# Official Journal L 84/2023

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 84 |
| | |
| English edition | Legislation | Volume 6623 March 2023 |

ISSN 1977-0677

Official Journal

of the European Union

L 84

English edition

Legislation

Volume 6623 March 2023

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) 2023/666 of 16 March 2023 entering a name in the register of protected designations of origin and protected geographical indications (Olio Campania (PGI)) | 1 |
| | * | Commission Implementing Regulation (EU) 2023/667 of 22 March 2023 authorising the placing on the market of Canarium indicum L. dried nuts as a traditional food from a third country and amending Implementing Regulation (EU) 2017/2470 (
  1
  ) | 3 |
| | * | Commission Implementing Regulation (EU) 2023/668 of 22 March 2023 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 as a feed additive for all laying poultry (holder of authorisation: Kemin Europa N.V.) (
  1
  ) | 7 |
| | * | Commission Implementing Regulation (EU) 2023/669 of 22 March 2023 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii DSM 33574 as a feed additive for all poultry species for fattening and all poultry species reared for laying and reared for breeding (holder of authorisation: BioResource, international, Inc. represented in the Union by Pen & Tec Consulting, S.L.U.) (
  1
  ) | 10 |
| | | DECISIONS |
| | * | Council Decision (EU) 2023/670 of 21 March 2023 amending Decision 1999/70/EC concerning the external auditors of the national central banks, as regards the external auditors of Banc Ceannais na hÉireann/the Central Bank of Ireland | 14 |
| | * | Council Decision (EU) 2023/671 of 21 March 2023 authorising the opening of negotiations for an agreement between the European Union and the Swiss Confederation establishing a basis for the exchange of information on persons benefitting from temporary protection | 16 |
| | * | Decision (EU) 2023/672 of the European Central Bank of 10 March 2023 on delegation of the power to adopt decisions relating to on-site inspections and internal model investigations (ECB/2023/5) | 18 |
| | * | Decision (EU) 2023/673 of the European Central Bank of 14 March 2023 nominating heads of work units to adopt delegated decisions relating to on-site inspections and internal model investigations (ECB/2023/6) | 24 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Implementing Regulation (EU) 2023/666 of 16 March 2023 entering a name in the register of protected designations of origin and protected geographical indications (Olio Campania (PGI))

1

*

Commission Implementing Regulation (EU) 2023/667 of 22 March 2023 authorising the placing on the market of Canarium indicum L. dried nuts as a traditional food from a third country and amending Implementing Regulation (EU) 2017/2470 (
  1
  )

Canarium indicum

1

3

*

Commission Implementing Regulation (EU) 2023/668 of 22 March 2023 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 as a feed additive for all laying poultry (holder of authorisation: Kemin Europa N.V.) (
  1
  )

Komagataella phaffii

1

7

*

Commission Implementing Regulation (EU) 2023/669 of 22 March 2023 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii DSM 33574 as a feed additive for all poultry species for fattening and all poultry species reared for laying and reared for breeding (holder of authorisation: BioResource, international, Inc. represented in the Union by Pen & Tec Consulting, S.L.U.) (
  1
  )

Komagataella phaffii

1

10

DECISIONS

*

Council Decision (EU) 2023/670 of 21 March 2023 amending Decision 1999/70/EC concerning the external auditors of the national central banks, as regards the external auditors of Banc Ceannais na hÉireann/the Central Bank of Ireland

14

*

Council Decision (EU) 2023/671 of 21 March 2023 authorising the opening of negotiations for an agreement between the European Union and the Swiss Confederation establishing a basis for the exchange of information on persons benefitting from temporary protection

16

*

Decision (EU) 2023/672 of the European Central Bank of 10 March 2023 on delegation of the power to adopt decisions relating to on-site inspections and internal model investigations (ECB/2023/5)

18

*

Decision (EU) 2023/673 of the European Central Bank of 14 March 2023 nominating heads of work units to adopt delegated decisions relating to on-site inspections and internal model investigations (ECB/2023/6)

24

| | | Corrigenda |
| --- | --- | --- |
| | * | Corrigendum to Regulation (EU, Euratom) 2022/2434 of the European Parliament and of the Council of 6 December 2022 amending Regulation (EU, Euratom) 2018/1046 as regards the establishment of a diversified funding strategy as a general borrowing method ( OJ L 319, 13.12.2022 ) | 26 |
| | * | Corrigendum to Definitive Adoption (EU, Euratom) 2023/278 of the European Union’s annual budget for the financial year 2023 ( OJ L 58, 23.2.2023 ) | 27 |

Corrigenda

*

Corrigendum to Regulation (EU, Euratom) 2022/2434 of the European Parliament and of the Council of 6 December 2022 amending Regulation (EU, Euratom) 2018/1046 as regards the establishment of a diversified funding strategy as a general borrowing method ( OJ L 319, 13.12.2022 )

( OJ L 319, 13.12.2022 )

26

*

Corrigendum to Definitive Adoption (EU, Euratom) 2023/278 of the European Union’s annual budget for the financial year 2023 ( OJ L 58, 23.2.2023 )

( OJ L 58, 23.2.2023 )

27

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| | (1)   Text with EEA relevance. |

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(1)   Text with EEA relevance.

1

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

EN

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

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

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II Non-legislative acts

REGULATIONS

| 23.3.2023 | EN | Official Journal of the European Union | L 84/1 |
| --- | --- | --- | --- |

23.3.2023

EN

Official Journal of the European Union

L 84/1

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COMMISSION IMPLEMENTING REGULATION (EU) 2023/666

of 16 March 2023

entering a name in the register of protected designations of origin and protected geographical indications (‘Olio Campania’ (PGI))

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,

Whereas:

| (1) | Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Italy’s application to register the name ‘Olio Campania’ was published in the Official Journal of the European Union (2). |
| --- | --- |

(1)

Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Italy’s application to register the name ‘Olio Campania’ was published in the Official Journal of the European Union (2).

| (2) | As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Olio Campania’ should therefore be entered in the register, |
| --- | --- |

(2)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Olio Campania’ should therefore be entered in the register,

HAS ADOPTED THIS REGULATION:

Article 1

The name ‘Olio Campania’ (PGI) is hereby entered in the register.

The name specified in the first paragraph denotes a product in Class 1.5. Oils and fats (butter, margarine, oil, etc.), as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).

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, 16 March 2023.

For the Commission,

On behalf of the President,

Janusz WOJCIECHOWSKI

Member of the Commission

---

(1)  
  OJ L 343, 14.12.2012, p. 1.

1

(2)  
  OJ C 448, 25.11.2022, p. 39.

2

(3)  Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).

3

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| 23.3.2023 | EN | Official Journal of the European Union | L 84/3 |
| --- | --- | --- | --- |

23.3.2023

EN

Official Journal of the European Union

L 84/3

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COMMISSION IMPLEMENTING REGULATION (EU) 2023/667

of 22 March 2023

authorising the placing on the market of Canarium indicum L. dried nuts as a traditional food from a third country and amending Implementing Regulation (EU) 2017/2470

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 15(4) thereof,

Whereas:

| (1) | Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union. On the basis of the definition set out in Article 3(2)(c) of Regulation (EU) 2015/2283, traditional food from a third country is considered a novel food. |
| --- | --- |

(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union. On the basis of the definition set out in Article 3(2)(c) of Regulation (EU) 2015/2283, traditional food from a third country is considered a novel food.

| (2) | Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) has established a Union list of novel foods. |
| --- | --- |

(2)

Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) has established a Union list of novel foods.

| (3) | On 26 March 2020, the company Kawanasi Sehat Dasacatur, PT (‘the applicant’) submitted a notification to the Commission in accordance with Article 14 of Regulation (EU) 2015/2283 of its intention to place dried nuts of Canarium indicum L. (‘Kenari’) on the Union market as a traditional food from a third country. The applicant requested that the food concerned be used as such or added as an ingredient in cereal and bakery products, confectionary, snacks and prepared dishes intended for the general population. |
| --- | --- |

(3)

On 26 March 2020, the company Kawanasi Sehat Dasacatur, PT (‘the applicant’) submitted a notification to the Commission in accordance with Article 14 of Regulation (EU) 2015/2283 of its intention to place dried nuts of Canarium indicum L. (‘Kenari’) on the Union market as a traditional food from a third country. The applicant requested that the food concerned be used as such or added as an ingredient in cereal and bakery products, confectionary, snacks and prepared dishes intended for the general population.

| (4) | The notification complies with the requirements laid down in Article 14 of Regulation (EU) 2015/2283. In particular, the data presented by the applicant demonstrate that dried nuts of Canarium indicum L. have a history of safe food use in the Spice Islands region of Indonesia. |
| --- | --- |

(4)

The notification complies with the requirements laid down in Article 14 of Regulation (EU) 2015/2283. In particular, the data presented by the applicant demonstrate that dried nuts of Canarium indicum L. have a history of safe food use in the Spice Islands region of Indonesia.

| (5) | Pursuant to Article 15(1) of Regulation (EU) 2015/2283, on 13 June 2022, the Commission forwarded the valid notification to the Member States and to the European Food Safety Authority (‘the Authority’). |
| --- | --- |

(5)

Pursuant to Article 15(1) of Regulation (EU) 2015/2283, on 13 June 2022, the Commission forwarded the valid notification to the Member States and to the European Food Safety Authority (‘the Authority’).

