for the accounting year.

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1.7.   Only in 2024: Continuation of projects – Article 39(4), point (e), of Regulation (EU) 2021/1147

Report on any projects continued after 1 January 2021 that were selected and started under Regulation (EU) No 516/2014 of the European Parliament and of the Council (15), in accordance with Regulation (EU) No 514/2014 of the European Parliament and of the Council (16).

| Insert text here. Max Length: 4 000 characters |
| --- |

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2.   Complementarity – Article 35(2), point (c), of Regulation (EU) 2021/1147

Describe the complementarity and, if relevant, synergies achieved during the accounting year between the actions supported by the fund and the support provided by other Union funds, in particular external financing instruments (17), the European Social Fund + (ESF+) or its predecessors, European Regional Development Fund (ERDF) – be it under the Investment for Jobs and Growth or the European Territorial Cooperation goals –, the Internal Security Fund (ISF) and the Border Management and Visa Instrument (BMVI) (18).

Pay specific attention to:

| — | complementarity with Union’s external financing instruments for actions taken in or in relation to third countries, underlining the aspects that are consistent with the principles and general objectives of the Union’s external policy; and |
| --- | --- |

—

complementarity with Union’s external financing instruments for actions taken in or in relation to third countries, underlining the aspects that are consistent with the principles and general objectives of the Union’s external policy; and

| — | the use of enabling mechanisms, such as existing organisational and procedural arrangements that help achieve synergies and complementarities, and to any actions implemented to improve them in the accounting year. |
| --- | --- |

—

the use of enabling mechanisms, such as existing organisational and procedural arrangements that help achieve synergies and complementarities, and to any actions implemented to improve them in the accounting year.

If relevant, describe also the complementarity of the activities carried out from the perspective of strengthening inter-agency cooperation (19).

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| --- |

Insert text here. Max Length: 6 000 characters

3.   Implementation of the Union acquis, cooperation and solidarity – Article 35(2), point (d), of Regulation (EU) 2021/1147

Describe briefly how, during the accounting year, the programme contributed to implementing the Union acquis (the body of Union law) on asylum, legal migration, integration, return and irregular migration and relevant action plans, and to cooperation and solidarity between Member States.

| Insert text here. Max Length: 4 000 characters |
| --- |

Insert text here. Max Length: 4 000 characters

4.   Communication and Visibility – Article 35(2), point (e), of Regulation (EU) 2021/1147

Describe how communication and visibility activities were carried out during the accounting year. In particular, refer to any progress made on the objectives set out in the communication strategy, as measured by the relevant indicators and their targets. If relevant, describe any good practices in reaching out to the target groups and/or disseminating and exploiting the results of the projects.

| Insert text here. Max Length: 4 000 characters |
| --- |

Insert text here. Max Length: 4 000 characters

Provide a link to the website portal referred to in Article 46, point (b), of Regulation (EU) 2021/1060 and, if different, to the website referred to in Article 49(1) of that Regulation.

| |
| --- |

5.   Enabling conditions and horizontal principles

5.1.   Enabling conditions – Article 35(2), point (f), of Regulation (EU) 2021/1147

Describe how it was ensured that the applicable enabling conditions in Annex III of Regulation (EU) 2021/1060 were fulfilled and applied throughout the accounting year, in particular as regards complying with the Charter of Fundamental Rights of the European Union. If relevant, describe any change that had an impact on how the enabling conditions were fulfilled, as provided for in Article 15(6) of Regulation (EU) 2021/1060.

| Insert text here. Max Length: 5 000 characters |
| --- |

Insert text here. Max Length: 5 000 characters

5.2.   Compliance with horizontal principles – Article 9 of Regulation (EU) 2021/1060

Describe how compliance during the accounting year with the horizontal principles laid down in the Common Provision Regulation was ensured, in particular equality between men and women and the promotion of gender mainstreaming, as well as avoiding discrimination based on gender, racial or ethnic origin, religion or belief, disability, age or sexual orientation.

| Insert text here. Max Length: 5 000 characters |
| --- |

Insert text here. Max Length: 5 000 characters

6.   Projects in or in relation to third countries – Article 35(2), point (i), of Regulation (EU) 2021/1147

Describe any actions taking place in or in relation to third countries during the accounting year and how these bring Union added value in achieving the objectives set by the fund. Indicate the names of the third countries concerned. Provide a description that clarifies that the actions supported by the fund are not development-oriented, serve the interest of internal Union policies and are consistent with activities undertaken within the Union. If relevant, refer to the consultations with the Commission before the project was approved (Article 16(11) of Regulation (EU) 2021/1147).

| Insert text here. Max Length: 6 000 characters |
| --- |

Insert text here. Max Length: 6 000 characters

7.   Summary – Article 35(2) of Regulation (EU) 2021/1147

Provide a summary of the Sections 1 to 6, which will be translated and made available to the public.

As a minimum, the summary shall cover all the points listed in Article 35(2), and should preferably be structured around them.

The use of bullet points, bold text or informative headings is encouraged, so that interested stakeholders can easily identify the programme’s main achievements, and the main issues affecting its performance.

| Insert text here. Max Length: 7 500 characters |
| --- |

Insert text here. Max Length: 7 500 characters

---

(1)  This refers to the situation when there is a gap between the nominal target achievement rate measured by the indicators and the actual progress in implementation. For instance, under-reporting of output and results could be due to issues with the development of the IT system, ongoing operations for which output and results are not yet reported, issues with the data collection leading to slow or incomplete reporting, etc.

