# Official Journal L 143/2023

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 143 |
| | |
| English edition | Legislation | Volume 662 June 2023 |

ISSN 1977-0677

Official Journal

of the European Union

L 143

English edition

Legislation

Volume 662 June 2023

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Council Regulation (EU) 2023/1062 of 1 June 2023 amending Regulation (EU) 2023/194 fixing for 2023 the fishing opportunities for certain fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters, as well as fixing for 2023 and 2024 such fishing opportunities for certain deep-sea fish stocks | 1 |
| | * | Commission Implementing Regulation (EU) 2023/1063 of 26 May 2023 entering a name in the register of protected designations of origin and protected geographical indications (Suruç Narı (PDO)) | 4 |
| | * | Commission Implementing Regulation (EU) 2023/1064 of 26 May 2023 entering a name in the register of protected designations of origin and protected geographical indications (Haricot de Soissons (PGI)) | 5 |
| | * | Commission Regulation (EU) 2023/1065 of 1 June 2023 amending Annex II to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards nicotinamide riboside chloride added to foods (
  1
  ) | 6 |
| | * | Commission Regulation (EU) 2023/1066 of 1 June 2023 on the application of Article 101(3) of the Treaty on the Functioning of the European Union to certain categories of research and development agreements (
  1
  ) | 9 |
| | * | Commission Regulation (EU) 2023/1067 of 1 June 2023 on the application of Article 101(3) of the Treaty on the Functioning of the European Union to certain categories of specialisation agreements (
  1
  ) | 20 |
| | * | Commission Regulation (EU) 2023/1068 of 1 June 2023 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for cyantraniliprole in or on certain products (
  1
  ) | 27 |
| | * | Commission Regulation (EU) 2023/1069 of 1 June 2023 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for bixafen, cyprodinil, fenhexamid, fenpicoxamid, fenpyroximate, flutianil, isoxaflutole, mandipropamid, methoxyfenozide, and spinetoram in or on certain products (
  1
  ) | 40 |
| | * | Commission Implementing Regulation (EU) 2023/1070 of 1 June 2023 on technical arrangements for developing, maintaining and employing electronic systems for the exchange and storage of information under Regulation (EU) No 952/2013 of the European Parliament and the Council | 65 |
| | * | Commission Implementing Regulationz (EU) 2023/1071 of 1 June 2023 amending certain Annexes to Implementing Regulation (EU) 2021/620 as regards the approval or withdrawal of the disease-free status of certain Member States or zones or compartments thereof as regards certain listed diseases and the approval of eradication programmes for certain listed diseases (
  1
  ) | 105 |
| | * | Commission Implementing Regulation (EU) 2023/1072 of 1 June 2023 fixing the adjustment rate for direct payments pursuant to Regulation (EU) 2021/2116 of the European Parliament and of the Council in respect of the calendar year 2023 | 116 |
| | * | Commission Implementing Regulation (EU) 2023/1073 of 1 June 2023 granting a Union authorisation for the single biocidal product Spray On wipes in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (
  1
  ) | 118 |
| | | DECISIONS |
| | * | Council Decision (EU) 2023/1074 of 25 May 2023 authorising the opening of negotiations for a protocol between the European Union and the Republic of Kazakhstan amending the Enhanced Partnership and Cooperation Agreement between the European Union and its Member States, of the one part, and the Republic of Kazakhstan, of the other part, as regards the protection of geographical indications for agricultural products and foodstuffs, wines and spirits | 127 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Council Regulation (EU) 2023/1062 of 1 June 2023 amending Regulation (EU) 2023/194 fixing for 2023 the fishing opportunities for certain fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters, as well as fixing for 2023 and 2024 such fishing opportunities for certain deep-sea fish stocks

1

*

Commission Implementing Regulation (EU) 2023/1063 of 26 May 2023 entering a name in the register of protected designations of origin and protected geographical indications (Suruç Narı (PDO))

4

*

Commission Implementing Regulation (EU) 2023/1064 of 26 May 2023 entering a name in the register of protected designations of origin and protected geographical indications (Haricot de Soissons (PGI))

5

*

Commission Regulation (EU) 2023/1065 of 1 June 2023 amending Annex II to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards nicotinamide riboside chloride added to foods (
  1
  )

1

6

*

Commission Regulation (EU) 2023/1066 of 1 June 2023 on the application of Article 101(3) of the Treaty on the Functioning of the European Union to certain categories of research and development agreements (
  1
  )

1

9

*

Commission Regulation (EU) 2023/1067 of 1 June 2023 on the application of Article 101(3) of the Treaty on the Functioning of the European Union to certain categories of specialisation agreements (
  1
  )

1

20

*

Commission Regulation (EU) 2023/1068 of 1 June 2023 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for cyantraniliprole in or on certain products (
  1
  )

1

27

*

Commission Regulation (EU) 2023/1069 of 1 June 2023 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for bixafen, cyprodinil, fenhexamid, fenpicoxamid, fenpyroximate, flutianil, isoxaflutole, mandipropamid, methoxyfenozide, and spinetoram in or on certain products (
  1
  )

1

40

*

Commission Implementing Regulation (EU) 2023/1070 of 1 June 2023 on technical arrangements for developing, maintaining and employing electronic systems for the exchange and storage of information under Regulation (EU) No 952/2013 of the European Parliament and the Council

65

*

Commission Implementing Regulationz (EU) 2023/1071 of 1 June 2023 amending certain Annexes to Implementing Regulation (EU) 2021/620 as regards the approval or withdrawal of the disease-free status of certain Member States or zones or compartments thereof as regards certain listed diseases and the approval of eradication programmes for certain listed diseases (
  1
  )

1

105

*

Commission Implementing Regulation (EU) 2023/1072 of 1 June 2023 fixing the adjustment rate for direct payments pursuant to Regulation (EU) 2021/2116 of the European Parliament and of the Council in respect of the calendar year 2023

116

*

Commission Implementing Regulation (EU) 2023/1073 of 1 June 2023 granting a Union authorisation for the single biocidal product Spray On wipes in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (
  1
  )

1

118

DECISIONS

*

Council Decision (EU) 2023/1074 of 25 May 2023 authorising the opening of negotiations for a protocol between the European Union and the Republic of Kazakhstan amending the Enhanced Partnership and Cooperation Agreement between the European Union and its Member States, of the one part, and the Republic of Kazakhstan, of the other part, as regards the protection of geographical indications for agricultural products and foodstuffs, wines and spirits

127

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

| 2.6.2023 | EN | Official Journal of the European Union | L 143/1 |
| --- | --- | --- | --- |

2.6.2023

EN

Official Journal of the European Union

L 143/1

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COUNCIL REGULATION (EU) 2023/1062

of 1 June 2023

amending Regulation (EU) 2023/194 fixing for 2023 the fishing opportunities for certain fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters, as well as fixing for 2023 and 2024 such fishing opportunities for certain deep-sea fish stocks

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(3) thereof,

Having regard to the proposal from the European Commission,

Whereas:

| (1) | Council Regulation (EU) 2023/194 (1) fixes for 2023 the fishing opportunities for certain fish stocks applicable in Union waters and, for Union fishing vessels, in certain non-Union waters. The total allowable catches (TACs) and measures functionally linked to the TACs set by Regulation (EU) 2023/194 should be amended in order to take into account the outcome of consultations with third countries. |
| --- | --- |

(1)

Council Regulation (EU) 2023/194 (1) fixes for 2023 the fishing opportunities for certain fish stocks applicable in Union waters and, for Union fishing vessels, in certain non-Union waters. The total allowable catches (TACs) and measures functionally linked to the TACs set by Regulation (EU) 2023/194 should be amended in order to take into account the outcome of consultations with third countries.

| (2) | Regulation (EU) 2023/194 sets a provisional Union quota for cod (Gadus morhua) in Svalbard waters and international waters of the International Council for the Exploration of the Sea (ICES) subarea 1 and division 2b for the period from 1 January 2023 to 31 March 2023. In order to allow fishing activities to continue, it is necessary to replace that provisional Union quota by a definitive Union quota for that stock for 2023. The Council should therefore set the Union quota for cod in Svalbard waters and international waters of ICES subarea 1 and division 2b based on the reference TAC for northeast Arctic cod and the Union’s historic fishing rights. The definitive Union quota for cod in Svalbard waters and international waters of ICES subarea 1 and division 2b for 2023 should be set at the level of 15 629 tonnes, which corresponds to the percentage indicated in paragraph 3, point (a) of the EU-Norway political understanding in relation to the fisheries in ICES subareas 1 and 2. The Union quota for cod in Svalbard waters and international waters of ICES subarea 1 and division 2b should be allocated to the Member States in accordance with Council Decision 87/277/EEC (2), subject to the adaptations necessary due to the withdrawal of the United Kingdom from the Union as set out in Annex 36(E) to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part (3). |
| --- | --- |

(2)

Regulation (EU) 2023/194 sets a provisional Union quota for cod (Gadus morhua) in Svalbard waters and international waters of the International Council for the Exploration of the Sea (ICES) subarea 1 and division 2b for the period from 1 January 2023 to 31 March 2023. In order to allow fishing activities to continue, it is necessary to replace that provisional Union quota by a definitive Union quota for that stock for 2023. The Council should therefore set the Union quota for cod in Svalbard waters and international waters of ICES subarea 1 and division 2b based on the reference TAC for northeast Arctic cod and the Union’s historic fishing rights. The definitive Union quota for cod in Svalbard waters and international waters of ICES subarea 1 and division 2b for 2023 should be set at the level of 15 629 tonnes, which corresponds to the percentage indicated in paragraph 3, point (a) of the EU-Norway political understanding in relation to the fisheries in ICES subareas 1 and 2. The Union quota for cod in Svalbard waters and international waters of ICES subarea 1 and division 2b should be allocated to the Member States in accordance with Council Decision 87/277/EEC (2), subject to the adaptations necessary due to the withdrawal of the United Kingdom from the Union as set out in Annex 36(E) to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part (3).

| (3) | Regulation (EU) 2023/194 sets a provisional Union quota for Greenland halibut (Reinhardtius hippoglossoides) in international waters of ICES subareas 1 and 2 for the period from 1 January 2023 to 31 March 2023. In order to allow fishing activities to continue, it is necessary to replace that provisional Union quota by a definitive Union quota for that stock for 2023. The definitive Union quota for Greenland halibut in international waters of ICES subareas 1 and 2 for 2023 should be set at the level of 1 711 tonnes. The level of that Union quota corresponds to 9,25 % of the TAC for Greenland halibut in ICES subareas 1 and 2 for 2023, as proposed by the Union at the North-East Atlantic Fisheries Commission, namely 18 494 tonnes, in line with the ICES advice. |
| --- | --- |

(3)

Regulation (EU) 2023/194 sets a provisional Union quota for Greenland halibut (Reinhardtius hippoglossoides) in international waters of ICES subareas 1 and 2 for the period from 1 January 2023 to 31 March 2023. In order to allow fishing activities to continue, it is necessary to replace that provisional Union quota by a definitive Union quota for that stock for 2023. The definitive Union quota for Greenland halibut in international waters of ICES subareas 1 and 2 for 2023 should be set at the level of 1 711 tonnes. The level of that Union quota corresponds to 9,25 % of the TAC for Greenland halibut in ICES subareas 1 and 2 for 2023, as proposed by the Union at the North-East Atlantic Fisheries Commission, namely 18 494 tonnes, in line with the ICES advice.

| (4) | Regulation (EU) 2023/194 does not set the fishing opportunities for redfish (Sebastes spp.) in international waters of ICES subareas 1 and 2 for 2023. In order to allow fishing for that stock to commence once the relevant fishing season starts on 1 July 2023, the Union quota for redfish in international waters in ICES subareas 1 and 2 should be set based on the average of the three highest annual Union catches of redfish in international waters of ICES subareas 1 and 2 in the period from 2013 to 2022. |
| --- | --- |

(4)

Regulation (EU) 2023/194 does not set the fishing opportunities for redfish (Sebastes spp.) in international waters of ICES subareas 1 and 2 for 2023. In order to allow fishing for that stock to commence once the relevant fishing season starts on 1 July 2023, the Union quota for redfish in international waters in ICES subareas 1 and 2 should be set based on the average of the three highest annual Union catches of redfish in international waters of ICES subareas 1 and 2 in the period from 2013 to 2022.

| (5) | Regulation (EU) 2023/194 should therefore be amended accordingly. |
| --- | --- |

(5)

Regulation (EU) 2023/194 should therefore be amended accordingly.

| (6) | The fishing opportunities provided for in Regulation (EU) 2023/194 apply from 1 January 2023. The provisions introduced by this Regulation concerning fishing opportunities should therefore also apply from 1 January 2023. Such retroactive application does not affect the principles of legal certainty and protection of legitimate expectations, as the fishing opportunities concerned are increased or have not yet been exhausted. Given the urgency of avoiding any interruption of fishing activities, this Regulation should enter into force on the day of its publication in the Official Journal of the European Union, |
| --- | --- |

(6)

The fishing opportunities provided for in Regulation (EU) 2023/194 apply from 1 January 2023. The provisions introduced by this Regulation concerning fishing opportunities should therefore also apply from 1 January 2023. Such retroactive application does not affect the principles of legal certainty and protection of legitimate expectations, as the fishing opportunities concerned are increased or have not yet been exhausted. Given the urgency of avoiding any interruption of fishing activities, this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

HAS ADOPTED THIS REGULATION:

Article 1

Amendment of Regulation (EU) 2023/194

Annex IB to Regulation (EU) 2023/194 is amended in accordance with the Annex to this Regulation.

Article 2

Entry into force and application

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

It shall apply from 1 January 2023.

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

Done at Brussels, 1 June 2023.

For the Council

The President

A. CARLSON

---

(1)  Council Regulation (EU) 2023/194 of 30 January 2023 fixing for 2023 the fishing opportunities for certain fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters, as well as fixing for 2023 and 2024 such fishing opportunities for certain deep-sea fish stocks (OJ L 28, 31.1.2023, p. 1).

1

(2)  Council Decision 87/277/EEC of 18 May 1987 on the allocation of the catch possibilities for cod in the Spitsbergen and Bear Island area and in Division 3M as defined in the NAFO Convention (OJ L 135, 23.5.1987, p. 29).

2

(3)  OJ L 149, 30.4.2021, p. 10.

3

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ANNEX

Annex IB to Regulation (EU) 2023/194 is amended as follows:

| (i) | the table for cod (Gadus morhua) in Svalbard waters and international waters of 1 and 2b is replaced by the following:









  ‘Species: | Cod

  Gadus morhua | Zone: | Svalbard waters; international waters of 1 and 2b
  (COD/1/2B.) |
| --- | --- | --- | --- | --- |
| Germany | 3 094 | (1)(2) | Analytical TAC
  Article 3 of Regulation (EC) No 847/96 shall not apply.
  Article 4 of Regulation (EC) No 847/96 shall not apply. |
| Spain | 7 994 | (1)(2) |
| France | 1 320 | (1)(2) |
| Poland | 1 448 | (1)(2) |
| Portugal | 1 688 | (1)(2) |
| Other Member States | 85 | (1)(2)(3) |
| Union | 15 629 | (1)(2) |
| TAC | Not relevant | |
| (1) | The allocation of the share of the cod stock available to the Union in the Spitzbergen and Bear Island zone and the associated by-catches of haddock are without prejudice to the rights and obligations deriving from the 1920 Treaty of Paris. |
| (2) | By-catches of haddock may represent up to 14 % per haul. The by-catch quantities of haddock are in addition to the quota for cod. |
| (3) | Except Germany, Spain, France, Poland and Portugal. Catches to be counted against this shared quota shall be reported separately (COD/1/2B_AMS).’; |

(i)

the table for cod (Gadus morhua) in Svalbard waters and international waters of 1 and 2b is replaced by the following:

‘Species:

Cod

Gadus morhua

Zone:

Svalbard waters; international waters of 1 and 2b

(COD/1/2B.)

Germany

3 094

(1)(2)

Analytical TAC

Article 3 of Regulation (EC) No 847/96 shall not apply.

Article 4 of Regulation (EC) No 847/96 shall not apply.

Spain

7 994

(1)(2)

France

1 320

(1)(2)

Poland

1 448

(1)(2)

Portugal

1 688

(1)(2)

Other Member States

85

(1)(2)(3)

Union

15 629

(1)(2)

TAC

Not relevant

(1)

The allocation of the share of the cod stock available to the Union in the Spitzbergen and Bear Island zone and the associated by-catches of haddock are without prejudice to the rights and obligations deriving from the 1920 Treaty of Paris.

(2)

By-catches of haddock may represent up to 14 % per haul. The by-catch quantities of haddock are in addition to the quota for cod.

(3)

Except Germany, Spain, France, Poland and Portugal. Catches to be counted against this shared quota shall be reported separately (COD/1/2B_AMS).’;

| (ii) | the table for Greenland halibut (Reinhardtius hippoglossoides) in international waters of 1 and 2 is replaced by the following:









  ‘Species: | Greenland halibut

  Reinhardtius hippoglossoides | Zone: | International waters of 1 and 2
  (GHL/1/2INT) |
| --- | --- | --- | --- | --- |
| Union | 1 711 | (1) | Precautionary TAC |
| TAC | Not relevant | |
| (1) | Exclusively for by-catches. No directed fisheries are permitted under this quota.’; |

(ii)

the table for Greenland halibut (Reinhardtius hippoglossoides) in international waters of 1 and 2 is replaced by the following:

‘Species:

Greenland halibut

Reinhardtius hippoglossoides

Zone:

International waters of 1 and 2

(GHL/1/2INT)

Union

1 711

(1)

Precautionary TAC

TAC

Not relevant

(1)

Exclusively for by-catches. No directed fisheries are permitted under this quota.’;

| (iii) | the table for redfish (Sebastes spp.) in international waters of 1 and 2 is replaced by the following:









  ‘Species: | Redfish

  Sebastes spp. | Zone: | International waters of 1 and 2
  (RED/1/2INT) |
| --- | --- | --- | --- | --- |
| Union | 6 000 | (1) | Analytical TAC
  Article 3 of Regulation (EC) No 847/96 shall not apply.
  Article 4 of Regulation (EC) No 847/96 shall not apply. |
| TAC | Not relevant | |
| (1) | May only be fished from 1 July to 31 December. Fishing vessels shall limit their by-catches of redfish in other fisheries to a maximum of 1 % of the total catch retained on board.’. |

(iii)

the table for redfish (Sebastes spp.) in international waters of 1 and 2 is replaced by the following:

‘Species:

Redfish

Sebastes spp.

Zone:

International waters of 1 and 2

(RED/1/2INT)

Union

6 000

(1)

Analytical TAC

Article 3 of Regulation (EC) No 847/96 shall not apply.

Article 4 of Regulation (EC) No 847/96 shall not apply.

TAC

Not relevant

(1)

May only be fished from 1 July to 31 December. Fishing vessels shall limit their by-catches of redfish in other fisheries to a maximum of 1 % of the total catch retained on board.’.

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| 2.6.2023 | EN | Official Journal of the European Union | L 143/4 |
| --- | --- | --- | --- |

2.6.2023

EN

Official Journal of the European Union

L 143/4

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COMMISSION IMPLEMENTING REGULATION (EU) 2023/1063

of 26 May 2023

entering a name in the register of protected designations of origin and protected geographical indications (‘Suruç Narı’ (PDO))

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, Türkiye’s application to register the name ‘Suruç Narı’ was published in the Official Journal of the European Union (2). |
| --- | --- |

(1)

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

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

(2)

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

HAS ADOPTED THIS REGULATION:

Article 1

The name ‘Suruç Narı’ (PDO) is hereby entered in the register.

The name specified in the first paragraph denotes a product in Class 1.6. – Fruit, vegetables and cereals, fresh or processed, 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, 26 May 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 51, 10.2.2023, p. 19.

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

---

| 2.6.2023 | EN | Official Journal of the European Union | L 143/5 |
| --- | --- | --- | --- |

2.6.2023

EN

Official Journal of the European Union

L 143/5

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/1064

of 26 May 2023

entering a name in the register of protected designations of origin and protected geographical indications (‘Haricot de Soissons’ (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, France’s application to register the name ‘Haricot de Soissons’ was published in the Official Journal of the European Union (2). |
| --- | --- |

(1)

Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, France’s application to register the name ‘Haricot de Soissons’ 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 ‘Haricot de Soissons’ 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 ‘Haricot de Soissons’ should therefore be entered in the register,

HAS ADOPTED THIS REGULATION:

Article 1

The name ‘Haricot de Soissons’ (PGI) is hereby entered in the register.

The name specified in the first paragraph denotes a product in Class 1.6. – Fruit, vegetables and cereals, fresh or processed, 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, 26 May 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 56, 15.2.2023, p. 23.

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

---

| 2.6.2023 | EN | Official Journal of the European Union | L 143/6 |
| --- | --- | --- | --- |

2.6.2023

EN

Official Journal of the European Union

L 143/6

---

COMMISSION REGULATION (EU) 2023/1065

of 1 June 2023

amending Annex II to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards nicotinamide riboside chloride added to foods

(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 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (1), and in particular Article 3(3) thereof,

Whereas:

| (1) | Annexes I and II to Regulation (EC) No 1925/2006 establish the list of vitamin and mineral substances, and for each of them the forms, which may be added to foods. |
| --- | --- |

(1)

Annexes I and II to Regulation (EC) No 1925/2006 establish the list of vitamin and mineral substances, and for each of them the forms, which may be added to foods.

| (2) | Commission Implementing Regulation (EU) 2020/16 (2) authorised the placing on the market of nicotinamide riboside chloride as a novel food for use in food supplements as defined in Article 2 of Directive 2002/46/EC of the European Parliament and of the Council (3), for the adult population. |
| --- | --- |

(2)

Commission Implementing Regulation (EU) 2020/16 (2) authorised the placing on the market of nicotinamide riboside chloride as a novel food for use in food supplements as defined in Article 2 of Directive 2002/46/EC of the European Parliament and of the Council (3), for the adult population.

| (3) | As the initial authorisation of this substance as a novel food as set out in Implementing Regulation (EU) 2020/16 concerned only food supplements, the substance has been included in the list set out in Annex II to Directive 2002/46/EC by Commission Regulation (EU) 2021/418 (4). Following an application for extension of the use of nicotinamide riboside chloride as a novel food to cover also its use for nutritional purposes as a source of niacin, in particular, in meal replacements, the Commission requested the European Food Safety Authority (‘the Authority’) to deliver an opinion on such extension of use in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council (5) and, following the outcome of that assessment, to evaluate in the context of Regulation (EC) No 1925/2006, the safety and bio-availability of that substance when added to the foods in question. On 14 September 2021, the Authority adopted a scientific opinion on the extension of use of nicotinamide riboside chloride as a novel food (6). |
| --- | --- |

(3)

As the initial authorisation of this substance as a novel food as set out in Implementing Regulation (EU) 2020/16 concerned only food supplements, the substance has been included in the list set out in Annex II to Directive 2002/46/EC by Commission Regulation (EU) 2021/418 (4). Following an application for extension of the use of nicotinamide riboside chloride as a novel food to cover also its use for nutritional purposes as a source of niacin, in particular, in meal replacements, the Commission requested the European Food Safety Authority (‘the Authority’) to deliver an opinion on such extension of use in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council (5) and, following the outcome of that assessment, to evaluate in the context of Regulation (EC) No 1925/2006, the safety and bio-availability of that substance when added to the foods in question. On 14 September 2021, the Authority adopted a scientific opinion on the extension of use of nicotinamide riboside chloride as a novel food (6).

| (4) | It follows from that opinion that the use of nicotinamide riboside chloride in foods is not of safety concern as a source of niacin provided that certain conditions are fulfilled. Those conditions are set out in the authorisation of this substance by Commission Implementing Regulation (EU) 2022/1160 (7). |
| --- | --- |

(4)

It follows from that opinion that the use of nicotinamide riboside chloride in foods is not of safety concern as a source of niacin provided that certain conditions are fulfilled. Those conditions are set out in the authorisation of this substance by Commission Implementing Regulation (EU) 2022/1160 (7).

| (5) | In accordance with Article 3(1) of Regulation (EC) No 1925/2006, only vitamins and/or minerals listed in Annex I, in the form listed in Annex II to that act may be added to foods. Based on the Authority’s favourable opinion and on the authorisation as a novel food as set out in Implementing Regulation (EU) 2022/1160, nicotinamide riboside chloride should be included in in Annex II to Regulation (EC) No 1925/2006 as a form of niacin. |
| --- | --- |

(5)

In accordance with Article 3(1) of Regulation (EC) No 1925/2006, only vitamins and/or minerals listed in Annex I, in the form listed in Annex II to that act may be added to foods. Based on the Authority’s favourable opinion and on the authorisation as a novel food as set out in Implementing Regulation (EU) 2022/1160, nicotinamide riboside chloride should be included in in Annex II to Regulation (EC) No 1925/2006 as a form of niacin.

| (6) | The Advisory Group on the Food Chain and Animal and Plant Health was consulted and its comments were taken into consideration. |
| --- | --- |

(6)

The Advisory Group on the Food Chain and Animal and Plant Health was consulted and its comments were taken into consideration.

| (7) | Regulation (EC) No 1925/2006 should therefore be amended accordingly. |
| --- | --- |

(7)

Regulation (EC) No 1925/2006 should therefore be amended accordingly.

| (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

Annex II to Regulation (EC) No 1925/2006 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, 1 June 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 404, 30.12.2006, p. 26.

1

(2)  Commission Implementing Regulation (EU) 2020/16 of 10 January 2020 authorising the placing on the market of nicotinamide riboside chloride as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (OJ L 7, 13.1.2020, p. 6).

2

(3)  Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).

3

(4)  Commission Regulation (EU) 2021/418 of 9 March 2021 amending Directive 2002/46/EC of the European Parliament and of the Council as regards nicotinamide riboside chloride and magnesium citrate malate used in the manufacture of food supplements and as regards the units of measurement used for copper (OJ L 83, 10.3.2021, p. 1).

4

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

5

(6)  EFSA Journal 2021;19(11):6843.

6

EFSA Journal

(7)  Commission Implementing Regulation (EU) 2022/1160 of 5 July 2022 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use and the specifications of the novel food nicotinamide riboside chloride (OJ L 179, 6.7.2022, p. 25).

7

---

ANNEX

In Annex II to Regulation (EC) No 1925/2006, within Point 1 on ‘Vitamin formulations’, under ‘NIACIN’, the following entry is added after the entry for ‘nicotinamide’:

‘nicotinamide riboside chloride’.

---

| 2.6.2023 | EN | Official Journal of the European Union | L 143/9 |
| --- | --- | --- | --- |

2.6.2023

EN

Official Journal of the European Union

L 143/9

---

COMMISSION REGULATION (EU) 2023/1066

of 1 June 2023

on the application of Article 101(3) of the Treaty on the Functioning of the European Union to certain categories of research and development agreements

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EEC) No 2821/71 of the Council of 20 December 1971 on application of Article 85(3) of the Treaty to categories of agreements, decisions and concerted practices (1), and in particular Article 1(1), point (b), thereof,

Having published a draft of this Regulation (2),

After consulting the Advisory Committee on Restrictive Practices and Dominant Positions,

Whereas:

| (1) | Regulation (EEC) No 2821/71 empowers the Commission to apply Article 101(3) of the Treaty by regulation to certain categories of agreements, decisions and concerted practices falling within the scope of Article 101(1) of the Treaty which have as their object the research and development of products, technologies or processes up to the stage of industrial application, and the exploitation of the results, including provisions regarding intellectual property rights. |
| --- | --- |

(1)

Regulation (EEC) No 2821/71 empowers the Commission to apply Article 101(3) of the Treaty by regulation to certain categories of agreements, decisions and concerted practices falling within the scope of Article 101(1) of the Treaty which have as their object the research and development of products, technologies or processes up to the stage of industrial application, and the exploitation of the results, including provisions regarding intellectual property rights.

| (2) | Article 179(2) of the Treaty calls upon the Union to encourage undertakings, including small and medium-sized undertakings, in their research and technological development activities of high quality, and to support their efforts to cooperate with one another. Cooperation between undertakings on research and development can contribute to achieving the objectives of the European Green Deal (3). |
| --- | --- |

(2)

Article 179(2) of the Treaty calls upon the Union to encourage undertakings, including small and medium-sized undertakings, in their research and technological development activities of high quality, and to support their efforts to cooperate with one another. Cooperation between undertakings on research and development can contribute to achieving the objectives of the European Green Deal (3).

| (3) | Commission Regulation (EU) No 1217/2010 (4) defines categories of research and development agreements that the Commission regarded as normally satisfying the conditions laid down in Article 101(3) of the Treaty. That Regulation expires on 30 June 2023. In view of the overall positive experience with the application of that Regulation and the results of the evaluation of that Regulation, it is appropriate to adopt a new block exemption regulation. |
| --- | --- |

(3)

Commission Regulation (EU) No 1217/2010 (4) defines categories of research and development agreements that the Commission regarded as normally satisfying the conditions laid down in Article 101(3) of the Treaty. That Regulation expires on 30 June 2023. In view of the overall positive experience with the application of that Regulation and the results of the evaluation of that Regulation, it is appropriate to adopt a new block exemption regulation.

| (4) | This Regulation aims to facilitate research and development while at the same time effectively protecting competition. This Regulation also aims to provide adequate legal security for undertakings. The pursuit of those objectives should take account of the need to simplify administrative supervision and the legislative framework to the greatest extent possible. |
| --- | --- |

(4)

This Regulation aims to facilitate research and development while at the same time effectively protecting competition. This Regulation also aims to provide adequate legal security for undertakings. The pursuit of those objectives should take account of the need to simplify administrative supervision and the legislative framework to the greatest extent possible.

| (5) | Below a certain level of market power, it can in general be presumed, for the application of Article 101(3) of the Treaty, that the positive effects of research and development agreements will outweigh any negative effects on competition. |
| --- | --- |

(5)

Below a certain level of market power, it can in general be presumed, for the application of Article 101(3) of the Treaty, that the positive effects of research and development agreements will outweigh any negative effects on competition.

| (6) | For the application of Article 101(3) of the Treaty by regulation, it is not necessary to define those agreements which are capable of falling within the scope of Article 101(1) of the Treaty. In the individual assessment of agreements under Article 101(1) of the Treaty, account has to be taken of several factors, and in particular the structure of the relevant market. |
| --- | --- |

(6)

For the application of Article 101(3) of the Treaty by regulation, it is not necessary to define those agreements which are capable of falling within the scope of Article 101(1) of the Treaty. In the individual assessment of agreements under Article 101(1) of the Treaty, account has to be taken of several factors, and in particular the structure of the relevant market.

| (7) | Cooperation in joint or paid-for research and development and in the exploitation of the results is most likely to promote technical and economic progress if the parties contribute complementary skills, assets or activities to the cooperation. |
| --- | --- |

(7)

Cooperation in joint or paid-for research and development and in the exploitation of the results is most likely to promote technical and economic progress if the parties contribute complementary skills, assets or activities to the cooperation.

| (8) | Consumers can generally be expected to benefit from the increased volume and effectiveness of research and development through the introduction of new or improved products, technologies or processes, a quicker launch of such products, technologies or processes, or a reduction of prices brought about by new or improved products, technologies or processes. |
| --- | --- |

(8)

Consumers can generally be expected to benefit from the increased volume and effectiveness of research and development through the introduction of new or improved products, technologies or processes, a quicker launch of such products, technologies or processes, or a reduction of prices brought about by new or improved products, technologies or processes.

| (9) | The joint exploitation of results can take different forms, such as the production and distribution of products, the application of technologies or processes, or the assignment or licensing of intellectual property rights or communication of know-how required for such production or application that substantially contribute to technical or economic progress. |
| --- | --- |

(9)

The joint exploitation of results can take different forms, such as the production and distribution of products, the application of technologies or processes, or the assignment or licensing of intellectual property rights or communication of know-how required for such production or application that substantially contribute to technical or economic progress.

| (10) | In order to justify the exemption established by this Regulation, the joint exploitation should relate to products (including goods and services), technologies or processes for which the use of the results of the research and development is indispensable. |
| --- | --- |

(10)

In order to justify the exemption established by this Regulation, the joint exploitation should relate to products (including goods and services), technologies or processes for which the use of the results of the research and development is indispensable.

| (11) | Moreover, all the parties should agree in the research and development agreement that they will all have full access to the final results of the joint research and development, including any arising intellectual property rights and know-how, for the purpose of further research and development, and for the purpose of exploitation, as soon as the final results become available. Access to the results should generally not be limited as regards the use of the results for the purposes of further research and development. However, where the parties, in accordance with this Regulation, limit their rights of exploitation, in particular where they specialise in the context of exploitation, access to the results for the purposes of exploitation may be limited accordingly. Furthermore, where academic bodies, research institutes, or undertakings which supply research and development as a commercial service without normally being active in the exploitation of results participate in research and development, they may agree to use the results of research and development solely for the purpose of further research and development. |
| --- | --- |

(11)

Moreover, all the parties should agree in the research and development agreement that they will all have full access to the final results of the joint research and development, including any arising intellectual property rights and know-how, for the purpose of further research and development, and for the purpose of exploitation, as soon as the final results become available. Access to the results should generally not be limited as regards the use of the results for the purposes of further research and development. However, where the parties, in accordance with this Regulation, limit their rights of exploitation, in particular where they specialise in the context of exploitation, access to the results for the purposes of exploitation may be limited accordingly. Furthermore, where academic bodies, research institutes, or undertakings which supply research and development as a commercial service without normally being active in the exploitation of results participate in research and development, they may agree to use the results of research and development solely for the purpose of further research and development.

| (12) | Depending on their capabilities and commercial needs, the parties may make unequal contributions to their research and development cooperation. Therefore, in order to reflect, and to make up for, the differences in the value or the nature of the parties’ contributions, a research and development agreement benefiting from the exemption established by this Regulation may provide that one party is to compensate another for obtaining access to the results for the purposes of further research and development or exploitation. However, the compensation should not be so high as to effectively impede such access. |
| --- | --- |

(12)

Depending on their capabilities and commercial needs, the parties may make unequal contributions to their research and development cooperation. Therefore, in order to reflect, and to make up for, the differences in the value or the nature of the parties’ contributions, a research and development agreement benefiting from the exemption established by this Regulation may provide that one party is to compensate another for obtaining access to the results for the purposes of further research and development or exploitation. However, the compensation should not be so high as to effectively impede such access.

| (13) | Where the research and development agreement does not provide for joint exploitation of the results, the parties should agree in the research and development agreement to grant each other access to their respective pre-existing know-how if such know-how is indispensable for the purpose of the exploitation of the results by the other parties. Any compensation (for example, licence fees) charged should not be so high as to effectively impede access to the know-how by the other parties. |
| --- | --- |

(13)

Where the research and development agreement does not provide for joint exploitation of the results, the parties should agree in the research and development agreement to grant each other access to their respective pre-existing know-how if such know-how is indispensable for the purpose of the exploitation of the results by the other parties. Any compensation (for example, licence fees) charged should not be so high as to effectively impede access to the know-how by the other parties.

| (14) | The exemption established by this Regulation should be limited to research and development agreements that do not afford the undertakings the possibility of eliminating competition in respect of a substantial part of the products, technologies or processes in question. It is therefore necessary to exclude from the block exemption agreements between competitors whose combined share of the market for products, technologies or processes capable of being improved, substituted or replaced by the results of the research and development exceeds a certain level at the time the agreement is entered into. |
| --- | --- |

(14)

The exemption established by this Regulation should be limited to research and development agreements that do not afford the undertakings the possibility of eliminating competition in respect of a substantial part of the products, technologies or processes in question. It is therefore necessary to exclude from the block exemption agreements between competitors whose combined share of the market for products, technologies or processes capable of being improved, substituted or replaced by the results of the research and development exceeds a certain level at the time the agreement is entered into.

| (15) | Where one party finances several research and development projects carried out by competitors with regard to the same products, technologies or processes, it cannot be excluded that anti-competitive foreclosure effects may arise, in particular where that party obtains the exclusive right to exploit the results vis-à-vis third parties. Therefore, as regards paid-for research and development agreements, the benefit of the exemption established by this Regulation should be limited to agreements under which the combined market share of all the parties involved in the connected agreements, namely the financing party and all the parties carrying out the research and development, does not exceed a certain level. |
| --- | --- |

(15)

Where one party finances several research and development projects carried out by competitors with regard to the same products, technologies or processes, it cannot be excluded that anti-competitive foreclosure effects may arise, in particular where that party obtains the exclusive right to exploit the results vis-à-vis third parties. Therefore, as regards paid-for research and development agreements, the benefit of the exemption established by this Regulation should be limited to agreements under which the combined market share of all the parties involved in the connected agreements, namely the financing party and all the parties carrying out the research and development, does not exceed a certain level.

| (16) | However, the exemption established by this Regulation should not be subject to a market share threshold where the parties to the research and development agreement are not competing undertakings in respect of products, technologies or processes capable of being improved, substituted or replaced by the products, technologies or processes arising from the agreement. This includes, for example, agreements relating to the development of products, technologies or processes that would create an entirely new demand, or research and development that is not closely related to a specific product, technology or process, or is not yet targeted at a specific objective. |
| --- | --- |

(16)

However, the exemption established by this Regulation should not be subject to a market share threshold where the parties to the research and development agreement are not competing undertakings in respect of products, technologies or processes capable of being improved, substituted or replaced by the products, technologies or processes arising from the agreement. This includes, for example, agreements relating to the development of products, technologies or processes that would create an entirely new demand, or research and development that is not closely related to a specific product, technology or process, or is not yet targeted at a specific objective.

| (17) | There is no presumption that research and development agreements are either caught by Article 101(1) of the Treaty or that they fail to satisfy the conditions of Article 101(3) of the Treaty where the market share threshold set out in this Regulation is exceeded or other conditions of this Regulation are not met. In such cases, it is necessary to conduct an individual assessment of the research and development agreement under Article 101 of the Treaty. |
| --- | --- |

(17)

There is no presumption that research and development agreements are either caught by Article 101(1) of the Treaty or that they fail to satisfy the conditions of Article 101(3) of the Treaty where the market share threshold set out in this Regulation is exceeded or other conditions of this Regulation are not met. In such cases, it is necessary to conduct an individual assessment of the research and development agreement under Article 101 of the Treaty.

| (18) | In order to ensure the maintenance of effective competition during the joint exploitation of the results of the joint or paid-for research and development, provision should be made for the block exemption to cease to apply if the parties’ combined share in the market for the products, technologies or processes arising from the research and development exceeds a certain level. However, the exemption should continue to apply irrespective of the parties’ market shares for a certain period after the commencement of joint exploitation, so as to await stabilisation of their market shares, in particular after the introduction of an entirely new product, and to guarantee a minimum period of return on the investments involved. |
| --- | --- |

(18)

In order to ensure the maintenance of effective competition during the joint exploitation of the results of the joint or paid-for research and development, provision should be made for the block exemption to cease to apply if the parties’ combined share in the market for the products, technologies or processes arising from the research and development exceeds a certain level. However, the exemption should continue to apply irrespective of the parties’ market shares for a certain period after the commencement of joint exploitation, so as to await stabilisation of their market shares, in particular after the introduction of an entirely new product, and to guarantee a minimum period of return on the investments involved.

| (19) | The exemption established by this Regulation should not apply to agreements containing restrictions which are not indispensable to the attainment of the positive effects generated by a research and development agreement. In principle, agreements containing certain types of severe restrictions of competition, such as limitations on the freedom of parties to carry out research and development in a field unconnected to the agreement, the fixing of prices charged to third parties, limitations on output or sales, and limitations on effecting passive sales of the products, technologies or processes arising from the joint or paid-for research and development should be excluded from the benefit of the exemption established by this Regulation, irrespective of the market share of the parties. In this context, field of use restrictions do not constitute limitations of output or sales, and do not constitute territorial or customer restrictions. |
| --- | --- |

(19)

The exemption established by this Regulation should not apply to agreements containing restrictions which are not indispensable to the attainment of the positive effects generated by a research and development agreement. In principle, agreements containing certain types of severe restrictions of competition, such as limitations on the freedom of parties to carry out research and development in a field unconnected to the agreement, the fixing of prices charged to third parties, limitations on output or sales, and limitations on effecting passive sales of the products, technologies or processes arising from the joint or paid-for research and development should be excluded from the benefit of the exemption established by this Regulation, irrespective of the market share of the parties. In this context, field of use restrictions do not constitute limitations of output or sales, and do not constitute territorial or customer restrictions.

| (20) | The market share thresholds, the non-exemption of certain agreements and the conditions provided for in this Regulation generally ensure that the agreements to which the block exemption applies do not enable the parties to eliminate competition in respect of a substantial part of the products, technologies or processes in question. |
| --- | --- |

(20)

The market share thresholds, the non-exemption of certain agreements and the conditions provided for in this Regulation generally ensure that the agreements to which the block exemption applies do not enable the parties to eliminate competition in respect of a substantial part of the products, technologies or processes in question.

| (21) | Agreements between undertakings which are not competing suppliers of products, technologies or processes capable of being improved, substituted or replaced by the results of the research and development and which satisfy the conditions of this Regulation will only eliminate effective innovation competition in exceptional circumstances. It is therefore appropriate to enable such agreements to benefit from the exemption established by this Regulation irrespective of market share and to address any exceptional cases by way of withdrawal of the benefit of the exemption established by this Regulation. The exemption of such agreements pursuant to this Regulation is without prejudice to the competitive assessment of research and development agreements that do not meet the conditions of this Regulation or agreements in respect of which the benefit of the exemption established by this Regulation has been withdrawn. |
| --- | --- |

(21)

Agreements between undertakings which are not competing suppliers of products, technologies or processes capable of being improved, substituted or replaced by the results of the research and development and which satisfy the conditions of this Regulation will only eliminate effective innovation competition in exceptional circumstances. It is therefore appropriate to enable such agreements to benefit from the exemption established by this Regulation irrespective of market share and to address any exceptional cases by way of withdrawal of the benefit of the exemption established by this Regulation. The exemption of such agreements pursuant to this Regulation is without prejudice to the competitive assessment of research and development agreements that do not meet the conditions of this Regulation or agreements in respect of which the benefit of the exemption established by this Regulation has been withdrawn.

| (22) | This Regulation should indicate typical situations in which it may be considered appropriate to withdraw the benefit of the exemption established by it, pursuant to Article 29 of Council Regulation (EC) No 1/2003 (5). |
| --- | --- |

(22)

This Regulation should indicate typical situations in which it may be considered appropriate to withdraw the benefit of the exemption established by it, pursuant to Article 29 of Council Regulation (EC) No 1/2003 (5).

| (23) | As research and development agreements are often of a long-term nature, especially where the cooperation extends to the exploitation of the results, the period of validity of this Regulation should be fixed at 12 years, |
| --- | --- |

(23)

As research and development agreements are often of a long-term nature, especially where the cooperation extends to the exploitation of the results, the period of validity of this Regulation should be fixed at 12 years,

HAS ADOPTED THIS REGULATION:

Article 1

Definitions

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

| (1) | ‘research and development agreement’ means an agreement entered into between two or more parties which relates to the conditions under which those parties pursue any of the following:






  (a) | joint research and development of contract products or contract technologies which:






  (i) | does not include joint exploitation of the results of that research and development; or |
| --- | --- | --- | --- |

(1)

‘research and development agreement’ means an agreement entered into between two or more parties which relates to the conditions under which those parties pursue any of the following:

(a)

joint research and development of contract products or contract technologies which:

(i)

does not include joint exploitation of the results of that research and development; or

| (ii) | includes joint exploitation of the results of that research and development; |
| --- | --- |

(ii)

includes joint exploitation of the results of that research and development;

| (b) | paid-for research and development of contract products or contract technologies which:






  (i) | does not include joint exploitation of the results of that research and development; or |
| --- | --- | --- |

(b)

paid-for research and development of contract products or contract technologies which:

(i)

does not include joint exploitation of the results of that research and development; or

| (ii) | includes joint exploitation of the results of that research and development; |
| --- | --- |

(ii)

includes joint exploitation of the results of that research and development;

| (c) | joint exploitation of the results of research and development of contract products or contract technologies carried out pursuant to a prior agreement falling under point (a) between the same parties; |
| --- | --- |

(c)

joint exploitation of the results of research and development of contract products or contract technologies carried out pursuant to a prior agreement falling under point (a) between the same parties;

| (d) | joint exploitation of the results of research and development of contract products or contract technologies carried out pursuant to a prior agreement falling under point (b) between the same parties; |
| --- | --- |

(d)

joint exploitation of the results of research and development of contract products or contract technologies carried out pursuant to a prior agreement falling under point (b) between the same parties;

| (2) | ‘agreement’ means an agreement between undertakings, a decision by an association of undertakings or a concerted practice; |
| --- | --- |

(2)

‘agreement’ means an agreement between undertakings, a decision by an association of undertakings or a concerted practice;

| (3) | ‘research and development’ means activities aimed at acquiring know-how relating to products, technologies or processes, the carrying out of theoretical analysis, systematic study or experimentation, including experimental and demonstrator production, technical testing of products or processes, the establishment of the necessary facilities up to demonstrator scale and the obtaining of intellectual property rights for the results; |
| --- | --- |

(3)

‘research and development’ means activities aimed at acquiring know-how relating to products, technologies or processes, the carrying out of theoretical analysis, systematic study or experimentation, including experimental and demonstrator production, technical testing of products or processes, the establishment of the necessary facilities up to demonstrator scale and the obtaining of intellectual property rights for the results;

| (4) | ‘product’ means a good or a service, including both intermediary goods or services and final goods or services; |
| --- | --- |

(4)

‘product’ means a good or a service, including both intermediary goods or services and final goods or services;

| (5) | ‘contract technology’ means a technology or process arising out of the joint or paid-for research and development; |
| --- | --- |

(5)

‘contract technology’ means a technology or process arising out of the joint or paid-for research and development;

| (6) | ‘contract product’ means a product arising out of the joint or paid-for research and development or produced by applying the contract technologies; |
| --- | --- |

(6)

‘contract product’ means a product arising out of the joint or paid-for research and development or produced by applying the contract technologies;

| (7) | ‘exploitation of the results’ means the production or distribution of the contract products or the application of the contract technologies or the assignment or licensing of intellectual property rights or the communication of know-how required for such production, distribution or application; |
| --- | --- |

(7)

‘exploitation of the results’ means the production or distribution of the contract products or the application of the contract technologies or the assignment or licensing of intellectual property rights or the communication of know-how required for such production, distribution or application;

| (8) | ‘intellectual property rights’ include industrial property rights, for example patents and trademarks, as well as copyright and neighbouring rights; |
| --- | --- |

(8)

‘intellectual property rights’ include industrial property rights, for example patents and trademarks, as well as copyright and neighbouring rights;

| (9) | ‘know-how’ means a package of practical information, resulting from experience and testing, which is:






  (a) | ‘secret’, meaning that it is not generally known or easily accessible; |
| --- | --- | --- |

(9)

‘know-how’ means a package of practical information, resulting from experience and testing, which is:

(a)

‘secret’, meaning that it is not generally known or easily accessible;

| (b) | ‘substantial’, meaning that it is significant and useful for the production of the contract products or the application of the contract technologies; and |
| --- | --- |

(b)

‘substantial’, meaning that it is significant and useful for the production of the contract products or the application of the contract technologies; and

| (c) | ‘identified’, meaning that it is described in a sufficiently comprehensive manner so as to make it possible to verify that it fulfils the criteria of secrecy and substantiality; |
| --- | --- |

(c)

‘identified’, meaning that it is described in a sufficiently comprehensive manner so as to make it possible to verify that it fulfils the criteria of secrecy and substantiality;

| (10) | ‘joint’, in the context of activities carried out under a research and development agreement, means activities where the work involved is:






  (a) | carried out by a joint team, organisation or undertaking; |
| --- | --- | --- |

(10)

‘joint’, in the context of activities carried out under a research and development agreement, means activities where the work involved is:

(a)

carried out by a joint team, organisation or undertaking;

| (b) | jointly entrusted to a third party; or |
| --- | --- |

(b)

jointly entrusted to a third party; or

| (c) | allocated between the parties by way of specialisation in the context of research and development or specialisation in the context of exploitation; |
| --- | --- |

(c)

allocated between the parties by way of specialisation in the context of research and development or specialisation in the context of exploitation;

| (11) | ‘specialisation in the context of research and development’ means that each of the parties is involved in the research and development activities covered by the research and development agreement and they divide the research and development work between them in any way that they consider appropriate; this does not include paid-for research and development; |
| --- | --- |

(11)

‘specialisation in the context of research and development’ means that each of the parties is involved in the research and development activities covered by the research and development agreement and they divide the research and development work between them in any way that they consider appropriate; this does not include paid-for research and development;

| (12) | ‘specialisation in the context of exploitation’ means that the parties allocate between them individual tasks such as production or distribution, or impose restrictions upon each other regarding the exploitation of the results, such as restrictions in relation to certain territories, customers or fields of use; this includes a scenario where only one party produces and distributes the contract products or applies the contract technologies on the basis of an exclusive licence granted by the other parties; |
| --- | --- |

(12)

‘specialisation in the context of exploitation’ means that the parties allocate between them individual tasks such as production or distribution, or impose restrictions upon each other regarding the exploitation of the results, such as restrictions in relation to certain territories, customers or fields of use; this includes a scenario where only one party produces and distributes the contract products or applies the contract technologies on the basis of an exclusive licence granted by the other parties;

| (13) | ‘paid-for research and development’ means research and development that is carried out by one party and financed by a financing party; |
| --- | --- |

(13)

‘paid-for research and development’ means research and development that is carried out by one party and financed by a financing party;

| (14) | ‘financing party’ means a party financing paid-for research and development while not carrying out any of the research and development activities itself; |
| --- | --- |

(14)

‘financing party’ means a party financing paid-for research and development while not carrying out any of the research and development activities itself;

| (15) | ‘competing undertaking’ means an actual or a potential competitor:






  (a) | ‘actual competitor’ means an undertaking that is supplying a product, technology or process capable of being improved, substituted or replaced by the contract product or the contract technology on the relevant geographic market; |
| --- | --- | --- |

(15)

‘competing undertaking’ means an actual or a potential competitor:

(a)

‘actual competitor’ means an undertaking that is supplying a product, technology or process capable of being improved, substituted or replaced by the contract product or the contract technology on the relevant geographic market;

| (b) | ‘potential competitor’ means an undertaking that, in the absence of the research and development agreement, would, on realistic grounds and not just as a mere theoretical possibility, be likely to undertake, within not more than 3 years, the necessary additional investments or incur the necessary costs to supply a product, technology or process capable of being improved, substituted or replaced by the contract product or contract technology on the relevant geographic market; |
| --- | --- |

(b)

‘potential competitor’ means an undertaking that, in the absence of the research and development agreement, would, on realistic grounds and not just as a mere theoretical possibility, be likely to undertake, within not more than 3 years, the necessary additional investments or incur the necessary costs to supply a product, technology or process capable of being improved, substituted or replaced by the contract product or contract technology on the relevant geographic market;

| (16) | ‘relevant product market’ means the relevant market for the products capable of being improved, substituted or replaced by the contract products; |
| --- | --- |

(16)

‘relevant product market’ means the relevant market for the products capable of being improved, substituted or replaced by the contract products;

| (17) | ‘relevant technology market’ means the relevant market for the technologies or processes capable of being improved, substituted or replaced by the contract technologies; |
| --- | --- |

(17)

‘relevant technology market’ means the relevant market for the technologies or processes capable of being improved, substituted or replaced by the contract technologies;

| (18) | ‘active sales’ means all forms of selling other than passive sales; |
| --- | --- |

(18)

‘active sales’ means all forms of selling other than passive sales;

| (19) | ‘passive sales’ means sales made in response to unsolicited requests from individual customers, including delivery of products to the customer, without the sale having been initiated by actively targeting the particular customer, customer group or territory, and including sales resulting from participating in public procurement or responding to private invitations to tender. |
| --- | --- |

(19)

‘passive sales’ means sales made in response to unsolicited requests from individual customers, including delivery of products to the customer, without the sale having been initiated by actively targeting the particular customer, customer group or territory, and including sales resulting from participating in public procurement or responding to private invitations to tender.