| (6) | No duly reasoned safety objections to the placing on the market within the Union of the food concerned were submitted to the Commission by the Member States or the Authority within the period set in Article 15(2) of Regulation (EU) 2015/2283. |
| --- | --- |

(6)

No duly reasoned safety objections to the placing on the market within the Union of the food concerned were submitted to the Commission by the Member States or the Authority within the period set in Article 15(2) of Regulation (EU) 2015/2283.

| (7) | On 11 November 2022, the Authority published its ‘Technical Report on the notification of dried nuts of Canarium indicum L. as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283’ (3). In that report, the Authority concluded that the available data on the composition and the history of the requested use of dried nuts of Canarium indicum L.do not raise safety concerns. |
| --- | --- |

(7)

On 11 November 2022, the Authority published its ‘Technical Report on the notification of dried nuts of Canarium indicum L. as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283’ (3). In that report, the Authority concluded that the available data on the composition and the history of the requested use of dried nuts of Canarium indicum L.do not raise safety concerns.

| (8) | In its report, the Authority also noted on the basis of limited published evidence on food allergy related to nuts of Canarium indicum L., that allergic reactions may be expected after the consumption of nuts of Canarium indicum L. In particular, studies showed cross-reactivity of nuts of Canarium indicum L. to hazel, cashew and pistachio. It is important that information on the presence of foods that may cause allergic reactions is given in a clear manner to enable consumers to make informed choices which are safe for them. Therefore, it is appropriate that nuts of Canarium indicum L. made available to the consumers are appropriately labelled following the requirements of Article 9 of Regulation (EU) 2015/2283 and by virtue of Regulation (EU) No 1169/2011 of the European Parliament and of the Council (4). |
| --- | --- |

(8)

In its report, the Authority also noted on the basis of limited published evidence on food allergy related to nuts of Canarium indicum L., that allergic reactions may be expected after the consumption of nuts of Canarium indicum L. In particular, studies showed cross-reactivity of nuts of Canarium indicum L. to hazel, cashew and pistachio. It is important that information on the presence of foods that may cause allergic reactions is given in a clear manner to enable consumers to make informed choices which are safe for them. Therefore, it is appropriate that nuts of Canarium indicum L. made available to the consumers are appropriately labelled following the requirements of Article 9 of Regulation (EU) 2015/2283 and by virtue of Regulation (EU) No 1169/2011 of the European Parliament and of the Council (4).

| (9) | The Commission should therefore authorise the placing on the market within the Union of Canarium indicum L. dried nuts as a traditional food from a third country and update the Union list of novel foods accordingly. |
| --- | --- |

(9)

The Commission should therefore authorise the placing on the market within the Union of Canarium indicum L. dried nuts as a traditional food from a third country and update the Union list of novel foods accordingly.

| (10) | Canarium indicum L. dried nuts should be included as a traditional food from a third country in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly, |
| --- | --- |

(10)

Canarium indicum L. dried nuts should be included as a traditional food from a third country in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

(1)   Canarium indicum L. dried nuts is authorised to be placed on the market within the Union.

Canarium indicum L. dried nuts shall be included as a traditional food from a third country in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.

(2)   The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

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, 22 March 2023.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 327, 11.12.2015, p. 1.

1

(2)  Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).

2

(3)  EFSA Supporting publication 2022:EN-7640.

3

(4)  Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18).

4

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ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

| (1) | in Table 1 (Authorised novel foods), the following entry is inserted:









  Authorised novel food | Conditions under which the novel food may be used | Additional specific labelling requirements | Other requirements |
| --- | --- | --- | --- | --- |
| ‘
  Canarium indicum L. dried nuts (Kenari) (Traditional food from a third country) | Specified food category | Maximum levels (g/100 g) | 1. | The designation of the traditional food on the labelling of the foodstuffs containing it shall be “dried kenari (Canarium indicum) nuts”. |

(1)

in Table 1 (Authorised novel foods), the following entry is inserted:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

‘
  Canarium indicum L. dried nuts (Kenari) (Traditional food from a third country)

Specified food category

Maximum levels (g/100 g)

1.

The designation of the traditional food on the labelling of the foodstuffs containing it shall be “dried kenari (Canarium indicum) nuts”.

| 2. | The labelling of the foodstuffs containing dried nuts of Canarium indicum L. shall bear a statement that the nuts may cause allergic reactions to consumers with known allergies to hazel, cashew and pistachio. This statement shall appear in close proximity to the list of ingredients or, in the absence of a list of ingredient, in close proximity to the name of the food.’ |
| --- | --- |

2.

The labelling of the foodstuffs containing dried nuts of Canarium indicum L. shall bear a statement that the nuts may cause allergic reactions to consumers with known allergies to hazel, cashew and pistachio. This statement shall appear in close proximity to the list of ingredients or, in the absence of a list of ingredient, in close proximity to the name of the food.’

Not specified

| (2) | in Table 2 (Specifications), the following entry is inserted:






  Authorised Novel Food | Specifications |
| --- | --- | --- |
| ‘
  Canarium indicum L. dried nuts (Kenari) (Traditional food from a third country) | Description/Definition:

  The traditional food is processed dried kenari nuts. The term “Kenari Nuts” refers to the kernels of ripe Kenari Fruit, scientifically known as Canarium indicum L. (or Canarium amboinense Hochr.; family: Burseraceae).

  Composition: | Ash: ≤ 5 (g/100 g) |

(2)

in Table 2 (Specifications), the following entry is inserted:

Authorised Novel Food

Specifications

‘
  Canarium indicum L. dried nuts (Kenari) (Traditional food from a third country)

Description/Definition:

The traditional food is processed dried kenari nuts. The term “Kenari Nuts” refers to the kernels of ripe Kenari Fruit, scientifically known as Canarium indicum L. (or Canarium amboinense Hochr.; family: Burseraceae).

Composition:

Ash: ≤ 5 (g/100 g)

| | Moisture: ≤ 6 (g/100 g) |
| --- | --- |

Moisture: ≤ 6 (g/100 g)

| | Protein: 12,8 – 14,4 g/100 g |
| --- | --- |

Protein: 12,8 – 14,4 g/100 g

| | Carbohydrates: 11,0 – 16,4 g/100 g |
| --- | --- |

Carbohydrates: 11,0 – 16,4 g/100 g

| | Fat: 59,3 – 66,3 g/100 g |
| --- | --- |

Fat: 59,3 – 66,3 g/100 g

| | Dietary fibre: 4,4 – 9,8 g/100 g |
| --- | --- |

Dietary fibre: 4,4 – 9,8 g/100 g

Microbiological criteria:

| | Aerobic Plate Count: ≤ 5,0 × 103 CFU/g |
| --- | --- |

Aerobic Plate Count: ≤ 5,0 × 103 CFU/g

| | Coliforms: < 3 MPN/g |
| --- | --- |

Coliforms: < 3 MPN/g

| | E. coli: < 3 MPN/g |
| --- | --- |

E. coli: < 3 MPN/g

| | Yeasts and moulds: < 10 CFU/g |
| --- | --- |

Yeasts and moulds: < 10 CFU/g

| | Salmonella: Absent in 25 g |
| --- | --- |

Salmonella: Absent in 25 g

| | Staphylococcus aureus (absent/25 g) |
| --- | --- |

Staphylococcus aureus (absent/25 g)

| | Listeria monocytogenes (absent/25 g) |
| --- | --- |

Listeria monocytogenes (absent/25 g)

| | Aflatoxins |
| --- | --- |

Aflatoxins

| | Aflatoxins B1: ≤ 2 mcg/kg |
| --- | --- |

Aflatoxins B1: ≤ 2 mcg/kg

| | Aflatoxins (Sum of B1, B2, G1, G2): ≤ 4 mcg/kg |
| --- | --- |

Aflatoxins (Sum of B1, B2, G1, G2): ≤ 4 mcg/kg

| | Dioxins and dioxin like PCBs |
| --- | --- |

Dioxins and dioxin like PCBs

| | Sum of dioxins: ≤ 0,75 pg/g fat |
| --- | --- |

Sum of dioxins: ≤ 0,75 pg/g fat

| | Sum of dioxins and dioxin-like PCBs: ≤ 1,5 pg/g fat |
| --- | --- |

Sum of dioxins and dioxin-like PCBs: ≤ 1,5 pg/g fat

| | Heavy metals |
| --- | --- |

Heavy metals

| | Cadmium (Cd): ≤ 0,02 mg/kg |
| --- | --- |

Cadmium (Cd): ≤ 0,02 mg/kg

| | Lead (Pb): ≤ 0,07 mg/kg |
| --- | --- |

Lead (Pb): ≤ 0,07 mg/kg

CFU: Colony Forming Units’

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| 23.3.2023 | EN | Official Journal of the European Union | L 84/7 |
| --- | --- | --- | --- |

23.3.2023

EN

Official Journal of the European Union

L 84/7

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COMMISSION IMPLEMENTING REGULATION (EU) 2023/668

of 22 March 2023

concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 as a feed additive for all laying poultry (holder of authorisation: Kemin Europa N.V.)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. |
| --- | --- |

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

| (2) | In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | The application concerns the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 as a feed additive for all laying poultry, to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’. |
| --- | --- |

(3)

The application concerns the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 as a feed additive for all laying poultry, to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded, in its opinion of 29 June 2022 (2), that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 did not have an adverse effect on consumer safety or the environment. As regards the target species, the Authority concluded that the additive is safe and has the potential to be efficacious for laying hens when added to feed at 45 000 U/kg and that the conclusions on laying hens can be extrapolated to all laying poultry species. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded, in its opinion of 29 June 2022 (2), that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 did not have an adverse effect on consumer safety or the environment. As regards the target species, the Authority concluded that the additive is safe and has the potential to be efficacious for laying hens when added to feed at 45 000 U/kg and that the conclusions on laying hens can be extrapolated to all laying poultry species.

| (5) | The Authority concluded that that additive was not irritant to eyes and skin but was considered a dermal and respiratory sensitiser. |
| --- | --- |

(5)

The Authority concluded that that additive was not irritant to eyes and skin but was considered a dermal and respiratory sensitiser.

| (6) | The Authority considered that there was no need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed, submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| --- | --- |

(6)

The Authority considered that there was no need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed, submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (7) | The assessment of the preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised. The Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. |
| --- | --- |

(7)

The assessment of the preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii ATCC PTA-127053 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised. The Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive.