(2)  This refers to a situation where the low target achievement rate is not due to slow progress but rather to incorrect or unrealistic target setting. It may include lessons learned in connection with the establishment of a methodology for target setting – such as wrong or incomplete assumptions or issues with the benchmark values selected – and any planned changes to it.

(3)  For instance, issues related to tendering procedures, issues with audit procedures, issues linked to lack of resources at the managing authority level, an unforeseen delay in the adoption of the programme, etc.

(4)  This can include, for instance, socioeconomic or political factors, changes in the regulatory context, etc.

(5)  For instance, issues to do with the scope of the action (e.g. eligibility criteria), low interest from beneficiaries or participants, any deviation in the implementation of the action, etc.

(6)  If relevant for this purpose, refer to the information which is in scope of Regulation (EU) 2021/1147 and available as a result of Schengen evaluations, carried out in accordance with Council Regulation (EU) No 1053/2013 of 7 October 2013 establishing an evaluation and monitoring mechanism to verify the application of the Schengen acquis and repealing the Decision of the Executive Committee of 16 September 1998 setting up a Standing Committee on the evaluation and implementation of Schengen (OJ L 295, 6.11.2013, p. 27) and Council Regulation (EU) 2022/922 of 9 June 2022 on the establishment and operation of an evaluation and monitoring mechanism to verify the application of the Schengen acquis, and repealing Regulation (EU) No 1053/2013 (OJ L 160, 15.6.2022, p. 1).

(7)  In the case of specific actions with a transnational nature, the scope of this section varies according to the distribution of roles and responsibilities between the lead Member States and the other participating Member States, as well as the choice of the reporting method used. This is described in the Commission’s note of 14 February 2022 – Transnational specific actions under the Asylum, Migration and Integration Fund (AMIF), the Instrument for Financial Support for Border Management and Visa Policy (BMVI),and the Internal Security Fund (ISF) – Arrangements between partners (Ares (2022)1060102).

(8)  Union added value is defined as the generation of results beyond what would have been achieved by Member States acting alone.

(9)  For instance, in connection to procurement activities or any other preparatory steps taken.

(10)  For instance, in terms of deliverables, outputs, results etc.

(11)  As set out in the Commission’s note of 14 February 2022 (Ares (2022)1060102).

(12)  Total eligible cost of selected operations, as reported to the Commission by 31 July of the last accounting year

(13)  Total amount of eligible expenditure declared by beneficiaries to the managing authority, by 31 July of the last accounting year.

(14)  If specific actions represent a top-up of previous operations and there are no dedicated monitoring arrangements, report the output and results pro-rata.

(15)  Regulation (EU) No 516/2014 of the European Parliament and of the Council of 16 April 2014 establishing the Asylum, Migration and Integration Fund, amending Council Decision 2008/381/EC and repealing Decisions No 573/2007/EC and No 575/2007/EC of the European Parliament and of the Council and Council Decision 2007/435/EC (OJ L 150, 20.5.2014, p. 168).

(16)  Regulation (EU) No 514/2014 of the European Parliament and of the Council of 16 April 2014 laying down general provisions on the Asylum, Migration and Integration Fund and on the instrument for financial support for police cooperation, preventing and combating crime, and crisis management (OJ L 150, 20.5.2014, p. 112).

(17)  In particular, e.g. the Neighbourhood, Development and International Cooperation Instrument (NDICI) – Global Europe and the Instrument for Pre-accession assistance (IPA).

(18)  Complementarity with any other relevant EU funds (e.g. Recovery and Resilience Facility, Erasmus+, Creative Europe, Cohesion Fund, Just transition Fund etc.) could also be relevant.

(19)  Such as cooperation at EU level between the Member States, and between Member States and relevant EU bodies, offices and agencies, as well as cooperation at national level among the competent authorities within each Member State.

---

| 26.1.2023 | EN | Official Journal of the European Union | L 24/24 |
| --- | --- | --- | --- |

26.1.2023

EN

Official Journal of the European Union

L 24/24

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/170

of 25 January 2023

establishing the template for the annual performance reports on the Internal Security Fund for the 2021-2027 programming period, pursuant to Regulation (EU) 2021/1149 of the European Parliament and of the Council

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2021/1149 of the European Parliament and of the Council of 7 July 2021 establishing the Internal Security Fund (1), and in particular Article 30(5) thereof,

After consulting the Home Affairs Funds Committee,

Whereas:

| (1) | Regulation (EU) 2021/1060 of the European Parliament and of the Council (2), together with the Regulations (EU) 2021/1147 of the European Parliament and of the Council (3) and (EU) 2021/1148 (4), and Regulation (EU) 2021/1149 (‘Fund-specific Regulations’) establishing respectively the Asylum, Migration and Integration Fund, the Instrument for Financial Support for Border Management and Visa Policy and the Internal Security Fund constitute a framework for Union funding contributing to the development of the area of freedom, security and justice. |
| --- | --- |

(1)

Regulation (EU) 2021/1060 of the European Parliament and of the Council (2), together with the Regulations (EU) 2021/1147 of the European Parliament and of the Council (3) and (EU) 2021/1148 (4), and Regulation (EU) 2021/1149 (‘Fund-specific Regulations’) establishing respectively the Asylum, Migration and Integration Fund, the Instrument for Financial Support for Border Management and Visa Policy and the Internal Security Fund constitute a framework for Union funding contributing to the development of the area of freedom, security and justice.

| (2) | Regulation (EU) 2021/1060, and in particular Article 41(7) thereof, requires Member States to submit an annual performance report to the Commission for each programme in accordance with the Fund-specific Regulations. |
| --- | --- |

(2)