2.   For the purposes of this Regulation, the terms ‘undertaking’ and ‘party’ shall include their respective connected undertakings. ‘Connected undertakings’ means:

| (1) | undertakings in which a party to the research and development agreement, directly or indirectly, has one or more of the following rights or powers:






  (a) | the power to exercise more than half the voting rights; |
| --- | --- | --- |

(1)

undertakings in which a party to the research and development agreement, directly or indirectly, has one or more of the following rights or powers:

(a)

the power to exercise more than half the voting rights;

| (b) | the power to appoint more than half the members of the supervisory board, board of management or bodies legally representing the undertaking; |
| --- | --- |

(b)

the power to appoint more than half the members of the supervisory board, board of management or bodies legally representing the undertaking;

| (c) | the right to manage the undertaking’s affairs; |
| --- | --- |

(c)

the right to manage the undertaking’s affairs;

| (2) | undertakings which directly or indirectly have, over a party to the research and development agreement, one or more of the rights or powers listed in point (1); |
| --- | --- |

(2)

undertakings which directly or indirectly have, over a party to the research and development agreement, one or more of the rights or powers listed in point (1);

| (3) | undertakings in which an undertaking referred to in point (2) has, directly or indirectly, one or more of the rights or powers listed in point (1); |
| --- | --- |

(3)

undertakings in which an undertaking referred to in point (2) has, directly or indirectly, one or more of the rights or powers listed in point (1);

| (4) | undertakings in which a party to the research and development agreement together with one or more of the undertakings referred to in points (1), (2) or (3), or in which two or more of the latter undertakings, jointly have one or more of the rights or powers listed in point (1); |
| --- | --- |

(4)

undertakings in which a party to the research and development agreement together with one or more of the undertakings referred to in points (1), (2) or (3), or in which two or more of the latter undertakings, jointly have one or more of the rights or powers listed in point (1);

| (5) | undertakings in which one or more of the rights or powers listed in point (1) are jointly held by:






  (a) | parties to the research and development agreement or their respective connected undertakings referred to in points (1) to (4); or |
| --- | --- | --- |

(5)

undertakings in which one or more of the rights or powers listed in point (1) are jointly held by:

(a)

parties to the research and development agreement or their respective connected undertakings referred to in points (1) to (4); or

| (b) | one or more of the parties to the research and development agreement or one or more of their connected undertakings referred to in points (1) to (4) and one or more third parties. |
| --- | --- |

(b)

one or more of the parties to the research and development agreement or one or more of their connected undertakings referred to in points (1) to (4) and one or more third parties.

Article 2

Exemption

1.   Pursuant to Article 101(3) of the Treaty and subject to the provisions of this Regulation, Article 101(1) of the Treaty shall not apply to research and development agreements.

2.   The exemption established in paragraph 1 shall apply to the extent that research and development agreements contain restrictions of competition falling within the scope of Article 101(1) of the Treaty.

3.   The exemption established in paragraph 1 shall also apply to research and development agreements which include provisions on the assignment or licensing of intellectual property rights to one or more of the parties or to an entity established by the parties to carry out the joint or paid-for research and development or joint exploitation of the results, provided that those provisions are directly related to and necessary for the implementation of the agreement and do not constitute the primary object of the agreement.

Article 3

Access to the final results

1.   The exemption established in Article 2 shall apply subject to the conditions set out in paragraphs 2, 3 and 4 of this Article.

2.   The research and development agreement must stipulate that all the parties have full access to the final results of the joint or paid-for research and development for the purpose of further research and development and for the purpose of exploitation.

3.   The access provided for in paragraph 2 must:

| (a) | include any resulting intellectual property rights and know-how; |
| --- | --- |

(a)

include any resulting intellectual property rights and know-how;

| (b) | be granted as soon as the results of the research and development become available. |
| --- | --- |

(b)

be granted as soon as the results of the research and development become available.

4.   Where the research and development agreement provides that the parties compensate each other for giving access to the results for the purposes of further research and development or for the purpose of exploitation, the compensation must not be so high as to effectively impede such access.

5.   Research institutes, academic bodies, or undertakings which supply research and development as a commercial service without normally being active in the exploitation of results may agree to confine their use of the results for the purposes of further research and development.

6.   Where the parties limit their rights of exploitation in accordance with this Regulation, in particular where they specialise in the context of exploitation, access to the results for the purposes of exploitation may be limited accordingly.

Article 4

Access to pre-existing know-how

1.   Where the research and development agreement does not include joint exploitation of the results, the exemption established in Article 2 shall apply subject to the conditions set out in paragraphs 2 and 3 of this Article.

2.   The agreement must stipulate that each party shall be granted access to any pre-existing know-how of the other parties if such know-how is indispensable for the purposes of exploitation of the results.

3.   Where the agreement provides that the parties compensate each other for giving access to their pre-existing know-how, the compensation must not be so high as to effectively impede such access.

Article 5

Joint exploitation

1.   The exemption established in Article 2 shall apply on condition that any joint exploitation only pertains to results which fulfil both of the following conditions:

| (a) | the results are indispensable for the production of the contract products or the application of the contract technologies; |
| --- | --- |

(a)

the results are indispensable for the production of the contract products or the application of the contract technologies;

| (b) | the results are protected by intellectual property rights or constitute know-how. |
| --- | --- |

(b)

the results are protected by intellectual property rights or constitute know-how.

2.   Where one or more parties are charged with the production of the contract products by way of specialisation in the context of exploitation, the exemption established in Article 2 shall apply on condition that those parties are required to fulfil orders for supplies of the contract products from the other parties, except where one of the following applies:

| (a) | the research and development agreement also provides for distribution to be carried out by a joint team, organisation or undertaking or to be jointly entrusted to a third party; |
| --- | --- |

(a)

the research and development agreement also provides for distribution to be carried out by a joint team, organisation or undertaking or to be jointly entrusted to a third party;

| (b) | the parties have agreed that only the party producing the contract products may distribute them. |
| --- | --- |

(b)

the parties have agreed that only the party producing the contract products may distribute them.

Article 6

Market share thresholds and duration of exemption

1.   Where two or more of the parties are competing undertakings within the meaning of Article 1(1), point (15), the exemption established in Article 2 shall apply for the duration of the research and development if, at the time the agreement is entered into:

| (a) | for the research and development agreements referred to in Article 1(1), points (1) (a) and (c), the combined market share of the parties to the agreement does not exceed 25 % on the relevant product and technology markets; |
| --- | --- |

(a)

for the research and development agreements referred to in Article 1(1), points (1) (a) and (c), the combined market share of the parties to the agreement does not exceed 25 % on the relevant product and technology markets;

| (b) | for the research and development agreements referred to in Article 1(1), points (1) (b) and (d), the combined market share of the financing party and all the parties with which the financing party has entered into research and development agreements with regard to the same contract products or contract technologies does not exceed 25 % on the relevant product and technology markets. |
| --- | --- |

(b)

for the research and development agreements referred to in Article 1(1), points (1) (b) and (d), the combined market share of the financing party and all the parties with which the financing party has entered into research and development agreements with regard to the same contract products or contract technologies does not exceed 25 % on the relevant product and technology markets.

2.   Where the parties are not competing undertakings within the meaning of Article 1(1), point (15), the exemption established in Article 2 shall apply for the duration of the research and development.

3.   For research and development agreements where the results are jointly exploited, the exemption established in Article 2 shall continue to apply for 7 years from the time the contract products or contract technologies are first put on the market within the internal market, if the conditions provided for in paragraphs 1 or 2 of this Article are satisfied at the time the agreement referred to in Article 1(1), point (1) (a) or (b) is entered into. For the research and development agreements referred to in Article 1(1), point (1) (c) and (d) to benefit from such a continued exemption, the conditions provided for in paragraphs 1 or 2 of this Article must be satisfied at the time the prior agreement referred to in Article 1(1), point (1) (a) or (b) was entered into.

4.   After the end of the 7-year period referred to in paragraph 3 of this Article, the exemption established in Article 2 shall continue to apply as long as:

| (a) | for the research and development agreements referred to in Article 1(1), points (1) (a) and (c), the combined market share of the parties to the agreement does not exceed 25 % on the relevant markets to which the contract products or contract technologies belong; |
| --- | --- |

(a)

for the research and development agreements referred to in Article 1(1), points (1) (a) and (c), the combined market share of the parties to the agreement does not exceed 25 % on the relevant markets to which the contract products or contract technologies belong;

| (b) | for the research and development agreements referred to in Article 1(1), points (1) (b) and (d), the combined market share of the financing party and all the parties with which the financing party has entered into research and development agreements relating to the same contract products or contract technologies does not exceed 25 % on the relevant markets to which the contract products or contract technologies belong. |
| --- | --- |

(b)

for the research and development agreements referred to in Article 1(1), points (1) (b) and (d), the combined market share of the financing party and all the parties with which the financing party has entered into research and development agreements relating to the same contract products or contract technologies does not exceed 25 % on the relevant markets to which the contract products or contract technologies belong.

5.   If the combined market share of the relevant parties does not exceed the relevant threshold referred to in paragraph 4 at the end of the 7-year period referred to in paragraph 3, but subsequently rises above that threshold, the exemption established in Article 2 shall continue to apply for a period of 2 consecutive calendar years following the year in which the relevant market share threshold was first exceeded.

Article 7

Application of the market share thresholds

1.   For the purpose of applying the market share thresholds provided for in Article 6(1) and (4), the rules set out in paragraphs 2, 3 and 4 of this Article shall apply.

2.   Market shares shall be calculated on the basis of market sales value or, if market sales value data are not available, on the basis of market sales volumes. If market sales volumes data are not available, estimates based on other reliable market information, including expenditure on research and development, or research and development capabilities may be used.

3.   Market shares shall be calculated on the basis of data relating to the preceding calendar year. If the preceding calendar year is not representative of the parties’ position in the relevant market(s), the market share shall be calculated as an average of the parties’ market shares for the 3 preceding calendar years.

4.   The market share held by the undertakings referred to in Article 1(2), point (5), shall be apportioned equally to each undertaking having one or more of the rights or powers listed in Article 1(2), point (1).

Article 8

Hardcore restrictions

The exemption established in Article 2 shall not apply to research and development agreements which, directly or indirectly, in isolation or in combination with other factors under the control of the parties, have as their object any of the following restrictions:

| (a) | the restriction of the freedom of the parties to carry out research and development independently or in cooperation with third parties:






  (i) | in a field unconnected with that to which the research and development agreement relates; or |
| --- | --- | --- |

(a)

the restriction of the freedom of the parties to carry out research and development independently or in cooperation with third parties:

(i)

in a field unconnected with that to which the research and development agreement relates; or

| (ii) | after the completion of the joint or paid-for research and development, in the field to which the research and development agreement relates or in a connected field; |
| --- | --- |

(ii)

after the completion of the joint or paid-for research and development, in the field to which the research and development agreement relates or in a connected field;

| (b) | the limitation of output or sales, with the exception of:






  (i) | the setting of production targets, where the joint exploitation of the results includes the joint production of the contract products; |
| --- | --- | --- |

(b)

the limitation of output or sales, with the exception of:

(i)

the setting of production targets, where the joint exploitation of the results includes the joint production of the contract products;

| (ii) | the setting of sales targets, where the joint exploitation of the results:






  (1) | includes the joint distribution of the contract products or the joint licensing of the contract technologies; and |
| --- | --- | --- |

(ii)

the setting of sales targets, where the joint exploitation of the results:

(1)

includes the joint distribution of the contract products or the joint licensing of the contract technologies; and

| (2) | is carried out by a joint team, organisation or undertaking, or is jointly entrusted to a third party; |
| --- | --- |

(2)

is carried out by a joint team, organisation or undertaking, or is jointly entrusted to a third party;

| (iii) | practices constituting specialisation in the context of exploitation; |
| --- | --- |

(iii)

practices constituting specialisation in the context of exploitation;

| (iv) | the restriction of the freedom of the parties to produce, sell, assign or license products, technologies or processes which compete with the contract products or contract technologies during the period for which the parties have agreed to jointly exploit the results; |
| --- | --- |

(iv)

the restriction of the freedom of the parties to produce, sell, assign or license products, technologies or processes which compete with the contract products or contract technologies during the period for which the parties have agreed to jointly exploit the results;

| (c) | the fixing of prices when selling the contract products or licensing the contract technologies to third parties, with the exception of the fixing of prices charged to immediate customers or the fixing of licence fees charged to immediate licensees where the joint exploitation of the results:






  (i) | includes the joint distribution of the contract products or the joint licensing of the contract technologies; and |
| --- | --- | --- |

(c)

the fixing of prices when selling the contract products or licensing the contract technologies to third parties, with the exception of the fixing of prices charged to immediate customers or the fixing of licence fees charged to immediate licensees where the joint exploitation of the results:

(i)

includes the joint distribution of the contract products or the joint licensing of the contract technologies; and

| (ii) | is carried out by a joint team, organisation or undertaking, or is jointly entrusted to a third party; |
| --- | --- |

(ii)

is carried out by a joint team, organisation or undertaking, or is jointly entrusted to a third party;

| (d) | the restriction of the territory in which, or of the customers to whom, the parties may passively sell the contract products or license the contract technologies, with the exception of the requirement to exclusively license the results of the research and development to another party; |
| --- | --- |

(d)

the restriction of the territory in which, or of the customers to whom, the parties may passively sell the contract products or license the contract technologies, with the exception of the requirement to exclusively license the results of the research and development to another party;

| (e) | the restriction of active sales of the contract products or contract technologies in territories or to customers which have not been exclusively allocated to one of the parties by way of specialisation in the context of exploitation; |
| --- | --- |

(e)

the restriction of active sales of the contract products or contract technologies in territories or to customers which have not been exclusively allocated to one of the parties by way of specialisation in the context of exploitation;

| (f) | the requirement to refuse to meet demand from customers in the parties’ respective territories, or from customers otherwise allocated between the parties by way of specialisation in the context of exploitation, where such customers would market the contract products in other territories within the internal market; |
| --- | --- |

(f)

the requirement to refuse to meet demand from customers in the parties’ respective territories, or from customers otherwise allocated between the parties by way of specialisation in the context of exploitation, where such customers would market the contract products in other territories within the internal market;

| (g) | the requirement to make it difficult for users or resellers to obtain the contract products from other resellers within the internal market. |
| --- | --- |

(g)

the requirement to make it difficult for users or resellers to obtain the contract products from other resellers within the internal market.

Article 9

Excluded restrictions

1.   The exemption established in Article 2 shall not apply to the following obligations in research and development agreements:

| (a) | the obligation not to challenge:






  (i) | after completion of the research and development, the validity of intellectual property rights which:






  (1) | the parties hold in the internal market; and |
| --- | --- | --- | --- |

(a)

the obligation not to challenge:

(i)

after completion of the research and development, the validity of intellectual property rights which:

(1)

the parties hold in the internal market; and

| (2) | are relevant to the research and development; or |
| --- | --- |

(2)

are relevant to the research and development; or

| (ii) | after the expiry of the research and development agreement, the validity of intellectual property rights which:






  (1) | the parties hold in the internal market; and |
| --- | --- | --- |

(ii)

after the expiry of the research and development agreement, the validity of intellectual property rights which:

(1)

the parties hold in the internal market; and

| (2) | protect the results of the research and development; |
| --- | --- |

(2)

protect the results of the research and development;

| (b) | the obligation not to grant licences to third parties to produce the contract products or to apply the contract technologies unless the agreement provides for the exploitation of the results of the joint or paid-for research and development by one or more of the parties and such exploitation takes place in the internal market vis-à-vis third parties. |
| --- | --- |

(b)

the obligation not to grant licences to third parties to produce the contract products or to apply the contract technologies unless the agreement provides for the exploitation of the results of the joint or paid-for research and development by one or more of the parties and such exploitation takes place in the internal market vis-à-vis third parties.

2.   Paragraph 1, point (a), is without prejudice to the possibility to provide for the termination of the research and development agreement in the event that one of the parties challenges the validity of the intellectual property rights referred to in paragraph 1, points (a) (i) and (ii).

3.   If the research and development agreement includes any of the excluded restrictions referred to in paragraph 1 of this Article, the exemption established in Article 2 shall continue to apply to the remaining part of the research and development agreement, provided that the excluded restrictions can be severed from that remaining part and provided that the other conditions of this Regulation are met.

Article 10

Withdrawal in individual cases by the Commission

1.   The Commission may withdraw the benefit of the exemption established by this Regulation, pursuant to Article 29(1) of Regulation (EC) No 1/2003, where it finds in any particular case that a research and development agreement to which the exemption established by this Regulation applies, nevertheless has effects which are incompatible with Article 101(3) of the Treaty.

2.   The Commission may withdraw the benefit of the exemption established by this Regulation, pursuant to Article 29(1) of Regulation (EC) No 1/2003, in particular where:

| (a) | the existence of a research and development agreement substantially restricts the scope for third parties to carry out research and development in field(s) related to the contract products or contract technologies; |
| --- | --- |

(a)

the existence of a research and development agreement substantially restricts the scope for third parties to carry out research and development in field(s) related to the contract products or contract technologies;

| (b) | the existence of a research and development agreement substantially restricts the access of third parties to the relevant market for the contract products or contract technologies; |
| --- | --- |

(b)

the existence of a research and development agreement substantially restricts the access of third parties to the relevant market for the contract products or contract technologies;

| (c) | the parties do not exploit the results of the joint or paid-for research and development vis-à-vis third parties without any objectively valid reason; |
| --- | --- |

(c)

the parties do not exploit the results of the joint or paid-for research and development vis-à-vis third parties without any objectively valid reason;

| (d) | the contract products or contract technologies are not subject in the whole or a substantial part of the internal market to effective competition; or |
| --- | --- |

(d)

the contract products or contract technologies are not subject in the whole or a substantial part of the internal market to effective competition; or

| (e) | the existence of the research and development agreement would substantially restrict innovation competition in a particular field. |
| --- | --- |

(e)

the existence of the research and development agreement would substantially restrict innovation competition in a particular field.

Article 11

Withdrawal in individual cases by the competition authority of a Member State

The competition authority of a Member State may withdraw the benefit of the exemption established by this Regulation where the conditions of Article 29(2) of Regulation (EC) No 1/2003 are fulfilled.

Article 12

Transitional period

The prohibition laid down in Article 101(1) of the Treaty shall not apply during the period from 1 July 2023 to 30 June 2025 in respect of agreements already in force on 30 June 2023 which do not satisfy the conditions for exemption established by this Regulation but which satisfy the conditions for exemption established by Regulation (EU) No 1217/2010.

Article 13

Entry into force and application

This Regulation shall enter into force on 1 July 2023.

It shall apply until 30 June 2035.

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

Done at Brussels, 1 June 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 285, 29.12.1971, p. 46.

1

(2)  OJ C 120, 15.3.2022, p. 9.

2

(3)  Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions – The European Green Deal (COM(2019) 640 final).

3

(4)  Commission Regulation (EU) No 1217/2010 of 14 December 2010 on the application of Article 101(3) of the Treaty on the Functioning of the European Union to certain categories of research and development agreements (OJ L 335, 18.12.2010, p. 36).

4

(5)  Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles 81 and 82 of the Treaty (OJ L 1, 4.1.2003, p. 1).

5

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| 2.6.2023 | EN | Official Journal of the European Union | L 143/20 |
| --- | --- | --- | --- |

2.6.2023

EN

Official Journal of the European Union

L 143/20

---

COMMISSION REGULATION (EU) 2023/1067

of 1 June 2023

on the application of Article 101(3) of the Treaty on the Functioning of the European Union to certain categories of specialisation agreements

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EEC) No 2821/71 of the Council of 20 December 1971 on application of Article 85(3) of the Treaty to categories of agreements, decisions and concerted practices (1), and in particular Article 1(1), point (c), thereof,

Having published a draft of this Regulation (2),

After consulting the Advisory Committee on Restrictive Practices and Dominant Positions,

Whereas:

| (1) | Regulation (EEC) No 2821/71 empowers the Commission to apply Article 101(3) of the Treaty by regulation to certain categories of agreements, decisions and concerted practices falling within the scope of Article 101(1) of the Treaty which have as their object specialisation, including agreements necessary for achieving such specialisation. |
| --- | --- |

(1)

Regulation (EEC) No 2821/71 empowers the Commission to apply Article 101(3) of the Treaty by regulation to certain categories of agreements, decisions and concerted practices falling within the scope of Article 101(1) of the Treaty which have as their object specialisation, including agreements necessary for achieving such specialisation.

| (2) | Commission Regulation (EU) No 1218/2010 (3) defines categories of specialisation agreements which the Commission regarded as normally satisfying the conditions laid down in Article 101(3) of the Treaty. That Regulation expires on 30 June 2023. In view of the overall positive experience with the application of that Regulation and the results of the evaluation of that Regulation, it is appropriate to adopt a new block exemption regulation. |
| --- | --- |

(2)

Commission Regulation (EU) No 1218/2010 (3) defines categories of specialisation agreements which the Commission regarded as normally satisfying the conditions laid down in Article 101(3) of the Treaty. That Regulation expires on 30 June 2023. In view of the overall positive experience with the application of that Regulation and the results of the evaluation of that Regulation, it is appropriate to adopt a new block exemption regulation.

| (3) | This Regulation aims to ensure effective protection of competition and to provide adequate legal security for undertakings. The pursuit of those objectives should take account of the need to simplify administrative supervision and the legislative framework to the greatest extent possible. |
| --- | --- |

(3)

This Regulation aims to ensure effective protection of competition and to provide adequate legal security for undertakings. The pursuit of those objectives should take account of the need to simplify administrative supervision and the legislative framework to the greatest extent possible.

| (4) | For the application of Article 101(3) of the Treaty by regulation, it is not necessary to define those agreements which are capable of falling within Article 101(1) of the Treaty. In the individual assessment of agreements under Article 101(1) of the Treaty, account has to be taken of several factors, and in particular the structure of the relevant market. |
| --- | --- |

(4)

For the application of Article 101(3) of the Treaty by regulation, it is not necessary to define those agreements which are capable of falling within Article 101(1) of the Treaty. In the individual assessment of agreements under Article 101(1) of the Treaty, account has to be taken of several factors, and in particular the structure of the relevant market.

| (5) | The benefit of the exemption established by this Regulation should be limited to those agreements for which it can be assumed with sufficient certainty that they satisfy the conditions of Article 101(3) of the Treaty. Below a certain level of market power, it can in general be presumed, for the application of Article 101(3) of the Treaty, that the positive effects of specialisation agreements will outweigh any negative effects on competition. |
| --- | --- |

(5)

The benefit of the exemption established by this Regulation should be limited to those agreements for which it can be assumed with sufficient certainty that they satisfy the conditions of Article 101(3) of the Treaty. Below a certain level of market power, it can in general be presumed, for the application of Article 101(3) of the Treaty, that the positive effects of specialisation agreements will outweigh any negative effects on competition.

| (6) | This Regulation should apply to agreements concerning the manufacture of goods and the preparation of services. The preparation of services refers to activities carried out upstream of the provision of services to customers (for example, cooperation in the creation or operation of a platform through which a service will be provided). The provision of services to customers falls outside the scope of this Regulation, except where the parties agree to jointly provide services prepared under the specialisation agreement. |
| --- | --- |

(6)

This Regulation should apply to agreements concerning the manufacture of goods and the preparation of services. The preparation of services refers to activities carried out upstream of the provision of services to customers (for example, cooperation in the creation or operation of a platform through which a service will be provided). The provision of services to customers falls outside the scope of this Regulation, except where the parties agree to jointly provide services prepared under the specialisation agreement.

| (7) | Specialisation agreements are most likely to contribute to improving the manufacture of goods or the preparation of services and their distribution if the parties have complementary skills, assets or activities, because, in that case, the agreement allows them to focus on the manufacture of certain goods or the preparation of certain services and thus operate more efficiently and supply the products more cheaply. Given effective competition, it is likely that consumers will receive a fair share of the resulting benefits. |
| --- | --- |

(7)

Specialisation agreements are most likely to contribute to improving the manufacture of goods or the preparation of services and their distribution if the parties have complementary skills, assets or activities, because, in that case, the agreement allows them to focus on the manufacture of certain goods or the preparation of certain services and thus operate more efficiently and supply the products more cheaply. Given effective competition, it is likely that consumers will receive a fair share of the resulting benefits.

| (8) | Such benefits can arise first from agreements whereby one or more parties fully or partly give up the manufacture of certain goods or the preparation of certain services in favour of another party or parties (‘unilateral specialisation’); second, from agreements whereby two or more parties fully or partly give up the manufacture of certain but different goods or the preparation of certain but different services in favour of another party or parties (‘reciprocal specialisation’), and third, from agreements whereby two or more parties undertake to jointly manufacture certain goods or prepare certain services (‘joint production’). |
| --- | --- |

(8)

Such benefits can arise first from agreements whereby one or more parties fully or partly give up the manufacture of certain goods or the preparation of certain services in favour of another party or parties (‘unilateral specialisation’); second, from agreements whereby two or more parties fully or partly give up the manufacture of certain but different goods or the preparation of certain but different services in favour of another party or parties (‘reciprocal specialisation’), and third, from agreements whereby two or more parties undertake to jointly manufacture certain goods or prepare certain services (‘joint production’).

| (9) | The application of this Regulation to unilateral and reciprocal specialisation agreements should be limited to scenarios where the parties are active on the same product market. However, it is not necessary for the parties to be active on the same geographic market. In addition, the concepts of unilateral and reciprocal specialisation should not require a party to reduce capacity, as it is sufficient if they reduce their production volumes. |
| --- | --- |

(9)

The application of this Regulation to unilateral and reciprocal specialisation agreements should be limited to scenarios where the parties are active on the same product market. However, it is not necessary for the parties to be active on the same geographic market. In addition, the concepts of unilateral and reciprocal specialisation should not require a party to reduce capacity, as it is sufficient if they reduce their production volumes.

| (10) | To ensure that the benefits of specialisation materialise without one party leaving the market downstream of production entirely, unilateral and reciprocal specialisation agreements should only be covered by this Regulation where they provide for supply and purchase obligations. Supply and purchase obligations may be, but do not have to be, of an exclusive nature. |
| --- | --- |

(10)

To ensure that the benefits of specialisation materialise without one party leaving the market downstream of production entirely, unilateral and reciprocal specialisation agreements should only be covered by this Regulation where they provide for supply and purchase obligations. Supply and purchase obligations may be, but do not have to be, of an exclusive nature.

| (11) | This Regulation should apply to joint production agreements entered into by parties that are already active on the same product market but also by parties that wish to enter a product market by means of the joint production agreement. The concept of joint production agreement should not require the parties to reduce their individual activities regarding the manufacture of goods or preparation of services outside the scope of their envisaged joint arrangement. |
| --- | --- |

(11)

This Regulation should apply to joint production agreements entered into by parties that are already active on the same product market but also by parties that wish to enter a product market by means of the joint production agreement. The concept of joint production agreement should not require the parties to reduce their individual activities regarding the manufacture of goods or preparation of services outside the scope of their envisaged joint arrangement.

| (12) | It can be presumed that, where the parties’ share of the relevant market for the products which are the subject of a specialisation agreement does not exceed a certain level, the agreement will, as a general rule, give rise to economic benefits in the form of economies of scale or scope or better production technologies, while allowing consumers a fair share of the resulting benefits. |
| --- | --- |

(12)

It can be presumed that, where the parties’ share of the relevant market for the products which are the subject of a specialisation agreement does not exceed a certain level, the agreement will, as a general rule, give rise to economic benefits in the form of economies of scale or scope or better production technologies, while allowing consumers a fair share of the resulting benefits.

| (13) | Where the products covered by a specialisation agreement are intermediary products that are fully or partly used captively by one or more of the parties as an input for their own production of downstream products which they subsequently sell on the market, the exemption conferred by this Regulation should also be conditional on the parties’ market share on the relevant market for those downstream products not exceeding a certain level. In that case, taking into account the parties’ market share only at the level of the intermediary product would ignore the potential risk of foreclosing or increasing the price of inputs for competitors at the level of the downstream products. |
| --- | --- |

(13)

Where the products covered by a specialisation agreement are intermediary products that are fully or partly used captively by one or more of the parties as an input for their own production of downstream products which they subsequently sell on the market, the exemption conferred by this Regulation should also be conditional on the parties’ market share on the relevant market for those downstream products not exceeding a certain level. In that case, taking into account the parties’ market share only at the level of the intermediary product would ignore the potential risk of foreclosing or increasing the price of inputs for competitors at the level of the downstream products.

| (14) | There is no presumption that specialisation agreements are either caught by Article 101(1) of the Treaty or that they fail to satisfy the conditions of Article 101(3) of the Treaty where the market share threshold set out in this Regulation is exceeded or other conditions of this Regulation are not met. In such cases, it is necessary to conduct an individual assessment of the specialisation agreement under Article 101 of the Treaty. |
| --- | --- |

(14)

There is no presumption that specialisation agreements are either caught by Article 101(1) of the Treaty or that they fail to satisfy the conditions of Article 101(3) of the Treaty where the market share threshold set out in this Regulation is exceeded or other conditions of this Regulation are not met. In such cases, it is necessary to conduct an individual assessment of the specialisation agreement under Article 101 of the Treaty.

| (15) | The exemption established by this Regulation should not apply to agreements containing restrictions which are not indispensable to the attainment of the positive effects generated by specialisation agreements. In principle, agreements containing certain types of severe restrictions of competition, such as the fixing of prices charged to third parties, the limitation of output or sales, and the allocation of markets or customers should be excluded from the benefit of the exemption established by this Regulation, irrespective of the market share of the parties. |
| --- | --- |

(15)

The exemption established by this Regulation should not apply to agreements containing restrictions which are not indispensable to the attainment of the positive effects generated by specialisation agreements. In principle, agreements containing certain types of severe restrictions of competition, such as the fixing of prices charged to third parties, the limitation of output or sales, and the allocation of markets or customers should be excluded from the benefit of the exemption established by this Regulation, irrespective of the market share of the parties.

| (16) | The market share threshold, the non-exemption of certain agreements and the conditions provided for in this Regulation generally ensure that the agreements to which the block exemption applies do not enable the parties to eliminate competition in respect of a substantial part of the goods or services in question. |
| --- | --- |

(16)

The market share threshold, the non-exemption of certain agreements and the conditions provided for in this Regulation generally ensure that the agreements to which the block exemption applies do not enable the parties to eliminate competition in respect of a substantial part of the goods or services in question.

| (17) | This Regulation should indicate typical situations in which it may be considered appropriate to withdraw the benefit of the exemption established by it, pursuant to Article 29 of Council Regulation (EC) No 1/2003 (4). |
| --- | --- |

(17)

This Regulation should indicate typical situations in which it may be considered appropriate to withdraw the benefit of the exemption established by it, pursuant to Article 29 of Council Regulation (EC) No 1/2003 (4).

| (18) | In order to facilitate the conclusion of specialisation agreements, which can have a bearing on the structure of the parties, the period of validity of this Regulation should be fixed at 12 years, |
| --- | --- |

(18)

In order to facilitate the conclusion of specialisation agreements, which can have a bearing on the structure of the parties, the period of validity of this Regulation should be fixed at 12 years,

HAS ADOPTED THIS REGULATION:

Article 1

Definitions

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

| (1) | ‘specialisation agreement’ means a unilateral specialisation agreement, a reciprocal specialisation agreement or a joint production agreement;






  (a) | ‘unilateral specialisation agreement’ means an agreement between two or more parties which are active on the same product market and under which one or more parties agree to fully or partly cease production of certain products or to refrain from producing those products and to purchase them from another party or parties, which agree to produce and supply them; |
| --- | --- | --- |

(1)

‘specialisation agreement’ means a unilateral specialisation agreement, a reciprocal specialisation agreement or a joint production agreement;

(a)

‘unilateral specialisation agreement’ means an agreement between two or more parties which are active on the same product market and under which one or more parties agree to fully or partly cease production of certain products or to refrain from producing those products and to purchase them from another party or parties, which agree to produce and supply them;

| (b) | ‘reciprocal specialisation agreement’ means an agreement between two or more parties which are active on the same product market and under which two or more parties, on a reciprocal basis, agree to fully or partly cease or refrain from producing certain but different products and to purchase those products from one or more of the other parties, which agree to produce and supply them; |
| --- | --- |

(b)

‘reciprocal specialisation agreement’ means an agreement between two or more parties which are active on the same product market and under which two or more parties, on a reciprocal basis, agree to fully or partly cease or refrain from producing certain but different products and to purchase those products from one or more of the other parties, which agree to produce and supply them;

| (c) | ‘joint production agreement’ means an agreement under which two or more parties agree to produce certain products jointly; |
| --- | --- |

(c)

‘joint production agreement’ means an agreement under which two or more parties agree to produce certain products jointly;

| (2) | ‘agreement’ means an agreement between undertakings, a decision by an association of undertakings or a concerted practice; |
| --- | --- |

(2)

‘agreement’ means an agreement between undertakings, a decision by an association of undertakings or a concerted practice;

| (3) | ‘product’ means a good or a service, including both intermediary goods or services and final goods or services, with the exception of distribution and rental services; |
| --- | --- |

(3)

‘product’ means a good or a service, including both intermediary goods or services and final goods or services, with the exception of distribution and rental services;

| (4) | ‘production’ means the manufacture of goods or the preparation of services, including by way of subcontracting; |
| --- | --- |

(4)

‘production’ means the manufacture of goods or the preparation of services, including by way of subcontracting;

| (5) | ‘preparation of services’ means activities carried out upstream of the provision of services to customers; |
| --- | --- |

(5)

‘preparation of services’ means activities carried out upstream of the provision of services to customers;

| (6) | ‘specialisation product’ means a product which is produced under a specialisation agreement; |
| --- | --- |

(6)

‘specialisation product’ means a product which is produced under a specialisation agreement;

| (7) | ‘downstream product’ means a product for which a specialisation product is used as an input by one or more of the parties and which is sold by those parties on the market; |
| --- | --- |

(7)

‘downstream product’ means a product for which a specialisation product is used as an input by one or more of the parties and which is sold by those parties on the market;

| (8) | ‘relevant market’ means the relevant product and geographic market to which the specialisation products belong, and, in addition, where the specialisation products are intermediary products that are fully or partly used captively by one or more of the parties as inputs for the production of downstream products, the relevant product and geographic market to which the downstream products belong; |
| --- | --- |

(8)

‘relevant market’ means the relevant product and geographic market to which the specialisation products belong, and, in addition, where the specialisation products are intermediary products that are fully or partly used captively by one or more of the parties as inputs for the production of downstream products, the relevant product and geographic market to which the downstream products belong;

| (9) | ‘competing undertaking’ means an actual or potential competitor:






  (a) | ‘actual competitor’ means an undertaking that is active on the same relevant market; |
| --- | --- | --- |

(9)

‘competing undertaking’ means an actual or potential competitor:

(a)

‘actual competitor’ means an undertaking that is active on the same relevant market;

| (b) | ‘potential competitor’ means an undertaking that, in the absence of the specialisation agreement, would, on realistic grounds and not just as a mere theoretical possibility, be likely to undertake, within not more than 3 years, the necessary additional investments or other necessary costs to enter the relevant market; |
| --- | --- |

(b)

‘potential competitor’ means an undertaking that, in the absence of the specialisation agreement, would, on realistic grounds and not just as a mere theoretical possibility, be likely to undertake, within not more than 3 years, the necessary additional investments or other necessary costs to enter the relevant market;

| (10) | ‘exclusive supply obligation’ means an obligation not to supply the specialisation products to a competing undertaking other than a party or parties to the specialisation agreement; |
| --- | --- |

(10)

‘exclusive supply obligation’ means an obligation not to supply the specialisation products to a competing undertaking other than a party or parties to the specialisation agreement;

| (11) | ‘exclusive purchase obligation’ means an obligation to purchase the specialisation products only from a party or parties to the specialisation agreement; |
| --- | --- |

(11)

‘exclusive purchase obligation’ means an obligation to purchase the specialisation products only from a party or parties to the specialisation agreement;

| (12) | ‘joint’, in the context of distribution, means activities where the work involved is:






  (a) | carried out by a joint team, organisation or undertaking; or |
| --- | --- | --- |

(12)

‘joint’, in the context of distribution, means activities where the work involved is:

(a)

carried out by a joint team, organisation or undertaking; or

| (b) | undertaken by a jointly appointed third party distributor on an exclusive or non-exclusive basis, provided that the third party is not a competing undertaking; |
| --- | --- |

(b)

undertaken by a jointly appointed third party distributor on an exclusive or non-exclusive basis, provided that the third party is not a competing undertaking;

| (13) | ‘distribution’ means the sale and supply of the specialisation products to customers, including the commercialisation of those products. |
| --- | --- |

(13)

‘distribution’ means the sale and supply of the specialisation products to customers, including the commercialisation of those products.

2.   For the purposes of this Regulation, the terms ‘undertaking’ and ‘party’ shall include their respective connected undertakings. ‘Connected undertakings’ means:

| (1) | undertakings in which a party to the specialisation agreement, directly or indirectly has one or more of the following rights or powers:






  (a) | the power to exercise more than half the voting rights; |
| --- | --- | --- |

(1)

undertakings in which a party to the specialisation agreement, directly or indirectly has one or more of the following rights or powers:

(a)

the power to exercise more than half the voting rights;

| (b) | the power to appoint more than half the members of the supervisory board, board of management or bodies legally representing the undertaking; |
| --- | --- |

(b)

the power to appoint more than half the members of the supervisory board, board of management or bodies legally representing the undertaking;

| (c) | the right to manage the undertaking’s affairs; |
| --- | --- |

(c)

the right to manage the undertaking’s affairs;

| (2) | undertakings which directly or indirectly have, over a party to the specialisation agreement, one or more of the rights or powers listed in point (1); |
| --- | --- |

(2)

undertakings which directly or indirectly have, over a party to the specialisation agreement, one or more of the rights or powers listed in point (1);

| (3) | undertakings in which an undertaking referred to in point (2) has, directly or indirectly, one or more of the rights or powers listed in point (1); |
| --- | --- |

(3)

undertakings in which an undertaking referred to in point (2) has, directly or indirectly, one or more of the rights or powers listed in point (1);

| (4) | undertakings in which a party to the specialisation agreement together with one or more of the undertakings referred to in points (1), (2) or (3), or in which two or more of the latter undertakings, jointly have one or more of the rights or powers listed in point (1); |
| --- | --- |

(4)

undertakings in which a party to the specialisation agreement together with one or more of the undertakings referred to in points (1), (2) or (3), or in which two or more of the latter undertakings, jointly have one or more of the rights or powers listed in point (1);

| (5) | undertakings in which one or more of the rights or powers listed in point (1) are jointly held by:






  (a) | parties to the specialisation agreement or their respective connected undertakings referred to in points (1) to (4); or |
| --- | --- | --- |

(5)

undertakings in which one or more of the rights or powers listed in point (1) are jointly held by:

(a)

parties to the specialisation agreement or their respective connected undertakings referred to in points (1) to (4); or

| (b) | one or more of the parties to the specialisation agreement or one or more of their connected undertakings referred to in points (1) to (4) and one or more third parties. |
| --- | --- |

(b)

one or more of the parties to the specialisation agreement or one or more of their connected undertakings referred to in points (1) to (4) and one or more third parties.