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

(8)

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

HAS ADOPTED THIS REGULATION:

Article 1

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

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

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

Done at Brussels, 22 March 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  
  EFSA Journal 2022;20(7):7439.

2

EFSA Journal

---

ANNEX

| Identification number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Units of activity/kg of complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: digestibility enhancers |
| 4a36 | Kemin Europa N.V. | Endo-1,4-beta-xylanase (EC 3.2.1.8) | Additive composition

  Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Komagataella phaffii ATCC PTA-127053 with a minimum activity of:
  3 000 000 U (1)/g
  Solid form

  Characterisation of the active substance

  Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Komagataella phaffii ATCC PTA-127053

  Analytical method
   (2)

  For the determination of endo-1,4-beta-xylanase in the feed additive:






  — | colorimetric method based on the enzymatic hydrolysis of endo-1,4-beta-xylanase on the beechwood xylan substrate. |

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Units of activity/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers

4a36

Kemin Europa N.V.

Endo-1,4-beta-xylanase (EC 3.2.1.8)

Additive composition

Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Komagataella phaffii ATCC PTA-127053 with a minimum activity of:

3 000 000 U (1)/g

Solid form

Characterisation of the active substance

Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Komagataella phaffii ATCC PTA-127053

Analytical method
   (2)

For the determination of endo-1,4-beta-xylanase in the feed additive:

—

colorimetric method based on the enzymatic hydrolysis of endo-1,4-beta-xylanase on the beechwood xylan substrate.

For the determination of endo-1,4-beta-xylanase in premixtures and compound feed:

| — | colorimetric method based the enzymatic reaction of endo-1,4-beta-xylanase on the azurine cross-linked wheat arabinoxylan substrate. |
| --- | --- |

—

colorimetric method based the enzymatic reaction of endo-1,4-beta-xylanase on the azurine cross-linked wheat arabinoxylan substrate.

All laying poultry

—

45 000 U

—

| 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

1.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 2. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including breathing and skin protection. |
| --- | --- |

2.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including breathing and skin protection.

13.4.2033

---

(1)  One U unit is the amount of enzyme that releases 0,0067 μmol of reducing sugar (xylose equivalent) per minute and per gram of enzyme product at 50 °C and pH 5,3.

(2)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

---

| 23.3.2023 | EN | Official Journal of the European Union | L 84/10 |
| --- | --- | --- | --- |

23.3.2023

EN

Official Journal of the European Union

L 84/10

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/669

of 22 March 2023

concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii DSM 33574 as a feed additive for all poultry species for fattening and all poultry species reared for laying and reared for breeding (holder of authorisation: BioResource, international, Inc. represented in the Union by Pen & Tec Consulting, S.L.U.)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. |
| --- | --- |

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

| (2) | In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii DSM 33574. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii DSM 33574. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | That application concerns the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii DSM 33574 as a feed additive for all poultry species for fattening and all poultry species reared for laying and reared for breeding, to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’. |
| --- | --- |

(3)

That application concerns the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii DSM 33574 as a feed additive for all poultry species for fattening and all poultry species reared for laying and reared for breeding, to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 29 June 2022 (2) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii DSM 33574 does not have an adverse effect on animal health as regards the target species, on consumer safety or on the environment. In addition, the Authority concluded that the exposure of users to the preparation by inhalation is very likely, that the preparation is a respiratory sensitiser and that it has a potential to be eye irritant. No conclusions could be drawn on the potential of the preparation to cause skin sensitisation. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 29 June 2022 (2) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii DSM 33574 does not have an adverse effect on animal health as regards the target species, on consumer safety or on the environment. In addition, the Authority concluded that the exposure of users to the preparation by inhalation is very likely, that the preparation is a respiratory sensitiser and that it has a potential to be eye irritant. No conclusions could be drawn on the potential of the preparation to cause skin sensitisation.

| (5) | The Authority further concluded that the preparation has the potential to be efficacious for all poultry species for fattening and all poultry species reared for laying and reared for breeding. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| --- | --- |

(5)

The Authority further concluded that the preparation has the potential to be efficacious for all poultry species for fattening and all poultry species reared for laying and reared for breeding. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (6) | The assessment of the preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii DSM 33574 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation. The Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of that preparation. |
| --- | --- |

(6)

The assessment of the preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii DSM 33574 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation. The Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of that preparation.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(7)

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

HAS ADOPTED THIS REGULATION:

Article 1

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

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

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

Done at Brussels, 22 March 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  
  EFSA Journal 2022;20(7):7428.

2

EFSA Journal

---

ANNEX

| Identification number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Units of activity/kg of complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: digestibility enhancers |
| 4a35 | BioResource International, Inc. represented in the Union by Pen &
  Tec Consulting, S.L.U. | Endo-1,4-beta-xylanase (EC 3.2.1.8) | Additive composition

  Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Komagataella phaffii DSM 33574 with a minimum activity of:
  150 000 XU (1)/g
  Solid form

  Characterisation of the active substance

  Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Komagataella phaffii (DSM 33574)

  Analytical method
   (2)

  For the determination of endo-1,4-beta-xylanase activity in the feed additive: colorimetric (DNS) method based on the enzymatic hydrolysis of the beechwood xylan substrate.
  For the determination of endo-1,4-beta-xylanase activity in compound feed: colorimetric method based on the enzymatic reaction of endo-1,4-beta-xylanase on the Xy1X6 substrate. | All poultry species for fattening
  All poultry species reared for laying or reared for breeding purposes | — | 10 000 XU | — | 1. | The additive shall not be used in premixtures. |

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Units of activity/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers

4a35

BioResource International, Inc. represented in the Union by Pen &

Tec Consulting, S.L.U.

Endo-1,4-beta-xylanase (EC 3.2.1.8)

Additive composition

Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Komagataella phaffii DSM 33574 with a minimum activity of:

150 000 XU (1)/g

Solid form

Characterisation of the active substance

Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Komagataella phaffii (DSM 33574)

Analytical method
   (2)

For the determination of endo-1,4-beta-xylanase activity in the feed additive: colorimetric (DNS) method based on the enzymatic hydrolysis of the beechwood xylan substrate.

For the determination of endo-1,4-beta-xylanase activity in compound feed: colorimetric method based on the enzymatic reaction of endo-1,4-beta-xylanase on the Xy1X6 substrate.

All poultry species for fattening

All poultry species reared for laying or reared for breeding purposes

—

10 000 XU

—

1.

The additive shall not be used in premixtures.

| 2. | In the directions for use of the additive, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive, the storage conditions and stability to heat treatment shall be indicated.

| 3. | For users of the additive, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive shall be used with personal protective equipment, including breathing, skin and eyes protection. |
| --- | --- |

3.

For users of the additive, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive shall be used with personal protective equipment, including breathing, skin and eyes protection.

13.4.2033

---

(1)  One XU unit is the amount of enzyme which releases 1 nano-mol of reducing sugar (xylose equivalent) per second from xylan of beechwood at 50 °C and pH 6,0.