Regulation (EU) 2021/1060, and in particular Article 41(7) thereof, requires Member States to submit an annual performance report to the Commission for each programme in accordance with the Fund-specific Regulations.

| (3) | To ensure uniform conditions in the implementation of annual reporting and that the information provided to the Commission is consistent and comparable, Regulation (EU) 2021/1149 sets out the need to establish a template for the annual performance reports by means of an implementing act. |
| --- | --- |

(3)

To ensure uniform conditions in the implementation of annual reporting and that the information provided to the Commission is consistent and comparable, Regulation (EU) 2021/1149 sets out the need to establish a template for the annual performance reports by means of an implementing act.

| (4) | In accordance with Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Ireland takes part in and is bound by Regulation (EU) 2021/1149. Therefore, Ireland is bound by this Regulation. |
| --- | --- |

(4)

In accordance with Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Ireland takes part in and is bound by Regulation (EU) 2021/1149. Therefore, Ireland is bound by this Regulation.

| (5) | In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark does not take part in and is not bound by Regulation (EU) 2021/1149. Therefore, Denmark is not bound by this Regulation. |
| --- | --- |

(5)

In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark does not take part in and is not bound by Regulation (EU) 2021/1149. Therefore, Denmark is not bound by this Regulation.

| (6) | To allow for the prompt application of the measures provided for in this Regulation and to ensure that there is no delay in the implementation of the programmes, this Regulation should enter into force on the third day following that of its publication in the Official Journal of the European Union, |
| --- | --- |

(6)

To allow for the prompt application of the measures provided for in this Regulation and to ensure that there is no delay in the implementation of the programmes, this Regulation should enter into force on the third day following that of its publication in the Official Journal of the European Union,

HAS ADOPTED THIS REGULATION:

Article 1

This Regulation establishes the template for the annual performance reports on the Internal Security Fund referred to in Article 41(7) of Regulation (EU) 2021/1060 and Article 30 of Regulation (EU) 2021/1149.

The template is set out in the Annex.

Article 2

This Regulation shall enter into force on the third 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 in accordance with the Treaties.

Done at Brussels, 25 January 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 251, 15.7.2021, p. 94.

1

(2)  
  OJ L 231, 30.6.2021, p. 159.

2

(3)  
  OJ L 251, 15.7.2021, p. 1.

3

(4)  
  OJ L 251, 15.7.2021, p. 48.

4

---

ANNEX

Template for the Annual Performance Report by the Member States to the Commission on the Internal Security Fund, as referred to in Article 30 of Regulation (EU) 2021/1149

IDENTIFICATION

| CCI | |
| --- | --- |
| Title | |
| Version | |
| Accounting year | |
| Date of approval of the report by the monitoring committee | |

CCI

Title

Version

Accounting year

Date of approval of the report by the monitoring committee

1.   PERFORMANCE

1.1.   Progress in implementation – Article 30(2), point (a), of Regulation (EU) 2021/1149

For each specific objective, report on progress in implementing the programme and in achieving the milestones and targets set out in it, taking into account the most recent data for the accounting year, as required under Article 42 of Regulation (EU) 2021/1060. This refers to the cumulative data provided by 31 July of the year before the year that the report is submitted.

Within each specific objective, the information on progress should preferably be structured around the implementation measures, indicative actions and desired outcomes identified in the programme.

Describe also any steps taken and relevant activities related to the implementation of the partnership as per Article 8(2) of Regulation (EU) 2021/1060.

| Insert text here. Max Length: 7 000 characters |
| --- |

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1.2.   Issues affecting performance – Article 30(2), point (b), of Regulation (EU) 2021/1149

For each specific objective, describe any issues affecting the performance of the programme during the accounting year and any action taken to address them.

Whenever possible and relevant, you are encouraged to distinguish between issues related to:

| — | underreporting of achievements (1); |
| --- | --- |

—

underreporting of achievements (1);

| — | target setting (2); |
| --- | --- |

—

target setting (2);

| — | procedural delays and administrative capacity (3); |
| --- | --- |

—

procedural delays and administrative capacity (3);

| — | contextual changes (4); |
| --- | --- |

—

contextual changes (4);

| — | the design and/or implementation of the operations (5); and |
| --- | --- |

—

the design and/or implementation of the operations (5); and

| — | any other matter. |
| --- | --- |

—

any other matter.

Describe any changes to strategy or national objectives, or any factors that may lead to changes in the future, as well as the modifications that those changes have produced in the targets estimated as per the methodology to establish the performance framework.

Include information on any reasoned opinions delivered by the Commission in respect of infringement proceedings under Article 258 of the Treaty on the Functioning of the European Union (TFEU), and which are linked to the implementation of the fund.

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| --- |

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1.3.   Specific mitigation measures

If relevant, describe briefly how the programme activities contributed to mitigating the effects of any relevant and sudden contextual changes resulting in unforeseen security threats. Whenever possible, refer to the volume of resources redeployed for this purpose, and the related outputs and results achieved.

Pay specific attention to activities carried out to mitigate the unforeseen security threats and whose achievements may not be fully captured by the common output and result indicators.

| Insert text here. Max Length: 4 000 characters |
| --- |

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1.4.   Operating support – Article 16(3) of Regulation (EU) 2021/1149

If operating support was used during the accounting year, describe how it contributed to achieving the objectives of the fund (6).

If the total cumulative eligible cost of operating support for the operations selected for support exceeds 20 % of the total programme allocation at the end of the accounting year, explain the reasons. Additionally, if there is a risk that the threshold is exceeded by the end of the programming period, describe the measures envisaged to mitigate it.

| Insert text here. Max Length: 4 000 characters |
| --- |

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1.5.   Specific actions (7)

Describe the main achievements of any specific actions carried out during the accounting year, and how they contributed to achieving the objectives of the programme and to generating Union added value (8).