Article 2

Exemption

1.   Pursuant to Article 101(3) of the Treaty, and subject to the provisions of this Regulation, Article 101(1) of the Treaty shall not apply to specialisation agreements.

2.   The exemption established in paragraph 1 shall apply to the extent that such agreements contain restrictions of competition falling within the scope of Article 101(1) of the Treaty.

3.   The exemption established in paragraph 1 shall also apply to specialisation agreements which include provisions on the assignment or licensing of intellectual property rights to one or more of the parties, provided that those provisions are directly related to and necessary for the implementation of the agreement and do not constitute the primary object of the agreement.

4.   The exemption established in paragraph 1 shall also apply to specialisation agreements whereby:

| (a) | the parties accept an exclusive purchase or an exclusive supply obligation; or |
| --- | --- |

(a)

the parties accept an exclusive purchase or an exclusive supply obligation; or

| (b) | the parties jointly distribute the specialisation products. |
| --- | --- |

(b)

the parties jointly distribute the specialisation products.

Article 3

Market share threshold

1.   The exemption established in Article 2 shall apply on condition that the combined market share of the parties does not exceed 20 % on the relevant market(s) to which the specialisation products belong.

2.   Where the specialisation products are intermediary products that are fully or partly used captively by one or more of the parties as inputs for the production of downstream products, which they also sell, the exemption established in Article 2 shall only apply if both of the following conditions are fulfilled:

| (a) | the parties’ combined market share does not exceed 20 % on the relevant market(s) to which the specialisation products belong; |
| --- | --- |

(a)

the parties’ combined market share does not exceed 20 % on the relevant market(s) to which the specialisation products belong;

| (b) | the parties’ combined market share does not exceed 20 % on the relevant market(s) to which the downstream products belong. |
| --- | --- |

(b)

the parties’ combined market share does not exceed 20 % on the relevant market(s) to which the downstream products belong.

Article 4

Application of the market share threshold

For the purposes of applying the market share threshold provided for in Article 3, the following rules shall apply:

| (a) | market shares shall be calculated on the basis of market sales value; if market sales value data are not available, estimates based on other reliable market information, including market sales volumes, may be used; |
| --- | --- |

(a)

market shares shall be calculated on the basis of market sales value; if market sales value data are not available, estimates based on other reliable market information, including market sales volumes, may be used;

| (b) | market shares shall be calculated on the basis of data relating to the preceding calendar year or, where the preceding calendar year is not representative of the parties’ position in the relevant market(s), market shares shall be calculated as an average of the parties’ market shares for the 3 preceding calendar years; |
| --- | --- |

(b)

market shares shall be calculated on the basis of data relating to the preceding calendar year or, where the preceding calendar year is not representative of the parties’ position in the relevant market(s), market shares shall be calculated as an average of the parties’ market shares for the 3 preceding calendar years;

| (c) | the market share held by the undertakings referred to in Article 1(2), point (5) shall be apportioned equally to each undertaking having one or more of the rights or powers listed in Article 1(2), point (1); |
| --- | --- |

(c)

the market share held by the undertakings referred to in Article 1(2), point (5) shall be apportioned equally to each undertaking having one or more of the rights or powers listed in Article 1(2), point (1);

| (d) | if the market shares referred to in Article 3 are initially not more than 20 %, but subsequently rise above that level in at least one of the relevant markets, the exemption established in Article 2 shall continue to apply for a period of 2 consecutive calendar years following the year in which the 20 % threshold was first exceeded. |
| --- | --- |

(d)

if the market shares referred to in Article 3 are initially not more than 20 %, but subsequently rise above that level in at least one of the relevant markets, the exemption established in Article 2 shall continue to apply for a period of 2 consecutive calendar years following the year in which the 20 % threshold was first exceeded.

Article 5

Hardcore restrictions

The exemption established in Article 2 shall not apply to specialisation agreements which, directly or indirectly, in isolation or in combination with other factors under the control of the parties, have as their object any of the following:

| (a) | the fixing of prices when selling the specialisation products to third parties, with the exception of the fixing of prices charged to immediate customers in the context of joint distribution; |
| --- | --- |

(a)

the fixing of prices when selling the specialisation products to third parties, with the exception of the fixing of prices charged to immediate customers in the context of joint distribution;

| (b) | the limitation of output or sales, with the exception of:






  (i) | provisions on the agreed amount of products in the context of unilateral or reciprocal specialisation agreements; |
| --- | --- | --- |

(b)

the limitation of output or sales, with the exception of:

(i)

provisions on the agreed amount of products in the context of unilateral or reciprocal specialisation agreements;

| (ii) | the setting of capacity and production volumes in the context of a joint production agreement; |
| --- | --- |

(ii)

the setting of capacity and production volumes in the context of a joint production agreement;

| (iii) | the setting of sales targets in the context of joint distribution; |
| --- | --- |

(iii)

the setting of sales targets in the context of joint distribution;

| (c) | the allocation of markets or customers. |
| --- | --- |

(c)

the allocation of markets or customers.

Article 6

Withdrawal in individual cases by the Commission

1.   The Commission may withdraw the benefit of the exemption established by this Regulation, pursuant to Article 29(1) of Regulation (EC) No 1/2003, where it finds, in any particular case, that a specialisation agreement to which the exemption established by this Regulation applies nevertheless has effects which are incompatible with Article 101(3) of the Treaty.

2.   The Commission may withdraw the benefit of the exemption established by this Regulation pursuant to Article 29(1) of Regulation (EC) No 1/2003 in particular where the relevant market is highly concentrated and competition is already weak, for example due to one or more of the following:

| (a) | the individual market positions of other market participants; |
| --- | --- |

(a)

the individual market positions of other market participants;

| (b) | links between other market participants created by parallel specialisation agreements; |
| --- | --- |

(b)

links between other market participants created by parallel specialisation agreements;

| (c) | links between the parties and other market participants. |
| --- | --- |

(c)

links between the parties and other market participants.

Article 7

Withdrawal in individual cases by the competition authority of a Member State

The competition authority of a Member State may withdraw the benefit of the exemption established by this Regulation where the conditions of Article 29(2) of Regulation (EC) No 1/2003 are fulfilled.

Article 8

Transitional period

The prohibition laid down in Article 101(1) of the Treaty shall not apply during the period from 1 July 2023 to 30 June 2025 in respect of agreements already in force on 30 June 2023 which do not satisfy the conditions for exemption established by this Regulation but which satisfy the conditions for exemption established by Regulation (EU) No 1218/2010.

Article 9

Entry into force and application

This Regulation shall enter into force on 1 July 2023.

It shall apply until 30 June 2035.

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

Done at Brussels, 1 June 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 285, 29.12.1971, p. 46.

1

(2)  OJ C 120, 15.3.2022, p. 1.

2

(3)  Commission Regulation (EU) No 1218/2010 of 14 December 2010 on the application of Article 101(3) of the Treaty on the Functioning of the European Union to certain categories of specialisation agreements (OJ L 335, 18.12.2010, p. 43).

3

(4)  Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles 81 and 82 of the Treaty (OJ L 1, 4.1.2003, p. 1).

4

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| 2.6.2023 | EN | Official Journal of the European Union | L 143/27 |
| --- | --- | --- | --- |

2.6.2023

EN

Official Journal of the European Union

L 143/27

---

COMMISSION REGULATION (EU) 2023/1068

of 1 June 2023

amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for cyantraniliprole in or on certain products

(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 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (1), and in particular Article 14(1), point (a), thereof,

Whereas:

| (1) | For cyantraniliprole, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005. |
| --- | --- |

(1)

For cyantraniliprole, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005.

| (2) | As regards cyantraniliprole, an application for import tolerances pursuant to Article 6(2) and (4) of Regulation (EC) No 396/2005 was submitted for that substance used in Canada and in the United States on potatoes, ‘tropical root and tuber vegetables’, ‘cucurbits with inedible peel’, Chinese cabbages/pe-tsai, other leafy brassica, ‘lettuces and salad plants’, ‘spinaches and similar leaves’ (except spinach), parsley and minor oilseeds (i.e. linseeds, poppy seeds, sesame seeds, mustard seeds, pumpkin seeds, safflower seeds, borage seeds, gold of pleasure seeds, hemp seeds and castor beans). The applicant provided data showing that the authorised uses of that substance on these crops in Canada and in the United States lead to residues exceeding the MRLs provided for in Regulation (EC) No 396/2005 and that higher MRLs are necessary to avoid trade barriers for the importation of those crops into the Union. A second application pursuant to Article 6(1) of Regulation (EC) No 396/2005 requesting a modification of the existing MRLs was submitted for apricots. |
| --- | --- |

(2)

As regards cyantraniliprole, an application for import tolerances pursuant to Article 6(2) and (4) of Regulation (EC) No 396/2005 was submitted for that substance used in Canada and in the United States on potatoes, ‘tropical root and tuber vegetables’, ‘cucurbits with inedible peel’, Chinese cabbages/pe-tsai, other leafy brassica, ‘lettuces and salad plants’, ‘spinaches and similar leaves’ (except spinach), parsley and minor oilseeds (i.e. linseeds, poppy seeds, sesame seeds, mustard seeds, pumpkin seeds, safflower seeds, borage seeds, gold of pleasure seeds, hemp seeds and castor beans). The applicant provided data showing that the authorised uses of that substance on these crops in Canada and in the United States lead to residues exceeding the MRLs provided for in Regulation (EC) No 396/2005 and that higher MRLs are necessary to avoid trade barriers for the importation of those crops into the Union. A second application pursuant to Article 6(1) of Regulation (EC) No 396/2005 requesting a modification of the existing MRLs was submitted for apricots.

| (3) | In accordance with Article 8 of Regulation (EC) No 396/2005, both of those applications were evaluated by the Member State concerned and the evaluation reports were forwarded to the Commission. |
| --- | --- |

(3)

In accordance with Article 8 of Regulation (EC) No 396/2005, both of those applications were evaluated by the Member State concerned and the evaluation reports were forwarded to the Commission.

| (4) | The European Food Safety Authority (‘the Authority’) assessed the applications and the evaluation reports, examining in particular the risks to consumers and, where relevant, to animals, and submitted a reasoned opinion on the proposed MRLs (2). It forwarded this opinion to the applicants, the Commission and the Member States and made it available to the public. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) assessed the applications and the evaluation reports, examining in particular the risks to consumers and, where relevant, to animals, and submitted a reasoned opinion on the proposed MRLs (2). It forwarded this opinion to the applicants, the Commission and the Member States and made it available to the public.

| (5) | As regards cyantraniliprole in apricots, potatoes, ‘tropical root and tuber vegetables’, ‘cucurbits with inedible peel’, Chinese cabbages/pe-tsai, other leafy brassica, escaroles/broad-leaved endives, ‘spinaches and similar leaves’ (except spinach) and parsley, the Authority concluded that further consideration by risk managers was required as some information on the toxicity of cyantraniliprole degradation products in processed products was not available. Since the Authority concluded that the consumers’ exposure to those degradation products is low and that the safety margin is wide, it is appropriate to propose setting the MRLs derived by the Authority for cyantraniliprole in all of those products. |
| --- | --- |

(5)

As regards cyantraniliprole in apricots, potatoes, ‘tropical root and tuber vegetables’, ‘cucurbits with inedible peel’, Chinese cabbages/pe-tsai, other leafy brassica, escaroles/broad-leaved endives, ‘spinaches and similar leaves’ (except spinach) and parsley, the Authority concluded that further consideration by risk managers was required as some information on the toxicity of cyantraniliprole degradation products in processed products was not available. Since the Authority concluded that the consumers’ exposure to those degradation products is low and that the safety margin is wide, it is appropriate to propose setting the MRLs derived by the Authority for cyantraniliprole in all of those products.

| (6) | As regards cyantraniliprole in lettuces, the Authority concluded that further consideration by risk managers was required concerning the choice of the data set for deriving the MRLs. Based on the information provided by the Authority, it is appropriate to propose setting the MRL for cyantraniliprole in lettuces at 15 mg/kg based on the residue data on open leaf lettuces. |
| --- | --- |

(6)

As regards cyantraniliprole in lettuces, the Authority concluded that further consideration by risk managers was required concerning the choice of the data set for deriving the MRLs. Based on the information provided by the Authority, it is appropriate to propose setting the MRL for cyantraniliprole in lettuces at 15 mg/kg based on the residue data on open leaf lettuces.

| (7) | As regards all other modifications to MRLs requested by the applicants for cyantraniliprole, the Authority concluded that all requirements with respect to completeness of data submission were met and that the modifications to the MRLs requested by the applicants were acceptable concerning consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. In its assessment the Authority took into account the most recent data on the toxicological properties of the substance. Neither the long-term exposure to this substance via consumption of all food products that may contain it, nor the short-term exposure due to high consumption of the relevant products showed a risk that the acceptable daily intake or the acute reference dose is exceeded. |
| --- | --- |

(7)

As regards all other modifications to MRLs requested by the applicants for cyantraniliprole, the Authority concluded that all requirements with respect to completeness of data submission were met and that the modifications to the MRLs requested by the applicants were acceptable concerning consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. In its assessment the Authority took into account the most recent data on the toxicological properties of the substance. Neither the long-term exposure to this substance via consumption of all food products that may contain it, nor the short-term exposure due to high consumption of the relevant products showed a risk that the acceptable daily intake or the acute reference dose is exceeded.

| (8) | Based on the reasoned opinion of the Authority and taking into account the relevant factors listed in Article 14(2) of Regulation (EC) No 396/2005, the proposed modifications to the MRLs fulfil the requirements of that article. |
| --- | --- |

(8)

Based on the reasoned opinion of the Authority and taking into account the relevant factors listed in Article 14(2) of Regulation (EC) No 396/2005, the proposed modifications to the MRLs fulfil the requirements of that article.

| (9) | Regulation (EC) No 396/2005 should therefore be amended accordingly. |
| --- | --- |

(9)

Regulation (EC) No 396/2005 should therefore be amended accordingly.

| (10) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(10)

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

HAS ADOPTED THIS REGULATION:

Article 1

Annex II to Regulation (EC) No 396/2005 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, 1 June 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 70, 16.3.2005, p. 1.

1

(2)  Reasoned Opinion on the modification of the existing maximum residue level for apricots and setting of import tolerances for cyantraniliprole in various crops. EFSA Journal 2022;20(3):7219.

2

---

ANNEX

In Annex II to Regulation (EC) No 396/2005, the column for cyantraniliprole is replaced by the following:

‘Pesticide residues and maximum residue levels (mg/kg)

| Code number | Groups and examples of individual products to which the MRLs apply
   (1) | Cyantraniliprole |
| --- | --- | --- |
| (1) | (2) | (3) |
| 0100000 | FRUITS, FRESH or FROZEN; TREE NUTS | |
| 0110000 | Citrus fruits | 0,9 |
| 0110010 | Grapefruits | |
| 0110020 | Oranges | |
| 0110030 | Lemons | |
| 0110040 | Limes | |
| 0110050 | Mandarins | |
| 0110990 | Others (2) | |
| 0120000 | Tree nuts | 0,04 |
| 0120010 | Almonds | |
| 0120020 | Brazil nuts | |
| 0120030 | Cashew nuts | |
| 0120040 | Chestnuts | |
| 0120050 | Coconuts | |
| 0120060 | Hazelnuts/cobnuts | |
| 0120070 | Macadamias | |
| 0120080 | Pecans | |
| 0120090 | Pine nut kernels | |
| 0120100 | Pistachios | |
| 0120110 | Walnuts | |
| 0120990 | Others (2) | |
| 0130000 | Pome fruits | 0,8 |
| 0130010 | Apples | |
| 0130020 | Pears | |
| 0130030 | Quinces | |
| 0130040 | Medlars | |
| 0130050 | Loquats/Japanese medlars | |
| 0130990 | Others (2) | |
| 0140000 | Stone fruits | |
| 0140010 | Apricots | 0,7 |
| 0140020 | Cherries (sweet) | 6 |
| 0140030 | Peaches | 1,5 |
| 0140040 | Plums | 0,7 |
| 0140990 | Others (2) | 0,01  ((*)) |
| 0150000 | Berries and small fruits | |
| 0151000 | (a) | grapes |

Code number

Groups and examples of individual products to which the MRLs apply
   (1)

Cyantraniliprole

(1)

(2)

(3)

0100000

FRUITS, FRESH or FROZEN; TREE NUTS

0110000

Citrus fruits

0,9

0110010

Grapefruits

0110020

Oranges

0110030

Lemons

0110040

Limes

0110050

Mandarins

0110990

Others (2)

0120000

Tree nuts

0,04

0120010

Almonds

0120020

Brazil nuts

0120030

Cashew nuts

0120040

Chestnuts

0120050

Coconuts

0120060

Hazelnuts/cobnuts

0120070

Macadamias

0120080

Pecans

0120090

Pine nut kernels

0120100

Pistachios

0120110

Walnuts

0120990

Others (2)

0130000

Pome fruits

0,8

0130010

Apples

0130020

Pears

0130030

Quinces

0130040

Medlars

0130050

Loquats/Japanese medlars

0130990

Others (2)

0140000

Stone fruits

0140010

Apricots

0,7

0140020

Cherries (sweet)

6

0140030

Peaches

1,5

0140040

Plums

0,7

0140990

Others (2)

0,01  ((*))

0150000

Berries and small fruits

0151000

(a)

grapes

1,5

0151010

Table grapes

0151020

Wine grapes

0152000

| (b) | strawberries |
| --- | --- |

(b)

strawberries

1,5

0153000

| (c) | cane fruits |
| --- | --- |

(c)

cane fruits

0,01  ((*))

0153010

Blackberries

0153020

Dewberries

0153030

Raspberries (red and yellow)

0153990

Others (2)

0154000

| (d) | other small fruits and berries |
| --- | --- |

(d)

other small fruits and berries

0154010

Blueberries

4

0154020

Cranberries

0,08

0154030

Currants (black, red and white)

4

0154040

Gooseberries (green, red and yellow)

4

0154050

Rose hips

4

0154060

Mulberries (black and white)

0,01  ((*))

0154070

Azaroles/Mediterranean medlars

0,8

0154080

Elderberries

0,01  ((*))

0154990

Others (2)

0,01  ((*))

0160000

Miscellaneous fruitswith

0161000

| (a) | edible peel |
| --- | --- |

(a)

edible peel

0161010

Dates

0,01  ((*))

0161020

Figs

0,01  ((*))

0161030

Table olives

3

0161040

Kumquats

0,01  ((*))

0161050

Carambolas

0,01  ((*))

0161060

Kaki/Japanese persimmons

0,8

0161070

Jambuls/jambolans

0,01  ((*))

0161990

Others (2)

0,01  ((*))

0162000

| (b) | inedible peel, small |
| --- | --- |

(b)

inedible peel, small

0,01  ((*))

0162010

Kiwi fruits (green, red, yellow)

0162020

Litchis/lychees

0162030

Passionfruits/maracujas

0162040

Prickly pears/cactus fruits

0162050

Star apples/cainitos

0162060

American persimmons/Virginia kaki

0162990

Others (2)

0163000

| (c) | inedible peel, large |
| --- | --- |

(c)

inedible peel, large

0163010

Avocados

0,01  ((*))

0163020

Bananas

0,01  ((*))

0163030

Mangoes

0,7

0163040

Papayas

0,01  ((*))

0163050

Granate apples/pomegranates

0,01  ((*))

0163060

Cherimoyas

0,01  ((*))

0163070

Guavas

0,01  ((*))

0163080

Pineapples

0,01  ((*))

0163090

Breadfruits

0,01  ((*))

0163100

Durians

0,01  ((*))

0163110

Soursops/guanabanas

0,01  ((*))

0163990

Others (2)

0,01  ((*))

0200000

VEGETABLES, FRESH or FROZEN

0210000

Root and tuber vegetables

0211000

| (a) | potatoes |
| --- | --- |

(a)

potatoes

0,15

0212000

| (b) | tropical root and tuber vegetables |
| --- | --- |

(b)

tropical root and tuber vegetables

0,15

0212010

Cassava roots/manioc

0212020

Sweet potatoes

0212030

Yams

0212040

Arrowroots

0212990

Others (2)

0213000

| (c) | other root and tuber vegetables except sugar beets |
| --- | --- |

(c)

other root and tuber vegetables except sugar beets

0,05

0213010

Beetroots

0213020

Carrots

0213030

Celeriacs/turnip rooted celeries

0213040

Horseradishes

0213050

Jerusalem artichokes

0213060

Parsnips

0213070

Parsley roots/Hamburg roots parsley

0213080

Radishes

0213090

Salsifies

0213100

Swedes/rutabagas

0213110

Turnips

0213990

Others (2)

0220000

Bulb vegetables

0220010

Garlic

0,05

0220020

Onions

0,05

0220030

Shallots

0,05

0220040

Spring onions/green onions and Welsh onions

8

0220990

Others (2)

0,05

0230000

Fruiting vegetables

0231000

| (a) | Solanaceae and Malvaceae |
| --- | --- |

(a)

Solanaceae and Malvaceae

0231010

Tomatoes

1

0231020

Sweet peppers/bell peppers

1,5

0231030

Aubergines/eggplants

1

0231040

Okra/lady's fingers

1,5

0231990

Others (2)

1,5

0232000

| (b) | cucurbits with edible peel |
| --- | --- |

(b)

cucurbits with edible peel

0,4

0232010

Cucumbers

0232020

Gherkins

0232030

Courgettes

0232990

Others (2)

0233000

| (c) | cucurbits with inedible peel |
| --- | --- |

(c)

cucurbits with inedible peel

0,4

0233010

Melons

0233020

Pumpkins

0233030

Watermelons

0233990

Others (2)

0234000

| (d) | sweet corn |
| --- | --- |

(d)

sweet corn

0,01  ((*))

0239000

| (e) | other fruiting vegetables |
| --- | --- |

(e)

other fruiting vegetables

0,01
   ((*))

0240000

Brassica vegetables(excluding brassica roots and brassica baby leaf crops)

0241000

| (a) | flowering brassica |
| --- | --- |

(a)

flowering brassica

2

0241010

Broccoli

0241020

Cauliflowers

0241990

Others (2)

0242000

| (b) | head brassica |
| --- | --- |

(b)

head brassica

2

0242010

Brussels sprouts

0242020

Head cabbages

0242990

Others (2)

0243000

| (c) | leafy brassica |
| --- | --- |

(c)

leafy brassica

0243010

Chinese cabbages/pe-tsai

30

0243020

Kales

0,01  ((*))

0243990

Others (2)

30

0244000

| (d) | kohlrabies |
| --- | --- |

(d)

kohlrabies

2

0250000

Leaf vegetables, herbs and edible flowers

0251000

| (a) | lettuces and salad plants |
| --- | --- |

(a)

lettuces and salad plants

15

0251010

Lamb's lettuces/corn salads

0251020

Lettuces

0251030

Escaroles/broad-leaved endives

0251040

Cresses and other sprouts and shoots

0251050

Land cresses

0251060

Roman rocket/rucola

0251070

Red mustards

0251080

Baby leaf crops (including brassica species)

0251990

Others (2)

0252000

| (b) | spinaches and similar leaves |
| --- | --- |

(b)

spinaches and similar leaves

0252010

Spinaches

0,01  ((*))

0252020

Purslanes

20

0252030

Chards/beet leaves

20

0252990

Others (2)

20

0253000

| (c) | grape leaves and similar species |
| --- | --- |

(c)

grape leaves and similar species

0,01  ((*))

0254000

| (d) | watercresses |
| --- | --- |

(d)

watercresses

0,01  ((*))

0255000

| (e) | witloofs/Belgian endives |
| --- | --- |

(e)

witloofs/Belgian endives

0,01  ((*))

0256000

| (f) | herbs and edible flowers |
| --- | --- |

(f)

herbs and edible flowers

0256010

Chervil

0,02  ((*))

0256020

Chives

0,02  ((*))

0256030

Celery leaves

0,02  ((*))

0256040

Parsley

20

0256050

Sage

0,02  ((*))

0256060

Rosemary

0,02  ((*))

0256070

Thyme

0,02  ((*))

0256080

Basil and edible flowers

0,02  ((*))

0256090

Laurel/bay leaves

0,02  ((*))

0256100

Tarragon

0,02  ((*))

0256990

Others (2)

0,02  ((*))

0260000

Legume vegetables

0260010

Beans (with pods)

1,5

0260020

Beans (without pods)

0,3

0260030

Peas (with pods)

2

0260040

Peas (without pods)

0,3

0260050

Lentils

0,01  ((*))

0260990

Others (2)

0,01  ((*))

0270000

Stem vegetables

0270010

Asparagus

0,01  ((*))

0270020

Cardoons

0,01  ((*))

0270030

Celeries

15

0270040

Florence fennels

0,01  ((*))

0270050

Globe artichokes

0,1

0270060

Leeks

0,01  ((*))

0270070

Rhubarbs

0,01  ((*))

0270080

Bamboo shoots

0,01  ((*))

0270090

Palm hearts

0,01  ((*))

0270990

Others (2)

0,01  ((*))

0280000

Fungi, mosses and lichens

0,01  ((*))

0280010

Cultivated fungi

0280020

Wild fungi

0280990

Mosses and lichens

0290000

Algae and prokaryotes organisms

0,01  ((*))

0300000

PULSES

0300010

Beans

0,3

0300020

Lentils

0,01  ((*))

0300030

Peas

0,01  ((*))

0300040

Lupins/lupini beans

0,01  ((*))

0300990

Others (2)

0,01  ((*))

0400000

OILSEEDS AND OIL FRUITS

0401000

Oilseeds

0401010

Linseeds

1,5

0401020

Peanuts/groundnuts

0,01  ((*))

0401030

Poppy seeds

1,5

0401040

Sesame seeds

1,5

0401050

Sunflower seeds

0,5

0401060

Rapeseeds/canola seeds

0,8

0401070

Soyabeans

0,4

0401080

Mustard seeds

1,5

0401090

Cotton seeds

1,5

0401100

Pumpkin seeds

1,5

0401110

Safflower seeds

1,5

0401120

Borage seeds

1,5

0401130

Gold of pleasure seeds

1,5

0401140

Hemp seeds

1,5

0401150

Castor beans

1,5

0401990

Others (2)

0,01  ((*))

0402000

Oil fruits

0402010

Olives for oil production

3

0402020

Oil palms kernels

0,01  ((*))

0402030

Oil palms fruits

0,01  ((*))

0402040

Kapok

0,01  ((*))

0402990

Others (2)

0,01  ((*))

0500000

CEREALS

0,01  ((*))

0500010

Barley

0500020

Buckwheat and other pseudocereals

0500030

Maize/corn

0500040

Common millet/proso millet

0500050

Oat

0500060

Rice

0500070

Rye

0500080

Sorghum

0500090

Wheat

0500990

Others (2)

0600000

TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS

0610000

Teas

0,05  ((*))

0620000

Coffee beans

0,05

0630000

Herbal infusions from

0631000

| (a) | flowers |
| --- | --- |

(a)

flowers

0,05  ((*))

0631010

Chamomile

0631020

Hibiscus/roselle

0631030

Rose

0631040

Jasmine

0631050

Lime/linden

0631990

Others (2)

0632000

| (b) | leaves and herbs |
| --- | --- |

(b)

leaves and herbs

0,05  ((*))

0632010

Strawberry

0632020

Rooibos

0632030

Mate/maté

0632990

Others (2)

0633000

| (c) | roots |
| --- | --- |

(c)

roots

0,2

0633010

Valerian

0633020

Ginseng

0633990

Others (2)

0639000

| (d) | any other parts of the plant |
| --- | --- |

(d)

any other parts of the plant

0,05  ((*))

0640000

Cocoa beans

0,05  ((*))

0650000

Carobs/Saint John's breads

0,05  ((*))

0700000

HOPS

0,05  ((*))

0800000

SPICES

0810000

Seed spices

0,05  ((*))

0810010

Anise/aniseed

0810020

Black caraway/black cumin

0810030

Celery

0810040

Coriander

0810050

Cumin

0810060

Dill

0810070

Fennel

0810080

Fenugreek

0810090

Nutmeg

0810990

Others (2)

0820000

Fruit spices

0,05  ((*))

0820010

Allspice/pimento

0820020

Sichuan pepper

0820030

Caraway

0820040

Cardamom

0820050

Juniper berry

0820060

Peppercorn (black, green and white)

0820070

Vanilla

0820080

Tamarind

0820990

Others (2)

0830000

Bark spices

0,05  ((*))

0830010

Cinnamon

0830990

Others (2)

0840000

Root and rhizome spices

0840010

Liquorice

0,2

0840020

Ginger (10)

0840030

Turmeric/curcuma

0,2

0840040

Horseradish (11)

0840990

Others (2)

0,2

0850000

Bud spices

0,05  ((*))

0850010

Cloves

0850020

Capers

0850990

Others (2)

0860000

Flower pistil spices

0,05  ((*))

0860010

Saffron

0860990

Others (2)

0870000

Aril spices

0,05  ((*))

0870010

Mace

0870990

Others (2)

0900000

SUGAR PLANTS

0900010

Sugar beet roots

0,05

0900020

Sugar canes

0,01  ((*))

0900030

Chicory roots

0,05

0900990

Others (2)

0,01  ((*))

1000000

PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS

1010000

Commodities from

1011000

| (a) | swine |
| --- | --- |

(a)

swine

1011010

Muscle

0,2

1011020

Fat

0,5

1011030

Liver

1,5

1011040

Kidney

1,5

1011050

Edible offals (other than liver and kidney)

1,5

1011990

Others (2)

0,01

1012000

| (b) | bovine |
| --- | --- |

(b)

bovine

1012010

Muscle

0,2

1012020

Fat

0,5

1012030

Liver

1,5

1012040

Kidney

1,5

1012050

Edible offals (other than liver and kidney)

1,5

1012990

Others (2)

0,01

1013000

| (c) | sheep |
| --- | --- |

(c)

sheep

1013010

Muscle

0,2

1013020

Fat

0,5

1013030

Liver

1,5

1013040

Kidney

1,5

1013050

Edible offals (other than liver and kidney)

1,5

1013990

Others (2)

0,01

1014000

| d) | goat |
| --- | --- |

d)

goat

1014010

Muscle

0,2

1014020

Fat

0,5

1014030

Liver

1,5

1014040

Kidney

1,5

1014050

Edible offals (other than liver and kidney)

1,5

1014990

Others (2)

0,01

1015000

| (e) | equine |
| --- | --- |

(e)

equine

1015010

Muscle

0,2

1015020

Fat

0,5

1015030

Liver

1,5

1015040

Kidney

1,5

1015050

Edible offals (other than liver and kidney)

1,5

1015990

Others (2)

0,01

1016000

| (f) | poultry |
| --- | --- |

(f)

poultry

1016010

Muscle

0,02

1016020

Fat

0,04

1016030

Liver

0,15

1016040

Kidney

0,15

1016050

Edible offals (other than liver and kidney)

0,15

1016990

Others (2)

0,01

1017000

| (g) | other farmed terrestrial animals |
| --- | --- |

(g)

other farmed terrestrial animals

1017010

Muscle

0,2

1017020

Fat

0,5

1017030

Liver

1,5

1017040

Kidney

1,5

1017050

Edible offals (other than liver and kidney)

1,5

1017990

Others (2)

0,01

1020000

Milk

0,02

1020010

Cattle

1020020

Sheep

1020030

Goat

1020040

Horse

1020990

Others (2)

1030000

Birds eggs

0,15

1030010

Chicken

1030020

Duck

1030030

Geese

1030040

Quail

1030990

Others (2)

1040000

Honey and other apiculture products (7)

0,05  ((*))

1050000

Amphibians and Reptiles

0,01

1060000

Terrestrial invertebrate animals

0,01

1070000

Wild terrestrial vertebrate animals

0,01

1100000

PRODUCTS OF ANIMAL ORIGIN - FISH, FISHPRODUCTS AND ANY OTHER MARINE AND FRESHWATER FOOD PRODUCTS (8)

1200000

PRODUCTS OR PART OF PRODUCTS EXCLUSIVELY USED FOR ANIMAL FEED PRODUCTION (8)

1300000

PROCESSED FOOD PRODUCTS (9)

---

((*))  Indicates lower limit of analytical determination

(*)

(1)  For the complete list of products of plant and animal origin to which MRL's apply, reference should be made to Annex I’

1

---

| 2.6.2023 | EN | Official Journal of the European Union | L 143/40 |
| --- | --- | --- | --- |

2.6.2023

EN

Official Journal of the European Union

L 143/40

---

COMMISSION REGULATION (EU) 2023/1069

of 1 June 2023

amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for bixafen, cyprodinil, fenhexamid, fenpicoxamid, fenpyroximate, flutianil, isoxaflutole, mandipropamid, methoxyfenozide, and spinetoram in or on certain products

(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 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (1), and in particular Article 14(1), point (a), thereof,

Whereas:

| (1) | On 13 December 2022, the Codex Alimentarius Commission adopted new Codex maximum residue limits (CXLs) for acetamiprid, bixafen, chlorothalonil, clofentezine, clothianidin, cyprodinil, difenoconazole, ethiprole, fenhexamid, fenpicoxamid, fenpyroximate, fluensulfone, fluopyram, flutianil, imazalil, isoprothiolane, isoxaflutole, mandipropamid, metconazole, methoprene, methoxyfenozide, prothioconazole, pydiflumetofen, pyrasulfotole, pyraziflumid, quinoxyfen, spinetoram, spiropidion, tebuconazole, thiamethoxam, trifloxystrobin, and trinexapac-ethyl (2). |
| --- | --- |

(1)

On 13 December 2022, the Codex Alimentarius Commission adopted new Codex maximum residue limits (CXLs) for acetamiprid, bixafen, chlorothalonil, clofentezine, clothianidin, cyprodinil, difenoconazole, ethiprole, fenhexamid, fenpicoxamid, fenpyroximate, fluensulfone, fluopyram, flutianil, imazalil, isoprothiolane, isoxaflutole, mandipropamid, metconazole, methoprene, methoxyfenozide, prothioconazole, pydiflumetofen, pyrasulfotole, pyraziflumid, quinoxyfen, spinetoram, spiropidion, tebuconazole, thiamethoxam, trifloxystrobin, and trinexapac-ethyl (2).

| (2) | Maximum residue levels (MRLs) had been set for those substances in Annexes II, III and V to Regulation (EC) No 396/2005, except for ethiprole, fluensulfone and pydiflumetofen, for which no specific MRLs were set nor were those substances included in Annex IV to Regulation (EC) No 396/2005, so the default value of 0,01 mg/kg laid down in Article 18(1), point (b), of that Regulation applies. |
| --- | --- |

(2)

Maximum residue levels (MRLs) had been set for those substances in Annexes II, III and V to Regulation (EC) No 396/2005, except for ethiprole, fluensulfone and pydiflumetofen, for which no specific MRLs were set nor were those substances included in Annex IV to Regulation (EC) No 396/2005, so the default value of 0,01 mg/kg laid down in Article 18(1), point (b), of that Regulation applies.

| (3) | In accordance with Article 5(3) of Regulation (EC) No 178/2002 of the European Parliament and of the Council (3), where international standards exist or their completion is imminent, they are to be taken into consideration in the development or adaptation of food law, except where such standards or relevant parts would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives of food law or where there is a scientific justification, or where they would result in a different level of protection from the one determined as appropriate in the Union. Moreover, in accordance with Article 13, point (e), of that Regulation, the Union is to promote consistency between international technical standards and food law while ensuring that the high level of protection adopted in the Union is not reduced. |
| --- | --- |

(3)

In accordance with Article 5(3) of Regulation (EC) No 178/2002 of the European Parliament and of the Council (3), where international standards exist or their completion is imminent, they are to be taken into consideration in the development or adaptation of food law, except where such standards or relevant parts would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives of food law or where there is a scientific justification, or where they would result in a different level of protection from the one determined as appropriate in the Union. Moreover, in accordance with Article 13, point (e), of that Regulation, the Union is to promote consistency between international technical standards and food law while ensuring that the high level of protection adopted in the Union is not reduced.

| (4) | The European Food Safety Authority (‘the Authority’) assessed the risks to consumers and produced a scientific report (4). In cases where the Authority had identified a potential consumer health risk, the Union presented reservations (5), (6) to the Codex Committee on Pesticides Residues on the CXLs proposed. This was the case for the following pesticide/product combinations: acetamiprid (all products), chlorothalonil (all products), clofentezine (all products), clothianidin (all products), difenoconazole (all products), ethiprole (all products), fenpyroximate (lemons and lime, pummelo and grapefruits), fluensulfone (all products), imazalil (all products), isoprothiolane (all products), metconazole (all products), methoprene (all products), prothioconazole (all products), pydiflumetofen (all products), pyrasulfotole (all products), pyraziflumid (all products), quinoxyfen (all products), spinetoram (tea, green, black), spiropidion (all products), tebuconazole (all products), thiamethoxam (all products), trifloxystrobin (all products), and trinexapac-ethyl (all products). |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) assessed the risks to consumers and produced a scientific report (4). In cases where the Authority had identified a potential consumer health risk, the Union presented reservations (5), (6) to the Codex Committee on Pesticides Residues on the CXLs proposed. This was the case for the following pesticide/product combinations: acetamiprid (all products), chlorothalonil (all products), clofentezine (all products), clothianidin (all products), difenoconazole (all products), ethiprole (all products), fenpyroximate (lemons and lime, pummelo and grapefruits), fluensulfone (all products), imazalil (all products), isoprothiolane (all products), metconazole (all products), methoprene (all products), prothioconazole (all products), pydiflumetofen (all products), pyrasulfotole (all products), pyraziflumid (all products), quinoxyfen (all products), spinetoram (tea, green, black), spiropidion (all products), tebuconazole (all products), thiamethoxam (all products), trifloxystrobin (all products), and trinexapac-ethyl (all products).

| (5) | Those CXLs for which the Union did not present a reservation to the Codex Committee on Pesticides Residues since the Authority did not identify risks for consumers in the Union, can therefore be considered safe. This is the case for certain CXLs for bixafen, cyprodinil, fenhexamid, fenpicoxamid, fenpyroximate, flutianil, isoxaflutole, mandipropamid, methoxyfenozide and spinetoram. Those CXLs should therefore be included in Regulation (EC) No 396/2005, except where they relate to products which are not listed in Annex I to that Regulation or where they are at a lower level than the current MRLs. Thus, no change should be made as regards the MRLs for fluopyram. |
| --- | --- |

(5)

Those CXLs for which the Union did not present a reservation to the Codex Committee on Pesticides Residues since the Authority did not identify risks for consumers in the Union, can therefore be considered safe. This is the case for certain CXLs for bixafen, cyprodinil, fenhexamid, fenpicoxamid, fenpyroximate, flutianil, isoxaflutole, mandipropamid, methoxyfenozide and spinetoram. Those CXLs should therefore be included in Regulation (EC) No 396/2005, except where they relate to products which are not listed in Annex I to that Regulation or where they are at a lower level than the current MRLs. Thus, no change should be made as regards the MRLs for fluopyram.

| (6) | Based on the scientific report of the Authority and taking into account the relevant factors listed in Article 14(2) of Regulation (EC) No 396/2005, the appropriate modifications to the MRLs fulfil the requirements of that article. |
| --- | --- |

(6)

Based on the scientific report of the Authority and taking into account the relevant factors listed in Article 14(2) of Regulation (EC) No 396/2005, the appropriate modifications to the MRLs fulfil the requirements of that article.

| (7) | Regulation (EC) No 396/2005 should therefore be amended accordingly. |
| --- | --- |

(7)

Regulation (EC) No 396/2005 should therefore be amended accordingly.

| (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

Annex II to Regulation (EC) No 396/2005 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, 1 June 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 70, 16.3.2005, p. 1.

1

(2)  https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-701-45%252FFinal%252520Report%252520CAC45%252FCompiled%2BREP22_CAC.pdf

2

Joint FAO/WHO Food Standards Programme Codex Alimentarius Commission. Appendix III. Forty-fifth Session. Virtual, 21-25 November, 12-13 and 19 December 2022 and 6 February 2023.

(3)  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

3

(4)  Scientific support for preparing an EU position for the 53rd Session of the Codex Committee on Pesticide Residues (CCPR). EFSA Journal 2022;20(9):7521.

4

(5)  European Union comments on Codex CX/PR 22/53/5: https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-718-53%252FCRDs%252Fpr53_crd13revx.pdf.

5

(6)  Report of the 53rd session of the Codex Committee on Pesticide Residues REP22/PR53: https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-718-53%252FREPORT%252FFINAL%2BREPORT%252FREP22_PR53e.pdf.