(2)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

---

DECISIONS

| 23.3.2023 | EN | Official Journal of the European Union | L 84/14 |
| --- | --- | --- | --- |

23.3.2023

EN

Official Journal of the European Union

L 84/14

---

COUNCIL DECISION (EU) 2023/670

of 21 March 2023

amending Decision 1999/70/EC concerning the external auditors of the national central banks, as regards the external auditors of Banc Ceannais na hÉireann/the Central Bank of Ireland

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to Protocol No 4 on the Statute of the European System of Central Banks and of the European Central Bank, annexed to the Treaty on European Union and the Treaty on the Functioning of the European Union, and in particular Article 27.1 thereof,

Having regard to the Recommendation of the European Central Bank of 15 February 2023 to the Council of the European Union on the external auditors of the Central Bank of Ireland (ECB/2023/1) (1),

Whereas:

| (1) | The accounts of the European Central Bank (ECB) and of the national central banks of the Member States whose currency is the euro are to be audited by independent external auditors recommended by the Governing Council of the ECB and approved by the Council of the European Union. |
| --- | --- |

(1)

The accounts of the European Central Bank (ECB) and of the national central banks of the Member States whose currency is the euro are to be audited by independent external auditors recommended by the Governing Council of the ECB and approved by the Council of the European Union.

| (2) | In 2016, Banc Ceannais na hÉireann/the Central Bank of Ireland selected Mazars as its external auditors for the financial years 2016 to 2020. On 15 November 2021, the Council adopted Decision (EU) 2021/2018 (2), extending the mandate of Mazars as external auditors for Banc Ceannais na hÉireann/the Central Bank of Ireland for the financial years 2021 to 2022. |
| --- | --- |

(2)

In 2016, Banc Ceannais na hÉireann/the Central Bank of Ireland selected Mazars as its external auditors for the financial years 2016 to 2020. On 15 November 2021, the Council adopted Decision (EU) 2021/2018 (2), extending the mandate of Mazars as external auditors for Banc Ceannais na hÉireann/the Central Bank of Ireland for the financial years 2021 to 2022.

| (3) | The mandate of Mazars as current external auditors of Banc Ceannais na hÉireann/the Central Bank of Ireland expires after the audit for the financial year 2022. It is therefore necessary to appoint external auditors from the financial year 2023. |
| --- | --- |

(3)

The mandate of Mazars as current external auditors of Banc Ceannais na hÉireann/the Central Bank of Ireland expires after the audit for the financial year 2022. It is therefore necessary to appoint external auditors from the financial year 2023.

| (4) | Banc Ceannais na hÉireann/the Central Bank of Ireland has selected Grant Thornton Ireland as its external auditors for the financial years 2023 to 2027, with the option to extend the mandate to the financial years 2028 and 2029. |
| --- | --- |

(4)

Banc Ceannais na hÉireann/the Central Bank of Ireland has selected Grant Thornton Ireland as its external auditors for the financial years 2023 to 2027, with the option to extend the mandate to the financial years 2028 and 2029.

| (5) | The Governing Council of the ECB recommended that Grant Thornton Ireland be appointed as the external auditors of Banc Ceannais na hÉireann/the Central Bank of Ireland for the financial years 2023 to 2027, with the option to extend the mandate to the financial years 2028 and 2029. |
| --- | --- |

(5)

The Governing Council of the ECB recommended that Grant Thornton Ireland be appointed as the external auditors of Banc Ceannais na hÉireann/the Central Bank of Ireland for the financial years 2023 to 2027, with the option to extend the mandate to the financial years 2028 and 2029.

| (6) | Following the recommendation of the Governing Council of the ECB, Council Decision 1999/70/EC (3) should be amended accordingly, |
| --- | --- |

(6)

Following the recommendation of the Governing Council of the ECB, Council Decision 1999/70/EC (3) should be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

In Article 1 of Decision 1999/70/EC, paragraph 5 is replaced by the following:

‘5.   Grant Thornton Ireland are hereby approved as the external auditors of Banc Ceannais na hÉireann/the Central Bank of Ireland for the financial years 2023 to 2027.’.

Article 2

This Decision shall take effect on the date of its notification.

Article 3

This Decision is addressed to the European Central Bank.

Done at Brussels, 21 March 2023.

For the Council

The President

J. ROSWALL

---

(1)  
  OJ C 66, 23.2.2023, p. 1.

1

(2)  Council Decision (EU) 2021/2018 of 15 November 2021 amending Decision 1999/70/EC concerning the external auditors of the national central banks, as regards the external auditors of Banc Ceannais na hÉireann/the Central Bank of Ireland (OJ L 413, 19.11.2021, p. 1).

2

(3)  Council Decision 1999/70/EC of 25 January 1999 concerning the external auditors of the national central banks (OJ L 22, 29.1.1999, p. 69).

3

---

| 23.3.2023 | EN | Official Journal of the European Union | L 84/16 |
| --- | --- | --- | --- |

23.3.2023

EN

Official Journal of the European Union

L 84/16

---

COUNCIL DECISION (EU) 2023/671

of 21 March 2023

authorising the opening of negotiations for an agreement between the European Union and the Swiss Confederation establishing a basis for the exchange of information on persons benefitting from temporary protection

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 218(3) and (4) thereof,

Having regard to the recommendation from the European Commission,

Whereas:

| (1) | At its meeting of 4 March 2022, in response to a mass influx of persons fleeing Ukraine as a consequence of the Russian invasion of Ukraine, the Council adopted Implementing Decision (EU) 2022/382 (1) by unanimous vote to establish the existence of and offer protection to that mass influx of persons. |
| --- | --- |

(1)

At its meeting of 4 March 2022, in response to a mass influx of persons fleeing Ukraine as a consequence of the Russian invasion of Ukraine, the Council adopted Implementing Decision (EU) 2022/382 (1) by unanimous vote to establish the existence of and offer protection to that mass influx of persons.

| (2) | At that Council meeting, a statement was issued supporting the Member States that are the main entry points to the Union from Ukraine for the mass influx of displaced persons fleeing Russia’s war of aggression and promoting the need for a balance of efforts between all Member States in receiving those persons. |
| --- | --- |

(2)

At that Council meeting, a statement was issued supporting the Member States that are the main entry points to the Union from Ukraine for the mass influx of displaced persons fleeing Russia’s war of aggression and promoting the need for a balance of efforts between all Member States in receiving those persons.

| (3) | The Member States further agreed by way of that statement not to apply in respect of persons in the Union who are fleeing Russia’s war of aggression in Ukraine the provisions of Article 11 of Council Directive 2001/55/EC (2) on persons enjoying temporary protection in a given Member State who move to another Member State without authorisation unless, on a bilateral basis, the Member States concerned agree otherwise. |
| --- | --- |

(3)

The Member States further agreed by way of that statement not to apply in respect of persons in the Union who are fleeing Russia’s war of aggression in Ukraine the provisions of Article 11 of Council Directive 2001/55/EC (2) on persons enjoying temporary protection in a given Member State who move to another Member State without authorisation unless, on a bilateral basis, the Member States concerned agree otherwise.

| (4) | Pursuant to Article 10 of Directive 2001/55/EC, Member States have an obligation to register at national level the personal data of the persons enjoying temporary protection on their territory. In addition, Article 27(1) of that Directive provides that, for the purposes of the administrative cooperation required to implement temporary protection, the Member States are, in liaison with the Commission, to take all appropriate measures to establish direct cooperation and an exchange of information between the competent authorities. |
| --- | --- |

(4)

Pursuant to Article 10 of Directive 2001/55/EC, Member States have an obligation to register at national level the personal data of the persons enjoying temporary protection on their territory. In addition, Article 27(1) of that Directive provides that, for the purposes of the administrative cooperation required to implement temporary protection, the Member States are, in liaison with the Commission, to take all appropriate measures to establish direct cooperation and an exchange of information between the competent authorities.

| (5) | It is in the interests of the Member States to exchange information with third countries in the Schengen area. Switzerland, which counted, on 25 October 2022, a cumulative number of 65 953 registrations of persons enjoying temporary protection in its territory, has expressed an interest in such an exchange. As many persons enjoying temporary protection in the territory of Switzerland may have previously registered their personal data under Directive 2001/55/EC in a Member State, facilitating an exchange of those data can permit the Member States concerned to cease providing for the receipt by persons who are no longer on their territory of the necessary assistance associated with the right to temporary protection. |
| --- | --- |

(5)

It is in the interests of the Member States to exchange information with third countries in the Schengen area. Switzerland, which counted, on 25 October 2022, a cumulative number of 65 953 registrations of persons enjoying temporary protection in its territory, has expressed an interest in such an exchange. As many persons enjoying temporary protection in the territory of Switzerland may have previously registered their personal data under Directive 2001/55/EC in a Member State, facilitating an exchange of those data can permit the Member States concerned to cease providing for the receipt by persons who are no longer on their territory of the necessary assistance associated with the right to temporary protection.

| (6) | In addition, it is in the interests of the Member States to provide for a certain measure of stability and a balance of efforts between them in receiving persons fleeing Russia’s war of aggression in Ukraine, and to ensure that the system is not open to abuse. |
| --- | --- |

(6)

In addition, it is in the interests of the Member States to provide for a certain measure of stability and a balance of efforts between them in receiving persons fleeing Russia’s war of aggression in Ukraine, and to ensure that the system is not open to abuse.

| (7) | Negotiations should be opened with a view to concluding an agreement establishing a basis for the exchange of information on persons benefitting from temporary protection between the Union and the Swiss Confederation, |
| --- | --- |

(7)

Negotiations should be opened with a view to concluding an agreement establishing a basis for the exchange of information on persons benefitting from temporary protection between the Union and the Swiss Confederation,

HAS ADOPTED THIS DECISION:

Article 1

The Commission is hereby authorised to open negotiations for an agreement establishing a basis for the exchange of information on persons benefitting from temporary protection with the Swiss Confederation.

Article 2

The Commission shall negotiate the provisions of the agreement in consultation with the Council’s Working Party on Asylum and in accordance with the negotiating directives set out in the addendum to this Decision, subject to any further such directives which the Council may subsequently issue to the Commission.

Article 3

This Decision is addressed to the Commission.

Done at Brussels, 21 March 2023.