Describe how the individual actions have advanced, both procedurally (9) and operationally (10) and highlight any issues affecting their performance, in particular any risk of underspending.

If relevant, break this information down to the project level. If any deviation from the original planning is expected, explain the reasons for this, describe any mitigating actions taken, and provide the revised timetable.

| Insert text here. Max Length: 5 000 characters |
| --- |

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Enter in the Table below the details of all the national specific actions implemented in the programme. The reporting on transnational specific actions should be consistent with the chosen reporting option (11).

| Specific Objective | Name/reference number of the action | Beneficiary | Implementing Period | Eligible cost (12) | Eligible expenditure (13) | Progress in the relevant common and/or programme specific indicators (14) |
| --- | --- | --- | --- | --- | --- | --- |
| Output | Result |
| | | | | | | | |

Specific Objective

Name/reference number of the action

Beneficiary

Implementing Period

Eligible cost (12)

Eligible expenditure (13)

Progress in the relevant common and/or programme specific indicators (14)

Output

Result

1.6.   Compliance with Article 13(7) of Regulation (EU) 2021/1149

Report the total cumulative amount of incurred and paid expenditure for equipment, means of transport or the construction of security-relevant facilities pursuant to Article 13(7) of Regulation (EU) 2021/1149, as per the data to be stored electronically in line with field 142, Annex XVII of Regulation (EU) 2021/1060.

| Insert the amount here |
| --- |

Insert the amount here

Confirm that the total cumulative eligible cost of operations selected for support for equipment, means of transport or the construction of security-relevant facilities pursuant to Article 13(7) of Regulation (EU) 2021/1149 does not exceed 35 % of the total allocation of the programme by the end of the accounting year, or explain the reasons for this. Additionally, if there is a risk that the threshold is exceeded by the end of the programming period, describe the measures envisaged to mitigate it, or the duly justified reasons to exceed the threshold.

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| --- |

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1.7.   Only in 2024: continuation of projects – Article 34(4), point (e), of Regulation (EU) 2021/1149

Report on any projects continued after 1 January 2021 that were selected and started under Regulation (EU) No 513/2014 of the European Parliament and of the Council (15), in accordance with Regulation (EU) No 514/2014 of the European Parliament and of the Council (16).

| Insert text here. Max Length: 4 000 characters |
| --- |

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2.   COMPLEMENTARITY

2.1.   Complementarity with other Union funds – Article 30(2), point (c), of Regulation (EU) 2021/1149

Describe the complementarity and, if relevant, synergies between the actions supported by the fund and the support provided by other Union funds in the field of security, for example:

| — | the Asylum, Migration and Integration Fund (AMIF) and the Integrated Border Management Fund (IBMF), including the Border Management and Visa Instrument (BMVI) and the Instrument for Financial Support for Customs Control Equipment; |
| --- | --- |

—

the Asylum, Migration and Integration Fund (AMIF) and the Integrated Border Management Fund (IBMF), including the Border Management and Visa Instrument (BMVI) and the Instrument for Financial Support for Customs Control Equipment;

| — | the cohesion funds, especially the European Regional Development Fund (ERDF); |
| --- | --- |

—

the cohesion funds, especially the European Regional Development Fund (ERDF);

| — | the security research part of Horizon Europe; |
| --- | --- |

—

the security research part of Horizon Europe;

| — | the Citizens, Equality, Rights and Values programme and the Justice programme; |
| --- | --- |

—

the Citizens, Equality, Rights and Values programme and the Justice programme;

| — | the Digital Europe programme; |
| --- | --- |

—

the Digital Europe programme;

| — | the InvestEU programme; |
| --- | --- |

—

the InvestEU programme;

| — | the Technical Support Instrument; |
| --- | --- |

—

the Technical Support Instrument;

| — | the rescEU reserve; |
| --- | --- |

—

the rescEU reserve;

| — | the Neighbourhood, Development and International Cooperation Instrument (NDICI) – Global Europe; and |
| --- | --- |

—

the Neighbourhood, Development and International Cooperation Instrument (NDICI) – Global Europe; and

| — | the Instrument for Pre-Accession Assistance (IPA). |
| --- | --- |

—

the Instrument for Pre-Accession Assistance (IPA).

Pay specific attention to:

| — | complementarity with Union’s external financing instruments for actions taken in or in relation to third countries, underlining the aspects that are consistent with the principles and general objectives of the Union’s external policy; and |
| --- | --- |

—

complementarity with Union’s external financing instruments for actions taken in or in relation to third countries, underlining the aspects that are consistent with the principles and general objectives of the Union’s external policy; and

| — | the use of enabling mechanisms, such as organisational and procedural arrangements that help achieve complementarities, and, if relevant, synergies, and to any actions taken to improve them during the accounting year. |
| --- | --- |

—

the use of enabling mechanisms, such as organisational and procedural arrangements that help achieve complementarities, and, if relevant, synergies, and to any actions taken to improve them during the accounting year.

If relevant, describe also:

| — | the complementarity of the activities carried out from the perspective of strengthening inter-agency cooperation (17); |
| --- | --- |

—

the complementarity of the activities carried out from the perspective of strengthening inter-agency cooperation (17);

| — | synergies in relation to security of infrastructure and public spaces, cybersecurity, the protection of victims and the prevention of radicalisation.






  Insert text here. Max Length: 6 000 characters |
| --- | --- |

—

synergies in relation to security of infrastructure and public spaces, cybersecurity, the protection of victims and the prevention of radicalisation.