6

---

ANNEX

In Annex II to Regulation (EC) No 396/2005, the columns for bixafen, cyprodinil, fenhexamid, fenpicoxamid, fenpyroximate, flutianil, isoxaflutole, mandipropamid, methoxyfenozide and spinetoram are replaced by the following:

‘Pesticide residues and maximum residue levels (mg/kg)

| Code number | Groups and examples of individual products to which the MRLs apply
   (1) | Bixafen (R) (F) | Cyprodinil (R) (F) | Fenhexamid (F) | Fenpicoxamid (R) (F) | Fenpyroximate (R) (F) (A) | Flutianil | Isoxaflutole (sum of isoxaflutole and its diketonitrile-metabolite, expressed as isoxaflutole) | Mandipropamid (any ratio of constituent isomers) | Methoxyfenozide (F) | Spinetoram (sum of spinetoram-J and spinetoram-L) (F) (A) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9) | (10) | (11) | (12) |
| 0100000 | FRUITS, FRESH or FROZEN; TREE NUTS | 0,01  ((*)) | | | | | | 0,02  ((*)) | | | |
| 0110000 | Citrus fruits | | 0,02  ((*)) | 0,01  ((*)) | 0,01  ((*)) | 0,5 (+) | 0,01  ((*)) | | | 2 | |
| 0110010 | Grapefruits | | | | | (+) | | | 0,2 | | 0,02  ((*)) |
| 0110020 | Oranges | | | | | (+) | | | 0,4 | | 0,07 |
| 0110030 | Lemons | | | | | (+) | | | 0,5 | | 0,02  ((*)) |
| 0110040 | Limes | | | | | (+) | | | 0,5 | | 0,02  ((*)) |
| 0110050 | Mandarins | | | | | (+) | | | 0,5 | | 0,15 |
| 0110990 | Others (2) | | | | | (+) | | | 0,5 | | 0,02  ((*)) |
| 0120000 | Tree nuts | | | 0,02  ((*)) | 0,01  ((*)) | 0,05 | 0,01  ((*)) | | 0,01  ((*)) | 0,1 | 0,02  ((*)) |
| 0120010 | Almonds | | 0,02  ((*))(+) | | | | | | | | (+) |
| 0120020 | Brazil nuts | | 0,04 | | | | | | | | (+) |
| 0120030 | Cashew nuts | | 0,04 | | | | | | | | (+) |
| 0120040 | Chestnuts | | 0,04 | | | | | | | | (+) |
| 0120050 | Coconuts | | 0,04 | | | | | | | | (+) |
| 0120060 | Hazelnuts/cobnuts | | 0,04 | | | | | | | | (+) |
| 0120070 | Macadamias | | 0,04 | | | | | | | | (+) |
| 0120080 | Pecans | | 0,04 | | | | | | | | (+) |
| 0120090 | Pine nut kernels | | 0,04 | | | | | | | | (+) |
| 0120100 | Pistachios | | 0,02  ((*)) | | | | | | | | (+) |
| 0120110 | Walnuts | | 0,04 | | | | | | | | (+) |
| 0120990 | Others (2) | | 0,04 | | | | | | | | |
| 0130000 | Pome fruits | | 2 | | 0,01  ((*)) | | | | 0,01  ((*)) | | 0,15 |
| 0130010 | Apples | | | 0,01  ((*)) | | 0,3 (+) | 0,15 | | | 0,01  ((*)) | (+) |
| 0130020 | Pears | | | 6 | | 0,3 (+) | 0,01  ((*)) | | | 0,01  ((*)) | (+) |
| 0130030 | Quinces | | | 0,01  ((*)) | | 0,2 (+) | 0,01  ((*)) | | | 2 | (+) |
| 0130040 | Medlars | | | 0,01  ((*)) | | 0,2 (+) | 0,01  ((*)) | | | 2 | (+) |
| 0130050 | Loquats/Japanese medlars | | | 0,01  ((*)) | | 0,2 (+) | 0,01  ((*)) | | | 2 | (+) |
| 0130990 | Others (2) | | | 0,01  ((*)) | | 0,01  ((*)) | 0,01  ((*)) | | | 0,01  ((*)) | |
| 0140000 | Stone fruits | | 2 | | 0,01  ((*)) | | | | 0,01  ((*)) | | |
| 0140010 | Apricots | | | 10 | | 0,3 (+) | 0,01  ((*)) | | | 2 | 0,2 (+) |
| 0140020 | Cherries (sweet) | | | 7 | | 2 (+) | 0,4 | | | 2 | 2 |
| 0140030 | Peaches | | | 10 | | 0,3 (+) | 0,01  ((*)) | | | 0,01  ((*)) | 0,3 |
| 0140040 | Plums | | | 2 | | 0,1 (+) | 0,01  ((*)) | | | 2 | 0,02  ((*)) |
| 0140990 | Others (2) | | | 0,01  ((*)) | | 0,01  ((*)) | 0,01  ((*)) | | | 0,01  ((*)) | 0,02  ((*)) |
| 0150000 | Berries and small fruits | | | | 0,01  ((*)) | | | | | | |
| 0151000 | (a) | grapes |

Code number

Groups and examples of individual products to which the MRLs apply
   (1)

Bixafen (R) (F)

Cyprodinil (R) (F)

Fenhexamid (F)

Fenpicoxamid (R) (F)

Fenpyroximate (R) (F) (A)

Flutianil

Isoxaflutole (sum of isoxaflutole and its diketonitrile-metabolite, expressed as isoxaflutole)

Mandipropamid (any ratio of constituent isomers)

Methoxyfenozide (F)

Spinetoram (sum of spinetoram-J and spinetoram-L) (F) (A)

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

(9)

(10)

(11)

(12)

0100000

FRUITS, FRESH or FROZEN; TREE NUTS

0,01  ((*))

0,02  ((*))

0110000

Citrus fruits

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,5 (+)

0,01  ((*))

2

0110010

Grapefruits

(+)

0,2

0,02  ((*))

0110020

Oranges

(+)

0,4

0,07

0110030

Lemons

(+)

0,5

0,02  ((*))

0110040

Limes

(+)

0,5

0,02  ((*))

0110050

Mandarins

(+)

0,5

0,15

0110990

Others (2)

(+)

0,5

0,02  ((*))

0120000

Tree nuts

0,02  ((*))

0,01  ((*))

0,05

0,01  ((*))

0,01  ((*))

0,1

0,02  ((*))

0120010

Almonds

0,02  ((*))(+)

(+)

0120020

Brazil nuts

0,04

(+)

0120030

Cashew nuts

0,04

(+)

0120040

Chestnuts

0,04

(+)

0120050

Coconuts

0,04

(+)

0120060

Hazelnuts/cobnuts

0,04

(+)

0120070

Macadamias

0,04

(+)

0120080

Pecans

0,04

(+)

0120090

Pine nut kernels

0,04

(+)

0120100

Pistachios

0,02  ((*))

(+)

0120110

Walnuts

0,04

(+)

0120990

Others (2)

0,04

0130000

Pome fruits

2

0,01  ((*))

0,01  ((*))

0,15

0130010

Apples

0,01  ((*))

0,3 (+)

0,15

0,01  ((*))

(+)

0130020

Pears

6

0,3 (+)

0,01  ((*))

0,01  ((*))

(+)

0130030

Quinces

0,01  ((*))

0,2 (+)

0,01  ((*))

2

(+)

0130040

Medlars

0,01  ((*))

0,2 (+)

0,01  ((*))

2

(+)

0130050

Loquats/Japanese medlars

0,01  ((*))

0,2 (+)

0,01  ((*))

2

(+)

0130990

Others (2)

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0140000

Stone fruits

2

0,01  ((*))

0,01  ((*))

0140010

Apricots

10

0,3 (+)

0,01  ((*))

2

0,2 (+)

0140020

Cherries (sweet)

7

2 (+)

0,4

2

2

0140030

Peaches

10

0,3 (+)

0,01  ((*))

0,01  ((*))

0,3

0140040

Plums

2

0,1 (+)

0,01  ((*))

2

0,02  ((*))

0140990

Others (2)

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0150000

Berries and small fruits

0,01  ((*))

0151000

(a)

grapes

3

15

0,3

0,7

2

1

0,4

0151010

Table grapes

(+)

(+)

0151020

Wine grapes

(+)

(+)

0152000

| (b) | strawberries |
| --- | --- |

(b)

strawberries

5

10

0,3

0,3

0,01  ((*))

2

0,2

0153000

| (c) | cane fruits |
| --- | --- |

(c)

cane fruits

15

0,01  ((*))

0,01  ((*))

0,01  ((*))

1

0153010

Blackberries

3

0,7 (+)

(+)

0153020

Dewberries

0,02  ((*))

0,5 (+)

(+)

0153030

Raspberries (red and yellow)

3

1,5 (+)

0153990

Others (2)

0,02  ((*))

0,01  ((*))

0154000

| (d) | other small fruits and berries |
| --- | --- |

(d)

other small fruits and berries

0,01  ((*))

0,01  ((*))

0154010

Blueberries

8

20

0,4 (+)

4

0,4

0154020

Cranberries

8

20

0,5 (+)

0,7

0,4 (+)

0154030

Currants (black, red and white)

8

20

0,4 (+)

0,01  ((*))

0,5

0154040

Gooseberries (green, red and yellow)

8

20

0,4 (+)

0,01  ((*))

0,4 (+)

0154050

Rose hips

3

5

0,4 (+)

0,01  ((*))

0,4 (+)

0154060

Mulberries (black and white)

3

5

0,4 (+)

0,01  ((*))

0,4 (+)

0154070

Azaroles/Mediterranean medlars

3

15

0,4 (+)

0,01  ((*))

0,4 (+)

0154080

Elderberries

3

5

0,4 (+)

0,01  ((*))

0,4 (+)

0154990

Others (2)

3

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,4

0160000

Miscellaneous fruitswith

0,01  ((*))

0161000

| (a) | edible peel |
| --- | --- |

(a)

edible peel

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0161010

Dates

0,02  ((*))

0,01  ((*))

0,02  ((*))

0161020

Figs

0,02  ((*))

0,01  ((*))

0,02  ((*))

0161030

Table olives

0,02  ((*))

0,01  ((*))

0,07 (+)

0161040

Kumquats

0,02  ((*))

0,5

0,02  ((*))

0161050

Carambolas

0,02  ((*))

0,01  ((*))

0,02  ((*))

0161060

Kaki/Japanese persimmons

2

0,01  ((*))

0,02  ((*))

0161070

Jambuls/jambolans

0,02  ((*))

0,01  ((*))

0,02  ((*))

0161990

Others (2)

0,02  ((*))

0,01  ((*))

0,02  ((*))

0162000

| (b) | inedible peel, small |
| --- | --- |

(b)

inedible peel, small

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0162010

Kiwi fruits (green, red, yellow)

15

0,02  ((*))

0162020

Litchis/lychees

0,01  ((*))

0,015

0162030

Passionfruits/maracujas

0,01  ((*))

0,4

0162040

Prickly pears/cactus fruits

0,01  ((*))

0,5

0162050

Star apples/cainitos

0,01  ((*))

0,02  ((*))

0162060

American persimmons/Virginia kaki

0,01  ((*))

0,02  ((*))

0162990

Others (2)

0,01  ((*))

0,02  ((*))

0163000

| (c) | inedible peel, large |
| --- | --- |

(c)

inedible peel, large

0,01  ((*))

0,01  ((*))

0,02  ((*))

0163010

Avocados

1

0,01  ((*))

0,2

0,7

0163020

Bananas

0,02  ((*))

0,15

0,01  ((*))

0,01  ((*))

0163030

Mangoes

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0163040

Papayas

0,02  ((*))

0,01  ((*))

0,01  ((*))

1

0163050

Granate apples/pomegranates

5

0,01  ((*))

0,01  ((*))

0,6

0163060

Cherimoyas

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0163070

Guavas

1,5

0,01  ((*))

0,01  ((*))

0,01  ((*))

0163080

Pineapples

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0163090

Breadfruits

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0163100

Durians

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0163110

Soursops/guanabanas

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0163990

Others (2)

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0200000

VEGETABLES, FRESH or FROZEN

0210000

Root and tuber vegetables

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0,02  ((*))

0211000

| (a) | potatoes |
| --- | --- |

(a)

potatoes

0,06

0,02  ((*))

0,05

0,1

0,01  ((*))

0212000

| (b) | tropical root and tuber vegetables |
| --- | --- |

(b)

tropical root and tuber vegetables

0,06

0,02  ((*))

0,01  ((*))

0,01  ((*))

0212010

Cassava roots/manioc

0,01  ((*))

0212020

Sweet potatoes

0,02

0212030

Yams

0,01  ((*))

0212040

Arrowroots

0,01  ((*))

0212990

Others (2)

0,01  ((*))

0213000

| (c) | other root and tuber vegetables except sugar beets |
| --- | --- |

(c)

other root and tuber vegetables except sugar beets

0,09

0,01  ((*))

0213010

Beetroots

(+)

1,5

0,1

0,01  ((*))

0213020

Carrots

(+)

1,5

0,01  ((*))

0,5

0213030

Celeriacs/turnip rooted celeries

(+)

0,3

0,01  ((*))

0,01  ((*))

0213040

Horseradishes

(+)

1,5

0,01  ((*))

0,01  ((*))

0213050

Jerusalem artichokes

(+)

0,02  ((*))

0,01  ((*))

0,01  ((*))

0213060

Parsnips

(+)

1,5

0,01  ((*))

0,01  ((*))

0213070

Parsley roots/Hamburg roots parsley

(+)

1,5

0,01  ((*))

0,01  ((*))

0213080

Radishes

(+)

0,3

0,3

0,4

0213090

Salsifies

(+)

1,5

0,01  ((*))

0,01  ((*))

0213100

Swedes/rutabagas

(+)

0,02  ((*))

0,01  ((*))

0,01  ((*))

0213110

Turnips

(+)

0,02  ((*))

0,01  ((*))

0,01  ((*))

0213990

Others (2)

0,02  ((*))

0,01  ((*))

0,01  ((*))

0220000

Bulb vegetables

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0,01  ((*))

0220010

Garlic

0,07

3

0,01  ((*))

0,02  ((*))

0220020

Onions

0,3

3

0,1 (+)

0,02  ((*))

0220030

Shallots

0,07

3

0,01  ((*))

0,02  ((*))

0220040

Spring onions/green onions and Welsh onions

0,8

0,01  ((*))

7 (+)

0,8

0220990

Others (2)

0,02  ((*))

3

0,01  ((*))

0,02  ((*))

0230000

Fruiting vegetables

0,01  ((*))

0,01  ((*))

0,02  ((*))

0231000

| (a) | Solanaceae and Malvaceae |
| --- | --- |

(a)

Solanaceae and Malvaceae

0,01  ((*))

0231010

Tomatoes

1,5

2

0,3

3 (+)

0,6

0,06

0231020

Sweet peppers/bell peppers

1,5

3

0,3 (+)

1

2

0,4

0231030

Aubergines/eggplants

1,5

2

0,3

3

0,6 (+)

0,05

0231040

Okra/lady's fingers

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0231990

Others (2)

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0232000

| (b) | cucurbits with edible peel |
| --- | --- |

(b)

cucurbits with edible peel

0,5

1

0,08

0,3

0,06

0232010

Cucumbers

(+)

0,03

0,2

0232020

Gherkins

(+)

0,01  ((*))

0,01  ((*))

0232030

Courgettes

(+)

0,03

0,2 (+)

0232990

Others (2)

0,01  ((*))

0,01  ((*))

0233000

| (c) | cucurbits with inedible peel |
| --- | --- |

(c)

cucurbits with inedible peel

0,6

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,03

0233010

Melons

0,5

0,3

0233020

Pumpkins

0,3

0,3

0233030

Watermelons

0,3

0,01  ((*))

0233990

Others (2)

0,3

0,01  ((*))

0234000

| (d) | sweet corn |
| --- | --- |

(d)

sweet corn

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0,02  ((*))

0239000

| (e) | other fruiting vegetables |
| --- | --- |

(e)

other fruiting vegetables

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0240000

Brassica vegetables(excluding brassica roots and brassica baby leaf crops)

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,02  ((*))

0241000

| (a) | flowering brassica |
| --- | --- |

(a)

flowering brassica

2

0241010

Broccoli

2

0241020

Cauliflowers

0,3

0241990

Others (2)

0,01  ((*))

0242000

| (b) | head brassica |
| --- | --- |

(b)

head brassica

0242010

Brussels sprouts

0,02  ((*))

0,2

0242020

Head cabbages

0,7

3

0242990

Others (2)

0,02  ((*))

0,01  ((*))

0243000

| (c) | leafy brassica |
| --- | --- |

(c)

leafy brassica

0,02  ((*))

25

0243010

Chinese cabbages/pe-tsai

0243020

Kales

0243990

Others (2)

0244000

| (d) | kohlrabies |
| --- | --- |

(d)

kohlrabies

0,02  ((*))

0,1

0250000

Leaf vegetables, herbs and edible flowers

0251000

| (a) | lettuces and salad plants |
| --- | --- |

(a)

lettuces and salad plants

0,01  ((*))

15

50

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

25

0251010

Lamb's lettuces/corn salads

4

4

0251020

Lettuces

4

1,5

0251030

Escaroles/broad-leaved endives

0,01  ((*))

0,02  ((*))

0251040

Cresses and other sprouts and shoots

4

4

0251050

Land cresses

4

4

0251060

Roman rocket/rucola

4

4

0251070

Red mustards

4

4

0251080

Baby leaf crops (including brassica species)

4

4

0251990

Others (2)

0,01  ((*))

0,02  ((*))

0252000

| (b) | spinaches and similar leaves |
| --- | --- |

(b)

spinaches and similar leaves

0,01  ((*))

15

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

25

4

0252010

Spinaches

0,9

0252020

Purslanes

4

0252030

Chards/beet leaves

1,5

0252990

Others (2)

0,02  ((*))

0253000

| (c) | grape leaves and similar species |
| --- | --- |

(c)

grape leaves and similar species

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

25

0,01  ((*))

0,02  ((*))

0254000

| (d) | watercresses |
| --- | --- |

(d)

watercresses

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

25

0,01  ((*))

0,02  ((*))

0255000

| (e) | witloofs/Belgian endives |
| --- | --- |

(e)

witloofs/Belgian endives

0,01  ((*))

0,06

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0,15

0,01  ((*))

0,02  ((*))

0256000

| (f) | herbs and edible flowers |
| --- | --- |

(f)

herbs and edible flowers

0,02  ((*))

40

50

0,02  ((*))

0,02  ((*))

0,02  ((*))

0,05  ((*))

30

4

0256010

Chervil

4

0256020

Chives

4

0256030

Celery leaves

4

0256040

Parsley

4

0256050

Sage

4

0256060

Rosemary

4

0256070

Thyme

4

0256080

Basil and edible flowers

80

0256090

Laurel/bay leaves

4

0256100

Tarragon

4

0256990

Others (2)

4

0260000

Legume vegetables

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0260010

Beans (with pods)

2

15

0,7 (+)

1

2

0,05

0260020

Beans (without pods)

0,08

0,01  ((*))

0,05

0,01  ((*))

0,3

0,02  ((*))

0260030

Peas (with pods)

2

0,01  ((*))

0,01  ((*))

0,01  ((*))

2

0,02  ((*))

0260040

Peas (without pods)

0,08

0,01  ((*))

0,01  ((*))

0,3

0,3

0,02  ((*))

0260050

Lentils

2

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0260990

Others (2)

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0270000

Stem vegetables

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0,01  ((*))

0270010

Asparagus

0,02  ((*))

0,02

0,01  ((*))

0,02  ((*))

0270020

Cardoons

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0270030

Celeries

30

0,01  ((*))

20

0,02  ((*))

0270040

Florence fennels

4

0,01  ((*))

0,01  ((*))

0,02  ((*))

0270050

Globe artichokes

4

0,01  ((*))

0,3

0,02  ((*))

0270060

Leeks

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,05

0270070

Rhubarbs

2

0,01  ((*))

0,01  ((*))

0,02  ((*))

0270080

Bamboo shoots

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0270090

Palm hearts

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0270990

Others (2)

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0280000

Fungi, mosses and lichens

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0280010

Cultivated fungi

0280020

Wild fungi

0280990

Mosses and lichens

0290000

Algae and prokaryotes organisms

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0300000

PULSES

0,04

0,2

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,02  ((*))

0300010

Beans

0,5

0300020

Lentils

0,01  ((*))

0300030

Peas

5

0300040

Lupins/lupini beans

0,01  ((*))

0300990

Others (2)

0,01  ((*))

0400000

OILSEEDS AND OIL FRUITS

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0401000

Oilseeds

0,02  ((*))

0401010

Linseeds

0,05

0,02  ((*))

0,02  ((*))

0,01  ((*))

0401020

Peanuts/groundnuts

0,01  ((*))

0,02  ((*))

0,02  ((*))

0,03

0401030

Poppy seeds

0,01  ((*))

0,02  ((*))

0,02  ((*))

0,01  ((*))

0401040

Sesame seeds

0,01  ((*))

0,02  ((*))

0,02  ((*))

0,01  ((*))

0401050

Sunflower seeds

3

0,02  ((*))

0,02  ((*))

0,01  ((*))

0401060

Rapeseeds/canola seeds

0,08

0,02

0,02  ((*))

0,01  ((*))

0401070

Soyabeans

0,08

0,3

0,04

0,01  ((*))

(+)

0401080

Mustard seeds

0,05

0,02  ((*))

0,02  ((*))

0,01  ((*))

0401090

Cotton seeds

0,3

0,02  ((*))

0,02  ((*))

7

(+)

0401100

Pumpkin seeds

0,01  ((*))

0,02  ((*))

0,02  ((*))

0,01  ((*))

0401110

Safflower seeds

0,01  ((*))

0,02  ((*))

0,02  ((*))

0,01  ((*))

0401120

Borage seeds

0,01  ((*))

0,02  ((*))

0,02  ((*))

0,01  ((*))

0401130

Gold of pleasure seeds

0,01  ((*))

0,02  ((*))

0,02  ((*))

0,01  ((*))

0401140

Hemp seeds

0,01  ((*))

0,02  ((*))

0,02  ((*))

0,01  ((*))

0401150

Castor beans

0,01  ((*))

0,02  ((*))

0,02  ((*))

0,01  ((*))

0401990

Others (2)

0,01  ((*))

0,02  ((*))

0,02  ((*))

0,01  ((*))

0402000

Oil fruits

0,01  ((*))

0,02  ((*))

0,02  ((*))

0,01  ((*))

0402010

Olives for oil production

0,06 (+)

0402020

Oil palms kernels

0,02  ((*))

0402030

Oil palms fruits

0,02  ((*))

0402040

Kapok

0,02  ((*))

0402990

Others (2)

0,02  ((*))

0500000

CEREALS

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,02  ((*))

0500010

Barley

1,5

4

0,01  ((*))

0,01  ((*))

0500020

Buckwheat and other pseudocereals

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,01  ((*))

0500030

Maize/corn

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,02  ((*))

(+)

0500040

Common millet/proso millet

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,01  ((*))

0500050

Oat

0,4

4

0,01  ((*))

0,01  ((*))

0500060

Rice

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,01  ((*))

(+)

0500070

Rye

0,05

0,5

0,6

0,01  ((*))

0500080

Sorghum

2

0,02  ((*))

0,01  ((*))

0,01  ((*))

0500090

Wheat

0,3

0,5

0,6

0,01  ((*))

0500990

Others (2)

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,01  ((*))

0600000

TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,1  ((*))

0,1  ((*))

0610000

Teas

0,05  ((*))

0,1  ((*))

8

0,05  ((*))

80

0620000

Coffee beans

0,05  ((*))

0,1  ((*))

0,05  ((*))

0,05  ((*))

0,15

0630000

Herbal infusions from

0,05  ((*))

0,05  ((*))

0,05  ((*))

0631000

| (a) | flowers |
| --- | --- |

(a)

flowers

0,05  ((*))

0,1  ((*))

0631010

Chamomile

0631020

Hibiscus/roselle

0631030

Rose

0631040

Jasmine

0631050

Lime/linden

0631990

Others (2)

0632000

| (b) | leaves and herbs |
| --- | --- |

(b)

leaves and herbs

0,05  ((*))

0,1  ((*))

0632010

Strawberry

0632020

Rooibos

0632030

Mate/maté

0632990

Others (2)

0633000

| (c) | roots |
| --- | --- |

(c)

roots

0,9

0633010

Valerian

(+)

1,5 (+)

0633020

Ginseng

(+)

3 (+)

0633990

Others (2)

1,5 (+)

0639000

| (d) | any other parts of the plant |
| --- | --- |

(d)

any other parts of the plant

0,05  ((*))

0,1  ((*))

0640000

Cocoa beans

0,05  ((*))

0,1  ((*))

0,05  ((*))

0,06

0,05  ((*))

0650000

Carobs/Saint John's breads

0,05  ((*))

0,1  ((*))

0,05  ((*))

0,05  ((*))

0,05  ((*))

0700000

HOPS

0,05  ((*))

0,1  ((*))

0,05  ((*))

0,05  ((*))

15 (+)

0,05  ((*))

0,1  ((*))

90

0,05  ((*))

0,1  ((*))

0800000

SPICES

0810000

Seed spices

0,05  ((*))

0,1  ((*))

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,1  ((*))

0,05  ((*))

0,05  ((*))

0,1  ((*))

0810010

Anise/aniseed

0810020

Black caraway/black cumin

0810030

Celery

0810040

Coriander

0810050

Cumin

0810060

Dill

0810070

Fennel

0810080

Fenugreek

0810090

Nutmeg

0810990

Others (2)

0820000

Fruit spices

0,05  ((*))

0,1  ((*))

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,1  ((*))

0,05  ((*))

0,05  ((*))

0,1  ((*))

0820010

Allspice/pimento

0820020

Sichuan pepper

0820030

Caraway

0820040

Cardamom

0820050

Juniper berry

0820060

Peppercorn (black, green and white)

0820070

Vanilla

0820080

Tamarind

0820990

Others (2)

0830000

Bark spices

0,05  ((*))

0,1  ((*))

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,1  ((*))

0,05  ((*))

0,05  ((*))

0,1  ((*))

0830010

Cinnamon

0830990

Others (2)

0840000

Root and rhizome spices

0840010

Liquorice

0,05  ((*))

1,5 (+)

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,1  ((*))

0,05  ((*))

0,05  ((*))

0,1  ((*))

0840020

Ginger (10)

0840030

Turmeric/curcuma

0,05  ((*))

1,5 (+)

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,1  ((*))

0,05  ((*))

0,05  ((*))

0,1  ((*))

0840040

Horseradish (11)

0840990

Others (2)

0,05  ((*))

1,5 (+)

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,1  ((*))

0,05  ((*))

0,05  ((*))

0,1  ((*))

0850000

Bud spices

0,05  ((*))

0,1  ((*))

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,1  ((*))

0,05  ((*))

0,05  ((*))

0,1  ((*))

0850010

Cloves

0850020

Capers

0850990

Others (2)

0860000

Flower pistil spices

0,05  ((*))

0,1  ((*))

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,1  ((*))

0,05  ((*))

0,05  ((*))

0,1  ((*))

0860010

Saffron

0860990

Others (2)

0870000

Aril spices

0,05  ((*))

0,1  ((*))

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,1  ((*))

0,05  ((*))

0,05  ((*))

0,1  ((*))

0870010

Mace

0870990

Others (2)

0900000

SUGAR PLANTS

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,02  ((*))

0900010

Sugar beet roots

0,09 (+)

0,3

0900020

Sugar canes

0,01  ((*))

0,015

0900030

Chicory roots

0,09 (+)

0,01  ((*))

0900990

Others (2)

0,01  ((*))

0,01  ((*))

1000000

PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS

1010000

Commodities from

(+)

0,05  ((*))

0,01  ((*))

0,02  ((*))

1011000

| (a) | swine |
| --- | --- |

(a)

swine

0,02  ((*))(+)

1011010

Muscle

0,8

(+)

0,015

0,02

0,02  ((*))

0,01  ((*))

0,01  ((*))(+)

1011020

Fat

2

(+)

0,015

0,2

0,02  ((*))

0,02

0,3 (+)

1011030

Liver

4

(+)

0,02

0,8

0,1

0,01  ((*))

0,2 (+)

1011040

Kidney

4

(+)

0,02

0,8

0,1

0,01  ((*))

0,2 (+)

1011050

Edible offals (other than liver and kidney)

4

(+)

0,02

0,8

0,1

0,01  ((*))

0,2 (+)

1011990

Others (2)

0,02  ((*))

(+)

0,02

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,01  ((*))(+)

1012000

| (b) | bovine |
| --- | --- |

(b)

bovine

1012010

Muscle

0,8

0,02  ((*))(+)

0,015

0,02

0,02  ((*))

0,01  ((*))

0,01  ((*))(+)

1012020

Fat

2

0,02  ((*))(+)

0,015

0,2

0,02  ((*))

0,02

0,3 (+)

(+)

1012030

Liver

4

0,05 (+)

0,02

0,8

0,1

0,01  ((*))

0,2 (+)

(+)

1012040

Kidney

4

0,05 (+)

0,02

0,8

0,1

0,01  ((*))

0,2 (+)

(+)

1012050

Edible offals (other than liver and kidney)

4

0,02  ((*))(+)

0,02

0,8

0,1

0,01  ((*))

0,2 (+)

1012990

Others (2)

0,02  ((*))

0,02  ((*))(+)

0,02

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,01  ((*))(+)

1013000

| (c) | sheep |
| --- | --- |

(c)

sheep

1013010

Muscle

0,8

0,02  ((*))(+)

0,015

0,02

0,02  ((*))

0,01  ((*))

0,01  ((*))(+)

1013020

Fat

2

0,02  ((*))(+)

0,015

0,2

0,02  ((*))

0,02

0,3 (+)

1013030

Liver

4

0,05 (+)

0,02

0,8

0,1

0,01  ((*))

0,2 (+)

1013040

Kidney

4

0,05 (+)

0,02

0,8

0,1

0,01  ((*))

0,2 (+)

1013050

Edible offals (other than liver and kidney)

4

0,02  ((*))(+)

0,02

0,8

0,1

0,01  ((*))

0,2 (+)

1013990

Others (2)

0,02  ((*))

0,02  ((*))(+)

0,02

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,01  ((*))(+)

1014000

| d) | goat |
| --- | --- |

d)

goat

1014010

Muscle

0,8

0,02  ((*))(+)

0,015

0,02

0,02  ((*))

0,01  ((*))

0,01  ((*))(+)

1014020

Fat

2

0,02  ((*))(+)

0,015

0,2

0,02  ((*))

0,02

0,3 (+)

1014030

Liver

4

0,05 (+)

0,02

0,8

0,1

0,01  ((*))

0,2 (+)

1014040

Kidney

4

0,05 (+)

0,02

0,8

0,1

0,01  ((*))

0,2 (+)

1014050

Edible offals (other than liver and kidney)

4

0,02  ((*))(+)

0,02

0,8

0,1

0,01  ((*))

0,2 (+)

1014990

Others (2)

0,02  ((*))

0,02  ((*))(+)

0,02

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,01  ((*))(+)

1015000

| (e) | equine |
| --- | --- |

(e)

equine

1015010

Muscle

0,8

0,02  ((*))(+)

0,015

0,02

0,02  ((*))

0,01  ((*))

0,01  ((*))

1015020

Fat

2

0,02  ((*))(+)

0,015

0,2

0,02  ((*))

0,02

0,3

(+)

1015030

Liver

4

0,05 (+)

0,02

0,8

0,1

0,01  ((*))

0,2

(+)

1015040

Kidney

4

0,05 (+)

0,02

0,8

0,1

0,01  ((*))

0,2

(+)

1015050

Edible offals (other than liver and kidney)

4

0,02  ((*))(+)

0,02

0,8

0,1

0,01  ((*))

0,2

1015990

Others (2)

0,02  ((*))

0,02  ((*))(+)

0,02

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,01  ((*))

1016000

| (f) | poultry |
| --- | --- |

(f)

poultry

0,02  ((*))(+)

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

1016010

Muscle

0,02  ((*))

(+)

0,02  ((*))

(+)

1016020

Fat

0,05

(+)

0,02  ((*))

(+)

(+)

1016030

Liver

0,05

(+)

0,2

(+)

(+)

1016040

Kidney

0,02  ((*))

0,2

1016050

Edible offals (other than liver and kidney)

0,05

(+)

0,2

1016990

Others (2)

0,02  ((*))

(+)

0,02  ((*))

1017000

| (g) | other farmed terrestrial animals |
| --- | --- |

(g)

other farmed terrestrial animals

1017010

Muscle

0,8

0,02  ((*))(+)

0,015

0,02

0,02  ((*))

0,01  ((*))

0,01  ((*))

1017020

Fat

2

0,02  ((*))(+)

0,015

0,2

0,02  ((*))

0,02

0,3

1017030

Liver

4

0,05 (+)

0,02

0,8

0,1

0,01  ((*))

0,2

1017040

Kidney

4

0,05 (+)

0,02

0,8

0,1

0,01  ((*))

0,2

1017050

Edible offals (other than liver and kidney)

4

0,02  ((*))(+)

0,02

0,8

0,1

0,01  ((*))

0,2

1017990

Others (2)

0,02  ((*))

0,02  ((*))(+)

0,02

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,01  ((*))

1020000

Milk

0,2

0,02  ((*))(+)

0,01  ((*))

0,015

0,01  ((*))

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,05 (+)

0,02  ((*))

1020010

Cattle

(+)

(+)

1020020

Sheep

(+)

(+)

1020030

Goat

(+)

(+)

1020040

Horse

(+)

1020990

Others (2)

(+)

1030000

Birds eggs

0,05

0,02  ((*))(+)

0,05  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,01  ((*))(+)

0,02  ((*))

1030010

Chicken

(+)

(+)

(+)

1030020

Duck

(+)

(+)

(+)

1030030

Geese

(+)

(+)

(+)

1030040

Quail

(+)

(+)

(+)

1030990

Others (2)

(+)

(+)

1040000

Honey and other apiculture products (7)

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,05  ((*))

0,05  ((*))

1050000

Amphibians and Reptiles

0,02  ((*))

0,02  ((*))

0,05  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

1060000

Terrestrial invertebrate animals

0,02  ((*))

0,02  ((*))

0,05  ((*))

0,01  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

1070000

Wild terrestrial vertebrate animals

0,02  ((*))

0,02  ((*))

0,05  ((*))

0,01  ((*))

0,02

0,01  ((*))

0,02  ((*))

0,01  ((*))

0,01  ((*))

0,02  ((*))

1100000

PRODUCTS OF ANIMAL ORIGIN - FISH, FISHPRODUCTS AND ANY OTHER MARINE AND FRESHWATER FOOD PRODUCTS (8)

1200000

PRODUCTS OR PART OF PRODUCTS EXCLUSIVELY USED FOR ANIMAL FEED PRODUCTION (8)

1300000

PROCESSED FOOD PRODUCTS (9)

Bixafen (R) (F)

(R) The residue definition differs for the following combinations pesticide-code number: Bixafen- code 1000000 except 1040000: sum of bixafen and desmethyl bixafen expressed as bixafen

(F) Fat soluble

MRL derived from rotational crops.

0213010 Beetroots

0213020 Carrots

0213030 Celeriacs/turnip rooted celeries

0213040 Horseradishes

0213050 Jerusalem artichokes

0213060 Parsnips

0213070 Parsley roots/Hamburg roots parsley

0213080 Radishes

0213090 Salsifies

0213100 Swedes/rutabagas

0213110 Turnips

0633010 Valerian

0633020 Ginseng

0900010 Sugar beet roots

0900030 Chicory roots

Cyprodinil (R) (F)

(R) The residue definition differs for the following combinations pesticide-code number: Cyprodinil - code 1000000 except 1020000, 1040000: Cyprodinil (sum of cyprodinil and CGA 304075 (free), expressed as cyprodinil)\n\rCyprodinil-1020000: Cyprodinil (Sum of cyprodinil and CGA 304075 (free and conjugated), expressed as cyprodinil)

(F) Fat soluble

The European Food Safety Authority identified some information on analytical and/or confirmatory methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 14 March 2017, or, if that information is not submitted by that date, the lack of it.

0120010 Almonds

0633000 (c) roots

0633010 Valerian

0633020 Ginseng

0633990 Others (2)

0840010 Liquorice

0840030 Turmeric/curcuma

0840990 Others (2)

1000000 PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS

1010000 Commodities from

1011000 (a) swine

1011010 Muscle

1011020 Fat

1011030 Liver

1011040 Kidney

1011050 Edible offals (other than liver and kidney)

1011990 Others (2)

1012000 (b) bovine

1012010 Muscle

1012020 Fat

1012030 Liver

1012040 Kidney

1012050 Edible offals (other than liver and kidney)

1012990 Others (2)

1013000 (c) sheep

1013010 Muscle

1013020 Fat

1013030 Liver

1013040 Kidney

1013050 Edible offals (other than liver and kidney)

1013990 Others (2)

1014000 d) goat

1014010 Muscle

1014020 Fat

1014030 Liver

1014040 Kidney

1014050 Edible offals (other than liver and kidney)

1014990 Others (2)

1015000 (e) equine

1015010 Muscle

1015020 Fat

1015030 Liver

1015040 Kidney

1015050 Edible offals (other than liver and kidney)

1015990 Others (2)

1016000 (f) poultry

1016010 Muscle

1016020 Fat

1016030 Liver

1016050 Edible offals (other than liver and kidney)

1016990 Others (2)

1017000 (g) other farmed terrestrial animals

1017010 Muscle

1017020 Fat

1017030 Liver

1017040 Kidney

1017050 Edible offals (other than liver and kidney)

1017990 Others (2)

1020000 Milk

1020010 Cattle

1020020 Sheep

1020030 Goat

1030000 Birds eggs

1030010 Chicken

1030020 Duck

1030030 Geese

1030040 Quail

1030990 Others (2)

Fenhexamid (F)

(F) Fat soluble

Fenpicoxamid (R) (F)

(R) The residue definition differs for the following combinations pesticide-code number: Fenpicoxamid - code 1000000 except 1040000: X12326349 expressed as fenpicoxamid

(F) Fat soluble

Fenpyroximate (R) (F) (A)

(R) The residue definition differs for the following combinations pesticide-code number: Fenpyroximate — codes 1012030, 1012040, 1013030, 1013040, 1014030, 1014040, 1015030, 1015040, 1017030, 1017040: Fenpyroximate (metabolite M-3, expressed as fenpyroximate (F))

(F) Fat soluble

(A) (A) The EU reference labs identified the reference standard for the M-3 metabolite as commercially not available. When re-viewing the MRL, the Commission will take into account the commercial availability of the reference standard referred to in the first sentence by 7 April 2018, or, if that reference standard is not commercially available by that date, the unavailability of it.

The European Food Safety Authority identified some information on residue trials and the nature of residues in processed commodities as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 7 April 2019, or, if that information is not submitted by that date, the lack of it.

0110000 Citrus fruits

0110010 Grapefruits

0110020 Oranges

0110030 Lemons

0110040 Limes

0110050 Mandarins

0110990 Others (2)

0130010 Apples

0130020 Pears

0140010 Apricots

0140020 Cherries (sweet)

0140040 Plums

The European Food Safety Authority identified some information on the nature of residues in processed commodities as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 7 April 2019, or, if that information is not submitted by that date, the lack of it.

0130030 Quinces

0130040 Medlars

0130050 Loquats/Japanese medlars

0140030 Peaches

0151010 Table grapes

0151020 Wine grapes

The European Food Safety Authority identified some information on metabolism in rotational crops and the nature of residues in processed commodities as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 7 April 2019, or, if that information is not submitted by that date, the lack of it.

0153010 Blackberries

0153030 Raspberries (red and yellow)

0154010 Blueberries

0154030 Currants (black, red and white)

0154040 Gooseberries (green, red and yellow)

0154050 Rose hips

0154060 Mulberries (black and white)

0154070 Azaroles/Mediterranean medlars

0154080 Elderberries

0260010 Beans (with pods)

The European Food Safety Authority identified some information on residue trials, metabolism in rotational crops and the nature of residues in processed commodities as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 7 April 2019, or, if that information is not submitted by that date, the lack of it.

0153020 Dewberries

0154020 Cranberries

0231020 Sweet peppers/bell peppers

0232010 Cucumbers

0232020 Gherkins

0232030 Courgettes

The European Food Safety Authority identified some information on metabolism, analytical methods, metabolism in rotational crops and the nature of residues in processed commodities as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 7 April 2019, or, if that information is not submitted by that date, the lack of it.

0700000 HOPS

Isoxaflutole (sum of isoxaflutole and its diketonitrile-metabolite, expressed as isoxaflutole)

(O) RPA 202248 is 2-cyano-3-cyclopropyl-1-(2-methylsulfonyl-4-trifluoromethylphenyl) propane-1,3-dione. RPA 203328 is 2-methanesulfonyl-4-trifluoromethylbenzoic acid.

Mandipropamid (any ratio of constituent isomers)

The European Food Safety Authority identified some information on toxicity of metabolites as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 11 July 2021, or, if that information is not submitted by that date, the lack of it.

0220020 Onions

0220040 Spring onions/green onions and Welsh onions

The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 11 July 2021, or, if that information is not submitted by that date, the lack of it.

0231010 Tomatoes

0232030 Courgettes

Methoxyfenozide (F)

(F) Fat soluble

The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 1 July 2017, or, if that information is not submitted by that date, the lack of it.

0231030 Aubergines/eggplants

The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 1 July 2017, or, if that information is not submitted by that date, the lack of it.

1011000 (a) swine

1011010 Muscle

1011020 Fat

1011030 Liver

1011040 Kidney

1011050 Edible offals (other than liver and kidney)

1011990 Others (2)

1012000 (b) bovine

1012010 Muscle

1012020 Fat

1012030 Liver

1012040 Kidney

1012050 Edible offals (other than liver and kidney)

1012990 Others (2)

1013000 (c) sheep

1013010 Muscle

1013020 Fat

1013030 Liver

1013040 Kidney

1013050 Edible offals (other than liver and kidney)

1013990 Others (2)

1014000 d) goat

1014010 Muscle

1014020 Fat

1014030 Liver

1014040 Kidney

1014050 Edible offals (other than liver and kidney)

1014990 Others (2)

1016010 Muscle

1016020 Fat

1016030 Liver

1020000 Milk

1020010 Cattle

1020020 Sheep

1020030 Goat

1020040 Horse

1020990 Others (2)

1030000 Birds eggs

1030010 Chicken

1030020 Duck

1030030 Geese

1030040 Quail

1030990 Others (2)

Spinetoram (sum of spinetoram-J and spinetoram-L) (F) (A)

(F) Fat soluble

(A) The EU reference laboratories identified the reference standard for spinetoram-J and spinetoram- L as commercially not available. When reviewing the MRLs, the Commission will take into account the commercial availability of the reference standard referred to it in the first sentence by 07/07/2022, or, if that reference standard is not commercially available by that date, the unavailability of it.

The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 2 June 2025, or, if that information is not submitted by that date, the lack of it.

0120010 Almonds

0120020 Brazil nuts

0120030 Cashew nuts

0120040 Chestnuts

0120050 Coconuts

0120060 Hazelnuts/cobnuts

0120070 Macadamias

0120080 Pecans

0120090 Pine nut kernels

0120100 Pistachios

0120110 Walnuts

0161030 Table olives

0401070 Soyabeans

0401090 Cotton seeds

0402010 Olives for oil production

0500030 Maize/corn

0500060 Rice

1012020 Fat

1012030 Liver

1012040 Kidney

1015020 Fat

1015030 Liver

1015040 Kidney

1016020 Fat

1016030 Liver

1030010 Chicken

1030020 Duck

1030030 Geese

1030040 Quail

The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 2 June 2025, or, if that information is not submitted by that date, the lack of it.