For the Council

The President

J. ROSWALL

---

(1)  Council Implementing Decision (EU) 2022/382 of 4 March 2022 establishing the existence of a mass influx of displaced persons from Ukraine within the meaning of Article 5 of Directive 2001/55/EC, and having the effect of introducing temporary protection (OJ L 71, 4.3.2022, p. 1).

1

(2)  Council Directive 2001/55/EC of 20 July 2001 on minimum standards for giving temporary protection in the event of a mass influx of displaced persons and on measures promoting a balance of efforts between Member States in receiving such persons and bearing the consequences thereof (OJ L 212, 7.8.2001, p. 12).

2

---

| 23.3.2023 | EN | Official Journal of the European Union | L 84/18 |
| --- | --- | --- | --- |

23.3.2023

EN

Official Journal of the European Union

L 84/18

---

DECISION (EU) 2023/672 OF THE EUROPEAN CENTRAL BANK

of 10 March 2023

on delegation of the power to adopt decisions relating to on-site inspections and internal model investigations (ECB/2023/5)

THE GOVERNING COUNCIL OF THE EUROPEAN CENTRAL BANK,

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

Having regard to Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (1), and in particular Article 99 thereof,

Having regard to Council Regulation (EU) No 1024/2013 of 15 October 2013 conferring specific tasks on the European Central Bank concerning policies relating to the prudential supervision of credit institutions (2), and in particular Articles 11 and 12 thereof,

Having regard to Regulation (EU) No 468/2014 of the European Central Bank of 16 April 2014 establishing the framework for cooperation within the Single Supervisory Mechanism between the European Central Bank and national competent authorities and with national designated authorities (SSM Framework Regulation) (ECB/2014/17) (3), and in particular Articles 143, 144, 145 and 146 thereof,

Having regard to Decision (EU) 2017/933 of the European Central Bank of 16 November 2016 on a general framework for delegating decision-making powers for legal instruments related to supervisory tasks (ECB/2016/40) (4), and in particular Article 4 thereof,

Whereas:

| (1) | Within the framework of Article 6 of Regulation (EU) No 1024/2013, the European Central Bank (ECB) carries out the exclusive task to supervise credit institutions with the aim of ensuring a consistent application of supervisory standards, fostering financial stability and ensuring a level playing field. |
| --- | --- |

(1)

Within the framework of Article 6 of Regulation (EU) No 1024/2013, the European Central Bank (ECB) carries out the exclusive task to supervise credit institutions with the aim of ensuring a consistent application of supervisory standards, fostering financial stability and ensuring a level playing field.

| (2) | Pursuant to Article 12 of Regulation (EU) No 1024/2013, the ECB, in order to carry out the tasks conferred on it by that Regulation, may conduct all necessary on-site inspections at the business premises of the legal persons referred to in Article 10(1) of that Regulation and any other undertaking included in supervision on a consolidated basis where the ECB is the consolidating supervisor in accordance with point (g) of Article 4(1) of that Regulation. |
| --- | --- |

(2)

Pursuant to Article 12 of Regulation (EU) No 1024/2013, the ECB, in order to carry out the tasks conferred on it by that Regulation, may conduct all necessary on-site inspections at the business premises of the legal persons referred to in Article 10(1) of that Regulation and any other undertaking included in supervision on a consolidated basis where the ECB is the consolidating supervisor in accordance with point (g) of Article 4(1) of that Regulation.

| (3) | Pursuant to Article 99(1) of Directive 2013/36/EU, the ECB, as competent authority, adopts annually an ECB decision on a supervisory examination programme (SEP) (hereinafter a ‘SEP decision’) which contains, inter alia, the plan for inspections at the premises used by an institution, including its branches and subsidiaries established in other Member States in accordance with Articles 52, 119 and 122 of Directive 2013/36/EU. In particular, the SEP relates to on-site inspections of an institution’s risk, risk controls and governance, and on-site inspections concerning in-depth assessments of internal models used by an institution for the calculation of own fund requirements, in particular with regard to methodologies, economic appropriateness, risks, risk controls and governance. |
| --- | --- |

(3)

Pursuant to Article 99(1) of Directive 2013/36/EU, the ECB, as competent authority, adopts annually an ECB decision on a supervisory examination programme (SEP) (hereinafter a ‘SEP decision’) which contains, inter alia, the plan for inspections at the premises used by an institution, including its branches and subsidiaries established in other Member States in accordance with Articles 52, 119 and 122 of Directive 2013/36/EU. In particular, the SEP relates to on-site inspections of an institution’s risk, risk controls and governance, and on-site inspections concerning in-depth assessments of internal models used by an institution for the calculation of own fund requirements, in particular with regard to methodologies, economic appropriateness, risks, risk controls and governance.

| (4) | A SEP decision may be amended in the course of the year in order to address the ECB’s operational business needs, changes in the situation of supervised entities or requests of supervised entities, and to ensure the effective conduct of planned inspections. Amendments to a SEP decision must be made via a decision adopted by the ECB. Such amending decision may provide for the cancellation of approved inspections, an amendment of the scope of planned inspections or the inclusion of additional inspections in the SEP for the given year. Pursuant to Article 12(3) of Regulation (EU) No 1024/2013, the inspected legal entity is notified of the ECB decision to conduct an on-site inspection or internal model investigation prior to the start of the inspection. |
| --- | --- |

(4)

A SEP decision may be amended in the course of the year in order to address the ECB’s operational business needs, changes in the situation of supervised entities or requests of supervised entities, and to ensure the effective conduct of planned inspections. Amendments to a SEP decision must be made via a decision adopted by the ECB. Such amending decision may provide for the cancellation of approved inspections, an amendment of the scope of planned inspections or the inclusion of additional inspections in the SEP for the given year. Pursuant to Article 12(3) of Regulation (EU) No 1024/2013, the inspected legal entity is notified of the ECB decision to conduct an on-site inspection or internal model investigation prior to the start of the inspection.

| (5) | In order to facilitate the decision-making process and enable the ECB to efficiently respond to changes in the situation of supervised entities which affect the conduct and scope of planned inspections, a delegation decision is necessary in relation to the adoption of such decisions amending SEP decisions. Such a delegation decision should allow for cases where a single delegated decision includes amendments to more than one planned inspection. The Court of Justice of the European Union has recognised that delegation of powers may be necessary to enable an institution required to adopt a considerable number of decisions to perform its duties. Similarly, it has recognised the need to ensure that decision-making bodies are able to function as a principle inherent to all institutional systems (5). |
| --- | --- |

(5)

In order to facilitate the decision-making process and enable the ECB to efficiently respond to changes in the situation of supervised entities which affect the conduct and scope of planned inspections, a delegation decision is necessary in relation to the adoption of such decisions amending SEP decisions. Such a delegation decision should allow for cases where a single delegated decision includes amendments to more than one planned inspection. The Court of Justice of the European Union has recognised that delegation of powers may be necessary to enable an institution required to adopt a considerable number of decisions to perform its duties. Similarly, it has recognised the need to ensure that decision-making bodies are able to function as a principle inherent to all institutional systems (5).

| (6) | Delegation of decision-making powers should be limited and proportionate, and the scope of the delegation should be clearly defined. |
| --- | --- |

(6)

Delegation of decision-making powers should be limited and proportionate, and the scope of the delegation should be clearly defined.

| (7) | On 24 June 2020, the Governing Council decided to establish close cooperation between the ECB and the Republic of Bulgaria (6). Article 7(1) of Regulation (EU) No 1024/2013 provides that to carry out certain tasks in relation to credit institutions established in a Member State whose currency is not the euro, where close cooperation has been established in accordance with that Article, the ECB may address instructions to the national competent authority of the relevant Member State. It is therefore appropriate to include such instructions among the acts that the ECB may adopt by means of delegation to heads of work units pursuant to the relevant provisions of this Decision. |
| --- | --- |

(7)

On 24 June 2020, the Governing Council decided to establish close cooperation between the ECB and the Republic of Bulgaria (6). Article 7(1) of Regulation (EU) No 1024/2013 provides that to carry out certain tasks in relation to credit institutions established in a Member State whose currency is not the euro, where close cooperation has been established in accordance with that Article, the ECB may address instructions to the national competent authority of the relevant Member State. It is therefore appropriate to include such instructions among the acts that the ECB may adopt by means of delegation to heads of work units pursuant to the relevant provisions of this Decision.

| (8) | Decision (EU) 2017/933 (ECB/2016/40) specifies the procedure to be followed for adopting delegation decisions concerning supervision and the persons who may be delegated decision-making powers. That Decision does not affect the ECB’s exercise of its supervisory tasks and is without prejudice to the Supervisory Board’s competence to propose complete draft decisions to the Governing Council. |
| --- | --- |

(8)

Decision (EU) 2017/933 (ECB/2016/40) specifies the procedure to be followed for adopting delegation decisions concerning supervision and the persons who may be delegated decision-making powers. That Decision does not affect the ECB’s exercise of its supervisory tasks and is without prejudice to the Supervisory Board’s competence to propose complete draft decisions to the Governing Council.