Insert text here. Max Length: 6 000 characters

2.2.   Multipurpose equipment and ICT systems – Article 5(4) of Regulation (EU) 2021/1149

Describe briefly the relevant operations involving equipment and ICT systems purchased within the programme and partly used in the complementary area covered by Regulation (EU) 2021/1148 and for achieving the objectives of the Instrument for Financial Support for Border Management and Visa Policy. Indicate the place(s) where the multipurpose equipment and ICT systems were deployed.

For equipment, also provide information on the period when it was used in the complementary areas of the Instrument for Financial Support for Border Management and Visa Policy.

| Insert text here. Max Length: 3 000 characters |
| --- |

Insert text here. Max Length: 3 000 characters

For a Union information system funded under the Regulation (EU) 2021/1149 which also serves the objectives of Regulation (EU) 2021/1148 (multipurpose) or activities required under the EU interoperability legal framework (18), fill in the table below.

| Specific Objective | Name of the operation | Beneficiary of the operation | Objective of the operation | Implementation period | Co-financing rate | Eligible costs (19) | Eligible expenditure (20) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | | | | |

Specific Objective

Name of the operation

Beneficiary of the operation

Objective of the operation

Implementation period

Co-financing rate

Eligible costs (19)

Eligible expenditure (20)

3.   IMPLEMENTATION OF THE UNION ACQUIS – ARTICLE 30(2), POINT (d), OF REGULATION (EU) 2021/1149

Describe how, during the accounting year, the programme contributed to implementing the relevant Union acquis (the body of Union law) on security and exchange of relevant information, and to any relevant action plans.

| Insert text here. Max Length: 4 000 characters |
| --- |

Insert text here. Max Length: 4 000 characters

4.   COMMUNICATION AND VISIBILITY – ARTICLE 30(2), POINT (e), OF REGULATION (EU) 2021/1149

Describe how communication and visibility actions were carried out during the accounting year. In particular, refer to any progress made in relation to the objectives set out in the communication strategy, as measured by the relevant indicators and their targets. If relevant, describe any good practices in reaching out to the target groups and/or disseminating and exploiting the results of the projects.

| Insert text here. Max Length: 4 000 characters |
| --- |

Insert text here. Max Length: 4 000 characters

Provide a link to the website portal referred to in Article 46, point (b), of Regulation (EU) 2021/1060 and, if different, to the website referred to in Article 49(1) of that Regulation.

| |
| --- |

5.   ENABLING CONDITIONS AND HORIZONTAL PRINCIPLES

5.1.   Enabling conditions – Article 30(2), point (f), of Regulation (EU) 2021/1149

Describe how it was ensured that the applicable enabling conditions in Annex III of Regulation (EU) 2021/1060 were fulfilled and applied throughout the accounting year, in particular as regards complying with the Charter of Fundamental Rights of the European Union. If relevant, describe any change that had an impact on how the enabling conditions were fulfilled, as provided for in Article 15(6) of Regulation (EU) 2021/1060.

| Insert text here. Max Length: 5 000 characters |
| --- |

Insert text here. Max Length: 5 000 characters

5.2.   Compliance with horizontal principles – Article 9 of Regulation (EU) 2021/1060

Describe how you ensured compliance with the horizontal principles laid down in the Common Provision Regulation during the accounting year, in particular equality between men and women and the promotion of gender mainstreaming, as well as avoiding discrimination based on gender, racial or ethnic origin, religion or belief, disability, age or sexual orientation.

| Insert text here. Max Length: 5 000 characters |
| --- |

Insert text here. Max Length: 5 000 characters

6.   PROJECTS IN OR IN RELATION TO THIRD COUNTRIES – ARTICLE 30(2), POINT (g), OF REGULATION (EU) 2021/1149

Describe any actions taking place in or in relation to third countries during the accounting year and how these bring Union added value in achieving the objectives set by the fund. Indicate the names of the third countries concerned. If relevant, refer to the consultations with the Commission before the project was approved (Article 13(11) of Regulation (EU) 2021/1149).

| Insert text here. Max Length: 6 000 characters |
| --- |

Insert text here. Max Length: 6 000 characters

7.   SUMMARY – ARTICLE 30(2) OF REGULATION (EU) 2021/1149

Provide a summary of sections 1 to 6, which will be translated and made available to the public.

As a minimum, the summary must cover all the points listed in Article 30(2), and should preferably be structured around them.

The use of bullet points, bold text or informative headings is encouraged, so that interested stakeholders can easily identify the programme’s main achievements and the main issues affecting its performance.

| Insert text here. Max Length: 7 500 characters |
| --- |

Insert text here. Max Length: 7 500 characters

---

(1)  This refers to the situation when there is a gap between the nominal target achievement rate measured by the indicators and the actual progress in implementation. For instance, under-reporting of output and results could be due to issues with the development of the IT system, ongoing operations for which output and results are not yet reported, issues with the data collection leading to slow or incomplete reporting, etc.

(2)  This refers to a situation where the low target achievement rate is not due to slow progress but rather to incorrect or unrealistic target setting. It may include lessons learned in connection with the establishment of the methodology for target setting – such as wrong or incomplete assumptions or issues with the benchmark values selected – and any planned changes to it.

(3)  For instance, issues related to tendering procedures, issues with audit procedures, issues linked to lack of resources at the managing authority level, an unforeseen delay in the adoption of the programme, etc.

(4)  This can include, for instance, socioeconomic or political factors, changes in the regulatory context, etc.