0130010 Apples

0130020 Pears

0130030 Quinces

0130040 Medlars

0130050 Loquats/Japanese medlars

0140010 Apricots

0151010 Table grapes

0151020 Wine grapes

0153010 Blackberries

0153020 Dewberries

0154020 Cranberries

0154040 Gooseberries (green, red and yellow)

0154050 Rose hips

0154060 Mulberries (black and white)

0154070 Azaroles/Mediterranean medlars

0154080 Elderberries’

---

((*))  Indicates lower limit of analytical determination

(*)

(1)  For the complete list of products of plant and animal origin to which MRL's apply, reference should be made to Annex I

1

---

| 2.6.2023 | EN | Official Journal of the European Union | L 143/65 |
| --- | --- | --- | --- |

2.6.2023

EN

Official Journal of the European Union

L 143/65

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/1070

of 1 June 2023

on technical arrangements for developing, maintaining and employing electronic systems for the exchange and storage of information under Regulation (EU) No 952/2013 of the European Parliament and the Council

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (1), and in particular Article 8(1), point (b), and Article 17 and Article 50(1), thereof,

Whereas:

| (1) | Article 6(1) of Regulation (EU) No 952/2013 (referred to as ‘the Code’ or ‘UCC’) requires that all exchanges of information, such as declarations, applications or decisions, between customs authorities of the Member States and between economic operators and customs authorities of the Member States, and the storage of that information, as required under the customs legislation of the Union, be made by using electronic data-processing techniques. |
| --- | --- |

(1)

Article 6(1) of Regulation (EU) No 952/2013 (referred to as ‘the Code’ or ‘UCC’) requires that all exchanges of information, such as declarations, applications or decisions, between customs authorities of the Member States and between economic operators and customs authorities of the Member States, and the storage of that information, as required under the customs legislation of the Union, be made by using electronic data-processing techniques.

| (2) | Commission Implementing Decision (EU) 2019/2151 (2) establishes the work programme for the implementation of the electronic systems required for the application of the Code, which are to be developed through projects listed in Section II of the Annex to that Implementing Decision. |
| --- | --- |

(2)

Commission Implementing Decision (EU) 2019/2151 (2) establishes the work programme for the implementation of the electronic systems required for the application of the Code, which are to be developed through projects listed in Section II of the Annex to that Implementing Decision.

| (3) | Important technical arrangements for the functioning of the electronic systems should be specified, such as arrangements for development, testing and deployment as well as for maintenance and for changes to be introduced in the electronic systems. Further arrangements should be specified concerning data protection, updating of data, limitation of data processing and systems ownership and security. |
| --- | --- |

(3)

Important technical arrangements for the functioning of the electronic systems should be specified, such as arrangements for development, testing and deployment as well as for maintenance and for changes to be introduced in the electronic systems. Further arrangements should be specified concerning data protection, updating of data, limitation of data processing and systems ownership and security.

| (4) | In order to safeguard the rights and interests of the Union, Member States and economic operators, it is important to lay down the procedural rules and provide for alternative solutions to be implemented in the event of a temporary failure of the electronic systems. |
| --- | --- |

(4)

In order to safeguard the rights and interests of the Union, Member States and economic operators, it is important to lay down the procedural rules and provide for alternative solutions to be implemented in the event of a temporary failure of the electronic systems.

| (5) | The European Union Customs Trader Portal (EUCTP), as initially developed through the UCC Authorised Economic Operator (AEO), European Binding Tariff Information (EBTI) and Information Sheets (INF) for Special Procedures (INF SP) projects, aims at providing a unique access point for economic operators and other persons, and to access each of the Specific Trader Portals, developed for their related systems. |
| --- | --- |

(5)

The European Union Customs Trader Portal (EUCTP), as initially developed through the UCC Authorised Economic Operator (AEO), European Binding Tariff Information (EBTI) and Information Sheets (INF) for Special Procedures (INF SP) projects, aims at providing a unique access point for economic operators and other persons, and to access each of the Specific Trader Portals, developed for their related systems.

| (6) | The Customs Decisions System (CDS), developed through the UCC Customs Decisions project referred to in Implementing Decision (EU) 2019/2151, pursues the objective of harmonising the processes for the application for a customs decision, for the decision taking and the decision management in the whole of the Union using only electronic data-processing techniques. It is therefore necessary to lay down the rules governing that electronic system. The scope of the system should be determined by reference to the customs decisions which are to be applied for, taken and managed using that system. Detailed rules should be set out for the system’s common components (EU trader portal, central customs decisions management system and customer reference services) and national components (national trader portal and national customs decisions management system), by specifying their functions and their interconnections. |
| --- | --- |

(6)

The Customs Decisions System (CDS), developed through the UCC Customs Decisions project referred to in Implementing Decision (EU) 2019/2151, pursues the objective of harmonising the processes for the application for a customs decision, for the decision taking and the decision management in the whole of the Union using only electronic data-processing techniques. It is therefore necessary to lay down the rules governing that electronic system. The scope of the system should be determined by reference to the customs decisions which are to be applied for, taken and managed using that system. Detailed rules should be set out for the system’s common components (EU trader portal, central customs decisions management system and customer reference services) and national components (national trader portal and national customs decisions management system), by specifying their functions and their interconnections.

| (7) | The Uniform User Management and Digital Signature (UUM&DS) system, developed through the Direct Trader Access to the European Information Systems (Uniform User Management & Digital Signature) project referred to in Implementing Decision (EU) 2019/2151, is to manage the authentication and access verification process for economic operators and other persons. Detailed rules need to be set out regarding the scope and characteristics of the system by defining the different components (common and national components) of the system, their functions and interconnections. |
| --- | --- |

(7)

The Uniform User Management and Digital Signature (UUM&DS) system, developed through the Direct Trader Access to the European Information Systems (Uniform User Management & Digital Signature) project referred to in Implementing Decision (EU) 2019/2151, is to manage the authentication and access verification process for economic operators and other persons. Detailed rules need to be set out regarding the scope and characteristics of the system by defining the different components (common and national components) of the system, their functions and interconnections.

| (8) | The European Binding Tariff Information (EBTI) system, as upgraded through the UCC Binding Tariff Information (BTI) project referred to in Implementing Decision (EU) 2019/2151, is aimed at aligning the processes for applying for, taking and managing BTI decisions with the requirements of the Code using only electronic data-processing techniques. It is therefore necessary to lay down rules governing that system. Detailed rules should be laid down for the system’s common components (EU trader portal, central EBTI system and BTI usage monitoring) and national components (national trader portal and national BTI system), by specifying their functions and interconnections. Moreover, the project aims to facilitate the monitoring of compulsory BTI usage and the monitoring and management of BTI extended usage. |
| --- | --- |

(8)

The European Binding Tariff Information (EBTI) system, as upgraded through the UCC Binding Tariff Information (BTI) project referred to in Implementing Decision (EU) 2019/2151, is aimed at aligning the processes for applying for, taking and managing BTI decisions with the requirements of the Code using only electronic data-processing techniques. It is therefore necessary to lay down rules governing that system. Detailed rules should be laid down for the system’s common components (EU trader portal, central EBTI system and BTI usage monitoring) and national components (national trader portal and national BTI system), by specifying their functions and interconnections. Moreover, the project aims to facilitate the monitoring of compulsory BTI usage and the monitoring and management of BTI extended usage.

| (9) | The Economic Operator Registration and Identification (EORI) system, as upgraded through the UCC Economic Operator Registration and Identification system (EORI 2) project referred to in Implementing Decision (EU) 2019/2151, is aimed at upgrading the existing trans-European EORI system, which enables the registration and identification of economic operators of the Union and of third country economic operators and other persons for the purposes of applying the customs legislation of the Union. It is therefore necessary to lay down rules governing the system by specifying the components (central EORI system and national EORI systems) and the use of the EORI system. |
| --- | --- |

(9)

The Economic Operator Registration and Identification (EORI) system, as upgraded through the UCC Economic Operator Registration and Identification system (EORI 2) project referred to in Implementing Decision (EU) 2019/2151, is aimed at upgrading the existing trans-European EORI system, which enables the registration and identification of economic operators of the Union and of third country economic operators and other persons for the purposes of applying the customs legislation of the Union. It is therefore necessary to lay down rules governing the system by specifying the components (central EORI system and national EORI systems) and the use of the EORI system.

| (10) | The AEO system, as upgraded through the UCC Authorised Economic Operators (AEO) project referred to in Implementing Decision (EU) 2019/2151, is aimed at improving the business processes relating to AEO applications and authorisations and their management. The system is also aimed at implementing the electronic form to be used for AEO applications and decisions, and providing economic operators with an EUCTP through which to submit AEO applications and receive AEO decisions electronically. Detailed rules should be laid down for the system’s common components. |
| --- | --- |

(10)

The AEO system, as upgraded through the UCC Authorised Economic Operators (AEO) project referred to in Implementing Decision (EU) 2019/2151, is aimed at improving the business processes relating to AEO applications and authorisations and their management. The system is also aimed at implementing the electronic form to be used for AEO applications and decisions, and providing economic operators with an EUCTP through which to submit AEO applications and receive AEO decisions electronically. Detailed rules should be laid down for the system’s common components.

| (11) | The Import Control System 2 (ICS2), as developed through the ICS2 project referred to in Implementing Decision (EU) 2019/2151 is aimed at strengthening safety and security of goods entering the Union. The system supports the collection of entry summary declaration (ENS) data from different economic operators and other persons acting in the international supply chains for goods. It is aimed at supporting all exchanges of information related to fulfilment of the ENS requirements between the customs authorities of the Member States and economic operators and other persons through a Harmonised Trader Interface developed either as a common or as a national application. It is also aimed at supporting via a common repository and related processes, the real-time collaborative implementation of security and safety risk analysis by the customs offices of first entry and exchange of risk analysis results among the customs authorities of the Member States, prior to goods departure from third countries and/or prior to their arrival in the customs territory of the Union. The system supports customs measures to address safety and security risks identified following risk analysis, including customs controls and the exchange of results of controls, and, where relevant, notifications to economic operators and other persons regarding certain measures which they need to take to mitigate risks. The system supports monitoring and evaluation by the Commission and Member States’ customs authorities of the implementation of the common safety and security risk criteria and standards and of the control measures and priority control areas referred to in the Code. |
| --- | --- |

(11)

The Import Control System 2 (ICS2), as developed through the ICS2 project referred to in Implementing Decision (EU) 2019/2151 is aimed at strengthening safety and security of goods entering the Union. The system supports the collection of entry summary declaration (ENS) data from different economic operators and other persons acting in the international supply chains for goods. It is aimed at supporting all exchanges of information related to fulfilment of the ENS requirements between the customs authorities of the Member States and economic operators and other persons through a Harmonised Trader Interface developed either as a common or as a national application. It is also aimed at supporting via a common repository and related processes, the real-time collaborative implementation of security and safety risk analysis by the customs offices of first entry and exchange of risk analysis results among the customs authorities of the Member States, prior to goods departure from third countries and/or prior to their arrival in the customs territory of the Union. The system supports customs measures to address safety and security risks identified following risk analysis, including customs controls and the exchange of results of controls, and, where relevant, notifications to economic operators and other persons regarding certain measures which they need to take to mitigate risks. The system supports monitoring and evaluation by the Commission and Member States’ customs authorities of the implementation of the common safety and security risk criteria and standards and of the control measures and priority control areas referred to in the Code.

| (12) | The Automated Export System, as upgraded through the UCC Automated Export System (AES) project referred to in Implementing Decision (EU) 2019/2151, is aimed at upgrading the existing Export Control System to be aligned with the new business and data requirements laid down in the Code. The system is also aimed at offering all the required functionalities and at covering the necessary interfaces with supporting systems, namely the New Computerised Transit System and the Excise Movement Control System. In addition, AES supports the implementation of the centralised clearance at export functionalities. As AES is a decentralised system, it is necessary to lay down rules by specifying the components and the use of the system. |
| --- | --- |

(12)

The Automated Export System, as upgraded through the UCC Automated Export System (AES) project referred to in Implementing Decision (EU) 2019/2151, is aimed at upgrading the existing Export Control System to be aligned with the new business and data requirements laid down in the Code. The system is also aimed at offering all the required functionalities and at covering the necessary interfaces with supporting systems, namely the New Computerised Transit System and the Excise Movement Control System. In addition, AES supports the implementation of the centralised clearance at export functionalities. As AES is a decentralised system, it is necessary to lay down rules by specifying the components and the use of the system.

| (13) | The New Computerised Transit System, as upgraded through the UCC New Computerised Transit System (NCTS) project referred to in Implementing Decision (EU) 2019/2151, is aimed at upgrading the existing NCTS Phase 4 to be aligned with the new business and data requirements laid down in the Code. The system is also aimed at offering new functionalities referred to in the Code and at covering the necessary interfaces with supporting systems and AES. As NCTS is a decentralised system, it is necessary to lay down rules by specifying the components and the use of the system. |
| --- | --- |

(13)

The New Computerised Transit System, as upgraded through the UCC New Computerised Transit System (NCTS) project referred to in Implementing Decision (EU) 2019/2151, is aimed at upgrading the existing NCTS Phase 4 to be aligned with the new business and data requirements laid down in the Code. The system is also aimed at offering new functionalities referred to in the Code and at covering the necessary interfaces with supporting systems and AES. As NCTS is a decentralised system, it is necessary to lay down rules by specifying the components and the use of the system.

| (14) | The INF SP system, developed through the UCC Information Sheets (INF) for Special Procedures project referred to in Implementing Decision (EU) 2019/2151, aims at developing a new trans-European system to support and streamline the processes of INF data management and the electronic handling of INF data in the domain of Special Procedures. Detailed rules should be laid down to specify the system’s components and its usage. |
| --- | --- |

(14)

The INF SP system, developed through the UCC Information Sheets (INF) for Special Procedures project referred to in Implementing Decision (EU) 2019/2151, aims at developing a new trans-European system to support and streamline the processes of INF data management and the electronic handling of INF data in the domain of Special Procedures. Detailed rules should be laid down to specify the system’s components and its usage.

| (15) | The customs risk management system referred to in Article 36 of Commission Implementing Regulation (EU) 2015/2447 (3) aims at supporting the exchange of risk information between Member States’ customs authorities and between them and the Commission with a view to supporting the implementation of the common risk management framework. |
| --- | --- |

(15)

The customs risk management system referred to in Article 36 of Commission Implementing Regulation (EU) 2015/2447 (3) aims at supporting the exchange of risk information between Member States’ customs authorities and between them and the Commission with a view to supporting the implementation of the common risk management framework.

| (16) | The Centralised Clearance for Import system, as developed through UCC Centralised Clearance for Import (CCI) project referred to in Implementing Decision (EU) 2019/2151 aims at allowing goods to be placed under a customs procedure using centralised clearance, thereby allowing economic operators to centralise their business from a customs viewpoint. The processing of the customs declaration and the physical release of the goods should be coordinated between the customs offices involved. As CCI is a decentralised system, it is necessary to lay down rules by specifying the components and the use of the system. |
| --- | --- |

(16)

The Centralised Clearance for Import system, as developed through UCC Centralised Clearance for Import (CCI) project referred to in Implementing Decision (EU) 2019/2151 aims at allowing goods to be placed under a customs procedure using centralised clearance, thereby allowing economic operators to centralise their business from a customs viewpoint. The processing of the customs declaration and the physical release of the goods should be coordinated between the customs offices involved. As CCI is a decentralised system, it is necessary to lay down rules by specifying the components and the use of the system.

| (17) | The Registered Exporter (REX) system, referred to in Articles 68 to 93 of Implementing Regulation (EU) 2015/2447, aims at allowing exporters registered in the Union and in some third countries with which the Union has a preferential arrangement to self-certify the origin of their goods. Detailed rules should be laid down to specify the system’s components and their usage. Within the REX system, exporters are to be provided with the information laid down in Article 13 of Regulation (EU) 2016/679 of the European Parliament and of the Council (4) and Article 15 of Regulation (EU) 2018/1725 of the European Parliament and of the Council (5), via a notice attached to the application to become a registered exporter, and the rights of data subjects with regard to the processing of their personal data in connection with their application for registration are to be exercised in accordance with Chapter III of Regulations (EU) 2016/679 and (EU) 2018/1725. |
| --- | --- |

(17)

The Registered Exporter (REX) system, referred to in Articles 68 to 93 of Implementing Regulation (EU) 2015/2447, aims at allowing exporters registered in the Union and in some third countries with which the Union has a preferential arrangement to self-certify the origin of their goods. Detailed rules should be laid down to specify the system’s components and their usage. Within the REX system, exporters are to be provided with the information laid down in Article 13 of Regulation (EU) 2016/679 of the European Parliament and of the Council (4) and Article 15 of Regulation (EU) 2018/1725 of the European Parliament and of the Council (5), via a notice attached to the application to become a registered exporter, and the rights of data subjects with regard to the processing of their personal data in connection with their application for registration are to be exercised in accordance with Chapter III of Regulations (EU) 2016/679 and (EU) 2018/1725.

| (18) | The Proof of Union Status (PoUS) system, developed through the UCC PoUS project referred to in Implementing Decision (EU) 2019/2151, aims at creating a new trans-European system to store, manage and retrieve the proofs of Union status in the form of T2L/T2LF and customs goods manifest (CGM) documents. |
| --- | --- |

(18)

The Proof of Union Status (PoUS) system, developed through the UCC PoUS project referred to in Implementing Decision (EU) 2019/2151, aims at creating a new trans-European system to store, manage and retrieve the proofs of Union status in the form of T2L/T2LF and customs goods manifest (CGM) documents.

| (19) | The Surveillance system, as upgraded through the UCC Surveillance 3 (SURV3) project referred to in Implementing Decision (EU) 2019/2151, is aimed at upgrading the Surveillance 2+ system to ensure it is aligned with the UCC requirements such as the standard exchange of information via electronic data processing techniques and the establishment of the functionalities needed for processing and analysing the full surveillance dataset obtained from Member States. The Surveillance system, which is available to the Commission and the Member States, further includes data mining capabilities and reporting functionalities. |
| --- | --- |

(19)

The Surveillance system, as upgraded through the UCC Surveillance 3 (SURV3) project referred to in Implementing Decision (EU) 2019/2151, is aimed at upgrading the Surveillance 2+ system to ensure it is aligned with the UCC requirements such as the standard exchange of information via electronic data processing techniques and the establishment of the functionalities needed for processing and analysing the full surveillance dataset obtained from Member States. The Surveillance system, which is available to the Commission and the Member States, further includes data mining capabilities and reporting functionalities.

| (20) | Commission Implementing Regulation (EU) 2021/414 (6) sets out technical arrangements for developing, maintaining and employing electronic systems for the exchange of information and for the storage of such information under the Code. Given the number of changes to that Regulation that would be necessary in order to take account of the fact that REX, PoUS and SURV3 have now or will become operational, and for reasons of clarity, Implementing Regulation (EU) 2021/414 should be repealed and replaced by a new Implementing Regulation. |
| --- | --- |

(20)

Commission Implementing Regulation (EU) 2021/414 (6) sets out technical arrangements for developing, maintaining and employing electronic systems for the exchange of information and for the storage of such information under the Code. Given the number of changes to that Regulation that would be necessary in order to take account of the fact that REX, PoUS and SURV3 have now or will become operational, and for reasons of clarity, Implementing Regulation (EU) 2021/414 should be repealed and replaced by a new Implementing Regulation.

| (21) | This Regulation respects the fundamental rights and observes the principles recognised by the Charter of Fundamental Rights of the European Union, and notably the right to protection of personal data. Where for the purposes of the application of the customs legislation of the Union it is necessary to process personal data in the electronic systems, those data must be processed in accordance with Regulations (EU) 2016/679 and (EU) 2018/1725. The personal data of economic operators and other persons processed by the electronic systems are restricted to the datasets as set out in Annex A, Title I, Chapter 1, in the table titled Data groups, Group 3 – Parties; Annex A, Title I, Chapter 2, Group 3 – Parties; Annex B, Title II, Group 13 – Parties; and Annex 12-01 to Commission Delegated Regulation (EU) 2015/2446 (7). |
| --- | --- |

(21)

This Regulation respects the fundamental rights and observes the principles recognised by the Charter of Fundamental Rights of the European Union, and notably the right to protection of personal data. Where for the purposes of the application of the customs legislation of the Union it is necessary to process personal data in the electronic systems, those data must be processed in accordance with Regulations (EU) 2016/679 and (EU) 2018/1725. The personal data of economic operators and other persons processed by the electronic systems are restricted to the datasets as set out in Annex A, Title I, Chapter 1, in the table titled Data groups, Group 3 – Parties; Annex A, Title I, Chapter 2, Group 3 – Parties; Annex B, Title II, Group 13 – Parties; and Annex 12-01 to Commission Delegated Regulation (EU) 2015/2446 (7).

| (22) | The European Data Protection Supervisor was consulted in accordance with Article 42 of Regulation (EU) 2018/1725. |
| --- | --- |

(22)

The European Data Protection Supervisor was consulted in accordance with Article 42 of Regulation (EU) 2018/1725.

| (23) | The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee, |
| --- | --- |

(23)

The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee,

HAS ADOPTED THIS REGULATION:

CHAPTER I

General provisions

Article 1

Scope

1.   This Regulation shall apply to the following central systems as developed or upgraded through the following projects referred to in the Annex to Implementing Decision (EU) 2019/2151:

| (a) | the Customs Decisions System (CDS), as developed through the Union Customs Code (referred to as ‘the Code’ or ‘UCC’) Customs Decisions project; |
| --- | --- |

(a)

the Customs Decisions System (CDS), as developed through the Union Customs Code (referred to as ‘the Code’ or ‘UCC’) Customs Decisions project;

| (b) | the Uniform User Management and Digital Signature (UUM&DS) system, as developed through the Direct trader access to the European Information Systems (Uniform User Management & Digital Signature) project; |
| --- | --- |

(b)

the Uniform User Management and Digital Signature (UUM&DS) system, as developed through the Direct trader access to the European Information Systems (Uniform User Management & Digital Signature) project;

| (c) | the European Binding Tariff Information (EBTI) system, as upgraded through the UCC Binding Tariff Information (BTI) project; |
| --- | --- |

(c)

the European Binding Tariff Information (EBTI) system, as upgraded through the UCC Binding Tariff Information (BTI) project;

| (d) | the Economic Operator Registration and Identification (EORI) system, as upgraded in line with the requirements of the Code through the EORI 2 project; |
| --- | --- |

(d)

the Economic Operator Registration and Identification (EORI) system, as upgraded in line with the requirements of the Code through the EORI 2 project;

| (e) | the Authorised Economic Operator (AEO) system, as upgraded in line with the requirements of the Code through the AEO upgrade project; |
| --- | --- |

(e)

the Authorised Economic Operator (AEO) system, as upgraded in line with the requirements of the Code through the AEO upgrade project;

| (f) | the Import Control System 2 (ICS2), as developed through the ICS2 project; |
| --- | --- |

(f)

the Import Control System 2 (ICS2), as developed through the ICS2 project;

| (g) | the Information Sheets (INF) for Special Procedures (INF SP) system, as developed through the UCC Information Sheets (INF) for Special Procedures project; |
| --- | --- |

(g)

the Information Sheets (INF) for Special Procedures (INF SP) system, as developed through the UCC Information Sheets (INF) for Special Procedures project;

| (h) | the Registered Exporter system (the REX system), as developed through the UCC REX project; |
| --- | --- |

(h)

the Registered Exporter system (the REX system), as developed through the UCC REX project;

| (i) | the Proof of Union Status (PoUS) system, as developed through the UCC PoUS project; |
| --- | --- |

(i)

the Proof of Union Status (PoUS) system, as developed through the UCC PoUS project;

| (j) | the Surveillance system, as developed through the UCC Surveillance 3 (SURV3) project. |
| --- | --- |

(j)

the Surveillance system, as developed through the UCC Surveillance 3 (SURV3) project.

2.   This Regulation shall apply to the following decentralised systems as developed or upgraded through the following projects referred to in the Annex to Implementing Decision (EU) 2019/2151:

| (a) | the Automated Export System (AES), as developed in line with the requirements of the Code through the AES project; |
| --- | --- |

(a)

the Automated Export System (AES), as developed in line with the requirements of the Code through the AES project;

| (b) | the New Computerised Transit System (NCTS), as upgraded in line with the requirements of the Code through the NCTS upgrade project; |
| --- | --- |

(b)

the New Computerised Transit System (NCTS), as upgraded in line with the requirements of the Code through the NCTS upgrade project;

| (c) | the Centralised Clearance for Import System (CCI), as developed through the UCC CCI project. |
| --- | --- |

(c)

the Centralised Clearance for Import System (CCI), as developed through the UCC CCI project.

3.   This Regulation shall also apply to the following central systems:

| (a) | the European Union Customs Trader Portal (EUCTP); |
| --- | --- |

(a)

the European Union Customs Trader Portal (EUCTP);

| (b) | the customs risk management system (CRMS) referred to in Article 36 of Implementing Regulation (EU) 2015/2447. |
| --- | --- |

(b)

the customs risk management system (CRMS) referred to in Article 36 of Implementing Regulation (EU) 2015/2447.

Article 2

Definitions

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

| (1) | ‘common component’ means a component of the electronic systems developed at Union level, which is available for all Member States or identified as common by the Commission for reasons of efficiency, security and rationalisation; |
| --- | --- |

(1)

‘common component’ means a component of the electronic systems developed at Union level, which is available for all Member States or identified as common by the Commission for reasons of efficiency, security and rationalisation;

| (2) | ‘national component’ means a component of the electronic systems developed at national level, which is available in the Member State that created such component or contributed to its joint creation; |
| --- | --- |

(2)

‘national component’ means a component of the electronic systems developed at national level, which is available in the Member State that created such component or contributed to its joint creation;

| (3) | ‘trans-European system’ means a collection of collaborating systems with responsibilities distributed across the national administrations and the Commission, and developed in cooperation with the Commission; |
| --- | --- |

(3)

‘trans-European system’ means a collection of collaborating systems with responsibilities distributed across the national administrations and the Commission, and developed in cooperation with the Commission;

| (4) | ‘central system’ means a trans-European system developed at Union level, consisting of common components, available for all Member States and which do not necessitate the creation of a national component; |
| --- | --- |

(4)

‘central system’ means a trans-European system developed at Union level, consisting of common components, available for all Member States and which do not necessitate the creation of a national component;

| (5) | ‘decentralised system’ means a trans-European system consisting of common and national components based on common specificiations; |
| --- | --- |

(5)

‘decentralised system’ means a trans-European system consisting of common and national components based on common specificiations;

| (6) | ‘EU Login’ is the Commission’s user authentication service, which allows authorised users to securely access a wide range of Commission web services; |
| --- | --- |

(6)

‘EU Login’ is the Commission’s user authentication service, which allows authorised users to securely access a wide range of Commission web services;

Article 3

Contact points for the electronic systems

The Commission and the Member States shall designate contact points for each of the electronic systems referred to in Article 1 of this Regulation, for the purposes of exchanging information to ensure a coordinated development, operation and maintenance of those electronic systems.

They shall communicate the details of those contact points to each other and inform each other immediately of any changes to those details.

CHAPTER II

CHAPTER II

EU customs trader portal

EU customs trader portal

Article 4

Objective and structure of the EUCTP

The EUCTP shall provide a unique entry point for economic operators and other persons to access the Specific Trader Portals of the trans-European systems referred to in Article 6(1) of this Regulation.

Article 5

Authentication and access to the EUCTP

1.   The authentication and access verification of economic operators and other persons for the purposes of access to the EUCTP shall be effected using the UUM&DS system.

For customs representatives to be authenticated and be able to access the EUCTP, their empowerment to act in that capacity shall be registered in the UUM&DS system or in an identity and access management system set up by a Member State pursuant to Article 20 of this Regulation. The empowerment shall not be registered for the purpose of accessing the EU Specific Trader Portal for PoUS as referred to in Article 95 of this regulation, or for accessing the shared trader interface for ICS2 as referred to in Article 45 of this Regulation.

2.   The authentication and access verification of Member States’ customs authorities for the purposes of access to the EUCTP shall be effected using the network services provided by the Commission.

3.   The authentication and access verification of the Commission’s staff for the purposes of access to the EUCTP shall be effected using the UUM&DS system or the network services provided by the Commission.

Article 6

Use of the EUCTP

1.   The EUCTP shall provide access to the specific trader portals of the trans-European systems EBTI, AEO, INF, REX and PoUS referred to in Articles 24, 38, 67, 82 and 95 of this Regulation, respectively, as well as to the shared trader interface for the ICS2 referred to in Article 45 of this Regulation.

2.   The EUCTP shall be used for the exchange of information between customs authorities of the Member States and economic operators and other persons, on the requests, applications, authorisations and decisions related to EBTI, AEO, INF, the REX system and PoUS.

3.   The EUCTP may be used for the exchange of information between customs authorities of the Member States and economic operators and other persons, on entry summary declarations and where applicable, on their amendments, issued referrals and invalidation related to the ICS2.

CHAPTER III

CHAPTER III

Customs decisions system

Customs decisions system

Article 7

Objective and structure of the CDS

1.   The CDS shall enable communication between the Commission, customs authorities of the Member States, economic operators and other persons for the purposes of submitting and processing applications and decisions referred to in Article 8(1) of this Regulation, as well as the management of decisions related to the authorisations, namely, amendments, revocations, annulments and suspensions.

2.   The CDS shall consist of the following common components:

| (a) | an EU trader portal; |
| --- | --- |

(a)

an EU trader portal;

| (b) | a central customs decisions management system (‘central CDMS’); |
| --- | --- |

(b)

a central customs decisions management system (‘central CDMS’);

| (c) | customer reference services (CRS). |
| --- | --- |

(c)

customer reference services (CRS).

3.   Member States may create the following national components:

| (a) | a national trader portal; |
| --- | --- |

(a)

a national trader portal;

| (b) | a national customs decisions management system (‘national CDMS’). |
| --- | --- |

(b)

a national customs decisions management system (‘national CDMS’).

Article 8

Use of the CDS

1.   The CDS shall be used for the purposes of submitting and processing applications for the following authorisations, as well as the management of decisions related to the applications or authorisations:

| (a) | authorisation for the simplification of the determination of amounts being part of the customs value of the goods, as referred to in Article 73 of the Code; |
| --- | --- |

(a)

authorisation for the simplification of the determination of amounts being part of the customs value of the goods, as referred to in Article 73 of the Code;

| (b) | authorisation for the provision of a comprehensive guarantee, including possible reduction or waiver, as referred to in Article 95 of the Code; |
| --- | --- |

(b)

authorisation for the provision of a comprehensive guarantee, including possible reduction or waiver, as referred to in Article 95 of the Code;

| (c) | authorisation of deferment of the payment of the duty payable, as far as the permission is not granted in relation to a single operation, as referred to in Article 110 of the Code; |
| --- | --- |

(c)

authorisation of deferment of the payment of the duty payable, as far as the permission is not granted in relation to a single operation, as referred to in Article 110 of the Code;

| (d) | authorisation for the operation of temporary storage facilities, as referred to in Article 148 of the Code; |
| --- | --- |

(d)

authorisation for the operation of temporary storage facilities, as referred to in Article 148 of the Code;

| (e) | authorisation to establish regular shipping services, as referred to in Article 120 of Delegated Regulation (EU) 2015/2446; |
| --- | --- |

(e)

authorisation to establish regular shipping services, as referred to in Article 120 of Delegated Regulation (EU) 2015/2446;

| (f) | authorisation for the status of authorised issuer, as referred to in Article 128 of Delegated Regulation (EU) 2015/2446; |
| --- | --- |

(f)

authorisation for the status of authorised issuer, as referred to in Article 128 of Delegated Regulation (EU) 2015/2446;

| (g) | authorisation for the regular use of a simplified declaration, as referred to in Article 166(2) of the Code; |
| --- | --- |

(g)

authorisation for the regular use of a simplified declaration, as referred to in Article 166(2) of the Code;

| (h) | authorisation for centralised clearance, as referred to in Article 179 of the Code; |
| --- | --- |

(h)

authorisation for centralised clearance, as referred to in Article 179 of the Code;

| (i) | authorisation to lodge a customs declaration through an entry of data in the declarant’s records, including for the export procedure, as referred to in Article 182 of the Code; |
| --- | --- |

(i)

authorisation to lodge a customs declaration through an entry of data in the declarant’s records, including for the export procedure, as referred to in Article 182 of the Code;

| (j) | authorisation for self-assessment, as referred to in Article 185 of the Code; |
| --- | --- |

(j)

authorisation for self-assessment, as referred to in Article 185 of the Code;

| (k) | authorisation for the status of an authorised weigher of bananas, as referred to in Article 155 of Delegated Regulation (EU) 2015/2446; |
| --- | --- |

(k)

authorisation for the status of an authorised weigher of bananas, as referred to in Article 155 of Delegated Regulation (EU) 2015/2446;

| (l) | authorisation for the use of the inward processing procedure, as referred to in Article 211(1), point (a), of the Code; |
| --- | --- |

(l)

authorisation for the use of the inward processing procedure, as referred to in Article 211(1), point (a), of the Code;

| (m) | authorisation for the use of the outward processing procedure, as referred to in Article 211(1), point (a), of the Code; |
| --- | --- |

(m)

authorisation for the use of the outward processing procedure, as referred to in Article 211(1), point (a), of the Code;

| (n) | authorisation for the use of the end-use procedure, as referred to in Article 211(1), point (a), of the Code; |
| --- | --- |

(n)

authorisation for the use of the end-use procedure, as referred to in Article 211(1), point (a), of the Code;

| (o) | authorisation for the use of the temporary admission procedure, as referred to in Article 211(1), point (a), of the Code; |
| --- | --- |

(o)

authorisation for the use of the temporary admission procedure, as referred to in Article 211(1), point (a), of the Code;

| (p) | authorisation for the operation of storage facilities for customs warehousing of goods, as referred to in Article 211(1), point (b) of the Code; |
| --- | --- |

(p)

authorisation for the operation of storage facilities for customs warehousing of goods, as referred to in Article 211(1), point (b) of the Code;

| (q) | authorisation for the status of an authorised consignee for TIR operation, as referred to in Article 230 of the Code; |
| --- | --- |

(q)

authorisation for the status of an authorised consignee for TIR operation, as referred to in Article 230 of the Code;

| (r) | authorisation for the status of an authorised consignor for Union transit, as referred to in Article 233(4), point (a) of the Code; |
| --- | --- |

(r)

authorisation for the status of an authorised consignor for Union transit, as referred to in Article 233(4), point (a) of the Code;

| (s) | authorisation for the status of an authorised consignee for Union transit, as referred to in Article 233(4), point (b), of the Code; |
| --- | --- |

(s)

authorisation for the status of an authorised consignee for Union transit, as referred to in Article 233(4), point (b), of the Code;

| (t) | authorisation for the use of seals of a special type, as referred to in Article 233(4), point (c), of the Code; |
| --- | --- |

(t)

authorisation for the use of seals of a special type, as referred to in Article 233(4), point (c), of the Code;

| (u) | authorisation to use a transit declaration with reduced data requirements, as referred to in Article 233(4), point (d), of the Code; |
| --- | --- |

(u)

authorisation to use a transit declaration with reduced data requirements, as referred to in Article 233(4), point (d), of the Code;

| (v) | authorisation for the use of an electronic transport document as a customs declaration, as referred to in Article 233(4), point (e), of the Code. |
| --- | --- |

(v)

authorisation for the use of an electronic transport document as a customs declaration, as referred to in Article 233(4), point (e), of the Code.

2.   The common components of the CDS shall be used with respect to applications and authorisations referred to in paragraph 1, as well as the management of decisions related to those applications and authorisations, where those authorisations or decisions may have an impact in more than one Member State.

3.   A Member State may decide that the common components of the CDS may be used with respect to applications and authorisations referred to in paragraph 1, as well as the management of decisions related to those applications and authorisations, where those authorisations or decisions have an impact only in that Member State.

4.   The CDS shall not be used with respect to applications, authorisations or decisions other than those listed in paragraph 1.

Article 9

Authentication and access to the CDS

1.   The authentication and access verification of economic operators and other persons for the purposes of access to the common components of the CDS shall be effected using the UUM&DS system.

For customs representatives to be authenticated and be able to access the common components of the CDS, their empowerment to act in that capacity shall be registered in the UUM&DS system or in an identity and access management system set up by a Member State pursuant to Article 20 of this Regulation.

2.   The authentication and access verification of Member States’ customs authorities for the purposes of access to the common components of the CDS shall be effected using the network services provided by the Commission.

3.   The authentication and access verification of the Commission’s staff for the purposes of access to the common components of the CDS shall be effected using the UUM&DS system or the network services provided by the Commission.

Article 10

EU trader portal

1.   The EU trader portal shall be an entry point to the CDS for economic operators and other persons.

2.   The EU trader portal shall interoperate with the central CDMS as well as with national CDMS where created by Member States.

3.   The EU trader portal shall be used for applications and authorisations referred to in Article 8(1) of this Regulation, as well as the management of decisions related to those applications and authorisations, where those authorisations or decisions may have an impact in more than one Member State.

4.   A Member State may decide that the EU trader portal may be used for applications and authorisations referred to in Article 8(1) of this Regulation, as well as the management of decisions related to those applications and authorisations, where those authorisations or decisions have an impact only in that Member State.

Where a Member State takes a decision to use the EU trader portal for authorisations or decisions that have an impact only in that Member State, it shall inform the Commission thereof.

Article 11

Central CDMS

1.   The central CDMS shall be used by the customs authorities of the Member States for the processing of the applications and authorisations referred to in Article 8(1) of this Regulation, as well as the management of decisions related to those applications and authorisations for the purposes of verifying whether the conditions for the acceptance of an application and for taking a decision are fulfilled.

2.   The central CDMS shall interoperate with the EU trader portal, the customer reference services referred to in Article 13 of this Regulation, and the national CDMS, where created by the Member States.

Article 12

Consultation between the customs authorities of the Member States using the CDMS

A customs authority of a Member State shall use the central CDMS when it needs to consult a customs authority of another Member State before taking a decision regarding the applications or authorisations referred to in Article 8(1) of this Regulation.

Article 13

Customer reference services

1.   The customer reference services shall be used for the central storage of data relating to the authorisations referred to in Article 8(1), as well as decisions related to those authorisations, and shall enable the consultation, replication and validation of those authorisations by other electronic systems established for the purposes of Article 16 of the Code.

2.   The customer reference services shall be used for the central storage of data relating to the registrations from the REX system referred to in Articles 80 and 87 of this Regulation, and shall enable the consultation, replication and validation of those registrations by other electronic systems established for the purposes of Article 16 of the Code. Those services shall be used by Andorra, Norway, San Marino, Switzerland and Türkiye to store data from their national registered economic operators, and to consult, replicate, and validate data from the REX system for Member States and from the REX system for third countries with which the Union has a preferential trade arrangement, for the purpose of their respective schemes of Generalised System of Preferences.

3.   The customer reference services shall be used to store data from the EORI, EBTI and AEO systems and shall enable the consultation, replication and validation of those data by other electronic systems established for the purposes of Article 16 of the Code.

Article 14

National trader portal

1.   The national trader portal, where created, shall be an additional entry point to the CDS for economic operators and other persons.

2.   With respect to applications and authorisations referred to in Article 8(1) of this Regulation, as well as the management of decisions related to those applications and authorisations where those authorisations or decisions may have an impact in more than one Member State, economic operators and other persons may choose to use the national trader portal, where created, or the EU trader portal.

3.   The national trader portal shall interoperate with the national CDMS, where created.

4.   Where a Member State creates a national trader portal, it shall inform the Commission thereof.

Article 15

National CDMS

1.   A national CDMS, where created, shall be used by the customs authority of the Member State which created it for processing the applications and authorisations referred to in Article 8(1) of this Regulation, as well as the management of decisions related to those applications and authorisations for the purposes of verifying whether the conditions for the acceptance of an application and for taking a decision are fulfilled.

2.   The national CDMS shall interoperate with the central CDMS for the purposes of consultation between the customs authorities of the Member States as referred to in Article 12 of this Regulation.

CHAPTER IV

CHAPTER IV

Uniform user management and digital signature system

Uniform user management and digital signature system

Article 16

Objective and structure of the UUM&DS system

1.   The UUM&DS system shall enable the communication between the Commission and the Member States’ identity and access management systems referred to in Article 20 of this Regulation for the purposes of providing secure authorised access to the electronic systems to the Commission’s staff, economic operators and other persons.

2.   The UUM&DS system shall consist of the following common components:

| (a) | an access management system; |
| --- | --- |

(a)

an access management system;

| (b) | an administration management system. |
| --- | --- |

(b)

an administration management system.

3.   A Member State shall create an identity and access management system as a national component of the UUM&DS system.

Article 17

Use of the UUM&DS system

The UUM&DS system shall be used to ensure the authentication and access verification of:

| (a) | economic operators and other persons for the purposes of having access to the EUCTP, the common components of the CDS, the EBTI system, the AEO system, the INF SP system, the REX system, the PoUS system and the ICS2; |
| --- | --- |

(a)

economic operators and other persons for the purposes of having access to the EUCTP, the common components of the CDS, the EBTI system, the AEO system, the INF SP system, the REX system, the PoUS system and the ICS2;

| (b) | the Commission’s staff for the purposes of having access to the EUCTP, the common components of the CDS, the EBTI system, the EORI system, AEO system, the ICS2, AES, NCTS, CRMS, CCI, the REX system, the PoUS system and INF SP system for the purposes of maintenance and management of the UUM&DS system. |
| --- | --- |

(b)

the Commission’s staff for the purposes of having access to the EUCTP, the common components of the CDS, the EBTI system, the EORI system, AEO system, the ICS2, AES, NCTS, CRMS, CCI, the REX system, the PoUS system and INF SP system for the purposes of maintenance and management of the UUM&DS system.

Article 18

Access management system

The Commission shall set up the access management system to validate the access requests submitted by economic operators and other persons within the UUM&DS system by interoperating with the Member States’ identity and access management systems referred to in Article 20 of this Regulation.

Article 19

Administration management system

The Commission shall set up the administration management system to manage the authentication and authorisation rules for validating the identification data of economic operators and other persons for the purposes of allowing access to the electronic systems.

Article 20

Member States’ identity and access management systems

The Member States shall set up an identity and access management system to ensure:

| (a) | a secure registration and storage of identification data of economic operators and other persons; |
| --- | --- |

(a)

a secure registration and storage of identification data of economic operators and other persons;

| (b) | a secure exchange of signed and encrypted identification data of economic operators and other persons. |
| --- | --- |

(b)

a secure exchange of signed and encrypted identification data of economic operators and other persons.

CHAPTER V

CHAPTER V

European binding tariff information system

European binding tariff information system

Article 21

Objective and structure of the EBTI system

1.   The EBTI system shall in accordance with Articles 33 and 34 of the Code, enable the following:

| (a) | communication between the Commission, customs authorities of the Member States, economic operators and other persons for the purposes of submitting and processing BTI applications and BTI decisions; |
| --- | --- |

(a)

communication between the Commission, customs authorities of the Member States, economic operators and other persons for the purposes of submitting and processing BTI applications and BTI decisions;

| (b) | the management of any subsequent event which may affect the original application or decision; |
| --- | --- |

(b)

the management of any subsequent event which may affect the original application or decision;

| (c) | the monitoring of the compulsory use of BTI decisions; |
| --- | --- |

(c)

the monitoring of the compulsory use of BTI decisions;

| (d) | the monitoring and management of the extended use of BTI decisions; |
| --- | --- |

(d)

the monitoring and management of the extended use of BTI decisions;

| (e) | the monitoring by the Commission of BTI decisions, including the processes for applying for, taking and managing those decisions, for the purposes of ensuring the uniform application of the customs legislation and other Union legislation. |
| --- | --- |

(e)

the monitoring by the Commission of BTI decisions, including the processes for applying for, taking and managing those decisions, for the purposes of ensuring the uniform application of the customs legislation and other Union legislation.

2.   The EBTI system shall consist of the following common components:

| (a) | an EU Specific Trader Portal for EBTI; |
| --- | --- |

(a)

an EU Specific Trader Portal for EBTI;

| (b) | a central EBTI system; |
| --- | --- |

(b)

a central EBTI system;

| (c) | capability to monitor the usage of BTI decisions. |
| --- | --- |

(c)

capability to monitor the usage of BTI decisions.

3.   Member States may create, as a national component, a national binding tariff information system (‘national BTI system’) together with a national trader portal.

Article 22

Use of the EBTI system

1.   The EBTI system shall be used for the submission, processing, exchange and storage of information pertaining to applications and decisions related to BTI or to any subsequent event which may affect the original application or decision as referred to in Article 21(1) of Implementing Regulation (EU) 2015/2447.

2.   The EBTI system shall be used to support the monitoring by the customs authorities of the Member States of the compliance with the obligations resulting from the BTI in accordance with Article 21(3) of Implementing Regulation (EU) 2015/2447.

3.   The EBTI system shall be used by the Commission to inform the Member States, pursuant to the third subparagraph of Article 22(2) of Implementing Regulation (EU) 2015/2447, as soon as the quantities of goods that may be cleared during a period of extended use have been reached.

Article 23

Authentication and access to the EBTI system

1.   The authentication and access verification of economic operators and other persons for the purposes of access to the common components of the EBTI system shall be effected using the UUM&DS system.

For customs representatives to be authenticated and be able to access the common components of the EBTI system, their empowerment to act in that capacity shall be registered in the UUM&DS system or in an identity and access management system set up by a Member State pursuant to Article 20 of this Regulation.

2.   The authentication and access verification of Member States’ customs authorities for the purposes of access to the common components of the EBTI system shall be effected using the network services provided by the Commission.

3.   The authentication and access verification of the Commission’s staff for the purposes of access to the common components of the EBTI system shall be effected using the UUM&DS system or the network services provided by the Commission.

Article 24

EU Specific Trader Portal for EBTI

1.   The EU Specific Trader Portal for EBTI shall communicate with the EUCTP, where the EUCTP shall be an entry point to the EBTI system for economic operators and other persons.

2.   The EU Specific Trader Portal for EBTI shall interoperate with the central EBTI system and offer redirection to national trader portals where national BTI systems have been created by Member States.

3.   The EU Specific Trader Portal for EBTI shall be used for submitting and exchanging information pertaining to applications and decisions related to BTI or to any subsequent event which may affect the original application or decision.

Article 25

Central EBTI system

1.   The central EBTI system shall be used by the customs authorities of the Member States to process, exchange and store information pertaining to applications and decisions related to BTI or to any subsequent event which may affect the original application or decision, for the purposes of verifying whether the conditions for the acceptance of an application, and for taking a decision, are fulfilled.

2.   The central EBTI system shall be used by the customs authorities of the Member States for the purposes of consultation, processing, exchange and storage of information as referred to in Article 16(4), Article 17, Article 21(2), point (b), and Article 21(5) of Implementing Regulation (EU) 2015/2447.

3.   The central EBTI system shall interoperate with the EU Specific Trader Portal for EBTI, and with the national BTI systems, where created.

Article 26

Consultation between the customs authorities of the Member States using the central EBTI system

A customs authority of a Member State shall use the central EBTI system for the purposes of consulting a customs authority of another Member State in order to ensure compliance with Article 16(1) of Implementing Regulation (EU) 2015/2447.

Article 27

Monitoring of the usage of BTI decisions

The capability to monitor the usage of BTI decisions shall be used for the purposes of Article 21(3) and of the third subparagraph of Article 22(2) of Implementing Regulation (EU) 2015/2447.

Article 28

National trader portal

1.   Where a Member State has created a national BTI system in accordance with Article 21(3) of this Regulation, the national trader portal shall be the main entry point to the national BTI system for economic operators and other persons.

2.   Economic operators and other persons shall use the national trader portal, where created, with respect to applications and decisions related to BTI or to any subsequent event which may affect the original application or decision.

3.   The national trader portal shall interoperate with the national BTI system, where created.

4.   The national trader portal shall facilitate processes equivalent to those facilitated by the EU Specific Trader Portal for EBTI.

5.   Where a Member State creates a national trader portal, it shall inform the Commission thereof. The Commission shall ensure that the national trader portal can be accessed directly from the EU Specific Trader Portal for EBTI.

Article 29

National BTI system

1.   A national BTI system, where created, shall be used by the customs authority of the Member State which created it to process, exchange and store information pertaining to applications and decisions related to BTI or to any subsequent event which may affect the original application or decision, for the purposes of verifying whether the conditions for the acceptance of an application or for taking a decision are fulfilled.

2.   The customs authority of a Member State shall use its national BTI system for the purposes of consultation, processing, exchange and storage of information as referred to in Article 16(4), Article 17, Article 21(2), point (b), and Article 21(5) of Implementing Regulation (EU) 2015/2447, unless it uses the central EBTI system for those purposes.

3.   The national BTI system shall interoperate with the national trader portal and with the central EBTI system.

CHAPTER VI

CHAPTER VI

Economic operator registration and identification system

Economic operator registration and identification system

Article 30

Objective and structure of the EORI system

The EORI system shall enable a unique registration and identification, at Union level, of economic operators and other persons.

The EORI system shall consist of the following components:

| (a) | a central EORI system; |
| --- | --- |

(a)

a central EORI system;

| (b) | national EORI systems, where created by the Member States. |
| --- | --- |

(b)

national EORI systems, where created by the Member States.

Article 31

Use of the EORI system

1.   The EORI system shall be used by the Member States’ customs authorities for the following purposes:

| (a) | to receive the data for the registration of economic operators and other persons as referred to in Annex 12-01 to Delegated Regulation (EU) 2015/2446 (‘EORI data’) provided by the Member States; |
| --- | --- |

(a)

to receive the data for the registration of economic operators and other persons as referred to in Annex 12-01 to Delegated Regulation (EU) 2015/2446 (‘EORI data’) provided by the Member States;

| (b) | to centrally store EORI data pertaining to the registration and identification of economic operators and other persons; |
| --- | --- |

(b)

to centrally store EORI data pertaining to the registration and identification of economic operators and other persons;

| (c) | to make available EORI data to the Member States. |
| --- | --- |

(c)

to make available EORI data to the Member States.

2.   The EORI system shall enable, to the customs authorities of the Member States, online access to the EORI data stored at central system level.

3.   The EORI system shall interoperate with all the other electronic systems where the EORI number is used.

Article 32

Authentication and access to the central EORI system

1.   The authentication and access verification of Member States’ customs authorities for the purposes of access to the common components of the EORI system shall be effected using the network services provided by the Commission.

2.   The authentication and access verification of the Commission’s staff for the purposes of access to the common components of the EORI system shall be effected using the UUM&DS system or the network services provided by the Commission.

Article 33

Central EORI system

1.   The central EORI system shall be used by the customs authorities of the Member States for the purposes of Article 7 of Implementing Regulation (EU) 2015/2447.

2.   The central EORI system shall interoperate with the national EORI systems, where created.

Article 34

National EORI system

1.   A national EORI system, where created, shall be used by the customs authority of the Member State which created it to exchange and store EORI data.

2.   A national EORI system shall interoperate with the central EORI system.

CHAPTER VII

CHAPTER VII

Authorised economic operator system

Authorised economic operator system

Article 35

Objective and structure of the AEO system

1.   The AEO system shall enable communication between the Commission, customs authorities of the Member States, economic operators and other persons for the purposes of submitting and processing AEO applications and granting of AEO authorisations as well as the management of any subsequent event which may affect the original decision as referred to in Article 30(1) of Implementing Regulation (EU) 2015/2447.

2.   The AEO system shall consist of the following common components:

| (a) | an EU Specific Trader Portal for AEO; |
| --- | --- |

(a)

an EU Specific Trader Portal for AEO;

| (b) | a central AEO system. |
| --- | --- |

(b)

a central AEO system.

3.   Member States may create the following national components:

| (a) | a national trader portal; |
| --- | --- |

(a)

a national trader portal;

| (b) | a national Authorised Economic Operator system (‘national AEO system’). |
| --- | --- |

(b)

a national Authorised Economic Operator system (‘national AEO system’).

Article 36

Use of the AEO system

1.   The AEO system shall be used for the submission, exchange, processing and storage of information pertaining to AEO applications and decisions or to any subsequent event which may affect the original decision as referred to in Article 30(1) and Article 31(1) and (4) of Implementing Regulation (EU) 2015/2447.