| (9) | Where the criteria for the adoption of a delegated decision, as laid down in this Decision, are not met, decisions should be adopted in accordance with the non-objection procedure set out in Article 26(8) of Regulation (EU) No 1024/2013 and Article 13g of Decision ECB/2004/2 of the European Central Bank (7). Furthermore, the non-objection procedure should also be used where heads of work units have concerns regarding the fulfilment of assessment criteria due the complexity of the assessment or sensitivity of the matter and where the outcome of the relevant assessment directly impacts another decision and therefore the decisions should be considered simultaneously by the same decision-maker in order to prevent conflicting outcomes. |
| --- | --- |

(9)

Where the criteria for the adoption of a delegated decision, as laid down in this Decision, are not met, decisions should be adopted in accordance with the non-objection procedure set out in Article 26(8) of Regulation (EU) No 1024/2013 and Article 13g of Decision ECB/2004/2 of the European Central Bank (7). Furthermore, the non-objection procedure should also be used where heads of work units have concerns regarding the fulfilment of assessment criteria due the complexity of the assessment or sensitivity of the matter and where the outcome of the relevant assessment directly impacts another decision and therefore the decisions should be considered simultaneously by the same decision-maker in order to prevent conflicting outcomes.

| (10) | ECB supervisory decisions may be subject to administrative review pursuant to Article 24 of Regulation (EU) No 1024/2013 and as further specified in Decision ECB/2014/16 of the European Central Bank (8). In the event of such administrative review, the Supervisory Board should take into account the opinion of the Administrative Board of Review and submit a new draft decision to the Governing Council for adoption under the non-objection procedure, |
| --- | --- |

(10)

ECB supervisory decisions may be subject to administrative review pursuant to Article 24 of Regulation (EU) No 1024/2013 and as further specified in Decision ECB/2014/16 of the European Central Bank (8). In the event of such administrative review, the Supervisory Board should take into account the opinion of the Administrative Board of Review and submit a new draft decision to the Governing Council for adoption under the non-objection procedure,

HAS ADOPTED THIS DECISION:

Article 1

Definitions

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

| (1) | ‘supervisory examination programme’ or ‘SEP’ has the same meaning as in Article 99(1) of Directive 2013/36/EU; |
| --- | --- |

(1)

‘supervisory examination programme’ or ‘SEP’ has the same meaning as in Article 99(1) of Directive 2013/36/EU;

| (2) | ‘SEP decision’ means an ECB decision on a supervisory examination programme; |
| --- | --- |

(2)

‘SEP decision’ means an ECB decision on a supervisory examination programme;

| (3) | ‘on-site inspection’ means an inspection conducted at the business premises of any of the legal persons referred to in Article 10(1) of Regulation (EU) No 1024/2013 and any other undertaking included in supervision on a consolidated basis where the ECB is the consolidating supervisor in accordance with point (g) of Article 4(1) of Regulation (EU) No 1024/2013; |
| --- | --- |

(3)

‘on-site inspection’ means an inspection conducted at the business premises of any of the legal persons referred to in Article 10(1) of Regulation (EU) No 1024/2013 and any other undertaking included in supervision on a consolidated basis where the ECB is the consolidating supervisor in accordance with point (g) of Article 4(1) of Regulation (EU) No 1024/2013;

| (4) | ‘internal model investigation’ means an on-site inspection in relation to the use of internal models for the calculation of the own funds requirements set out in Regulation (EU) No 575/2013 of the European Parliament and of the Council (9) for the purpose of adopting an internal models decision; |
| --- | --- |

(4)

‘internal model investigation’ means an on-site inspection in relation to the use of internal models for the calculation of the own funds requirements set out in Regulation (EU) No 575/2013 of the European Parliament and of the Council (9) for the purpose of adopting an internal models decision;

9

| (5) | ‘inspection’ means an on-site inspection or an internal model investigation; |
| --- | --- |

(5)

‘inspection’ means an on-site inspection or an internal model investigation;

| (6) | ‘ECB supervisory decision’ means an ECB supervisory decision as defined in point (26) of Article 2 of Regulation (EU) No 468/2014 (ECB/2014/17); |
| --- | --- |

(6)

‘ECB supervisory decision’ means an ECB supervisory decision as defined in point (26) of Article 2 of Regulation (EU) No 468/2014 (ECB/2014/17);

| (7) | ‘significant supervised entity’ means a significant supervised entity as defined in point (16) of Article 2 of Regulation (EU) No 468/2014 (ECB/2014/17); |
| --- | --- |

(7)

‘significant supervised entity’ means a significant supervised entity as defined in point (16) of Article 2 of Regulation (EU) No 468/2014 (ECB/2014/17);

| (8) | ‘less significant supervised entity’ means a less significant supervised entity as defined in point (7) of Article 2 of Regulation (EU) No 468/2014 (ECB/2014/17); |
| --- | --- |

(8)

‘less significant supervised entity’ means a less significant supervised entity as defined in point (7) of Article 2 of Regulation (EU) No 468/2014 (ECB/2014/17);

| (9) | ‘inspected legal entity’ means any of the following:






  (a) | a significant institution; |
| --- | --- | --- |

(9)

‘inspected legal entity’ means any of the following:

(a)

a significant institution;

| (b) | a less significant institution in respect of which the ECB has adopted a decision pursuant to point (b) of Article 6(5) of Regulation (EU) No 1024/2013 to the effect that the ECB will exercise directly all relevant powers referred to in Article 6(4) of that Regulation; |
| --- | --- |

(b)

a less significant institution in respect of which the ECB has adopted a decision pursuant to point (b) of Article 6(5) of Regulation (EU) No 1024/2013 to the effect that the ECB will exercise directly all relevant powers referred to in Article 6(4) of that Regulation;

| (c) | any other legal entity as referred to in Article 10(1) of Regulation (EU) No 1024/2013 and any other undertaking included in supervision on a consolidated basis where the ECB is the consolidating supervisor in accordance with point (g) of Article 4(1) of Regulation (EU) No 1024/2013; |
| --- | --- |

(c)

any other legal entity as referred to in Article 10(1) of Regulation (EU) No 1024/2013 and any other undertaking included in supervision on a consolidated basis where the ECB is the consolidating supervisor in accordance with point (g) of Article 4(1) of Regulation (EU) No 1024/2013;

| (10) | ‘SSM resources’ means the staff members of the ECB and national competent authorities which compose the on-site inspection team in accordance with Article 144 of Regulation (EU) No 468/2014 (ECB/2014/17); |
| --- | --- |

(10)

‘SSM resources’ means the staff members of the ECB and national competent authorities which compose the on-site inspection team in accordance with Article 144 of Regulation (EU) No 468/2014 (ECB/2014/17);

| (11) | ‘decision on on-site inspections’ means any ECB decision amending the approved SEP decision in relation to one or more planned on-site inspections; |
| --- | --- |

(11)

‘decision on on-site inspections’ means any ECB decision amending the approved SEP decision in relation to one or more planned on-site inspections;

| (12) | ‘decision on internal model investigations’ means any ECB decision amending the approved SEP decision in relation to one or more planned internal model investigations; |
| --- | --- |

(12)

‘decision on internal model investigations’ means any ECB decision amending the approved SEP decision in relation to one or more planned internal model investigations;

| (13) | ‘delegation decision’ means a delegation decision as defined in point (2) of Article 3 of Decision (EU) 2017/933 (ECB/2016/40); |
| --- | --- |

(13)

‘delegation decision’ means a delegation decision as defined in point (2) of Article 3 of Decision (EU) 2017/933 (ECB/2016/40);

| (14) | ‘delegated decision’ means a delegated decision as defined in point (4) of Article 3 of Decision (EU) 2017/933 (ECB/2016/40); |
| --- | --- |

(14)

‘delegated decision’ means a delegated decision as defined in point (4) of Article 3 of Decision (EU) 2017/933 (ECB/2016/40);

| (15) | ‘heads of work units’ means the heads of work units of the ECB to whom the power to adopt decisions on on-site inspections and decisions on internal model investigations is delegated; |
| --- | --- |

(15)

‘heads of work units’ means the heads of work units of the ECB to whom the power to adopt decisions on on-site inspections and decisions on internal model investigations is delegated;

| (16) | ‘non-objection procedure’ means the procedure set out in Article 26(8) of Regulation (EU) No 1024/2013 and further specified in Article 13g of Decision ECB/2004/2; |
| --- | --- |

(16)

‘non-objection procedure’ means the procedure set out in Article 26(8) of Regulation (EU) No 1024/2013 and further specified in Article 13g of Decision ECB/2004/2;

| (17) | ‘negative decision’ means a decision that extends the scope of a planned on-site inspection or a planned internal model investigation, unless that decision is taken pursuant to a request by the supervised entity. A decision with ancillary provisions such as conditions, obligations or limitations shall be considered a negative decision unless such ancillary provisions (a) ensure that the supervised entity fulfils the requirements of relevant Union law and have been agreed in writing or (b) merely restate one or more of the existing requirements that the supervised entity has to comply with pursuant to Union law or require information on the fulfilment of one or more of such requirements; |
| --- | --- |

(17)

‘negative decision’ means a decision that extends the scope of a planned on-site inspection or a planned internal model investigation, unless that decision is taken pursuant to a request by the supervised entity. A decision with ancillary provisions such as conditions, obligations or limitations shall be considered a negative decision unless such ancillary provisions (a) ensure that the supervised entity fulfils the requirements of relevant Union law and have been agreed in writing or (b) merely restate one or more of the existing requirements that the supervised entity has to comply with pursuant to Union law or require information on the fulfilment of one or more of such requirements;

| (18) | ‘sensitivity’ means a characteristic or factor that may have a negative impact on the ECB’s reputation and/or on the effective and consistent functioning of the Single Supervisory Mechanism, including but not limited to any of the following: (a) where the relevant supervised entity has previously been, or is currently, subject to severe supervisory measures such as early intervention measures; (b) the draft decision once adopted will set a new precedent that could bind the ECB in the future; (c) the draft decision once adopted may attract negative media or public attention; or (d) a national competent authority that has entered into close cooperation with the ECB communicates its disagreement with the proposed draft instructions to the ECB. |
| --- | --- |

(18)

‘sensitivity’ means a characteristic or factor that may have a negative impact on the ECB’s reputation and/or on the effective and consistent functioning of the Single Supervisory Mechanism, including but not limited to any of the following: (a) where the relevant supervised entity has previously been, or is currently, subject to severe supervisory measures such as early intervention measures; (b) the draft decision once adopted will set a new precedent that could bind the ECB in the future; (c) the draft decision once adopted may attract negative media or public attention; or (d) a national competent authority that has entered into close cooperation with the ECB communicates its disagreement with the proposed draft instructions to the ECB.