(5)  For instance, issues to do with the scope of the action (e.g. eligibility criteria), low interest from beneficiaries or participants, any deviation in the implementation of the action etc.

(6)  If relevant for this purpose, refer to the recommendations from quality control and evaluation mechanisms, such as: (i) the Schengen evaluation and monitoring mechanism, in accordance with Council Regulation (EU) No 1053/2013 of 7 October 2013 establishing an evaluation and monitoring mechanism to verify the application of the Schengen acquis and repealing the Decision of the Executive Committee of 16 September 1998 setting up a Standing Committee on the evaluation and implementation of Schengen (OJ L 295, 6.11.2013, p. 27), and Council Regulation (EU) 2022/922 of 9 June 2022 on the establishment and operation of an evaluation and monitoring mechanism to verify the application of the Schengen acquis, and repealing Regulation (EU) No 1053/2013 (OJ L 160, 15.6.2022, p. 1); or (ii) other quality control and evaluation mechanisms, as applicable.

(7)  In the case of specific actions with a transnational nature, the scope of this section varies according to the distribution of roles and responsibilities between the lead Member States and the other participating Member States, as well as the choice of the reporting method. This is described in the Commission’s note of 14 February 2022 – Transnational specific actions under the Asylum, Migration and Integration Fund (AMIF), the Instrument for Financial Support for Border Management and Visa Policy (BMVI),and the Internal Security Fund (ISF) – Arrangements between partners (Ares (2022)1060102).

(8)  Union added value is defined as the generation of results beyond what would have been achieved by Member States acting alone.

(9)  For instance, in connection to procurement activities or any other preparatory steps taken.

(10)  For instance, in terms of deliverables, outputs, results etc.

(11)  As set out in the Commission’s note of 14 February 2022 (Ares (2022)1060102).

(12)  Total eligible cost of selected operations, as reported to the Commission by 31 July of the last accounting year.

(13)  Total amount of eligible expenditure declared by the beneficiaries to the managing authority, as reported to the Commission by 31 July of the last accounting year.

(14)  If specific actions represent a top-up of previous operations and there are no dedicated monitoring arrangements, report the output and results pro-rata.

(15)  Regulation (EU) No 513/2014 of the European Parliament and of the Council of 16 April 2014 establishing, as part of the Internal Security Fund, the instrument for financial support for police cooperation, preventing and combating crime, and crisis management and repealing Council Decision 2007/125/JHA (OJ L 150, 20.5.2014, p. 93).

(16)  Regulation (EU) No 514/2014 of the European Parliament and of the Council of 16 April 2014 laying down general provisions on the Asylum, Migration and Integration Fund and on the instrument for financial support for police cooperation, preventing and combating crime, and crisis management (OJ L 150, 20.5.2014, p. 112).

(17)  Such as cooperation at Union level between the Member States, and between Member States and relevant Union bodies, offices and agencies, as well as cooperation at national level among the competent authorities within each Member State.

(18)  Regulation (EU) 2019/817 of the European Parliament and of the Council of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of borders and visa and amending Regulations (EC) No 767/2008, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1726 and (EU) 2018/1861 of the European Parliament and of the Council and Council Decisions 2004/512/EC and 2008/633/JHA (OJ L 135, 22.5.2019, p. 27).

Regulation (EU) 2019/818 of the European Parliament and of the Council of 20 May 2019 on establishing a framework for interoperability between EU information systems in the field of police and judicial cooperation, asylum and migration and amending Regulations (EU) 2018/1726, (EU) 2018/1862 and (EU) 2019/816 (OJ L 135, 22.5.2019, p. 85).

(19)  Total eligible cost of selected operations, as reported to the Commission by 31 July of the last accounting year.

(20)  Total amount of eligible expenditure declared by the beneficiaries to the managing authority, as reported to the Commission by 31 July of the last accounting year.

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DIRECTIVES

| 26.1.2023 | EN | Official Journal of the European Union | L 24/33 |
| --- | --- | --- | --- |

26.1.2023

EN

Official Journal of the European Union

L 24/33

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COMMISSION DELEGATED DIRECTIVE (EU) 2023/171

of 28 October 2022

amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for hexavalent chromium as an anticorrosion agent in gas absorption heat pumps

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (1), and in particular Article 5(1), point (a), thereof,

Whereas:

| (1) | Directive 2011/65/EU requires Member States to ensure that electrical and electronic equipment placed on the market does not contain the hazardous substances listed in Annex II to that Directive. That restriction does not apply to certain exempted applications listed in Annex III to that Directive. |
| --- | --- |

(1)

Directive 2011/65/EU requires Member States to ensure that electrical and electronic equipment placed on the market does not contain the hazardous substances listed in Annex II to that Directive. That restriction does not apply to certain exempted applications listed in Annex III to that Directive.

| (2) | The categories of electrical and electronic equipment to which Directive 2011/65/EU applies are listed in Annex I to that Directive. |
| --- | --- |

(2)

The categories of electrical and electronic equipment to which Directive 2011/65/EU applies are listed in Annex I to that Directive.

| (3) | Hexavalent chromium is a restricted substance listed in Annex II to Directive 2011/65/EU. |
| --- | --- |

(3)

Hexavalent chromium is a restricted substance listed in Annex II to Directive 2011/65/EU.

| (4) | On 23 December 2020, the Commission received an application made in accordance with Article 5(3) of Directive 2011/65/EU for an exemption to be listed in Annex III to that Directive, for the use of hexavalent chromium as an anticorrosion agent in the working fluid of the carbon steel sealed circuit of gas absorption heat pumps (‘the requested exemption’). |
| --- | --- |

(4)