2.   Customs authorities of the Member States shall use the AEO system to fulfil their obligations under Article 31(1) and (4) of Implementing Regulation (EU) 2015/2447 and to keep record of the relevant consultations.

Article 37

Authentication and access to the central AEO system

1.   The authentication and access verification of economic operators and other persons for the purposes of access to the common components of the AEO system shall be effected using the UUM&DS system.

For customs representatives to be authenticated and be able to access the common components of the AEO system, their empowerment to act in that capacity shall be registered in the UUM&DS system or in an identity and access management system set up by a Member State pursuant to Article 20 of this Regulation.

2.   The authentication and access verification of Member States’ customs authorities for the purposes of access to the common components of the AEO system shall be effected using the network services provided by the Commission.

3.   The authentication and access verification of the Commission’s staff for the purposes of access to the common components of the AEO system shall be effected using the UUM&DS system or the network services provided by the Commission.

Article 38

EU Specific Trader Portal for AEO

1.   The EU Specific Trader Portal for AEO shall communicate with the EUCTP, where the EUCTP shall be an entry point to the AEO system for economic operators and other persons.

2.   The EU Specific Trader Portal for AEO shall interoperate with the central AEO system and offer redirection to the national trader portal, where created.

3.   The EU Specific Trader Portal for AEO shall be used for submitting and exchanging information pertaining to AEO applications and decisions or to any subsequent event which may affect the original decision.

Article 39

Central AEO system

1.   The central AEO system shall be used by the customs authorities of the Member States to exchange and store information pertaining to AEO applications and decisions or to any subsequent event which may affect the original decision.

2.   The customs authorities of the Member States shall use the central AEO system for the purposes of the exchange and storage of information, consultation and the management of decisions as referred to in Articles 30 and 31 of Implementing Regulation (EU) 2015/2447.

3.   The central AEO system shall interoperate with the EU trader portal and with the national AEO systems, where created.

Article 40

National trader portal

1.   The national trader portal, where created, shall allow the exchange of information pertaining to AEO applications and decisions.

2.   Economic operators and other persons shall use the national trader portal, where created, to exchange information with the customs authorities of the Member States with respect to AEO applications and decisions.

3.   The national trader portal shall interoperate with the national AEO system.

Article 41

National AEO system

1.   A national AEO system, where created, shall be used by the customs authority of the Member State which created it to exchange and store information pertaining to AEO applications and decisions or to any subsequent event which may affect the original decision.

2.   The national AEO system shall interoperate with the national trader portal, where created, and with the central AEO system.

CHAPTER VIII

CHAPTER VIII

Import control system 2

Import control system 2

Article 42

Objective and structure of the ICS2

1.   The ICS2 shall support communication between customs authorities of the Member States and the Commission, and between economic operators and other persons and the customs authorities of the Member States, for the following purposes:

| (a) | fulfilment of entry summary declaration requirements; |
| --- | --- |

(a)

fulfilment of entry summary declaration requirements;

| (b) | risk analysis by customs authorities of the Member States primarily for security and safety purposes and for customs measures aimed at mitigating relevant risks including customs controls; |
| --- | --- |

(b)

risk analysis by customs authorities of the Member States primarily for security and safety purposes and for customs measures aimed at mitigating relevant risks including customs controls;

| (c) | communication between customs authorities of the Member States for the purpose of fulfilment of entry summary declaration requirements; |
| --- | --- |

(c)

communication between customs authorities of the Member States for the purpose of fulfilment of entry summary declaration requirements;

| (d) | ensuring uniform application of the customs legislation and minimising risks, using among others processing, comparing, analysing data by the Member States and the Commission, enriching and communicating data to Member States. |
| --- | --- |

(d)

ensuring uniform application of the customs legislation and minimising risks, using among others processing, comparing, analysing data by the Member States and the Commission, enriching and communicating data to Member States.

2.   The ICS2 shall consist of the following common components:

| (a) | a shared trader interface; |
| --- | --- |

(a)

a shared trader interface;

| (b) | a common repository. |
| --- | --- |

(b)

a common repository.

3.   Each Member State shall create its national entry system as a national component.

4.   A Member State may create its national trader interface as a national component.

Article 43

Use of the ICS2

1.   The ICS2 shall be used for the following purposes:

| (a) | submitting, processing and storing the particulars of entry summary declarations, requests for amendments and invalidations referred to in Articles 127 and 129 of the Code; |
| --- | --- |

(a)

submitting, processing and storing the particulars of entry summary declarations, requests for amendments and invalidations referred to in Articles 127 and 129 of the Code;

| (b) | receiving, processing and storing the particulars of entry summary declarations extracted from declarations as referred to in Article 130 of the Code; |
| --- | --- |

(b)

receiving, processing and storing the particulars of entry summary declarations extracted from declarations as referred to in Article 130 of the Code;

| (c) | submitting, processing and storing of information regarding notifications of arrival of a sea-going vessel or an aircraft as referred to in Article 133 of the Code; |
| --- | --- |

(c)

submitting, processing and storing of information regarding notifications of arrival of a sea-going vessel or an aircraft as referred to in Article 133 of the Code;

| (d) | receiving, processing and storing of information regarding presentation of goods to customs as referred to in Article 139 of the Code; |
| --- | --- |

(d)

receiving, processing and storing of information regarding presentation of goods to customs as referred to in Article 139 of the Code;

| (e) | receiving, processing and storing of information regarding risk analysis requests and results, control recommendations, decisions on controls, and control results as referred to in Articles 46(3) and (5) and 47(2) of the Code; |
| --- | --- |

(e)

receiving, processing and storing of information regarding risk analysis requests and results, control recommendations, decisions on controls, and control results as referred to in Articles 46(3) and (5) and 47(2) of the Code;

| (f) | receiving, processing, storing and communicating of the notifications and information to economic operators or other persons as referred to in Article 186(2), point (e), and Article 186(3) to (6) of Implementing Regulation (EU) 2015/2447 and Article 24(2) of Delegated Regulation (EU) 2015/2446; |
| --- | --- |

(f)

receiving, processing, storing and communicating of the notifications and information to economic operators or other persons as referred to in Article 186(2), point (e), and Article 186(3) to (6) of Implementing Regulation (EU) 2015/2447 and Article 24(2) of Delegated Regulation (EU) 2015/2446;

| (g) | submitting, processing and storing of information by the economic operators or other persons requested by customs authorities of the Member States pursuant to Article 186(3) and (4) of Implementing Regulation (EU) 2015/2447. |
| --- | --- |

(g)

submitting, processing and storing of information by the economic operators or other persons requested by customs authorities of the Member States pursuant to Article 186(3) and (4) of Implementing Regulation (EU) 2015/2447.

2.   The ICS2 shall be used to support the monitoring and evaluating by the Commission and the Member States of the implementation of the common safety and security risk criteria and standards and of the control measures and priority control areas referred to in Article 46(3) of the Code.

3.   In order to further support risk management processes, in addition to data referred to in paragraph 1, the ICS2 shall be used to collect, store, process and analyse the following elements of information:

| (a) | other information referred to in paragraph 1 of this article; |
| --- | --- |

(a)

other information referred to in paragraph 1 of this article;

| (b) | risk information and risk analysis results exchanged under Article 46(5) of the Code; |
| --- | --- |

(b)

risk information and risk analysis results exchanged under Article 46(5) of the Code;

| (c) | data exchanged under Article 47(2) of the Code; |
| --- | --- |

(c)

data exchanged under Article 47(2) of the Code;

| (d) | data collected by the Member States or the Commission from national, Union or international sources under Article 46(4), second subparagraph, of the Code. |
| --- | --- |

(d)

data collected by the Member States or the Commission from national, Union or international sources under Article 46(4), second subparagraph, of the Code.

Article 44

Authentication and access to the ICS2

1.   The authentication and access verification of economic operators and other persons for the purposes of access to the common components of the ICS2 shall be effected using the UUM&DS system.

2.   The authentication and access verification of Member States’ customs authorities for the purposes of access to the common components of the ICS2 shall be effected using the network services provided by the Commission.

3.   The authentication and access verification of the Commission’s staff for the purposes of access to the common components of the ICS2 shall be effected using the UUM&DS system or the network services provided by the Commission.

Article 45

Shared trader interface

1.   The shared trader interface shall be an entry point to the ICS2 for economic operators and other persons for the purpose of Article 182(1a) of Implementing Regulation (EU) 2015/2447.

2.   The shared trader interface shall interoperate with the ICS2 common repository referred to in Article 46 of this Regulation.

3.   The shared trader interface shall be used for submissions, requests for amendments, requests for invalidations, processing and storage of the particulars of the entry summary declarations and notifications of arrival, as well as exchange of information between the customs authorities of the Member States and economic operators and other persons.

Article 46

The ICS2 common repository

1.   The ICS2 common repository shall be used by the Commission and the customs authorities of the Member States for the processing, storing and exchange of the particulars of entry summary declarations, requests for amendment, requests for invalidation, notifications of arrival, information regarding presentation of goods, information regarding risk analysis requests and results, control recommendations, control decisions, and control results and information exchanged with economic operators or other persons.

2.   The ICS2 common repository shall be used by the Commission and the Member States for the purpose of statistics and evaluation, and for the exchange of entry summary declaration information between Member States, and between the Commission and the Member States.

3.   The ICS2 common repository shall be used by the Commission and the Member States for the purpose of collecting, storing, processing and analysing additional elements of information in conjunction with entry summary declarations, for providing support to risk management processes as referred to in Article 43(3) of this Regulation through the ICS2 safety and security analytics functionality.

4.   The ICS2 common repository shall interoperate with the shared trader interface, the national trader interfaces where created by the Member States, and with the national entry systems.

Article 47

Exchange of information between customs authorities of the Member States using the ICS2 common repository

A customs authority of a Member State shall use the ICS2 common repository to exchange information with a customs authority of another Member State in accordance with Article 186(2), point (a), of Implementing Regulation (EU) 2015/2447 before completing the risk analysis primarily for security and safety purposes.

A customs authority of a Member State shall also use the ICS2 common repository to exchange information with a customs authority of another Member State on the recommended controls, decisions taken with regard to recommended controls and on the results of customs controls in accordance with Article 186(7) and (7a) of Implementing Regulation (EU) 2015/2447.

Article 48

National trader interface

1.   The national trader interface, where created by the Member States, shall be an entry point to the ICS2 for economic operators and other persons in accordance with Article 182(1a) of Implementing Regulation (EU) 2015/2447 where the submission is addressed to the Member State operating the national trader interface.

2.   With respect to submissions, amendments, invalidation, processing, storage of the particulars of the entry summary declarations and notifications of arrival, as well as exchange of information between the custom authorities and economic operators and other persons, economic operators and other persons may choose to use the national trader interface, where created, or the shared trader interface.

3.   The national trader interface, where created, shall interoperate with the ICS2 common repository.

4.   Where a Member State creates a national trader interface, it shall inform the Commission thereof.

Article 49

National entry system

1.   A national entry system shall be used by the customs authority of the relevant Member State for the following purposes:

| (a) | exchange of entry summary declaration particulars extracted from the declarations referred in Article 130 of the Code; |
| --- | --- |

(a)

exchange of entry summary declaration particulars extracted from the declarations referred in Article 130 of the Code;

| (b) | exchange of information and notifications with the ICS2 common repository for information regarding arrival of sea-going vessel or an aircraft; |
| --- | --- |

(b)

exchange of information and notifications with the ICS2 common repository for information regarding arrival of sea-going vessel or an aircraft;

| (c) | exchange of information regarding presentation of goods; |
| --- | --- |

(c)

exchange of information regarding presentation of goods;

| (d) | processing of risk analysis requests, exchange and processing of information regarding risk analysis results, of control recommendations, of control decisions and of control results. |
| --- | --- |

(d)

processing of risk analysis requests, exchange and processing of information regarding risk analysis results, of control recommendations, of control decisions and of control results.

It shall also be used in the cases where a customs authority receives further information from the economic operators and other persons.

2.   The national entry system shall interoperate with the ICS2 common repository.

3.   The national entry system shall interoperate with systems developed at national level for the purpose of retrieving the information referred to in paragraph 1.

CHAPTER IX

CHAPTER IX

Automated export system

Automated export system

Article 50

Objective and structure of the AES

1.   The AES shall enable communication between customs authorities of the Member States, and between customs authorities of the Member States and economic operators and other persons for the purposes of submitting and processing export and re-export declarations where goods are taken out of the customs territory of the Union. The AES may also enable communication between customs authorities of the Member States for the purposes of transmitting the exit summary declarations particulars in the situations referred to in the second subparagraph of Article 271(1) of the Code.

2.   The AES shall consist of the following common components:

| (a) | a common communication network; |
| --- | --- |

(a)

a common communication network;

| (b) | central services. |
| --- | --- |

(b)

central services.

3.   Member States shall create the following national components:

| (a) | a national trader portal; |
| --- | --- |

(a)

a national trader portal;

| (b) | a national export system (‘national AES’); |
| --- | --- |

(b)

a national export system (‘national AES’);

| (c) | a common interface between AES and NCTS at national level; |
| --- | --- |

(c)

a common interface between AES and NCTS at national level;

| (d) | a common interface between AES and the Excise Movement Control System (EMCS) at national level. |
| --- | --- |

(d)

a common interface between AES and the Excise Movement Control System (EMCS) at national level.

Article 51

Use of the AES

The AES shall be used for the following purposes where goods are taken out of the customs territory of the Union or moved to or out of special fiscal territories:

| (a) | to ensure the implementation of formalities at export and exit determined by the Code; |
| --- | --- |

(a)

to ensure the implementation of formalities at export and exit determined by the Code;

| (b) | to submit and process export and re-export declarations; |
| --- | --- |

(b)

to submit and process export and re-export declarations;

| (c) | to handle message exchanges between the customs office of export and customs office of exit and, in respect of Centralised Clearance at Export, between the supervising customs office and customs office of presentation; |
| --- | --- |

(c)

to handle message exchanges between the customs office of export and customs office of exit and, in respect of Centralised Clearance at Export, between the supervising customs office and customs office of presentation;

| (d) | to handle message exchanges between the customs office of lodgement and customs office of exit in the situations referred to in the second subparagraph of Article 271(1) of the Code. |
| --- | --- |

(d)

to handle message exchanges between the customs office of lodgement and customs office of exit in the situations referred to in the second subparagraph of Article 271(1) of the Code.

Article 52

Authentication and access to the AES

1.   Economic operators and other persons shall have access only to the national AES via the national trader portal. The authentication and access verification shall be determined by the Member States.

2.   The authentication and access verification of Member States’ customs authorities for the purposes of access to the common components of the AES system shall be effected using the network services provided by the Commission.

3.   The authentication and access verification of the Commission’s staff for the purposes of access to the common components of the AES system shall be effected using the UUM&DS or the network services provided by the Commission.

Article 53

Common communication network of AES

1.   The common communication network shall ensure the electronic communication among Member States’ national AES.

2.   The customs authorities of the Member States shall use the common communication network for the exchange of information as referred to in Article 51(1), points (c) and (d) of this Regulation.

Article 54

National trader portal

1.   The national trader portal shall allow the exchange of information between economic operators or other persons, and the national AES of the customs authority of the Member States.

2.   The national trader portal shall interoperate with the national AES.

Article 55

National Export System

1.   The national AES interoperates with the national trader portal and shall be used by the customs authority of the Member State to process export and re-export declarations.

2.   The national AESs of the Member States shall communicate with each other electronically via the common communication network and shall process export and exit information received from other Member States.

3.   The Member States shall provide and maintain an interface at national level between their national AES and EMCS for the purposes of Article 280 of the Code and Articles 21 and 25 of Council Directive (EU) 2020/262 (8).

4.   The Member States shall provide and maintain an interface at national level between their national AES and NCTS for the purposes of Article 280 of the Code, Article 329(5) and (6), and Article 333(2), points (b) and (c), of Implementing Regulation (EU) 2015/2447.

Article 56

IT transition

1.   During the AES deployment window as set out in the Annex to Implementing Decision (EU) 2019/2151, the Commission shall provide the Member States with additional common components, transitional rules and supporting mechanisms to establish an operational environment in which the Member States that have not yet deployed the new system may continue, on a temporary basis, to interoperate with the Member States that have already deployed the new system.

2.   The Commission shall offer a common component in the form of a central convertor for the exchange of messages over the common communication network. A Member State may decide to implement this at national level.

3.   In the case of a gradual connectivity of economic operators and other persons, a Member State may offer a national convertor for the exchange of messages between the economic operator and other persons and the customs authority.

4.   The Commission, in collaboration with the Member States, shall draw up the technical rules to be applied during the transition period and which are of a business and technical nature to enable mapping and interoperability between information exchange requirements defined in Commission Delegated Regulation (EU) 2016/341 (9) and Delegated Regulation (EU) 2015/2446 together with Implementing Regulation (EU) 2015/2447.

CHAPTER X

CHAPTER X

New computerised transit system

New computerised transit system

Article 57

Objective and structure of the NCTS

1.   The NCTS shall enable communication between the customs authorities of the Member States, and between the customs authorities of the Member States and economic operators and other persons, for the purposes of submitting and processing customs declaration and notification where goods are placed under the transit procedure.

2.   The NCTS shall consist of the following common components:

| (a) | common communication network; |
| --- | --- |

(a)

common communication network;

| (b) | central services. |
| --- | --- |

(b)

central services.

3.   Member States shall create the following national components:

| (a) | a national trader portal; |
| --- | --- |

(a)

a national trader portal;

| (b) | a national transit system (‘national NCTS’); |
| --- | --- |

(b)

a national transit system (‘national NCTS’);

| (c) | a common interface between NCTS and AES at national level. |
| --- | --- |

(c)

a common interface between NCTS and AES at national level.

Article 58

Use of the NCTS

The NCTS shall be used for the following purposes where goods are moved under a transit procedure:

| (a) | to ensure the formalities of transit determined by the Code; |
| --- | --- |

(a)

to ensure the formalities of transit determined by the Code;

| (b) | to ensure the formalities of the Convention on a common transit procedure (10); |
| --- | --- |

(b)

to ensure the formalities of the Convention on a common transit procedure (10);

| (c) | to lodge and process transit declarations; |
| --- | --- |

(c)

to lodge and process transit declarations;

| (d) | to lodge a transit declaration containing the particulars necessary for risk analysis for safety and security purposes in accordance with Article 263(4) of the Code; |
| --- | --- |

(d)

to lodge a transit declaration containing the particulars necessary for risk analysis for safety and security purposes in accordance with Article 263(4) of the Code;

| (e) | to lodge a transit declaration instead of an entry summary declaration as referred to in Article 130(1) of the Code. |
| --- | --- |

(e)

to lodge a transit declaration instead of an entry summary declaration as referred to in Article 130(1) of the Code.

Article 59

Authentication and access to the NCTS

1.   Economic operators have access only to the national transit system via a national trader portal. The authentication and access verification shall be determined by the Member States.

2.   The authentication and access verification of Member States’ customs authorities for the purposes of access to the common components of the NCTS shall be effected using the network services provided by the Commission.

3.   The authentication and access verification of the Commission’s staff for the purposes of access to the common components of the NCTS shall be effected using the UUM&DS or the network services provided by the Commission.

Article 60

Common communication network of the NCTS

1.   The common communication network shall ensure the electronic communication among the national NCTS of Member States and the Contracting Parties to the Convention on a common transit procedure.

2.   The customs authorities of the Member States shall use the common communication network for the exchange of information related to transit formalities.

Article 61

National trader portal

1.   The national trader portal shall allow the exchange of information between the economic operators and other persons, and the national NCTS of the customs authorities of the Member States.

2.   The national trader portal shall interoperate with the national NCTS.

Article 62

National transit system

1.   The national NCTS shall interoperate with the national trader portal and shall be used by the customs authorities of the Member State or Contracting Parties to the Convention on a common transit procedure to submit and process the transit declaration.

2.   The national NCTS shall communicate electronically via the common communication network with all national transit applications of Member States and Contracting Parties to the Convention on a common transit procedure and shall process transit information received from other Member States and Contracting Parties to the Convention on a common transit procedure.

3.   The Member States shall provide and maintain an interface between their national NCTS and AES systems for the purpose of Article 329(5) and (6) of Implementing Regulation (EU) 2015/2447.

Article 63

IT transition

1.   During the NCTS transition period as set out in the Annex to Implementing Decision (EU) 2019/2151, the Commission shall provide the Member States with additional common components, transitional rules and supporting mechanisms to establish an operational environment in which the Member States that have not yet deployed the new system may continue, on a temporary basis, to interoperate with the Member States that have already deployed the new system.

2.   The Commission shall offer a common component in the form of a central convertor for the exchange of messages over the common communication network. A Member State may decide to implement this at national level.

3.   In the case of a gradual connectivity of economic operators and other persons, a Member State may offer a national convertor for the exchange of messages between the economic operator and other persons, and the customs authority.

4.   The Commission, in collaboration with the Member States, shall draw up the technical rules to be applied during the transition period and which are of a business and technical nature to enable mapping and interoperability between information exchange requirements defined in Delegated Regulation (EU) 2016/341 and information exchange requirements defined in Delegated Regulation (EU) 2015/2446 together with Implementing Regulation (EU) 2015/2447.

CHAPTER XI

CHAPTER XI

INF special procedures system

INF special procedures system

Article 64

Objective and structure of the INF SP system

1.   The INF SP system shall enable communication between the customs authorities of the Member States and the economic operators and other persons for the purpose of issuing and managing INF data in the domain of Special Procedures.

2.   The INF SP system shall consist of the following common components:

| (a) | an EU Specific Trader Portal for INF; |
| --- | --- |

(a)

an EU Specific Trader Portal for INF;

| (b) | a central INF SP system. |
| --- | --- |

(b)

a central INF SP system.

Article 65

Use of the INF SP system

1.   The INF SP system shall be used for economic operators and other persons to submit INF requests and follow up on the status of such requests and for customs authorities of the Member States to process such requests and manage INF.

2.   The INF SP system shall allow the creation of INF by customs authorities of the Member States and communication between the customs authorities of Member States where needed.

3.   The INF SP system shall allow the calculation of the amount of import duties to be made in accordance with Article 86(3) of the Code.

Article 66

Authentication and access to the central INF SP system

1.   The authentication and access verification of economic operators and other persons for the purposes of accessing the common components of the INF SP system shall be effected using the UUM&DS system.

For customs representatives to be authenticated and be able to access the common components of the INF SP system, their empowerment to act in that capacity must be registered in the UUM&DS system or in an identity and access management system set up by a Member State pursuant to Article 20 of this Regulation.

2.   The authentication and access verification of Member States’ customs authorities for the purposes of access to the common components of the INF SP system shall be effected using the network services provided by the Commission.

3.   The authentication and access verification of the Commission’s staff for the purposes of access to the common components of the INF SP system shall be effected using the UUM&DS system or the network services provided by the Commission.

Article 67

EU Specific Trader Portal for INF

1.   The EUCTP shall provide access to the EU Specific Trader Portal for INF as referred to in Article 6 of this Regulation, where the EU Specific Trader Portal shall be an entry point to the INF SP system for economic operators and other persons.

2.   The EU Specific Trader Portal for INF shall interoperate with the central INF SP system.

Article 68

Central INF SP system

1.   The central INF SP system shall be used by the customs authorities of the Member States to exchange and store information pertaining to submitted INFs.

2.   The central INF SP system shall interoperate with the EU Specific Trader Portal for INF.

CHAPTER XII

CHAPTER XII

Customs risk management system

Customs risk management system

Article 69

Objective and structure of the CRMS

1.   CRMS shall enable the communication, storage and exchange of risk information between Member States and between Member States and the Commission to support the implementation of the common risk management framework.

2.   Where created, a web service for national systems may be used, which allows the exchange of data with national systems through a web interface. CRMS shall interoperate with the ICS2 common components.

Article 70

Use of the CRMS

1.   CRMS shall be used for the following purposes in line with Article 46(3) and (5) of the Code:

| (a) | the exchange of risk information between the Member States and between Member States and the Commission as referred to in Article 46(5) of the Code and in Article 36(1) of Implementing Regulation (EU) 2015/2447, and the storage and processing of such information; |
| --- | --- |

(a)

the exchange of risk information between the Member States and between Member States and the Commission as referred to in Article 46(5) of the Code and in Article 36(1) of Implementing Regulation (EU) 2015/2447, and the storage and processing of such information;

| (b) | the communication between the Member States and between Member States and the Commission of the information related to the implementation of common risk criteria, priority control actions, crisis management as referred to in Article 36(2) of Implementing Regulation (EU) 2015/2447, and the submission, processing and storage of such information including the exchange of related-risk information and the analysis of the results of those actions; |
| --- | --- |

(b)

the communication between the Member States and between Member States and the Commission of the information related to the implementation of common risk criteria, priority control actions, crisis management as referred to in Article 36(2) of Implementing Regulation (EU) 2015/2447, and the submission, processing and storage of such information including the exchange of related-risk information and the analysis of the results of those actions;

| (c) | to enable Member States and the Commission to retrieve electronically from the system risk analysis reports on existing risks and new trends to feed into the common risk management framework and national risk management system. |
| --- | --- |

(c)

to enable Member States and the Commission to retrieve electronically from the system risk analysis reports on existing risks and new trends to feed into the common risk management framework and national risk management system.

2.   Where the transfer of data between CRMS and national systems can be automated, national systems shall be adapted to use the CRMS web service.

Article 71

Authentication and access to the CRMS

1.   The authentication and access verification of Member States’ customs authorities for the purposes of access to the common components of the CRMS shall be effected using the network services provided by the Commission.

2.   The authentication and access verification of the Commission’s staff for the purposes of access to the common components of CRMS shall be effected using the UUM&DS system or the network services provided by the Commission.

Article 72

Common component of CRMS

1.   The CRMS shall provide for risk information forms and feedback forms on risk analysis and control results to be filled in online in the system, processed for reporting and stored in the system. Authorised users shall be able to retrieve the forms and use them for national risk management and control purposes.

2.   The CRMS shall provide for communication mechanisms allowing users (individually or as part of an organisational unit) to provide and exchange risk information, to respond to specific requests from other users and to provide to the Commission facts and analysis of the results of their actions in the course of the implementation of common risk criteria, priority control actions and crisis management.

3.   The CRMS shall provide for tools enabling analyse and aggregation of data from risk information forms stored in the systems.

4.   The CRMS shall provide for a platform where information, including guides, detection technology information and data, and links to other databases, relevant for risk management and controls shall be stored and made available to authorised users for risk management and control purposes.

CHAPTER XIII

CHAPTER XIII

Centralised clearance for import

Centralised clearance for import

Article 73

Objective and structure of the CCI

1.   The CCI shall enable communication between the customs authorities of the Member States, and between the customs authorities of the Member States and economic operators for the purposes of submitting and processing customs declarations in the context of centralised clearance for import where more than one Member State is involved.

2.   The CCI shall consist of the following common components:

| (a) | common communication network; |
| --- | --- |

(a)

common communication network;

| (b) | central services. |
| --- | --- |

(b)

central services.

3.   Member States shall ensure that their national CCI systems communicate through the common communication network for CCI with the national CCI systems of the other Member States and that includes the following national components:

| (a) | a national trader portal; |
| --- | --- |

(a)

a national trader portal;

| (b) | a national CCI application; |
| --- | --- |

(b)

a national CCI application;

| (c) | an interface with EMCS/System for Exchange of Excise Data at national level. |
| --- | --- |

(c)

an interface with EMCS/System for Exchange of Excise Data at national level.

Article 74

Use of the CCI

The CCI System shall be used for the following purposes:

| (a) | to ensure the formalities of centralised clearance for import, where more than one Member State is involved, laid down in the Code; |
| --- | --- |

(a)

to ensure the formalities of centralised clearance for import, where more than one Member State is involved, laid down in the Code;

| (b) | to lodge and process standard customs declarations under the centralised clearance for import; |
| --- | --- |

(b)

to lodge and process standard customs declarations under the centralised clearance for import;

| (c) | to lodge and process simplified customs declarations and the respective supplementary declarations under the centralised clearance for import; |
| --- | --- |

(c)

to lodge and process simplified customs declarations and the respective supplementary declarations under the centralised clearance for import;

| (d) | to lodge and process the respective customs declarations and presentation notifications provided in the authorisation for entry in the declarant’s records under the centralised clearance for import. |
| --- | --- |

(d)

to lodge and process the respective customs declarations and presentation notifications provided in the authorisation for entry in the declarant’s records under the centralised clearance for import.

Article 75

Authentication and access to the CCI

1.   Economic operators shall only have access to the national CCI systems via a national trader portal developed by the Member States. The authentication and access verification shall be determined by the Member States.

2.   The authentication and access verification of Member States’ customs authorities for the purposes of access to the common components of the CCI system shall be effected using the network services provided by the Commission.

3.   The authentication and access verification of the Commission’s staff for the purposes of access to the common components of the CCI system shall be effected using the UUM&DS or the network services provided by the Commission.

Article 76

Common communication network of the CCI

1.   The common communication network shall ensure the electronic communication among Member States’ national CCI applications.

2.   The customs authorities of the Member States shall use the common communication network for the exchange of information relevant to CCI related import formalities.

Article 77

National trader portal

1.   The national trader portal shall allow the exchange of information between the economic operators and the national CCI systems of the customs authorities of the Member States.

2.   The national trader portal shall interoperate with the national CCI applications.

Article 78

National CCI system

1.   The national CCI system shall be used by the customs authority of the Member State which created it for the purposes of processing customs declarations under the CCI.

2.   The national CCI systems of the Member States shall communicate electronically via the common domain with each other and shall process import information received from other Member States.

CHAPTER XIV

CHAPTER XIV

The registered exporter system

The registered exporter system

Section 1

Section 1

The REX system for Member States

The REX system for Member States

Article 79

Objective and structure of the REX system for Member States

1.   The REX system for Member States shall enable the customs authorities of the Member States to register economic operators established in the Union for the purpose of declaring the preferential origin of goods, as well as to manage those registrations, namely modifications of registrations, revocations of registrations, cancellation of revocations and reporting of registrations.

2.   The REX system for Member States shall consist of the following common components:

| (a) | an EU Specific Trader Portal for the REX system for Member States; |
| --- | --- |

(a)

an EU Specific Trader Portal for the REX system for Member States;

| (b) | a central REX system for Member States. |
| --- | --- |

(b)

a central REX system for Member States.

3.   Member States may create the following national components:

| (a) | a national trader portal; |
| --- | --- |

(a)

a national trader portal;

| (b) | a national Registered Exporter system (‘national REX system’). |
| --- | --- |

(b)

a national Registered Exporter system (‘national REX system’).

Article 80

Use of the REX system for Member States

The REX system for Member States shall be used by exporters and the customs authorities of the Member States, in accordance with the provisions in force for the purpose of the Union preferential trade arrangements.

Article 81

Authentication and access to the REX system for Member States

1.   The authentication and access verification of economic operators and other persons for the purposes of access to the EU Specific Trader Portal for the REX system for Member States shall be effected using the UUM&DS system.

For customs representatives to be authenticated and be able to access the EU Specific Trader Portal for the REX system for Member States, their empowerment to act in that capacity shall be registered in the UUM&DS system or in an identity and access management system set up by a Member State pursuant to Article 20 of this Regulation.

2.   The authentication and access verification of Member States’ officials for the purposes of access to the central REX system for Member States shall be effected using the network services provided by the Commission.

3.   The authentication and access verification of the Commission’s staff for the purposes of access to the central REX system for Member States shall be effected using the network services provided by the Commission.

Article 82

EU Specific Trader Portal for the REX system for Member States

1.   The EU Specific Trader Portal for the REX system for Member States shall interoperate with the EUCTP, and the EUCTP shall be an entry point for requests from economic operators and other persons to the central REX system for Member States.

2.   The EU Specific Trader Portal for the REX system for Member States shall be interoperable with the central REX system for Member States and be capable of redirecting users to the national trader portal, where created.

3.   In Member States where no national trader portal is created the EU Specific Trader Portal for the REX system for Member States shall be used to submit and exchange information pertaining to applications for registrations and decisions of registrations, and in relation to any subsequent event which may affect the original application or registration as referred to in Article 79 of this Regulation.

Article 83

Central REX system for Member States

1.   Customs authorities of the Member States shall use the central REX system for Member States to process the applications for registrations referred to in Article 82 of this Regulation, to store the registrations, to process any subsequent event which may affect the original application or registration, or for performing queries in the registrations.

2.   The central REX system for Member States shall be interoperable with the EU Specific Trader Portal for the REX system, the customer reference services, and other relevant systems.

Article 84

National Trader Portal

1.   When a Member State puts in place a national trader portal, economic operators and other persons shall use that portal to submit and exchange information pertaining to applications for registrations and decisions of registrations, and in relation to any subsequent event which may affect the original application or registration as referred to in Article 79 of this Regulation.

2.   Where a Member State creates a national trader portal, it shall inform the Commission thereof.

3.   The national trader portal shall be interoperable with the national REX system.

Article 85

National REX system

1.   Customs authorities of the Member States shall use the national REX system, where created, to process the applications for registrations referred to in Article 84 of this Regulation, to store the registrations, to process any subsequent event which may affect the original application or registration, or to perform queries in the registrations.

2.   The national REX system shall interoperate and remain synchronised with the central REX system for Member States.

Section 2

Section 2

The REX system for third countries with which the Union has a preferential trade arrangement

The REX system for third countries with which the Union has a preferential trade arrangement

Article 86

Objective and structure of the REX system for third countries with which the Union has a preferential trade arrangement

1.   The REX system for third countries with which the Union has a preferential trade arrangement (the REX system for third countries) shall enable the economic operators in those countries to prepare applications for registration as registered exporters and competent authorities in those countries to process those applications, as well as to manage those registrations, namely modifications of registrations, revocations of registrations, cancellation of revocations and reporting of registrations.

2.   The REX system for third countries shall consist of the following common components:

| (a) | a pre-application system; |
| --- | --- |

(a)

a pre-application system;

| (b) | a central REX system for third countries. |
| --- | --- |

(b)

a central REX system for third countries.

Article 87

Use of the REX system for third countries

The REX system for third countries shall apply in certain third countries, in accordance with the Union preferential trade arrangements.

Article 88

Authentication and access to the REX system for third countries

1.   The authentication and access verification of third countries’ officials for the purposes of access to the central REX system for third countries shall be effected using EU Login and the user management system for the REX system for third countries (T-REX).

2.   The access of economic operators and other persons to the pre-application system referred to in Article 86(2), point (a) of this Regulation, shall be anonymous.

3.   The authentication and access verification of the Commission’s staff for the purposes of access to the central REX system for third countries shall be effected using the network services provided by the Commission.

4.   Where the preferential trade arrangement of the Union is no longer applicable to a third country, the competent authorities in that third country shall retain access to the REX system for third countries for as long as required in order to enable these competent authorities to comply with their obligations.

Article 89

Data protection as regards the REX system for third countries

The personal data of data subjects established in third countries in the REX system for third countries registered by competent authorities in third countries shall be processed for the purpose of implementing and monitoring the relevant preferential trade arrangement with the Union.

Article 90

Central REX system for third countries with which the Union has a preferential trade arrangement

1.   The competent authorities in the third countries shall use the central REX system for third countries to process applications for registrations, to store the registrations, to process any subsequent event which may affect the original application or registration, or to perform queries in the registrations.

2.   The central REX system for third countries shall be interoperable with the pre-application system, the customer reference services and other relevant systems.

Article 91

Pre-application system in the REX system for third countries with which the Union has a preferential trade arrangement

1.   The pre-application system shall be an entry point for economic operators and other persons to submit electronically the data in their application to become registered exporter. The pre-application system shall not be used for submitting requests for modification or revocation of existing registrations.

2.   The pre-application system shall interoperate with the central REX system for third countries with which the Union has a preferential trade arrangement.

CHAPTER XV

CHAPTER XV

Proof of Union Status system

Proof of Union Status system

Article 92

Objective and structure of the PoUS system

1.   The PoUS system shall enable communication between the customs authorities of the Member States and the economic operators and other persons for the purpose of issuing and managing T2L/T2LF and customs goods manifests (CGM) documents as means to prove the customs status of Union goods.

2.   The PoUS system shall consist of the following common components:

| (a) | an EU Specific Trader Portal for PoUS; |
| --- | --- |

(a)

an EU Specific Trader Portal for PoUS;

| (b) | a central PoUS system. |
| --- | --- |

(b)

a central PoUS system.

3.   Member States may create the following national components:

| (a) | a national trader portal; |
| --- | --- |

(a)

a national trader portal;

| (b) | a national PoUS system. |
| --- | --- |

(b)

a national PoUS system.

Article 93

Use of the PoUS system

1.   Economic operators and other persons shall use the PoUS system to submit requests for endorsement and registration, or registration without endorsement, of proof of Union status in the form of T2L/T2LF and CGM documents and to manage the use of the proof of Union status of goods upon presentation.

2.   The PoUS system shall allow the endorsement and registration of economic operators’ and other persons’ requests and the management of the usage of the proof of Union status.

Article 94

Authentication and access to the central PoUS system

1.   The authentication and access verification of economic operators and other persons for the purposes of accessing the common components of the PoUS system shall be effected using the UUM&DS system.

2.   The authentication and access verification of Member States’ customs authorities for the purposes of access to the common components of the PoUS system shall be effected using the network services provided by the Commission.

The authentication and access verification of Member States’ customs authorities for the purposes of access to the national PoUS system shall be effected using an identity and access management system set up by the relevant Member State.

3.   The authentication and access verification of the Commission’s staff for the purposes of access to the common components of the PoUS system shall be effected using the UUM&DS system or the network services provided by the Commission.

Article 95

EU Specific Trader Portal for PoUS

1.   The EU Specific Trader Portal for PoUS shall communicate with the EUCTP, where the EUCTP shall be an entry point to the PoUS system for economic operators and other persons.

2.   The EU Specific Trader Portal for PoUS shall be interoperable with the central PoUS system.

Article 96

Central PoUS system

1.   The central PoUS system shall be used by the customs authorities of the Member States to exchange and store information pertaining to submitted T2L/T2LF and CGM documents.

2.   The central PoUS system shall be interoperable with the EU Specific Trader Portal for PoUS.

Article 97

National Trader Portal

1.   Where a Member State has created a national PoUS system in accordance with Article 92(3), point (b) of this Regulation, the national trader portal shall be the main entry point to the national PoUS system for economic operators and other persons.

2.   The national trader portal shall interoperate with the national PoUS system, where created.

3.   The national trader portal shall provide for the functionalities equivalent to those provided for by the EU Specific Trader Portal for PoUS.

4.   Where a Member State creates a national trader portal, it shall inform the Commission thereof.

Article 98

National PoUS system

The national PoUS system shall be interoperable with the central PoUS system in order to make proofs created in the national PoUS system available in the central system.

CHAPTER XVI

CHAPTER XVI

Surveillance system

Surveillance system

Article 99

Objective and structure of the Surveillance system

1.   The Surveillance system shall, in accordance with Article 56(5) of the Code and with Union acts providing for its use, enable communication between the customs authorities of the Member States and the Commission for the purpose of customs surveillance, and the collection of data extracted from the customs declaration for entry into free circulation or for export of goods.

2.   Member States shall submit the requested information from the customs declaration systems to the Surveillance system in an automated way.

3.   The Surveillance system is a central system consisting of one common component.

Article 100

Use of the Surveillance system

The data in the Surveillance system shall be used for the purpose of the surveillance of the release for free circulation and export procedures which entails:

| (a) | supporting the Commission and Member States’ customs authorities in ensuring the uniform application of customs controls and customs legislation; |
| --- | --- |

(a)

supporting the Commission and Member States’ customs authorities in ensuring the uniform application of customs controls and customs legislation;

| (b) | minimising risks, including through data mining and exchanging risk information; and |
| --- | --- |

(b)

minimising risks, including through data mining and exchanging risk information; and

| (c) | implementing specific measures prescribed by other Union provisions that have to be implemented by the Member States’ customs authorities at the border. |
| --- | --- |

(c)

implementing specific measures prescribed by other Union provisions that have to be implemented by the Member States’ customs authorities at the border.

Article 101

Authentication and access to the Surveillance system

1.   The authentication and access verification of Member States’ customs authorities for the purposes of access to the common components of the Surveillance system shall be effected using the network services provided by the Commission.

2.   The authentication and access verification of the Commission’s staff for the purposes of access to the common components of the Surveillance system shall be effected using the network services provided by the Commission.

Article 102

Central Surveillance system

The Member States and the Commission shall use the central Surveillance system to collect, store, process and analyse the data referred to in Article 100 of this Regulation.

CHAPTER XVII

CHAPTER XVII

Functioning of the electronic systems and training in the use thereof

Functioning of the electronic systems and training in the use thereof

Article 103

Development, testing, deployment and management of the electronic systems

1.   The common components shall be developed, tested, deployed and managed by the Commission, and may be tested by the Member States. The national components shall be developed, tested, deployed and managed by the Member States.

2.   Member States shall ensure that the national components are interoperable with the common components.

3.   The Commission shall design and maintain the common specifications for the decentralised systems in close cooperation with the Member States.

4.   The Member States shall develop, operate and maintain interfaces to provide the functionality for the decentralised systems necessary for the exchange of information with economic operators and other persons through national components and interfaces, and with other Member States through common components.

Article 104

Maintenance of and changes to the electronic systems

1.   The Commission shall perform the maintenance of the common components and the Member States shall perform the maintenance of their national components.

2.   The Commission and the Member States shall ensure uninterrupted operation of the electronic systems.

3.   The Commission may change the common components of the electronic systems to correct malfunctions, to add new functionalities or to alter existing ones.

4.   The Commission shall inform the Member States of changes and updates to the common components.

5.   Member States shall inform the Commission of changes and updates to the national components that may affect the functioning of the common components.

6.   The Commission and the Member States shall make the information on the changes and updates to the electronic systems set out in paragraphs 4 and 5 publicly available.

Article 105

Temporary failure of the electronic systems

1.   In the event of a temporary failure of the electronic systems as referred to in Article 6(3), point (b), of the Code, economic operators and other persons shall submit the information required to fulfil the formalities concerned by the means determined by the Member States, including by means other than electronic data-processing techniques.

2.   The customs authorities of the Member States shall make sure the information submitted in accordance with paragraph 1 is made available in the respective electronic systems within 7 days of the respective electronic systems becoming available again.

3.   The Commission and the Member States shall inform each other about any unavailability of the electronic systems resulting from a temporary failure.

The Commission and the Member States shall also inform each other of the unavailability of economic operators’ systems as regards the ICS2.

4.   By way of derogation from paragraph 1, in the event of a temporary failure of the ICS2, AES, CRMS or CCI, the business continuity plan agreed between the Member States and the Commission shall apply.

5.   With regard to the ICS2, each Member State shall decide on the activation of the business continuity plan where that Member State is affected by the temporary failure of the system or where an economic operator referred to in Article 127(4) and (6) of the Code obliged to file the entry summary declaration or particulars of it is unable to submit those.

6.   By way of derogation from paragraph 1, in the event of a temporary failure of the NCTS system, the business continuity procedure as referred to in Annex 72-04 to Implementing Regulation (EU) 2015/2447 shall apply.

Article 106

Training support on the use and functioning of the common components

The Commission shall support the Member States on the use and functioning of the common components of the electronic systems by providing the appropriate training material.

CHAPTER XVIII

CHAPTER XVIII

Data protection, data management and the ownership and security of the electronic systems

Data protection, data management and the ownership and security of the electronic systems

Article 107

Personal data protection

1.   The personal data registered in the electronic systems shall be processed for the purposes of implementing the customs legislation and other legislation as referred to in the Code having regard to the specific objectives of each of the electronic systems as set out in Article 4, Articles 7(1), 16(1), 21(1), Article 30, Articles 35(1), 42(1), 50(1), 57(1), 64(1), 69(1), 73(1), 79(1), 86(1), 92(1) and 99(1) of this Regulation.

2.   The Member States’ national supervisory authorities in the field of personal data protection and the European Data Protection Supervisor shall cooperate, in accordance with Article 62 of Regulation (EU) 2018/1725, to ensure coordinated supervision of the processing of personal data registered in the electronic systems.

3.   Any request by a data subject registered in the REX system to exercise his or her rights under Chapter III of Regulations (EU) 2016/679 and (EU) 2018/1725 shall be first submitted to the competent authorities in the third country or to the customs authorities in the Member State which registered the personal data.

Where a data subject has submitted such a request to the Commission without having tried to obtain his or her rights from the competent authorities in the third country or from the customs authorities in the Member State which registered the personal data, the Commission shall forward that request to the competent authorities in the third country or to the customs authorities in the Member State respectively which registered that data.

If the registered exporter fails to obtain his or her rights from the competent authorities in the third country or from the customs authorities in the Member State which registered the personal data, the registered exporter shall submit such request to the Commission acting as controller as defined in Article 4, point (7), of Regulation (EU) 2016/679 and Article 3, point (8), of Regulation (EU) 2018/1725.

Article 108

Updating of data in the electronic systems

1.   Member States shall ensure that the data registered at national level corresponds to the data registered in the common components and is kept up to date.

2.   By way of derogation from paragraph 1, in respect of the ICS2, Member States shall ensure that the following data is kept up to date and corresponds to the data in the ICS2 common repository:

| (a) | data registered at national level and communicated from the national entry system to the ICS2 common repository; |
| --- | --- |

(a)

data registered at national level and communicated from the national entry system to the ICS2 common repository;

| (b) | data received by the national entry system from the ICS2 common repository. |
| --- | --- |

(b)

data received by the national entry system from the ICS2 common repository.

Article 109

Limitation of data access and data processing

1.   The data registered in the common components of the electronic systems by a Member State may be accessed or processed by that Member State. It may also be accessed and processed by another Member State which is involved in the processing of an application or the management of a decision to which the data relates.