Article 2

Subject matter and scope

1.   This Decision specifies the criteria for the delegation of decision-making powers to the heads of work units of the ECB for the adoption of decisions on on-site inspections and decisions on internal model investigations.

2.   The delegation of decision-making powers is without prejudice to the supervisory assessment to be performed for the purposes of taking ECB supervisory decisions following the on-site inspection and the internal model investigation.

Article 3

Delegation of decisions on on-site inspections and decisions on internal model investigations

1.   In accordance with Article 4 of Decision (EU) 2017/933 (ECB/2016/40), the Governing Council hereby delegates to the heads of work units nominated by the Executive Board in accordance with Article 5 of that Decision the power to adopt decisions on:

| (a) | on-site inspections pursuant to Article 12 of Regulation (EU) No 1024/2013; |
| --- | --- |

(a)

on-site inspections pursuant to Article 12 of Regulation (EU) No 1024/2013;

| (b) | internal model investigations pursuant to Article 12 of Regulation (EU) No 1024/2013. |
| --- | --- |

(b)

internal model investigations pursuant to Article 12 of Regulation (EU) No 1024/2013.

2.   The delegation of decision-making powers pursuant to paragraph 1 shall apply to:

| (a) | the ECB’s adoption of decisions; |
| --- | --- |

(a)

the ECB’s adoption of decisions;

| (b) | the ECB’s adoption of instructions addressed, pursuant to Article 7 of Regulation (EU) No 1024/2013, to the national competent authorities with which the ECB has established close cooperation. |
| --- | --- |

(b)

the ECB’s adoption of instructions addressed, pursuant to Article 7 of Regulation (EU) No 1024/2013, to the national competent authorities with which the ECB has established close cooperation.

3.   Decisions on on-site inspections as referred to in paragraph 1 shall be adopted by means of a delegated decision if one or more of the criteria for the adoption of delegated decisions, as set out in Article 4, are fulfilled.

4.   Decisions on internal model investigations as referred to in paragraph 1 shall be adopted by means of a delegated decision if one or more of the criteria for the adoption of delegated decisions, as set out in Article 5, are fulfilled.

5.   Decisions on on-site inspections and decisions on internal model investigations shall not be adopted by means of a delegated decision if the complexity of the assessment or the sensitivity of the matter require that they are adopted under the non-objection procedure or if the supervisory assessment of those decisions has a direct impact on the supervisory assessment of another decision which is to be adopted under the non-objection procedure.

6.   Negative decisions on on-site inspections and negative decisions on internal model investigations shall not be adopted by means of a delegated decision.

Article 4

Criteria for the adoption of delegated decisions relating to on-site inspections

1.   Decisions on on-site inspections shall be taken by means of a delegated decision only if they belong to one or more of the following categories and one or more of the relevant criteria specified for that category are met.

| (a) | Decisions cancelling planned on-site inspections: such decisions shall be taken by means of a delegated decision if the planned on-site inspection cannot be conducted or has become devoid of purpose due to one or more of the following: (i) a change in the internal organisation or ownership of the inspected legal entity which makes it impossible to conduct the on-site inspection, (ii) the inspected legal entity’s lack of readiness for the on-site inspection in the planned time period, according to the inspected legal entity’s own statements; |
| --- | --- |

(a)

Decisions cancelling planned on-site inspections: such decisions shall be taken by means of a delegated decision if the planned on-site inspection cannot be conducted or has become devoid of purpose due to one or more of the following: (i) a change in the internal organisation or ownership of the inspected legal entity which makes it impossible to conduct the on-site inspection, (ii) the inspected legal entity’s lack of readiness for the on-site inspection in the planned time period, according to the inspected legal entity’s own statements;

| (b) | Decisions changing the name of legal entities included in the scope of on-site inspections: such decisions shall be taken by means of a delegated decision if the specific decision is to be taken following the communication to the ECB of (i) a change in the ownership of an inspected legal entity, or (ii) a change of name of an inspected legal entity; |
| --- | --- |

(b)

Decisions changing the name of legal entities included in the scope of on-site inspections: such decisions shall be taken by means of a delegated decision if the specific decision is to be taken following the communication to the ECB of (i) a change in the ownership of an inspected legal entity, or (ii) a change of name of an inspected legal entity;

| (c) | Decisions reducing the scope of planned on-site inspections: such decisions shall be taken by means of a delegated decision if the planned on-site inspection cannot be conducted within the scope originally planned due to one or more of the following: (i) the lack of availability of SSM resources to conduct the on-site inspection, (ii) a change in the internal organisation or ownership of the inspected legal entity which makes it impossible to conduct the on-site inspection, (iii) the inspected legal entity’s lack of readiness for the on-site inspection in the planned time period according to the inspected legal entity’s own statements; |
| --- | --- |

(c)

Decisions reducing the scope of planned on-site inspections: such decisions shall be taken by means of a delegated decision if the planned on-site inspection cannot be conducted within the scope originally planned due to one or more of the following: (i) the lack of availability of SSM resources to conduct the on-site inspection, (ii) a change in the internal organisation or ownership of the inspected legal entity which makes it impossible to conduct the on-site inspection, (iii) the inspected legal entity’s lack of readiness for the on-site inspection in the planned time period according to the inspected legal entity’s own statements;

| (d) | Decisions rectifying clerical mistakes and other obvious inaccuracies in the SEP decision: such decisions shall be taken by means of a delegated decision if the rectifications do not affect the scope of the planned on-site inspection. |
| --- | --- |

(d)

Decisions rectifying clerical mistakes and other obvious inaccuracies in the SEP decision: such decisions shall be taken by means of a delegated decision if the rectifications do not affect the scope of the planned on-site inspection.

2.   Heads of work units shall assess the appropriateness of amendments to the SEP decision for on-site inspections having regard to the supervisory purpose of the on-site inspection, the need for an effective and efficient conduct of on-site inspections, the availability of SSM resources and any relevant development affecting the inspected legal entity.

Article 5

Criteria for the adoption of delegated decisions relating to internal model investigations

1.   Decisions on internal model investigations shall be taken by means of a delegated decision only if they belong to one or more of the following categories and one or more of the relevant criteria specified for that category are met.

| (a) | Decisions cancelling planned internal model investigations: such decisions shall be taken by means of a delegated decision if the specific decision is to be taken in accordance with an inspected legal entity’s (i) revocation of an application for the initial use or for material change or extension of internal models (hereinafter referred to as an ‘application’), (ii) amendment of an application, (iii) request for a postponement of the decision on an application; or if the planned internal model investigation cannot be conducted due to the lack of availability of SSM resources to conduct the investigation; |
| --- | --- |

(a)

Decisions cancelling planned internal model investigations: such decisions shall be taken by means of a delegated decision if the specific decision is to be taken in accordance with an inspected legal entity’s (i) revocation of an application for the initial use or for material change or extension of internal models (hereinafter referred to as an ‘application’), (ii) amendment of an application, (iii) request for a postponement of the decision on an application; or if the planned internal model investigation cannot be conducted due to the lack of availability of SSM resources to conduct the investigation;

| (b) | Decisions changing the name of legal entities included in the scope of internal model investigations: such decisions shall be taken by means of a delegated decision if the specific decision is to be taken following the communication to the ECB of (i) a change in the ownership of an inspected legal entity, or (ii) a change of name of an inspected legal entity; |
| --- | --- |

(b)

Decisions changing the name of legal entities included in the scope of internal model investigations: such decisions shall be taken by means of a delegated decision if the specific decision is to be taken following the communication to the ECB of (i) a change in the ownership of an inspected legal entity, or (ii) a change of name of an inspected legal entity;

| (c) | Decisions amending the scope of planned internal model investigations: such decisions shall be taken by means of a delegated decision if the specific decision is taken in accordance with an inspected legal entity’s revocation or amendment of an application; |
| --- | --- |

(c)

Decisions amending the scope of planned internal model investigations: such decisions shall be taken by means of a delegated decision if the specific decision is taken in accordance with an inspected legal entity’s revocation or amendment of an application;

| (d) | Decisions rectifying clerical mistakes and other obvious inaccuracies in the SEP decision: such decisions shall be taken by means of a delegated decision if the rectifications do not affect the scope of the planned internal model investigation. |
| --- | --- |

(d)

Decisions rectifying clerical mistakes and other obvious inaccuracies in the SEP decision: such decisions shall be taken by means of a delegated decision if the rectifications do not affect the scope of the planned internal model investigation.