On 23 December 2020, the Commission received an application made in accordance with Article 5(3) of Directive 2011/65/EU for an exemption to be listed in Annex III to that Directive, for the use of hexavalent chromium as an anticorrosion agent in the working fluid of the carbon steel sealed circuit of gas absorption heat pumps (‘the requested exemption’).

| (5) | Gas absorption heat pumps require electricity for auxiliary functions like pumping a working fluid through the system. The gas absorption heat pumps described in the requested exemption fall under category 1 ‘large household appliances’ of Annex I to Directive 2011/65/EU. |
| --- | --- |

(5)

Gas absorption heat pumps require electricity for auxiliary functions like pumping a working fluid through the system. The gas absorption heat pumps described in the requested exemption fall under category 1 ‘large household appliances’ of Annex I to Directive 2011/65/EU.

| (6) | The evaluation of the exemption application, which included a technical and scientific assessment study (2), concluded that substitution of hexavalent chromium in the refrigerant solution is currently scientifically and technically impracticable, and other heating technologies eliminating the use of hexavalent chromium in the form of sodium chromate cannot offer equivalent functionality and performance. Gas absorption heat pumps can indeed provide higher energy efficiency than condensing boiler technologies, can help to replace those systems and can lead to carbon dioxide emission savings. That evaluation thus concluded that at least one of the relevant conditions specified in Article 5(1), point (a), of Directive 2011/65/EU is met, namely that the total negative environmental, health and consumer safety impacts of substituting hexavalent chromium in the uses covered by the exemption application are likely to outweigh the total environmental, health and consumer safety benefits thereof. The evaluation included stakeholder consultations as required by Article 5(7) of Directive 2011/65/EU. The comments received during those consultations were made publicly available on a dedicated website. |
| --- | --- |

(6)

The evaluation of the exemption application, which included a technical and scientific assessment study (2), concluded that substitution of hexavalent chromium in the refrigerant solution is currently scientifically and technically impracticable, and other heating technologies eliminating the use of hexavalent chromium in the form of sodium chromate cannot offer equivalent functionality and performance. Gas absorption heat pumps can indeed provide higher energy efficiency than condensing boiler technologies, can help to replace those systems and can lead to carbon dioxide emission savings. That evaluation thus concluded that at least one of the relevant conditions specified in Article 5(1), point (a), of Directive 2011/65/EU is met, namely that the total negative environmental, health and consumer safety impacts of substituting hexavalent chromium in the uses covered by the exemption application are likely to outweigh the total environmental, health and consumer safety benefits thereof. The evaluation included stakeholder consultations as required by Article 5(7) of Directive 2011/65/EU. The comments received during those consultations were made publicly available on a dedicated website.

| (7) | A maximum concentration of 0,7 % hexavalent chromium by weight in the refrigerant solution is considered as sufficient for the requested exemption. |
| --- | --- |

(7)

A maximum concentration of 0,7 % hexavalent chromium by weight in the refrigerant solution is considered as sufficient for the requested exemption.

| (8) | The placing on the market for a use and the use of substances listed in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3) are subject to an authorisation requirement under that Regulation. That Annex lists a number of hexavalent chromium compounds, including sodium chromate. Regulation (EC) No 1907/2006 and Directive 2011/65/EU apply without prejudice to each other. The use of a hexavalent chromium compound listed in Annex XIV to Regulation (EC) No 1907/2006 and its placing on the market for a use is subject to authorisation under that Regulation. The granting of an exemption under Directive 2011/65/EU does not affect that authorisation requirement under Regulation (EC) No 1907/2006, nor would the granting of an authorisation under Regulation (EC) No 1907/2006 affect the need to obtain an exemption under Directive 2011/65/EU. No reasons have been found according to which granting the requested exemption under Directive 2011/65/EU would weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006. |
| --- | --- |

(8)

The placing on the market for a use and the use of substances listed in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3) are subject to an authorisation requirement under that Regulation. That Annex lists a number of hexavalent chromium compounds, including sodium chromate. Regulation (EC) No 1907/2006 and Directive 2011/65/EU apply without prejudice to each other. The use of a hexavalent chromium compound listed in Annex XIV to Regulation (EC) No 1907/2006 and its placing on the market for a use is subject to authorisation under that Regulation. The granting of an exemption under Directive 2011/65/EU does not affect that authorisation requirement under Regulation (EC) No 1907/2006, nor would the granting of an authorisation under Regulation (EC) No 1907/2006 affect the need to obtain an exemption under Directive 2011/65/EU. No reasons have been found according to which granting the requested exemption under Directive 2011/65/EU would weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006.

| (9) | It is, therefore, appropriate to grant the requested exemption by including the applications covered by it in Annex III to Directive 2011/65/EU with respect to electrical and electronic equipment of category 1. |
| --- | --- |

(9)

It is, therefore, appropriate to grant the requested exemption by including the applications covered by it in Annex III to Directive 2011/65/EU with respect to electrical and electronic equipment of category 1.

| (10) | Research efforts to find possibilities for reducing the hexavalent chromium content and/or to substitute or eliminate the use of hexavalent chromium will foreseeably require more than 5 years. Thus, it is appropriate to grant the requested exemption until 31 December 2026, in accordance with Article 5(2), first subparagraph, of Directive 2011/65/EU. |
| --- | --- |

(10)

Research efforts to find possibilities for reducing the hexavalent chromium content and/or to substitute or eliminate the use of hexavalent chromium will foreseeably require more than 5 years. Thus, it is appropriate to grant the requested exemption until 31 December 2026, in accordance with Article 5(2), first subparagraph, of Directive 2011/65/EU.

| (11) | Directive 2011/65/EU should therefore be amended accordingly, |
| --- | --- |

(11)

Directive 2011/65/EU should therefore be amended accordingly,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annex III to Directive 2011/65/EU is amended as set out in the Annex to this Directive.