2.   The data registered in the common components of the electronic systems by an economic operator or other person may be accessed or processed by that economic operator or that other person. It may also be accessed and processed by a Member State involved in the processing of an application or the management of a decision to which the data relates.

3.   The data in the ICS2 common component that is communicated to or registered in the shared trader interface by an economic operator or other person may be accessed or processed by that economic operator or that other person.

4.   The data registered in the central EBTI system by a Member State may be processed by that Member State. It may also be processed by another Member State which is involved in the processing of an application to which the data relates, including by way of a consultation between customs authorities of the Member States in accordance with Article 26 of this Regulation. It may be accessed by all the customs authorities of the Member States in accordance with Article 25(2) and by the Commission for the purpose of Article 21(1) of this Regulation.

5.   The data registered in the central EBTI system by an economic operator or other person may be accessed or processed by that economic operator or that person. It may be accessed by all the customs authorities of the Member States in accordance with Article 25(2) and by the Commission for the purpose of Article 21(1) of this Regulation.

6.   The data in the ICS2 common components:

| (a) | communicated to a Member State by an economic operator or other person through shared trader interface into the ICS2 common repository may be accessed and processed by that Member State in the ICS2 common repository. Where needed, that Member State may also access this information registered in the shared trader interface; |
| --- | --- |

(a)

communicated to a Member State by an economic operator or other person through shared trader interface into the ICS2 common repository may be accessed and processed by that Member State in the ICS2 common repository. Where needed, that Member State may also access this information registered in the shared trader interface;

| (b) | communicated to or registered in the ICS2 common repository by a Member State may be accessed or processed by that Member State; |
| --- | --- |

(b)

communicated to or registered in the ICS2 common repository by a Member State may be accessed or processed by that Member State;

| (c) | referred to in points (a) and (b) may also be accessed and processed by another Member State where the latter is involved in the risk analysis or control process, or both, to which the data relates in accordance with Article 186(2), points (a), (b) and (d), Article 186(5), (7) and (7a), and Article 189(3) and (4) of Implementing Regulation (EU) 2015/2447, with exception of data recorded in the system by customs authorities of other Member States in relation to information on security and safety risks as referred to in Article 186(2), point (a), of Implementing Regulation (EU) 2015/2447; |
| --- | --- |

(c)

referred to in points (a) and (b) may also be accessed and processed by another Member State where the latter is involved in the risk analysis or control process, or both, to which the data relates in accordance with Article 186(2), points (a), (b) and (d), Article 186(5), (7) and (7a), and Article 189(3) and (4) of Implementing Regulation (EU) 2015/2447, with exception of data recorded in the system by customs authorities of other Member States in relation to information on security and safety risks as referred to in Article 186(2), point (a), of Implementing Regulation (EU) 2015/2447;

| (d) | may be processed by the Commission in cooperation with the Member States for the purposes referred to in Article 43(2) of this Regulation and in Article 182(1), point (c), of Implementing Regulation (EU) 2015/2447. The results of such processing may be accessed by the Commission and the Member States; |
| --- | --- |

(d)

may be processed by the Commission in cooperation with the Member States for the purposes referred to in Article 43(2) of this Regulation and in Article 182(1), point (c), of Implementing Regulation (EU) 2015/2447. The results of such processing may be accessed by the Commission and the Member States;

| (e) | may be accessed and processed by the Member States and the Commission for the purposes referred to in Article 43(3) of this Regulation, under the conditions referred to in Article 112 of this Regulation and according to the specific project agreements detailing processing operations between the Member States and the Commission. |
| --- | --- |

(e)

may be accessed and processed by the Member States and the Commission for the purposes referred to in Article 43(3) of this Regulation, under the conditions referred to in Article 112 of this Regulation and according to the specific project agreements detailing processing operations between the Member States and the Commission.

7.   The data in the ICS2 common component that is registered in the ICS2 common repository by the Commission may be accessed and processed by the Commission and Member States.

8.   The data in the Surveillance system may be accessed and processed by the Commission and Member States.

9.   The data registered in the central REX system for EU Member States may be accessed for the purpose of implementing and monitoring Union’s preferential trade arrangements by the customs authorities of Member States and the Commission.

10.   The data registered in the central REX system for third countries with which the Union has a preferential trade arrangement may be accessed by the following:

| (a) | the competent authorities of the third country in which the data has been registered; |
| --- | --- |

(a)

the competent authorities of the third country in which the data has been registered;

| (b) | the customs authorities of Member States for the purpose of carrying out verifications of customs declarations under Article 188 of the Code or post-release control under Article 48 of the Code; |
| --- | --- |

(b)

the customs authorities of Member States for the purpose of carrying out verifications of customs declarations under Article 188 of the Code or post-release control under Article 48 of the Code;

| (c) | the Commission for the purpose of implementing and monitoring Union’s preferential trade arrangements. |
| --- | --- |

(c)

the Commission for the purpose of implementing and monitoring Union’s preferential trade arrangements.

11.   Where Member States report incidents and problems in the operational processes for the provision of the services of the systems where the Commission act as a processor, the Commission may have access to the data only for the purpose of resolving a registered incident or problem. The Commission shall ensure the confidentiality of such data in accordance with Article 12 of the Code.

Article 110

System ownership

1.   The Commission shall be the system owner of the common components.

2.   The Member States shall be the system owners of the respective national components.

Article 111

System security

1.   The Commission shall ensure the security of the common components. The Member States shall ensure the security of the national components.

For those purposes, the Commission and Member States shall take the necessary measures to:

| (a) | prevent any unauthorised person from having access to installations used for the processing of data; |
| --- | --- |

(a)

prevent any unauthorised person from having access to installations used for the processing of data;

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

(b)

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

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

(c)

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

2.   The Commission and the Member States shall inform each other of any activities that might result in a breach or a suspected breach of the security of the electronic systems.

3.   The Commission and the Member States shall establish security plans concerning all systems.

Article 112

Controller and Processor for the systems

For systems referred to in Article 1 of this Regulation and in relation to the processing of personal data:

| (a) | the Member States shall act as controllers as defined in Article 4, point (7), of Regulation (EU) 2016/679 and comply with the obligations in that Regulation, |
| --- | --- |

(a)

the Member States shall act as controllers as defined in Article 4, point (7), of Regulation (EU) 2016/679 and comply with the obligations in that Regulation,

| (b) | the Commission shall act as processor as defined in Article 3, point (12), of Regulation (EU) 2018/1725 and comply with the obligations in that Regulation, |
| --- | --- |

(b)

the Commission shall act as processor as defined in Article 3, point (12), of Regulation (EU) 2018/1725 and comply with the obligations in that Regulation,

| (c) | by way of derogation from point (b), the Commission shall act as a joint controller together with the Member States in the ICS2,






  — | where processing the data for monitoring and evaluating the implementation of the common security and safety risk criteria and standards and of the control measures and priority control in accordance with Article 109(6), point (d) of this Regulation; |
| --- | --- | --- |

(c)

by way of derogation from point (b), the Commission shall act as a joint controller together with the Member States in the ICS2,

—

where processing the data for monitoring and evaluating the implementation of the common security and safety risk criteria and standards and of the control measures and priority control in accordance with Article 109(6), point (d) of this Regulation;

| — | where processing the data for the purpose of collecting storing, processing and analysing additional elements of information in conjunction with entry summary declarations and for providing support to risk management processes as referred in Article 43(3) of this Regulation, under the conditions set out by Article 109(6), point (e) of this Regulation. |
| --- | --- |

—

where processing the data for the purpose of collecting storing, processing and analysing additional elements of information in conjunction with entry summary declarations and for providing support to risk management processes as referred in Article 43(3) of this Regulation, under the conditions set out by Article 109(6), point (e) of this Regulation.

| (d) | by way of derogation from point (b), the Commission shall also act as a joint controller together with the Member States in CRMS. |
| --- | --- |

(d)

by way of derogation from point (b), the Commission shall also act as a joint controller together with the Member States in CRMS.

| (e) | by way of derogation from point (b), the Commission shall act as joint controller together with the Member States in the REX system,






  — | where processing the data for synchronisation with a national system; |
| --- | --- | --- |

(e)

by way of derogation from point (b), the Commission shall act as joint controller together with the Member States in the REX system,

—

where processing the data for synchronisation with a national system;

| — | where processing the data for the purpose of accessing the data for verifications of customs declarations under Article 188 of the Code or post-release control under Article 48 of the Code; |
| --- | --- |

—

where processing the data for the purpose of accessing the data for verifications of customs declarations under Article 188 of the Code or post-release control under Article 48 of the Code;

| — | where processing data for statistics and monitoring purposes on the use of the REX system for EU Member States; |
| --- | --- |

—

where processing data for statistics and monitoring purposes on the use of the REX system for EU Member States;

| — | where processing data for statistics and monitoring purposes on the use of the REX system for third countries. |
| --- | --- |

—

where processing data for statistics and monitoring purposes on the use of the REX system for third countries.

| (f) | by way of derogation from point (b), the Commission shall act as a joint controller together with the Member States in the Surveillance system. |
| --- | --- |

(f)

by way of derogation from point (b), the Commission shall act as a joint controller together with the Member States in the Surveillance system.

Article 113

Data retention period

1.   The data retention period for the systems where the Member States are controllers, as defined in Article 112 of this Regulation, shall be defined by those Member States, taking into account the requirements of the customs legislation, and shall inform the Commission of this period.

2.   The data retention period for the systems where the Commission and Member States are joint controllers, shall be defined as follows:

| (a) | The ICS2: 10 years, starting from the moment the data is processed in the central system for the first time; |
| --- | --- |

(a)

The ICS2: 10 years, starting from the moment the data is processed in the central system for the first time;

| (b) | REX: 10 years, after the registration has been revoked; |
| --- | --- |

(b)

REX: 10 years, after the registration has been revoked;

| (c) | CRMS: 10 years, starting from the moment the data is processed in the central system for the first time; |
| --- | --- |

(c)

CRMS: 10 years, starting from the moment the data is processed in the central system for the first time;

| (d) | Surveillance: 10 years, starting from the moment the data is processed in the central system for the first time. |
| --- | --- |

(d)

Surveillance: 10 years, starting from the moment the data is processed in the central system for the first time.

3.   The data retention period shall be applicable for all data covered by the electronic systems.

4.   Notwithstanding paragraph 2, where an appeal has been lodged or where court proceedings have begun involving data stored in the electronic systems, those data shall be retained until the appeal procedure or court proceedings are terminated.

CHAPTER XIX

CHAPTER XIX

Final provisions

Final provisions

Article 114

Assessment of the electronic systems

The Commission and the Member States shall conduct assessments of the components they are responsible for and shall in particular analyse the security and integrity of those components and the confidentiality of the data processed within those components.

The Commission and the Member States shall inform each other of the results of those assessments.

Article 115

Repeal

Implementing Regulation (EU) 2021/414 is repealed.

References to the repealed Implementing Regulation shall be construed as references to this Regulation.

Article 116

Entry into force

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

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

Done at Brussels, 1 June 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 269, 10.10.2013, p. 1.

1

(2)  Commission Implementing Decision (EU) 2019/2151 of 13 December 2019 establishing the work programme relating to the development and deployment of the electronic systems provided for in the Union Customs Code (OJ L 325, 16.12.2019, p. 168).

2

(3)  Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015 laying down detailed rules for implementing certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code (OJ L 343, 29.12.2015, p. 558).

3

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

4

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

5

(6)  Commission Implementing Regulation (EU) 2021/414 of 8 March 2021 on technical arrangements for developing, maintaining and employing electronic systems for the exchange of information and for the storage of such information under Regulation (EU) No 952/2013 of the European Parliament and of the Council(OJ L 81, 9.3.2021, p. 37).

6

(7)  Commission Delegated Regulation (EU) 2015/2446 of 28 July 2015 supplementing Regulation (EU) No 952/2013 of the European Parliament and of the Council as regards detailed rules concerning certain provisions of the Union Customs Code (OJ L 343, 29.12.2015, p. 1).

7

(8)  Council Directive (EU) 2020/262 of 19 December 2019 laying down the general arrangements for excise duty (OJ L 58, 27.2.2020, p. 4).

8

(9)  Commission Delegated Regulation (EU) 2016/341 of 17 December 2015 supplementing Regulation (EU) No 952/2013 of the European Parliament and of the Council as regards transitional rules for certain provisions of the Code where the relevant electronic systems are not yet operational and amending Delegated Regulation (EU) 2015/2446 (OJ L 69, 15.3.2016, p. 1).

9

(10)  Convention between the European Economic Community, the Republic of Austria, the Republic of Finland, the Republic of Iceland, the Kingdom of Norway, the Kingdom of Sweden and the Swiss Confederation, on a common transit procedure (OJ L 226, 13.8.1987, p. 2).

10

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| 2.6.2023 | EN | Official Journal of the European Union | L 143/105 |
| --- | --- | --- | --- |

2.6.2023

EN

Official Journal of the European Union

L 143/105

---

COMMISSION IMPLEMENTING REGULATIONZ (EU) 2023/1071

of 1 June 2023

amending certain Annexes to Implementing Regulation (EU) 2021/620 as regards the approval or withdrawal of the disease-free status of certain Member States or zones or compartments thereof as regards certain listed diseases and the approval of eradication programmes for certain listed diseases

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (1), and in particular Articles 31(3), 36(4) and 42(4) thereof,

Whereas:

| (1) | Regulation (EU) 2016/429 lays down disease-specific rules for the diseases listed in accordance with Article 5(1) thereof and lays down how those rules are to be applied to different categories of listed diseases. Regulation (EU) 2016/429 provides for the Member States to establish compulsory eradication programmes for the listed diseases referred to in Article 9(1), point (b), thereof, and for optional eradication programmes for listed diseases referred to in Article 9(1), point (c), thereof, and for the approval of such programmes by the Commission. That Regulation also provides for the approval or withdrawal by the Commission of the disease-free status of Member States or zones or compartments thereof regarding certain listed diseases referred to in Article 9(1), points (b) and (c), thereof. |
| --- | --- |

(1)

Regulation (EU) 2016/429 lays down disease-specific rules for the diseases listed in accordance with Article 5(1) thereof and lays down how those rules are to be applied to different categories of listed diseases. Regulation (EU) 2016/429 provides for the Member States to establish compulsory eradication programmes for the listed diseases referred to in Article 9(1), point (b), thereof, and for optional eradication programmes for listed diseases referred to in Article 9(1), point (c), thereof, and for the approval of such programmes by the Commission. That Regulation also provides for the approval or withdrawal by the Commission of the disease-free status of Member States or zones or compartments thereof regarding certain listed diseases referred to in Article 9(1), points (b) and (c), thereof.

| (2) | Commission Delegated Regulation (EU) 2020/689 (2) supplements Regulation (EU) 2016/429 and lays down the criteria for granting, maintaining, suspending, and withdrawing disease-free status for Member States or zones or compartments thereof, and the requirements for the approval of compulsory or optional eradication programmes for Member States or zones or compartments thereof. |
| --- | --- |

(2)

Commission Delegated Regulation (EU) 2020/689 (2) supplements Regulation (EU) 2016/429 and lays down the criteria for granting, maintaining, suspending, and withdrawing disease-free status for Member States or zones or compartments thereof, and the requirements for the approval of compulsory or optional eradication programmes for Member States or zones or compartments thereof.

| (3) | Commission Implementing Regulation (EU) 2021/620 (3) lays down implementing rules for the listed diseases referred to in Article 9(1), points (a), (b) and (c), of Regulation (EU) 2016/429 of animals, as regards the disease-free and non-vaccination status of certain Member States or zones or compartments thereof, and the approval of eradication programmes for those listed diseases. More particularly, it lists in the Annexes thereto, the Member States or zones or compartments thereof with disease-free status and it also lists the existing approved compulsory or optional eradication programmes. The changing epidemiological situation of certain diseases makes it necessary to amend certain Annexes to Implementing Regulation (EU) 2021/620 to list new disease-free Member States or zones thereof and to delete from the lists zones where disease outbreaks have been confirmed or where the conditions for maintaining the disease-free status are no longer met, and to approve certain compulsory or optional eradication programmes submitted to the Commission. |
| --- | --- |

(3)

Commission Implementing Regulation (EU) 2021/620 (3) lays down implementing rules for the listed diseases referred to in Article 9(1), points (a), (b) and (c), of Regulation (EU) 2016/429 of animals, as regards the disease-free and non-vaccination status of certain Member States or zones or compartments thereof, and the approval of eradication programmes for those listed diseases. More particularly, it lists in the Annexes thereto, the Member States or zones or compartments thereof with disease-free status and it also lists the existing approved compulsory or optional eradication programmes. The changing epidemiological situation of certain diseases makes it necessary to amend certain Annexes to Implementing Regulation (EU) 2021/620 to list new disease-free Member States or zones thereof and to delete from the lists zones where disease outbreaks have been confirmed or where the conditions for maintaining the disease-free status are no longer met, and to approve certain compulsory or optional eradication programmes submitted to the Commission.

| (4) | For infection with Brucella abortus, B. melitensis and B. suis, infection with Mycobacterium tuberculosis complex (Mycobacterium bovis, M. caprae and M. tuberculosis) (MTBC), infection with the rabies virus (RABV), enzootic bovine leukosis (EBL), infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV), infection with Aujeszky’s disease virus (ADV), bovine viral diarrhoea (BVD) and infection with bluetongue virus (serotypes 1-24) (BTV), several Member States have recently applied to the Commission to have disease-free status granted or compulsory or optional eradication programmes approved for certain zones of their territory. Several Member States have also notified outbreaks of infection with RABV, and of infection with BTV that also need to be reflected in certain Annexes to Implementing Regulation (EU) 2021/620. |
| --- | --- |

(4)

For infection with Brucella abortus, B. melitensis and B. suis, infection with Mycobacterium tuberculosis complex (Mycobacterium bovis, M. caprae and M. tuberculosis) (MTBC), infection with the rabies virus (RABV), enzootic bovine leukosis (EBL), infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV), infection with Aujeszky’s disease virus (ADV), bovine viral diarrhoea (BVD) and infection with bluetongue virus (serotypes 1-24) (BTV), several Member States have recently applied to the Commission to have disease-free status granted or compulsory or optional eradication programmes approved for certain zones of their territory. Several Member States have also notified outbreaks of infection with RABV, and of infection with BTV that also need to be reflected in certain Annexes to Implementing Regulation (EU) 2021/620.

| (5) | For infection with Brucella abortus, B. melitensis and B. suis in bovine animals, Italy and Portugal have submitted to the Commission information demonstrating that the conditions for the recognition of disease-free status laid down in Delegated Regulation (EU) 2020/689 are fulfilled in the province of Matera in the region of Basilicata, and in the districts of Santarem and Setubal, respectively. Following the assessment by the Commission, those applications have been shown to comply with the criteria laid down in Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 for the granting of disease-free status. Therefore, those zones should be listed as free from Brucella abortus, B. melitensis and B. suis in bovine animals in Part I, Chapter 1, of Annex I to Implementing Regulation (EU) 2021/620. |
| --- | --- |

(5)

For infection with Brucella abortus, B. melitensis and B. suis in bovine animals, Italy and Portugal have submitted to the Commission information demonstrating that the conditions for the recognition of disease-free status laid down in Delegated Regulation (EU) 2020/689 are fulfilled in the province of Matera in the region of Basilicata, and in the districts of Santarem and Setubal, respectively. Following the assessment by the Commission, those applications have been shown to comply with the criteria laid down in Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 for the granting of disease-free status. Therefore, those zones should be listed as free from Brucella abortus, B. melitensis and B. suis in bovine animals in Part I, Chapter 1, of Annex I to Implementing Regulation (EU) 2021/620.

| (6) | For infection with Brucella abortus, B. melitensis and B. suis in ovine and caprine animals, France and Italy have submitted to the Commission information demonstrating that the conditions for the recognition of disease-free status laid down in Delegated Regulation (EU) 2020/689 are fulfilled in the overseas regions of Guyane, Guadeloupe, Martinique, Mayotte and Réunion, and in the provinces of Napoli and Salerno in the region of Campania, respectively. Following the assessment by the Commission, those applications have been shown to comply with the criteria laid down in Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 for the granting of disease-free status. Therefore, those zones should be listed as free from Brucella abortus, B. melitensis and B. suis in ovine and caprine animals in Part I, Chapter 2, of Annex I to Implementing Regulation (EU) 2021/620. |
| --- | --- |

(6)

For infection with Brucella abortus, B. melitensis and B. suis in ovine and caprine animals, France and Italy have submitted to the Commission information demonstrating that the conditions for the recognition of disease-free status laid down in Delegated Regulation (EU) 2020/689 are fulfilled in the overseas regions of Guyane, Guadeloupe, Martinique, Mayotte and Réunion, and in the provinces of Napoli and Salerno in the region of Campania, respectively. Following the assessment by the Commission, those applications have been shown to comply with the criteria laid down in Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 for the granting of disease-free status. Therefore, those zones should be listed as free from Brucella abortus, B. melitensis and B. suis in ovine and caprine animals in Part I, Chapter 2, of Annex I to Implementing Regulation (EU) 2021/620.

| (7) | For infection with MTBC, Italy and Spain have submitted to the Commission information demonstrating that the conditions for recognition of disease-free status from infection with MTBC laid down in Delegated Regulation (EU) 2020/689 are fulfilled in the province of Catanzaro in the region of Calabria, in the province of Napoli in the region of Campania, in the provinces of Barletta-Andria-Trani, Brindisi and Lecce in the region of Puglia, in the province of Nord Est Sardegna in the region of Sardinia, and in the provinces of Burgos, León and Valladolid in the Autonomous Community of Castilla y León, respectively. Following the assessment by the Commission, those applications have been shown to comply with the criteria laid down in Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 for the granting of disease-free status from infection with MTBC. Therefore, those zones should be listed in Part I of Annex II to Implementing Regulation (EU) 2021/620, as having disease-free status from infection with MTBC. |
| --- | --- |

(7)

For infection with MTBC, Italy and Spain have submitted to the Commission information demonstrating that the conditions for recognition of disease-free status from infection with MTBC laid down in Delegated Regulation (EU) 2020/689 are fulfilled in the province of Catanzaro in the region of Calabria, in the province of Napoli in the region of Campania, in the provinces of Barletta-Andria-Trani, Brindisi and Lecce in the region of Puglia, in the province of Nord Est Sardegna in the region of Sardinia, and in the provinces of Burgos, León and Valladolid in the Autonomous Community of Castilla y León, respectively. Following the assessment by the Commission, those applications have been shown to comply with the criteria laid down in Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 for the granting of disease-free status from infection with MTBC. Therefore, those zones should be listed in Part I of Annex II to Implementing Regulation (EU) 2021/620, as having disease-free status from infection with MTBC.

| (8) | For EBL, Portugal has submitted to the Commission information demonstrating that the conditions for recognition of disease-free status from EBL laid down in Delegated Regulation (EU) 2020/689 are fulfilled for the district of Porto. Following the assessment by the Commission, that application has been shown to comply with the criteria laid down in Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 for the granting of disease-free status from EBL. Therefore, that zone should be listed in Part I of Annex IV to Implementing Regulation (EU) 2021/620, as having disease-free status from EBL. |
| --- | --- |

(8)

For EBL, Portugal has submitted to the Commission information demonstrating that the conditions for recognition of disease-free status from EBL laid down in Delegated Regulation (EU) 2020/689 are fulfilled for the district of Porto. Following the assessment by the Commission, that application has been shown to comply with the criteria laid down in Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 for the granting of disease-free status from EBL. Therefore, that zone should be listed in Part I of Annex IV to Implementing Regulation (EU) 2021/620, as having disease-free status from EBL.

| (9) | For IBR/IPV, Slovakia has submitted to the Commission an application to have an optional eradication programme approved for a zone comprising the regions of Bratislava, Košice, Prešov, Trnava and Žilina. Following the assessment by the Commission, that application has been shown to comply with the criteria laid down in Part II, Chapter 2, of Delegated Regulation (EU) 2020/689 for approval of eradication programmes for IBR/IPV. Therefore, that zone should be listed in Part II of Annex V to Implementing Regulation (EU) 2021/620, as a zone with an approved eradication programme for IBR/IPV. |
| --- | --- |

(9)

For IBR/IPV, Slovakia has submitted to the Commission an application to have an optional eradication programme approved for a zone comprising the regions of Bratislava, Košice, Prešov, Trnava and Žilina. Following the assessment by the Commission, that application has been shown to comply with the criteria laid down in Part II, Chapter 2, of Delegated Regulation (EU) 2020/689 for approval of eradication programmes for IBR/IPV. Therefore, that zone should be listed in Part II of Annex V to Implementing Regulation (EU) 2021/620, as a zone with an approved eradication programme for IBR/IPV.

| (10) | For infection with ADV, Poland has submitted to the Commission information demonstrating that the conditions for recognition of disease-free status from infection with ADV laid down in Delegated Regulation (EU) 2020/689 are fulfilled for all the regions currently listed in Part II of Annex VI to Implementing Regulation (EU) 2021/620 as having an approved eradication programme. Following the assessment by the Commission, that application has been shown to comply with the criteria laid down in Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 for the granting of disease-free status from infection with ADV. Therefore, those zones should be listed in Part I of Annex VI to Implementing Regulation (EU) 2021/620, as having disease-free status from infection with ADV. |
| --- | --- |

(10)

For infection with ADV, Poland has submitted to the Commission information demonstrating that the conditions for recognition of disease-free status from infection with ADV laid down in Delegated Regulation (EU) 2020/689 are fulfilled for all the regions currently listed in Part II of Annex VI to Implementing Regulation (EU) 2021/620 as having an approved eradication programme. Following the assessment by the Commission, that application has been shown to comply with the criteria laid down in Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 for the granting of disease-free status from infection with ADV. Therefore, those zones should be listed in Part I of Annex VI to Implementing Regulation (EU) 2021/620, as having disease-free status from infection with ADV.

| (11) | For BVD, Germany has submitted to the Commission information demonstrating that the conditions for recognition of disease-free status from BVD laid down in Delegated Regulation (EU) 2020/689 are fulfilled for the regions of Augsburg and Ostallgäu in Regierungsbezirk Schwaben, in the state of Bavaria. Following the assessment by the Commission, that application has been shown to comply with the criteria laid down in Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 for the granting of disease-free status from BVD. Therefore, those zones should be listed in Part I of Annex VII to Implementing Regulation (EU) 2021/620, as having disease-free status from BVD. |
| --- | --- |

(11)

For BVD, Germany has submitted to the Commission information demonstrating that the conditions for recognition of disease-free status from BVD laid down in Delegated Regulation (EU) 2020/689 are fulfilled for the regions of Augsburg and Ostallgäu in Regierungsbezirk Schwaben, in the state of Bavaria. Following the assessment by the Commission, that application has been shown to comply with the criteria laid down in Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 for the granting of disease-free status from BVD. Therefore, those zones should be listed in Part I of Annex VII to Implementing Regulation (EU) 2021/620, as having disease-free status from BVD.

| (12) | For BVD, Germany has also informed the Commission that the zones of Regierungbezirk Oberfranken, Regierungsbezirk Oberpfalz, Regierungsbezirk Mittelfranken and Regierungsbezirk Unterfranken in the state of Bavaria as listed in Part I of Annex VII to Implementing Regulation (EU) 2021/620, as having disease-free status from BVD should be updated. The whole territory of those zones is free from BVD, as opposed to Regierungsbezirk Niederbayern, where BVD is still present in some parts of those territories. Therefore, it is not necessary to mention the smaller entities such as cities and Landkreis listed under Regierungsbezirk Oberfranken, Regierungsbezirk Oberpfalz, Regierungsbezirk Mittelfranken and Regierungsbezirk Unterfranken, which should be deleted. Part I of Annex VII to Implementing Regulation (EU) 2021/620 should be amended accordingly. |
| --- | --- |

(12)

For BVD, Germany has also informed the Commission that the zones of Regierungbezirk Oberfranken, Regierungsbezirk Oberpfalz, Regierungsbezirk Mittelfranken and Regierungsbezirk Unterfranken in the state of Bavaria as listed in Part I of Annex VII to Implementing Regulation (EU) 2021/620, as having disease-free status from BVD should be updated. The whole territory of those zones is free from BVD, as opposed to Regierungsbezirk Niederbayern, where BVD is still present in some parts of those territories. Therefore, it is not necessary to mention the smaller entities such as cities and Landkreis listed under Regierungsbezirk Oberfranken, Regierungsbezirk Oberpfalz, Regierungsbezirk Mittelfranken and Regierungsbezirk Unterfranken, which should be deleted. Part I of Annex VII to Implementing Regulation (EU) 2021/620 should be amended accordingly.

| (13) | Slovakia has notified to the Commission several outbreaks of infection with RABV affecting the regions of Humenné, Medzilaborce, Snina, Stropkov, Svidnik and Vranov nad Topl’ou in kraj Prešovský and the regions of Michalovce, Sobrance and Trebišov in kraj Košický. As the whole territory of Slovakia has disease-free status from infection with RABV and is listed in Part I of Annex III to Implementing Regulation (EU) 2021/620, the disease-free status for those regions should be withdrawn, and the entry for Slovakia in that list should be amended accordingly. |
| --- | --- |

(13)

Slovakia has notified to the Commission several outbreaks of infection with RABV affecting the regions of Humenné, Medzilaborce, Snina, Stropkov, Svidnik and Vranov nad Topl’ou in kraj Prešovský and the regions of Michalovce, Sobrance and Trebišov in kraj Košický. As the whole territory of Slovakia has disease-free status from infection with RABV and is listed in Part I of Annex III to Implementing Regulation (EU) 2021/620, the disease-free status for those regions should be withdrawn, and the entry for Slovakia in that list should be amended accordingly.

| (14) | For infection with RABV, Slovakia also has submitted to the Commission an application to have a compulsory eradication programme approved for a zone comprising the regions of Humenné, Medzilaborce, Snina, Stropkov, Svidnik and Vranov nad Topl’ou in kraj Prešovský and the regions of Michalovce, Sobrance and Trebišov in kraj Košický. Following the assessment by the Commission, that application has been shown to comply with the criteria laid down in Part II, Chapter 2, of Delegated Regulation (EU) 2020/689 for approval of eradication programmes for infection with RABV. Therefore, that zone should be listed in Part II of Annex III to Implementing Regulation (EU) 2021/620, as a zone with an approved eradication programme for infection with RABV. |
| --- | --- |

(14)

For infection with RABV, Slovakia also has submitted to the Commission an application to have a compulsory eradication programme approved for a zone comprising the regions of Humenné, Medzilaborce, Snina, Stropkov, Svidnik and Vranov nad Topl’ou in kraj Prešovský and the regions of Michalovce, Sobrance and Trebišov in kraj Košický. Following the assessment by the Commission, that application has been shown to comply with the criteria laid down in Part II, Chapter 2, of Delegated Regulation (EU) 2020/689 for approval of eradication programmes for infection with RABV. Therefore, that zone should be listed in Part II of Annex III to Implementing Regulation (EU) 2021/620, as a zone with an approved eradication programme for infection with RABV.

| (15) | As regards infection with BTV, Belgium and Germany have submitted to the Commission information demonstrating that the conditions for recognition of disease-free status from infection with BTV are fulfilled for the whole territory of Belgium and for the districts of Bernkastel-Wittlich, Eifelkreis Bitburg-Prüm, Trier, Trier-Saarburg and Vulkaneifel in the state of Rhineland-Palatinate within that federal state, respectively. Following the assessment by the Commission, those applications have been shown to comply with the criteria laid down in Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 for the granting of disease-free status from infection with BTV. Therefore, Belgium should be listed, and that zone in the state of Rhineland-Palatinate should be added to the territory of Germany which is already listed as free from infection with BTV, in Part I of Annex VIII to Implementing Regulation (EU) 2021/620, as having disease-free status from infection with BTV. |
| --- | --- |

(15)

As regards infection with BTV, Belgium and Germany have submitted to the Commission information demonstrating that the conditions for recognition of disease-free status from infection with BTV are fulfilled for the whole territory of Belgium and for the districts of Bernkastel-Wittlich, Eifelkreis Bitburg-Prüm, Trier, Trier-Saarburg and Vulkaneifel in the state of Rhineland-Palatinate within that federal state, respectively. Following the assessment by the Commission, those applications have been shown to comply with the criteria laid down in Part II, Chapter 4, of Delegated Regulation (EU) 2020/689 for the granting of disease-free status from infection with BTV. Therefore, Belgium should be listed, and that zone in the state of Rhineland-Palatinate should be added to the territory of Germany which is already listed as free from infection with BTV, in Part I of Annex VIII to Implementing Regulation (EU) 2021/620, as having disease-free status from infection with BTV.

| (16) | Spain has notified to the Commission outbreaks of infection with BTV serotype 4 in the provinces of Ourense and Pontevedra in the Autonomous Community of Galicia, affecting also the surrounding districts of Sarria, Chantada and Terra de Lemos-Quiroga in the province of Lugo, as well as the districts of Alcañices and Puebla de Sanabria in the province of Zamora in the Autonomous Community of Castilla y León. As those areas have disease-free status and are listed in Part I of Annex VIII to Implementing Regulation (EU) 2021/620, their disease-free status from infection with BTV should be withdrawn, and the entry for Spain in that list should be amended accordingly. |
| --- | --- |

(16)

Spain has notified to the Commission outbreaks of infection with BTV serotype 4 in the provinces of Ourense and Pontevedra in the Autonomous Community of Galicia, affecting also the surrounding districts of Sarria, Chantada and Terra de Lemos-Quiroga in the province of Lugo, as well as the districts of Alcañices and Puebla de Sanabria in the province of Zamora in the Autonomous Community of Castilla y León. As those areas have disease-free status and are listed in Part I of Annex VIII to Implementing Regulation (EU) 2021/620, their disease-free status from infection with BTV should be withdrawn, and the entry for Spain in that list should be amended accordingly.

| (17) | As regards infection with BTV, Spain has also informed the Commission that it has extended the territorial scope of the optional eradication programme already approved for the zone listed in Part II of Annex VIII to Implementing Regulation (EU) 2021/620 with the addition of a zone comprising the provinces of Ourense and Pontevedra, several districts in the province of Lugo in the Autonomous Community of Galicia, several districts in the province of Toledo in the Autonomous Community of Castilla-La Mancha, the province of Salamanca, several districts in the provinces of Avila and Zamora in the Autonomous Community of Castilla y Leon and several districts in the Autonomous Community of Madrid. Therefore, that zone should be added to the entry for Spain in Part II of Annex VIII to Implementing Regulation (EU) 2021/620, as a zone with an approved eradication programme for infection with BTV. |
| --- | --- |

(17)

As regards infection with BTV, Spain has also informed the Commission that it has extended the territorial scope of the optional eradication programme already approved for the zone listed in Part II of Annex VIII to Implementing Regulation (EU) 2021/620 with the addition of a zone comprising the provinces of Ourense and Pontevedra, several districts in the province of Lugo in the Autonomous Community of Galicia, several districts in the province of Toledo in the Autonomous Community of Castilla-La Mancha, the province of Salamanca, several districts in the provinces of Avila and Zamora in the Autonomous Community of Castilla y Leon and several districts in the Autonomous Community of Madrid. Therefore, that zone should be added to the entry for Spain in Part II of Annex VIII to Implementing Regulation (EU) 2021/620, as a zone with an approved eradication programme for infection with BTV.

| (18) | Annexes I to VIII to Implementing Regulation (EU) 2021/620 should therefore be amended accordingly. |
| --- | --- |

(18)

Annexes I to VIII to Implementing Regulation (EU) 2021/620 should therefore be amended accordingly.

| (19) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(19)

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

Annexes I to VIII to Implementing Regulation (EU) 2021/620 are amended in accordance with the Annex to this Regulation.

Article 2

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

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

Done at Brussels, 1 June 2023.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  OJ L 84, 31.3.2016, p. 1.

1

(2)  Commission Delegated Regulation (EU) 2020/689 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases (OJ L 174, 3.6.2020, p. 211).

2

(3)  Commission Implementing Regulation (EU) 2021/620 of 15 April 2021 laying down rules for the application of Regulation (EU) 2016/429 of the European Parliament and of the Council as regards the approval of the disease-free and non-vaccination status of certain Member States or zones or compartments thereof as regards certain listed diseases and the approval of eradication programmes for those listed diseases (OJ L 131, 16.4.2021, p. 78).

3

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ANNEX

Annexes I to VIII to Implementing Regulation (EU) 2021/620 are amended as follows:

| (1) | Annex I is amended as follows:






  (a) | in Part I, Chapter 1 is amended as follows:






  (i) | the entry for Italy is replaced by the following:






  Member State | Territory |
| --- | --- | --- | --- | --- |
| ‘Italy | Regione Abruzzo: Provincia di Pescara, Teramo
  Regione Basilicata: Provincia di Matera
  Regione Calabria: Provincia di Vibo Valentia
  Regione Campania: Provincia di Avellino, Benevento, Napoli
  Regione Emilia-Romagna
  Regione Friuli Venezia Giulia
  Regione Lazio
  Regione Liguria
  Regione Lombardia
  Regione Marche
  Regione Molise: Provincia di Campobasso
  Regione Piemonte
  Regione Puglia: Province di Bari, Barletta-Andria-Trani, Brindisi, Lecce
  Regione Sardegna
  Regione Toscana
  Regione Trentino – Alto Adige
  Regione Umbria
  Regione Valle d’Aosta
  Regione Veneto’ |

(1)

Annex I is amended as follows:

(a)

in Part I, Chapter 1 is amended as follows:

(i)

the entry for Italy is replaced by the following:

Member State

Territory

‘Italy

Regione Abruzzo: Provincia di Pescara, Teramo

Regione Basilicata: Provincia di Matera

Regione Calabria: Provincia di Vibo Valentia

Regione Campania: Provincia di Avellino, Benevento, Napoli

Regione Emilia-Romagna

Regione Friuli Venezia Giulia

Regione Lazio

Regione Liguria

Regione Lombardia

Regione Marche

Regione Molise: Provincia di Campobasso

Regione Piemonte

Regione Puglia: Province di Bari, Barletta-Andria-Trani, Brindisi, Lecce

Regione Sardegna

Regione Toscana

Regione Trentino – Alto Adige

Regione Umbria

Regione Valle d’Aosta

Regione Veneto’

| (ii) | the entry for Portugal is replaced by the following:






  Member State | Territory |
| --- | --- | --- |
| ‘Portugal | Distritos Aveiro, Castelo Branco, Coimbra, Faro, Guarda, Leiria, Santarem, Setubal, Viseu
  Região Autónoma dos Açores: Ilhas de Corvo, Faial, Flores, Graciosa, Pico, São Jorge, Santa Maria, Terceira’ |

(ii)

the entry for Portugal is replaced by the following:

Member State

Territory

‘Portugal

Distritos Aveiro, Castelo Branco, Coimbra, Faro, Guarda, Leiria, Santarem, Setubal, Viseu

Região Autónoma dos Açores: Ilhas de Corvo, Faial, Flores, Graciosa, Pico, São Jorge, Santa Maria, Terceira’

| (b) | in Part I, Chapter 2 is amended as follows:






  (i) | the entry for France is replaced by the following:






  Member State | Territory |
| --- | --- | --- | --- |
| ‘France | Whole territory’ |

(b)

in Part I, Chapter 2 is amended as follows:

(i)

the entry for France is replaced by the following:

Member State

Territory

‘France

Whole territory’

| (ii) | the entry for Italy is replaced by the following:






  Member State | Territory |
| --- | --- | --- |
| ‘Italy | Regione Abruzzo
  Regione Calabria: Province di Catanzaro, Cosenza
  Regione Campania: Provincia di Benevento, Napoli, Salerno
  Regione Emilia-Romagna
  Regione Friuli Venezia Giulia
  Regione Lazio
  Regione Liguria
  Regione Lombardia
  Regione Marche
  Regione Molise
  Regione Piemonte
  Regione Puglia: Province di Bari, Barletta-Andria-Trani, Brindisi, Lecce, Taranto
  Regione Sardegna
  Regione Toscana
  Regione Trentino – Alto Adige
  Regione Umbria
  Regione Valle d’Aosta
  Regione Veneto’ |

(ii)

the entry for Italy is replaced by the following:

Member State

Territory

‘Italy

Regione Abruzzo

Regione Calabria: Province di Catanzaro, Cosenza

Regione Campania: Provincia di Benevento, Napoli, Salerno

Regione Emilia-Romagna

Regione Friuli Venezia Giulia

Regione Lazio

Regione Liguria

Regione Lombardia

Regione Marche

Regione Molise

Regione Piemonte

Regione Puglia: Province di Bari, Barletta-Andria-Trani, Brindisi, Lecce, Taranto

Regione Sardegna

Regione Toscana

Regione Trentino – Alto Adige

Regione Umbria

Regione Valle d’Aosta

Regione Veneto’

| (c) | in Part II, Chapter 1 is amended as follows:






  (i) | the entry for Italy is replaced by the following:






  Member State | Territory |
| --- | --- | --- | --- |
| ‘Italy | Regione Abruzzo: Provincia dell’Aquila, di Chieti
  Regione Basilicata: Provincia di Potenza
  Regione Calabria: Provincia di Catanzaro, Cosenza, Crotone, Reggio Calabria
  Regione Campania: Provincia di Caserta, Salerno
  Regione Molise: Provincia di Isernia
  Regione Puglia: Provincia di Foggia, Taranto
  Regione Sicilia’ |

(c)

in Part II, Chapter 1 is amended as follows:

(i)

the entry for Italy is replaced by the following:

Member State

Territory

‘Italy

Regione Abruzzo: Provincia dell’Aquila, di Chieti

Regione Basilicata: Provincia di Potenza

Regione Calabria: Provincia di Catanzaro, Cosenza, Crotone, Reggio Calabria

Regione Campania: Provincia di Caserta, Salerno

Regione Molise: Provincia di Isernia

Regione Puglia: Provincia di Foggia, Taranto

Regione Sicilia’

| (ii) | the entry for Portugal is replaced by the following:






  Member State | Territory |
| --- | --- | --- |
| ‘Portugal | Distritos Beja, Braga, Braganca, Evora, Lisboa, Portalegre, Porto, Viana do Castelo, Vila Real
  Região Autónoma da Madeira
  Região Autónoma dos Açores: Ilha de São Miguel’ |

(ii)

the entry for Portugal is replaced by the following:

Member State

Territory

‘Portugal

Distritos Beja, Braga, Braganca, Evora, Lisboa, Portalegre, Porto, Viana do Castelo, Vila Real

Região Autónoma da Madeira

Região Autónoma dos Açores: Ilha de São Miguel’

| (d) | in Part II, in Chapter 2, the entry for Italy is replaced by the following:






  Member State | Territory |
| --- | --- | --- |
| ‘Italy | Regione Basilicata
  Regione Calabria: Provincia di Crotone, Reggio Calabria, Vibo Valentia
  Regione Campania: Provincia di Caserta, Avellino
  Regione Puglia: Provincia di Foggia
  Regione Sicilia’ |

(d)

in Part II, in Chapter 2, the entry for Italy is replaced by the following:

Member State

Territory

‘Italy

Regione Basilicata

Regione Calabria: Provincia di Crotone, Reggio Calabria, Vibo Valentia

Regione Campania: Provincia di Caserta, Avellino

Regione Puglia: Provincia di Foggia

Regione Sicilia’

| (2) | Annex II is amended as follows:






  (a) | Part I is amended as follows:






  (i) | the entry for Italy is replaced by the following:






  Member State | Territory |
| --- | --- | --- | --- | --- |
| ‘Italy | Regione Abruzzo
  Regione Basilicata: Provincia di Matera
  Regione Calabria: Provincia di Catanzaro
  Regione Campania: Provincia di Napoli
  Regione Emilia-Romagna
  Regione Friuli Venezia Giulia
  Regione Lazio: Provincia di Frosinone, Latina, Rieti, Viterbo
  Regione Liguria
  Regione Lombardia
  Regione Marche: Provincia di Ancona, Ascoli Piceno, Fermo, Pesaro-Urbino
  Regione Molise
  Regione Piemonte
  Regione Puglia: Provincia di Bari, Barletta-Andria-Trani, Brindisi, Lecce, Taranto
  Regione Sardegna: Città metropolitana di Cagliari, Provincia di Medio Campidano, Nord Est Sardegna, Nuoro, Ogliastra, Oristano, Sulcis Iglesiente
  Regione Toscana
  Regione Trentino – Alto Adige
  Regione Umbria
  Regione Valle d’Aosta
  Regione Veneto’ |

(2)

Annex II is amended as follows:

(a)

Part I is amended as follows:

(i)

the entry for Italy is replaced by the following:

Member State

Territory

‘Italy

Regione Abruzzo

Regione Basilicata: Provincia di Matera

Regione Calabria: Provincia di Catanzaro

Regione Campania: Provincia di Napoli

Regione Emilia-Romagna

Regione Friuli Venezia Giulia

Regione Lazio: Provincia di Frosinone, Latina, Rieti, Viterbo

Regione Liguria

Regione Lombardia

Regione Marche: Provincia di Ancona, Ascoli Piceno, Fermo, Pesaro-Urbino

Regione Molise

Regione Piemonte

Regione Puglia: Provincia di Bari, Barletta-Andria-Trani, Brindisi, Lecce, Taranto

Regione Sardegna: Città metropolitana di Cagliari, Provincia di Medio Campidano, Nord Est Sardegna, Nuoro, Ogliastra, Oristano, Sulcis Iglesiente

Regione Toscana

Regione Trentino – Alto Adige

Regione Umbria

Regione Valle d’Aosta

Regione Veneto’

| (ii) | the entry for Spain is replaced by the following:






  Member State | Territory |
| --- | --- | --- |
| ‘Spain | Comunidad Autónoma de Canarias
  Comunidad Autónoma de Castilla y León: Province of Burgos, León, Valladolid
  Comunidad Autónoma de Cataluña
  Comunidad Autónoma de Galicia
  Comunidad Autónoma de Islas Baleares
  Comunidad Autónoma de Murcia
  Comunidad Autónoma del País Vasco
  Comunidad Autónoma del Principado de Asturias’ |

(ii)

the entry for Spain is replaced by the following:

Member State

Territory

‘Spain

Comunidad Autónoma de Canarias

Comunidad Autónoma de Castilla y León: Province of Burgos, León, Valladolid

Comunidad Autónoma de Cataluña

Comunidad Autónoma de Galicia

Comunidad Autónoma de Islas Baleares

Comunidad Autónoma de Murcia

Comunidad Autónoma del País Vasco

Comunidad Autónoma del Principado de Asturias’

| (b) | Part II is amended as follows:






  (i) | the entry for Italy is replaced by the following:






  Member State | Territory |
| --- | --- | --- | --- |
| ‘Italy | Regione Basilicata: Provincia di Potenza
  Regione Calabria: Provincia di Cosenza, Crotone, Reggio Calabria, Vibo Valentia
  Regione Campania: Provincia d’Avellino, Caserta, Benevento, Salerno
  Regione Lazio: Provincia di Roma
  Regione Marche: Provincia di Macerata
  Regione Puglia: Provincia di Foggia
  Regione Sardegna: Città metropolitana di Sassari
  Regione Sicilia’ |

(b)

Part II is amended as follows:

(i)

the entry for Italy is replaced by the following:

Member State

Territory

‘Italy

Regione Basilicata: Provincia di Potenza

Regione Calabria: Provincia di Cosenza, Crotone, Reggio Calabria, Vibo Valentia

Regione Campania: Provincia d’Avellino, Caserta, Benevento, Salerno

Regione Lazio: Provincia di Roma

Regione Marche: Provincia di Macerata

Regione Puglia: Provincia di Foggia

Regione Sardegna: Città metropolitana di Sassari

Regione Sicilia’

| (ii) | the entry for Spain is replaced by the following:






  Member State | Territory |
| --- | --- | --- |
| ‘Spain | Comunidad Autónoma de Andalucía
  Comunidad Autónoma de Aragón
  Comunidad Autónoma de Cantabria
  Comunidad Autónoma de Castilla-La Mancha
  Comunidad Autónoma de Castilla y León: Province of Ávila, Palencia, Salamanca, Segovia, Soria, Zamora
  Comunidad Autónoma de Extremadura
  Comunidad Autónoma de La Rioja
  Comunidad Autónoma de Madrid
  Comunidad Autónoma de Navarra
  Comunidad Autónoma de Valencia’ |

(ii)

the entry for Spain is replaced by the following:

Member State

Territory

‘Spain

Comunidad Autónoma de Andalucía

Comunidad Autónoma de Aragón

Comunidad Autónoma de Cantabria

Comunidad Autónoma de Castilla-La Mancha

Comunidad Autónoma de Castilla y León: Province of Ávila, Palencia, Salamanca, Segovia, Soria, Zamora

Comunidad Autónoma de Extremadura

Comunidad Autónoma de La Rioja

Comunidad Autónoma de Madrid

Comunidad Autónoma de Navarra

Comunidad Autónoma de Valencia’

| (3) | Annex III is amended as follows:






  (a) | in Part I, the entry for Slovakia is replaced by the following:






  Member State | Territory |
| --- | --- | --- | --- |
| ‘Slovakia | Whole territory, except the following regions:
  Humenné, Medzilaborce, Snina, Stropkov, Svidnik, Vranov nad Topl’ou in kraj Prešovský
  Michalovce, Sobrance, Trebišov in kraj Košický’ |

(3)

Annex III is amended as follows:

(a)

in Part I, the entry for Slovakia is replaced by the following:

Member State

Territory

‘Slovakia

Whole territory, except the following regions:

Humenné, Medzilaborce, Snina, Stropkov, Svidnik, Vranov nad Topl’ou in kraj Prešovský

Michalovce, Sobrance, Trebišov in kraj Košický’

| (b) | in Part II, the following entry for Slovakia is inserted after the entry for Romania:






  Member State | Territory |
| --- | --- | --- |
| ‘Slovakia | Region Humenné, Medzilaborce, Snina, Stropkov, Svidnik, Vranov nad Topl’ou in kraj Prešovský
  Region Michalovce, Sobrance, Trebišov in kraj Košický’ |

(b)

in Part II, the following entry for Slovakia is inserted after the entry for Romania:

Member State

Territory

‘Slovakia

Region Humenné, Medzilaborce, Snina, Stropkov, Svidnik, Vranov nad Topl’ou in kraj Prešovský

Region Michalovce, Sobrance, Trebišov in kraj Košický’

| (4) | in Annex IV, in Part I, the entry for Portugal is replaced by the following:






  Member State | Territory |
| --- | --- | --- |
| ‘Portugal | Whole territory, except Região Autónoma da Madeira’ |

(4)

in Annex IV, in Part I, the entry for Portugal is replaced by the following:

Member State

Territory

‘Portugal

Whole territory, except Região Autónoma da Madeira’

| (5) | in Annex V, in Part II, the following entry for Slovakia is inserted after the entry for Luxembourg:







  Member State | Territory | Date of initial approval as referred to in Article 15, point 2, of Delegated Regulation (EU) 2020/689 |
| --- | --- | --- | --- |
| ‘Slovakia | Kraj Bratislava
  Kraj Košice
  Kraj Prešov
  Kraj Trnava
  Kraj Žilina | 5 June 2023’ |

(5)

in Annex V, in Part II, the following entry for Slovakia is inserted after the entry for Luxembourg:

Member State

Territory

Date of initial approval as referred to in Article 15, point 2, of Delegated Regulation (EU) 2020/689

‘Slovakia

Kraj Bratislava

Kraj Košice

Kraj Prešov

Kraj Trnava

Kraj Žilina

5 June 2023’

| (6) | Annex VI is amended as follows






  (a) | in Part I, the entry for Poland is replaced by the following:






  Member State | Territory |
| --- | --- | --- | --- |
| ‘Poland | Whole territory’ |

(6)

Annex VI is amended as follows

(a)

in Part I, the entry for Poland is replaced by the following:

Member State

Territory

‘Poland

Whole territory’

| (b) | in Part II, the entry for Poland is deleted; |
| --- | --- |

(b)

in Part II, the entry for Poland is deleted;

| (7) | Annex VII is amended as follows:






  (a) | in Part I, the entry for Germany is replaced by the following:






  Member State | Territory |
| --- | --- | --- | --- |
| ‘Germany | Bundesland Baden-Württemberg
  Bundesland Bayern:
  Regierungsbezirk Oberbayern
  The following cities and Landkreis in Regierungsbezirk Niederbayern: Stadt Landshut, Stadt Passau, Stadt Straubing, Freyung-Grafenau, Kelheim, Lkr. Landshut, Lkr. Passau, Regen, Rottal-Inn, Lkr. Straubing-Bogen,
  Regierungsbezirk Mittelfranken
  Regierungsbezirk Oberfranken
  Regierungsbezirk Oberpfalz
  Regierungsbezirk Unterfranken
  Regierungsbezirk Schwaben
  Bundesland Brandenburg
  Bundesland Bremen
  Bundesland Hamburg
  Bundesland Hessen
  Bundesland Mecklenburg-Vorpommern
  Bundesland Rheinland-Pfalz
  Bundesland Saarland
  Bundesland Sachsen
  Bundesland Sachsen-Anhalt
  Bundesland Thüringen’ |

(7)

Annex VII is amended as follows:

(a)

in Part I, the entry for Germany is replaced by the following:

Member State

Territory

‘Germany

Bundesland Baden-Württemberg

Bundesland Bayern:

Regierungsbezirk Oberbayern

The following cities and Landkreis in Regierungsbezirk Niederbayern: Stadt Landshut, Stadt Passau, Stadt Straubing, Freyung-Grafenau, Kelheim, Lkr. Landshut, Lkr. Passau, Regen, Rottal-Inn, Lkr. Straubing-Bogen,

Regierungsbezirk Mittelfranken

Regierungsbezirk Oberfranken

Regierungsbezirk Oberpfalz

Regierungsbezirk Unterfranken

Regierungsbezirk Schwaben

Bundesland Brandenburg

Bundesland Bremen

Bundesland Hamburg

Bundesland Hessen

Bundesland Mecklenburg-Vorpommern

Bundesland Rheinland-Pfalz

Bundesland Saarland

Bundesland Sachsen

Bundesland Sachsen-Anhalt

Bundesland Thüringen’

| (b) | in Part II, the entry for Germany is replaced by the following:







  Member State | Territory | Date of initial approval as referred to in Article 15(2) of Delegated Regulation (EU) 2020/689 |
| --- | --- | --- | --- |
| ‘Germany | Bundesland Bayern:
  The following cities and Landkreis in Regierungsbezirk Niederbayern: Deggendorf, Dingolfing-Landau
  Bundesland Berlin
  Bundesland Niedersachsen
  Bundesland Nordrhein-Westfalen
  Bundesland Schleswig-Holstein | 21 February 2022’ |

(b)

in Part II, the entry for Germany is replaced by the following:

Member State

Territory

Date of initial approval as referred to in Article 15(2) of Delegated Regulation (EU) 2020/689

‘Germany

Bundesland Bayern:

The following cities and Landkreis in Regierungsbezirk Niederbayern: Deggendorf, Dingolfing-Landau

Bundesland Berlin

Bundesland Niedersachsen

Bundesland Nordrhein-Westfalen

Bundesland Schleswig-Holstein

21 February 2022’

| (8) | Annex VIII is amended as follows:






  (a) | Part I is amended as follows:






  (i) | the following entry for Belgium is inserted before the entry for Czechia:






  Member State | Territory |
| --- | --- | --- | --- | --- |
| ‘Belgium | Whole territory’ |

(8)

Annex VIII is amended as follows:

(a)

Part I is amended as follows:

(i)

the following entry for Belgium is inserted before the entry for Czechia:

Member State

Territory

‘Belgium

Whole territory’

| (ii) | the entry for Germany is replaced by the following:






  Member State | Territory |
| --- | --- | --- |
| ‘Germany | Whole territory’ |

(ii)

the entry for Germany is replaced by the following:

Member State

Territory

‘Germany

Whole territory’

| (iii) | the entry for Spain is replaced by the following:






  Member State | Territory |
| --- | --- | --- |
| ‘Spain | Comunidad Autónoma de Andalucía: Province of Almería
  Province of Granada, the following districts: Alhama de Granada (Alhama/Temple), Baza (Altiplanicie Sur), Guadix (Hoya-Altiplanicie de Guadix), Huescar (Altiplanicie Norte), Iznalloz (Montes Orientales), Loja (Vega/Montes Occ.), Orgiva (Alpujarra/Valle de Lecrin), Santa Fe (Vega de Granada)
  Comunidad Autónoma de Aragón
  Comunidad Autónoma de Asturias
  Comunidad Autónoma de Canarias Comunidad Autónoma de Cantabria
  Comunidad Autónoma de Castilla-La Mancha, except the following districts:
  Almadén, Almodóvar del Campo, Piedrabuena in the Province of Ciudad Real
  Belvis de la Jara, Gálvez, Los Navalmorales, Oropesa, Talavera de la Reina, Toledo, Torrijos in the Province of Toledo
  Comunidad Autónoma de Castilla y León, except the following areas:
  Province of Salamanca
  Ávila, Arenas de San Pedro, Candeleda, Cebrero, El Barco de Ávila, El Barraco, Navaluenga, Navarredonda de Gredos, Piedrahíta, San Pedro del Arroyo, Sotillo de la Adrada in the Province of Ávila
  Alcañices, Bermillo de Sayago, Puebla de Sanabria in the Province of Zamora
  Comunidad Autónoma de Cataluña
  Comunidad Autónoma de Galicia except the following areas:
  Province of Orense
  Province of Pontevedra
  Sarria, Chantada and Terra de Lemos-Quiroga in the Province of Lugo
  Comunidad Autónoma de La Rioja
  Comunidad Autónoma de Madrid, except the following districts:
  Navalcarnero, San Martín de Valdeiglesias
  Comunidad Autónoma de Murcia
  Comunidad Autónoma de Navarra
  Comunidad Autónoma de País Vasco
  Comunidad Autónoma de Valencia’ |

(iii)

the entry for Spain is replaced by the following:

Member State

Territory

‘Spain

Comunidad Autónoma de Andalucía: Province of Almería

Province of Granada, the following districts: Alhama de Granada (Alhama/Temple), Baza (Altiplanicie Sur), Guadix (Hoya-Altiplanicie de Guadix), Huescar (Altiplanicie Norte), Iznalloz (Montes Orientales), Loja (Vega/Montes Occ.), Orgiva (Alpujarra/Valle de Lecrin), Santa Fe (Vega de Granada)

Comunidad Autónoma de Aragón

Comunidad Autónoma de Asturias

Comunidad Autónoma de Canarias Comunidad Autónoma de Cantabria

Comunidad Autónoma de Castilla-La Mancha, except the following districts:

Almadén, Almodóvar del Campo, Piedrabuena in the Province of Ciudad Real

Belvis de la Jara, Gálvez, Los Navalmorales, Oropesa, Talavera de la Reina, Toledo, Torrijos in the Province of Toledo

Comunidad Autónoma de Castilla y León, except the following areas:

Province of Salamanca

Ávila, Arenas de San Pedro, Candeleda, Cebrero, El Barco de Ávila, El Barraco, Navaluenga, Navarredonda de Gredos, Piedrahíta, San Pedro del Arroyo, Sotillo de la Adrada in the Province of Ávila

Alcañices, Bermillo de Sayago, Puebla de Sanabria in the Province of Zamora

Comunidad Autónoma de Cataluña

Comunidad Autónoma de Galicia except the following areas:

Province of Orense

Province of Pontevedra

Sarria, Chantada and Terra de Lemos-Quiroga in the Province of Lugo

Comunidad Autónoma de La Rioja

Comunidad Autónoma de Madrid, except the following districts:

Navalcarnero, San Martín de Valdeiglesias

Comunidad Autónoma de Murcia

Comunidad Autónoma de Navarra

Comunidad Autónoma de País Vasco

Comunidad Autónoma de Valencia’

| (b) | Part II is replaced by the following:
  ‘PART II

  Member States or zones thereof with an approved eradication programme for infection with BTV








  Member State | Territory | Date of initial approval as referred to in Article 15(2) of Delegated Regulation (EU) 2020/689 |
| --- | --- | --- | --- |
| Spain | Communidad Autónoma de Andalucía:
  Provinces of Cádiz, Córdoba, Huelva, Jáén, Málaga, Sevilla
  Province of Granada: Motril (Costa de Granada)
  Communidad Autónoma de Castilla-La Mancha:
  Province of Ciudad Real, the following districts: Almadén, Almodóvar del Campo and Piedrabuena
  Province of Toledo, the following districts: Belvis de la Jara, Gálvez, Los Navalmorales, Oropesa, Talavera de la Reina, Toledo, Torrijos
  Comunidad Autónoma de Castilla y León:
  Province of Salamanca
  Province of Ávila, the following districts: Ávila, Arenas de San Pedro, Candeleda, Cebrero, El Barco de Ávila, El Barraco, Navaluenga, Navarredonda de Gredos, Piedrahíta, San Pedro del Arroyo, Sotillo de la Adrada
  Province of Zamora, the following districts: Alcañices, Bermillo de Sayago Puebla de Sanabria
  Communidad Autónoma de Extremadura
  Communidad Autónoma de Galicia:
  Province of Orense
  Province of Pontevedra
  Sarria, Chantada and Terra de Lemos-Quiroga in the Province of Lugo
  Communidad Autónoma de Islas Baleares
  Comunidad Autónoma de Madrid, the following districts:
  Navalcarnero, San Martín de Valdeiglesias | 21 February 2022’ |

(b)

Part II is replaced by the following:

‘PART II

Member States or zones thereof with an approved eradication programme for infection with BTV

Member State

Territory

Date of initial approval as referred to in Article 15(2) of Delegated Regulation (EU) 2020/689

Spain

Communidad Autónoma de Andalucía:

Provinces of Cádiz, Córdoba, Huelva, Jáén, Málaga, Sevilla

Province of Granada: Motril (Costa de Granada)

Communidad Autónoma de Castilla-La Mancha:

Province of Ciudad Real, the following districts: Almadén, Almodóvar del Campo and Piedrabuena

Province of Toledo, the following districts: Belvis de la Jara, Gálvez, Los Navalmorales, Oropesa, Talavera de la Reina, Toledo, Torrijos

Comunidad Autónoma de Castilla y León:

Province of Salamanca

Province of Ávila, the following districts: Ávila, Arenas de San Pedro, Candeleda, Cebrero, El Barco de Ávila, El Barraco, Navaluenga, Navarredonda de Gredos, Piedrahíta, San Pedro del Arroyo, Sotillo de la Adrada

Province of Zamora, the following districts: Alcañices, Bermillo de Sayago Puebla de Sanabria

Communidad Autónoma de Extremadura

Communidad Autónoma de Galicia:

Province of Orense

Province of Pontevedra

Sarria, Chantada and Terra de Lemos-Quiroga in the Province of Lugo

Communidad Autónoma de Islas Baleares

Comunidad Autónoma de Madrid, the following districts:

Navalcarnero, San Martín de Valdeiglesias

21 February 2022’

---

| 2.6.2023 | EN | Official Journal of the European Union | L 143/116 |
| --- | --- | --- | --- |

2.6.2023

EN

Official Journal of the European Union

L 143/116

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/1072

of 1 June 2023

fixing the adjustment rate for direct payments pursuant to Regulation (EU) 2021/2116 of the European Parliament and of the Council in respect of the calendar year 2023

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2021/2116 of the European Parliament and of the Council of 2 December 2021 on the financing, management and monitoring of the common agricultural policy and repealing Regulation (EU) No 1306/2013 (1), and in particular Article 17(1), third subparagraph, thereof,

After consulting the Committee on the Agricultural Funds,

Whereas:

| (1) | Article 17(1), first subparagraph, of Regulation (EU) 2021/2116 provides that an adjustment rate for interventions in the form of direct payments referred to in Article 5(2), point (c), of that Regulation and for the specific measures referred to in Article 5(2), point (e), of that Regulation is to be determined where the forecasts for the financing of the interventions and measures financed under the corresponding sub-ceiling for a given budgetary year indicate that the applicable annual ceilings will be exceeded. |
| --- | --- |

(1)

Article 17(1), first subparagraph, of Regulation (EU) 2021/2116 provides that an adjustment rate for interventions in the form of direct payments referred to in Article 5(2), point (c), of that Regulation and for the specific measures referred to in Article 5(2), point (e), of that Regulation is to be determined where the forecasts for the financing of the interventions and measures financed under the corresponding sub-ceiling for a given budgetary year indicate that the applicable annual ceilings will be exceeded.

| (2) | Pursuant to Article 16(1) of Regulation (EU) 2021/2116 a Union agricultural reserve is to be established at the beginning of each year in the European Agricultural Guarantee Fund (EAGF). In accordance with Article 16(2), second subparagraph, of that Regulation, where available appropriations are not sufficient to fund the reserve up to the required amount, financial discipline may be used in accordance with Article 17 of that Regulation as a last resort to fund the reserve. |
| --- | --- |

(2)

Pursuant to Article 16(1) of Regulation (EU) 2021/2116 a Union agricultural reserve is to be established at the beginning of each year in the European Agricultural Guarantee Fund (EAGF). In accordance with Article 16(2), second subparagraph, of that Regulation, where available appropriations are not sufficient to fund the reserve up to the required amount, financial discipline may be used in accordance with Article 17 of that Regulation as a last resort to fund the reserve.

| (3) | The forecasts for the direct payments and market related expenditure determined in the Commission draft budget for 2024 indicate that there is currently no need for financial discipline. There is however great uncertainty as regards the future needs for support from the agricultural reserve in view of the consequences for the agri-food sector of Russia’s invasion of Ukraine, and as regards the effects of the extraordinarily high level of inflation on the market related expenditure. In addition, new and significantly more flexible financial management rules have been introduced for direct payments as of 2023, which adds to the uncertainties of estimating the level of budget execution for the financial year 2024. |
| --- | --- |

(3)

The forecasts for the direct payments and market related expenditure determined in the Commission draft budget for 2024 indicate that there is currently no need for financial discipline. There is however great uncertainty as regards the future needs for support from the agricultural reserve in view of the consequences for the agri-food sector of Russia’s invasion of Ukraine, and as regards the effects of the extraordinarily high level of inflation on the market related expenditure. In addition, new and significantly more flexible financial management rules have been introduced for direct payments as of 2023, which adds to the uncertainties of estimating the level of budget execution for the financial year 2024.

| (4) | In accordance with Article 17(1), third subparagraph, of Regulation (EU) 2021/2116, the adjustment rate is to be fixed by 30 June of the calendar year in respect of which the adjustment rate applies. In accordance with Article 17(2) of that Regulation, the adjustment rate may be adapted on the basis of new information until 1 December of the same calendar year. Adapting of the rate based on new information is however only possible if a rate has been fixed by 30 June. |
| --- | --- |

(4)

In accordance with Article 17(1), third subparagraph, of Regulation (EU) 2021/2116, the adjustment rate is to be fixed by 30 June of the calendar year in respect of which the adjustment rate applies. In accordance with Article 17(2) of that Regulation, the adjustment rate may be adapted on the basis of new information until 1 December of the same calendar year. Adapting of the rate based on new information is however only possible if a rate has been fixed by 30 June.

| (5) | In view of the uncertainties related to the budgetary forecasts and in order to maintain the possibility of adapting the adjustment rate until 1 December 2023 to ensure respect of the annual ceilings and additional funding for the agricultural reserve, should any of the two become necessary, it is considered appropriate to fix an adjustment rate of 0 % for the calendar year 2023. |
| --- | --- |

(5)

In view of the uncertainties related to the budgetary forecasts and in order to maintain the possibility of adapting the adjustment rate until 1 December 2023 to ensure respect of the annual ceilings and additional funding for the agricultural reserve, should any of the two become necessary, it is considered appropriate to fix an adjustment rate of 0 % for the calendar year 2023.

| (6) | Article 17(1), second subparagraph, of Regulation (EU) 2021/2116 provides that the adjustment rate is to apply, for the corresponding calendar year, to payments exceeding EUR 2 000 to be granted to farmers for interventions in the form of direct payments referred to in Article 5(2), point (c), of that Regulation and for the specific measures referred to in Article 5(2), point (e), of that Regulation. |
| --- | --- |

(6)

Article 17(1), second subparagraph, of Regulation (EU) 2021/2116 provides that the adjustment rate is to apply, for the corresponding calendar year, to payments exceeding EUR 2 000 to be granted to farmers for interventions in the form of direct payments referred to in Article 5(2), point (c), of that Regulation and for the specific measures referred to in Article 5(2), point (e), of that Regulation.

| (7) | As a general rule, farmers submitting an aid application for direct payments for one calendar year (N) are paid within a fixed payment period falling within the financial year (N+1). However, Member States may make late payments to farmers beyond that payment period, within certain limits. Such late payments may be made in a subsequent financial year. When financial discipline is applied for a given calendar year, the adjustment rate should not be applied to payments for which aid applications have been submitted in calendar years other than the calendar year for which the financial discipline applies. Therefore, to ensure equal treatment of farmers, it is appropriate to provide that the adjustment rate is to be applied only to payments for which aid applications have been submitted in the calendar year for which the financial discipline is applied, irrespective of when the payment to farmers is made, |
| --- | --- |

(7)

As a general rule, farmers submitting an aid application for direct payments for one calendar year (N) are paid within a fixed payment period falling within the financial year (N+1). However, Member States may make late payments to farmers beyond that payment period, within certain limits. Such late payments may be made in a subsequent financial year. When financial discipline is applied for a given calendar year, the adjustment rate should not be applied to payments for which aid applications have been submitted in calendar years other than the calendar year for which the financial discipline applies. Therefore, to ensure equal treatment of farmers, it is appropriate to provide that the adjustment rate is to be applied only to payments for which aid applications have been submitted in the calendar year for which the financial discipline is applied, irrespective of when the payment to farmers is made,

HAS ADOPTED THIS REGULATION:

Article 1

For the purpose of fixing the adjustment rate in accordance with Article 17 of Regulation (EU) 2021/2116, the payments to be granted to farmers for interventions in the form of direct payments referred to in Article 5(2), point (c), of that Regulation and for the specific measures referred to in Article 5(2), point (e), of that Regulation exceeding EUR 2 000 for an aid application submitted in respect of the calendar year 2023 shall be reduced by an adjustment rate of 0 %.

Article 2

This Regulation shall enter into force on the seventh 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, 1 June 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 435, 6.12.2021, p. 187.

1

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| 2.6.2023 | EN | Official Journal of the European Union | L 143/118 |
| --- | --- | --- | --- |

2.6.2023

EN

Official Journal of the European Union

L 143/118

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/1073

of 1 June 2023

granting a Union authorisation for the single biocidal product ‘Spray On wipes’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5), first subparagraph, thereof,

Whereas:

| (1) | On 23 April 2019, Laboratorium Dr Deppe GmbH submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for Union authorisation of the same single biocidal product, as referred to in Article 1 of that Regulation, named ‘Spray On wipes’, of product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-VA051119-47 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference biocidal product family ‘Knieler & Team Propanol Family’, recorded in the Register under case number BC-AQ050985-22. |
| --- | --- |

(1)

On 23 April 2019, Laboratorium Dr Deppe GmbH submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for Union authorisation of the same single biocidal product, as referred to in Article 1 of that Regulation, named ‘Spray On wipes’, of product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-VA051119-47 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference biocidal product family ‘Knieler & Team Propanol Family’, recorded in the Register under case number BC-AQ050985-22.

| (2) | The same single biocidal product ‘Spray On wipes’ contains propan-1-ol and propan-2-ol as the active substances, which are included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 4. |
| --- | --- |

(2)

The same single biocidal product ‘Spray On wipes’ contains propan-1-ol and propan-2-ol as the active substances, which are included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 4.

| (3) | On 8 December 2021, the Agency submitted to the Commission an opinion (3) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘Spray On wipes’ in accordance with Article 6 of Implementing Regulation (EU) No 414/2013. |
| --- | --- |

(3)

On 8 December 2021, the Agency submitted to the Commission an opinion (3) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘Spray On wipes’ in accordance with Article 6 of Implementing Regulation (EU) No 414/2013.

| (4) | The opinion concludes that the proposed differences between the same single biocidal product and the related reference biocidal product are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 (4), and that based on the assessment of the related reference biocidal product family ‘Knieler & Team Propanol Family’ and subject to compliance with the draft SPC, the same single biocidal product meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012. |
| --- | --- |

(4)

The opinion concludes that the proposed differences between the same single biocidal product and the related reference biocidal product are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 (4), and that based on the assessment of the related reference biocidal product family ‘Knieler & Team Propanol Family’ and subject to compliance with the draft SPC, the same single biocidal product meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012.

| (5) | On 20 October 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. |
| --- | --- |

(5)

On 20 October 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

| (6) | The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same single biocidal product ‘Spray On wipes’. |
| --- | --- |

(6)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same single biocidal product ‘Spray On wipes’.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation with authorisation number EU-0027668-0000 is granted to Laboratorium Dr Deppe GmbH for the making available on the market and use of the same single biocidal product ‘Spray On wipes’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 22 June 2023 until 31 July 2032.

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, 1 June 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 167, 27.6.2012, p. 1.

1

(2)  Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4).

2

(3)  ECHA opinion for ‘Spray On wipes’, 8 December 2021, https://echa.europa.eu/opinions-on-union-authorisation

3

(4)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4).

4

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ANNEX

Summary of product characteristics for a biocidal product

Spray On wipes

Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Product type 4 – Food and feed area (Disinfectants)

Authorisation number: EU-0027668-0000

R4BP asset number: EU-0027668-0000

1.   ADMINISTRATIVE INFORMATION

1.1.   Trade name(s) of the product

| Trade name(s) | Spray On wipes
  MyClean DS Tücher plus
  MyClean DS Flow Pack plus
  MyClean DS Tücher basic
  MyClean DS Flow Pack basic
  Medizid Rapid Pro Desinfektionstücher
  Medizid Rapid QF Pro Flowpack
  Medizid Rapid Next Desinfektionstücher
  Medizid Rapid QF Next Flowpack
  Bavicid Wipe
  FAVORIT Wet Wipes Pro
  FAVORIT Wet Wipes Classic
  FAVORIT Wet Wipes Viruguard
  FAVORIT Wet Wipes Pure
  FAVORIT Wet Wipes Soft
  FAVORIT Wet Wipes Premium
  FAVORIT Wet Wipes zero
  FAVORIT Wet Wipes Quick
  FAVORIT Wet Wipes Maxi
  FAVORIT Wet Wipes Protect
  FAVORIT Wet Wipes universal
  FAVORIT Wet Wipes Basic
  FAVORIT Wet Wipes Basic QF
  Immix Clean Pro Wipes
  FAVORIT Wet Wipes Xtra |
| --- | --- |

Trade name(s)

Spray On wipes

MyClean DS Tücher plus

MyClean DS Flow Pack plus

MyClean DS Tücher basic

MyClean DS Flow Pack basic

Medizid Rapid Pro Desinfektionstücher

Medizid Rapid QF Pro Flowpack

Medizid Rapid Next Desinfektionstücher

Medizid Rapid QF Next Flowpack

Bavicid Wipe

FAVORIT Wet Wipes Pro

FAVORIT Wet Wipes Classic

FAVORIT Wet Wipes Viruguard

FAVORIT Wet Wipes Pure

FAVORIT Wet Wipes Soft

FAVORIT Wet Wipes Premium

FAVORIT Wet Wipes zero

FAVORIT Wet Wipes Quick

FAVORIT Wet Wipes Maxi

FAVORIT Wet Wipes Protect

FAVORIT Wet Wipes universal

FAVORIT Wet Wipes Basic

FAVORIT Wet Wipes Basic QF

Immix Clean Pro Wipes

FAVORIT Wet Wipes Xtra

1.2.   Authorisation holder

| Name and address of the authorisation holder | Name | Laboratorium Dr Deppe GmbH |
| --- | --- | --- |
| Address | Hooghe Weg 35, 47906 Kempen Germany |
| Authorisation number | EU-0027668-0000 |
| R4BP asset number | EU-0027668-0000 |
| Date of the authorisation | 22 June 2023 |
| Expiry date of the authorisation | 31.7.2032 |

Name and address of the authorisation holder

Name

Laboratorium Dr Deppe GmbH

Address

Hooghe Weg 35, 47906 Kempen Germany

Authorisation number

EU-0027668-0000

R4BP asset number

EU-0027668-0000

Date of the authorisation

22 June 2023

Expiry date of the authorisation

31.7.2032

1.3.   Manufacturer(s) of the product

| Name of manufacturer | Laboratorium Dr Deppe GmbH |
| --- | --- |
| Address of manufacturer | Hooghe Weg 35, 47906 Kempen Germany |
| Location of manufacturing sites | Laboratorium Dr Deppe GmbH, Hooghe Weg 35, 47906 Kempen Germany |

Name of manufacturer

Laboratorium Dr Deppe GmbH

Address of manufacturer

Hooghe Weg 35, 47906 Kempen Germany

Location of manufacturing sites

Laboratorium Dr Deppe GmbH, Hooghe Weg 35, 47906 Kempen Germany

1.4.   Manufacturer(s) of the active substance(s)

| Active substance | Propan-1-ol |
| --- | --- |
| Name of manufacturer | OQ Chemicals GmbH (formerly Oxea GmbH) |
| Address of manufacturer | Rheinpromenade 4a, 40789 Monheim am Rhein Germany |
| Location of manufacturing sites | OQ Chemicals Corperation (formerly Oxea Coperation), 2001 FM 3057 TX, 77414 Bay City United States |

Active substance

Propan-1-ol

Name of manufacturer

OQ Chemicals GmbH (formerly Oxea GmbH)

Address of manufacturer

Rheinpromenade 4a, 40789 Monheim am Rhein Germany

Location of manufacturing sites

OQ Chemicals Corperation (formerly Oxea Coperation), 2001 FM 3057 TX, 77414 Bay City United States

| Active substance | Propan-1-ol |
| --- | --- |
| Name of manufacturer | BASF SE |
| Address of manufacturer | Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany |
| Location of manufacturing sites | BASF SE, Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany |

Active substance

Propan-1-ol

Name of manufacturer

BASF SE

Address of manufacturer

Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany

Location of manufacturing sites

BASF SE, Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany

| Active substance | Propan-1-ol |
| --- | --- |
| Name of manufacturer | SASOL Chemie GmbH & Co. KG |
| Address of manufacturer | Secunda Chemical Operations, Sasol Place, 50 Katherine Street, 2090 Sandton South Africa |
| Location of manufacturing sites | Secunda Chemical Operations, PDP Kruger Street, 2302 Secunda South Africa |

Active substance

Propan-1-ol

Name of manufacturer

SASOL Chemie GmbH & Co. KG

Address of manufacturer

Secunda Chemical Operations, Sasol Place, 50 Katherine Street, 2090 Sandton South Africa

Location of manufacturing sites

Secunda Chemical Operations, PDP Kruger Street, 2302 Secunda South Africa

| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | Stockmeier Chemie GmbH & Co. KG |
| Address of manufacturer | Am Stadtholz 37, 33609 Bielefeld Germany |
| Location of manufacturing sites | INEOS Solvent Germany GmbH, Römerstrasse 733, 47443 Moers Germany |

Active substance

Propan-2-ol

Name of manufacturer

Stockmeier Chemie GmbH & Co. KG

Address of manufacturer

Am Stadtholz 37, 33609 Bielefeld Germany

Location of manufacturing sites

INEOS Solvent Germany GmbH, Römerstrasse 733, 47443 Moers Germany

| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | Brenntag GmbH |
| Address of manufacturer | Stinnes-Platz 1, 45472 Mülheim an der Ruhr Germany |
| Location of manufacturing sites | Shell Nederland Raffinaderij B.V., 3196 KK Rotterdam-Pernis Netherlands
  Exxon Mobil, LA 70805 Baton Rouge United States |

Active substance

Propan-2-ol

Name of manufacturer

Brenntag GmbH

Address of manufacturer

Stinnes-Platz 1, 45472 Mülheim an der Ruhr Germany

Location of manufacturing sites

Shell Nederland Raffinaderij B.V., 3196 KK Rotterdam-Pernis Netherlands

Exxon Mobil, LA 70805 Baton Rouge United States

2.   PRODUCT COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the product

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Propan-1-ol | | Active Substance | 71-23-8 | 200-746-9 | 14,925 |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 44,73 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-1-ol

Active Substance

71-23-8

200-746-9

14,925

Propan-2-ol

Active Substance

67-63-0

200-661-7

44,73

2.2.   Type of formulation

AL – Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS

| Hazard statements | Highly flammable liquid and vapour.
  Causes serious eye damage.
  May cause drowsiness or dizziness.
  Repeated exposure may cause skin dryness or cracking. |
| --- | --- |
| Precautionary statements | Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
  Keep container tightly closed.
  Avoid breathing vapours.
  Use only outdoors or in a well-ventilated area.
  IF INHALED:Remove person to fresh air and keep comfortable for breathing.
  IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
  Immediately call a POISON CENTER/doctor.
  Store in a well-ventilated place.Keep cool.
  Store locked up.
  Dispose of contents to an authorised waste collection point. |

Hazard statements

Highly flammable liquid and vapour.

Causes serious eye damage.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.

Keep container tightly closed.

Avoid breathing vapours.

Use only outdoors or in a well-ventilated area.

IF INHALED:Remove person to fresh air and keep comfortable for breathing.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER/doctor.

Store in a well-ventilated place.Keep cool.

Store locked up.

Dispose of contents to an authorised waste collection point.

4.   AUTHORISED USES(S)

4.1.   Use description

Table 1. Use # 1 – hard non-porous small surface disinfection RTU wipes

| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: no data
  Common name: Bacteria
  Development stage:
  Scientific name: no data
  Common name: Yeasts
  Development stage:
  Scientific name: no data
  Common name: Enveloped viruses
  Development stage: |
| Field(s) of use | Indoor
  Health care facilities and pharmaceutical and cosmetic industry, for example patient-near surrounding, working areas/desks, general equipment (excluding food contact surfaces): disinfection of small hard/non-porous surfaces
  For professional use only. |
| Application method(s) | Method: Manual application
  Detailed description:
  Ready-to-use disinfectant wipes at room temperature (20 ± 2 °C).
  The surface to be disinfected is wiped and wetted with a sufficient amount of the product, ensuring complete Coverage. |
| Application rate(s) and frequency | Application Rate: Minimum exposure time: for the control of bacteria, yeasts and enveloped viruses: 60 sec; Make the surface completely wet.
  Dilution (%): Ready-to-use product
  Number and timing of application:
  A reasonable frequency of disinfection in a patient’s room is 1-2 per day. Maximum number of applications is 6 per day. No safety intervals need to be considered between the application phases. |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | Flow-pack of polyethylene (PE) composite foil with high-density polyethylene (HDPE) Flap cover, containing 80 Cellulose wipes;
  Dispenser bag of PE composite foil, containing 70 Cellulose wipes used with dispenser box |

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: no data

Common name: Bacteria

Development stage:

Scientific name: no data

Common name: Yeasts

Development stage:

Scientific name: no data

Common name: Enveloped viruses

Development stage:

Field(s) of use

Indoor

Health care facilities and pharmaceutical and cosmetic industry, for example patient-near surrounding, working areas/desks, general equipment (excluding food contact surfaces): disinfection of small hard/non-porous surfaces

For professional use only.

Application method(s)

Method: Manual application

Detailed description:

Ready-to-use disinfectant wipes at room temperature (20 ± 2 °C).

The surface to be disinfected is wiped and wetted with a sufficient amount of the product, ensuring complete Coverage.

Application rate(s) and frequency

Application Rate: Minimum exposure time: for the control of bacteria, yeasts and enveloped viruses: 60 sec; Make the surface completely wet.

Dilution (%): Ready-to-use product

Number and timing of application:

A reasonable frequency of disinfection in a patient’s room is 1-2 per day. Maximum number of applications is 6 per day. No safety intervals need to be considered between the application phases.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Flow-pack of polyethylene (PE) composite foil with high-density polyethylene (HDPE) Flap cover, containing 80 Cellulose wipes;

Dispenser bag of PE composite foil, containing 70 Cellulose wipes used with dispenser box

4.1.1.   Use-specific instructions for use

Surfaces should always be visibly clean prior to disinfection. Maximum number of applications is 6 per day.

4.1.2.   Use-specific risk mitigation measures

See general directions for use

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use

4.2.   Use description

Table 2. Use # 2 – hard non-porous small surface disinfection RTU wipes

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: no data
  Common name: Bacteria
  Development stage:
  Scientific name: no data
  Common name: Yeasts
  Development stage: |
| Field(s) of use | Indoor
  Health care facilities and food industry, for example patient-near surrounding, food preparation and handling in kitchens/restaurants): disinfection of small hard/non-porous surfaces.
  For professional use only. |
| Application method(s) | Method: Manual application
  Detailed description:
  Ready-to-use disinfectant wipes at room temperature (20 ± 2 °C).
  The surface to be disinfected is wetted with a sufficient amount of the product by wiping, ensuring complete coverage. |
| Application rate(s) and frequency | Application Rate: Minimum exposure time: for the control of bacteria and yeasts at 20 °C: 60 sec; Make the surface completely wet.
  Dilution (%): Ready-to-use product
  Number and timing of application:
  The product can be used as often as necessary. A reasonable frequency of disinfection in kitchens is 1-2 per day. No safety intervals need to be considered between the application phases. |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | Flow-pack of polyethylene (PE) composite foil with high-density polyethylene (HDPE) Flap cover, containing 80 Cellulose wipes;
  Dispenser bag of PE composite foil, containing 70 Cellulose wipes used with dispenser box |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: no data

Common name: Bacteria

Development stage:

Scientific name: no data

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Health care facilities and food industry, for example patient-near surrounding, food preparation and handling in kitchens/restaurants): disinfection of small hard/non-porous surfaces.

For professional use only.

Application method(s)

Method: Manual application

Detailed description:

Ready-to-use disinfectant wipes at room temperature (20 ± 2 °C).

The surface to be disinfected is wetted with a sufficient amount of the product by wiping, ensuring complete coverage.

Application rate(s) and frequency

Application Rate: Minimum exposure time: for the control of bacteria and yeasts at 20 °C: 60 sec; Make the surface completely wet.

Dilution (%): Ready-to-use product

Number and timing of application:

The product can be used as often as necessary. A reasonable frequency of disinfection in kitchens is 1-2 per day. No safety intervals need to be considered between the application phases.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

Flow-pack of polyethylene (PE) composite foil with high-density polyethylene (HDPE) Flap cover, containing 80 Cellulose wipes;

Dispenser bag of PE composite foil, containing 70 Cellulose wipes used with dispenser box

4.2.1.   Use-specific instructions for use

Surfaces should always be visibly clean prior to disinfection.

4.2.2.   Use-specific risk mitigation measures

See general directions for use

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use

5.   GENERAL DIRECTIONS FOR USE (1)

5.1.   Instructions for use

For professional use only.

For wipes reseal the package after opening.

5.2.   Risk mitigation measures

Avoid contact with eyes.

Keep out of reach of children

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention if you feel unwell. If possible, show this sheet.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.

IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.

IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.

Information to Healthcare personnel/doctor:

The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.

Accidental release measures:Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames. No smoking.Prevent entry to sewers and public waters.Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local regulations.

5.4.   Instructions for safe disposal of the product and its packaging

Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior to disposal. When totally empty, containers are recyclable like any other packing.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months

Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.

Recommended storage temperature: 0 – 30 °C

Do not store at temperatures below 0 °C

Do not store near food, drink and animal feedingstuff. Keep away from combustible material.

6.   OTHER INFORMATION

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(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.

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DECISIONS

| 2.6.2023 | EN | Official Journal of the European Union | L 143/127 |
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2.6.2023

EN

Official Journal of the European Union

L 143/127

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COUNCIL DECISION (EU) 2023/1074

of 25 May 2023

authorising the opening of negotiations for a protocol between the European Union and the Republic of Kazakhstan amending the Enhanced Partnership and Cooperation Agreement between the European Union and its Member States, of the one part, and the Republic of Kazakhstan, of the other part, as regards the protection of geographical indications for agricultural products and foodstuffs, wines and spirits

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207(4), first subparagraph, in conjunction with Article 218(3) and (4) thereof,

Having regard to the recommendation from the European Commission,

Whereas:

| (1) | The Enhanced Partnership and Cooperation Agreement between the European Union and its Member States, of the one part, and the Republic of Kazakhstan, of the other part (‘the EPCA’) (1) was concluded on behalf of the Union by means of Council Decision (EU) 2020/244 (2) and entered fully into force on 1 March 2020. |
| --- | --- |

(1)

The Enhanced Partnership and Cooperation Agreement between the European Union and its Member States, of the one part, and the Republic of Kazakhstan, of the other part (‘the EPCA’) (1) was concluded on behalf of the Union by means of Council Decision (EU) 2020/244 (2) and entered fully into force on 1 March 2020.

| (2) | Title III (Trade and Business) of the EPCA, which includes the provisions on geographical indications, has been provisionally applied since 1 May 2016. |
| --- | --- |

(2)

Title III (Trade and Business) of the EPCA, which includes the provisions on geographical indications, has been provisionally applied since 1 May 2016.

| (3) | The EPCA obliges the Parties to commence negotiations with a view to concluding an agreement on the protection of geographical indications in their respective territories no later than seven years after the date on which Title III of the EPCA starts to apply. |
| --- | --- |

(3)

The EPCA obliges the Parties to commence negotiations with a view to concluding an agreement on the protection of geographical indications in their respective territories no later than seven years after the date on which Title III of the EPCA starts to apply.

| (4) | Negotiations should therefore be opened with a view to concluding a protocol between the European Union and the Republic of Kazakhstan amending the EPCA as regards the protection of geographical indications for agricultural products and foodstuffs, wines and spirits, |
| --- | --- |

(4)

Negotiations should therefore be opened with a view to concluding a protocol between the European Union and the Republic of Kazakhstan amending the EPCA as regards the protection of geographical indications for agricultural products and foodstuffs, wines and spirits,

HAS ADOPTED THIS DECISION:

Article 1

1.   The Commission is hereby authorised to open negotiations for a protocol between the European Union and the Republic of Kazakhstan amending the Enhanced Partnership and Cooperation Agreement between the European Union and its Member States, of the one part, and the Republic of Kazakhstan, of the other part, as regards the protection of geographical indications for agricultural products and foodstuffs, wines and spirits.

2.   The negotiations shall be conducted on the basis of the negotiating directives of the Council set out in the addendum to this Decision.

Article 2

The negotiations shall be conducted in consultation with the Trade Policy Committee.

Article 3

This Decision is addressed to the Commission.

Done at Brussels, 25 May 2023.

For the Council

The President

J. FORSELL

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(1)  OJ L 29, 4.2.2016, p. 3.

1

(2)  Council Decision (EU) 2020/244 of 20 January 2020 on the conclusion, on behalf of the Union, of the Enhanced Partnership and Cooperation Agreement between the European Union and its Member States, of the one part, and the Republic of Kazakhstan, of the other part (OJ L 52, 25.2.2020, p. 1).

2

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