2.   Heads of work units shall assess the appropriateness of amendments to the SEP decision for internal model investigations having regard to the application submitted by the inspected legal entity triggering the investigations, the need for an effective and efficient conduct of investigations, the availability of SSM resources and any relevant development affecting the inspected legal entity.

Article 6

Entry into force

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

Official Journal of the European Union

Done at Frankfurt am Main, 10 March 2023.

The President of the ECB

Christine LAGARDE

---

(1)  
  OJ L 176, 27.6.2013, p. 338.

1

(2)  
  OJ L 287, 29.10.2013, p. 63.

2

(3)  
  OJ L 141, 14.5.2014, p. 1.

3

(4)  
  OJ L 141, 1.6.2017, p. 14.

4

(5)  Judgment of the Court of Justice of 23 September 1986, AKZO Chemie v Commission, 5/85, ECLI:EU:C:1986:328, paragraph 37, and judgment of the Court of Justice of 26 May 2005, Carmine Salvatore Tralli v ECB, C-301/02 P, ECLI:EU:C:2005:306, paragraph 59.

5

AKZO Chemie

Commission

Carmine Salvatore Tralli

ECB

(6)  Decision (EU) 2020/1015 of the European Central Bank of 24 June 2020 on the establishment of close cooperation between the European Central Bank and Българска народна банка (Bulgarian National Bank) (ECB/2020/30) (OJ L 224I, 13.7.2020, p. 1).

6

(7)  Decision ECB/2004/2 of the European Central Bank of 19 February 2004 adopting the Rules of Procedure of the European Central Bank (OJ L 80, 18.3.2004, p. 33).

7

(8)  Decision ECB/2014/16 of the European Central Bank of 14 April 2014 concerning the establishment of an Administrative Board of Review and its Operating Rules (OJ L 175, 14.6.2014, p. 47).

8

(9)  Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and amending Regulation (EU) No 648/2012 (OJ L 176, 27.6.2013, p. 1).

9

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| 23.3.2023 | EN | Official Journal of the European Union | L 84/24 |
| --- | --- | --- | --- |

23.3.2023

EN

Official Journal of the European Union

L 84/24

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DECISION (EU) 2023/673 OF THE EUROPEAN CENTRAL BANK

of 14 March 2023

nominating heads of work units to adopt delegated decisions relating to on-site inspections and internal model investigations (ECB/2023/6)

THE EXECUTIVE BOARD OF THE EUROPEAN CENTRAL BANK,

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

Having regard to the Statute of the European System of Central Banks and of the European Central Bank and in particular Article 11.6 thereof,

Having regard to Decision (EU) 2017/933 of the European Central Bank of 16 November 2016 on a general framework for delegating decision-making powers for legal instruments related to supervisory tasks (ECB/2016/40) (1), and in particular Articles 4 and 5 thereof,

Having regard to Decision (EU) 2023/672 of the European Central Bank of 10 March 2023 on delegation of the power to adopt decisions relating to on-site inspections and internal model investigations (ECB/2023/5) (2), and in particular Article 3 thereof,

Having regard to Decision ECB/2004/2 of the European Central Bank of 19 February 2004 adopting the Rules of Procedure of the European Central Bank (3), and in particular Article 10 thereof,

Whereas:

| (1) | To address the considerable number of decisions that the European Central Bank (ECB) is to adopt for the performance of its supervisory tasks, a procedure for the adoption of specific delegated decisions has been established. |
| --- | --- |

(1)

To address the considerable number of decisions that the European Central Bank (ECB) is to adopt for the performance of its supervisory tasks, a procedure for the adoption of specific delegated decisions has been established.

| (2) | A delegation decision is effective upon the adoption of a decision by the Executive Board nominating one or more heads of work units to take decisions on the basis of a delegation decision. |
| --- | --- |

(2)

A delegation decision is effective upon the adoption of a decision by the Executive Board nominating one or more heads of work units to take decisions on the basis of a delegation decision.

| (3) | The importance of the delegation decision and the number of addressees to whom delegated decisions need to be sent should be taken into account by the Executive Board in nominating heads of work units. |
| --- | --- |

(3)

The importance of the delegation decision and the number of addressees to whom delegated decisions need to be sent should be taken into account by the Executive Board in nominating heads of work units.

| (4) | Article 10(1) of Decision ECB/2004/2 of the European Central Bank provides that the Executive Board is to decide upon the number, name and respective competence of each of the work units of the ECB. |
| --- | --- |

(4)

Article 10(1) of Decision ECB/2004/2 of the European Central Bank provides that the Executive Board is to decide upon the number, name and respective competence of each of the work units of the ECB.

| (5) | The Chair of the Supervisory Board has been consulted on the heads of work units to whom the power to adopt delegated decisions relating to on-site inspections and internal model investigations should be delegated, |
| --- | --- |

(5)

The Chair of the Supervisory Board has been consulted on the heads of work units to whom the power to adopt delegated decisions relating to on-site inspections and internal model investigations should be delegated,

HAS ADOPTED THIS DECISION:

Article 1

Definitions

For the purposes of this Decision, the definitions contained in Article 1 of Decision (EU) 2023/672 (ECB/2023/5) shall apply.

Article 2

Delegated decisions relating to on-site inspection and internal model investigations

Delegated decisions pursuant to Article 3 of Decision (EU) 2023/672 (ECB/2023/5) shall be adopted by the Director-General or the Deputy Director-General of the Directorate-General On-Site and Internal Model Inspections.

Article 3

Entry into force

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

Official Journal of the European Union

Done at Frankfurt am Main, 14 March 2023.

The President of the ECB

Christine LAGARDE

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(1)  
  OJ L 141, 1.6.2017, p. 14.

1

(2)  
  OJ L 84, 23.3.2023, p. 18.

2

(3)  
  OJ L 80, 18.3.2004, p. 33.

3

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Corrigenda

| 23.3.2023 | EN | Official Journal of the European Union | L 84/26 |
| --- | --- | --- | --- |

23.3.2023

EN

Official Journal of the European Union

L 84/26

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Corrigendum to Regulation (EU, Euratom) 2022/2434 of the European Parliament and of the Council of 6 December 2022 amending Regulation (EU, Euratom) 2018/1046 as regards the establishment of a diversified funding strategy as a general borrowing method

(
  Official Journal of the European Union L 319 of 13 December 2022
  )

On page 3, recital 12:

for:

| ‘(12) | In the interest of legal certainty and clarity in respect of already granted financial assistance and in respect of financial assistance under Regulation (EU) .../... of the European Parliament and of the Council establishing an instrument for providing support to Ukraine for 2023 (macro-financial assistance +) (7), this Regulation should only apply to programmes of financial assistance the basic acts of which enter into force on or after 9 November 2022. |
| --- | --- |

‘(12)

read:

| ‘(12) | In the interest of legal certainty and clarity in respect of already granted financial assistance and in respect of financial assistance under Regulation (EU) 2022/2463 of the European Parliament and of the Council (7), this Regulation should only apply to programmes of financial assistance the basic acts of which enter into force on or after 9 November 2022. |
| --- | --- |

‘(12)

---

(7)  Not yet published in the Official Journal.’,

7

(7)  Regulation (EU) 2022/2463 of the European Parliament and of the Council of 14 December 2022 establishing an instrument for providing support to Ukraine for 2023 (macro-financial assistance +) (OJ L 322, 16.12.2022, p. 1).’.

7

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| 23.3.2023 | EN | Official Journal of the European Union | L 84/27 |
| --- | --- | --- | --- |

23.3.2023

EN

Official Journal of the European Union

L 84/27

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Corrigendum to Definitive Adoption (EU, Euratom) 2023/278 of the European Union’s annual budget for the financial year 2023

(
  Official Journal of the European Union L 58 of 23 February 2023
  )

In Section X ‘European External Action Service’, ‘Expenditure’, Title 2 ‘Buildings, equipment and operating expenditure at headquarters’ is modified as follows:

| (1) | on pages 2021 to 2024, in the ‘Heading’ column of the table, the term ‘Differentiated appropriations’ is replaced by ‘Non-differentiated appropriations’, with the exception of item 2 2 5 0 ‘Pilot project — Towards the creation of a European Diplomatic Academy’; |
| --- | --- |

(1)

on pages 2021 to 2024, in the ‘Heading’ column of the table, the term ‘Differentiated appropriations’ is replaced by ‘Non-differentiated appropriations’, with the exception of item 2 2 5 0 ‘Pilot project — Towards the creation of a European Diplomatic Academy’;

| (2) | on page 2040, in item 2 2 5 0 ‘Pilot project — Towards the creation of a European Diplomatic Academy’: |
| --- | --- |

(2)

on page 2040, in item 2 2 5 0 ‘Pilot project — Towards the creation of a European Diplomatic Academy’:

for:

‘
  Figures (Non-differentiated appropriations)
  ’,

read:

‘
  Figures (Differentiated appropriations)
  ’.

---