Article 2

1.   Member States shall adopt and publish, by 31 August 2023 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate the text of those provisions to the Commission.

They shall apply those provisions from 1 September 2023.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3

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

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 28 October 2022.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 174, 1.7.2011, p. 88.

1

(2)  Study to assess requests for renewal of 12 exemptions to Annex IV of Directive 2011/65/EU - Review of request for amendment of exemption III-9: final report.

2

(3)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

3

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ANNEX

In Annex III to Directive 2011/65/EU, the following entry 9(a)-III is inserted:

| ‘9(a)-III | Up to 0,7 % hexavalent chromium by weight, used as an anticorrosion agent in the working fluid of the carbon steel sealed circuit of gas absorption heat pumps for space and water heating | Applies to category 1 and expires on 31 December 2026.’. |
| --- | --- | --- |

‘9(a)-III

Up to 0,7 % hexavalent chromium by weight, used as an anticorrosion agent in the working fluid of the carbon steel sealed circuit of gas absorption heat pumps for space and water heating

Applies to category 1 and expires on 31 December 2026.’.

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DECISIONS

| 26.1.2023 | EN | Official Journal of the European Union | L 24/37 |
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26.1.2023

EN

Official Journal of the European Union

L 24/37

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COMMISSION IMPLEMENTING DECISION (EU) 2023/172

of 24 January 2023

amending Implementing Decision 2012/715/EU as regards the inclusion of Canada in the list of third countries established by that Decision

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use (1), and in particular Article 111b(1) thereof,

Whereas:

| (1) | In accordance with Article 111b(1) of Directive 2001/83/EC, a third country may request the Commission to assess whether that country’s regulatory framework applicable to active substances exported to the Union, and the respective control and enforcement activities, ensure a level of protection of public health equivalent to that of the Union in order to be included in a list of third countries ensuring an equivalent level of protection of public health. |
| --- | --- |

(1)

In accordance with Article 111b(1) of Directive 2001/83/EC, a third country may request the Commission to assess whether that country’s regulatory framework applicable to active substances exported to the Union, and the respective control and enforcement activities, ensure a level of protection of public health equivalent to that of the Union in order to be included in a list of third countries ensuring an equivalent level of protection of public health.

| (2) | Canada requested, by letter dated 1 October 2018, to be listed in accordance with Article 111b(1) of Directive 2001/83/EC. |
| --- | --- |

(2)

Canada requested, by letter dated 1 October 2018, to be listed in accordance with Article 111b(1) of Directive 2001/83/EC.

| (3) | The Commission has assessed the request by carrying on a review of the relevant documentation and an on-site review of Canada’s regulatory system and an observed inspection and taking due account of the action plan proposed on 23 September 2022, by the Canadian competent authority, Health Canada/Santé Canada. |
| --- | --- |

(3)

The Commission has assessed the request by carrying on a review of the relevant documentation and an on-site review of Canada’s regulatory system and an observed inspection and taking due account of the action plan proposed on 23 September 2022, by the Canadian competent authority, Health Canada/Santé Canada.

| (4) | The Commission has also assessed the regulations to extend Canada’s drug establishment licensing framework and Good Manufacturing Practice requirements to establishments that conduct regulated activities with active substances intended solely for export (2), which are to enter into force on 8 December 2022. |
| --- | --- |

(4)

The Commission has also assessed the regulations to extend Canada’s drug establishment licensing framework and Good Manufacturing Practice requirements to establishments that conduct regulated activities with active substances intended solely for export (2), which are to enter into force on 8 December 2022.

| (5) | Based on that equivalence assessment, the Commission concluded that the requirements of Article 111(b) of Directive 2001/83/EC were fulfilled. |
| --- | --- |

(5)

Based on that equivalence assessment, the Commission concluded that the requirements of Article 111(b) of Directive 2001/83/EC were fulfilled.

| (6) | Commission Implementing Decision 2012/715/EU (3) should be amended accordingly. |
| --- | --- |

(6)

Commission Implementing Decision 2012/715/EU (3) should be amended accordingly.

HAS ADOPTED THIS DECISION:

Article 1

The Annex to Implementing Decision 2012/715/EU is replaced by the text set out in the Annex to this Decision.

Article 2

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

Done at Brussels, 24 January 2023.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 311, 28.11.2001, p. 67.

1

(2)  Canada Gazette Part II, Vol. 156, No 12/Gazette du Canada Partie II, vol. 156, no 12 p. 1521

2

(3)  Commission Implementing Decision 2012/715/EU of 22 November 2012 establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union, in accordance with Directive 2001/83/EC of the European Parliament and of the Council (OJ L 325, 23.11.2012, p. 15).

3

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ANNEX

‘ANNEX

List of third countries with a regulatory framework applicable to active substances exported to the Union and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union

| Third country | Remarks |
| --- | --- |
| Australia | |
| Brazil | |
| Canada | |
| Israel (1) | |
| Japan | |
| South Korea | |
| Switzerland | |
| United States | |

Third country

Remarks

Australia

Brazil

Canada

Israel (1)

Japan

South Korea

Switzerland

United States

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(1)  Hereafter understood as the State of Israel, excluding the territories under Israeli administration since June 1967, namely the Golan Heights, the Gaza Strip, East Jerusalem and the rest of the West Bank (OJ L 171, 2.7.2015, p. 24).’

1

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